WO2014151329A1 - Particles for aerosolizing apparatus - Google Patents

Particles for aerosolizing apparatus Download PDF

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Publication number
WO2014151329A1
WO2014151329A1 PCT/US2014/025481 US2014025481W WO2014151329A1 WO 2014151329 A1 WO2014151329 A1 WO 2014151329A1 US 2014025481 W US2014025481 W US 2014025481W WO 2014151329 A1 WO2014151329 A1 WO 2014151329A1
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WO
WIPO (PCT)
Prior art keywords
extract
powder
vitamin
compound
ingestible
Prior art date
Application number
PCT/US2014/025481
Other languages
French (fr)
Inventor
David A. Edwards
Cecily Lalor
Deen BHATTA
Anmol GIRI
John A. LAMPPA
Original Assignee
Aerodesigns, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Aerodesigns, Inc. filed Critical Aerodesigns, Inc.
Publication of WO2014151329A1 publication Critical patent/WO2014151329A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G1/00—Cocoa; Cocoa products, e.g. chocolate; Substitutes therefor
    • A23G1/30—Cocoa products, e.g. chocolate; Substitutes therefor
    • A23G1/56—Cocoa products, e.g. chocolate; Substitutes therefor making liquid products, e.g. for making chocolate milk drinks and the products for their preparation, pastes for spreading, milk crumb
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L27/00—Spices; Flavouring agents or condiments; Artificial sweetening agents; Table salts; Dietetic salt substitutes; Preparation or treatment thereof
    • A23L27/86—Addition of bitterness inhibitors
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15—Vitamins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/16—Inorganic salts, minerals or trace elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the invention relates generally to aerosolized products and apparatus for the containment, aerosolization, and/or delivery thereof.
  • Light, consumable particles can be drawn into a user's mouth for deposition on surfaces of the mouth for consumption through transdermal surfaces and/or through the digestive tract (e.g., ingestion via intake into the stomach and gastrointestinal tract by means of enteral administration).
  • ingestion via intake into the stomach and gastrointestinal tract by means of enteral administration e.g., ingestion via intake into the stomach and gastrointestinal tract by means of enteral administration.
  • consuming particles that are sufficiently light to be drawn into a user's mouth by inhalation one must address the risk of those particles reaching the back of the mouth or lungs and causing coughing or other adverse events, especially when the goal is, for example, to provide taste, nourishment, dietary supplementation, medicinal absorption, etc., involving the mouth, tongue, etc.
  • approaches to deliver materials to the mouth via the airborne route have largely (if not exclusively) focused on directed, non-breath-actuated delivery, where the force of the air current and size of the particles are such that particle trajectories are primarily limited to within the mouth.
  • Described herein are approaches by which a casual or forced breathing maneuver (such as normal inhalation) leads to the delivery of food, drink, vitamins, medication, and/or various other particles to the mouth. The transport of these particles occurs with the flowing air, to the back of the throat with limited delivery the throat and lungs.
  • Manufactured formulations using various powdered ingredients are developed allowing for the controlled inertia and gravitational influence of the consumable particles and therefore optimal oral delivery of powdered formulations.
  • Particles are delivered towards surfaces of the mouth, not reaching the back of the throat and lungs.
  • Formulations are described for a variety of payloads including, but not limited to, energy supplements, pharmaceutical compounds, over-the-counter pharmaceutical compounds, sleep-aid compounds, weight-loss compounds, nutraceuticals, antioxidants, and oral health compounds.
  • Particle size is extremely important to our delivery system, namely that the particles need to be small enough to remain airborne during casual breathing, but large enough to be directed and deposited primarily in the mouth while limiting throat and lung deposition.
  • Typical pathways of aerosol particles through an aerosolizing device and out of a corresponding mouthpiece are directed to varying degrees away from the back of the throat.
  • an ingestible powder for use in an aerosolizing delivery apparatus can be made of particles, at least of which about 50% have a volume median distribution between about 20 microns and about 220 microns.
  • the powder can be ingestible, and be made of one or more of the following: a flavoring agent, at least one dietary supplement, and at least one of an energy supplement, a
  • an oral health compound an over-the-counter pharmaceutical compound, a sleep-aid compound, a weight-loss compound, and an oral health compound.
  • the flavoring agent of the ingestible powder can be a masking agent, an artificial sweetener, a natural sweetener, a flavor compound, and/or an acidulant.
  • the ingestible powder further includes an antioxidant compound, for example a carotenoid, a flavonoid, an isoflavone, a tocopherol, a tocotrienol, lipoic acid, melatonin, superoxide dismutase, coenzyme Q10, alpha lipoic acid, vitamin A, chromium biotin, selenium and/or ascorbic acid.
  • an antioxidant compound for example a carotenoid, a flavonoid, an isoflavone, a tocopherol, a tocotrienol, lipoic acid, melatonin, superoxide dismutase, coenzyme Q10, alpha lipoic acid, vitamin A, chromium biotin, selenium and/or ascorbic acid.
  • the flavonoid the ingestible powder can be one or more of esveratrol, quercetin, rutin, catechin, proanthocyanidins, acai berry extract, raspberry extract, cranberry extract, pomegranate extract, plum extract, cherry extract and rosemary extract.
  • the carotenoid can be one or more of of alpha-carotene, beta- carotene, cryptoxanthin, lycopene, lutein and zeaxathin.
  • the isoflavone of the ingestible powder is one or more of genistein, daidzein, biochanin A, formononetin.
  • the ingestible powder the dietary supplement may be at least one of coenzyme Q 10, folic acid, NADH, vitamin A, vitamin Bl, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B8, vitamin B9, vitamin B12, inositol, vitamin C, vitamin D, vitamin D2, vitamin D3, vitamin E, pyroxidine HCL, niacin, niacinamide, pantothenic acid, thiamin, calcium, iron, magnesium, phosphorous, zinc, copper, biotin, chromium, selenium, niacin, pyridoxine, and cyanocobalamin and complexes thereof.
  • the dietary supplement can be botanical dietary supplement.
  • the dietary supplement can be a specialty
  • the energy supplement of the ingestible powder is at least one of American ginseng, Red ginseng, Siberian ginseng, maca, rhodiola, ginger, guarana, turmeric, acetyl-L-carnitine, L-carnitine, creatine, taurine, L-phenylalanine, L-arginine, tyrosine, acetyl-tyrosine, N-acetyl L-tyrosine, ginko biloba, yerba-mate, kola nut, gotu kola, maitake, cordyceps sinensis, guarana, acai-berry, L-theanine, caffeine, quercitine, synephrine, green tea extract, theophylline, epigallocatechin gallate (EGCG),capsaicin, bee pollen, alpha-lipoic acid, and 1,3 dimethylamylamine (geranium), D-rib
  • the weight-loss compound of the ingestible powder can be an appetite suppressant compound and/or a thermogenic compound.
  • the weight loss compound can be hoodia, chitosan, chromium picolinate, conjugated linoleic acid, glucomannan, green tea extract, guar gum, guarana, guggal, senna, ephedra, bitter orange, fucoxanthin, white bean extract, vitamin D, human chorionic gonadotropin, resveratrol, capsaicin, chia, hoodia, L- carnitine, raspberry ketones, banaba leaf, red clover, ginger, almonds, acai berry, flax seeds, leucine and/or lipodrene.
  • the sleep aid compound of the ingestible powder can be melatonin, 5-hydroxytryptophan, 5-hydroxytrypatmine, diphenhydramine, doxylamine, benzodiazepine, kava, serenite, chamomile, phenibut, catnip herb, chamomile, glycine, hops, L-theanine, L-tryptophan, glycine, GABA, and/or valerian.
  • the ingestible powder may further comprise an excipient, a plant oil extract, an enzyme, a hormone and a probiotic.
  • the pharmaceutical compound of the ingestible powder can be an anti-depressant compound, an anti-anxiety compound, antibiotic compound, an allergy medicine, an/or an anti-inflammatory compound.
  • the oral health compound can be fluoride, vitamin C, vitamin B, zinc, menthol, thymol, eucaleptic, sodium bicarbonate, vitamin K, chlorhexidine, and/or xylitol.
  • embodiments of the ingestible powder include: an energy supplement, a dietary supplement, a flavoring agent, and sodium bicarbonate; wherein a mean size of particles of the ingestible powder is greater than 10 microns and less than 500 microns.
  • the ingestible powder also includes an energy supplement; a dietary supplement; and a flavoring agent, wherein a mean size of particles of the ingestible powder is between 18 and 70 microns.
  • Some embodiments of the ingestible powder includes citric acid.
  • the ingestible powder contains more citric acid than sodium bicarbonate, particularly wherein the weight ratio of citric acid to sodium bicarbonate is between 45 to 38 and 1 to 1.
  • the flavoring agent comprises thaumatin and stevia.
  • the weight ratio of thamatin to stevia is between 11 to 4 and 9 to 6.
  • the weight ratio of the energy supplement to thaumatin and stevia combined is between 25 to 220 and 90 to 17.
  • the flavoring agent of the ingestible powder is a natural flavoring agent.
  • the dietary supplement comprises at least one of niacin, pyridoxine, and cyanocobalamin.
  • the mean size of particles of the ingestible powder is between 18 and 70 microns.
  • an ingestible powder for use in an aerosolizing delivery apparatus comprises particles, at least of which about 50% have a volume median distribution between about 20 microns and about 220 microns; and the ingestible powder comprises at least one flavoring agent; and an oral health compound.
  • the ingestible powder comprises xylitol powder, spearmint powder, menthol crystals, and sodium bicarbonate powder.
  • the ingestible powder comprises about 75% xylitol by weight, about 22% spearmint powder by weight, about 1.5% menthol crystals by weight, and about 1.5% sodium bicarbonate powder by weight.
  • Embodiments can include one or more of the described features, alone or in combination. Brief Description of Drawings
  • Figure 1 is a graph from a HELOS-RODOS particle size analysis of crushed and sieved mint leaves.
  • Figure 2 is a graph from a HELOS-RODOS particle size analysis of a sample apple flavored energy supplement powder.
  • Figure 3 is a graph from a HELOS RODOS particle size analysis of a sample vitamin dietary supplement powder.
  • Figure 4 is a graph from a HELOS-RODOS particle size analysis of two sample flavored-chocolate powders.
  • the approach presented herein is based, at least in part, on the realization of a new form of ingestible particles and methods and apparatus for the delivery thereof. More specifically, the approach is directed to aerosolizable, dry powder products for use in aerosolizing apparatuses used to deliver powder formulations to the mouth. Exemplary devices for use with the embodiments of the present invention are described in, for example, Patent application # PCT/US2008/079214 and US Patent Application 61/705,081 (both incorporated herein in their entirety).
  • Physical and chemical aspects of particles, specific particle ingredient combinations, ingredients and formulations are optimized for 1) use in aerosolizing apparatuses, resulting in minimal or no pulmonary delivery to the back of the mouth, onto tongue, palate, etc., and 2) payload performance characteristics (taste, solubility) for enhanced user experience.
  • a primary consideration for physical and performance aspects of the particles making up the payload and product formulations is particle size, distribution of particle sizes in a formulation, and population density of particle sizes in a formulation.
  • the aerosolized product should be of a pre-determined size, i.e., of sufficient size to limit entry into the respiratory tract but of small enough size to allow for suspension in the air.
  • particles should be greater than approximately 10 microns to prevent pulmonary delivery. Additionally, particles greater than about 500 microns generally do not have sufficient airborne suspension characteristics for use in an aerosolizing apparatus, and therefore are undesirable.
  • the particle size distribution of a particular formulation can effect: user experience, solubility of the powder when contacting tissue, flight performance, manufacturing tolerances, manufacturing processes, and/or segregation/settling of various components of the formulation. Therefore, optimal or preferred particle size ranges and distributions for one ingestible powder formula may differ from another formulation.
  • volume mean distribution size of the aerosolized food product is at least 1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 75, 80, 95, 100, 105, 1 10, 1 15, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195, 200, 205, 210, 215, 220, 225, 230, 235, 240, 245, 250, 255, 260, 265, 270, 275, 280, 285, 290, 295, 300, 325, 350, 375, 400, 425, 450, 475, or 500 microns.
  • the predetermined, volume mean distribution size of the aerosolized food product is less than 500, 450, 400, 350, 325, 300, 275, 250, 245, 240, 235, 230, 225, 220, 215, 210, 205, 200, 195, 190, 185, 180, 175, 150, 140, 130, 120, 1 10, 100, 90, 80, 70, 60, 50, 40, 30, 20, or 10 microns in size. Ranges intermediate to those recited above, e.g., about 50 microns to about 215 microns, are also intended to be part of this disclosure. For example, ranges of values using a combination of any of the above recited values as upper and/or lower limits are intended to be included.
  • a size range/distribution of the ingestible powder particles wherein 50%, 60%, 70%, 80%, 90%, 95% or higher of the particles of a specific formulation have a volume median distribution between 10 and 100 microns, between 20 and 100 microns, between 30 and 100 microns, between 40 and 100 microns, between 20 and 90 microns, between 20 and 80 microns, between 20 and 70 microns, between 20 and 60 microns, between 20 and 120 microns, between 30 and 120 microns, between 40 and 120 microns, between 50 and 120 microns, between 60 and 120 microns, between 40 and 140 microns, between 50 and 140 microns, between 60 and 140 microns, between 70 and 140 microns, between 80 and 140 microns, between 60 and 160 microns, between 70 and 160 microns, between 80 and 160 microns, between 90 and 160 microns, between 100 and 160 microns, between 80 and 180 microns, between 90 and 180 microns, between 10 and 100 micron
  • Figure 1 shows the density distribution and cumulative distribution of a volume mean diameter determination of ground mint leaves using a HELOS-RODOS particle sizing system.
  • minimum particle size is an important feature of the approach.
  • the food aerosol particles are designed to be substantially delivered and deposited into the mouth, for example by the forces of gravity or inertial impaction, but to not be easily delivered and deposited substantially further into the respiratory tract, for example the trachea or lungs. Such food particles would thus possess a size larger than that which focuses penetration into the lungs (i.e., larger than about 10 microns).
  • maximum particle size is an important feature of the approach.
  • the aerosol cloud must remain suspended in air for at least a brief time so that displacement into the mouth can occur.
  • the particles must not be so large such that they rapidly settle from the air. This will greatly depend on the force(s) and/or mechanism(s) by which the particles are held in the air (e.g., by "natural” forces alone, such as inertia, diffusion, etc., or by additional forces, such as an impeller, air currents, convection, etc.).
  • the particles should be less than about 500 microns, less than about 400 microns, less than about 300 microns under typical suspension forces and mechanisms.
  • the aerosol may be carried via inhaled air that flows all the way to the lungs (for example, like the inhalation a smoker may have, which carries air and smoke through/from the cigarette, into the lungs).
  • the aerosol may be carried via "sucked” air that "stops” in the mouth (more like the approach used with a typical straw and beverage, or with cigars). (In some cases, elements of both approaches may be suitable.)
  • This potential distinction may have important implications for an aerosolizable, ingestible powder. For example, in the case in which the particles are carried by air that continues directly to the lungs, preventing deposition of particles too far into the respiratory tract may significantly depend on the physical parameters of the particles. Preliminary tests have shown that the water-solubility of the dry powders used plays a role in the taste and potential coughing reflex resulting from intake of the aerosolized food product.
  • Powders of particles that tend to be more rapidly water- soluble for example, ground chocolate bars, or certain chocolate-based powders, give rise to a generally pleasing reaction upon contact of the particles with the tongue and other surfaces within the mouth.
  • ground chocolate bars for example, the effect is in some cases similar to that of sensing chocolate melt very rapidly in one's mouth.
  • Particles that are less water-soluble, such as certain ground-cocoa-based powder products tend to be considered harsher and more likely to elicit less pleasurable reactions, such as a dry-mouth sensation or coughing.
  • a combination of both kinds of powders, in varying proportions provides interesting flavor complexity.
  • solubility of particles may be enhanced by combining the target payload ingredient (for example, an energy supplement, a pharmaceutical compound, and over the counter compound, etc.) with excipients or penetration enhancers including, but not limited to, solubilizing agents such as sucrose, for example Tweens (polysorbates), and spans (sorbitan esters) in the final formulation.
  • solubilizing agents such as sucrose, for example Tweens (polysorbates), and spans (sorbitan esters) in the final formulation.
  • a particle size is associated with solubility, with larger size particles being less soluble than smaller size particles of the same formulation or ingredient compound, wherein the effective surface area of the final formulation product is maximized. Therefore, optimizing the solubility and/or performance of the payload is a function of balancing particle size, inherent solubility, and/or excipients added to the formulation.
  • Dry powder particles can be created through a number of different methods.
  • the ingredients of a formulation may be dehydrated.
  • the ingredient may be frozen first to facilitate subsequent grinding or chopping.
  • the ingredient may subsequently be ground to form particle products of the appropriate size. Grinding of the products can be performed by use of a mortar and pestle. Alternatively or in addition, products may be chopped, for example using a mechanical or electrical grinder, knives, etc. The resulting ground or chopped particles can subsequently be filtered through sieves (for example by hand, using an electrical or mechanical sieve shaker, by an air classification system, by a screening system, etc.) to achieve the appropriate particle size.
  • a powder mill grinds down larger particles into predefined sizes.
  • spray drying in which a mixture of water and the material to be dried is forced through a nozzle into a high-temperature drum, instantly evaporating the water droplets clinging to the material, may be utilized. Spray drying gives the most consistent desired particle size distribution and population density, increasing the output of particles having the desired performance characteristics.
  • the particles By designing a dry powder formulation that can be aerosolized (particles much larger than 500 microns fall quickly out of the air unless supported by an external force) and yet has sufficiently large particles (greater than approximately 1, 2, 3, 4, 5, 10, 15 or 20 microns) such that few or no particles enter the lungs on inspiration, our technology results in deposition and delivery into the mouth.
  • the particles would be designed (sized) such that, for example, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 95%, at least about 97%, or at least about 99% of the particles deposit in the mouth and do not extend further into the respiratory tract.
  • the design of the particles should also take into consideration reducing any tendency to cough, gag, or otherwise react unfavorably to the ingestible powder when aerosolized.
  • aerosolizable products e.g. food powders, dietary supplements, pharmaceuticals, etc.
  • aerosolizable, consumable product it may be desirable to increase or decrease the number (or mass) of particles of a first size range (representing a subset of the overall initial size distribution), relative to the number (or mass) of particles of a second size range (representing a subset of the overall initial size distribution).
  • the initial particle size distribution of a consumable, aerosolizable formulation or ingredient may not be desirable for a variety of reasons.
  • the formulation contains several different ingredients, which are mixed or otherwise combined together.
  • the ingredients may include naturally-occurring powders that already have a particular particle size distribution.
  • various ingredients may have different physical/chemical properties, such as different crystalline shapes and sizes, which naturally lend themselves to form particles of a certain size upon crushing, milling, atomization, or some other process by which they are made into powders.
  • Some ingredients may typically be used in applications where a particular size distribution is appropriate. For example, caffeine commercially available in particulate form typically has a median particle size of roughly 15-20 microns (e.g., about 18 microns).
  • Certain commercially-available vitamins in particulate form such as B vitamins (e.g., B3 as niacin, B6 as pyridoxine, or B 12 as cyanocobalamin), may also have a typical median particle size below a desirable range. This may also be the case for other ingredients, such as the sweeteners stevia and/or thaumatin. Any such "pre-existing" distributions may not be ideal for the aerosol product being prepared and its intended use. Compositions and methods have been discovered that can lead to substantially increased mean (or median) particle sizes of powders.
  • a consumable oil when added to certain powdered ingredients, has been found to play a role in shifting the particle size distribution "upward" (i.e., to larger values), and to play a role in reducing the number/mass of smaller particles relative to larger particles.
  • a hypothesis as to why this occurs is that smaller particles agglomerate onto each other, and/or into the oil, and/or onto larger particles, and/or "self-agglomerate," creating relatively stable larger particles.
  • sample powders prepared with consumable oils for modulating particle size distribution contained chocolate and sugar.
  • a flavoring agent was further incorporated (e.g., peppermint and cherry flavoring agents).
  • BFC001C sample cherry-chocolate flavored powder
  • BFC001P sample peppermint chocolate flavored powder
  • the original ingredients typically had an initial particle size distribution with a cumulative density distribution below a desired value (e.g., an overall mean or median particle size of less than about 5, 10, 15, 20, 25, 30, 40, 50, 75, 100, 125, 150, 175, 200, 225, 250, 275, 300 microns).
  • a consumable oil representing roughly 2% of the total formulation (e.g., about 0.5%, 1%, 2%, 3%, 4%, or 5%)
  • the cumulative density distribution at 10% was found to shift upward (increase) substantially (e.g., by about 1, 2, 3, 4, 5, or 10 microns, or more).
  • changing a consumable, aerosolizable product from a first size distribution to a second size distribution is done in a way that preserves (or enhances) useful or desirable qualities.
  • the water-solubility of a consumable aerosol product may impact its dissolution within the mouth (e.g., into saliva), the taste it elicits, the risk of coughing, etc.
  • Changing the particle size distribution should be done using a process that does not substantially interfere with or eliminate such properties or processes, and ideally enhances them.
  • caffeine commercially available in particulate form typically has a median particle size of roughly 15-20 microns (e.g., about 18 microns).
  • Certain commercially-available vitamins in particulate form such as B vitamins (e.g., B3 as niacin, B6 as pyridoxine, or B 12 as cyanocobalamin), may also have a typical median particle size below a desirable range. This may also be the case for other ingredients, such as the sweeteners stevia and/or thaumatin. Any such "preexisting" distributions may not be ideal for the aerosol product being prepared and its intended use. Compositions and methods have been discovered that can lead to substantially increased mean (or median) particle sizes of powders.
  • a consumable oil when added to certain powdered ingredients, has been found to play a role in shifting the particle size distribution "upward" (i.e., to larger values), and to play a role in reducing the number/mass of smaller particles relative to larger particles.
  • a hypothesis as to why this occurs is that smaller particles agglomerate onto each other, and/or into the oil, and/or onto larger particles, and/or "self-agglomerate," creating relatively stable larger particles.
  • Upon intake of such powders using an aerosol delivery device it was found that often the powder was less likely to hit the back of the throat and thus less likely to elicit an unpleasant sensation or coughing.
  • agglomeration methods commonly known and applied by those in the art may use any one or more consumable oils, including, but not limited to, Aloe Vera, Artichoke Oil, Black Currant Seed Oil 14% GLA, Black Currant Seed Oil 15% GLA, Borage Oil 20% GLA, Borage Oil 22% GLA, Boswellia Serrata Oil, CLA Conjugated Linolic Acid 75% min., Evening Primrose Oil 10% GLA, Evening Primrose Oil 9% GLA, Flax Seed Oil 50% ALA, Garlic Oil, Grape Seed Oil, Guggul Lipid Oil, Olive Leak Extract, Oregano Oil, Perilla Oil 60% ALA, Pumpkin Seed Oil, Pygeum Oil, Rosehip Oil, Rosemary Oil, Saw Palmetto Oil, Sterols, Tocotrienol Palm Oil, Walnut Oil, Wheat Germ Oil, Sesame Seed Oil, Dill Seed Oil, Clove Bud Oil, Ginger Root Oil, Cinnamon Leaf Oil, Fennel Seed Oil, Curcuma Longa Oil, Cummin
  • ingredients processed to a certain size may be further processed in combination with one or more additional ingredients.
  • a desired particle size, distribution and density can be acquired by, for example, agglomeration techniques as known to those in the art.
  • the resultant agglomerated heterogenous particle can be combined into a specific formulation using other homogenous or heterogenous particles acquired by milling, spray drying, or agglomeration, and combined in a batch process.
  • certain embodiments may use any one technique, or any combination of two or more particle production techniques, for the production of particles in the size distribution and population density desired.
  • agglomeration techniques can result in a subset of ingredients having the desired particle size, another agglomeration preparation can result in the remainder of ingredients having the desired particle size, and the two processed particles can be quantitatively combined in a batch process.
  • agglomerated particles can be combined with another preparation of other ingredients (spray dried, for example) to develop a final consumable product formulation.
  • Dry powder particles could be created from a single ingredient, such as chocolate, coffee, or truffles, or from a combination of ingredients.
  • chocolate chocolate bars, chocolate powder, cocoa powder, and other forms and varieties of foods derived from the cocoa plant may be used.
  • spices and other (natural or artificial) flavorings may be used alone or in combination with such food ingredients to create other tastes or sensations (e.g., natural or artificial chocolate, raspberry, mango, mint, vanilla, cinnamon, caramel, and/or coffee flavors).
  • the food product may be stored and/or contained in the form of a tablet or pill, in a blister pack, within a capsule, as simply a powder in ajar-like container, and/or in a tray, box, container, thermos, bottle, etc.
  • formulations of the payload have a pleasant flavor, deliver effectively a desired target payload to the consumer, have stability both with respect to ingredient flavoring and biological activity, and have commercial stability with respect to manufacturing, processing and commerce activity (e.g., warehousing and transport).
  • Ingredients are broadly considered as flavoring agents, dietary
  • supplements, and target payloads including, but not limited to, energy products, over- the-counter pharmaceuticals, prescription pharmaceuticals, antioxidants, sleep-aids, weight-loss products, nutraceuticals, oral health compounds, and novelty products. While some of the compounds included herein are included and described under one category, it is understood that, based on the ingredient function, individual ingredients can be included in more than one category.
  • Vitamin C is considered both a vitamin and an anti-oxidant
  • quercitin is considered an energy supplement as well as an anti-oxidant.
  • Embodiments of the present invention are drawn to formulations for the delivery of ingestable, aerosolizable powders with specific target payloads.
  • Formulations can vary substantially to optimize payload delivery and performance, such as solubility, user experience (e.g., a desired flavoring, minimizing bitterness or unpleasant tastes or odors), and target payload activity (e.g. combinations of ingredients to enhance a particular effect, for example as a sleep aid, an energy compound, or kinetics of absorption of a pharmaceutical product).
  • a target payload may have a particular flavoring agent (for example a sweetener) that another target payload (for example, an ingredient already providing sweetened experience to the user) would not require for palatable flavor, or would require in different concentrations for a pleasant consumption experience, and/or for the desired delivery and performance characteristics.
  • Flavoring agents as used herein, can include, but are not limited to, a masking agent, an artificial sweetener, a natural sweetener, a flavor compound, an acidulant, and combinations thereof.
  • masking agents are used to manage or deflect taste, odor, visual characteristics of the payload, alter the mouth feel of the delivered payload, and to generate certain sensory perceptions of the payload.
  • Certain embodiments of the masking agents contemplated in the present invention include, but are not limited to, B-cyclodextrin, glycyrrizin, polymers (methylcellulose, polyvinylpyrrolidone, hydroxymethylcellulose,
  • Natural and artificial sweeteners are generally used to sweeten the payload sensory perception, deflect sensory aspects away from an undesired perception to a desired sensory perception. Sweeteners can also be used as flavor enhancers.
  • the choice of sweetener can be part of the overall characteristics desired in the aerosolizable powder (performance, user perception, manufacturing and commerce requirements, etc).
  • Natural sweeteners are produced directly from natural products (plants), wherein artificial sweeteners are synthesized de novo or are modified natural sweeteners.
  • Natural and artificial flavors contemplated in the present invention include, but are not limited to, stevia rebaudioside A, glycyrrizin, thaumatin, sorbitol, erythritol, mannitol, monk fruit, pentadin, xylitol, brazen, sugar, dextrose, crystalline fructose, maltodextrin, trehalose, molasses, aspartame, aspartame acesulfame salt, neotame, acesulfame, saccharin, sucralose, neohesperidin dihydrochalcone, sodium, saccharin, cyclamates, alitame and dulcim.
  • Flavoring compounds may be used to give the formulation payload a taste preferred by the end user, increase or enhance particular flavors or the perception of flavors. Flavors choices can include any fruit or vegetable flavor, or any artificial flavor, to elicit a desired taste perception (sweet, sour, bitter, salty and/or umami, and associated food or flavoring, e.g. mint, taste), as well as herbal or plant flavors that can otherwise be considered non-food (eg. Cinnamon), such as coffee, chocolate, and other confectionary flavors. Other flavor compounds considered as a novelty flavoring, including beer and other alcoholic beverages, hemp, vomitus, and novel combinations of flavors (e.g., beer flavoring with caffeine).
  • Acidulants may be considered as additives or compounds that change or maintain the final product acidity or alkalinity.
  • Acidulants can be organic or mineral acids, bases, neutralizing agents or buffering agents.
  • Acidulants contemplated as embodiments in the present invention include, but are not limited to, citric acid, malic acid, lactic acid, glycolic acid, tartaric acid, fumaric acid, oxalacetic acid, succinic acid, lactoisocitric acid, shikmik acid, eulagic acid and/or glutamic acid.
  • Another embodiment may be sodium bicarbonate, also serving the dual role of providing an effervescence effect to the palate and/or tongue upon contact dissolution.
  • dietary supplements may be considered as vitamins and/or minerals taken in addition to naturally obtained vitamins/minerals in food. Dietary supplements are taken 1) to enhance the physical well-being or state of health of the end user, 2) as a health related supplement, or 3) as supplements required to enhance deficient vitamin/mineral states in the end user. Dietary supplements can also add to a higher quality or perceived quality of the health state of the end user.
  • dietary supplements include, but are not limited to, Ascorbic Acid (Vitamin C), B Vitamins, Biotin, Fat Soluble Vitamins, Folic Acid, HCA (Hydroxycitric Acid), Inositol, pyruvate, Mineral Ascorbates, Mixed
  • Niacin Vitamin B3
  • Orotic Acid PABA (Para-Aminobenzoic Acid)
  • Pantothenates Pantothenic Acid
  • Pantothenic Acid Vitamin B5
  • Pyridoxine Hydrochloride Vitamin B6
  • Riboflavin Vitamin B2
  • Synthetic Vitamins Thiamine (Vitamin Bl)
  • Vitamin A Vitamin D, Vitamin E, Vitamin F, Vitamin K, Vitamin Oils, Vitamin Premixes, Vitamin-Mineral Premixes, Water Soluble Vitamins, arsenic, boron, calcium, chloride, chromium, cobalt, copper, fluorine, iodine, iron, magnesium, manganese, molybdenum, nickel, phosphorous, potassium, selenium, silicon, sodium, strontium, sulfur, vanadium and zinc.
  • Target payloads are contemplated for which an end user will obtain a desired effect upon ingestion of the specific powder compound.
  • Target payloads broadly include, but not limited to, energy supplements, over-the-counter pharmaceuticals, prescription pharmaceuticals, antioxidants, sleep-aids, weight-loss products, nutraceuticals, oral health compounds, and novelty product compounds.
  • ingestible powdered formulations for the present invention include, but are not limited to, American ginseng, Red ginseng, Siberian ginseng, maca, rhodiola, ginger, guarana, turmeric, acetyl-L-carnitine, L- carnitine, creatine, taurine, L-phenylalanine, L-arginine, tyrosine, acetyl-tyrosine, N- acetyl L-tyrosine, ginko biloba, yerba-mate, kola nut, gotu kola, maitake, cordyceps sinensis, guarana, acai-berry, L-theanine, caffeine, quercitine, synephrine, green tea extract, theophylline, epigallocatechin gallate (EGCG), capsaicin, bee pollen, al
  • EGCG epigallocatechin gallate
  • Oral health compounds contribute to decreasing unwanted bacterial flora and/or covering up unwanted odors and/or flavors. Control of the unwanted flora decreases incidence of tooth decay, halitosis, and potentially contributes to long-term health benefits including incidence of heart disease.
  • oral health compounds for use in the present invention include, but are not limited to, fluoride, vitamin C, vitamin B, zinc, menthol, thymol, eucaleptic, sodium bicarbonate, vitamin K, chlorhexidine, and xylitol.
  • Weight loss compounds are commonly divided into groups categorized as appetite suppressants, acting to manipulate hormonal and chemical processes in the body that otherwise increase hunger and/or the sense of feeling satiated (e.g.
  • Weight loss compounds can be synthetic or natural.
  • weight loss compositions contemplated herein include, but are not limited to, hoodia, chitosan, chromium picolinate, conjugated linoleic acid, glucomannan, green tea extract, guar gum, guarana, guggal, senna, ephedra, bitter orange, fucoxanthin, white bean extract, vitamin D, human chorionic gonadotropin, resveratrol, capsaicin, chia, hoodia, L- carnitine, raspberry ketones, banaba leaf, red clover, ginger, almonds, acai berry, flax seeds, leucine and lipodrene.
  • sleep-aid compounds assist in slowing the metabolic resting rate of an individual to allow one to relax and gain more restful or longer sleep periods.
  • sleep aid compositions contemplated herein include, but are not limited to melatonin, 5-hydroxytryptophan, 5- hydroxytrypatmine, diphenhydramine, doxylamine, benzodiazepine, kava, serenite, chamomile, phenibut, catnip herb, chamomile, glycine, hops, L-theanine, L- tryptophan, glycine, GABA and valerian.
  • over-the-counter (OTC) and prescription are examples of over-the-counter (OTC) and prescription
  • (pharmaceutical) drugs include, but are not limited to, amikacin, gentamicin, kanamycin, neomycin, netilmicin, tobramycin, paromomycin, geldanamycin, herbimycin, loracarbef, ertapenem, doripenim, imipenem/cilastatin, meropenem, cefadroxil, cefazolin, cefalotin, cefalexin, cefaclor, cefamandole, cefoxitin, cefprozil, cefuroxime, cefixime, cefdinir, cefditoren, cefoperazone, cefotaxime, cefpodoxime, ceftazidime, ceftibuten, ceftizoxime, ceftriaxone, cefepime, ceftobiprole, teicoplanin, vancomycin, telavancin, clindamycin, lincomycin
  • pyrazinamide rifampicin, rifabutin, rifapentine, streptomycin, arsphenamine, chloramphenicol, fosfomycin, fusidic acid, linezolid, metronidazole, mupriocin, platensimycin, quinupristin/dalfopristin, rifaximin, thiamphenicol, tigecycline, tinidazole, Fluoxetine, sertraline, paroxetine, fluvoxamine, citalopram, escitalopram, mirtazapine, triazolam, quazepam, estazolam, temazepam, Zolpidem eszopiclone zalepon, Trazodone, Citalopram, escitalopram, desvenlafaxine, duloxetine, milnacipran, venlafaxine, tramadol, sibutramine, etoperidone,
  • clomipramine desipramine, dosulepin, doxepin, imipramine, iprindole, lofepramine, melitracen, nortriptyline, opipramol, protriptyline, trimipramine, amoxapine, maprotiline, mianserin, mirtazapine, isocarboxazid, moclobemide, phenelzine, selegiline, tranylcypromine, pirlindone, busipirone, tandospirone, aripiprazole, vilazodone, quetiapine, agomelatine, nefazodone, quetiapine, asenapine,
  • Various other compounds are contemplated for use as target payload ingredients in ingestable powder formulations.
  • antioxidants, hormones and other proteins, enzymes, amino acids, probiotics, etc. are desirable target payloads.
  • hormones are used for hormone replacement and supplementation.
  • Various hormones contemplated for use in the invention described herein include, but are not limited to, apidonectin, aldosterone, androgen, natriuretic peptide, 7-Keto-DHEA, Androstenedione, dihydroepiandrosterone (DHEA), Melatonin, Nor- Androstenedione, pregnenolone, progesterone, 19 Nor-4-
  • Androstendiol 19 Nor-4-Androstenedione, 19 Nor-5-Androstenediol, 19 or-5- Androstendione, 3-Indolebutyric Acid, 4 Androstendiol, 4 Androstendione, 6 Furfurylaminopurene, 6-Benzylaminopurine, calcitonin, Cortisol, erythropoietin, gonadotropin, human growth hormone (HGH), incretins, leptin, lutenizing hormone, orexin, parathyroid hormone, pregnenolone, progesterone, prolactin, relaxin, renin, testosterone, and vasopressin.
  • HGH human growth hormone
  • enzymes and amino acids include, but are not limited to, alpha galactosidase, amylase, bromelain, cellulase, papain, peptidase, protease, proteolytic enzymes, superoxide dismutase, trypsin, betaine, casein, glutamic Acid, L-alanine, L-arginine, L-cysteine, L-glutamine, L- glycine, L-histidine, L-isoleucine, L-leucine, L-lysine, L-methionine, L-ornithine, L- phenylalanine, L-proline, L-taurine, L-threonine, L-tryptophan, L-tyrosine, L-valine, N-acetly-L-cysteine, protein soluble soy, soy protein isolates, and whey protein isolates.
  • antioxidants for use in powder formulations include, but are not limited to, carotenoids, flavonoids, isoflavones, tocopherol, tocotrienol, lipoic acid, melatonin, superoxide dismutase, coenzyme Q10, alpha lipoic acid, vitamin A, chromium biotin, selenium and ascorbic acid.
  • carotenoids contemplated for use in the present invention include alpha-carotene, beta-carotene, cryptoxanthin, lycopene, lutein, zeaxathin, apocarotenal astaxanthin, canthaxanthin, lutein/lutein esters, etc.
  • flavonoid used in the formulations include esveratrol, quercetin, rutin, catechin, proanthocyanidins, acai berry extract, raspberry extract, cranberry extract, pomegranate extract, plum extract, cherry extract, rosemary extract, etc.
  • isoflavones are used, including, but not limited to, genistein, daidzein, biochanin A, and formononetin.
  • probiotics for use in the present invention include, but are not limited to, Bacillus coagulans GBI-30, 6086, Bifidobacterium animalis subsp. lactis BB-12, Bifidobacterium longum subsp.
  • infantis 35624 Lactobacillus acidophilus NCFM, Lactobacillus paracasei Stl 1 (or NCC2461), Lactobacillus johnsonii NCC533), Lactobacillus plantarum 299v, Lactobacillus reuteri ATCC 55730 ⁇ Lactobacillus reuteri SD21 12), Lactobacillus reuteri Protectis (DSM 17938, daughter strain of ATCC 55730), Saccharomyces boulardii, Lactobacillus rhamnosus GR-1 & Lactobacillus reuteri RC-14,
  • Plants and plant extracts can provide compositions for dietary supplements, energy products, antioxidants, sleep-aids, weight-loss products, nutraceuticals, oral health compounds, novelty products, etc. Such compositions may be categorized as botanical supplements and botanical extracts. Aqueous or oil based botanical supplements can be combined at low volume with powdered components and or be used in, for example, agglomeration processes.
  • botanical extracts and plant-based supplements include, but are not limited to, Acerola Extracts, Alfalfa, Blue Green algea, Aloe, Amla, Angelica Root, Bacopa Monnieri, Mucuna Pruriens, Anise Seed, Arnica, Artichoke, Ashwagandha, Astragalus, Ayurvedic Herbs, Barberry, Barley Grass,
  • Barley Sprout Extract Benzoin, Bilberry, Bioflavonoids, Bitter Melon, Bitter Orange, Black Cohosh, Black Currant, Black Walnut, Bladderwrack, Blue Cohosh, Blueberry, Boswellia, Brahmi, Broccoli, Burdock, Butcher's Broom, Calendula, Capsicum, Cascara Sagrada, Cat's Claw, Catnip herb, Cayenne, Celery Seed, Certified Organic Herbs, Chamomile, Chapparal, Chaste Berry, Chicory Root, Chinese Herbs,
  • Chlorella Chlorophyll, Citrus Aurantium, Cocoa, Coriander, Corn Silk, Cranberry, Curcuminoids, Damiana, Dandelion, Devil's Claw, Diosgenin, Dong Quai, Echinacea, Elderberry, Elecampane Root, Ephedra, Essential Oils, Eucalyptus, Evening Primrose, Eyebright, Fennel, Fenugreek, Feverfew, Flax Products, Garcinia, Cambogia, Garlic, Gentian, Ginger, Ginkgo, Biloba, Ginseng (American), Ginseng (Panax), Ginseng (Siberian), Goldenseal, Gotu Kola, Grape Seed Extract, Grape Skin Extract,
  • Grapefruit Seed Extract Green Food Products, Green Lipped Mussel Powder, Green Tea, Griffonia simplicifolia, Guarana, Guggul, Gymnema Sylvestre, Hawthorne, Herbal Extracts, Herbal Teas, Hops, Horehound, Horse Chestnut, Horsetail, Hysop, Ipriflavone, Jojoba Oil, Juniper Berries, Kava Kava, Kelp Extract, Kombucha, Kudzu, Larch, Lavender, Lemon Balm, Licorice Extract, Linden Flowers, Lobelia, Maca, Maitake Mushroom, Marshmallow, Milk Thistle, Molasses, Mushrooms, Neem, Nettle, Noni, Nopal, Oatstraw, Octacosanol, Olive Extract, Orange Peel Extract, Oregano Oil, Oregon Mountain Grape, Organic Sweeteners, Parsley, Passion Flower, Pau d'Arco, Pennyroyal, Peppermint, Pfaffia Paniculata, Pine Bark Extract, Piper Longum,
  • Cistanches Extract 5 1, Citrus Aurantium Extract 6%, Citrus Bioflavonoid Complex 13%, Citrus Peel Extract 5: 1, Clove Extract 5: 1, Clove Powder, Coca Extract 4: 1, Codonopsis Pilosula Extract 5: 1, Colostrum, Common Peony Extract 8: 1, Cordyceps Extract 7%, Cornsilk Extract 4: 1, Cornsilk Powder, Corydalis Extract 10: 1, Cranberry Extract 4: 1, Cranberry Powder, Curcumin Extract 95%, Cuscuta Extract 5: 1, Damiana Extract 4: 1, Damiana Leaves Powder, Dandelion Powder, Dandelion Root Extract 6: 1, Danshen Extract 80%, D-Calcium Pantothenate, Devil's Claw Extract 2.5%, Devil's Claw Extract 4: 1, Devil's Claw Root Powder, DHEA 99%, Diosgenin 95%, DL-Phenyl Alanine, DMAE Bitartrate, Dong Quai Extract 10: 1, Dong Quai Extract 4: 1, Dong Quai
  • Periwinkle Extract 4 1, Pharbitidis Extract 4: 1, Phosphatidyl Serine 20%, Pine Bark Extract 4: 1, Plantago Asiatica Leaf Extract 5: 1, Polygala Tenoifolia Extract 4: 1, Polygonum Extract, Polygonum Extract 4: 1, Pregnenolone 99%, Propolis Extract 3%, Pseudoginseng Extract, Psyllium extract 4: 1, Pumpkin Seed Extract 4: 1, Purple Willow Bark Extract 4: 1, Purslane Herb Extract 4: 1, Pygeum Extract 4: 1, Quercetin, Radish Extract 4: 1, Radix Isatidis Extract 4: 1, Radix Polygoni Extract 4: 1, Red Clover Extract 4: 1, Red Pepper Extract 4: 1, Red Yeast Rice, Red Yeast Rice Extract 10: 1, Red Yeast Rice Powder, Rehmannia Root Extract 4: 1, Reishi Mushroom Extract 4: 1, Rhodiola Rosea Extract 4: 1, Rhododendron Extract 4: 1, Rhododendron Powder, Rhubarb Extract 4: 1, Rhu
  • Mushroom Extract Siberian Ginseng Extract 0.8%, Siberian Ginseng Extract 4: 1, Siberian Ginseng Powder, Skullcap Extract 4: 1, Skullcap Extract 4: 1, Slippery Elm Powder, Sodium-Pyruvate 99%, Songaria Cynomorium Extract 4: 1, Songaricum Powder, Spirulina Powder, St. John's Wort Extract 0.3%, St. John's Wort Extract 4: 1, St. John's Wort Powder, Stanol 50%, Stephania Extract 4: 1, Stevia Extract 4: 1,
  • Nutraceuticals are generally thought of as food or food product that reportedly provides health and medical benefits, including the prevention and treatment of disease, and can be defined as a product isolated or purified from foods that is generally sold in medicinal forms not usually associated with food.
  • a nutraceutical may have a physiological benefit or provide protection against chronic disease.
  • Such products may range from isolated nutrients, dietary supplements and specific diets to genetically engineered foods, herbal products, and processed foods such as cereals, soups, and beverages.
  • nutraceuticals are used, including, but not limited to, 5-Hydroxytryptophan, Acetyl L-Carnitine, Alpha Lipoic Acid, Alpha-Ketoglutarates, Bee Products, Betaine Hydrochloride, Bovine Cartilage, Caffeine, Cetyl Myristoleate, Charcoal, Chitosan, Choline, Chondroitin Sulfate, Coenzyme Q10, Collagen, Colostrum, Creatine, Cyanocobalamin (Vitamin B12), DMAE, Fumaric Acid, Germanium Sesquioxide, Glandular Products, Glucosamine HCL, Glucosamine Sulfate, HMB (Hydroxyl Methyl Butyrate), Immunoglobulin (Immune System
  • Lactic Acid Lactic Acid
  • L-Carnitine Liver Products
  • Malic Acid Maltose-anhydrous
  • Mannose Mannose
  • MSM Other Carnitine Products
  • Phytosterols Picolinic Acid, Pyruvate, Red Yeast Extract, S-adenylmethionine (SAMe), Selenium Yeast, Shark Cartilage, Theobromine, Vanadyl Sulfate, Velvet Deer Antler, Yeast, ATP, Forskolin, Sterol Esters, Stanol Esters, Probiotics, Lactoferin, Lutein Esters, Zeaxanthin, Immunoglobulins, Ipriflavone, Isoflavones, Fructo-Oligo-Saccharides, Inulin,
  • Huperzine A Melatonin, Medicinal Mushrooms, Bile Products, Peptone Products, Glandular Products, Pancreatic Products, Thyroid Products, Ribose, Probiotics, oleo resins, Dill Seed oleo resin, Black Pepper oleo resin, and Capsicum oleoresin.
  • formulations may contain a processing aid, for example talc or Nu-FLOW® (Ribus, Inc. of St. Louis, MO) a synthetic aid with characteristics similar to silicon to allow for a desired flowability upon manufacturing and/or delivery during aerosolizing device actuation.
  • a processing aid for example talc or Nu-FLOW® (Ribus, Inc. of St. Louis, MO) a synthetic aid with characteristics similar to silicon to allow for a desired flowability upon manufacturing and/or delivery during aerosolizing device actuation.
  • Other excipients may include penetration enhancers and/or solubility agents including, but not limited to, tweens (polysorbates), spans (sorbitan esters), sodium lauryl sulfate and other surfactants.
  • component ingredients may serve to provide several functions.
  • certain botanical extracts and botanical products may have multiple functions (for example as a flavoring agent, dietary supplement, sleep aid and as an appetite suppressant).
  • synergistic interactions between and among ingredients in the formulations may provide advantages in taste, product performance, manufacturing and handling attributes.
  • formulations consider that taste, in addition to intended use or benefits of the product (providing energy/high caffeine, providing vitamins, providing flavor, etc.), as well as regulatory restrictions on the use of particular products in particular jurisdictions, all may contribute to the individual ingredient quantities and/or concentrations used.
  • Example 1 Oral hygiene/breath freshener, serving size 200 milligrams
  • Example 2 Oral hygiene/breath freshener, serving size 200 milligrams Ingredient List % w/w
  • Example 4 Oral hygiene/breath freshener, serving size 200 milligrams Ingredient List % w/w
  • Example 6 Novelty powder: Stout flavored beer, serving size 300 milligrams
  • Example 8 Sleep aid: Melatonin Formula (DS) serving size 300 mg
  • Example 9 Pharmaceutical compound: ciprofloxacin, serving size 500 milligrams
  • Example 10 OTC allergy pharmaceutical: Claritin, serving size 200 milligrams
  • Example 11 Diet aid: Hoodia, serving size 400 milligrams
  • Example 12 Vitamin/Mineral/Supplement Formula (a). 400 mg
  • Vitamin C (ascorbic acid) 25%
  • Vitamin E (12 mg, as dl alpha tocopherol, 63.8%) 3%
  • Vitamin B2 riboflavin 0.4% Vitamin A (beta carotene) 5000 IU(20%) 1%
  • Example 13 Vitamin/Mineral/SuDDlement Formula (b). 400 me
  • Vitamin C (ascorbic acid) 30%
  • Vitamin E (12 mg, as dl alpha tocopherol, 63.8%) 3%
  • Vitamin B2 (riboflavin) 0.4%
  • Vitamin A (beta carotene) 5000 IU(20%) 1%
  • Example 14 Vitamin/Mineral/SuDDlement Formula (c). 400 me
  • Vitamin E (12 mg, as dl alpha tocopherol, 63.8%) 3%
  • Vitamin B2 (riboflavin) 0.4%
  • Vitamin A (beta carotene) 5000 IU(20%) 1 % Lysine 8%
  • Example 15 Vitamin/Mineral/Supplement Formula (d). 400 mg
  • Vitamin E (12 mg, as dl alpha tocopherol, 63.8%) 3%
  • Vitamin B2 (riboflavin) 0.4%
  • Vitamin A (beta carotene) 5000 IU(20%) 1 %
  • Example 16 Vitamin/Mineral/SuDDlement Formula (e). 400 me
  • Vitamin C (ascorbic acid) 35%
  • Vitamin E (12 mg, as dl alpha tocopherol, 63.8%) 3%
  • Vitamin B2 (riboflavin) 0.4%
  • Vitamin A (beta carotene) 5000 IU(20%) 1%
  • Example 17 Enerev (caffeine) Formula (Grape). 300 me
  • Example 20 Energy (caffeine) Formula (Strawberry 2). 300 mg
  • Example 22 Energy (caffeine) Formula (Coffee). 300 mg
  • Example 23 Energy (caffeine) Formula (Watermelon 1). 300 mg
  • Example 24 Energy (caffeine) Formula (Watermelon 2). 300 mg Ingredient List % w/w
  • Example 25 Oral hygiene/breath freshener, serving size 300 milligrams Ingredient List % w/w

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Abstract

Formulations and particle size descriptions are provided for an ingestible powder for use in an aerosolizing delivery apparatus. Particle formulations are designed to be aerosolized for delivery to a user's mouth. Formulations are can be designed for optimal delivery and payload performance, flavoring, comfort and sensory experience to a recipient. Formulations are provided for energy supplements, pharmaceutical compounds, over-the-counter pharmaceutical compounds, sleep-aid compounds, weight-loss compounds, and oral health compounds.

Description

PARTICLES FOR AEROSOLIZING APPARATUS
Related Applications
This application claims the benefit of U.S. Patent Application No. 61/788,212 filed on March 15, 2013 and U.S. Patent Application No. 61/942,410, filed on February 20, 2014; the entire teachings of these applications are incorporated herein by reference.
Technical Field
The invention relates generally to aerosolized products and apparatus for the containment, aerosolization, and/or delivery thereof.
Background
Previous researchers have demonstrated that aerosolized particles can be delivered to various parts of the body. Certain designs for apparatus to delivery particles have been proposed. Certain particles and constituents have been proposed for particle formulations used in delivery apparatuses.
Summary
Light, consumable particles can be drawn into a user's mouth for deposition on surfaces of the mouth for consumption through transdermal surfaces and/or through the digestive tract (e.g., ingestion via intake into the stomach and gastrointestinal tract by means of enteral administration). However, when consuming particles that are sufficiently light to be drawn into a user's mouth by inhalation, one must address the risk of those particles reaching the back of the mouth or lungs and causing coughing or other adverse events, especially when the goal is, for example, to provide taste, nourishment, dietary supplementation, medicinal absorption, etc., involving the mouth, tongue, etc.
Therefore, approaches to deliver materials to the mouth via the airborne route have largely (if not exclusively) focused on directed, non-breath-actuated delivery, where the force of the air current and size of the particles are such that particle trajectories are primarily limited to within the mouth. Described herein are approaches by which a casual or forced breathing maneuver (such as normal inhalation) leads to the delivery of food, drink, vitamins, medication, and/or various other particles to the mouth. The transport of these particles occurs with the flowing air, to the back of the throat with limited delivery the throat and lungs. Manufactured formulations using various powdered ingredients are developed allowing for the controlled inertia and gravitational influence of the consumable particles and therefore optimal oral delivery of powdered formulations. Particles are delivered towards surfaces of the mouth, not reaching the back of the throat and lungs. Formulations are described for a variety of payloads including, but not limited to, energy supplements, pharmaceutical compounds, over-the-counter pharmaceutical compounds, sleep-aid compounds, weight-loss compounds, nutraceuticals, antioxidants, and oral health compounds.
Three important aspects of our approach include:
1. Particle size is extremely important to our delivery system, namely that the particles need to be small enough to remain airborne during casual breathing, but large enough to be directed and deposited primarily in the mouth while limiting throat and lung deposition.
2. Typical pathways of aerosol particles through an aerosolizing device and out of a corresponding mouthpiece are directed to varying degrees away from the back of the throat.
3. Solubility and other characteristics of particle payload formulation
enhance performance of the aerosolized payload for optimal delivery and activation.
The combination of appropriate particle size, payload characteristics and a device directed air pathway leads to particles being deposited primarily in the mouth, onto tongue, palate, etc., rather than at the back of the throat or further into the respiratory tract for optimal product performance.
In some embodiments, an ingestible powder for use in an aerosolizing delivery apparatus can be made of particles, at least of which about 50% have a volume median distribution between about 20 microns and about 220 microns. The powder can be ingestible, and be made of one or more of the following: a flavoring agent, at least one dietary supplement, and at least one of an energy supplement, a
pharmaceutical compound, an over-the-counter pharmaceutical compound, a sleep-aid compound, a weight-loss compound, and an oral health compound.
In some embodiments, the flavoring agent of the ingestible powder can be a masking agent, an artificial sweetener, a natural sweetener, a flavor compound, and/or an acidulant.
In some embodiments, the ingestible powder further includes an antioxidant compound, for example a carotenoid, a flavonoid, an isoflavone, a tocopherol, a tocotrienol, lipoic acid, melatonin, superoxide dismutase, coenzyme Q10, alpha lipoic acid, vitamin A, chromium biotin, selenium and/or ascorbic acid.
In certain embodiments, the flavonoid the ingestible powder can be one or more of esveratrol, quercetin, rutin, catechin, proanthocyanidins, acai berry extract, raspberry extract, cranberry extract, pomegranate extract, plum extract, cherry extract and rosemary extract. The carotenoid can be one or more of of alpha-carotene, beta- carotene, cryptoxanthin, lycopene, lutein and zeaxathin.
In certain embodiments the isoflavone of the ingestible powder is one or more of genistein, daidzein, biochanin A, formononetin.
In some embodiments the ingestible powder the dietary supplement may be at least one of coenzyme Q 10, folic acid, NADH, vitamin A, vitamin Bl, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B8, vitamin B9, vitamin B12, inositol, vitamin C, vitamin D, vitamin D2, vitamin D3, vitamin E, pyroxidine HCL, niacin, niacinamide, pantothenic acid, thiamin, calcium, iron, magnesium, phosphorous, zinc, copper, biotin, chromium, selenium, niacin, pyridoxine, and cyanocobalamin and complexes thereof.
In certain embodiments, the dietary supplement can be botanical dietary supplement.
In certain embodiments, the dietary supplement can be a specialty
nutraceutical compound.
In certain embodiments, the energy supplement of the ingestible powder is at least one of American ginseng, Red ginseng, Siberian ginseng, maca, rhodiola, ginger, guarana, turmeric, acetyl-L-carnitine, L-carnitine, creatine, taurine, L-phenylalanine, L-arginine, tyrosine, acetyl-tyrosine, N-acetyl L-tyrosine, ginko biloba, yerba-mate, kola nut, gotu kola, maitake, cordyceps sinensis, guarana, acai-berry, L-theanine, caffeine, quercitine, synephrine, green tea extract, theophylline, epigallocatechin gallate (EGCG),capsaicin, bee pollen, alpha-lipoic acid, and 1,3 dimethylamylamine (geranium), D-ribose, Fo-Ti, cha de bugre extract, and St. Johns wort.
In some embodiments, the weight-loss compound of the ingestible powder can be an appetite suppressant compound and/or a thermogenic compound.
In certain embodiments the weight loss compound can be hoodia, chitosan, chromium picolinate, conjugated linoleic acid, glucomannan, green tea extract, guar gum, guarana, guggal, senna, ephedra, bitter orange, fucoxanthin, white bean extract, vitamin D, human chorionic gonadotropin, resveratrol, capsaicin, chia, hoodia, L- carnitine, raspberry ketones, banaba leaf, red clover, ginger, almonds, acai berry, flax seeds, leucine and/or lipodrene.
In some embodiments, the sleep aid compound of the ingestible powder can be melatonin, 5-hydroxytryptophan, 5-hydroxytrypatmine, diphenhydramine, doxylamine, benzodiazepine, kava, serenite, chamomile, phenibut, catnip herb, chamomile, glycine, hops, L-theanine, L-tryptophan, glycine, GABA, and/or valerian.
In certain embodiments, the ingestible powder may further comprise an excipient, a plant oil extract, an enzyme, a hormone and a probiotic.
In certain embodiments, the pharmaceutical compound of the ingestible powder can be an anti-depressant compound, an anti-anxiety compound, antibiotic compound, an allergy medicine, an/or an anti-inflammatory compound.
In some embodiments of the ingestible powder, the oral health compound can be fluoride, vitamin C, vitamin B, zinc, menthol, thymol, eucaleptic, sodium bicarbonate, vitamin K, chlorhexidine, and/or xylitol.
In one aspect, embodiments of the ingestible powder include: an energy supplement, a dietary supplement, a flavoring agent, and sodium bicarbonate; wherein a mean size of particles of the ingestible powder is greater than 10 microns and less than 500 microns. In one aspect, the ingestible powder also includes an energy supplement; a dietary supplement; and a flavoring agent, wherein a mean size of particles of the ingestible powder is between 18 and 70 microns.
Some embodiments of the ingestible powder includes citric acid.
In some cases, the ingestible powder contains more citric acid than sodium bicarbonate, particularly wherein the weight ratio of citric acid to sodium bicarbonate is between 45 to 38 and 1 to 1.
In some embodiments, the flavoring agent comprises thaumatin and stevia.
In some cases, the weight ratio of thamatin to stevia is between 11 to 4 and 9 to 6.
In some cases, the weight ratio of the energy supplement to thaumatin and stevia combined is between 25 to 220 and 90 to 17.
In some embodiments the flavoring agent of the ingestible powder is a natural flavoring agent.
In some embodiments, of the ingestible powder, the dietary supplement comprises at least one of niacin, pyridoxine, and cyanocobalamin.
In some embodiments, the mean size of particles of the ingestible powder is between 18 and 70 microns.
In some embodiments, an ingestible powder for use in an aerosolizing delivery apparatus, comprises particles, at least of which about 50% have a volume median distribution between about 20 microns and about 220 microns; and the ingestible powder comprises at least one flavoring agent; and an oral health compound.
In some embodiments, the ingestible powder comprises xylitol powder, spearmint powder, menthol crystals, and sodium bicarbonate powder.
In some embodiments, the ingestible powder comprises about 75% xylitol by weight, about 22% spearmint powder by weight, about 1.5% menthol crystals by weight, and about 1.5% sodium bicarbonate powder by weight.
Embodiments can include one or more of the described features, alone or in combination. Brief Description of Drawings
Figure 1 is a graph from a HELOS-RODOS particle size analysis of crushed and sieved mint leaves.
Figure 2 is a graph from a HELOS-RODOS particle size analysis of a sample apple flavored energy supplement powder.
Figure 3 is a graph from a HELOS RODOS particle size analysis of a sample vitamin dietary supplement powder.
Figure 4 is a graph from a HELOS-RODOS particle size analysis of two sample flavored-chocolate powders.
Detailed Description
The approach presented herein is based, at least in part, on the realization of a new form of ingestible particles and methods and apparatus for the delivery thereof. More specifically, the approach is directed to aerosolizable, dry powder products for use in aerosolizing apparatuses used to deliver powder formulations to the mouth. Exemplary devices for use with the embodiments of the present invention are described in, for example, Patent application # PCT/US2008/079214 and US Patent Application 61/705,081 (both incorporated herein in their entirety).
Particle size
Physical and chemical aspects of particles, specific particle ingredient combinations, ingredients and formulations are optimized for 1) use in aerosolizing apparatuses, resulting in minimal or no pulmonary delivery to the back of the mouth, onto tongue, palate, etc., and 2) payload performance characteristics (taste, solubility) for enhanced user experience. A primary consideration for physical and performance aspects of the particles making up the payload and product formulations is particle size, distribution of particle sizes in a formulation, and population density of particle sizes in a formulation.
In some embodiments, the aerosolized product should be of a pre-determined size, i.e., of sufficient size to limit entry into the respiratory tract but of small enough size to allow for suspension in the air. Generally, particles should be greater than approximately 10 microns to prevent pulmonary delivery. Additionally, particles greater than about 500 microns generally do not have sufficient airborne suspension characteristics for use in an aerosolizing apparatus, and therefore are undesirable.
The particle size distribution of a particular formulation can effect: user experience, solubility of the powder when contacting tissue, flight performance, manufacturing tolerances, manufacturing processes, and/or segregation/settling of various components of the formulation. Therefore, optimal or preferred particle size ranges and distributions for one ingestible powder formula may differ from another formulation. In some embodiments, it may be desirable for specific formulations to have a high population density, for example greater than 50%, 60%, 70%, 80%, 90%, 95% or higher of particles having a volume median size within a narrow particle size distribution, for example below 100 and above 20 microns, below 90 and above 20 microns, below 80 and above 20 microns, below 70 and above 20 microns, below 60 and above 20 microns, below 50 and above 20 microns.
In some embodiments, volume mean distribution size of the aerosolized food product is at least 1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 75, 80, 95, 100, 105, 1 10, 1 15, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195, 200, 205, 210, 215, 220, 225, 230, 235, 240, 245, 250, 255, 260, 265, 270, 275, 280, 285, 290, 295, 300, 325, 350, 375, 400, 425, 450, 475, or 500 microns. In some embodiments, the predetermined, volume mean distribution size of the aerosolized food product is less than 500, 450, 400, 350, 325, 300, 275, 250, 245, 240, 235, 230, 225, 220, 215, 210, 205, 200, 195, 190, 185, 180, 175, 150, 140, 130, 120, 1 10, 100, 90, 80, 70, 60, 50, 40, 30, 20, or 10 microns in size. Ranges intermediate to those recited above, e.g., about 50 microns to about 215 microns, are also intended to be part of this disclosure. For example, ranges of values using a combination of any of the above recited values as upper and/or lower limits are intended to be included.
In certain embodiments are contemplated a size range/distribution of the ingestible powder particles wherein 50%, 60%, 70%, 80%, 90%, 95% or higher of the particles of a specific formulation have a volume median distribution between 10 and 100 microns, between 20 and 100 microns, between 30 and 100 microns, between 40 and 100 microns, between 20 and 90 microns, between 20 and 80 microns, between 20 and 70 microns, between 20 and 60 microns, between 20 and 120 microns, between 30 and 120 microns, between 40 and 120 microns, between 50 and 120 microns, between 60 and 120 microns, between 40 and 140 microns, between 50 and 140 microns, between 60 and 140 microns, between 70 and 140 microns, between 80 and 140 microns, between 60 and 160 microns, between 70 and 160 microns, between 80 and 160 microns, between 90 and 160 microns, between 100 and 160 microns, between 80 and 180 microns, between 90 and 180 microns, between 100 and 180 microns, between 110 and 180 microns, between 120 and 180 microns, between 100 and 200 microns, between 1 10 and 200 microns, between 120 and 200 microns, between 130 and 200 microns, between 140 and 200 microns, between 120 and 220 microns, between 130 and 220 microns, between 140 and 220 microns, between 150 and 220 microns, between 160 and 220 microns, between 140 and 240 microns, between 150 and 240 microns, between 160 and 240 microns, between 170 and 240 microns, between 180 and 240 microns, between 160 and 260 microns, between 170 and 260 microns, between 180 and 260 microns, between 190 and 260 microns, between 200 and 260 microns, between 180 and 280 microns, between 190 and 280 microns, between 200 and 280 microns, between 210 and 280 microns, between 220 and 280 microns, between 200 and 300 microns, between 210 and 300 microns, between 220 and 300 microns, between 230 and 300 microns, between 240 and 300 microns, between 200 and 300 microns, between 210 and 300 microns, between 220 and 300 microns, between 230 and 300 microns, between 240 and 300 microns.
Figure 1 shows the density distribution and cumulative distribution of a volume mean diameter determination of ground mint leaves using a HELOS-RODOS particle sizing system. These data show that, for this particular sample, roughly 87% of the particles are larger than about 10 microns, and that roughly 79% of the particles are larger than about 20 microns. These findings demonstrate that a dehydrated botanical product (mint leaves) can be made into aerosolized particles substantially of a size (e.g. between at least 18 and 70 microns) that would typically deposit into the mouth upon actuation of an aerosolizing device.
In a sample of particles whose mean is approximately in this range, a small or negligible fraction of particles is able to enter into the throat and lungs and yet a considerable fraction of particles remains suspended for at least 5 seconds after a single device actuation. This demonstrates that particles of a desired size and density distribution can be engineered for a particular product and desired performance.
Especially, but not exclusively, in some embodiments in which intake is by inhalation, minimum particle size is an important feature of the approach. The food aerosol particles are designed to be substantially delivered and deposited into the mouth, for example by the forces of gravity or inertial impaction, but to not be easily delivered and deposited substantially further into the respiratory tract, for example the trachea or lungs. Such food particles would thus possess a size larger than that which focuses penetration into the lungs (i.e., larger than about 10 microns).
Especially, but not exclusively, in embodiments in which intake is by displacement of the subject or of the aerosol (e.g., with an aerosol cloud), maximum particle size is an important feature of the approach. Indeed, the aerosol cloud must remain suspended in air for at least a brief time so that displacement into the mouth can occur. Thus the particles must not be so large such that they rapidly settle from the air. This will greatly depend on the force(s) and/or mechanism(s) by which the particles are held in the air (e.g., by "natural" forces alone, such as inertia, diffusion, etc., or by additional forces, such as an impeller, air currents, convection, etc.).
Accordingly, in some embodiments, the particles should be less than about 500 microns, less than about 400 microns, less than about 300 microns under typical suspension forces and mechanisms. In some cases, the aerosol may be carried via inhaled air that flows all the way to the lungs (for example, like the inhalation a smoker may have, which carries air and smoke through/from the cigarette, into the lungs).
In some cases, the aerosol may be carried via "sucked" air that "stops" in the mouth (more like the approach used with a typical straw and beverage, or with cigars). (In some cases, elements of both approaches may be suitable.) This potential distinction may have important implications for an aerosolizable, ingestible powder. For example, in the case in which the particles are carried by air that continues directly to the lungs, preventing deposition of particles too far into the respiratory tract may significantly depend on the physical parameters of the particles. Preliminary tests have shown that the water-solubility of the dry powders used plays a role in the taste and potential coughing reflex resulting from intake of the aerosolized food product. Powders of particles that tend to be more rapidly water- soluble, for example, ground chocolate bars, or certain chocolate-based powders, give rise to a generally pleasing reaction upon contact of the particles with the tongue and other surfaces within the mouth. In the case of ground chocolate bars, for example, the effect is in some cases similar to that of sensing chocolate melt very rapidly in one's mouth. Particles that are less water-soluble, such as certain ground-cocoa-based powder products, tend to be considered harsher and more likely to elicit less pleasurable reactions, such as a dry-mouth sensation or coughing. However, in some instances, a combination of both kinds of powders, in varying proportions, provides interesting flavor complexity.
In certain embodiments, solubility of particles may be enhanced by combining the target payload ingredient (for example, an energy supplement, a pharmaceutical compound, and over the counter compound, etc.) with excipients or penetration enhancers including, but not limited to, solubilizing agents such as sucrose, for example Tweens (polysorbates), and spans (sorbitan esters) in the final formulation. In certain embodiments, a particle size is associated with solubility, with larger size particles being less soluble than smaller size particles of the same formulation or ingredient compound, wherein the effective surface area of the final formulation product is maximized. Therefore, optimizing the solubility and/or performance of the payload is a function of balancing particle size, inherent solubility, and/or excipients added to the formulation.
Production of Consumable Aerosol Powders Products
Dry powder particles can be created through a number of different methods.
Initially, the ingredients of a formulation may be dehydrated. In some embodiments, where the ingredient is a more malleable or liquid based food, the ingredient may be frozen first to facilitate subsequent grinding or chopping. The ingredient may subsequently be ground to form particle products of the appropriate size. Grinding of the products can be performed by use of a mortar and pestle. Alternatively or in addition, products may be chopped, for example using a mechanical or electrical grinder, knives, etc. The resulting ground or chopped particles can subsequently be filtered through sieves (for example by hand, using an electrical or mechanical sieve shaker, by an air classification system, by a screening system, etc.) to achieve the appropriate particle size.
In some embodiments, a powder mill grinds down larger particles into predefined sizes.
In certain embodiments, spray drying, in which a mixture of water and the material to be dried is forced through a nozzle into a high-temperature drum, instantly evaporating the water droplets clinging to the material, may be utilized. Spray drying gives the most consistent desired particle size distribution and population density, increasing the output of particles having the desired performance characteristics.
These methods, in addition to others, would allow for the creation of specifically sized particles capable of being aerosolized, but large enough not to pass easily through the mouth and throat and continue into the respiratory tract.
By designing a dry powder formulation that can be aerosolized (particles much larger than 500 microns fall quickly out of the air unless supported by an external force) and yet has sufficiently large particles (greater than approximately 1, 2, 3, 4, 5, 10, 15 or 20 microns) such that few or no particles enter the lungs on inspiration, our technology results in deposition and delivery into the mouth. Ideally, the particles would be designed (sized) such that, for example, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 95%, at least about 97%, or at least about 99% of the particles deposit in the mouth and do not extend further into the respiratory tract. The design of the particles should also take into consideration reducing any tendency to cough, gag, or otherwise react unfavorably to the ingestible powder when aerosolized.
In the preparation of consumable, aerosolizable products (e.g. food powders, dietary supplements, pharmaceuticals, etc.) intended for use with aerosol delivery mechanisms, it may be desirable to modify the particle size distribution. In some cases, it may be desirable to increase the overall mean particle size of an
aerosolizable, consumable product. In some cases, it may be desirable to increase or decrease the number (or mass) of particles of a first size range (representing a subset of the overall initial size distribution), relative to the number (or mass) of particles of a second size range (representing a subset of the overall initial size distribution).
Specifically, in some embodiments, one may wish to significantly reduce the number/mass of "finer" particles relative to the number/mass of "larger" particles. Reducing the number/mass of finer particles is particularly relevant to applications in which an aerosol is brought into the body via the mouth, and in which it is intended that aerosol particles deposit substantially on surfaces of the mouth before reaching the back of the throat or further into the respiratory tract. This is particularly true when the original size distribution includes a substantial proportion of particles of a size that can conducive to respiratory penetration (e.g., particles of a size less than about 2, 5, 10, 15, or 20 microns).
The initial particle size distribution of a consumable, aerosolizable formulation or ingredient may not be desirable for a variety of reasons. In some cases, the formulation contains several different ingredients, which are mixed or otherwise combined together. The ingredients may include naturally-occurring powders that already have a particular particle size distribution. In some cases, various ingredients may have different physical/chemical properties, such as different crystalline shapes and sizes, which naturally lend themselves to form particles of a certain size upon crushing, milling, atomization, or some other process by which they are made into powders. Some ingredients may typically be used in applications where a particular size distribution is appropriate. For example, caffeine commercially available in particulate form typically has a median particle size of roughly 15-20 microns (e.g., about 18 microns). Certain commercially-available vitamins in particulate form, such as B vitamins (e.g., B3 as niacin, B6 as pyridoxine, or B 12 as cyanocobalamin), may also have a typical median particle size below a desirable range. This may also be the case for other ingredients, such as the sweeteners stevia and/or thaumatin. Any such "pre-existing" distributions may not be ideal for the aerosol product being prepared and its intended use. Compositions and methods have been discovered that can lead to substantially increased mean (or median) particle sizes of powders. A consumable oil, when added to certain powdered ingredients, has been found to play a role in shifting the particle size distribution "upward" (i.e., to larger values), and to play a role in reducing the number/mass of smaller particles relative to larger particles. A hypothesis as to why this occurs is that smaller particles agglomerate onto each other, and/or into the oil, and/or onto larger particles, and/or "self-agglomerate," creating relatively stable larger particles.
Upon intake of such powders using an aerosol delivery device, it was found that often the powder was less likely to hit the back of the throat and thus less likely to elicit an unpleasant sensation or coughing.
These concepts were applied to the preparation of a range of powders. As shown in Figure 2, in a sample "Apple Energy" powder comprising caffeine, vitamin B3, vitamin B6, and vitamin B12, it was found that a roughly 2% content of flavored oil shifted upward (increased) the cumulative density distribution at 10%, by about 3 microns. As shown in Figure 3, in a sample "Age Smart" powder comprising vitamin D and flavoring, it was found that a roughly 2.3% content of vegetable oil shifted upward (increased) the cumulative density distribution at 10%, by about 4 microns.
Other sample powders prepared with consumable oils for modulating particle size distribution contained chocolate and sugar. In some powders, a flavoring agent was further incorporated (e.g., peppermint and cherry flavoring agents). As shown in Figure 4, in sample cherry-chocolate flavored powder ("BFC001C") and sample peppermint chocolate flavored powder ("BFC001P"), it was found that a roughly 2% content of oil shifted upward (increased) the cumulative density distribution at 10%, by at least about 2 microns, for each of the two powders. In these sample powders, the original ingredients typically had an initial particle size distribution with a cumulative density distribution below a desired value (e.g., an overall mean or median particle size of less than about 5, 10, 15, 20, 25, 30, 40, 50, 75, 100, 125, 150, 175, 200, 225, 250, 275, 300 microns). By adding a consumable oil representing roughly 2% of the total formulation (e.g., about 0.5%, 1%, 2%, 3%, 4%, or 5%), the cumulative density distribution at 10% was found to shift upward (increase) substantially (e.g., by about 1, 2, 3, 4, 5, or 10 microns, or more).
In some embodiments, changing a consumable, aerosolizable product from a first size distribution to a second size distribution is done in a way that preserves (or enhances) useful or desirable qualities. For example, the water-solubility of a consumable aerosol product may impact its dissolution within the mouth (e.g., into saliva), the taste it elicits, the risk of coughing, etc. Changing the particle size distribution should be done using a process that does not substantially interfere with or eliminate such properties or processes, and ideally enhances them.
Some ingredients may typically be processed in a way that leads to a particular particle size distribution. For example, caffeine commercially available in particulate form typically has a median particle size of roughly 15-20 microns (e.g., about 18 microns). Certain commercially-available vitamins in particulate form, such as B vitamins (e.g., B3 as niacin, B6 as pyridoxine, or B 12 as cyanocobalamin), may also have a typical median particle size below a desirable range. This may also be the case for other ingredients, such as the sweeteners stevia and/or thaumatin. Any such "preexisting" distributions may not be ideal for the aerosol product being prepared and its intended use. Compositions and methods have been discovered that can lead to substantially increased mean (or median) particle sizes of powders.
A consumable oil, when added to certain powdered ingredients, has been found to play a role in shifting the particle size distribution "upward" (i.e., to larger values), and to play a role in reducing the number/mass of smaller particles relative to larger particles. A hypothesis as to why this occurs is that smaller particles agglomerate onto each other, and/or into the oil, and/or onto larger particles, and/or "self-agglomerate," creating relatively stable larger particles. Upon intake of such powders using an aerosol delivery device, it was found that often the powder was less likely to hit the back of the throat and thus less likely to elicit an unpleasant sensation or coughing.
In certain embodiments, agglomeration methods commonly known and applied by those in the art may use any one or more consumable oils, including, but not limited to, Aloe Vera, Artichoke Oil, Black Currant Seed Oil 14% GLA, Black Currant Seed Oil 15% GLA, Borage Oil 20% GLA, Borage Oil 22% GLA, Boswellia Serrata Oil, CLA Conjugated Linolic Acid 75% min., Evening Primrose Oil 10% GLA, Evening Primrose Oil 9% GLA, Flax Seed Oil 50% ALA, Garlic Oil, Grape Seed Oil, Guggul Lipid Oil, Olive Leak Extract, Oregano Oil, Perilla Oil 60% ALA, Pumpkin Seed Oil, Pygeum Oil, Rosehip Oil, Rosemary Oil, Saw Palmetto Oil, Sterols, Tocotrienol Palm Oil, Walnut Oil, Wheat Germ Oil, Sesame Seed Oil, Dill Seed Oil, Clove Bud Oil, Ginger Root Oil, Cinnamon Leaf Oil, Fennel Seed Oil, Curcuma Longa Oil, Cummin Seed Oil, Celery Seed Oil, Coriander Seed Oil, Red Rasberry Seed Oil, Cranberry Seed Oil, Blackberry Seed Oil, Cod Liver Oil
(2500A/250D), Fish Oil 30% EPA/20% DHA, Fish Oil Concentrated, Fish Oil
Deodorized, Marine Lipid Oil 18/12, Marine Lipid Oil 30/20, Marine Lipid Oil 36/24, Salmon Oil 18% EPA/12% DHA, Squalene Oil (Shark), Corn Oil, Vegetable Oil, Alpha Lipoic Acid, Cetyl Myristoleate CM , Coenzyme Q10, Lecithin, and/or Medium Chain Triglycerides MCT, naturally flavored Oils, and /or artificially flavored Oils. See, for example, U.S. Patent Application Serial # 61/643871 and U.S. Patent Application Serial # 61/643876, both incorporated herein in their entirety.
In certain embodiments, ingredients processed to a certain size may be further processed in combination with one or more additional ingredients. It is contemplated that a desired particle size, distribution and density can be acquired by, for example, agglomeration techniques as known to those in the art. The resultant agglomerated heterogenous particle can be combined into a specific formulation using other homogenous or heterogenous particles acquired by milling, spray drying, or agglomeration, and combined in a batch process. It is further contemplated that certain embodiments may use any one technique, or any combination of two or more particle production techniques, for the production of particles in the size distribution and population density desired. For example, agglomeration techniques can result in a subset of ingredients having the desired particle size, another agglomeration preparation can result in the remainder of ingredients having the desired particle size, and the two processed particles can be quantitatively combined in a batch process. Alternatively, agglomerated particles can be combined with another preparation of other ingredients (spray dried, for example) to develop a final consumable product formulation.
Dry powder particles could be created from a single ingredient, such as chocolate, coffee, or truffles, or from a combination of ingredients. In the case of chocolate, chocolate bars, chocolate powder, cocoa powder, and other forms and varieties of foods derived from the cocoa plant may be used. In addition, in some cases, spices and other (natural or artificial) flavorings may be used alone or in combination with such food ingredients to create other tastes or sensations (e.g., natural or artificial chocolate, raspberry, mango, mint, vanilla, cinnamon, caramel, and/or coffee flavors). Depending on the food product(s) and device(s) used, the food product may be stored and/or contained in the form of a tablet or pill, in a blister pack, within a capsule, as simply a powder in ajar-like container, and/or in a tray, box, container, thermos, bottle, etc.
Formulations
It is desirable that formulations of the payload have a pleasant flavor, deliver effectively a desired target payload to the consumer, have stability both with respect to ingredient flavoring and biological activity, and have commercial stability with respect to manufacturing, processing and commerce activity (e.g., warehousing and transport). Ingredients are broadly considered as flavoring agents, dietary
supplements, and target payloads including, but not limited to, energy products, over- the-counter pharmaceuticals, prescription pharmaceuticals, antioxidants, sleep-aids, weight-loss products, nutraceuticals, oral health compounds, and novelty products. While some of the compounds included herein are included and described under one category, it is understood that, based on the ingredient function, individual ingredients can be included in more than one category. For example, Vitamin C is considered both a vitamin and an anti-oxidant, or quercitin is considered an energy supplement as well as an anti-oxidant.
Flavoring agents.
Embodiments of the present invention are drawn to formulations for the delivery of ingestable, aerosolizable powders with specific target payloads.
Formulations can vary substantially to optimize payload delivery and performance, such as solubility, user experience (e.g., a desired flavoring, minimizing bitterness or unpleasant tastes or odors), and target payload activity (e.g. combinations of ingredients to enhance a particular effect, for example as a sleep aid, an energy compound, or kinetics of absorption of a pharmaceutical product). For example, a target payload may have a particular flavoring agent (for example a sweetener) that another target payload (for example, an ingredient already providing sweetened experience to the user) would not require for palatable flavor, or would require in different concentrations for a pleasant consumption experience, and/or for the desired delivery and performance characteristics. Flavoring agents, as used herein, can include, but are not limited to, a masking agent, an artificial sweetener, a natural sweetener, a flavor compound, an acidulant, and combinations thereof.
Generally, masking agents are used to manage or deflect taste, odor, visual characteristics of the payload, alter the mouth feel of the delivered payload, and to generate certain sensory perceptions of the payload.
Certain embodiments of the masking agents contemplated in the present invention include, but are not limited to, B-cyclodextrin, glycyrrizin, polymers (methylcellulose, polyvinylpyrrolidone, hydroxymethylcellulose,
carboxymethylcellulose, ethylmethylcellulose) vanilla, etc.
Natural and artificial sweeteners are generally used to sweeten the payload sensory perception, deflect sensory aspects away from an undesired perception to a desired sensory perception. Sweeteners can also be used as flavor enhancers.
Generally, for embodiments of the present invention, the choice of sweetener can be part of the overall characteristics desired in the aerosolizable powder (performance, user perception, manufacturing and commerce requirements, etc). Natural sweeteners are produced directly from natural products (plants), wherein artificial sweeteners are synthesized de novo or are modified natural sweeteners.
Certain embodiments of natural and artificial flavors contemplated in the present invention include, but are not limited to, stevia rebaudioside A, glycyrrizin, thaumatin, sorbitol, erythritol, mannitol, monk fruit, pentadin, xylitol, brazen, sugar, dextrose, crystalline fructose, maltodextrin, trehalose, molasses, aspartame, aspartame acesulfame salt, neotame, acesulfame, saccharin, sucralose, neohesperidin dihydrochalcone, sodium, saccharin, cyclamates, alitame and dulcim.
Flavoring compounds, as used herein, may be used to give the formulation payload a taste preferred by the end user, increase or enhance particular flavors or the perception of flavors. Flavors choices can include any fruit or vegetable flavor, or any artificial flavor, to elicit a desired taste perception (sweet, sour, bitter, salty and/or umami, and associated food or flavoring, e.g. mint, taste), as well as herbal or plant flavors that can otherwise be considered non-food (eg. Cinnamon), such as coffee, chocolate, and other confectionary flavors. Other flavor compounds considered as a novelty flavoring, including beer and other alcoholic beverages, hemp, vomitus, and novel combinations of flavors (e.g., beer flavoring with caffeine).
Acidulants, as used herein, may be considered as additives or compounds that change or maintain the final product acidity or alkalinity. Acidulants can be organic or mineral acids, bases, neutralizing agents or buffering agents.
Acidulants contemplated as embodiments in the present invention include, but are not limited to, citric acid, malic acid, lactic acid, glycolic acid, tartaric acid, fumaric acid, oxalacetic acid, succinic acid, lactoisocitric acid, shikmik acid, eulagic acid and/or glutamic acid. Another embodiment may be sodium bicarbonate, also serving the dual role of providing an effervescence effect to the palate and/or tongue upon contact dissolution.
Dietary supplements.
Generally, dietary supplements may be considered as vitamins and/or minerals taken in addition to naturally obtained vitamins/minerals in food. Dietary supplements are taken 1) to enhance the physical well-being or state of health of the end user, 2) as a health related supplement, or 3) as supplements required to enhance deficient vitamin/mineral states in the end user. Dietary supplements can also add to a higher quality or perceived quality of the health state of the end user.
In certain embodiments, dietary supplements include, but are not limited to, Ascorbic Acid (Vitamin C), B Vitamins, Biotin, Fat Soluble Vitamins, Folic Acid, HCA (Hydroxycitric Acid), Inositol, pyruvate, Mineral Ascorbates, Mixed
Tocopherols, Niacin (Vitamin B3), Orotic Acid, PABA (Para-Aminobenzoic Acid), Pantothenates, Pantothenic Acid (Vitamin B5), Pyridoxine Hydrochloride (Vitamin B6), Riboflavin (Vitamin B2), Synthetic Vitamins, Thiamine (Vitamin Bl),
Tocotrienols, Vitamin A, Vitamin D, Vitamin E, Vitamin F, Vitamin K, Vitamin Oils, Vitamin Premixes, Vitamin-Mineral Premixes, Water Soluble Vitamins, arsenic, boron, calcium, chloride, chromium, cobalt, copper, fluorine, iodine, iron, magnesium, manganese, molybdenum, nickel, phosphorous, potassium, selenium, silicon, sodium, strontium, sulfur, vanadium and zinc.
Target payloads
Target payloads are contemplated for which an end user will obtain a desired effect upon ingestion of the specific powder compound. Target payloads broadly include, but not limited to, energy supplements, over-the-counter pharmaceuticals, prescription pharmaceuticals, antioxidants, sleep-aids, weight-loss products, nutraceuticals, oral health compounds, and novelty product compounds.
Energy supplements for use as described herein are designed to boost mental or physical activity. Various embodiments of ingestible powdered formulations for the present invention include, but are not limited to, American ginseng, Red ginseng, Siberian ginseng, maca, rhodiola, ginger, guarana, turmeric, acetyl-L-carnitine, L- carnitine, creatine, taurine, L-phenylalanine, L-arginine, tyrosine, acetyl-tyrosine, N- acetyl L-tyrosine, ginko biloba, yerba-mate, kola nut, gotu kola, maitake, cordyceps sinensis, guarana, acai-berry, L-theanine, caffeine, quercitine, synephrine, green tea extract, theophylline, epigallocatechin gallate (EGCG), capsaicin, bee pollen, alpha- lipoic acid, and 1,3 dimethylamylamine (geranium), D-ribose, Fo-Ti, cha de bugre extract and St. Johns wort.
Oral health compounds contribute to decreasing unwanted bacterial flora and/or covering up unwanted odors and/or flavors. Control of the unwanted flora decreases incidence of tooth decay, halitosis, and potentially contributes to long-term health benefits including incidence of heart disease.
In certain embodiments, oral health compounds for use in the present invention include, but are not limited to, fluoride, vitamin C, vitamin B, zinc, menthol, thymol, eucaleptic, sodium bicarbonate, vitamin K, chlorhexidine, and xylitol.
Weight loss compounds are commonly divided into groups categorized as appetite suppressants, acting to manipulate hormonal and chemical processes in the body that otherwise increase hunger and/or the sense of feeling satiated (e.g.
anorectics such as epinephrine and norepinephrine/noradrenaline), fat or cholesterol uptake inhibitors (such as green tea extract), gastrointestinal fillers, and thermogeneic compounds which boost a normal metabolic rate of the individual and result in metabolism of fat stores, all of which are contemplated for use in the present invention. Weight loss compounds can be synthetic or natural.
In certain embodiments of the present invention, weight loss compositions contemplated herein include, but are not limited to, hoodia, chitosan, chromium picolinate, conjugated linoleic acid, glucomannan, green tea extract, guar gum, guarana, guggal, senna, ephedra, bitter orange, fucoxanthin, white bean extract, vitamin D, human chorionic gonadotropin, resveratrol, capsaicin, chia, hoodia, L- carnitine, raspberry ketones, banaba leaf, red clover, ginger, almonds, acai berry, flax seeds, leucine and lipodrene.
Sleep-aid compounds assist in slowing the metabolic resting rate of an individual to allow one to relax and gain more restful or longer sleep periods. In certain embodiments of the present invention, sleep aid compositions contemplated herein include, but are not limited to melatonin, 5-hydroxytryptophan, 5- hydroxytrypatmine, diphenhydramine, doxylamine, benzodiazepine, kava, serenite, chamomile, phenibut, catnip herb, chamomile, glycine, hops, L-theanine, L- tryptophan, glycine, GABA and valerian.
Various over the counter and prescription based (pharmaceutical) drugs are contemplated for easier ingestion, and in some instances a more pleasant taste is experienced by the user.
Additionally, because of the dispersion of the powder upon aersolization, increased kinetic and/or metabolic uptake may be experienced by the user owning to the greater surface area of the dosed compound. In many instances, for example during an allergic reaction, increased kinetics of drug activity may be desirable.
In certain embodiments, over-the-counter (OTC) and prescription
(pharmaceutical) drugs include, but are not limited to, amikacin, gentamicin, kanamycin, neomycin, netilmicin, tobramycin, paromomycin, geldanamycin, herbimycin, loracarbef, ertapenem, doripenim, imipenem/cilastatin, meropenem, cefadroxil, cefazolin, cefalotin, cefalexin, cefaclor, cefamandole, cefoxitin, cefprozil, cefuroxime, cefixime, cefdinir, cefditoren, cefoperazone, cefotaxime, cefpodoxime, ceftazidime, ceftibuten, ceftizoxime, ceftriaxone, cefepime, ceftobiprole, teicoplanin, vancomycin, telavancin, clindamycin, lincomycin, daptomycin, azithromycin, clarithromycin, dirithromycin, erythromycin, roxithromycin, troleandomycin, telithromycin, spectinomycin, aztreonam, furazolidone, nitrofurantoin, amoxicillin, ampicillin, azlocillin, carbenicillin, cloxacillin, dicloxacillin, flucloxacillin, mezlocillin, methicillin, nafcillin, oxacillin, penicillin, piperacillin, temocillin, ticarcillin, ciprofloxacin, enoxacin, gatifloxacin, levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, trovafloxacin, grepafloxacin, sparfloxacine, temafloxacin, mafenide, sulfonamidochrysoiodine, sulfacetamide, sulfadiazine, silver, sulfadiazine, sulfamethizole, sulfamethoxazole, sulfanilamide, sulfasalazine, sulfisoxazole, trimethoprim, trimethoprim-sulfamethoxazole, demeclocycline, doxycycline, minocycline, oxytetracycline, tetracycline, clofazimine, dapsone, capreomycin, cycloserine, ethambutol, ethionamide, isoniazid,
pyrazinamide, rifampicin, rifabutin, rifapentine, streptomycin, arsphenamine, chloramphenicol, fosfomycin, fusidic acid, linezolid, metronidazole, mupriocin, platensimycin, quinupristin/dalfopristin, rifaximin, thiamphenicol, tigecycline, tinidazole, Fluoxetine, sertraline, paroxetine, fluvoxamine, citalopram, escitalopram, mirtazapine, triazolam, quazepam, estazolam, temazepam, Zolpidem eszopiclone zalepon, Trazodone, Citalopram, escitalopram, desvenlafaxine, duloxetine, milnacipran, venlafaxine, tramadol, sibutramine, etoperidone, lubazodone, nefazodone, trazodone, reboxetine, viloxazine, atomoxetine, bupropion,
dexmethylphenidate, methylphenidate, amphetamine, dextroamphetamine, dextromethamphetamine, lisdexamfetamine, amitriptyline, butriptyline,
clomipramine, desipramine, dosulepin, doxepin, imipramine, iprindole, lofepramine, melitracen, nortriptyline, opipramol, protriptyline, trimipramine, amoxapine, maprotiline, mianserin, mirtazapine, isocarboxazid, moclobemide, phenelzine, selegiline, tranylcypromine, pirlindone, busipirone, tandospirone, aripiprazole, vilazodone, quetiapine, agomelatine, nefazodone, quetiapine, asenapine,
carbamazepine, lithium, olanzapine, valproic acid , alprazolam, lorazipam, chlordiazepoxide, clonazepam, etizolam, tofizopam, Azelastine, cetirizine, clemastine, desloratadine, dimenhydrinate, diphenhydramine, doxylamine, fexofenadine, loratadine (Claritin), ketorolac tromethamine, pemirolast potassium, ketotifen, neodocromil sodium, loteprednol etabonate, ipratropium bromide, beclomethasone, dexamethasone, epinastine, fluticasone, oxymetazoline, triamcinolone, cromolyn sodium, flunisolide, mometasone, ciclesonide,
carbinoxamine maleate, olopatadine, budesonide, montelukast, clemastine, epinephrine, fluticasone furoate and levocetirizine, Celecoxib (Celebrex), etodolac (Iodine), meloxicam (Mobic), rofecoxib (Vioxx), valdecoxib (Bextra), ibuprofen, naproxen, diclofenac, flurbiprofin, indomethacin, ketoprofen, ketorolac, nabumetone, oxaprozin, piroxicam, sulindac, Aspirin, Acetaminophen, Pseudoephedrine HC1, Dextromethorphan, Chlorpheniramine Maleate, Pseudoephedrine HC1,
Xylometazoline, Benzododecinium, Butamirate citrate, Clemastine,
diphenynhydramine citrate, diphenynhydramine, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Oxymetazoline hydrochloride, guaifenesin, ibuprofin, phenylephrin, Acid production control (omeprazole), laxative (loperimide) smoking (nicotine), Ezetimibe, Simvastatin, Eptifibatide, Sitagliptin, Metformin, Losartan Potassium, Hydrochlorothiazide, Finasteride, Enalapril maleate,
Hydrochlorothiazide, raltegravir, peginterferon alpha-2b, caspofungin acetate, imipenem and cilastatin sodium, ertapenem sodium, moxifloxacin, posaconazole, Indinavir sulfate, efavirenz, ribavirin USP, peginterferon alfa and ribavirin, rizatriptan benzoate, dorzolamide hydrochloride, Montelukast sodium, infliximab, mometasone furoate monohydrate, desloratadine, etoricoxib, mometasone furoate, golimumab, albuterol sulfate, mometasone furoate/formoterol fumarate, temozolomide, fosaprepitant dimeglumine, Interferon alfa-2b, Gardasil™ , ProQuad™, MMR II™, Varivax™, RotaTeq™, Pneumovax™, Zostavax™, alendronate sodium, etonogestrel/ethinyl estradiol, follitropin beta, etonogestrel, desogestrel, Zelephon, Zolpidem Tartrate, estazolam, flurazepam, temazepam, eszopiclone, zaleplon, Zolpidem, Ramelteon, amitriptyline, doxepin, mirtazipine and trazodone.
Various other compounds are contemplated for use as target payload ingredients in ingestable powder formulations. For example, antioxidants, hormones and other proteins, enzymes, amino acids, probiotics, etc., are desirable target payloads. In certain embodiments, hormones are used for hormone replacement and supplementation. Various hormones contemplated for use in the invention described herein include, but are not limited to, apidonectin, aldosterone, androgen, natriuretic peptide, 7-Keto-DHEA, Androstenedione, dihydroepiandrosterone (DHEA), Melatonin, Nor- Androstenedione, pregnenolone, progesterone, 19 Nor-4-
Androstendiol, 19 Nor-4-Androstenedione, 19 Nor-5-Androstenediol, 19 or-5- Androstendione, 3-Indolebutyric Acid, 4 Androstendiol, 4 Androstendione, 6 Furfurylaminopurene, 6-Benzylaminopurine, calcitonin, Cortisol, erythropoietin, gonadotropin, human growth hormone (HGH), incretins, leptin, lutenizing hormone, orexin, parathyroid hormone, pregnenolone, progesterone, prolactin, relaxin, renin, testosterone, and vasopressin.
In certain embodiments, enzymes and amino acids are contemplated, and include, but are not limited to, alpha galactosidase, amylase, bromelain, cellulase, papain, peptidase, protease, proteolytic enzymes, superoxide dismutase, trypsin, betaine, casein, glutamic Acid, L-alanine, L-arginine, L-cysteine, L-glutamine, L- glycine, L-histidine, L-isoleucine, L-leucine, L-lysine, L-methionine, L-ornithine, L- phenylalanine, L-proline, L-taurine, L-threonine, L-tryptophan, L-tyrosine, L-valine, N-acetly-L-cysteine, protein soluble soy, soy protein isolates, and whey protein isolates.
In certain embodiments, antioxidants for use in powder formulations include, but are not limited to, carotenoids, flavonoids, isoflavones, tocopherol, tocotrienol, lipoic acid, melatonin, superoxide dismutase, coenzyme Q10, alpha lipoic acid, vitamin A, chromium biotin, selenium and ascorbic acid.
In certain embodiments, carotenoids contemplated for use in the present invention include alpha-carotene, beta-carotene, cryptoxanthin, lycopene, lutein, zeaxathin, apocarotenal astaxanthin, canthaxanthin, lutein/lutein esters, etc.
In certain embodiments of the present invention, flavonoid used in the formulations include esveratrol, quercetin, rutin, catechin, proanthocyanidins, acai berry extract, raspberry extract, cranberry extract, pomegranate extract, plum extract, cherry extract, rosemary extract, etc. In certain embodiments, isoflavones are used, including, but not limited to, genistein, daidzein, biochanin A, and formononetin.
Further embodiments for formulations of dry powders include probiotics to reestablish healthy intestinal bacterial flora. In certain embodiments, probiotics for use in the present invention include, but are not limited to, Bacillus coagulans GBI-30, 6086, Bifidobacterium animalis subsp. lactis BB-12, Bifidobacterium longum subsp. infantis 35624, Lactobacillus acidophilus NCFM, Lactobacillus paracasei Stl 1 (or NCC2461), Lactobacillus johnsonii NCC533), Lactobacillus plantarum 299v, Lactobacillus reuteri ATCC 55730 {Lactobacillus reuteri SD21 12), Lactobacillus reuteri Protectis (DSM 17938, daughter strain of ATCC 55730), Saccharomyces boulardii, Lactobacillus rhamnosus GR-1 & Lactobacillus reuteri RC-14,
Lactobacillus acidophilus NCFM & Bifidobacterium bifidum BB-12, Lactobacillus acidophilus CL1285 & Lactobacillus casei LBC80R, Lactobacillus plantarum HEAL 9 & Lactobacillus paracasei 8700:2, Lactobacillus bulgaricus, Streptococcus thermophiles , and/or Bifidobacterium spp.
Plants and plant extracts can provide compositions for dietary supplements, energy products, antioxidants, sleep-aids, weight-loss products, nutraceuticals, oral health compounds, novelty products, etc. Such compositions may be categorized as botanical supplements and botanical extracts. Aqueous or oil based botanical supplements can be combined at low volume with powdered components and or be used in, for example, agglomeration processes.
In certain embodiments, botanical extracts and plant-based supplements include, but are not limited to, Acerola Extracts, Alfalfa, Blue Green algea, Aloe, Amla, Angelica Root, Bacopa Monnieri, Mucuna Pruriens, Anise Seed, Arnica, Artichoke, Ashwagandha, Astragalus, Ayurvedic Herbs, Barberry, Barley Grass,
Barley Sprout Extract, Benzoin, Bilberry, Bioflavonoids, Bitter Melon, Bitter Orange, Black Cohosh, Black Currant, Black Walnut, Bladderwrack, Blue Cohosh, Blueberry, Boswellia, Brahmi, Broccoli, Burdock, Butcher's Broom, Calendula, Capsicum, Cascara Sagrada, Cat's Claw, Catnip herb, Cayenne, Celery Seed, Certified Organic Herbs, Chamomile, Chapparal, Chaste Berry, Chicory Root, Chinese Herbs,
Chlorella, Chlorophyll, Citrus Aurantium, Cocoa, Coriander, Corn Silk, Cranberry, Curcuminoids, Damiana, Dandelion, Devil's Claw, Diosgenin, Dong Quai, Echinacea, Elderberry, Elecampane Root, Ephedra, Essential Oils, Eucalyptus, Evening Primrose, Eyebright, Fennel, Fenugreek, Feverfew, Flax Products, Garcinia, Cambogia, Garlic, Gentian, Ginger, Ginkgo, Biloba, Ginseng (American), Ginseng (Panax), Ginseng (Siberian), Goldenseal, Gotu Kola, Grape Seed Extract, Grape Skin Extract,
Grapefruit Seed Extract, Green Food Products, Green Lipped Mussel Powder, Green Tea, Griffonia simplicifolia, Guarana, Guggul, Gymnema Sylvestre, Hawthorne, Herbal Extracts, Herbal Teas, Hops, Horehound, Horse Chestnut, Horsetail, Hysop, Ipriflavone, Jojoba Oil, Juniper Berries, Kava Kava, Kelp Extract, Kombucha, Kudzu, Larch, Lavender, Lemon Balm, Licorice Extract, Linden Flowers, Lobelia, Maca, Maitake Mushroom, Marshmallow, Milk Thistle, Molasses, Mushrooms, Neem, Nettle, Noni, Nopal, Oatstraw, Octacosanol, Olive Extract, Orange Peel Extract, Oregano Oil, Oregon Mountain Grape, Organic Sweeteners, Parsley, Passion Flower, Pau d'Arco, Pennyroyal, Peppermint, Pfaffia Paniculata, Pine Bark Extract, Piper Longum, Pygeum Africanum, Quercitin, Raspberry Powder, Reishi Mushroom, Resveratrol Extract, Rhubarb Root, Rice Products, Rose Hips, Rosemary Extract, Sage, Sarsaparilla, Saw Palmetto, Schizandra, Seaweed extracts, Senna, Shatavari, Shiitake Mushroom, Silymarin, Skullcap, Slippery Elm, Soy Isoflavones, Soybean Products, Spirulina, St. John's Wort, Stevia, Summa, Tea Tree Oil, Terminalia ajruna, Tribulus terrestris, Triphala, Tumeric, Uva Ursi, Valerian Extract, Vegetable
Extracts, Vitex, Wheat Germ, White Willow Bark, Wild Cherry bark, Wild Yam, Witch Hazel, Wormwood, Yarrow, Yellow Dock, Yerba Sante, Yohimbine, Yucca, 20-ECD 7-9%, Acetyl L-Carnitine HC1 99%, 4-Androstenedione 99%, Adenophora Tetraohylla Ext 5: 1, Alisma Extract 10: 1, Alpha Lipoic Acid 99%, Angelica Root Extract, Arbutin 99%, Artemisia Extract 4: 1, Artichoke Extract 5%, Globe Asparagus Extract 4: 1, Asparagus Powder, Astragulus Extract 10: 1, Astragulus Extract 4: 1, Astragulus Extract 5: 1, Astragulus Root Extract 0.5%, Astragulus Root Powder, Atractylodes Extract 10: 1, Avena Sativa Extract 10: 1, Avena Sativa Extract 4: 1, Barbed Skullcap Extract 10: 1, Barberry Extract 10%, Bee Pollen Powder, Beta- Sisterol 35%, Bilberry Extract 10: 1, Bitter Melon Extract 8: 1, Black Cohosh Extract 2.5%, Black Cohosh Root Powder, Black Pepper Extract 4: 1, Black Soy Bean Extract 10: 1, Bone Powder, Boswellia Serrata Extract 65%, Broccoli Sprout Extract 10: 1, Buchu Leaf Powder, Buplerum (Chai Hu) Extract 5: 1, Burdock Root Extract 4: 1, Cabbage Extract 4: 1, Caffeine (Natural) 86-87%, Caffeine 99%, Calcium Citrate Granular 21%, Calcium-Pyruvate 99%, Carrot Root Extract 4: 1, Cassia Nomame Extract 4: 1, Catnip Extract 4: 1, Cat's Claw (Inner Bark), Powder Cauliflower Extract 4: 1, Celandine (Greater) Extract 4: 1, Celery Seed Extract, Cetyl Myristoleate 1 1%, Cetyl Myristoleate 20%, Chaenomeles Extract 4: 1, Chamomile Flower Extract 10: 1, Chamomile Flower Extract 4: 1, Chaste Tree Berry Extract 4: 1, Chitin Chitosan 80%, Chitosan 90%, Chondroitin Sulfate 90%, Chrysin 99%, Cinnamon Powder,
Cistanches Extract 5: 1, Citrus Aurantium Extract 6%, Citrus Bioflavonoid Complex 13%, Citrus Peel Extract 5: 1, Clove Extract 5: 1, Clove Powder, Coca Extract 4: 1, Codonopsis Pilosula Extract 5: 1, Colostrum, Common Peony Extract 8: 1, Cordyceps Extract 7%, Cornsilk Extract 4: 1, Cornsilk Powder, Corydalis Extract 10: 1, Cranberry Extract 4: 1, Cranberry Powder, Curcumin Extract 95%, Cuscuta Extract 5: 1, Damiana Extract 4: 1, Damiana Leaves Powder, Dandelion Powder, Dandelion Root Extract 6: 1, Danshen Extract 80%, D-Calcium Pantothenate, Devil's Claw Extract 2.5%, Devil's Claw Extract 4: 1, Devil's Claw Root Powder, DHEA 99%, Diosgenin 95%, DL-Phenyl Alanine, DMAE Bitartrate, Dong Quai Extract 10: 1, Dong Quai Extract 4: 1, Dong Quai Root Powder, D-Ribose, Echinacea Angustifolia Extract 4: 1, Echinacea Leaf Powder, Echinacea Purpurea Extract 10: 1, Echinacea Purpurea
Extract 4%, Echinacea Purpurea Extract 4: 1, Echinacea Purpurea Root Powder, Elder Flower Extract 4: 1, Elderberry Extract 20: 1, Elderberry Extract 4: 1, Epimedium Extract 10%, Epimedium Extract 10: 1, Epimedium Extract 4: 1, Epimedium Extract 5%, Epimedium Powder, Eucommia (Du Zhong) Extract 5: 1, Fennel Seed Extract 4: 1, Fennel Seed Powder, Fenugreek Extract 4: 1, Fenugreek Extract 6: 1, Feverfew Extract 5: 1, Fisetin, Fish Oil Powder, Forbidden Palace Flower Extract 5: 1, Forskolin 8%, Fo-Ti Extract 12: 1, Fo-Ti Extract 8: 1, Fo-Ti Powder, Gardenia Extract 8: 1, Garlic Extract 4: 1, Garlic Powder, Gentian Root Extract 6: 1, Ginger Extract 4: 1, Ginger Root Extract 5%, Ginger Root Powder, Ginkgo Biloba Extract 8: 1, Ginkgo Extract 24/6%, Ginkgo Extract 24/6% < 5, Ginkgo Extract 24/7%, Ginkgo Leaf Extract 4: 1, Ginkgo Leaf Powder, Ginseng (Korean) Powder, Ginseng (Panax) Extract 5%, Ginseng (Panax) Extract 8%, Ginseng (Panax) Extract 80%,
Glucomannans Konjac Powder, Glucosamine HC1 95%, Granulation Glucosamine HC1 99%, Glucsosamine Sulfate Potassium, Glucsosamine Sulfate Sodium 95%, Granulation Glucsosamine Sulfate Sodium 99%, Goldenrod Extract 4: 1, Goldenrod Powder, Goldenseal Root Extract 14%, Goldenseal Root Powder, Gotu Kola Extract 16%, Gotu Kola Extract 4: 1, Gotu Kola Extract 8: 1, Gotu Kola Powder, Grape Fruit Powder, Grape Seed, Grape Seed Extract 10: 1, Grape Seed Extract 20: 1, Grape Seed Extract 4: 1, Grape Seed Extract 5: 1, Grape Seed Extract 95%, Grape Seed Powder, Grape Skin Extract 20: 1, Grape Skin Extract 4: 1, Grass-Leaved Sweetflai Extract, Green Lip Mussel Extract, Green Tea Extract 30%, Green Tea Extract 4: 1, Green Tea Extract 95%, Guarana Seed Extract 10%, Guarana Seed Extract 22%, Guarana Seed Extract 25%, Guggul Extract 10%, Guggul Extract 2.5%, Gugulipid Extract 10%, Gymnema Sylvestre Extract 25%, Gymnema Sylvestre Powder, Hawthorne Berry Extract 4: 1, Hawthorne Berry Powder, Hawthorne Leaf Extract 2%, Hearbacious Peony Extract 5: 1, Hesperidin Extract 98%, Honeysuckle Herb Extract 4: 1, Hops
Flower Extract 4: 1, Horehound Extract 10: 1, Horehound Extract 4: 1, Horehound Herb Powder, Horse Chestnut Extract 20%, Horse Chestnut Extract 4: 1, Horse Chestnut Powder, Horsetail Extract 7%, Horsetail Powder, Houttuynia Cordata Extract 5: 1, Hydrangea Extract 8: 1, Hydroxy Apatite, Hyssop Extract 4: 1, Indole-3-Carbinol 99%, Isodon Glaucocalyx Extract 10: 1, Japanese Knotweed Extract, Jiaogulan Extract 4: 1, Jin Qian Cao Extract 4: 1, Jingjie Extract 4: 1, Jujube Fruits Extract 4: 1, Kava Kava Extract 30%, Kava Kava Powder, Kelp Extract 4: 1, Kelp Powder, Kidney Bean Extract 10: 1, Kidney Bean Pole 4: 1, Kidney Bean Pole 8: 1, Kidney Bean Powder, Kola Nut Extract 10%, Kudzu Extract 4: 1, Kudzu Extract 6: 1, Lettuce Extract 4: 1, L- Glutamine, L-Glycine, Licorice Extract 10%, Licorice Extract 5: 1, Licorice Powder, Lotus Leaf Powder, L-Tyrosine, Lycium Fruit Extract 4: 1, Lycium Fruit Extract 5: 1, Ma Huang Extract 6%>, Ma Huang Extract 8%>, Maca Extract 0.6%>, Maca Root Powder, Magnesium Stearate, Magnolia Bark Powder, Magnolia Officinal Extract 4: 1, Maca Extract 4: 1, Maitake Mushroom Extract 4: 1, Marigold Extract (Lutein 5%), Methozyisoflavone 99%, Methylsufonylmethane 99%, Milk Thistle Extract 4: 1, Milk Thistle Seed Extract 80% silymarin, Morinda Extract 5: 1, Motherwort Extract 4: 1, Motherwort Powder, Mucuna Pruriens Extract (15% L-Dopa), Muira Puama Extract 12: 1, Muira Puama Extract 4: 1, Muira Puama Powder, Mushroom Extract 10: 1 (feishi), Mustard Seed Extract 8: 1, Myrobalan Extract 4: 1, Myrrha Gum Extract 2.5%, N-Acetyl-D-Glucosamine, N-Acetyl-L-Cysteine, Nettle Extract 7%>, Nettle Leaf Extract 4: 1, Nettle Leaf Powder, Noni Powder, Olive Leaf Extract 18%, Olive Powder Orange Peel Extract 4: 1, Orange Peel Powder, Oroxylum Indicum Extract 4: 1, Oroxylum Indicum Powder, Oyster Meat Powder, Oyster Shell Powder, Papaya Fruit Extract 4: 1, Parsley Extract 10: 1, Parsley Extract 4: 1, Parsley Leaf Extract 4: 1, Parsley Powder, Passion Flower Extract 4: 1, Passion Flower Powder, Pau D'Arco Powder, Peppermint Extract 4: 1, Peppermint Powder, Perilla Seed Extract 4: 1,
Periwinkle Extract 4: 1, Pharbitidis Extract 4: 1, Phosphatidyl Serine 20%, Pine Bark Extract 4: 1, Plantago Asiatica Leaf Extract 5: 1, Polygala Tenoifolia Extract 4: 1, Polygonum Extract, Polygonum Extract 4: 1, Pregnenolone 99%, Propolis Extract 3%, Pseudoginseng Extract, Psyllium extract 4: 1, Pumpkin Seed Extract 4: 1, Purple Willow Bark Extract 4: 1, Purslane Herb Extract 4: 1, Pygeum Extract 4: 1, Quercetin, Radish Extract 4: 1, Radix Isatidis Extract 4: 1, Radix Polygoni Extract 4: 1, Red Clover Extract 4: 1, Red Pepper Extract 4: 1, Red Yeast Rice, Red Yeast Rice Extract 10: 1, Red Yeast Rice Powder, Rehmannia Root Extract 4: 1, Reishi Mushroom Extract 4: 1, Rhodiola Rosea Extract 4: 1, Rhododendron Extract 4: 1, Rhododendron Powder, Rhubarb Extract 4: 1, Rhubarb Root Powder, Riboflavin (B2), Rice Powder, Rosemary Extract 20%, Rumex Madaid Extract 4: 1, Salvia Extract 10: 1, Salvia Extract 4: 1, SAMe, Saw Palmetto Extract 25%, Saw Palmetto Extract 4: 1, Saw Palmetto Extract 45-50%, Saw Palmetto Oil 85-95%, Saw Palmetto Powder, Schizandra Extract 10: 1, Schizandra Extract 4: 1, Scopolia Acutangula Powder, Sea Cucumber Powder, Senna Leaf Powder, Sesame (Black) Seed Powder, Shark Cartilage Powder, Shitake
Mushroom Extract, Siberian Ginseng Extract 0.8%, Siberian Ginseng Extract 4: 1, Siberian Ginseng Powder, Skullcap Extract 4: 1, Skullcap Extract 4: 1, Slippery Elm Powder, Sodium-Pyruvate 99%, Songaria Cynomorium Extract 4: 1, Songaricum Powder, Spirulina Powder, St. John's Wort Extract 0.3%, St. John's Wort Extract 4: 1, St. John's Wort Powder, Stanol 50%, Stephania Extract 4: 1, Stevia Extract 4: 1,
Sulfate N+ Suma Root Extract 4: 1, Suma Root Powder, Taurine Powder, Thorowax Extract 4: 1, Tomato Extract, Tomato Extract (0.2% Lycopene), (trans)-Resveratrol 20-25%, Tribulus Extract 10: 1, Tribulus Extract 40%, Tribulus Powder, Trifal Extract 4: 1, Turmeric Extract 4: 1, Turmeric Root Powder, Uva Ursi Extract 4: 1, Uva Ursi Powder, Valerian Root Extract 0.8%, Valerian Root Extract 4: 1, Valerian Root Powder, Vinca Major Seed Extract 10: 1, White Wax Extract 4: 1, White Willow Bark 15% (total salicins), White Willow Bark 20%, White Willow Bark 25%, White Willow Bark Extract 4: 1, White Willow Bark Powder, Wild Yam Extract 10: 1, Wild Yam Extract 16%, Wild Yam Extract 4: 1, Wild Yam Extract 6%, Wild Yam Powder, Williams Elder Extract 4: 1, Wolfberry Fruit Extract 10: 1, Wolfiporia Extract 8: 1, Yellow Dock Root Extract 4: 1 , Yerba Mate Extract (2%> caffeine), Yerba Mate
Extract 4: 1, Yohimbe Bark Extract 15: 1, Yohimbe Bark Extract 2%, Yohimbe Bark Extract 3%, Yohimbe Bark Powder, and Yucca Extract 4: 1.
Nutraceuticals are generally thought of as food or food product that reportedly provides health and medical benefits, including the prevention and treatment of disease, and can be defined as a product isolated or purified from foods that is generally sold in medicinal forms not usually associated with food. A nutraceutical may have a physiological benefit or provide protection against chronic disease. Such products may range from isolated nutrients, dietary supplements and specific diets to genetically engineered foods, herbal products, and processed foods such as cereals, soups, and beverages. With recent developments in cellular-level nutraceutical agents, researchers, and medical practitioners are developing templates for integrating and assessing information from clinical studies on complementary and alternative therapies into responsible medical practice.
In certain embodiments, nutraceuticals are used, including, but not limited to, 5-Hydroxytryptophan, Acetyl L-Carnitine, Alpha Lipoic Acid, Alpha-Ketoglutarates, Bee Products, Betaine Hydrochloride, Bovine Cartilage, Caffeine, Cetyl Myristoleate, Charcoal, Chitosan, Choline, Chondroitin Sulfate, Coenzyme Q10, Collagen, Colostrum, Creatine, Cyanocobalamin (Vitamin B12), DMAE, Fumaric Acid, Germanium Sesquioxide, Glandular Products, Glucosamine HCL, Glucosamine Sulfate, HMB (Hydroxyl Methyl Butyrate), Immunoglobulin (Immune System
Support), Lactic Acid, L-Carnitine, Liver Products, Malic Acid, Maltose-anhydrous, Mannose (d-mannose), MSM, Other Carnitine Products, Phytosterols, Picolinic Acid, Pyruvate, Red Yeast Extract, S-adenylmethionine (SAMe), Selenium Yeast, Shark Cartilage, Theobromine, Vanadyl Sulfate, Velvet Deer Antler, Yeast, ATP, Forskolin, Sterol Esters, Stanol Esters, Probiotics, Lactoferin, Lutein Esters, Zeaxanthin, Immunoglobulins, Ipriflavone, Isoflavones, Fructo-Oligo-Saccharides, Inulin,
Huperzine A, Melatonin, Medicinal Mushrooms, Bile Products, Peptone Products, Glandular Products, Pancreatic Products, Thyroid Products, Ribose, Probiotics, oleo resins, Dill Seed oleo resin, Black Pepper oleo resin, and Capsicum oleoresin.
In other powder embodiments, formulations may contain a processing aid, for example talc or Nu-FLOW® (Ribus, Inc. of St. Louis, MO) a synthetic aid with characteristics similar to silicon to allow for a desired flowability upon manufacturing and/or delivery during aerosolizing device actuation. Other excipients may include penetration enhancers and/or solubility agents including, but not limited to, tweens (polysorbates), spans (sorbitan esters), sodium lauryl sulfate and other surfactants.
For all formulations, component ingredients may serve to provide several functions. For example, certain botanical extracts and botanical products may have multiple functions (for example as a flavoring agent, dietary supplement, sleep aid and as an appetite suppressant). It is further understood that synergistic interactions between and among ingredients in the formulations may provide advantages in taste, product performance, manufacturing and handling attributes. Generally, formulations consider that taste, in addition to intended use or benefits of the product (providing energy/high caffeine, providing vitamins, providing flavor, etc.), as well as regulatory restrictions on the use of particular products in particular jurisdictions, all may contribute to the individual ingredient quantities and/or concentrations used.
The examples below are provided herein for illustrative purposes and are not intended to be restrictive. Examples
Example 1 : Oral hygiene/breath freshener, serving size 200 milligrams
Ingredient List % w/w
Thymol Range of ingredient 0.064% up to
Menthol Range of ingredient 0.04%> up to 4%
Eucalyptus powder 0.092% up to 9%
Vitamin B 3%
Vitamin C 5-30%
Maltodextrin Range of ingredient 12-20%
Xylitol Range of ingredient 15-35%
Sodium Bicarbonate (whitener) range 10-20%
Example 2: Oral hygiene/breath freshener, serving size 200 milligrams Ingredient List % w/w
Thymol Range of ingredient 0.064% up to
Menthol Range of ingredient 0.04%> up to 4% Eucalyptus powder 0.092% up to 9%
Vitamin B 3%
Vitamin C 5-30%
Maltodextrin Range of ingredient 12-20%
Xylitol Range of ingredient 15-35% Sodium Bicarbonate (whitener) range 10-20%
Peppermint 5%
Sucralose 2% Example 3 : Oral hygiene/breath freshener, serving size 200 milligrams Ingredient List % w/w
Thymol Range of ingredient 0.064% up to
6.4%
Menthol Range of ingredient 0.04% up to 4%
Eucalyptus powder 0.092% up to 9%
Vitamin B 3%
Vitamin C 5-30%
Maltodextrin Range of ingredient 12-20%
Xylitol Range of ingredient 15-35%
Sodium Bicarbonate (whitener) range 10-20%
Peppermint 5%
Sucralose 2%
Zinc Chloride
Example 4: Oral hygiene/breath freshener, serving size 200 milligrams Ingredient List % w/w
Thymol Range of ingredient 0.064% up to 6.4%
Menthol Range of ingredient 0.04%> up to 4%
Eucalyptus powder 0.092%> up to 9%
Vitamin B 3%
Vitamin C 5-30%
Maltodextrin Range of ingredient 12-20%
Xylitol Range of ingredient 15-35%
Sodium Bicarbonate (whitener) range 10-20%
Peppermint 5%
Sucralose 2%
Methyl Salicylate < 0.5% Example 5: Oral hygiene/breath freshener, serving size 200 milligrams
Ingredient List % w/w
Thymol Range of ingredient 0.064% up to
Menthol Range of ingredient 0.04% up to 4%
Eucolyptus powder 0.092% up to 9%
Vitamin B 3%
Vitamin C 5-30%
Maltodextrin Range of ingredient 12-20%
Xylitol Range of ingredient 15-35%
Sodium Bicarbonate (whitener) range 10-20%
Peppermint 5%
Sucralose 2%
Zinc Chloride < 1%
Methyl Salicylate < 0.5%
Example 6: Novelty powder: Stout flavored beer, serving size 300 milligrams
Ingredient List % w/w Caffeine 35%
Coffee or cappacino 8-10%
Chocolate 20%
Sucralose 1-2%
MonkFruit 0 - 9%
Maltodextrin 0 - 1 1%
Molasses 5% - 15%
Hops 2-7%
Yeast (brewers) 5% to 12%
Malt (german wheat) 0 - 9% Example 7: Novelty powder: Hefewiezen flavored beer, serving size 300 milligrams
Ingredient List % w/w Caffeine 35%
Sucralose 1-2%
MonkFruit 0 - 9%
Maltodextrin 0 - 1 1%
Molasses 5% - 15% Hops 2-7%
Yeast (brewers) 5% to 12%
Malt (german wheat) 0- 20%
Coriander 2%
Lemon 10% Example 8: Sleep aid: Melatonin Formula (DS) serving size 300 mg
Ingredient List % w/w
Melatonin 1%
Chocolate 50%
Sugar 50%
Example 9: Pharmaceutical compound: ciprofloxacin, serving size 500 milligrams
Ingredient List % w/w Ciprofloxacin 50%
Cherry flavor 24%
Monkfruit extract 9%
Sucralose 2%
Glycyrrihizine 5%
Maltodextrin 10% Example 10: OTC allergy pharmaceutical: Claritin, serving size 200 milligrams
Ingredient List % w/w Claritin 2-5%
Grape flavoring 30 - 40%
Sucralose 1- 2%
Tartaric acid 10 - 15%
Sodium bicarbonate 5 - 10% Sorbitol 10 - 15%
Maltodextrin 30 - 40%
Example 11 : Diet aid: Hoodia, serving size 400 milligrams
Ingredient List % w/w Hoodia 50%
Grapefruit flavor 25%
Citric acid 10%
Thaumatin 2%
Stevia 1% Maltodextrin 12%
Example 12: Vitamin/Mineral/Supplement Formula (a). 400 mg
Ingredient List % w/w Sucralose up to 6%
Lemon-lime flavor up to 25%
Vitamin C (ascorbic acid) 25%
Vitamin E (12 mg, as dl alpha tocopherol, 63.8%) 3%
Vitamin B2 (riboflavin) 0.4% Vitamin A (beta carotene) 5000 IU(20%) 1%
Lysine up to 9% Glutamine 4%
Manganese gluconate 0.75%
Magnesium citrate up to 5%
Sodium bicarbonate 5%
Potassium gluconate 10%
Ginger 1%
Camu powder 5%
Zinc chloride (48%) 2%
Example 13 : Vitamin/Mineral/SuDDlement Formula (b). 400 me
Ingredient List % w/w
Sucralose up to 6%
Green tea templar up to 20%
Vitamin C (ascorbic acid) 30%
Vitamin E (12 mg, as dl alpha tocopherol, 63.8%) 3%
Vitamin B2 (riboflavin) 0.4%
Vitamin A (beta carotene) 5000 IU(20%) 1%
Lysine up to 9%
Glutamine 4%
Manganese gluconate 0.75%
Magnesium citrate up to 5%
Sodium bicarbonate 5%
Potassium gluconate 10%
Ginger 1%
Camu powder 5%
Zinc chloride (48%) 2%
Example 14: Vitamin/Mineral/SuDDlement Formula (c). 400 me
Ingredient List % w/w
Grape flavoring 4%
Green tea templar 25% Vitamin C (ascorbic acid) 35%
Vitamin E (12 mg, as dl alpha tocopherol, 63.8%) 3%
Vitamin B2 (riboflavin) 0.4%
Vitamin A (beta carotene) 5000 IU(20%) 1 % Lysine 8%
Glutamine 4%
Manganese gluconate 0.75%
Magnesium citrate 5%
Sodium bicarbonate 6% Potassium gluconate 9%
Ginger 1%
Camu powder 5.85%
Zinc chloride (48%) 2%
Example 15: Vitamin/Mineral/Supplement Formula (d). 400 mg
Ingredient List % w/w
Pomagranate flavoring 4%
Green tea templar 25% Vitamin C (ascorbic acid) 35%
Vitamin E (12 mg, as dl alpha tocopherol, 63.8%) 3%
Vitamin B2 (riboflavin) 0.4%
Vitamin A (beta carotene) 5000 IU(20%) 1 %
Lysine 8% Glutamine 4%
Manganese gluconate 0.75%
Magnesium citrate 5%
Sodium bicarbonate 6%
Potassium gluconate 9% Ginger 1%
Camu powder 5.85% Zinc chloride (48%) 2%
Example 16: Vitamin/Mineral/SuDDlement Formula (e). 400 me
Ingredient List % w/w
Orange flavoring 4%
Green tea templar 25%
Vitamin C (ascorbic acid) 35%
Vitamin E (12 mg, as dl alpha tocopherol, 63.8%) 3%
Vitamin B2 (riboflavin) 0.4%
Vitamin A (beta carotene) 5000 IU(20%) 1%
Lysine 8%
Glutamine 4%
Manganese gluconate 0.75%
Magnesium citrate 5%
Sodium bicarbonate 6%
Potassium gluconate 9%
Ginger 1%
Camu powder 5.85%
Zinc chloride (48%) 2%
Example 17: Enerev (caffeine) Formula (Grape). 300 me
Ingredient List % w/w
Premix (see herein) 47.67%
Citric acid 9%
Sodium bicarbonate 6%
Grape flavor 20%
Monk fruit extract 10%
Sucralose 3%
Maltodextrine 4.33% Example 18: Energy (caffeine) Formula (Strawberry 1), 300 mg
Ingredient List % w/w
Premix (see herein) 47.67%
Citric acid 7.67%
Sodium bicarbonate 5.667%
Strawberry flavor (Givaudan) 25%
Talin 1.5%
Sucralose 43%
Maltodextrine 8.499%
Example 19: Energy (caffeine) Formula (Strawberry 2), 300 mg
Ingredient List % w/w
Premix (see herein) 47.67% Citric acid 7.67%
Sodium bicarbonate 5.667%
Strawberry flavor (natural) 24%
Monk fruit extract 12%
Sucralose 3%
Example 20: Energy (caffeine) Formula (Strawberry 2). 300 mg
Ingredient List % w/w
Premix (see herein) 47.67% Citric acid 7.67%
Sodium bicarbonate 5.667%
Strawberry flavor (Givaudan) 25%
Talin 1.5%
Sucralose 43% Maltodextrine 8.499% Example 21 : Energy (caffeine) Formula (Cherry), 300 mg
Ingredient List % w/w
Premix (see herein) 47.67%
Citric acid 5.67% Sodium bicarbonate 7.667%
Cherry flavor (Givaudan) 20%
Monk fruit extract 15 %
Sucralose 4%
Example 22: Energy (caffeine) Formula (Coffee). 300 mg
Ingredient List % w/w
Premix (see herein) 47.67%
Barry cocoa 7%
Monk fruit extract 10%
Stevia 2%
Isomalt 8.33%
Expresso 10%
Coffee 15%
Example 23: Energy (caffeine) Formula (Watermelon 1). 300 mg
Ingredient List % w/w
Premix (see herein) 47.67%
Malic acid 5.66%
Sodium bicarbonate 7.667%
Watermelon flavor (natural) 20%
Monk fruit extract 15 %
Sucralose 4%
Example 24: Energy (caffeine) Formula (Watermelon 2). 300 mg Ingredient List % w/w
Premix (see herein) 47.67%
Malic acid 5.66%
Sodium bicarbonate 7.667%
Watermelon flavor (natural + artificial) 20%
Monk fruit extract 15 %
Sucralose 4%
Example 25: Oral hygiene/breath freshener, serving size 300 milligrams Ingredient List % w/w
Xylitol (Xylosweet) -75%
Spearmint powder (Allen Flavors AF 15807) -21.7%
Menthol crystals powdered, LorAnn Oils) -1.7%
Sodium bicarbonate (Solvay Chemicals) -1.6%
Selected illustrative embodiments of the product formulations are described above in some detail. It should be understood that only the essential ingredients and/or particle sizes and distributions considered necessary for clarifying the exemplified embodiments have been described herein. Other formulation equivalents are assumed to be known and understood by those skilled in the art. Moreover, while working examples of formulations, particle sizes and distributions have been described, the present invention is not limited to the working examples described above, but various design alterations may be carried out without departing from the formulations and particle sizes as set forth in the claims.

Claims

CLAIMS What is claimed is:
1. An ingestible powder for use in an aerosolizing delivery apparatus, comprising:
particles, at least of which about 50% have a volume median distribution between about 20 microns and about 220 microns;
wherein said ingestible powder comprises:
at least one flavoring agent;
at least one dietary supplement; and
at least one of an energy supplement, a pharmaceutical compound, an over- the-counter pharmaceutical compound, a sleep-aid compound, a weight-loss compound, and an oral health compound.
2. The ingestible powder of claim one, wherein the flavoring agent is at least one of the group comprising a masking agent, an artificial sweetener, a natural sweetener, a flavor compound, acidulant, and combinations and complexes thereof.
3. The ingestible powder of claim 1, further comprising an antioxidant compound.
4. The ingestible powder of claim 3, wherein the antioxidant is at least one of the group comprising a carotenoid, a flavonoid, an isoflavone, a tocopherol, a tocotrienol, lipoic acid, melatonin, superoxide dismutase, coenzyme Q10, alpha lipoic acid, vitamin A, chromium biotin, selenium, ascorbic acid and combinations and complexes thereof.
5. The ingestible powder of claim 4, wherein the flavonoid is one or more of the group comprising esveratrol, quercetin, rutin, catechin, proanthocyanidins, acai berry extract, raspberry extract, cranberry extract, pomegranate extract, plum extract, cherry extract, rosemary extract, and combinations and complexes thereof.
6. The ingestible powder of claim 4, wherein the carotenoid is one or more of the group comprising alpha-carotene, beta-carotene, cryptoxanthin, lycopene, lutein, zeaxathin, and combinations and complexes thereof.
7. The ingestible powder of claim 4, wherein the isoflavone is one or more of the group comprising genistein, daidzein, biochanin A, formononetin, and
combinations and complexes thereof.
8. The ingestible powder of claim 1, wherein the dietary supplement is at least one of the group comprising coenzyme Q10, folic acid, NADH, vitamin A, vitamin Bl, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B8, vitamin B9, vitamin B12, inositol, vitamin C, vitamin D, vitamin D2, vitamin D3, vitamin E, pyroxidine HCL, niacin, niacinamide, pantothenic acid, thiamin, calcium, iron, magnesium, phosphorous, zinc, copper, biotin, chromium, selenium, niacin, pyridoxine, cyanocobalamin, and combinations and complexes thereof.
9. The ingestible powder of claim 1, wherein the energy supplement is at least one of the group comprising American ginseng, Red ginseng, Siberian ginseng, maca, rhodiola, ginger, guarana, turmeric, acetyl-L-carnitine, L-carnitine, creatine, taurine, L-phenylalanine, L-arginine, tyrosine, acetyl-tyrosine, N-acetyl L-tyrosine, ginko biloba, yerba-mate, kola nut, gotu kola, maitake, cordyceps sinensis, guarana, acai- berry, L-theanine, caffeine, quercitine, synephrine, green tea extract, theophylline, epigallocatechin gallate (EGCG),capsaicin, bee pollen, alpha-lipoic acid, and 1,3 dimethylamylamine (geranium), D-ribose, Fo-Ti, cha de bugre extract, St. Johns wort, and combinations and complexes thereof.
10. The ingestible powder of claim 1, wherein the weight-loss compound is selected from the group consisting of an appetite suppressant compound and a thermogenic compound.
1 1. The ingestible powder of claim 10, wherein the weight loss compound is at least one of the group comprising hoodia, chitosan, chromium picolinate, conjugated linoleic acid, glucomannan, green tea extract, guar gum, guarana, guggal, senna, ephedra, bitter orange, fucoxanthin, white bean extract, vitamin D, human chorionic gonadotropin, resveratrol, capsaicin, chia, hoodia, L-carnitine, raspberry ketones, banaba leaf, red clover, ginger, almonds, acai berry, flax seeds, leucine, lipodrene, and combinations and complexes thereof.
12. The ingestible powder of claim 1, wherein the sleep aide compound is selected from the group comprising melatonin, 5-hydroxytryptophan, 5- hydroxytrypatmine, diphenhydramine, doxylamine, benzodiazepine, kava, serenite, chamomile, phenibut, catnip herb, chamomile, glycine, hops, L-theanine, L- tryptophan, glycine, GABA, valerian, and combinations and complexes thereof.
13. The ingestible powder of claim 1, further comprising at least of the group comprising an excipient, a plant oil extract, an enzyme, a hormone, a probiotic, and combinations and complexes thereof.
14. The ingestible powder of claim 1, wherein the pharmaceutical compound is at least one of the group consisting of an anti-depressant compound, an anti-anxiety compound, antibiotic compound, an allergy medicine, an anti-inflammatory compound, and combinations and complexes thereof.
15. The ingestible powder of claim 1, wherein the dietary supplement comprises a botanical dietary supplement.
16. The ingestible powder of claim 1, wherein the dietary supplement comprises a specialty nutraceutical compound.
17. The ingestible powder of claim 1, wherein the oral health compound is at least one of the group comprising fluoride, vitamin C, vitamin B, zinc, menthol, thymol, eucaleptic, sodium bicarbonate, vitamin K, chlorhexidine, xylitol, and combinations and complexes thereof.
18. An ingestible powder for use in an aerosolizing delivery apparatus comprising: an energy supplement, a dietary supplement, a flavoring agent, and sodium bicarbonate; wherein a mean size of particles of the composition is greater than 10 microns and less than 500 microns.
19. The ingestible powder of claim 18, further comprising: citric acid.
20. The ingestible powder of claim 19, wherein the composition contains more citric acid than sodium bicarbonate, particularly wherein the weight ratio of citric acid to sodium bicarbonate is between 45 to 38 and 1 to 1.
21. The ingestible powder of any of claims 18-20, wherein the flavoring agent comprises thaumatin and stevia.
22. The ingestible powder of claim 21, wherein the weight ratio of thamatin to stevia is between 1 1 to 4 and 9 to 6.
23. The ingestible powder of claim 21 or claim 22, wherein the weight ratio of caffeine to thaumatin and stevia combined is between 25 to 2 and 90 to 17.
24. The ingestible powder of any of claims 18-23, wherein the flavoring agent is a natural flavoring agent.
25. The ingestible powder of any of claims 18-24, wherein the dietary supplement comprises at least one of niacin, pyridoxine, cyanocobalamin, and complexes and combinations thereof.
26. The ingestible powder of any of the preceding claims wherein the mean size of particles of the composition is between 18 and 70 microns.
PCT/US2014/025481 2013-03-15 2014-03-13 Particles for aerosolizing apparatus WO2014151329A1 (en)

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