EP1196138A1 - Vorgeformter gel-folie - Google Patents

Vorgeformter gel-folie

Info

Publication number
EP1196138A1
EP1196138A1 EP00943341A EP00943341A EP1196138A1 EP 1196138 A1 EP1196138 A1 EP 1196138A1 EP 00943341 A EP00943341 A EP 00943341A EP 00943341 A EP00943341 A EP 00943341A EP 1196138 A1 EP1196138 A1 EP 1196138A1
Authority
EP
European Patent Office
Prior art keywords
gel
agents
skin
gel sheet
available
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP00943341A
Other languages
English (en)
French (fr)
Inventor
George Endel Deckner
Delyth Myfanwy Jenkins
Kenneth Eugene Kyte
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Procter and Gamble Co
Original Assignee
Procter and Gamble Co
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 Procter and Gamble Co filed Critical Procter and Gamble Co
Publication of EP1196138A1 publication Critical patent/EP1196138A1/de
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/02Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/04Dispersions; Emulsions
    • A61K8/042Gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/02Cosmetics or similar toiletry preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/02Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/0208Tissues; Wipes; Patches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/02Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/0212Face masks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/73Polysaccharides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00Preparations for care of the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/40Chemical, physico-chemical or functional or structural properties of particular ingredients
    • A61K2800/59Mixtures
    • A61K2800/594Mixtures of polymers

Definitions

  • the present invention relates to novel pre-formed, gel sheet devices.
  • self-adhesive, pre-formed, gel sheet devices which are patches or masks, comprising from about 30% to about 99.5% of water and mixture of at least two water-soluble polymeric gel forming agents for delivering benefit agents to the skin, hair or nails.
  • Said devices are suitable for topical application and display desirable amounts of syneresis and improved mechanical properties such as strength and flexibility, as well as excellent moisturisation and hydration benefits.
  • the devices of the present invention are unobtrusive and conform to the contours of a target surface when applied. The desired properties are achieved by selecting the chemical composition and rheological characteristics of the pre-formed, gel sheet devices, in particular with reference to the relationship between the exudate release, force to rupture and percentage compression at rupture of the gel comprising the device.
  • a patch or other such device comprising a water-soluble polymeric gel forming agent instead of creams and lotions and the like, to cosmetically treat the skin, or to promote the healing of burns or wounds
  • a variety of cosmetic patches or devices are commercially marketed or described as being useful for the delivery of skin care actives such as vitamins, anti-acne actives, moisturisers and the like. Patches and devices have also been described in the literature and marketed in the medical field as a useful means for the transdermal administration of drugs. However, many of these patches or devices suffer drawbacks in their physical product forms resulting in undesirable in-use characteristics as perceived by the consumer or wearer.
  • patches or devices may be too wet or sticky, as the gelling agents comprising the patch or device do not form a solid gel structure, and as a result, the patches or devices are difficult to handle and apply to the skin. Others are strongly adhesive, tight and uncomfortable to wear and remove, and many patches do not provide an effective release and penetration of benefit agents. Some patches or devices are too dry or inflexible and therefore do not conform well to the contours of the surface to which they are applied. Further, some patches or devices require formation in-situ on the skin and are therefore messy to apply.
  • US-A-4,291,025 relates to a thermally reversible agar gel topical dressing comprising 5 to 12% agar, 20 to 75% diethylene glycol and water to 100 wt % and methods for preparing said dressing.
  • the compositions may additionally comprise gel strengthening agents and special purpose ingredients (e.g. vitamins, antibiotics).
  • gel strengthening agents e.g. vitamins, antibiotics.
  • solid, high strength, yieldable agar gels are prepared and then subdivided into smaller pellets or pieces.
  • the agar gel is then converted into a sol upon heating wherein the sol is applied to the target skin and cooled in-situ to form a removable gel form.
  • WO97/17944 discloses cosmetic formulations made up of a gel material consisting of a balanced mixture of polysaccharides containing a soluble alginate (0.1-5%), agar (0.01-0.5%), pectin (0.01- 0.5%), xanthan gum (0.05-1%) with the balance consisting of water.
  • the gel material is optionally enriched with water-soluble or water-dispersible active ingredients.
  • the gel material may be processed to form a structured gel which is disclosed as being easy to handle and well adapted to the skin surface.
  • US-A-4,318,746 relates to a gel comprising at least 0.5% of a first polymer that disperses, dissolves or hydrates in hot water and that forms, or can be made to form, a rigid gel on cooling, at least 2% of a second polymer that is insoluble in hot water and that dissolves or hydrates on cooling and is compatible with the first polymer, and water.
  • the document describes the gel as being firm, cohesive and adhesive and useful for example, as an electrode or for the topical administration of drugs.
  • the document outlines that one of the advantages of the gel is that it is relatively rigid and adhesive at temperatures below 60- 65°C.
  • WO90/14110 discloses pharmaceutical preparations which may take the form of a self- supporting slab, pad or wafer of a desired size, shape and thickness comprising a water insoluble alginate and suspending agents such as xanthan gum alone, or xanthan gum in combination with locust bean gum. Gellan gum is also disclosed as a further useful suspending agent. The suspending agents in the preparations may also act as gel forming agents. The preparations optionally comprise anti-inflammatory agents, or the antiseptic agent, iodine.
  • the slab or wafer forms of a preparation may be applied onto a plastic backing to form an integral surgical dressing, with the gel either exposed or covered with a gauze.
  • Substrate may also be employed to prevent evaporation of active ingredients, or act as a means for adhering a device to the skin when an adhesive is coated around its periphery.
  • a substrate may be impregnated with, adhered, or laminated to one surface of the composition layer of the patch or device.
  • EP-B-507,160 relates to an external preparation for application to the skin comprising a drug retaining layer placed on a support wherein the drug retaining layer comprises lidocaine, and an adhesive gel base comprising 0.5% to 50% of a water soluble high molecular weight substance, 20 to 70% of water and 1 to 70 % of a water retaining agent.
  • Suitable supports are described as flexible materials such as non-woven fabrics. Substrates need however, to be compatible with the gel. A substrate is not compatible with a gel if the gel delaminates from the substrate. Even if a gel composition is found of a desirable flexibility and strength, difficulties may still be incurred in matching such a gel with a substrate which is compatible with these gel properties.
  • a flexible substrate with a flexible gel does not necessarily produce a flexible patch or device.
  • many flexible substrates often display a degree of porosity such that the wet gel infiltrates the substrate and forms strong gel networks within its fibers. Such networks are thought to reduce the flexibility of the resultant device.
  • the substrate may not provide a patch or device with an unobtrusive appearance on the skin, hair, or nails. This will often depend on the choice of substrate and its characteristics.
  • GB 1,341,999 discloses a gelled medium suitable for treating burns comprising a liquid phase, a burn treating agent and an amount of a gel former.
  • the gelled medium is described as being flexible and having an essentially dry, continuous, non-adhesive surface and plasticity so as to conform to the body.
  • a preferred gel former is disclosed as a combination of xanthan and locust bean gum.
  • the examples also disclose a burn treating antiseptic pad comprising agarose, water and silver nitrate. The document discusses that a slight amount of syneresis in the gelled medium is helpful in wetting the surface with the burn treating substance and for ease in removal of the medium from a mould.
  • the gelled media described in the examples of GB 1,341,999 whilst displaying a desirable amount of syneresis, do not have sufficient flexibility as is claimed to conform well to the contours of a target surface, or are difficult to retain in sheet form as they are very elastic and deformable. All gels undergo syneresis to some degree. That is, upon standing, the gel contracts with the exudation of liquid. Syneresis provides a mechanism for delivery of a benefit agent to a target area.
  • the liquid layer of exudate formed on the surface of the gelled medium is readily available for diffusion facilitating a short wear time of the device.
  • a moderate amount of syneresis has been found by the present inventors as a highly desirable property of a device comprising a gel, as the liquid exuded onto the surface of the gelled device facilitates its adhesion to a target surface thus obviating the need for either an additional adhesive overlaying the gelled form or an adhesive coated substrate.
  • a gelled device exhibits too little syneresis, the device, although wetting an area, is not likely to provide good adhesion to the target area, whilst an excessive amount of syneresis results in an ineffective and unattractive product.
  • EP-A-161 681 discloses gel plates comprising a polysaccharide and an aqueous solution of a polyhydric alcohol.
  • Preferred polysaccharides for the gel plates are a blend of carrageenan and a galactomannan, or carrageenan alone.
  • the compositions optionally comprise medical components such as skin stimulants, antiphlogistics, analgesics and antibiotics.
  • the gel plates are disclosed as being transparent or inconspicuous, having a refreshing feeling and good adhesion, as well as being sufficiently elastic, stretchable and strong. The present inventors have found however, that the gel plates described by EP- A-161681 do not display a desirable amount of syneresis.
  • JP-B2-276 1936 discloses aqueous sheet-like packs comprising xanthan gum and locust bean gum in combination with a water-soluble solvent.
  • the sheet-like packs of the invention are disclosed as having excellent shape retention properties at high temperature, providing a moist feel and having a high skin moisturising effect.
  • the examples disclose that the packs may further comprise 0.1% of a skin beautifying component.
  • JP-A-54 92618 discloses a wet compress comprising an aqueous calcium ion cross-linked alginate gel as a base, substances having an antiphlogistic and analgesic action and water.
  • Example 5 discloses a wet compress comprising a mixture of locust bean gum, konjac powder, a 3% sodium alginate solution, a calcium monohydrate phosphate source and a styrene-butadiene copolymer latex. The document teaches that the addition of water soluble polymers increases the shape retaining power of a compress and a highly elastic gel is obtained by adding locust bean gum and konjac mannan, or carrageenan alone.
  • EP-A-750,905 discloses a water-soluble adhesive sheet which may optionally comprise a water-soluble protective material laminated on one surface of the sheet and/or one or more release liners.
  • the patches are disclosed as being useful as bathing preparations, which may be topically applied to the skin surface and dissolve during bathing to relieve various circulatory, muscular, joint and skin disease ailments.
  • the patches may optionally comprise numerous cosmetic and pharmaceutical actives.
  • Water soluble polymers such as polysaccharides are also employed in non patch compositions as gelling or thickening agents.
  • US- A-4,661,475 discloses gelling compositions and thickeners comprising (a) 10-90 parts by weight of cassia- galactomannans and (b) 90-10 parts by weight of carrageenan, agar, xanthan gum or mixtures thereof.
  • the compositions described in this document are useful for example as thickeners for pharmaceutical or cosmetic purposes.
  • JP97020649 discloses a base material composition containing a matrix agent which comprises gellan gum, a cation, and water
  • EP-A-803,245 describes a compact solid gel comprising 15 to 90% water, 0.3 to 4% thermoreversible polysaccharides, 4 to 40% humectant and 2 to 35% of a powder phase.
  • Example 2 of this document describes a solid gel comprising carrageenan (0.60%) and xanthan gum (1.00%).
  • the object of the invention is defined as providing an aqueous gel which may be applied directly to the skin with the fingers or with a special applicator.
  • the solid, compact gels of the invention are further described as easy to spread and the compact product form allows for controlled quantities of gel to be withdrawn.
  • aqueous self-supporting, pre-formed, gel sheet devices comprising a mixture of at least two water-soluble polymeric gel forming agents wherein said devices not only have a desirable amount of syneresis, but also strength and flexibility. Further, neither is it taught that all three parameters are essential for achieving desirable in-use characteristics from a pre-formed, gel sheet device.
  • a solid, pre-formed, gel sheet device may be formulated as a self-supporting, high strength structure which is not only flexible to conform to the contours of a target surface, but which also displays a moderate amount of syneresis.
  • the syneresis exhibited by a gelled device herein facilitates its adhesion to a target surface thus obviating the need either for an additional adhesive overlaying the gelled form or an adhesive coated substrate.
  • the devices herein are thin, yet easy to handle and apply. The desirable physical properties and in-use characteristics are achieved by selecting the chemical composition and rheo logical characteristics of the gelled devices with reference to the relationship between syneresis, strength and flexibility.
  • the sheet devices herein are patches or masks for cosmetic or therapeutic application.
  • the present invention relates to a pre-formed, gel sheet device which is a patch or mask for delivering benefit agents to the skin, hair or nails, comprising from about 30% to about 99.5% of water and a mixture of at least two water-soluble polymeric gel forming agents, wherein the gel comprising the device has an exudate release of greater than 0.7 grams and less than 1.3 grams; a percentage compression at rupture of greater than 45% and less than 90%; and requires a force to rupture of greater than 30 N.
  • a cosmetic method of treatment comprising applying to the skin, hair or nails a pre-formed, gel sheet device.
  • a pre-formed, gel sheet device comprising a polysaccharide mixture consisting of;
  • a mannose containing polysaccharide wherein the device comprises less than 2% total polysaccharide and the ratio of red seaweed polysaccharide to mannose containing polysaccharide is from about 1 : 1 to about 10:1 and wherein the gel comprising the device requires a force to rupture of greater than 60N.
  • the pre-formed, gel sheet devices of the present invention show a moderate amount of syneresis, as well as providing excellent in-use characteristics such as unobtrusiveness, conformability, hydration and moisturisation benefits upon topical application. Further, the pre-formed, gel sheet devices of the present invention have excellent mechanical properties and form a high strength structure which is flexible and has a degree of elasticity.
  • the pre-formed, gel sheet devices of the present invention comprise water and a mixture of at least two water-soluble polymeric gel forming agents, as well as various optional ingredients as indicated below. All levels and ratios are by weight of total composition of the device, unless otherwise indicated.
  • pre-formed means that the device so described is manufactured into a product form having a predetermined thickness, shape and size, wherein the device may be removed from the packaging and placed or draped onto the target surface by the fingers without the need to spread, rub or coat the target area with the product form.
  • sheet device means that the device described is a patch or mask for cosmetic or medical application having a planar or non planar topography, wherein the patch is a continuous, uni-, bi-, or multi- lamellar sheet, and the shape of which is pre-determined according to the specific area of skin, hair or nails to be treated and wherein the mask is a non-continuous, uni-, bi-, or multi- lamellar sheet covering the facial area with apertures for the eyes, nose or mouth.
  • water-soluble means the ability of a gellable polymeric gel forming agent to dissolve in an aqueous solution either at room temperature or upon heating thereby forming a continuous phase.
  • gel compositions form 3-dimensional matrices which bind or encapsulate other ingredients of the composition. Syneresis is believed to involve a spontaneous separation of an initial homogeneous system into a coherent gel phase and a liquid. The exuded liquid is a solution whose composition depends upon that of the original gel.
  • a device of the present invention When a device of the present invention is applied to a target area, the device loses some of its volume such that ingredients bound within the gel matrices such as water or benefit agents, are released towards and penetrate the target area.
  • polysaccharide as used herein, means a naturally occurring or synthetically produced, linear or branched polymer of monosaccharide units, which swells when dispersed in water at low dry concentrations and gels the aqueous phase.
  • exudate release is a measure of the amount of syneresis displayed by a gel. Said method is described in the section headed 'Methods'.
  • percentage compression at rupture is a measure of the flexibility of a gel. Said method is described in the section headed 'Methods'.
  • force to rupture is a measure of gel strength. Said method is described in the section headed 'Methods'.
  • brittle as used herein, means a gel which breaks easily when flexed.
  • the present pre-formed, gel sheet devices are suitable for topical application to the skin, hair or nails.
  • Water-Soluble Polymeric Gel Forming Agents are suitable for topical application to the skin, hair or nails.
  • the devices comprise a mixture of at least two water-soluble polymeric gel forming agents.
  • the pre-formed, gel sheet devices of the present invention comprise less than 30%, preferably less than 20%, more preferably less than 10% and especially less than 5% by total weight of a mixture of water-soluble polymeric gel forming agents.
  • Water-soluble polymeric gel forming agents can be self-gelling or may only form gels in combination with other substances such as sugar, alcohol, or mono- or multi- valent salts.
  • Mono- or multi- valent salts may additionally act as gel strengthening agents imparting added strength to the pre-formed, gel sheet devices herein.
  • Suitable cations for the mono- or multi- valent salts may be selected from potassium, sodium, ammonium, zinc, aluminium, calcium and magnesium ions, or mixtures thereof.
  • Suitable anions associated with the aforementioned cations may be selected from chloride, citrates, sulfate, carbonate, borate and phosphate anions, or mixtures thereof.
  • the water-soluble polymeric gel forming agents for use in the present invention are selected from synthetic or natural polymers, and mixtures thereof.
  • Suitable synthetic polymers for use herein include non-ionic water-soluble polymers; acrylic acid based polymers or derivatives thereof; or cellulose derivatives; and mixtures thereof.
  • the synthetic polymers useful herein can be categorised by their charge or constituent monomers. However, it is to be understood that the classifications herein are made for the sake of convenience and there may be overlap between the categories.
  • Non-Ionic Water-Soluble Polymers Suitable non-ionic water-soluble polymers for use herein include polydimethyl acrylamide, polyvinyl pyrrolidones, polyethylene glycol monomethacrylate, poly-2-ethyl-2-oxazoline, polyvinyl alcohol, polyethylene oxide, polyvinyl ethers, copolymers of polyvinylethers and polyvinylpyrrolidone and derivatives thereof, methyl vinyl ether and maleic anhydride, copolymers of ethylene and maleic anhydride, and mixtures thereof.
  • non-ionic water-soluble polymers for use herein include copolymers based on 2-hydroxyethylmethacrylate (“HEMA”) which includes the copolymer of "HEMA” and one more comonomers as described in US-A- 5,804,107 at column 14, lines 36-67 and column 15, lines 1-34; incorporated herein by reference.
  • HEMA 2-hydroxyethylmethacrylate
  • Acrylic Acid Based Polymers or Derivatives thereof include polyacrylic acids; salts of polyacrylic acid such as ammonium polyacrylate and sodium polyacrylate; copolymers of acrylamide and N,N'- methylene bisacrylamide and polyacrylamide; and polyacrylamide, or mixtures thereof.
  • cellulose derivatives suitable for use herein include carboxymethyl hydroxyethylcellulose, carboxymethyl cellulose, carboxymethylcellulose sodium, cellulose acetate propionate carboxylate, hydroxyethylcellulose, hydroxyethyl ethylcellulose, hydroxypropylcellulose, methyl cellulose, methylcellulose sodiiun, hydroxypropyl methylcellulose, methyl hydroxyethylcellulose, microcrystalline cellulose, sodium cellulose sulfate, and mixtures thereof. Also useful herein are the alkyl substituted celluloses.
  • the hydroxy groups of the cellulose polymer is hydroyxalkylated (preferably hydroxyethylated or hydroxypropylated) to form a hydroxyalkylated cellulose which is then further modified with a C10-C30 straight chain or branched chain alkyl group through an ether linkage.
  • these polymers are ethers of C10-C30 straight or branched chain alcohols with hydroxyalkylcelluloses.
  • alkyl groups useful herein include those selected from the group consisting of stearyl, isostearyl, lauryl, myristyl, cetyl, isocetyl, cocoyl (i.e.
  • alkyl groups derived from the alcohols of coconut oil palmityl, oleyl, linoleyl, linolenyl, ricinoleyl, behenyl, and mixtures thereof.
  • Preferred among the alkyl hydroxyalkyl cellulose ethers is the material given the CTFA designation cetyl hydroxyethylcellulose, which is the ether of cetyl alcohol and hydroxyethylcellulose. This material is sold under the tradename Natrosol® CS Plus from Aqualon Corporation.
  • Suitable natural polymers for use herein include gelatin, polysaccharides, and mixtures thereof.
  • the polysaccharides for use in the devices herein are preferably selected from red seaweed polysaccharides; galactomannans; glucomannans; fermentation polysaccharides or derivatives thereof; brown seaweed polysaccharides; extracts of marine invertebrates; starch, or derivatives thereof; natural fruit extracts; plant fiber derivatives; kelp; natural plant exudates; and resinous gums; or mixtures thereof.
  • the devices herein contain one or more polysaccharides, the devices comprise less than 10%, preferably less than 5% and more preferably less than 2% total by dry weight of polysaccharide.
  • Gelatin When gelatin is used in the devices herein, a high-molecular weight gelatin is combined with a low-molecular weight one to control the solubility. A gelatin having a low molecular weight of 20,000 or less is poor in gelling ability.
  • Brown Seaweed Polysaccharides Polysaccharides which are classified as brown seaweed polysaccharides are isolated by extraction from various species of Phaebophyceae. Suitable brown seaweed polysaccharides for use herein include algin, alginic acid, ammonium alginate, calcium alginate, potassium alginate, sodium alginate, propylene glycol alginate, and mixtures thereof.
  • Red Seaweed Polysaccharides Polysaccharides which are classified as red seaweed polysaccharides are isolated from marine plant species belonging to the class of Rhodophyceae. Red seaweed polysaccharides provide mechanical strength to an aqueous gel. Suitable red seaweed polysaccharides for use in the present invention include agar known in the industry under the (CTFA) trade designation as agar agar flake derived from various Gelidium plant species or closely related red algae commercially available as "Agar Agar 100" or "Agar Agar 150" from TIC Gums (Belcamp, MD, USA) or "Agar Agar K-100" from Gumix International Inc.
  • CTFA Cosmetic Acid
  • the red seaweed polysaccharide for use herein is selected from agar, agarose, kappa-carrageenan and furcellaran, or mixtures thereof. More preferably, the red seaweed polysaccharide for use herein is selected from agar and agarose, or mixtures thereof.
  • Glucomannans are mannose containing polysaccharides which comprise an essentially linear backbone of ⁇ (l->4)-linked glucose and mannose residues.
  • the C-6 position of a mannose or glucose residue in the polysaccharide backbone may be substituted with an acetyl group.
  • the acetyl groups are generally found on one per six sugar residues to one per twenty sugar residues.
  • Suitable glucomannans or derivatives thereof for use herein have a ratio of mannose to glucose of from about 0.2 to about 3.
  • glucomannans for use herein include konjac mannan, which is the generic name for the flour formed from grinding the tuber root of the Amorphophallus konjac plant (elephant yam), commercially available under the trade name "Nutricol® konjac flour” from FMC (Philadelphia, PA, USA); and deacetylated konjac mannan; or mixtures thereof
  • Galactomannans are vegetable reserve polysaccharides which occur in the endosperm cells of numerous seeds of Leguminosae.
  • the collective term "galactomannan” comprises all polysaccharides which are built up of galactose and mannose residues.
  • Galactomannans are mannose containing polysaccharides as they comprise a linear backbone of (l->4)-linked ⁇ -D-mannopyranosyl units. To these rings are attached as branches, isolated galactopyranose residues by ⁇ -(l,6)-glucoside bonds.
  • Galactomannans may in addition also contain minor amounts of other sugar residues.
  • Suitable galactomannans for use herein are fenugreek gum; lucern; clover; locust bean gum known for example in the industry under the (CTFA) trade designation as carob bean gum, commercially available as "Seagul L” from FMC (Philadelphia, PA, USA); tara gum commercially available from Starlight Products (Rouen, France) or Bunge Foods (Atlanta, GA, USA); guar gum derived from the ground endosperms of Cyamopsis tetragonolobus, commercially available as "Burtonite V7E” from TIC Gums (Belcamp, MD, USA), “Jaguar C” from Rhone-Poulenc (Marietta, GA, USA), or “Supercol” from Aqualon (Wilmington, DE, USA); and cassia gum commercially available from Starlight Products (Rouen, France), or mixtures thereof.
  • the galactomannans for use herein have an average one of every 1 to about 5 mannosyl units substituted with a (l- 6)-linked-cc- D-galactopyranosyl unit and are selected from guar gum, locust bean gum and cassia gum, or mixtures thereof.
  • Fermentation Polysaccharides are polysaccharides which are commercially produced by the fermentation of microorganisms in a medium containing a carbon and nitrogen source, buffering agent, and trace elements.
  • Suitable fermentation polysaccharides, or derivatives thereof, for use in the present invention include gellan gum known in the industry under the (CTFA) trade designation as gum gellan, a high molecular weight hetero polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with Pseudomonas elodea, commercially available as "Kelcogel” from Kelco (San Diego, CA, USA); xanthan gum which is a high molecular weight hetero polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with Xanthomonas campestris, known in the industry under the (CTFA) trade designation as xanthan, commercially available for example as "Keltrol CG 1000/BT/F/GM/RD/SF/T/TF", all from Calgon (Pittsburgh, PA, USA), or "Kelzan” from Kelco (San Diego, CA, USA); natto gum, pullulan; rhamsan gum
  • Extracts of Marine Invertebrates Polysaccharides derived from marine invertebrates, specifically the exoskeleton of such invertebrates, consist chiefly of N-acetyl-D- glucosamine residues.
  • polysaccharides suitable for use herein include; chitosan, commercially available for example as “Marine Dew” from Ajinomoto (Teakneck, NJ, USA); and hydroxypropyl chitosan commercially available for example as "HPCH Liquid” from Ichimaru Pharcos (Yamagata Gun Gifu-Pref, Japan) and derivatives; or mixtures thereof.
  • Starches are polysaccharides which consist of various proportions of two glucose polymers, amylose and amylopectin. Suitable materials for use herein include starch; amylopectin; and dextrin commercially available as "Nadex 360" from National Starch (Bridgewater, NJ, USA) and derivatives; or mixtures thereof.
  • Natural Fruit Extracts examples include pectin; and arabian; or mixtures thereof.
  • Plant Fiber Derivatives A suitable example of a plant fiber derivative for use herein is cellulose.
  • Natural Plant Exudates Suitable polysaccharides obtained from natural plant exudates for use herein include karaya gum, tragacanth gum, arabic gum, tamarind gum, and ghatty gum, or mixtures thereof.
  • Resinous Gums examples include shellac gum which is obtained from the resinous secretion of the insect Laccifer (Tachardia) lacca; damar gum; copal gum and rosin gum; or mixtures thereof.
  • the mixture of at least two water-soluble polymeric gel forming agents of the present invention forms solid, self-supporting and self-adhesive structures.
  • gels formed from a single water-soluble polymeric gel forming agent may demonstrate one or two of the desirable physical properties described herein, but not all three.
  • Gels formed from synthetic polymers per se are often slow setting and require water to be driven out of the reaction mixture before a continuous gel phase will form. As a result, the gel products are dry to touch and do not display a sufficient amount of syneresis. It has also been found by the present inventors, that polysaccharide gels prepared from individual polysaccharides do not meet the desired syneresis, strength and flexibility parameters described herein.
  • red seaweed polysaccharides alone form gels of sufficient strength but the resulting gels are too brittle and inflexible and do not conform to the contours of a target surface.
  • Gellan gum also forms a reasonably strong gel, which additionally is moist to the touch, but which is brittle and inflexible and often peels or lifts away at the edges from a non-planar target surface.
  • other polysaccharides such as locust bean gum and xanthan gum, or humectants may be incorporated into the gel, but this may alter the amount of syneresis shown by the gel.
  • Gels formed from gelatin and brown seaweed polysaccharides are attributed with sufficient strength, but require additional excipients to form a gel with a desirable amount of syneresis and in the case of brown seaweed polysaccharides, flexibility.
  • Galactomannans, glucomannans and xanthan gum when taken individually do not form gels per se, but display synergies when combined.
  • a gel comprising 1% locust bean and xanthan gum may possess sufficient moistness, but the gels are difficult to retain in sheet form as they are very elastic, deformable and drapable. At higher levels of total gum, the gels formed may retain their shape, but may be too dry.
  • the present inventors have therefore found that gels formed from synergistic mixtures of water-soluble polymeric gel forming agents display the desired mechanical strength and syneresis properties described herein. These properties are different from those achievable from the individual gel forming agent components.
  • the present inventors have also found, that in order to attain a gel with a desirable amount of syneresis, as well as the mechanical properties of strength and flexibility, when water- soluble polymeric gel forming agents selected for their strength are combined with humectants or other agents imparting a reduction in brittleness of the gel, the total level of the water-soluble polymeric gel forming agent mixture should be kept as low as possible without compromising on mechanical strength and flexibility. It is believed that low total polymer levels impart an open gel structure such that the other components of the original gel are not as tightly bound within the gel network and are freely available for diffusion.
  • the mixture of water-soluble polymeric gel forming agents comprises at least one polysaccharide.
  • the mixture therefore comprises at least one polysaccharide and a further water-soluble polymeric gel forming agent selected from one or more non-ionic water-soluble polymers; one or more acrylic acid based polymers or derivatives thereof; one or more polysaccharides; and mixtures thereof.
  • the water-soluble polymeric gel forming agent mixture herein may comprise one or more polysaccharides and a non-ionic water-soluble polymer, or alternatively, it may comprise two or more polysaccharides. More preferably, the mixture of at least two water-soluble polymeric gel forming agents is a polysaccharide mixture.
  • the polysaccharide mixture comprises (1) at least one red seaweed polysaccharide; brown seaweed polysaccharide; or mixtures thereof; and (2) at least one fermentation polysaccharide; galactomannan; glucomannan; natural plant exudate; or natural fruit extract; and derivatives or mixtures thereof. More preferably, the polysaccharide mixture comprises (1) at least one red seaweed polysaccharide, and; (2) at least one fermentation polysaccharide; galactomannan; glucomannan; and derivatives or mixtures thereof.
  • the mixture of at least two water-soluble polymeric gel forming agents of the present invention is a polysaccharide mixture consisting of, (1) a red seaweed polysaccharide and (2) a mannose containing polysaccharide wherein the device comprises less than 2% total polysaccharide.
  • the red seaweed polysaccharide is selected from agar and agarose, or mixtures thereof and wherein preferably the mannose containing polysaccharide is selected from a galactomannan, glucomannan and derivatives, or mixtures thereof.
  • the galactomannan or glucomannan in the polysaccharide mixture complements the red seaweed polysaccharide, and contributes to the mechanical strength and flexibility of the pre-formed, gel sheet devices of the present invention.
  • This synergy is believed to arise due to the interactions between the polysaccharides.
  • Red seaweed polysaccharides form double helical structures and glucomannans and galactomannans have areas of relative un-substitution on the polymer backbone. These areas of relative un-substitution on the galactomannan and glucomannan backbone synergistically interact with the helices of the red seaweed polysaccharides.
  • the polysaccharide mixture may additionally comprise xanthan gum in amounts less than or equal to the amount of mannose containing polysaccharide.
  • the ratio of red seaweed polysaccharide to mannose containing polysaccharide is from about 1:1 to about 10:1 and more preferably from about 2:1 to about 7:1.
  • the pre-formed, gel sheet devices of the present invention display a moderate amount of syneresis and preferably, the devices herein are moist to the touch.
  • the devices herein are moist to the touch.
  • an excessive amount of syneresis results in an ineffective and unattractive product.
  • the amount of syneresis is measured by the exudate release test, described under 'Methods'.
  • the gels comprising the devices have an exudate release of greater than 0.7 grams, and preferably greater than 0.8 grams and less than 1.3 grams, preferably less than 1.2 grams and more preferably less than 1.1 gram.
  • the mechanical properties of the pre-formed, gel sheet devices of the present invention are measured via compressive failure testing of the gel.
  • the parameters of interest are the strength (measured via the compressive force required to rupture a moulded cylinder of gel) and the flexibility (measured via the extent of gel compression at the point of rupture).
  • the gels comprising the devices have a percentage compression at rupture of greater than 45%, preferably greater than 50% and less than 90%, preferably less than 80%.
  • the gels comprising the devices require a force to rupture of greater than 30N, preferably greater than 60N and more preferably greater than 80N.
  • the pre-formed, gel sheet devices of the present invention comprise water.
  • the total water content of a pre-formed, gel sheet device of the present invention is from about 30% to about 99.5%, preferably from about 40% to about 95%, more preferably from about 50% to about 85% by weight of the device.
  • the pre-formed, gel sheet devices herein comprise a safe and effective amount of one or more benefit agents.
  • safe and effective amount means an amount of a benefit agent high enough to modify the condition to be treated or to deliver the desired skin, hair or nail benefit, but low enough to avoid serious side effects, at a reasonable benefit to risk ratio within the scope of sound medical judgement. What is a safe and effective amount of the benefit agent will vary with the specific agent, the ability of the agent to penetrate through the skin, into, or onto the hair and/or nails, the user's age, the user's health condition, and the condition of the skin, hair or nails of the user, and other like factors.
  • the benefit agents include their pharmaceutically-acceptable salts and by "pharmaceutically-acceptable salts" are meant any of the commonly-used salts that are suitable for use in contact with the tissues of humans without undue toxicity, irritation, incompatibility, instability, irritation, allergic response, and the like.
  • the pre-formed, gel sheet devices of the present invention comprise from about 0.01% to about 40%, preferably from about 0.05% to about 30% and most preferably from about 0.1% to about 20% by weight of the device of at least one benefit agent, or mixtures thereof.
  • the benefit agents useful herein can be categorised by their therapeutic benefit or their postulated mode of action. However, it is to be understood that the benefit agents useful herein can in some instances provide more than one therapeutic benefit or operate via more than one mode of action. Therefore, classifications herein are made for the sake of convenience and are not intended to limit the benefit agent to that particular application or applications listed. The following benefit agents are useful in the pre-formed, gel sheet devices of the present invention.
  • Anti-acne actives can be effective in treating and preventing acne vulgaris, a chronic disorder of the pilosebaceous follicles.
  • the condition involves inflammation of the pilosebaceous apparatus thereby resulting in lesions, which may include papules, pustules, cysts, comedones, and severe scarring.
  • the bacteria Corynebacterium acnes and Staphylococcus epidermis are usually present in the pustular contents. Examples of useful anti-acne actives include the keratolytics described in WO98/18444.
  • retinoids such as retinoic acid (e.g., cis and/or trans) and its derivatives (e.g., esters); retinol and its esters (e.g., retinyl propionate, retinyl acetate); abietic acid, adapalene, tazarotene, allantoin, aloe extracts, arbietic acid and its salts, ASEBIOL (available from Laboratories Serobiiquess located in Somerville, NJ), azaleic acid, barberry extracts, bearberry extracts, belamcanda chinensis, benzoquinolinones, benzoyl peroxide, berberine, BIODERMINE (available from Sederma located in Brooklyn, NY), bioflavonoids as a class, bisabolol, s-carboxymethyl cysteine, carrot extracts, cassin oil, clove extracts, citral, citronellal, climazole,
  • Non-Steroidal Anti-Inflammatory Actives examples of suitable NSATDS and their esters for use herein are described in WO98/18444, incorporated herein by reference. Further non-limiting examples of non-steroidal anti-inflammatory drugs (NSATDS) include flufenamic acid; panthenol and ether and ester derivatives thereof e.g.
  • the plant genus/species Glycyrrhiza glabra family including glycyrrhetic acid, glycyrrhizic acid, and derivatives thereof e.g. salts such as ammonium glycyrrhizinate and esters such as stearyl glycyrrhetinate.
  • Topical Anaesthetics examples of suitable topical anaesthetic drugs for use herein are benzocaine and bupivacaine. Further suitable examples are described in WO98/18444, incorporated herein by reference.
  • Artificial tanning agents can help in simulating a natural suntan by increasing melanin in the skin or by producing the appearance of increased melanin in the skin.
  • Non-limiting examples of artificial tanning agents and accelerators include glucose tyrosinate and acetyl tyrosine, brazilin, caffeine, coffee extracts, DNA fragments, isobutyl methyl xanthine, methyl xanthine, PHOTOTAN (available from Laboratoires Serobiiquess located in Somerville, NJ), prostaglandins, tea extracts, theophylline, UNIPERTAN P2002 (available from Unichem, located in Chicago, IL) and UNIPERTAN P27 (available from Unichem, located in Chicago, IL); and mixtures thereof. Further useful artificial tanning agents herein are described in WO98/18444.
  • Antiseptics examples include alcohols, benzoate, sorbic acid, and mixtures thereof.
  • Anti-microbial and anti-fungal actives can be effective to prevent the proliferation and growth of bacteria and fungi.
  • Non-limiting examples of antimicrobial and antifungal actives include ketoconazole, ciclopirox, benzoyl peroxide, tetracycline, azelaic acid and its derivatives, ethyl acetate, alantolactone, isoalantolactone, alkanet extract (alaninin), anise, arnica extract (helenalin acetate and 11, 13 dihydrohelenalin), aspidium extract (phloro, lucinol containing extract), barberry extract (berberine chloride), bay sweet extract, bayberry bark extract (myricitrin), benzalkonium chloride, benzethonium chloride, benzoic acid and its salts, benzoin, benzyl alcohol, blessed thistle, bletilla tuber, bloodroot, bois de rose oil, burdock,
  • Skin soothing agents can be effective in preventing or treating inflammation of the skin.
  • the soothing agent enhances the skin appearance benefits of the present invention, e.g., such agents contribute to a more uniform and acceptable skin tone or colour.
  • Non-limiting examples of skin soothing agents include absinthium, acacia, aescin, alder buckthorn extract, allantoin, aloe, APT (available from Centerchem, located in Stamford, CT), arnica, astragalus, astragalus root extract, azulene, BAICALIN SR 15 (available from Barnet Products Dist.
  • sunscreening agents examples include diethanolamine p-methoxycinnamate, dioxybenzone, ethyl dihydroxypropyl PABA, glyceryl aminobenzoate, lawsome and dihydroxyacetone, menthyl anthranilate, methyl anthranilate, octyl dimethyl PABA, red petroleum, sulisobenzone, triethanolamine salicylate, and mixtures thereof.
  • Skin Barrier Repair Aids are those skin care aids which can help repair and replenish the natural moisture barrier function of the epidermis.
  • Suitable examples of skin barrier repair aids include brassicasterol, caffeine, campesterol, canola derived sterols, CERAMAX (available from Quest, located in Ashford, England), CERAMIDE 2 (available from Sederma, located in Brooklyn, NY), CERAMIDE HO3TM (available from Sederma, located in Brooklyn, NY), CERAMIDE TT (available from Quest, located in Ashford, England), CERAMIDE ITT (available from Quest, located in Ashford, England), CERAMIDE TUB (available from Cosmoferm, located in Delft, Netherlands), CERAMIDE IS 3773 (available from Laboratories Serobi unanimouss, located in Somerville, NJ), CERAMINOL (available from Inocosm, located in Chatenay Malabry, France), CERASOL (available from Pentapharm, located in Basel, Switzerland), CEPHAL ⁇ P (available from Pentapharm, located in Basel, Switzerland), cholesterol, cholesterol hydroxystearate, cholesterol isostearate, 7-dehydrocholesterol, DERMATEIN BRC
  • Anti-wrinkle and anti-skin atrophy actives can be effective in replenishing or rejuvenating the epidermal and/or dermal layer. These actives generally provide these desirable skin care benefits by promoting or maintaining the natural process of desquamation and/or building skin matrix components (e.g., collagen and glycosaminoglycans).
  • skin matrix components e.g., collagen and glycosaminoglycans.
  • Non-limiting examples of anti-wrinkle and anti-skin atrophy actives include nicotinic acid and its esters, nicotinyl alcohol, estrogens and estrogenic compounds, or mixtures thereof. Further suitable anti-wrinkle and anti-skin atrophy actives useful herein are described in WO98/18444.
  • Skin repair actives can be effective in repairing the epidermal and/or dermal layer.
  • skin repair actives include actein 27 - deoxyactein cimicifugoside (cimigoside), adapalene, tazarotene, ademethionine, adenosine, aletris extract, aloe derived lectins, 3-aminopropyl dihydrogen phosphate, AMADORTNE (available from Barnet Products, located in Englewood, NJ), anise extracts, AOSINE (available from Secma, located in Pontrieux, France), arginine arnino benzoate, ASC ITT (available from E.
  • BIOPEPTTDE EL available from Sederma, located in Brooklyn, NY
  • biotin blackberry bark extract, blackberry lily extracts, black cohosh extract, blue cohesh extract, butanoyl betulinic acid, catecholamines, chalcones, chaste tree extract, cis retinoic acid, citric acid esters, clover extracts, coenzyme Q10 (ubiquinone), coumestrol, CPC
  • PEPTIDE Barnet Products, located in Englewood, NJ
  • daidzein dang gui extract
  • damtoside debromo laurinterol
  • 1-decanoyl-glycero-phosphonic acid dehydrocholesterol, dehydrodicreosol, dehydrodieugenol, dehydroepiandrosterone, DERMOLECTINE
  • flavonoids especially flavanones such as unsubstituted flavanone and chalcones such as unsubstituted chalcone and monohydroxy and dihydroxy chalcones
  • formononetin forsythia fruit extract
  • gallic acid esters gamma amino butyric acid
  • GATULINE RC available from Gattlefosse, located in Saint Priest, France
  • genistein genistic acid
  • gentisyl alcohol gingko bilboa extracts
  • ginseng extracts ginsenoside
  • RO R ⁇ -i, R ⁇ -2,R ⁇ -3, Re, RD, RE, RF, RF-2, RG-I , RG-2, gl co pyranosyl-1- ascorbate, glutathione and its esters, glycitein, eptyloxy 4 salicylic acid, hesperitin, hexahydro curcumin, HMG-Coenzyme A Reductase Inhibitors, hops extracts, 11 hydroxy undecanoic acid, 10 hydroxy decanoic acid, 25-hydroxycholesterol, ISOFAVONE SG 10
  • O- desmethylangoiensin O- desmethylangoiensin, oleanolic acid, pantethine, phenylalanine, photoanethone, phytic acid and its salts, piperdine, placental extracts, pratensein, pregnenolone, pregnenolone acetate, pregnenolone succinate, premarin, quillaic acid, raloxifene, REPAIR FACTOR 1
  • REPAIR FACTOR SPC available from Sederma, located in Brooklyn, NY
  • retinal retinoates (esters of C 2 -C 20 alcohols), retinol, retinyl acetate, retinyl glucuronate, retinyl linoleate, retinyl palmitate, retinyl propionate, REVITALTN BT (available from Pentapharm, located in Basel, Switzerland), s-carboxymethyl cysteine, salicylic acid, SEANAMINE FP (available from Laboratories
  • lipids examples include cetyl ricinoleate, cholesterol hydroxystearate, cholesterol isostearate, CREMEROL (available from Amerchol, located in Edison, NJ),
  • ESTERS available from Croda, located in Parsippany, NJ), or mixtures thereof.
  • Skin lightening agents can actually decrease the amount of melanin in the skin or provide such an effect by other mechanisms.
  • Skin lightening agents suitable for use herein are described in EP-A-758,882 and EP-A-748,307, both of which are incorporated herein by reference.
  • Further examples of skin lightening agents include adapalene, aloe extract, aminotyrosine, ammonium lactate, anethole derivatives, apple extract, arbutin, ascorbic acid, ascorbyl palmitate, azelaic acid, bamboo extract, bearberry extract, bletilla tuber, bupleurum falcatum extract, bumet extract, BURNET POWDER
  • GATULINE WHITENING available from Gattefosse, located in Saint Priest, France
  • genistic acid and its derivatives gentisyl alcohol, glabridin and its derivatives, gluco pyranosyl-1-ascorbate, gluconic acid, glucosamine, glycolic acid, glycyrrhizinic acid, green tea extract, 4-hydroxy-5-methyl-3[2h]-furanone, hydroquinine, 4-hydroxyanisole and its derivatives, 4-hydroxy benzoic acid derivatives, hydroxycaprylic acid, inositol ascorbate, kojic acid, lactic acid, lemon extract, licorice extract, LICORICE P-TH
  • MELA WHITE available from Pentapharm, located in Basel, Switzerland
  • mo s alba extract mulberry root extract, niacinamide, nicotinic acid and its esters, nicotinyl alcohol, 5-octanoyl salicylic acid, parsley extract, phellinus linteus extract, placenta extract, pyrogallol derivatives, retinoic acid, retinol, retinyl esters (acetate, propionate, palmitate, linoleate), 2,4 resorcinol derivatives, 3,5 resorcinol derivatives, rose fruit extract, cinol, salicylic acid, song-yi extract, SOPHORA POWDER (available from Barnet Products, located in Englewood, NJ), 4-thioresorein, 3, 4, 5 trihydroxybenzyl derivatives, tranexamic acid, TYROSLAT 10,11 (available from Fytokem), vitamin D 3 and its anaologs
  • Sebum inhibitors can decrease the production of sebum in the sebaceous glands.
  • suitable sebum inhibitors include aluminium hydroxy chloride, ASEBIOL (available from Laboratories Serobi unanimouss, located in Somerville,
  • BIODERMINE available from Sederma, located in Brooklyn, NY
  • climbazole
  • Sebum stimulators can increase the production of sebum by the sebaceous glands.
  • Non-limiting examples of sebum stimulators include bryonolic acid,
  • Non-limiting examples of suitable skin sensates for use herein include agents which impart a cool feel such as camphor, thymol, 1 -menthol and derivatives thereof, eucalyptus, carboxamides; menthane ethers and menthane esters; and agents imparting a warm feel such as cayenne tincture, cayenne extract, cayenne powder, vanillylamide nonanoate, nicotinic acid derivatives (benzyl nicotinate, methyl nicotinate, phenyl nicotinate, etc.), capsaicin, nasturtium officinale extract, Zanthoxylum piperitum extract and ginger extract, or mixtures thereof.
  • agents which impart a cool feel such as camphor, thymol, 1 -menthol and derivatives thereof, eucalyptus, carboxamides; menthane ethers and menthane esters; and agents imparting a warm feel such as cayenne
  • Protease inhibitors are compounds which inhibit the process of proteo lysis, that is, the splitting of proteins into smaller peptide fractions and amino acids.
  • suitable protease inhibitors include A E COMPLEX (available from Barnet Products located in Englewood, NJ), ALE (available from Laboratoires Seporgia located in Hospital Antipolis, France), allicin, AOSATNE (available from Secma Biotechnologies Marine located in Pontrieux, France), APROTININ (available from Pentapharm AG located in Basel, Switzerland), areca catechu extracts, BLUE ALGAE EXTRACT (available from Collaborative Labs Inc.
  • PEFABLOC SP available from Pentapharm AG located in Basel, Switzerland
  • SEPICONTROL AS available from Seppic located in Paris, France
  • S ⁇ EGESBECKIA available from Sederma located in Brooklyn, NY
  • SOPHORINE available from Barnet Products located in Englewood, NJ
  • THIOTATNE available from Barnet Products located in Englewood, NJ
  • Non-limiting examples of skin tightening agents include BIOCARE SA (available from Amerchol located in Edison, NJ), egg albumen, FLEXAN 130 (available from National Starch located in Bridgewater, NJ), GATULTNE LIFTING (available from Gattefosse located in Saint Priest, France), PENTACARE HP (available from Pentapharm AG located in Basel, Switzerland), VEGESERYL (available from Laboratories Serobioloques located in Somerville, NJ), and mixtures thereof.
  • Non-limiting examples of anti-itch ingredients include STTMU- TEX (available from Pentapharm AG located in Basel, Switzerland), TAKANAL (available from Ikeda-Distributor, located in Tokyo, Japan), ICHTHYOL (available from International Sourcing-Distributor, located in Upper Saddle River, NJ), OXYGENATED GLYCERYL TRIESTERS (available from Laboratoires Seporgia located in Hospital Antipolis, France), and mixtures thereof.
  • Non-limiting examples of suitable agents for inhibiting hair growth include 17 beta estradiol, adamantyguanidines, adamantylamidines, adenylosuccinate synthase inhibitors, anti angiogenic steroids, aspartate transcarbamylase inhibitors, betamethasone valerate, bisabolol, copper ions, curcuma extract, cycloxygenase inhibitors, cysteme pathway inhibitors, dehydroacetic acid, dehydroepiandrosterone, diopyros leak extract, epidermal growth factor, epigallocatechin, essential fatty acids, evening primrose oil, gamma glutamyl transpeptidase inhibitors, ginger oil, glucose metabolism inhibitors, glutamine metabolism inhibitors, glutathione, green tea extracts, heparin, KAPILANNE (available from International Sourcing Distributor, located in Upper Saddle River, NJ), L, 5 diammopentanoic acid, L-as
  • Non-limiting examples of 5-alpha reductase inhibitors include CLOVE 55 (available from Barnet Products Distributor located in Englewood, NJ), ethynylestradiol, geisseine, genistine, Licochalcone LR-15, saw palmetto extracts, SOPHORA EXTRACT (available from Maruzen located in Morristown, NJ), ZINCIDONE (available from UCTB, located in Clifton, NJ), and mixtures thereof
  • Desquamation Enzyme Enhancers These agents enhance the activity of endogenous desquamating enzymes.
  • Non-limiting examples of desquamation enzyme enhancers include, N-methyl serine, serine, trimethyl glycine, and mixtures thereof.
  • Anti Glycation Agents Anti-glycation agents prevent the sugar induced crosslinking of collagen.
  • a suitable example of an anti-glycation agent includes AMADORINE (available from Barnet Products Distributor located in Englewood, NJ).
  • benefit agents useful herein include those selected from the group consisting of salicylic acid, niacinamide, tocopheryl nicotinate, benzoyl peroxide, 3- hydroxy benzoic acid, fiavonoids (e.g., flavanone, chalcone), famesol, phytantriol, glycolic acid, lactic acid, 4-hydroxy benzoic acid, acetyl salicylic acid, 2-hydroxybutanoic acid, 2-hydroxypentanoic acid, 2-hydroxyhexanoic acid, cis-retinoic acid, trans-retinoic acid, retinol, retinyl esters (e.g., retinyl propionate), phytic acid, N-acetyl-L-cysteine, lipoic acid, tocopherol and its esters (e.g., tocopheryl acetate), azelaic acid, arachidonic acid, tetracycline, ibuprofen, naproxen,
  • the benefit agent is preferably selected from anti-wrinkle and anti-skin atrophy actives, anti-acne actives, artificial tanning agents and accelerators, skin repair actives, skin barrier repair aids, skin lightening agents, skin sensates, skin soothing agents, lipids, sebum inhibitors, sebum stimulators, sunscreening agents, protease inhibitors, skin tightening agents, anti-itch ingredients, and desquamation enzyme enhancers, or mixtures thereof.
  • Humectants selected from anti-wrinkle and anti-skin atrophy actives, anti-acne actives, artificial tanning agents and accelerators, skin repair actives, skin barrier repair aids, skin lightening agents, skin sensates, skin soothing agents, lipids, sebum inhibitors, sebum stimulators, sunscreening agents, protease inhibitors, skin tightening agents, anti-itch ingredients, and desquamation enzyme enhancers, or mixtures thereof.
  • Preferred pre-formed, gel sheet devices comprise at least one humectant.
  • Humectants can be added to achieve a plasticising effect and to increase the moisturising characteristics of the pre-formed, sheet device when applied to the target surface.
  • Certain humectants such as hexylene glycol may also contribute to the antibacterial properties and characteristics of a pre-formed, gel sheet device of the present invention.
  • incorporating humectants into the preformed, gel sheet devices of the present invention increases the stability of the devices such that they are less likely to undergo decomposition under extreme temperature conditions.
  • the pre-formed, gel sheet devices of the present invention comprise from about 1.0% to about 45%, preferably from about 5% to about 40%, more preferably from about 10% to about 30% by weight of a humectant.
  • Suitable humectants for use in the present invention are described in WO98/22085, WO98/18444 and WO97/01326, all of which are incoporated herein by reference.
  • Further suitable humectants include amino acids and derivatives thereof such as proline and arginine aspartate, 1,3-butylene glycol, propylene glycol and water and codium tomentosum extract, collagen amino acids or peptides, creatinine, diglycerol, biosaccharide gum-1, glucamme salts, glucuronic acid salts, glutamic acid salts, polyethylene glycol ethers of glycerin (e.g.
  • glycereth 20 glycerin, glycerol monopropoxylate, glycogen, hexylene glycol, honey, and extracts or derivatives thereof, hydrogenated starch hydrolysates, hydrolyzed mucopolysaccharides, inositol, keratin amino acids, LAREX A-200 (available from Larex), glycosaminoglycans, methoxy PEG 10, methyl gluceth-10 and -20 (both commercially available from Amerchol located in Edison, NJ), methyl glucose, 3-methyl-l,3-butandiol, N-acetyl glucosarnine salts, panthenol, polyethylene glycol and derivatives thereof (such as PEG 15 butanediol, PEG 4, PEG 5 pentaerythitol, PEG 6, PEG 8, PEG 9), pentaerythitol, 1,2 pentanediol, PPG-1 glyceryl ether, PPG-9, 2-
  • the humectants for use herein are selected from glycerine, butylene glycol, hexylene glycol, panthenol and polyethylene glycol and derivatives thereof, or mixtures thereof
  • the pre-formed, gel sheet devices of the present invention can also optionally comprise one or more surfactants and/or emulsifiers.
  • Emulsifiers and/or surfactants generally help to disperse and suspend the discontinuous phase within the continuous phase.
  • a surfactant may also be useful if the product is intended for skin, hair or nail cleansing.
  • emulsifiers will be referred to under the term 'surfactants', thus 'surfactant(s)' will be used to refer to surface active agents whether used as emulsifiers or for other surfactant purposes such as skin, hair or nail cleansing.
  • Known or conventional surfactants can be used in the composition, provided that the selected agent is chemically and physically compatible with essential components of the composition, and provides the desired characteristics. Suitable surfactants include silicone materials, non-silicone materials, and mixtures thereof.
  • compositions of the present invention preferably comprise from about 0.01% to about 15% of a surfactant or mixture of surfactants.
  • a surfactant or surfactant mixture chosen will depend upon the pH of the composition and the other components present.
  • Preferred surfactants are nonionic.
  • the nonionic surfactants that are useful herein are the condensation products of alkylene oxides with fatty acids (i.e. alkylene oxide esters of fatty acids). These materials have the general formula RCO(X) n OH wherein R is a Ci 0-30 a lkyl group, X is -OCH2CH2- (i.e. derived from ethylene glycol or oxide) or -OCH2CHCH3- (i.e. derived from propylene glycol or oxide), and n is an integer from about 6 to about 200.
  • Other nonionic surfactants are the condensation products of alkylene oxides with 2 moles of fatty acids (i.e.
  • alkylene oxide diesters of fatty acids These materials have the general formula RCO(X) n OOCR wherein R is a C 19.30 alkyl group, X is -OCH2CH2-(i.e. derived from ethylene glycol or oxide) or -OCH2CHCH3-
  • n is an integer from about 6 to about 100.
  • Other nonionic surfactants are the condensation products of alkylene oxides with fatty alcohols (i.e. alkylene oxide ethers of fatty alcohols). These materials have the general formula R(X) n OR' wherein R is a C19.30 aliphatic group, X is -OCH2CH2-(i.e. derived from ethylene glycol or oxide) or -OQ ⁇ CHCLL- (i.e.
  • n is an integer from about 6 to about 100 and R' is H or a C 10-30 aliphatic group, examples of which include PEG 40 Hydrogenated Castor Oil, available under the trade name "Cremophor RH 40" from BASF (Parsippany, NJ, USA); PEG 60
  • Nonionic surfactants are the condensation products of alkylene oxides with both fatty acids and fatty alcohols [i.e. wherein the polyalkylene oxide portion is esterified on one end with a fatty acid and etherified (i.e. connected via an ether linkage) on the other end with a fatty alcohol].
  • These materials have the general formula RCO(X) n OR' wherein R and R' are C1 Q-30 alkyl groups, X is -OCH2CH2 (i.e.
  • n is an integer from about 6 to about 100, examples of which include ceteth-6, ceteth-10, ceteth-12, ceteareth-6, ceteareth-10, ceteareth-12, steareth-6, steareth-10, steareth-12, PEG-6 stearate, PEG- 10 stearate, PEG- 100 stearate, PEG- 12 stearate, PEG-20 glyceryl stearate, PEG-80 glyceryl tallowate, PEG- 10 glyceryl stearate, PEG-30 glyceryl cocoate, PEG-80 glyceryl cocoate, PEG-200 glyceryl tallowate, PEG-8 dilaurate, PEG- 10 distearate, and mixtures thereof.
  • nonionic surfactants that are useful herein are alkyl glucosides and alkyl polyglucosides which are described in more detail in WO98/18444, incorporated herein by reference.
  • Still other useful nonionic surfactants include polyhydroxy fatty acid amide surfactants, which are described in more detail in WO98/04241.
  • nonionic surfactants suitable for use herein include sugar esters and polyesters, alkoxylated sugar esters and polyesters, C1 -C30 fatty acid esters of C1-C30 fatty alcohols, alkoxylated derivatives of C1-C30 fatty acid esters of C1 -C30 fatty alcohols, alkoxylated ethers of C1-C30 fatty alcohols, polyglyceryl esters of C1-C30 fatty acids, C1 -C30 esters of polyols, C1-C30 ethers of polyols, alkyl phosphates, polyoxyalkylene fatty ether phosphates, fatty acid amides, acyl lactylates, and mixtures thereof.
  • non-silicon-containing surfactants examples include: polysorbate 20, polyethylene glycol 5 soya sterol, steareth-20, ceteareth-20, PPG-2 methyl glucose ether distearate, polysorbate 80; polysorbate 60, available under the trade name "Tween 60" from ICI (Wilmington, MA, USA); glyceryl stearate, sorbitan monolaurate, polyoxyethylene 4 lauryl ether sodium stearate, polyglyceryl-4 isostearate, hexyl laurate, PPG-2 methyl glucose ether distearate, and mixtures thereof.
  • nonionic surfactants are those selected from ceteareth-12, sucrose cocoate, steareth-100, polysorbate 60, PEG-60 Hydrogenated Castor Oil, isoceteth-20, oleth-20, PEG-100 stearate, and mixtures thereof.
  • emulsifiers for use herein are polyoxypropylene, polyoxyethylene ethers of fatty alcohols. These materials have the general formula R(CH2CHCH3O) x - (CH2CH2 ⁇ )y-H, wherein R is an OC10-C30 alkyl group or C10- 30 alkyl group, x has an average value from 1 to 20 and y has an average value from 1 to 30, examples of which include PPG-6-Decyltetradeceth-30, available under the trade name "Pen 4630" from Nikko Chemicals Co. Ltd. (Tokyo, Japan); PPG-6-Decyltetradeceth-20, available under the trade name "Pen 4620” from Nikko Chemicals Co. Ltd. (Tokyo, Japan); and PPG-5- Ceteth-20, available under the trade name "Procetyl AWS” from Croda Chemicals Ltd. (Goole, North Humberside, England).
  • emulsifier useful herein are fatty acid ester blends based on a mixture of sorbitan or sorbitol fatty acid ester and sucrose fatty acid ester, as described in more detail in WO98/22085, incorporated by reference herein.
  • hydrophilic surfactants useful herein can alternatively or additionally include any of a wide variety of cationic, anionic, zwitterionic, and amphoteric surfactants such as are known in the art. See, e.g., McCutcheon's, Detergents and Emulsifiers, North American Edition (1986), published by Allured Publishing Corporation; US-A-5,011,681 to Ciotti et al., issued April 30, 1991; US-A-4,421,769 to Dixon et al., issued December 20, 1983; and US-A-3,755,560 to Dickert et al, issued August 28, 1973; these four references are incorporated herein by reference in their entirety.
  • cationic surfactants are useful herein. Suitable cationic surfactants for use herein are disclosed in WO98/18444. A wide variety of anionic surfactants are also useful herein. See, e.g., US-A-3,929,678, to
  • anionic surfactants include the alkoyl isethionates (e.g., C12 -
  • alkyl and alkyl ether sulfates and salts thereof alkyl and alkyl ether phosphates and salts thereof, alkyl methyl taurates (e.g., C12 - C30), and soaps (e.g., alkali metal salts, e.g., sodium or potassium salts) of fatty acids.
  • amphoteric and zwitterionic surfactants are also useful herein.
  • amphoteric and zwitterionic surfactants which can be used in the compositions of the present invention are those which are broadly described as derivatives of aliphatic secondary and tertiary amines in which the aliphatic radical can be straight or branched chain and wherein one of the aliphatic substituents contains from about 8 to about 22 carbon atoms (preferably Cg - Ci g) and one contains an anionic water solubilising group, e.g., carboxy, sulfonate, sulfate, phosphate, or phosphonate.
  • amphoteric and zwitterionic surfactants are those selected from the group consisting of betaines, sultaines, hydroxysultaines, alkyl sarcosinates (e.g., C12 - C30), and alkanoyl sarcosinates.
  • the pre-formed, gel sheet devices of the present invention may optionally contain a silicone containing emulsifier or surfactant.
  • a silicone containing emulsifier or surfactant may optionally contain a silicone containing emulsifier or surfactant.
  • silicone emulsifiers are useful herein. These silicone emulsifiers are typically organically modified organopolysiloxanes, also known to those skilled in the art as silicone surfactants.
  • Useful silicone emulsifiers include dimethicone copolyols. These materials are polydimethyl siloxanes which have been modified to include polyether side chains such as polyethylene oxide chains, polypropylene oxide chains, mixtures of these chains, and polyether chains containing moieties derived from both ethylene oxide and propylene oxide.
  • dimethicone copolyols examples include alkyl-modified dimethicone copolyols, i.e., compounds which contain C2-C30 pendant side chains.
  • Still other useful dimethicone copolyols include materials having various cationic, anionic, amphoteric, and zwitterionic pendant moieties.
  • the present invention can also optionally comprise oil soluble conditioning agents.
  • conditioning agents useful as oil soluble conditioning agents include those selected from the group consisting of mineral oil, petrolatum, C7-C40 branched chain hydrocarbons, C1-C30 alcohol esters of C1-C30 carboxylic acids, C1-C30 alcohol esters of C2-C30 dicarboxylic acids, monoglycerides of C1-C30 carboxylic acids, diglycerides of C1-C30 carboxylic acids, triglycerides of C1-C30 carboxylic acids, ethylene glycol monoesters of C1-C30 carboxylic acids, ethylene glycol diesters of Cl- C30 carboxylic acids, propylene glycol monoesters of C1-C30 carboxylic acids, propylene glycol diesters of C1-C30 carboxylic acids, C1-C30 carboxylic acid monoesters and polyesters of sugars, polydialkylsiloxanes, polydiarylsilox
  • compositions of the present invention can comprise a wide range of other optional components. These additional components should be pharmaceutically acceptable.
  • abrasives examples include: abrasives, absorbents, antibiotics, anticaking agents, anti- dandruff agents, anti-perspirant agents, antioxidants, vitamins, biological additives, bleach, bleach activators, brighteners, builders, buffering agents, chelating agents, chemical additives, colorants, cosmetics, cleansers, cosmetic astringents, cosmetic biocides, denaturants, dental treatments, deodorants, desquamation actives, depilatories, drug astringents, dyes, dye transfer agents, enzymes, external analgesics, flavors, film formers, fragrance components, insect repellants, mildewcides, opacifying agents, oxidative dyes, oxidising agents, pest control ingredients, pH adjusters, pH buffers, pharmaceutical actives, plasticizers, preservatives, radical scavengers, skin, hair or nail bleaching agents, skin, hair or nail conditioners, skin, hair or nail penetration enhancers, stabilisers, surface conditioners, reducing agents
  • aesthetic components such as colorings, essential oils, and skin, hair or nail healing agents.
  • pigments include pigments.
  • Pigments suitable for use in the compositions of the present invention can be organic and/or inorganic. Also included within the term pigment are materials having a low colour or lustre such as matte finishing agents, and also light scattering agents. Examples of suitable pigments are iron oxides, acyglutamate iron oxides, titanium dioxide, ultramarine blue, D&C dyes, carmine, and mixtures thereof. Depending upon the type of composition, a mixture of pigments will normally be used.
  • substrates which are compatible with the properties of the pre-formed, gel sheet devices.
  • suitable substrates are paper, for example "Kimwipes EX-L” available from Kimberley-Clarke Corp., Roswell, GA, USA, and collagen sheets, for example "Collagen Fiber Mask” available from Beaute Attica Inc., Redmond, WA, USA; “Professional Collagen Masks” available from Luminescence, Maple Plain, MN, USA; “Pure Soluble Collagen Lifting Masque” available from Five Star Formulators Inc., Palo Alto, CA, USA; and “Pure Collagen Masks” available from Maybrook Inc., Lawrence, MA, USA.
  • the pH of the sheet devices herein is preferably from about 3 to about 9, more preferably from about 4 to about 8.
  • the pre-formed, gel sheet devices of the present invention are patches or masks having a size and shape adapted to conform to the desired target area. The exact size and shape will depend upon the intended use and product charcteristics.
  • the pre-formed, gel sheet devices herein are suitable for topical application to the nails or cuticles, the hair or scalp, a human face or part thereof, legs, hands, arms, feet, or human torso.
  • the devices herein may be for example, square, circular, rectangular, oval, or other shapes which are composites of these such as shapes that could be described as "semi-circle", "donut", or others.
  • the surface area for devices shaped to fit the face have a surface area ranging from
  • the devices herein have a thickness of from about 0.5 mm to about 20 mm, preferably from about 1 mm to about 5 mm.
  • the pre-formed, sheet devices of the present invention may also be made and used in the form of handwear, footwear, or a body wrap.
  • the handwear will comprise a glove for the hand or any portion thereof
  • the footwear will comprise a sock for the foot or any portion thereof.
  • the term "glove” is meant to be inclusive of
  • the handwear comprises a glove body comprising a middle section, from one to four finger receptacles connected with the middle section, a thumb receptacle connected with the middle section, a palm side and an opposite back side.
  • the footwear comprises a sock body forming a tubular foot portion having a closed end and an open end.
  • inventive devices may also be made or used in the form of a body wrap.
  • the body wrap is wrapped radially around any body part having a longitudinal axis. Its ends may communicate with each other, or its length may be shortened so as to only wrap partially around. In either case, the wraps should exhibit excellent conformity to the shape of the body part.
  • body parts will include the user's back, upper arm, lower arm, upper leg, lower leg, neck, and torso.
  • the device may be left on the target area for about 3 hours, preferably about 1 hour, more preferably less than 15 minutes.
  • the pre-formed, gel sheet device can then be removed all in one piece.
  • the pre-formed, gel sheet devices of the present invention may have at least one of the following uses; hydrating the skin, hair or nails, smoothing fine lines and wrinkles; cosmetically treating acne; firming the skin; strengthening; softening; exfoliating; improving and/or evening skin tone and/or texture; skin, hair or nail lightening; conditioning the skin or hair; tanning; reducing the appearance of pores; absorbing or controlling secretions; protecting and/or soothing the skin, hair or nails, muscles, aches or pains; reducing puffiness, and/or dark circles; stimulating wound healing; warming, refreshing or cooling the skin; relieving inflammation; brightening the complexion; decongesting; reducing swelling; treating dermatological conditions; cushioning; purifying; fragrancing; reducing bacterial or micro-organism growth; healing; repelling insects; removing unwanted hair, dirt, or make-up; and colouring or bleaching the target area to which the device is applied.
  • the amount of syneresis from a pre-formed, gel sheet device of the present invention is measured on a gel comprising the device via an exudate release test.
  • a gel formulation of interest is prepared as described below. While still a hot liquid (>80°C), nine grams (+/- 0.1 g) is poured into a 91 mm diameter shallow receptacle, e.g. the lid of a Falcon- 1029 Petri dish. This receptacle is hermetically sealed to reduce evaporative losses. The gel is allowed to solidify undisturbed with cooling to room temperature. The gel is stored at room temperature overnight before readings are taken. The covering is removed and the receptacle with sample tared (+/- 0.005g). Three pieces of filter paper (9.0 cm Whatman- 114 Wet Strengthened) are stacked on the flat gel surface.
  • a 9.0 cm diameter flat-bottomed weight of 200 g is placed on the filter paper to ensure close contact with the gel surface. After one minute the weight is removed and filter paper gently peeled away from the gel. The paper should impart a clearly visible matte surface to the gel, which confirms good contact by the filter paper. The sample is reweighed and mass loss calculated by difference. This is reported as grams of exudate released for the 9cm diameter gel disc described above.
  • Compressive failure testing is performed using a Stable Micro Systems (SMS) Texture Analyser (TA), model TA-XT2i available from Stable Micro Systems Ltd (Godalming, Surrey, UK).
  • SMS Texture Expert Exceed software
  • a 100 mm diameter Aluminum compression plate (P-100 probe) is attached to a 50 Kg load cell. This is mounted within the TA Probe Carrier, the extended arm whose vertical travel is under computer control.
  • a gel formulation of interest is prepared as described below.
  • Gel discs of a precise cylindrical-solid shape (26 mm diameter by 12 mm depth) are formed in moulds.
  • the moulds with sample are hermetically sealed against evaporation during storage. These gel discs are stored at ambient temperature overnight.
  • Each gel disc is removed from its mould just prior to testing and visually inspected for defects. Any gel discs with defects (e.g. trapped air bubbles) are discarded as these defects may impact the measured mechanical properties.
  • the non-defective gel disc is then centered under the P- 100 compression plate.
  • the Texture Expert Exceed software is set-up in Force / Compressive mode.
  • the compression plate is pre-set to a starting height of 12.0 mm. Its rate of descent is set to 0.8 mm/second and total travel distance set to 10.8 mm (i.e. measurement stops when the gel disc is compressed by 90% of its original height). Data is automatically collected on force and position of the compression plate at the rate of 200 pps (points per second).
  • the software is pre-set to mark the compression plate position at the maximum force achieved. This maximum force is the mpture strength, that is, the force required to rapture the gel disc.
  • the distance travelled by the plate from its original starting height to the point of gel mpture represents the extent of deformation of the gel. The maximum force at the point of rupture is averaged across samples (typically 5 replicates) and reported in Newtons.
  • KelgumTM is a 1 :1 mixture of xanthan gum and locust bean gum supplied by Kelco, San Diego, CA, USA.
  • the polysaccharide gums are mixed with water to form a uniform dispersion (this can be facilitated by pre-dispersing the polysaccharides in a non-solvent e.g. polyhydric alcohol) and any additional components are added.
  • a non-solvent e.g. polyhydric alcohol
  • the mixture is heated with stirring to a first temperature above the gel point of the mixture (ca. 90°C) to fully hydrate the polysaccharide gums.
  • the liquid gel is then dispensed into a suitably shaped mould.
  • the gel is dispensed via injection moulding. This eliminates any defects which may be introduced by cutting the gel and so improves the robustness of the device.
  • Injection moulding also allows devices to be readily formed with varying regions of thickness and other structural features.
  • the liquid gel may be cast into a sheet.
  • the liquid gel is then cooled to a second temperature cooler than the first temperature at or below the gel point of the mixture (e.g. ambient temperature) to set up the gel structure.
  • the device may then be removed from the mould or appropriately shaped patches may be cut from the gel sheet.
  • the devices herein are then packaged into materials which have low water vapour permeability to minimise drying out of the device during storage.
  • Suitable packaging for devices herein include sachets or sealed trays. If the device is packaged in a sachet, it is preferably protected prior to use. This protection can be provided by a release liner such as a plastic film, which provides easy release for the device.
  • a substrate is to be used, this may be placed in the suitably shaped mould prior to dispensing the gel or it may be placed on the surface of the liquid gel during the cooling stage.
  • metal ions e.g. Ca 2+ , K +
  • the metal ions may be included in the formulation to increase the gel strength of the device.
  • the metal ions are added in the form of an aqueous solution and are stirred into the hydrated liquid gel as the final addition to the mixture.
  • the above method may be modified as necessary depending on the nature of any additional components.
  • the liquid gel may be homogenised immediately prior to moulding or casting to ensure dispersion of the non-aqueous components.
  • the formulation should be cooled to an appropriate temperature (dependent on the ingredient) after the gum hydration step and the heat sensitive ingredient added at this stage.
  • the liquid gel may be de-gassed, e.g. by vacuum, to remove air bubbles dispersed within the liquid. This de-gassing step, if followed, would be the final step immediately prior to dispensing the liquid gel.
  • the pre-formed, gel sheet devices herein display desirable amounts of syneresis and have excellent strength and flexibility.
  • Examples 7 - 14 are comparative examples of gel patches described in the literature, and the gels are prepared according to the methods outlined in Examples 1-6 herein. Measurements are taken on the exudate release from the gel compositions, the percentage compression at the point of rapture and the force required to rapture the gel for each example, and the results obtained from these measurements are shown. As can be seen from these comparative examples, whilst most of the gels comprising the patches discussed in the literature meet one or two of the parameters described by the present invention, none of the gels of the examples have a desirable amount of syneresis, strength and flexibility.
  • KelgumTM is a 1 :1 mixture of xanthan gum and locust bean gum supplied by Kelco, San Diego, CA, USA.
  • Orgasol 2002D TM is Nylon- 12 powder commercially available from ELF Atochem, Paris, France.
  • Example 7 WO90/14110, Example 2 - no calcium alginate
  • Example 8 WO90/14110, Example 3 - no calcium alginate.
  • Example 9 JP920649, Example 1.
  • Example 10 EP-A-803245, Gel based on teaching in document.
  • Example 11 GB 1,341, 999, Example 2 - no silver nitrate.
  • Example 12 EP-A-161681, Example 1.
  • Example 13 EP-A- 161681, Gel based on teaching that the polysaccharide gum may comprise a combination of carrageenan and galactomannan.
  • Example 14 US-A-4,661,475, Example 3.

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