WO2019203813A1 - Compositions contenant des tétrahydrocurcuminoïdes pour l'amélioration de la santé et de l'hygiène buccales - Google Patents

Compositions contenant des tétrahydrocurcuminoïdes pour l'amélioration de la santé et de l'hygiène buccales Download PDF

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Publication number
WO2019203813A1
WO2019203813A1 PCT/US2018/028077 US2018028077W WO2019203813A1 WO 2019203813 A1 WO2019203813 A1 WO 2019203813A1 US 2018028077 W US2018028077 W US 2018028077W WO 2019203813 A1 WO2019203813 A1 WO 2019203813A1
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WIPO (PCT)
Prior art keywords
tablets
candies
gingivitis
lotions
ointments
Prior art date
Application number
PCT/US2018/028077
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English (en)
Inventor
Muhammed Majeed
Kalyanam Nagabhushanam
Shaheen Majeed
Original Assignee
Muhammed Majeed
Kalyanam Nagabhushanam
Shaheen Majeed
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 Muhammed Majeed, Kalyanam Nagabhushanam, Shaheen Majeed filed Critical Muhammed Majeed
Priority to PCT/US2018/028077 priority Critical patent/WO2019203813A1/fr
Publication of WO2019203813A1 publication Critical patent/WO2019203813A1/fr

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    • 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
    • A61K31/12—Ketones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9783—Angiosperms [Magnoliophyta]
    • A61K8/9794—Liliopsida [monocotyledons]
    • 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
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0063—Periodont
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/485—Inorganic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses

Definitions

  • the present invention relates to a novel composition containing tetrahydroeurcuminoids for die improvement of oral health and hygiene. More specifically, the invention relates to a novel tetrahydrocurcuminoid composition and its application in therapeutic management of canker sore mid gingivitis.
  • the health and hygiene of the teeth, the mouth, and mucosal tracts of the oral cavity is important to a person's overall health-
  • the common type of oral disease include dental cavities, caries, bad breath and gum diseases, including canker sore, gingivitis, and periodontitis.
  • RAS Recurrent aphthous stomatitis
  • canker sores is one of the most common, painful oral ailments, characterized by multiple, small, round, or ovoid ulcers with circumscribed margins, erythematous haloes, and yellow or grey floors that presents itself in childhood or adolescence.
  • Scully C Porter S. Oral mucosal disease: recurrent aphthous stomatitis, Br J Oral Maxillofac Surg. 2008 Apr;46(3): 198-206; Preeti L, et al., Recurrent aphthous stomatitis, J Oral Maxillofac
  • Gingivitis affects an estimated 80% of the population and is the world's most predominant inflammatory periodontal disease. The disease is initiated with a pathogenic biofilm, or plaque, around the teeth followed by a host immune-inflammatory response that advances the disease.
  • the principle objective of the invention is to disclose a composition containing tetrahydrocurcuminoids and for the improvement of oral health and hygiene.
  • the present invention discloses a composition containing tetrahydrocurcuminoids for the improvement of oral health and hygiene. Specifically the invention discloses a novel composition of tetrahydrocurcuminoids for the therapeutic management of canker sore and gingivitis.
  • Fig,la shows graphical representation of median VAS seme at three time points; p value ⁇ 0.001 using Friedman ANNOV A,
  • Fig, lb shows graphical representation of median throat relief score at three points
  • Fig. lc shows graphical representation of distribution of patients as per throat numbness at different time points
  • Fig. 2a and 2b shows Line plots mean values of different LOE & SILNESS Index parameters ami total points at three times in Gingivitis group
  • the invention relates to a novel composition containing tetrahydrocurcuminoids for the improvement of oral health and hygiene.
  • the composition contains tetrahydrocurcumin, teirahydrodemethoxycurcumin, tetrahydrobis-demethoxycurcumin, octahydrocurcuminoids and hexahydrocurcuminoids.
  • the composition is formulated with pharmaceutically, nutraceuticaily and cosmeceutically acceptable excipients, adjuvants, diluents or carriers and administered in the form of tablets, capsules, syrups, gummies, powders, suspensions, emulsions, chewables, candies, creams, gels, lotions, ointments, mouth wash, tooth paste and eatables.
  • the tablets, capsules, syrups, gummies, powders, suspensions, emulsions, chewables, candies, creams, gels, lotions, ointments, mouth wash, tooth paste and eatables are available separately or together in an oral health kit containing the said forms.
  • the present invention discloses a method for therapeutic management of canker sore in mammals, said method comprising steps of administering an effective concentration of a composition containing tetrahydrocurcuminoids to mammals in need of such therapy, to bring about reduction in symptoms associated with canker sore.
  • the symptoms of canker sore include, but not limited to. throat pain, ulcer, lesion, throat numbness, sore throat, bleeding, swelling at the site, reddening at the site, inflammation at the site, burning, swelling and paid in lymph node, difficulty in chewing and difficulty in swallowing.
  • the composition is formulated with pharmaceutically, nutraceutically and cosmeceutically acceptable excipients, adjuvants, diluents of carriers and administered in the form of tablets, capsules, syrups, gummies, powders, suspensions, emulsions, chewables, candies, creams, gels, lotions, ointments, mouth wash, tooth paste and eatables hi a related embodiment, the tablets, capsules, syrups, gummies, powders, suspensions, emulsions, chewables, candies, creams, gels, lotions, ointments, mouth wash, tooth paste and eatables, are available separately or together in an oral health kit containing the said forms.
  • the mammal is preferably human.
  • the present invention discloses a method for therapeutic management of gingivitis in mammals, said method comprising steps of administering an effective concentration of a composition containing tetrahydrocurcuminoids to mammals in need of such therapy, to bring about reduction in symptoms associated with gingivitis.
  • the symptoms of gingivitis include, but not limited to, taste acceptability, burning sensation, dryness, soreness, ulcer, staining of teeth and tongue, and allergy.
  • the composition is formulated with pharmaceutically, nutraceutically and cosmeceutically acceptable excipients, adjuvants, diluents or carriers and administered in the form of tablets, capsules, syrups, gummies, powders, suspensions, emulsions, chewables, candies, creams, gels, lotions, ointments, mouth wash, tooth paste and eatables.
  • the tablets, capsules, syrups, gummies, powders, suspensions, emulsions, chewables, candies, creams, gels, lotions, ointments, mouth wash, tooth paste and eatables are available separately or together in an oral health kit containing the said forms.
  • the mammal is preferably human. [Para0017] Specific illustrative examples enunciating the most preferred embodiments are included herein below.
  • the sample size of the study was 60, with 30 subjects assigned to each of die two study arms in a manner there would be 30 subjects with canker sore and throat pain and 30 subjects with gingivitis. However, 31 subjects were enrolled for Canker Sore and 29 were enrolled for
  • [ParaOQ32] AU enrolled subjects were instructed to self administer one chewable tablet (oral dosing) twice daily containing lOOmg of tetrahydrocurcuminoids for a period of 21 days.
  • Table 1 Distribution of patients with different no of lesions across study visits.
  • Example 3 Compositions / formulations containing tetrahydrocurcuminoids
  • Tables 4-9 provide illustrative examples of nutraceutical formulations containing tetrahydrocurcuminoids for the management of canker sore and gingivitis [Para0059] Table 4: Tetrahydrocurcuminoids Chewable Tablet
  • Table 10 and 11 provides illustrative examples for a mouth gel and mouth wash formulation containing tetrahydrocurcuminoids for the management of canker sore and gingivitis
  • the invention also provides an illustrative example of an oral health kit comprising of formulation containing tetrahydracurcuminoids which include, but not limited to, the following: 1. Chewable tablets, candies and guinmies

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Mycology (AREA)
  • Botany (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Birds (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Medical Informatics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

L'invention concerne une nouvelle composition contenant des tétrahydrocurcuminoïdes pour l'amélioration de la santé et de l'hygiène buccales. Plus spécifiquement, l'invention concerne une nouvelle composition de tétrahydrocurcuminoïdes et son application dans le traitement thérapeutique de l'aphte et de gingivites.
PCT/US2018/028077 2018-04-18 2018-04-18 Compositions contenant des tétrahydrocurcuminoïdes pour l'amélioration de la santé et de l'hygiène buccales WO2019203813A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2018/028077 WO2019203813A1 (fr) 2018-04-18 2018-04-18 Compositions contenant des tétrahydrocurcuminoïdes pour l'amélioration de la santé et de l'hygiène buccales

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2018/028077 WO2019203813A1 (fr) 2018-04-18 2018-04-18 Compositions contenant des tétrahydrocurcuminoïdes pour l'amélioration de la santé et de l'hygiène buccales

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WO2019203813A1 true WO2019203813A1 (fr) 2019-10-24

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100034757A1 (en) * 2006-11-24 2010-02-11 Mitsukiyo Fujii Extract powder of indigo plant, and its preparation and uses
US8182843B2 (en) * 2006-06-30 2012-05-22 Piramal Life Sciences Limited Herbal compositions for the treatment of diseases of the oral cavity
US20140275271A1 (en) * 2011-10-17 2014-09-18 The Research Foundation For The State University Of New York Novel modified curcumins and their uses
US8916139B2 (en) * 2010-04-09 2014-12-23 Conopco, Inc. Oral care compositions
US20170319642A1 (en) * 2014-10-27 2017-11-09 Fbm Indústria Farmacêutica Ltda. Soluble, stable, anti-inflammatory, proliferative, protective and mucoadhesive pharmaceutical compositions; use thereof for treating mucositis conditions and method for producing same; base pharmaceutical composition for preparing the pharmaceutical compositions and method for producing same

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8182843B2 (en) * 2006-06-30 2012-05-22 Piramal Life Sciences Limited Herbal compositions for the treatment of diseases of the oral cavity
US20100034757A1 (en) * 2006-11-24 2010-02-11 Mitsukiyo Fujii Extract powder of indigo plant, and its preparation and uses
US8916139B2 (en) * 2010-04-09 2014-12-23 Conopco, Inc. Oral care compositions
US20140275271A1 (en) * 2011-10-17 2014-09-18 The Research Foundation For The State University Of New York Novel modified curcumins and their uses
US20170319642A1 (en) * 2014-10-27 2017-11-09 Fbm Indústria Farmacêutica Ltda. Soluble, stable, anti-inflammatory, proliferative, protective and mucoadhesive pharmaceutical compositions; use thereof for treating mucositis conditions and method for producing same; base pharmaceutical composition for preparing the pharmaceutical compositions and method for producing same

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