Classifications

• • 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
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
  • A61K8/34—Alcohols
  • A61K8/345—Alcohols containing more than one hydroxy group
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
  • A61K8/0241—Containing particulates characterized by their shape and/or structure
  • A61K8/0254—Platelets; Flakes
• • 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
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
  • A61K8/4993—Derivatives containing from 2 to 10 oxyalkylene groups
• • 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
  • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
  • A61K8/73—Polysaccharides
  • A61K8/731—Cellulose; Quaternized cellulose derivatives
• • 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
  • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
  • A61K8/81—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions involving only carbon-to-carbon unsaturated bonds
  • A61K8/8129—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by an alcohol, ether, aldehydo, ketonic, acetal or ketal radical; Compositions of hydrolysed polymers or esters of unsaturated alcohols with saturated carboxylic acids; Compositions of derivatives of such polymers, e.g. polyvinylmethylether
• • 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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
  • A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
  • A61K2800/42—Colour properties
  • A61K2800/43—Pigments; Dyes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
  • A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
  • A61K2800/42—Colour properties
  • A61K2800/45—Colour indicators, e.g. pH- or Redox indicators
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
  • A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
  • A61K2800/56—Compounds, absorbed onto or entrapped into a solid carrier, e.g. encapsulated perfumes, inclusion compounds, sustained release forms
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
  • A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
  • A61K2800/805—Corresponding aspects not provided for by any of codes A61K2800/81 - A61K2800/95

Definitions

• Toothpaste comprising colored film fragments are known in the art, e.g., as described in US 6669929, the contents of which are incorporated herein by reference, but this reference does not address the need for encouraging brushing for an appropriate period.
• Film fragments as known in the art for such purposes are generally dissolvable in water, that is, they utilize polymer systems that will swell and eventually dissolve when placed in water.
• polymer systems comprising of relatively high levels of poly( vinyl alcohol) not only have extended dissolution and enhanced stability in formulation, but are in fact substantially insoluble under formulation or use conditions. These systems readily and abruptly disintegrate during brushing, to provide fast release of entrapped pigment/color (or other components for which quick release is desired, e.g. flavoring or whitening agents), thereby providing a clear signal and complete release of the material when the desired brushing threshold is reached.
• the invention provides an orally acceptable, water insoluble film which does not dissolve under formulation conditions, but disintegrates upon brushing, comprising a polymer matrix, plasticizer (e.g., propylene glycol), releasable material (e.g., color or pigment) incorporated therein (e.g., that is released upon disintegration of the film by mechanical action, e.g., brushing); and (optionally) nonionic surfactant (e.g. polysorbate), wherein the polymer matrix comprises at least 50%, e.g., at least 75%, of poly( vinyl alcohol), and 50%> or less, e.g. 25% or less, of a water-soluble cellulose ether, for example hydroxypropyl methyl cellulose (HPMC); as well as dentifrice comprising such films, and methods of making and using the same.
• plasticizer e.g., propylene glycol
• releasable material e.g., color or pigment
• nonionic surfactant e.g
• the invention thus provides, in a first embodiment, an orally acceptable, water-insoluble film (Film 1), which disintegrates upon brushing in the presence of water, comprising
• polymer matrix a polymer matrix, a releasable material incorporated therein, and a plasticizer, wherein the polymer matrix comprises at least 50% of poly( vinyl alcohol), and 50% or less of a water-soluble cellulose ether;
• the releasable material is a pigment or combination of pigments, e.g., that is released upon disintegration of the film by mechanical action, e.g., brushing; e.g., wherein the pigment or combination of pigments is selected from one or more of a red pigment, for example D&C Red 30, a green pigment, for example Pigment Green 7, a yellow pigment, e.g. (Natpure LC 128 Yellow, from Sensient Co.), a blue pigment, for example a phthalocyanine, for example Pigment Blue 15:
• the water-soluble cellulose ether is a hydroxyalkyl cellulose, e.g., selected from hydroxypropyl methyl cellulose, hydroxyethylpropyl cellulose, hydroxybutyl methyl cellulose, carboxymethyl cellulose and mixtures thereof.
• the water soluble cellulose ether is hydroxypropyl methyl cellulose;
• n is an integer 500-2500, e.g., 1000-2000, e.g, about 1400; e.g., having a weight average molecular weight (M w ) of 20-120kD, e.g., 35-100 kD or 50-70kD, e.g., about 61kD, e.g., Mowiol® 10-98 (PVA 10-98);
• any of the foregoing films wherein the water-soluble cellulose ether is hydroxypropyl methyl cellulose (HPMC), e.g., a low viscosity HPMC, e.g., having a viscosity at 2% concentration in water at 20°C of 2-20 mPa*s (cP), e.g., 4-6 mPa*sec, e.g., as measured with an Ubbelohde viscometer, for example HPMC E5 (Methocel® E5);
• HPMC hydroxypropyl methyl cellulose
• plasticizer is a polyalcohol, e.g., sorbitol, propylene glycol, glycerol, low molecular weight polyethylene glycol, e.g., PEG 200, or mixtures thereof; e.g., in an amount effective to provide plasticity to the film, e.g., about 10-30%), e.g., 15-25% by dry weight of the film; Any of the foregoing films wherein the plasticizer is propylene glycol;
• any of the foregoing films comprising a non-ionic surfactant or emulsifier, e.g., a polysorbate, e.g., polysorbate 80 (also known as polyoxyethylene(20) sorbitan monooleate, available commercially e.g., as Tween® 80), e.g., in an amount of about 1-5% by dry weight of the film;
• a non-ionic surfactant or emulsifier e.g., a polysorbate, e.g., polysorbate 80 (also known as polyoxyethylene(20) sorbitan monooleate, available commercially e.g., as Tween® 80), e.g., in an amount of about 1-5% by dry weight of the film;
• any of the foregoing films wherein the film is coated by a powder coating which comprises a pigment e.g., wherein the powder coating comprises a white powder pigment, e.g., comprising particles of titanium dioxide or Ca 2 P 2 0y; or wherein the powder coating comprises a red powder pigment, e.g., comprising particles of red iron oxide or D&C Red 30;
• the releasable material comprises a water- insoluble material, e.g., a water-insoluble antimicrobial agent, e.g., selected from triclosan and zinc oxide;
• a water-insoluble antimicrobial agent e.g., selected from triclosan and zinc oxide
• the films are also characterized in that in the films do not disintegrate in the absence of brushing for the time periods mentioned above.
• any of the foregoing films wherein the polymer matrix comprises at least 75%, e.g. at least 90% of poly( vinyl alcohol), and 25% or less, e.g. 10% or less, of a water-soluble cellulose ether;
• any of the foregoing films wherein the polymer matrix comprises 50% - 100%, e.g. 75%-90% of polyvinyl alcohol), and 1 - 50%, e.g. 10%-25% of a water- soluble cellulose ether;
• any of the foregoing films wherein the average thickness of the film is 1-3 mil; Any of the foregoing films comprising
• Surfactant e.g., polysorbate 80 1-5%, e.g., 2-3%
• ingredients as set forth in the foregoing embodiments e.g., an aqueous slurry of polyvinyl alcohol, water-soluble cellulose ether, releasable material, plasticizer, and optionally surfactant, and drying the slurry to form a film.
• the invention further provides an oral care product, e.g., a dentifrice, for example a toothpaste, e.g., a clear gel toothpaste, comprising particles, e.g. squares, stars, flakes or fragments, e.g., 1-10 mm, e.g.
• a dentifrice for example a toothpaste, e.g., a clear gel toothpaste, comprising particles, e.g. squares, stars, flakes or fragments, e.g., 1-10 mm, e.g.
• any of Film 1, et seq. wherein upon application to the oral cavity and brushing, the film disintegrates and releases the releasable material following at least 30 seconds and not more than about 180 seconds, e.g., about 45-60 seconds in a toothpaste for use by a child and about 90-120 seconds in a toothpaste for use by an adult; for example wherein the releasable material is a pigment the release of which provides a color signal to the user of adequate brushing. If used in animals or pets, veterinary pastes or chewables may be used in lieu of a dentifrice.
• the toothpaste is a clear gel, in which the film particles can be seen clearly.
• the film particles may be, for example, small squares 2-4 mm across. They may be all one color or assorted colors, the color being imparted by any pigment in the film, and/or by a powder coating where present, and the film may contain a high concentration of pigment. After a period of brushing, e.g., at least 30 seconds, the film is disrupted, and the clear gel toothpaste is suddenly colored by the pigment, signaling to the user that he or she has brushed for an adequate period.
• the invention further provides a method of cleaning the teeth comprising brushing with a toothpaste comprising an orally acceptable film, e.g, as described in the preceding paragraphs, e.g., wherein the film is any of Film 1, et seq., for example
• the method wherein the orally acceptable film comprises a pigment in the film matrix and brushing is continued until the film disintegrates and the pigment provides a color signal to the user of adequate brushing, for example, b. the foregoing method when the brushing time before the film disinegrates is between 30 and 180 seconds, e.g., about 45-60 seconds for a toothpaste for use by a child and about 90-120 seconds for a toothpaste for use by an adult.
• the invention further provides a method of manufacturing any of Film 1, et seq.
• Film 1 et seq., e.g., making an aqueous slurry of poly(vinyl alcohol), water- soluble cellulose ether, releasable material, plasticizer, and optionally surfactant, and drying the slurry to form a film.
• compositions of the invention are intended for topical use in the mouth, thus components for use in the present invention should be orally acceptable, that is, safe for topical use in the mouth, in the amounts and concentrations provided.
• Films are prepared with various proportions of poly( vinyl alcohol) (PVA) and hydroxypropylmethyl cellulose (HPMC) as follows in Table 1 :

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Birds (AREA)
• Epidemiology (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Emergency Medicine (AREA)
• Cosmetics (AREA)
• Medicinal Preparation (AREA)

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Applications Claiming Priority (1)

Publications (1)

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Family Applications (1)

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Citations (12)

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• 2012
  • 2012-12-14 MX MX2015007516A patent/MX352308B/es active IP Right Grant
  • 2012-12-14 CA CA2891330A patent/CA2891330C/en active Active
  • 2012-12-14 US US14/651,622 patent/US9498418B2/en active Active
  • 2012-12-14 JP JP2015547911A patent/JP5986690B2/ja not_active Expired - Fee Related
  • 2012-12-14 WO PCT/US2012/069900 patent/WO2014092738A1/en not_active Ceased
  • 2012-12-14 AU AU2012396806A patent/AU2012396806B2/en not_active Ceased
  • 2012-12-14 BR BR112015013667-2A patent/BR112015013667B1/pt not_active IP Right Cessation
  • 2012-12-14 EP EP12809519.7A patent/EP2931226B1/en active Active
  • 2012-12-14 KR KR1020157017700A patent/KR20150095728A/ko not_active Withdrawn
  • 2012-12-14 RU RU2015122424A patent/RU2611355C2/ru active
  • 2012-12-14 CN CN201280077674.0A patent/CN104837476B/zh not_active Expired - Fee Related
• 2013
  • 2013-11-25 TW TW102142772A patent/TWI501783B/zh not_active IP Right Cessation
  • 2013-12-13 AR ARP130104731A patent/AR094013A1/es unknown
• 2015
  • 2015-05-20 PH PH12015501125A patent/PH12015501125A1/en unknown
  • 2015-05-22 ZA ZA2015/03659A patent/ZA201503659B/en unknown
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