Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
• • 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
  • A61K8/0216—Solid or semisolid forms
• • 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
  • A61K8/18—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
  • A61K8/35—Ketones, e.g. benzophenone
• • 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
  • A61K8/39—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
  • 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
  • A61K8/817—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 a single or double bond to nitrogen or by a heterocyclic ring containing nitrogen; Compositions or derivatives of such polymers, e.g. vinylimidazol, vinylcaprolactame, allylamines (Polyquaternium 6)
  • A61K8/8176—Homopolymers of N-vinyl-pyrrolidones. Compositions of derivatives of such polymers
• • 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
• • 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
  • A61K8/9706—Algae
  • A61K8/9711—Phaeophycota or Phaeophyta [brown algae], e.g. Fucus
• • 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
  • A61K8/9728—Fungi, e.g. yeasts
• • 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
  • A61K8/9755—Gymnosperms [Coniferophyta]
  • A61K8/9761—Cupressaceae [Cypress family], e.g. juniper or cypress
• • 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]
  • A61K8/9789—Magnoliopsida [dicotyledons]
• • 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
  • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
  • A61K9/7007—Drug-containing films, membranes or sheets
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P17/00—Drugs for dermatological disorders
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
  • A61Q17/00—Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings
  • A61Q17/04—Topical preparations for affording protection against sunlight or other radiation; Topical sun tanning preparations
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
  • A61Q19/00—Preparations for care of the skin
  • A61Q19/02—Preparations for care of the skin for chemically bleaching or whitening the skin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
  • A61Q19/00—Preparations for care of the skin
  • A61Q19/08—Anti-ageing preparations
• • 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
  • A61K2800/88—Two- or multipart kits
  • A61K2800/882—Mixing prior to application

Definitions

• the present invention relates to a dissolvable film composition for application to the skin.
• the present invention relates to a dissolvable film composition that provides stable actives for delivery to the skin.
• a common problem in cosmetic compositions has been the effective delivery of actives to the skin. Since cosmetic compositions often have numerous ingredients to make it cosmetically acceptable, the amount of active is often diluted. Moreover, the presence of other ingredients can impede the amount of active that is actually delivered within the skin. Even if ingredients in the cosmetic compositions do not impede effective delivery of the active to the skin, the active may fail to successfully adhere to the skin to deliver essential actives to the skin.
• Hinokitiol is a bacterial fungicide that is known to have anti-irritant, anti-microbial and skin lightening properties. However, when Hinokitiol is incorporated into an emulsion, the Hinokitiol develops a strong, unpleasant odor and discolors the emulsion to a yellowish-brown color upon storage.
• Retinoids constitute a large group of synthetic and naturally occurring compounds related to retinol, the vitamin A alcohol. In mammals, retinoids fulfill essential roles, including maintenance of epithelial cells. However, retinoids are known to be chemically unstable and nearly insoluble in water. Therefore, retinoids are difficult to incorporate into cosmetic compositions.
• vitamin C has many skin benefits for the skin, including whitening and stimulating collagen synthesis. As is known in the art, collagen synthesis makes the skin stronger, which helps reduce lines and wrinkles. However, vitamin C is known to be very unstable when exposed to water, oxygen and light and therefore loses its activity and drastically discolors.
• the present invention provides a system, a kit and methods for delivering an effective amount of a labile active to the skin, comprising a composition comprising an effective amount of a labile active agent incorporated into a water-soluble polymeric film and an additive composition capable of dissolving the water-soluble polymeric film.
• an effective amount means an amount sufficient to cause a cosmetic effect to the skin.
• water soluble means the material is at least 95% soluble in water.
• labile active refers to an active that changes or breaks down from its natural state and/or loses potency or activity when exposed to environmental factors such as air, water, and light as well as cosmetic formulations such as emulsions.
• the present invention provides a system that delivers an effective amount of a labile active to the skin in a protected manner.
• the system comprises a composition comprising an effective amount of a labile active agent incorporated into a water-soluble polymeric film and an additive composition capable of dissolving the water-soluble polymeric film.
• the labile active may be any cosmetic ingredient that is subject to environmental degradation, as for example, antioxidants, antiaging agents, whitening agents, UV-protective agents, skin conditioning agents, or combinations thereof.
• the actives of the present invention is selected from polyphenol actives.
• the labile active is specifically selected from the group of green tea extracts, white tea extracts, red tea extracts, black tea extracts, licorice extracts, phytosphingosine, ethylbisiminomethylguaiacol manganese chloride, white birch extract, hinokitiol, coffee extract, hoelen mushroom extract, ascorbic acid, siegesbeckia, rosemary extract, silymarin, Boswellia extract, ubiquinone, retinoids, resveratrol, potassium cholesterol sulfate, protease enzymes, lipase enzymes, apigenin, vitamin E, grape seed extract, lutein, licochalcone, luteolin, ursolic acid, Centella asiatica extract, ximenynic acid, ferulic acid, amentoflavone, dihydroxyacetone, conjugated linoleate, salicylic acid, 1,3-Beta Glucan, and triclosan,
• Salicylic Acid and derivatives Formula Keratolytic, anti-acne AHWM compatibility, solubility 1,3-Beta Glucan(1′ 6′), Formula Wound healing agent AHM compatibility, solubility Triclosan Formula Antibacterial agent LHM compatibility, stability
• the effective amounts of the labile active as used in the system of the present application will vary depending on the active selected and the cosmetic benefit desired, but ordinarily will be within the range of known active concentrations for the selected material, or in some cases, may be lower because of the greater retained activity. Overall, as a guideline, the ranges will typically be from 0.001% to 5% by weight of the total composition.
• the effective amounts of hinokitiol is from 0.001% to 0.5%, preferably from 0.01 to 0.3% and most preferably from 0.05 to 0.1%.
• the effective amounts of antioxidants such as from plant extracts, are from 0.001% to 2%, preferably from 0.01% to 1.5% and most preferably from 0.1% to 1%.
• labile actives may be used in combination in the system of the present invention as long as each active does not interfere with the stability of the other actives.
• a person of ordinary skill in the art would be capable of identifying such combinations based on information generally available regarding the lability of different actives.
• Another component of the system of the present invention is a water-soluble polymeric film, comprising at least one water-soluble film-forming agent in which the labile active is incorporated.
• the water-soluble polymeric film protects the labile active from the factors that contribute to their lability before incorporation.
• the water-soluble polymeric film does not contain any water or water-based ingredient, thereby avoiding the solubility and stability issues encountered when attempting to incorporate the labile active within a typical, water-containing cosmetic medium.
• the labile active is preferably incorporated into a side of the water-soluble polymeric film that contacts the skin. Upon application of the water-soluble soluble polymeric film to the skin and subsequent dissolution of the film, the labile active is effectively transferred to the skin in a substantially unaltered state to provide the desired cosmetic benefits.
• the water-soluble polymeric film should be inherently tacky or sticky/adhesive such that the film is capable of adhering to the skin upon application of the water-soluble polymeric film to the skin.
• methods of making films from these water-soluble film-forming agents is well known in the art.
• water-soluble polymeric film-forming agent may be used in combination to form a first layer in which the labile active is incorporated.
• the composition comprises at least two layers of polymeric films.
• a second water-soluble polymeric film is also used to provide physical stability to the final composition, thereby providing more lubrication and spreadability for the adhesive water-soluble polymeric film layer incorporating the labile active.
• Such a second film should be used in such amounts so as not to interfere with the dissolvability of the composition on the skin. It is preferred that the second water-soluble polymeric film be different from the first water soluble polymeric film containing the active so that two discrete layers may be maintained.
• water-soluble film-forming agents examples include, but are not limited to, polyethylene, high molecular weight polyethylene glycols (PEGs), hydrophilic siloxysilicates, hydrophilic silicone polyacrylates and combinations thereof. (checking on this list) It should be noted that more than one water-soluble film-forming agent may be used in combination to form the second layer of water-soluble polymeric film, with the limitation that each of the agents of the second layer must be different from the water-soluble film-forming agent or agents of the first layer to maintain the two distinct layers.
• PEGs high molecular weight polyethylene glycols
• hydrophilic siloxysilicates hydrophilic silicone polyacrylates and combinations thereof.
• the water-soluble film-forming agent of the first adhesive film layer is used in an amount of 30% to 90% by weight of the wet composition, preferably from 35% to 75%, and most preferably from 40% to 70%.
• the water-soluble film-forming agent of the second film layer is present in an amount of from 2% to 50% by weight of the wet composition, preferably from 4% to 40%, and most preferably from 6% to 30%.
• the first layer of a water-soluble polymeric film incorporating the labile active is made with a solution for casting films.
• the solution is made by dissolving a small amount of a water-soluble film forming polymer in water. An effective amount of the labile active ingredient of choice is added directly to the resulting solution.
• the solution is then mixed to uniformity, and poured, for example, onto a clean ceramic tile plate or other suitable surface, and rolled over the plate until a uniform coating of the solution is achieved.
• the plate is then either baked in an oven to accelerate the evaporation of the water (if the labile active can tolerate the heat), or it is dried with means known to those of ordinary skill in the art, such as a commercial hand-held hair dryer, or overnight with a fan, to render the solution coating to a film.
• the method used will depend on the active used and the reactivity of the active to water. For example, films containing those actives that are more water sensitive will be dried immediately, whereas those actives that are water-stable can be dried overnight.
• the water-soluble polymeric film is dried so that the film is essentially dry and contains no more than 2% water, preferably no more than between 0.1% to 1%.
• the second layer of water-soluble polymeric film is adjacently adhered to a side opposite the active in the first water-soluble polymeric film by methods known to those skilled in the art, such that the second polymeric film does not interfere with the active.
• both the first layer of water-soluble polymeric film and second layer of water-soluble polymeric film are dried, as described above.
• the second layer of water-soluble polymeric film is adhered by methods to those skilled in the art for creating polymeric layers, such as by roller laminating the second layer of water-soluble polymeric film upon the first layer of water-soluble polymeric film so that the second layer is adjacently adhered to the first layer, thereby creating two distinct layers.
• the second layer of water-soluble polymeric film may be roller laminated onto the first layer of water-soluble polymeric film by methods known in the art.
• the resultant water-soluble polymeric film composition is then cut to size.
• the film composition will be further packaged, for example in a plastic or foil packet, in the form of a patch, or in other protective enclosures.
• the patch is applied to skin, where it is re-dissolved by means described hereinbelow.
• An example of the resultant first layer of water-soluble polymeric film composition is provided in Example 1 below.
• An example of the resultant two layer film composition is provided in Example 2 below.
• composition comprising a labile active incorporated in to a water-soluble polymeric film.
• a labile active incorporated in to a water-soluble polymeric film.
• the inventive water-soluble polymeric film composition may further comprise a plasticizer incorporated therein to provide additional lubrication and spread for the water-soluble film-forming polymer.
• the plasticizer may be any material which does not interfere with the labile active, as would be known to those skilled in the art. If a plasticizer is used, the labile active or actives may be incorporated directly into the plasticizer before the plasticizer and water-soluble film forming polymer are dried using the methods described hereinabove.
• a nonlimiting list of exemplary materials which may act as plasticizers for the film forming polymers of the present invention includes diisobutyl adipate, acetyl tri-n-butyl titrate, di(2-ethyl hexyl) azelate, 2-ethyl hexyl diphenyl phosphate, diisoctyl isophthalate, isooctyl benzyl phthalate, butyl stearate, tri-2-ethyl hexyl trimellitate, N-octyl neopentanoate, diisostearyl malate, colloidal fumed silica (such as Cab-O-Sil®, sold by Cabot Corp.) and most perfume materials.
• the plasticizer is a polyol such as 1,3 butylene glycol, because of its known properties of providing plasticizing effects at minimal concentrations.
• the plasticizer if used, is present in an amount from 0.01% to 20%, preferably from 0.1% to 10%, and most preferably from 0.15% to 5% of the wet composition.
• the foregoing components represent the preferred elements of the inventive film, but that other optional elements that constitute the cosmetic/therapeutic effect may be included. These optional elements are selected so as not to disturb and in some cases, will preferably enhance the stability of the labile active.
• Such optional components include but are not limited to, stabilizers, preservatives, surfactants, emulsifiers, dyes and other non-labile actives.
• a wetting solution or additive solution is utilized as an additional component of the system for delivering labile actives. Since the labile actives are relatively unstable when exposed to factors such as water or air, it is recommended that such labile actives be sheltered from such factors until the actives are transferred into the skin.
• the water-soluble polymeric film is preferably wetted with an additive composition that is a wetting solution or activator.
• the additive composition is provided separately from the water-soluble polymeric film so that the composition does not contribute to the instability of the labile active prior to delivery of the active to the skin.
• the additive composition is used to wet the water-soluble polymeric film so that when the labile active contacts the skin, it is transferred to the skin as the water-soluble polymeric film dissolves.
• the labile active is maintained, as part of the film, in a relatively stable state until the actual moment of application to the user's skin.
• the additive composition may be as simple as ordinary water or water miscible ingredients or components such as polyols, depending on the relative water solubility of the water-soluble polymeric film used and the nature of the additional components in the inventive composition.
• the additive composition is preferably capable of wetting the film carrying the labile active upon application of the film to the skin to release the labile active therein.
• the additive composition may beneficially comprise any number of additives and actives as long as such additives and actives are not of a nature or used in an amount to interfere with the aqueous nature of the additive composition, including, but not limited to such ingredient classes as described in The CTFA Cosmetic Ingredient Handbook, Tenth Edition (2004), including abrasives, absorbents, aesthetic components such as fragrances, pigments, colorings/colorants, essential oils, skin sensates, astringents, etc., anti-acne agents, anti-caking agents, antifoaming agents, antimicrobial, antioxidants, binders, biological additives, buffering agents, bulking agents, chelating agents, chemical additives, colorants, cosmetic astringents, cosmetic biocides, denaturants, drug astringents, external analgesics, film formers or materials, e.g., polymers, for aiding the film-forming properties and substantivity of the composition, opacifying agents, pH adjusters, propellants, reducing agents, sequestrant
• retinoids such as retinol, and esters, acids, and aldehydes thereof; ascorbic acid, and esters and metal salts thereof, tocopherol and esters and amide derivatives thereof; shark cartilage; milk proteins; alpha- or beta-hydroxy acids; DHEA and derivatives thereof; topical cardiovascular agents; clotrimazole, ketoconazole, miconozole, griseofulvin, hydroxyzine, diphenhydramine, pramoxine, lidocaine, procaine, mepivacaine, monobenzone, erythromycin, tetracycline, clindamycin, meclocyline, hydroquinone, minocycline, naproxen, ibuprofen, theophylline, cromolyn, albuterol, hydrocortisone, hydrocortisone 21-acetate, hydrocortisone 17-valerate, hydrocortisone 17-butyrate, betamethas
• ingredients in the additive composition may overlap those identified as labile actives in the water-soluble film forming polymer.
• the actives in the additive composition are used in the manner commonly used in cosmetic formulations and not to provide the surprisingly effective cosmetic benefit provided by delivering the labile active in a relatively better protected state, as is found in the present inventive system.
• the system of the present invention comprising the two elements of the film comprising a labile active and the additive composition, may be provided as separate elements.
• the user may apply the film to the skin, and thereafter dissolve the film by application of simple tap water, or by the application of a separately obtained additive cosmetic composition, such as a water-based emulsion or toner, that is capable of dissolving the film.
• a separately obtained additive cosmetic composition such as a water-based emulsion or toner, that is capable of dissolving the film.
• the system is provided as a kit, i.e., a unit package containing both the water-soluble film containing the labile active, combined with a separate container containing the additive composition.
• the unit package may be a box, tin, cardboard cylinder, or shrink wrap that conveniently holds the components together.
• the package may be adapted to further stabilize the components by reducing exposure to environmental factors, i.e., it may be airtight or darkened to avoid exposure to light.
• the elements provided in the package may also be presented in different forms.
• the film may be provided in a convenient dispenser, or may be individually packaged in plastic, foil, paper, cellophane, or glassine packets or envelopes in the form of a patch.
• the additive composition which will typically be of a fluid nature, may be packaged in a glass or plastic bottle (e.g., squeeze or pour bottle, or aerosol or non-aerosol pump), or glass or plastic jar, or any other suitable container for holding a fluid composition.
• the present inventive system and kit can be used to yield numerous benefits.
• the water-soluble polymeric film incorporating a labile active may be applied to the skin and rewetted using the additive composition, thereby transferring the labile active to the skin in a stable form.
• the system and/or kit therefore serve as an excellent means of delivering a labile active to the skin.
• the film carrying the labile active may be made in any shape or size to accommodate the treatment needed. Therefore, the appropriately shaped film could be used for spot treatment or as a mask for a larger area of treatment.
• a specific example is the use of the system and/or kit for delivering actives that provide a whitening effect.
• a film patch can deliver whitening agents directly to age spots or discolored areas.
• whitening agents such as hinokitiol, kojic acid, hydroquinone, ascorbic acid, magnesium ascorbyl phosphate, and ascorbyl glucoside may be incorporated into the film and wetted using the additive composition to transfer the whitening agent to the areas of the skin where whitening is desired.
• the system and/or kit may be used on various parts of the skin such as corners of the eyes, along the upper lips, and other areas in need of an intense direct treatment, for example, with an anti-aging or anti-wrinkle treatment.
• a preferred use of the present inventive system and/or kit is for spot wrinkle treatment.
• a patch containing one or more anti-wrinkle actives can be applied directly to the area to be treated, for example, on crow's feet, under eyes, around the lips, neck area, deep furrows on the forehead, and brow area.
• labile, anti-wrinkle or anti-aging actives include retinoids, vitamin C, 2-hydroxyalkanoic acids, prostaglandins, ceramides and their derivatives.
• a water-soluble polymeric film of the present invention incorporating a labile active may be formulated as provided below in Table 2.
• Table 2 provides the weight percentages of the elements of the composition prior to drying the film. TABLE 2 Ingredient CTFA name Percent Methocel K4M Premium Cellulose Ether 2.00% 1,3-Butylene Glycol 1,3 Butylene Glycol 2.00% Green Tea Polyphenol Polyphenol 0.5% Deionized Water Purified Water Q/s
• composition shown below in Table 3 provides an example of an alternative embodiment of the present invention providing a first layer of adhesive water-soluble polymeric films incorporating labile actives and a second layer of water-soluble polymeric film adjacently adhered to the first layer.
• the patch is intended primarily for whitening of the skin.
• the weight percentages of the elements indicate the amount in the final, dried composition.
• This example illustrates the use and performance of the system of the present invention.
• test site is the face of selected female panelists. The women are instructed to refrain from using any treatment products on the test site during the test period except for the test products provided. Skin evaluations are carried out before treatment (baseline), and two, four, and eight weeks during the course of treatment.
• the women are instructed to apply 2 patches of the composition described in Table 3 above, to each side of the face once a day in the morning.
• the patch is pressed firmly onto the skin for 15 to 30 seconds.
• the tab is gently peeled back, leaving the blue active film on the face.
• a dab of additive composition described in Table 4 hereinabove is applied to each patch, and blended into the skin for 10 to 15 rotations until the film dissolves and is absorbed into the skin.
• the women do not apply the product for at least 12 hours before measurements are taken. Product use is monitored by a daily diary as well as assessment of remaining package content at the end of the study.
• a particular area demonstrating age spots on the cheeks or hand of each panelist is marked.
• the images of that specific portion of the face or hand are obtained using a fiber optic microscope (Hi-Scope) at a magnification of 20 ⁇ . Three age spots are chosen per panelist. The same area is photographed at each time point following the initial visit.
• the stored RGB images are digitized and analyzed using an image analysis program, Optimas 6.51.
• the stored RGB images are digitized and analyzed to determine the average Grey value (i.e. density) and area of the corresponding age spot. If a product is effective in diminishing the appearance of age spots, an increase in Grey Value (density) and a decrease in spot area will occur.
• Skin whitening is assessed and documented with close up photography.
• Photos of the right and left facial cheeks are taken with a Nikon M 3 digital camera. Panelists heads are placed in a head rest to insure reproducibility of positioning. The camera is positioned two feet from the panelist at an F stop of 32. A crossed polarized lens is used to remove all glare from the photographs. Photos are evaluated via an image analysis program, Optimas 6.51, comparing before and after product use. Whitening is analyzed by determining the average Grey value of the three color channels (RGB) in each photograph. If the product has been effective in whitening skin there will be an increase in the Grey value.
• RGB three color channels
• the kit of the present invention significantly (p ⁇ 0.05) improved skin tone, as compared to the baseline measurement, by an average of 46%, reduced the appearance of age spots by an average of 44%, and improved skin whitening by an average of 36% after 8 weeks of product use as compared to pre-treatment.
• the system of the present invention improved skin tone compared to the baseline evaluation, by 49%, reduction in appearance of age spots by 47% and skin whitening by 40%.

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• 2005
  • 2005-06-21 AU AU2005265249A patent/AU2005265249A1/en not_active Abandoned
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• 2008
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