MXPA02000270A

MXPA02000270A - Pre-formed gel sheet.

Info

Publication number: MXPA02000270A
Application number: MXPA02000270A
Authority: MX
Inventors: George Endel Deckner
Original assignee: Procter & Gamble
Priority date: 1999-07-06
Filing date: 2000-06-30
Publication date: 2002-06-21
Also published as: JP2003518008A; CZ200235A3; AU5782600A; CN1367680A; KR20020040742A; BR0012232A; CA2373979A1; EP1196138A1; WO2001001950A1

Abstract

A pre-formed, sheet device comprising; (a) less than 10 % of a polysaccharide mixture consisting of; (i) a red seaweed polysaccharide; (ii) a mannose containing polysaccharide selected from a galactomannan, glucomannan, and derivatives or mixtures thereof and; (iii) a fermentation polysaccharide, or derivatives thereof; and (b) from about 30 % to about 99.5 % of water; wherein the device comprises less than 10 % total polysaccharide. The pre-formed, sheet devices of the invention are suitable for topical application and display desirable amounts of syneresis and/or improved mechanical properties such as strength or flexibility, as well as excellent moisturisation, hydration and cooling benefits. Further, the devices of the present invention are easy to handle, unobtrusive and conform to the contours of a target surface when applied.

Description

PREFORMED GEL SHEET TECHNICAL FIELD The present invention relates to novel, preformed gel sheet devices. In particular, it relates to gel sheet, pre-formed, self-adhesive devices, which are patches or masks comprising about 30% about 99.5% water and a mixture of at least two water-soluble polymeric gel-forming agents to supply agents of benefit to the skin, hair or nails. Such devices are suitable for topical application and exhibit desirable amounts of syneresis and improved mechanical properties such as strength and flexibility, as well as excellent wetting and hydration benefits. In addition, the devices of the present invention are discrete and conformed to the contours of a target surface upon application. The desired properties are achieved by selecting the chemical composition and rheological characteristics of the gel sheet devices, pre-formed, in particular with reference to the relationship between the release of exudate, force for rupture and percentage of compression at rupture of the gel comprising the device.

BACKGROUND OF THE INVENTION The benefits of using a patch or other device comprising a water-soluble polymeric gel-forming agent instead of creams and lotions and the like, to consitetically treat the skin, or promote the healing of burns or wounds, have been recognized in the art. A variety of patches or cosmetic devices are commercially available or described as being useful for the supply of skin care assets such as vitamins, anti acne actives, humectants and the like. Patches and devices have also been described in the literature and sold in the medical field as a means for the transdermal administration of drugs. However, many of these patches or devices have disadvantages in their physical forms of products resulting in undesirable characteristics during use as perceived by the consumer or user. For example, some patches or devices may be too wet or sticky, since 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 highly adhesive, tight and uncomfortable to use and remove, and many patches do not provide effective release and penetration of the 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. In addition, some patches or devices require in situ training on the skin, and therefore, are annoying to apply. For example, the patent of E.U.A. 4,291, 025 relates to a topical, thermally reversible agar gel bandage, comprising 5 to 12% agar, 20 to 75% diethylene glycol and 100% water by weight, and methods for preparing said bandage. The compositions may further comprise gel reinforcing agents and special purpose ingredients (eg, vitamins, antibiotics). In accordance with one aspect of the invention of the U.S.A. 4,291, 025, high-strength, solid, deformable agar gels are prepared and then subdivided into pellets or smaller pieces. According to a further aspect, the agar gel is then converted to a solution after heating, when the solution is applied to the target skin and cooled in situ to form a removable gel form. Flexibility and resistance are important aspects of a gelled device. WO 97/17944 describes cosmetic formulations made as 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%) the rest consisting of water. The gel material is optionally enriched with water-soluble or water-dispersible active ingredients. The gel material can be processed to form a structured gel, which is described as being easy to handle and being well suited for the surface of the skin.

The patent of E.U.A. 4,318,746 refers to a gel comprising at least 0.5% of a first polymer that disperses, dissolves or hydrates in hot water and which forms, or can be made to form, a rigid gel after cooling, at least 2% of a second polymer that is insoluble in hot water and dissolves or hydrates after 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 for topical administration of drugs. The document emphasizes 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 be in the form of a self-supporting slice, pad or wafer of a desired size, shape and thickness comprising a water soluble alginate and suspending agents such as xanthan gum alone, or Xanthan in combination with locust bean gum. A gellan gum is also disclosed as a useful additional suspending agent. The suspending agents in the preparations can also act as gel-forming agents. The preparations optionally comprise anti-inflammatory agents, or the antiseptic agent, iodine. The slice or wafer forms of a preparation can be applied on a plastic backing to form an integral surgical bandage, with the gel either exposed or covered with a gauze. However, many gels may not possess adequate strength to be preformed into freestanding sheet devices, and, therefore, require support or reinforcement through an occlusive or non-occlusive backing material usually referred to as a "substrate". " Substrates may also be employed to prevent evaporation of the active ingredients, or to act as a means to adhere a device to the skin when an adhesive is coated around its periphery. A substrate can be impregnated with, adhered, or laminated to a surface of the composition layer of the patch or device. EP-B-507,160 relates to an external preparation for applying to the skin, comprising a drug retention layer placed on a support wherein the drug retention layer comprises lidocaine and an adhesive gel base comprising 0.5% to 50% of a high molecular weight substance, soluble in water, 20 to 70% water and 1 to 70% of a water retention agent. Suitable supports are described as flexible materials such as non-woven fabrics. However the substrates need 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 of desirable flexibility and strength is found, difficulties may still be encountered in the matching of said gel with a substrate that is compatible with these gel properties. The combination of a flexible substrate with a flexible gel does not necessarily produce a patch or flexible device. Further, from the delamination problem many flexible substrates usually exhibit a degree of porosity so that the wet gel infiltrates the substrate and forms strong gel networks within its fibers. Such networks are believed to reduce the flexibility of the resulting device. In addition, the substrate may not provide a patch or device with a discreet appearance on the skin, hair or nails. This will usually depend on the selection of the substrate and its characteristics. GB 1, 341, 999 discloses a gelled medium suitable for treating burns, comprising the liquid phase, a burn treatment agent and an amount of a gel former. The gelled medium is described as being flexible and having a non-adhesive, continuous, essentially dry surface, and a plasticity in order to conform to the body. A preferred gel former is described as a combination of xanthan and locust bean gum. The example also describes an antiseptic burn treatment pad, which comprise agarose, water and silver nitrate. The document discloses that a slight amount of syneresis in the gelled medium is helpful in wetting the surface with the burn treatment substance and in facilitating the removal of the medium from a mold. However, the inventors of the present have found that the gelled medium described in the examples of GB 1, 341, 999, while presenting a desirable amount of syneresis, does not have sufficient flexibility as requested to conform well to the contours of a target surface, or are difficult to retain as a sheet since they are very elastic and deformable. All gels experience syneresis to some degree. That is, after resting, the gel contracts with the exudation of the liquid. The syneresis provides a supply of a beneficial agent to a target area. The liquid layer of the 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 inventors herein as a highly desirable property of a device comprising a gel, since the liquid exuded on the surface of the gelled device facilitates its adhesion to a target surface, thus eliminating the need of an additional adhesive that covers the gelled form or a substrate covered with adhesive. In comparison, if a gelled device receives very little syneresis, the device, although wetting an area, probably does not provide good adhesion in the target area, while an excess amount of syneresis results in a non-effective and non-attractive product. EP-A-161 681 discloses gel plates comprising a polysaccharide and an aqueous solution of a polyhydric alcohol. The preferred polysaccharides for gel plates are a mixture of carrageenan and a galactomannan, or only carrageenan. The compositions optionally comprise medical components such as skin stimulants, antifogistins, analgesics and antibiotics. The gel plates are described as being transparent or little apparent, having a refreshing feel and good adhesion, as well as being sufficiently elastic, stretchable and strong. However, the inventors of the present have found that the gel plates described in EP-A-161681 do not exhibit a desirable amount of syneresis. JP-B2-276 1936 discloses aqueous sheet-like packages comprising xanthan gum and locust bean gum in combination with a water soluble solvent. The sheet-like packages of the invention are described as having excellent shape retention properties at a high temperature, and provide a good feeling and have a high skin-wetting effect. The examples described in the packages may further comprise 0.1% of a skin embellishing component. JP-A-54 92618 describes a wet compress comprising an interlaced alginate gel of aqueous calcium ion, as a base, substances having an antiphlogistic and analgesic action and water. Example 5 describes 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. The document teaches that the addition of water-soluble polymers increases the retention-form powder of a compress and a highly elastic gel is obtained by adding locust bean gum and konjac morning, or only carrageenan. In addition, the addition of water-soluble polymers such as konjac gum, and locust bean gum, among others, to the wet napkin teaches that it prevents the release of water. In addition, gels containing a base of the wet compresses of the invention are taught that they are not exposed to release water. EP-A-750,905 discloses a water soluble adhesive sheet, which may optionally comprise a water-soluble protective material laminated on a sheet surface and / or one or more release liners. The patches are described as being useful as preparations for the bath, which can be applied topically to the surface of the skin and dissolve during the bath to alleviate various diseases of circulatory, muscular, joint and skin diseases. The patches may optionally comprise numerous cosmetic and pharmaceutical active agents. Water-soluble polymers such as polysaccharides are also employed in non-patch compositions as gelling or thickening agents. For example, the patent of E.U.A. 4,661, 475 discloses gelling compositions and thickeners comprising (a) 10-90 parts by weight of casia-galactomannans and (b) 90-10 parts by weight of carrageenan, agar, xanthan gum, or mixtures thereof. The compositions described herein are useful, for example, as thickeners for pharmaceutical or cosmetic purposes. JP 97020649 discloses a composition of base material containing a matrix agent, which comprises gellan gum, a cation, and water, and EP-A-803,245 describes a compact solid gel comprising from 15 to 90% water, 0.3 to 4% of thermo reversible polysaccharides, of 4 to 40% of humectant, and of 2 to 35% of a powder phase. Example two of this document describes a solid gel comprising carrageenan (0.60%) and xanthan gum (1.00%). The object of the invention is defined by providing an aqueous gel, which can be applied directly to the skin with the fingers or a special applicator. The solid, compact gels of the invention are further described as being easy to spread and the form of compact product and controlled amounts of gel are removed. Although the aforementioned patches or sheets of the medical and cosmetic field provide advances to obtain desirable physical characteristics and in use, the documents do not describe gel sheet devices, preformed, freestanding, aqueous, comprising a mixture of at least two forming agents of water-soluble polymeric gel, wherein said devices do not only have a desirable amount of syneresis, but also strength and flexibility. Furthermore, none teaches that the three parameters are essential to achieve desirable in-use characteristics of a preformed gel sheet device. It has now been surprisingly discovered that a solid, preformed, gel sheet device can be formulated as a high-strength, self-supporting structure, which is not only flexible to conform to the contours of a target surface, but also presents an amount moderate syneresis. The syneresis exhibited by a purified device of the present facilitates its adhesion to a target surface, thus eliminating the need for an additional adhesive by overlapping the gel form or a substrate coated with adhesive. The devices of the present are thin, yet easy to handle and apply. The desirable physical properties and characteristics in use are achieved by selecting a chemical composition and rheological characteristics of the gelled devices with reference to the relationship between syneresis, strength and flexibility. The sheet devices of the present are patches or masks for cosmetic and therapeutic application.

BRIEF DESCRIPTION OF THE INVENTION The present invention relates to a preformed gel sheet device, which is a patch or mask for delivering beneficial agents to the skin, hands or nails, comprising from about 30% to 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 greater than 0.7 grams and less than 1.3 grams; a percentage of breaking compression in addition to 45% and less than 90%; and requires a breaking force of 30 N. According to a second aspect of the present invention, there is provided a cosmetic method for treatment, comprising applying a preformed gel sheet device to the skin, hair or nails. According to a third aspect of the present invention, there is provided a preformed gel sheet device comprising a mixture of polysaccharides consisting of: (i) a polysaccharide of red seaweed; (I) a polysaccharide containing mannose; wherein device comprises less than 2% total polysaccharide and the ratio of polysaccharides of red seaweed to polysaccharides containing mannose is about 1: 1 to about 10: 1, and wherein the gel comprising the device requires a force to the rupture greater than 60N. The preformed gel sheet devices of the present invention show a moderate amount of syneresis, as well as providing excellent characteristics during use such as benefits of discretion, formability, hydration and wetting after topical application. In addition, the preformed 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.

DETAILED DESCRIPTION OF THE INVENTION The preformed 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 relationships are by weight of the total composition of the device, unless otherwise indicated. The term "preformed" as used herein, means the device so described is manufactured in a product form having a predetermined thickness, shape and size, wherein the device can be removed from the package and placed or wrapped on the target surface with the fingers without the need to extend, rub, or cover the target area with the product form. The term "sheet device", as used herein, means that the device described is a patch or mask for cosmetic or medical application having a flat or non-planar topography, wherein the patch is a continuous, uni-sheet, bi-, or multi-laminar and the shape of which is predetermined according to the specific area of the skin, hair or nails that is going to be treated, and where the mask is a non-continuous, uni-, bi- Multi-laminar covering the facial area with openings for the eyes, nose or mouth. The term "water soluble", as used herein, means the ability of a gellable polymer gel forming agent to dissolve in an aqueous solution either at room temperature or after heating, thereby forming a continuous phase. The term "syneresis", as used herein, means the process through which a gel contracts after resting with fluid exudation. Without being limited by theory, it is believed that the gel compositions form three-dimensional matrices, which bind or encapsulate other ingredients of the composition. It is believed that syneresis involves a spontaneous separation from an initial homogeneous system to a coherent gel phase of a liquid. The exudate liquid is a solution whose composition depends on that of the original gel. When a device of the present invention is applied to a target area, the device loses some of its volume, so that the ingredients attached within the gei matrices, such as water or beneficial agents, are released into and penetrate the target area. The term "polysaccharides" as used herein, means a linear or branched polymer of naturally occurring or synthetically produced, monosaccharide units which swells when dispersed in water at low dry concentrations and gels the aqueous phase. The term "exudate libration" as used herein is a measure of the amount of syneresis presented by a gel. This method is described in the section entitled "methods". The term "rupture compression percentage", as used herein, is a measure of the flexibility of a gel. This method is described in the section entitled "methods". The term "force to rupture", as used herein, is a measure of gel strength. This method is described in the section entitled "methods". The term "brittle" as used herein means a gel that breaks easily when flexed. In the gel sheet devices, preformed herein are suitable for topical application to the skin, hair or nails.

Water-soluble polymeric gel forming agents As an essential component of the gel sheet devices, preformed herein described, the devices comprise a mixture of at least two water-soluble polymeric gel forming agents. In general, the preformed gel sheet devices of the present invention comprise less than 30%, preferably less than 20%, most preferably less than 10% and especially less than 5% by total weight of a mixture of forming agents of polymeric gel soluble in water. The water-soluble polymeric gel forming agents can be self-gelling or can only form gels in combination with other substances such as sugar, alcohol or mono- or multivalent salts. The mono or multivalent salts can also act as gel reinforcing agents imparting additional strength to the preformed gel sheet devices herein. Suitable cations for mono- or multivalent salts can be selected from potassium, sodium, ammonium, zinc, aluminum, calcium and magnesium ions, or mixtures thereof. Suitable anions associated with the aforementioned cations can be selected from chlorine, citrate, 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.

Synthetic Polymers Synthetic polymers suitable for use herein include water-soluble, non-ionic polymers; polymers based on acrylic acid or its derivatives; or cellulose derivatives; and mixtures thereof. The synthetic polymers useful herein may be categorized by their charge or constituent monomers. However, it should be understood that the classifications of the present, are made only for convenience and may be overlapped between the categories.

Nonionic Water Soluble Polymers Nonionic water soluble polymers suitable for use herein include polydimethylacrylamide, polyvinylpyrrolidones, polyethylene glycol monomethacrylate, poly-2-ethyl-2-oxazoline, polyvinyl alcohol, polyethylene oxide, polyvinyl ethers, copolymers of polyvinyl ethers and polyvinyl pyrrolidone and derivatives thereof, methyl vinyl ether and maleic anhydride, copolymers of ethylene and maleic anhydride, and mixtures thereof. In addition, nonionic water soluble polymers suitable for use herein include copolymers based on 2-hydroxyethylmethacrylate ("HEMA"), which includes the "HEMA" copolymer and one or more comonomers as described in the US Pat. USA 5,804,197 in column 14, lines 36-67 and column 15, columns 1-34; Incorporate here by reference.

Polymers based on acrylic acid and its derivatives Polymers based on acrylic acid or its derivatives include polyacrylic acids, polyacrylic acid salts such as ammonium polyacrylate and sodium polyacrylate, copolymers of acrylamide and N, N'-methylenebisacrylamide and acrylamide; and polyacrylamide and mixtures thereof.

Cellulose Derivatives Examples of cellulose derivatives suitable for use herein include carboxymethyl hydroxyethylcellulose, carboxymethylcellulose, sodium carboxymethyl cellulose, cellulose propionate carboxylate acetate, hydroxyethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, methylcellulose, sodium methylcellulose, hydroxypropylmethylcellulose, methylhydroxyethylcellulose, cellulose. microcrystalline, sodium sulfate and cellulose, and mixtures thereof. Also useful herein are alkyl-substituted celluloses. In these polymers, the hydroxy groups of the cellulose polymer are hydroxyalkylated (preferably hydroxyethylated or hydroxypropylated) to form a hydroxyalkylated cellulose, which is then further modified with a straight chain or branched chain alkyl group of 10 to 30 carbon atoms to through an ether link. Typically these polymers are ethers of straight or branched chain alcohols of 10 to 30 carbon atoms with hydroxylalkyl celluloses. Examples of alkyl groups useful herein include those selected from the group consisting of stearyl, isostearyl, lauryl, myristyl, cetyl, isocetyl, cocoyl, (ie alkyl groups derived from the coconut oil alcohols) and palmityl, oleyl, linoleyl, linolenyl, ricinoleyl, venyl and mixtures thereof. Among the preferred ones are the alkyl hydroxyalkyl cellulose ethers which is the material which is given the designation CTFA, cetyl hydroxyethyl cellulose, which is the ether of cetyl alcohol and hydroxyethyl cellulose. This material is sold under the trade name of Natrosol® CS Plus by Aqualon Corporation.

Natural polymers Natural polymers for use herein include gelatin, polysaccharides and mixtures thereof. The polysaccharides for use in the devices herein are preferably selected from polysaccharides of red seaweed; galactomannan; glucomannan; marine invertebrate extracts; starch or its derivatives; natural fruit extracts; plant fiber derivatives; seaweed ashes; exudates of natural plants, and resinous gums; or mixtures thereof. When the devices herein contain one or more polysaccharides, the devices comprise less than 10%, preferably less than 5% and most preferably less than 2% by dry weight of the polysaccharide.

Gelatin When gelatin is used in the devices herein, a high molecular weight gelatin is combined with a low molecular weight gelatin to control the solubility. A gelatin having a low molecular weight of 20,000 or less is poor in its ability to gel.

Brown seaweed polysaccharides The polysaccharides that are classified as brown seaweed polysaccharides are isolated through extraction of several species of Phaebophyceae. Brown seaweed polysaccharides, suitable for use herein include algin, alginic acid, ammonium alginate, calcium alginate, potassium alginate, sodium alginate, propylene glycol alginate and mixtures thereof.

Red seaweed polysaccharides The polysaccharides that are classified as red seaweed polysaccharides are isolated from marine species belonging to the class of Rhodophyceae. Red seaweed polysaccharides provide mechanical resistance to an aqueous gel. The red seaweed polysaccharides suitable for use in the present invention include agar known in the industry under the trade designation (CTFA) as agar-flake derived from several species of closely related Gelidium plant or 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. (Fort Lee, NJ, USA); agarose commercially available as "Sea Plaque® from FMC (Philadelphia, PA, USA) and" Agarose Type 1-b "from Sigma-Aldrich Co. Ltd. (Poole, UK), carrageenan comprising the fractions lamba-, iota- and kappa-, which are water extracts obtained from several members of the families Gigartinaceae or Solieriaceae known in the industry under the commercial designation (CTFA) as chondrus, commercially available as "Gelcarin® 3 / LCM", or "Viscarin® XLV" , all from FMC (Philadelphia, PA, USA), and furcellaran commercially available from Gum Technology Corporation (Tucson, Arizona, USA) and Continental Colloids Inc. (Chicago, IL, USA), or a mixture thereof. Red seaweed polysaccharide for use herein is selected from agar, agarose, carrageenan-layer and furcelarán, or mixtures thereof .. Most preferably, the red seaweed polysaccharide to be used herein is selected from agar and mannose, and mixtures thereof.

Glucomannan Glucomannan are polysaccharides containing mannose, which comprise an essentially linear base structure of glucose linked to - (1-4) - and residues of mannose. The C-6 position of a mannose or glucose residue in the polysaccharide base structure can be substituted with an acetyl group. Acetyl groups are usually found in 1 x 6 sugar residues, 1 x 20 sugar residues. Suitable glucomannans or their derivatives for use herein have a mannose to glucose ratio of about 0.2 to about 3. Preferred glucomannans for use herein include konjac morning which is the generic name for the flour formed by grinding tuber root of the plant Amorphophallus konjac (yam of elephants), commercially available under the tradename "Nutrico® konjac flour" from FMC (Philadelphia, PA, USA); and tomorrow de konjac desacetilada; or mixtures thereof.

Galactomanana Galactomannans are plant reserve polysaccharides, with which they occur in endosperm cells of numerous Leguminosae seeds. The collective term "galactomannan" includes all polysaccharides which are composed of galactose and mannose residues.

Galactomannans are polysaccharides containing mannose since they comprise a linear base structure of -D-mannopyranosyl units linked to (1α) - these rings are attached as branches, isolated galactopyranose residues through o-bonds (1, 6) -glucoside. Galactomannans may also contain smaller amounts of other sugar residues. Suitable galactomannan for use herein are fenegreco gum; Lucerne clover; locust bean gum known, for example, in the industry under the trade designation (CTFFA) as pea 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 milled guar endosperms derived from 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" (Wilmington, DE, USA); and cassia gum commercially available from Starlight Products Aqualon (Rouen, France); or mixtures thereof. Preferably, the galactomannans for use herein have an average of one to about 5 mansilo units substituted with a (1-6) -oc-D-galactopyranosyl unit, and are selected from guar gum, locust bean gum, gum Cassia or mixtures thereof.

Fermentation polysaccharides or derivatives thereof Fermentation polysaccharides are polysaccharides that are commercially produced from the fermentation of microorganisms in a medium containing a nitrogen carbon source, a pH regulating agent and trace elements. Suitable fermentation polysaccharides, or their derivatives, for use in the present invention include gelatin gum known in the industry under the trade designation (CTFA) as gelatin gum, an ethereal polysaccharide gum with a high molecular weight produced through a fermentation of pure culture of a carbohydrate with Pseudomonas elodea, commercially available as "Kelcogel" from Kelco (San Diego, CA, USA), xanthan gum, which is a high molecular weight heteropolysaccharide gum produced through a fermentation of pure culture of a carbohydrate with Xanthomonas campestres, known in the industry under commercial designation (CTFA) as xanthan, commercially available, for example, as "Keltrol CG 1000 / BT / F / GM / RD / SF / T / TF", all from Calgon (Pittsburg, PA, USA), or "Kelzan" from Kelco (San Diego, CA, USA); born rubber, swarm, ramsana gum; curian; succinoglycan; Welan gum; dextran, commercially available as "Sephadex G-25" from Pharmacia Fine Chemicals (Piscataway, NJ, USA) and derivatives thereof; and sclerotium gum, commercially available as "Amigel" from Alban Muller International (Montreal, France), or mixtures thereof. Preferably, the fermentation polysaccharide or its derivatives is selected from gellan gum or xanthan gum, or mixtures thereof. Most preferably the fermentation polysaccharide is xanthan gum.

Extracts of marine invertebrates The polysaccharides derived from marine invertebrates, specifically the exoskeleton of these invertebrates, consist mainly of N-acetyl-D-glucosamine derivatives. Examples of such polysaccharides suitable 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.

Starch or its derivatives Starches are polysaccharides consisting of various proportions of two polymers of glucose, amylose and amylopectin. Suitable materials 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 of natural fruit extracts for use herein include pectin; and arabian; or mixtures thereof.

Plant fiber derivatives A suitable example of a plant fiber derivative to be used herein is cellulose.

Exudates from natural plants Suitable polysaccharides obtained from exudates of natural plants for use herein include Baraya gum, tragacanth gum, gum arabic, tamarind gum and gati gum or mixtures thereof.

Resinous gums Examples of resinous gums suitable for use herein include shellac, which is obtained from the resinous secretion of the insect Laccifer (Tachardia) lacea; Damar gum; copal gum, and gum rubber; or mixtures thereof. Preferably, the mixture of at least two water-soluble polymeric gel-forming agents of the present invention forms solid, self-stable and self-adhesive structures. In general, gels formed from a single polymeric water soluble gel forming agent can demonstrate one or two of the desirable physical properties described herein, but not all three. Gels formed from synthetic polymers per se are generally low sedimentation and require water to be directed out of the reaction mixture before a continuous gel phase is formed. As a result, the gel products are dry to the touch and do not have a sufficient amount of syneresis. It has also been found, by the present inventors, that polysaccharide gels prepared from individual polysaccharides do not satisfy the desired syneresis, strength and flexibility parameters described herein. For example, 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. The gellan gum also forms a reasonably strong gel, which is also wet to the touch but is brittle and inflexible and usually breaks off at the edges of a flat target surface. In order to reduce the brittleness of the gel and, therefore, increase its flexibility, 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. gel. The gels formed from gelatin and brown seaweed polysaccharides are attributed sufficient strength, but require excipients to form a gel with a desirable amount of syneresis and in the case of brown seaweed polysaccharides, flexibility. Galactomannans, comananas and xanthan gum when individual gels are taken per se, but present synergies when combined. A gel comprising 1% locust bean gum and xanthan gum may possess sufficient moisture, but it is difficult for the gels to retain the sheet form since they are very elastic, deformable and wrinkle easily. At higher levels of total gum, the gels formed may retain their shape, but may be too dry. The inventors of the present, therefore, have found that gels formed from synergistic mixtures of water-soluble polymeric gel forming agents exhibit the desired mechanical strength and syneresis properties described herein. These properties are different from those that can be obtained from individual gel-forming agent components. The inventors of the present have also found, that in order to obtain a gel with a desirable amount of syneresis, as well as mechanical properties of strength and flexibility when the polymeric or water-soluble gel-forming agents selected for their strength are combined with humectants or other agents that impart a reduction in the brittle gel characteristic, the level of the forming mixture. Water soluble polymer gel should be kept as low as possible without compromising mechanical strength and flexibility. It is believed that low total polymer levels impart an open gei structure, so that the other general gel components are not hermetically bound between the gel network and are freely available for diffusion. Preferably, the mixture of water-soluble, polymeric gel forming agents comprises at least one polysaccharide. Therefore, the mixture comprises at least one polysaccharide and an additional water-soluble polymeric gel-forming agent, selected from one or more non-ionic, water-soluble polymers.; one or more polymers based on acrylic acid or its derivatives; one or more polysaccharides; and mixtures thereof. For example, the water soluble polymeric gel forming agent mixture of the present invention may comprise one or more polysaccharides and a nonionic water soluble polymer or alternatively, may comprise two or more polysaccharides. Most preferably, the mixture of at least two water-soluble polymer gel-forming gel agents is a mixture of polysaccharide. Preferably, the polysaccharide mixture comprises (1) at least one polysaccharide of red seaweed; a brown seaweed polysaccharide; or mixtures thereof; and (2) at least one fermentation polysaccharide; galactomanana; glucomannan; exudate of natural plants; or natural fruit extracts; and derivatives or mixtures thereof. Most preferably the polysaccharide mixture comprises (1) at least one red seaweed polysaccharide, (2) at least one fermentation polysaccharide; galactomannan, glucomannan and derivatives or mixtures thereof. In a preferred embodiment, the mixture of at least two water-soluble polymeric gel-forming agents of the present invention is a polysaccharide mixture consisting of (1) a polysaccharide of red seaweed and (2) a polysaccharide containing mannose wherein the device comprises less than 2% of the total polysaccharide. Preferably, the red seaweed polysaccharide is selected from agar and agarose, or mixtures thereof, and wherein preferably the polysaccharide containing mannose is selected from a galactomannan, glucomannan and derivatives, or mixtures thereof. While not wishing to be bound by theory, it is believed that galactomannan or glucomannan in the polysaccharide mixture complements in red seaweed polysaccharide, and contributes to the mechanical strength and flexibility of the preformed gel sheet devices of the present invention. This synergy is believed to arise due to the interactions between the polysaccharides. The red seaweed polysaccharides form double helical structures and the glucomannans and galactomannans have areas of relative substitution on the base structure of the polymer. These areas of no relative substitution in the base structure of galactomannan or glucomannan synergistically interact in the helices of the red seaweed polysaccharide. The polysaccharide mixture may further comprise xanthan gum in amounts less than or equal to the amount of polysaccharide containing mannose. Further, from the viewpoint of providing improved mechanical properties and a moderate amount of syneresis from a preformed gel sheet device, preferably, the polysaccharide ratio of red seaweed to polysaccharide containing mannose is about 1: 1. to about 10: 1, and preferably about 2: 1 to 7: 1. The preformed gel sheet devices of the present invention exhibit a moderate amount of syneresis and preferably, the devices herein are wet to the touch. As mentioned above, although a gel-comprising device will always experience some syneresis, an excessive amount of syneresis results in a non-effective and non-attractive product. In order to evaluate what is a desirable amount of syneresis exhibited by a gel of a preformed gel sheet device as described herein, the amount of syneresis is measured through the exudate release test described in FIG. section entitled "Methods". Highly preferred are the preformed gel sheet devices, wherein the gels comprising the devices have an exudate release greater than 0.7 grams, and preferably greater than 0.8 grams and less than 1.3 grams, preferably less than 1.2 grams. grams and most preferably less than 1.1 grams. The mechanical properties of the preformed gel sheet devices of the present invention are measured through the gel compression failure test. The parameters of interest are the resistance (measured by the compression force required for the rupture of a molded gel cylinder) and the flexibility (measured by the degree of compression of the gel at the point of rupture). As a highly preferred and additional feature of the preformed gel sheet devices of the present, the gels comprising the devices have a rupture compression percentage of greater than 45%, preferably greater than 50% and less than 90%, preferably less than 80%. As a further, highly preferred feature of the preformed gel sheet devices of the present invention, the gels comprising the devices require a breaking force greater than 30N, preferably greater than 60N and most preferably greater than 80N.

Water As an essential feature of the preformed gel sheet devices herein comprises water. The total water content of a preformed gel sheet device of the present invention is from about 30% to about 99.5%, preferably from about 40% to about 95%, most preferably about 50% to 85% by weight of the device.

Beneficial Agents A preferred embodiment of the present invention, the preformed gel sheet devices herein comprise a safe and effective amount of one or more beneficial agents. The term "safe and effective amount" as used herein means a quantity of a beneficial agent highly sufficient to modify the condition to be treated or to provide the skin, hair or nails with the desired benefit, but low enough to avoid effects serious side effects, to a reasonable ratio of benefit to risk within the scope of medical judgment. What is a safe and effective amount of the beneficial agent will vary with the specific agent, the agent's ability to penetrate through the skin, in or on the hair and / or nails, the age of the user, the health condition of the user , and the condition of the user's skin, hair or nails and other similar factors. The beneficial agents include pharmaceutically acceptable salts and by "pharmaceutically acceptable salts" is meant any of the commonly used salts which are suitable for use in contact with human tissues, without undue toxicity, irritation, incompatibility, instability, irritation, allergic response and the like. In general, the preformed 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 20% by weight of the devices of at least one beneficial agent or mixtures thereof. The beneficial agents useful herein may be categorized by their therapeutic benefit or their postulated mode of action. However, it should be understood that the beneficial agents useful herein may, in some cases, provide more than one therapeutic benefit or operate through more than one mode of action. Therefore, classifications are made here for safety and convenience and are not intended to limit the beneficial agent to that particular application or listed applications. The following beneficial agents are useful in the preformed gel sheet devices of the present invention.

Active against acne The active ingredients against acne can be effective to treat and prevent acne vulgaris, a chronic disorder of the pilosebaceous follicles. The condition involves inflammation of the pilosebaceous apparatus resulting in lesions, which may include papules, pustules, cysts, pimples and severe scarring. The bacteria Corynebacterium acne and Staphylococcus epidermis are usually present in postulated contents. Examples of useful acne-active ingredients include the keratolytics described in WO98 / 18444. Other useful actives include retinoids such as retinoic acid (e.g., cis and / or trans) and their derivatives (e.g., esters); retinol and its esters (for example, retinyl propionate, retinyl acetate); abiotic acid; adapalene, tazarotene, allantoin, aloe extracts, arbic acid and its salts, ASEBIOL (available from Serobiologiques laboratories located in Somerville, NJ), azaleic acid, rosewood extracts, belamcanda chinensis, benzoquinolinones, benzoyl peroxide, berberine, BIODERMINE (available from Sederma located in Brooklyn, NY), bioflavonoids such as a class of bisbobol, s-carboxymethyl cysteine, carrot extracts, casein oil, clove extracts, citral, citronella, climazol, COMPLETECH MBAC-OS (available from Lipo , located in Paterson, NJ), CREMOGEN M82 (available from Dragoco, located in Totowa, NJ), cucumber extracts, dehydroacetic acid, and its salts, dehydroepiandrosterone and sulfate derivative, dichlorophenyl imidazoliumoxane, d, l-valine and its esters, DMDM hydantoin , erythromycin, escinol, ethyl hexyl monoglyceryl ether, ethyl 2-hydroxy undecanoate, famesol, farnesyl acetate, geraniol, geranium geraniol, glabridin, gluconic acid, gluconolactone, glyceryl monocaprate, glycolic acid, grapefruit seed extract, lipid gugu, HEDERAGENIN (available from Maruzen located in Morristown, NJ), spirit, inositol, hops extract, hydrogenated rocina, 10-hydroxydecanoic acid, ictiol, interleukin-1 alpha antagonists, KAPILARINE (available from Greentech, located in Saint Beauzire, France), ketoconazole, lactic acid, lemon oil, LOCHOCHALCONE LR15 (available from Maruzen located in Morristown, NJ), linoleic acid, LIPACIDE C8CO (available from Seppic located in Pari s, France), lovastatin, 4-methoxysalicylic acid, metronidazole, nemocycline, mucurosi, nee seed oil, niacinamide, nicotinic acid, and their esters, nisin, panthenol, 1-pentadecanol, peony extract, peppermint extract, extract of fenadeltron, derivatives of 2-phenyl-2-benzothiophene, floretin, PHLORGINE (available from Secma located in Pontrieux, France), phosphatidyl choline, proteolytic enzymes, kecetin, red sandalwood extract, rosemary extract, rutin, artemisia extract , salicin, salicylic acid, serine, skullcap extract, Siberian saxifrage extract, silicol, sodium lauryl sulfate, sodium sulfoacetamide, SOPHORA EXTRACT (available from Maruzen located in Morristown, NJ), sorbic acid, sulfur, sunder extract , tea tree oil, tetrahydroabietic acid, threonine, thymus extract, thioxolone, tocopherol and its esters, trehalose 6-undecyle thic acid, 3-tridicin-2-ol, triclosan, tropolone, UNITRIENOL T27 (disp unible from Unichem, located in Chicago, IL), vitamin D3 and its analogues, white thymus oil, willow bark extract, wogonin, ylang ylang, zinc glycerolate, zinc linoleate, zinc oxide, zinc pyrithione, sulfate of zinc, surfactants, zwitterionics, (for example cetyl dimethyl botaina) and their mixtures.

Non-steroidal anti-inflammatory actives (NSAIDS) Examples of suitable non-steroidal anti-inflammatory actives and their esters for use herein in W098 / 18444, incorporated by reference. Other non-limiting examples of non-steroidal anti-inflammatory drugs (NSAIDS) include fluflenamic acid; panthenol and ether and ester derivatives thereof, for example, panthenol ethyl ether, panthenyl triacetate; pantothenic acid and its salts and ester derivatives, especially calcium pantothenate; aloe vera, bisabolol, allantoin and compounds of the orozuz family (the genus / plant species Glycyrrhiza glabra), including glycyrrhizic acid, glycyrrhizic acid and its derivatives, for example, salts such as ammonium glycyrrhizinate, and esters such stearyl glycyrrheinate .

Topical Anesthetics Examples of topical anesthetic drugs suitable for use herein are benzocaine and bupivacaine. Other suitable examples are described in WO98 / 18444, incorporated herein by reference.

Artificial Tanning Agents and Accelerators Artificial tanning agents can help simulate a natural tanning effect by increasing melanin in the skin or producing the appearance of elevated melanin in the skin. Non-limiting examples of artificial bronzing agents and accelerators include glucose tyrosinate, and acetyl tyrosine, brazilin, caffeine, coffee extracts, DNA fragments, sobutyl methyl xanthine, methyl xanthine, PHOTOTAN (available from Laboratorios Serobiologiques 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 its mixtures. Other useful artificial bronzing agents herein are described in WO98 / 18444.

Antiseptics Examples of suitable antiseptics for use herein include alcohols, benzoate, sorbic acid and mixtures thereof.

Antimicrobial and antifungal assets Antimicrobial and antifungal assets can be effective in preventing the proliferation and growth of bacteria and fungi. Non-limiting examples of antimicrobial and antifungal agents include ketoconazole, cyclopirox, benzoyl peroxide, tetracycline, acelaic acid and its derivatives, ethyl acetate, alantolactone, isoalantolactone, alknet extract (alanine), anise, arnica extract (helenaline acetate and 11, 13-dihydrohelenaline), aspidium extract (floro, lucinol-containing extract), rosewood extract (berberine chloride), sweet bay extract, laurel berry bark extract (miricitrin), benzalkonium chloride, chloride of benzethonium, benzoic acid and its salts, benzoin, benzyl alcohol, thistle, tubercle seed, bloodthirsty, rose oil, burdock, butyl paraben, oil of each, CAE (available from Ajinomoto located in Teaneck, NJ), cayputi oil , cangzu, caraway oil, cascarillo bark (sold under the trade name ESSENTIAL OIL), cedar leaf oil, chamomile, chaparral, chlorphenecine, chloroxylenol, cinnamon oil, oil citronella, clove oil, dehydroacetic acid and its salts, dill seed oil, DOWICIL 200 (available from Dow Chemical located in Midland, Ml), echinacea, elenoic acid, epimedium, ethyl paraben, FO-Ti, galbanum, pimpernel , GERMALL 115 and GERMANLL II (available from ISP-Sutton Labs located in Wayne, NJ), German chamomile oil, giant black centaury, GLYDANT (available from Lonza located in Fairlawn NJ), GLYDANT PLUS (available from de Lonza located in Fairlawn NJ), grapefruit seed oil, hexamidine diisetionate, hinoquitiol, honey, honeysuckle flower, hops, immortel, YODOPROPINIL BUTIL CARBAMIDE (available from Lonza located in Fairlawn NJ), isobutyl paraben, isopropyl paraben, JM ACTICARE (available from Microbial Systems International located in Nottingham, UK), juniper raspberries, KATHON CG (available from Rohm and Haas located in Philadelphia, PA, USA), lavender, lavender, lemon balm oil, lemon, methyl paraben, peppermint, mustard, chrysanthemum, myrrh, neem seed oil, ortho phenyl phenol, OLIVE LEAF EXTRACT (available from Bio Botánica, located in Hauppauge, NY), parsley, patchouli oil, peony root, PHENONIP (available from Nipa Labs located in Wilmington, DE), phytosphinesin, pine oil, PLANSERVATIVE (available from Field Research, located at Raffles Quay, Singapore), propil paraben, purslane, quilaria, rhubarb, geranium rose oil, rosemary, mugwort, salicylic acid, sassafras, savory, liguric, sodium metabisulphite, sodium sulfite, SOPHOLIANCE (available from Soliance located in Compiegne, France), acid sorbic and its salts, sphingosine, stevia, esotras, tannic acid, tea, tea tree oil (cajeputi oil), thymus, triclosan, triclocarban, tropolone, turpentine, umbeliferota (antifungal) and cassava or mixtures thereof. Other examples of antimicrobial and antifungal actives useful herein are described in W098 / 18444.

Skin softening agents Skin softening agents can be effective in preventing or treating inflammation of the skin. The softening agent improves the appearance benefits of the skin of the present invention, for example, said agents contribute to a more uniform and acceptable skin tone or color. Non-limiting examples of skin softening agents include absintio, acacia, aesine, arraclán extract, allantoin, aloe, APT (available from Centerchem, located in Stamford, CT), arnica, tragacanth, tragacanth root extract, azulene, BAICALIN SR 15 (available from Barnet Products Dist. located in Englewood, NJ), skullcap, Baizu, Canada balsam, bee pollen, BIOPHYTEX (available from Laboratories Serobiologiques located in Somerville, NJ), bisabolol, black cohosh, black cohosh extract , blue cohosh extract, blue cohosh, eupatorium, borage oil, borage oil, borage seed, bromelain, calendula, calendula extract, CANADIAN Willowbark eXTRACT (available from Fytokem), candelilla wax, cangzu, phytosterols, canola pepper, carboxypeptidase, celery seed, celery stalk extract, CENTAURIUM (available from Sederma, located in Brooklyn, NY), centaur extract, camazulene, chamomile, chamomile extract, chaparral, p uro, pure tree extract, chickweed, chicory root, chicory root extract, chirata, chisao, colloidal oatmeal, comfrey, comfrey extract, CROMIST CM GLUCAN (available from Croda, located in Parsippany, NJ), darutoside , urian angelica, DEVIL'S CLAW (available from MMP located in Plainfield, NJ), divalent metals (such as magnesium, strontium, manganese), grass, wild cherry, EASHAVE (available from Pentapharm, located in Basel, Switzerland), eleuthero, ELHIBIN (available from Pentapharm, located in Basel, Switzerland), enteline 2 (available from Secma, located in Pontrieux, France), ephedra, epimedio, esculósida, ass grass, eyebright, EXTRACT LE-100 (available from Sino Lion, located in World Trade Center, NY), roots, magarza, fisina, forsitia fruit, ganoderma, gaoben, GATULINE (available from Gattefosse, located in Saint Priest, France), gentian, germanium extract, gingko biloba, ginkgo, ginseng extract , American ranunculacea, gor extract gonid, gotu kola, grape fruit extract, guaiac wood oil, gugal extract, helenaline esters, henna, honeysuckle flower, horehound extract, horse chestnut, horsetail, huzhang, hypericum, ichthyol, everlasting, ipecuacana, tears of david, azofaifo, tail extract, LANACHRYS 28 (available from Lana Tech, located in Paris, France), lemon oil, lianquio, sweet stick, ligusticum, ligustrum, liguric root, scourer, mace, flower magnolia, extract from the manjista, margaespidina, margaespidina, matricida, MICROAT IRC (available from Nurture, located in Missoula, MT), mistletoe, MODULENE (available from Seporga, located in Sophia Antipolis, France), extract from mung, musk, extract from oats, orange, panthenol, papain, peony bark, peony root, PHYTOPLENOLIN (available from Bio Botanica, located in Hauppauge, NY), PREREGEN (available from Pentapharm, located in Base, Switzerland), purslane, QUENCH T (available from Centerchem, located in Stamford, CT), quilaria, red sage, remanía, rubarba, rosemary, rosamarínico oil, royal jelly, rue, routine, sandalwood, Yankee, sarsaparilla, palmetto, SENSILINE (available from de Silab, located in Brive, France), SIEGESBECKIA (available from Sederma, located in Brooklyn, NY), stearyl gliciretinate, STIMUTEX (available from Pentapharm, located in Basel, Switzerland), esotrax, sweet birch oil, sweet rubilla, tagetos, tea extract, thymus extract, gensing tienchi, tocopherol, tocopheryl acetate, triclosan, batadilla, urimei, ursolic acid, white pine bark, witch hazel, xinyi, bastard sagebrush, yeast extract, cassava, and mixtures thereof.

Sunscreen Agents Suitable sunscreen agents useful herein are described in WO98 / 18444 incorporated herein by reference. Other examples of sunscreens that are useful herein include diethanolamine p-methoxycinnamate, dioxybenzone, ethyl dihydroxypropyl PABA, glyceryl aminobenzoate, dihydroxyacetone, menthyl anthranilate, methyl anthranilate, octal dimethyl PABA, red oil, sulisobenzone, triethanolamine salicylate. , and mixtures thereof.

Skin barrier repair aids Skin barrier repair aids are skin care aids that can help repair and fill 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), CERAMIDA 2 (available from Sederma, located in Brooklyn, NY), CERAMIDA HO3TM (available from Quest, located in Ashford, England), CERAMIDE II (available from Queso, located in Ashford, England), CERAMIDA IIIB (available from Cosmoferm, located in Delft, The Netherlands), CERAMIDE IS 3773 (available from Laboratorios Serobiologiques, located in Somerville, NJ), CERAMINOL (available from Inocosm, located in Chatenay Malabry, France), CERASOL (available from Pentapharm, located in Base, Switzerland), CEPHALIP (available from Pentapharm, located in Base, Switzerland), cholesterol, cholesterol hydroxystearate, cholesterol isostearate, 7- dehydrocholesterol, DEMATEIN BRC (available from Hormel, located in Austin, MN), DEMATEIN GSL (available from Hormel, located in Austin, MN), ELDEW CL 301 (available from Ajinomoto, located in Teaneck, NJ), ELDEW PS 203 (available from Ajinomoto, located in Teaneck, NJ), FITROBROSIDE (available from Pentapharm, located at Base, Switzerland), GENEROL 122 (available from Henke, located at Hoboken, NJ), glyceryl serine amide, lactic acid, LACTOMIDE (available from Pentapharm, located in Base, Switzerland), lanolin, lanolin alcohols, lanesterol, n-laurylglucamide of lipoic acid, lipoic acid, n-acetyl cysteine, serine, n-acetyl-L-serine, n-methyl-L-serine, NET STEROL-ISO (available from Barnet Products, located in Englewood, NJ), niacynamide, nicotinic acid and its esters, nicotinic alcohol, palmitic acid, panthenol, pantethine , phosphodiesterase inhibitors, PHYTO / CER (available from Intergen, located in Purchaser, NY), PHYTOGLYCOLIPOD MILLET EXTRACT (available from Bamet Products Distributor, located in Englewood, NJ), PHYTOSPH1NGOSINE (available from Gist Brocades, located in King of Prussia, PA), PSENDOFILAGGRIN (available d e Brooks Industries, located in South Plainfield, NJ); QUESTAMIDE H (available from Cheese, located in Ashford, England), serine, stigmasterol, cytosterol, stigmastanol, sterols derived from soybean, sphingosine, s-lactoil glutathione, stearic acid, SUPER STEROL STRESS (available from Croda, located in Parsippany, NJ ), thioctic acid, THSC CERAMIDE OIL (available from Field Research, located at Raffles Quay, Singapore), thymic glycine, tocopheryl nicotinate, vitamin D3 and analogues or derivatives thereof, and Y2 (available from Ocean Pharmaceutical), or mixtures thereof.

Anti-wrinkle and anti-atrophy active ingredients Anti-wrinkle and anti-atrophy skin can be effective to fill or rejuvenate the epidermal and / or dermal layer. These assets generally provide these desirable skin care benefits by promoting or maintaining the natural process of scaling and / or developing skin matrix components (eg, collagen and glycosaminoglycans). Non-limiting examples of anti-wrinkle and skin anti-antria actives include nicotinic acid and its esters, nicotinyl alcohol, estrogens and estrogenic compounds, or mixtures thereof. Other suitable anti-wrinkle and anti-skin atrophy actives useful herein are described in W098 / 18444.

Skin repair assets Skin repair assets can be effective in repairing the epidermal and / or dermal layer. Non-limiting examples of skin repair actives include acyin 27-deoxyactein cimicifugoside (cimigoside), adapalene, tazarotene, ademetionin, adenosine, aletris extract, lectins derived from aloe, 3-aminopropyl diacid phosphate, AMADORINE (available from Barnet Products, located in Englewood, NJ), anise extract, AOSINE (available from Secma, located in Pontrieux, France), arginine aminobenzoate, ASC III (available from E. Merck, located in Darmstadt, Germany), ascorbic acid, ascorbyl palmitate, Asian acid, asiaticocosides, ARLAMOL GEO (available from ICI, located at Wilmington, DE), azaleic acid, benzoic acid derivatives, bertoletia extracts, butylinic acid, BIOCHANIN A, BIOPEPTIDE CL (available from Sederma, located in Brooklyn, NY), BIOPEPTIDE EL (available from Sederma located in Brooklyn, NY), biotin, blackberry bark extract, lily extracts, black cohosh extract, blue cohosh extract, botulinum butanoyl acid, catecholamines, calconas , pure tree extract, cis-retinoic acid, citric acid esters, clover extracts, coenzyme Q10 (ubiquinone), coumestrol, CPC PEPTIDE (Barnet Products, located in Englewood, NJ), daidezin, simicaria extract, darutoside, debromine laurinterol, 1-decanoyl-glycerol-phosphonic acid, dehydrocholesterol, dehydrodicreosol, dehydrodeugenol, dehydroepiandosterone, DERMOLECTIN (available from Sederma, located in Brooklyn, NY), dehydroascorbic acid, dehydroepiandosterone sulfate, diantol, 2,4-dihydrobenzoic acid, diosgenin, disodium ascorbyl phosphate, dodecanedioic acid, EDERLINE (available from Seporga, located in Sophia Antipolis, France), ELESERYL SH (available from Laboratorios Serobiologiques, located in Somerville, NJ), ENDONUCLEINE (available from Laboratorios Serobiologiques, located in Somerville, NJ), ecuol, ergoteros, eriodictiol, estrogen and its derivatives, atocin, eitrobic acid, famesol, famesyl acetate, hemp extract, FIBRASTIL (available from Sederma, located in Brooklyn, NY), FIBROSTIMULINES S AND P (available from Sederma, located in Brooklyn, NY), FIRMOGEN IS 8445 (available from Laboratorios Serobiologiques, located in Somerville, NJ), flavonoids (especially flavanones such as unsubstituted flavanone and calconas such as unsubstituted chalcone and monohydroxy and dihydroxychalcones), formononet ina, forsythia fruit extract, gallic acid esters, amino butyric acid, GATULINE RC (available from Fattlefosse, located in Saint Priest, France), genistein, genistein, genetic acid, gentisyl alcohol, gingko bilboa extracts, extracts of ginseng, ginsenoside, RO, R6-- ?, Rß-2, Re-3, Rc, RD > RE, RF, RF-2, RG-I, RG-2, pyranosyl-1-glucocortoules, glutathione and its esters, glycitein, 4-salicylic heptyloxy acid, hesperitin, hexahydrocurcumin, HMG-coenzyme A reductase inhibitors, hops extracts, 11-hydroxy undecanoic acid, 10-hydroxydecanoic acid, 25-hydroxycholesterol, ISOFAVONE SG 10 (available from Barnet Products, located in Englewood, NJ), kinetin, esters of L-2-oxo-thiazolidin-4 acid carboxylic, lactate dehydrogenase inhibitors, 1-lauryl-lyso-phosphatidyl choline, lectins, LICHOCHALCONE LR15 (available from Maruzen, located in Morristown, NJ), liquorice extract, lipoic acid, lumisterol, liteolin, magnesium-ascorbyl phosphate, melatonin, melibiose, metalloproteinase inhibitors, methoprene, metoprénic acid, 4-methoxy salicylic acid, mevalonic acid, MPC COMPLEX (available from CLR, located in Berlin, Germany), N-acetyl cysteine, N-methyl serine, N-methyl taurine , N, N'-bis (lactyl) cysteamine, naringenin, neotigo genin, 5-octanoyl salicylic acid, O-demethylangosensin, oleanolic acid, pantin, phenylalanine, photoanetone, phytic acid and its salts, piperidine, placental extracts, pratensein, pregnenolone, pregnenolone acetate, pregnenolone succinate, premarin, chyloic acid, raloxifene , REPAIR FACTOR 1 (available from Sederma, located in Brooklyn, NY), REPAIR FACTOR SPC (available from Sederma, located in Brooklyn, NY), retinal, retinoates (esters of alcohols of 2 to 20 carbon atoms), retinol, acetate of retinyl, retinyl glucuronate, retinyl linoleate, retinyl palmitate, retinyl propionate, REVITALIN BT (available from Pentapharm, located in Base, Switzerland), s-carboxymethyl cysteine, salicylic acid, SEANAMINE FP (available from Laboratorios Serobiologiques, located in Somerville, NJ), sodium-ascorbyl phosphate, soy extracts, spleen extracts, tachysterol, taurine, tasarotene, thymolen, thymus extract, thyroid hormones, tigogenin , tocopheryl retinoate, toxifolin, trasn-retinoic acid, traumatic acid, tricholine citrate, triphoside, uracil derivatives, ursolic acid, vitamin D3 and its analogs, vitamin K, vitex extract, yam extract, yamogenin and ketamine and mixtures thereof.

Lipids Examples of suitable lipids include cetyl risinoleate, cholesterol hydroxystearate, cholesterol isostearate, CREMEROL (available from Amerchol, located in Edison, NJ), ELDEW C1301 (available from Ajinomoto, located in Teaneck, NJ), lanolin, MODULAN (available from Amerchol, located in Edison, NJ), OHLAN (available from Amerchol, located in Edison, NJ), petrolatum, fitantrioil and SUPER STEROL ESTERES (available from Croda, located in Parsippany, NJ), or mixtures thereof.

Skin lightening agents Skin lightening agents can actually reduce the amount of melanin in the skin or provide this effect through 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. Other 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, tubercle Bletilla extract, Bupléurum extract, pimpernel extract, BURNET POWDER (available from Barnet Products, located in Englewood, NJ), butyl hydroxy anisole, butyl hydroxy toluene, chuanxiong, symmetry, deoxiarbutine, 1,3-diphenyl propane derivatives, acid 2,5-dihydroxybenzoic acid and its derivatives, 2- (4-acetoxyphenyl) -1,3-ditano, 2, (4-hydroxyphenyl) -1,3-ditano, ellagic acid, escinol, estragole derivatives, esculoside, esculetin, FADEOUT (available from Pentapharm, located in Basel, Switzerland), fangfeng, fennel extract, gallic acid and its derivatives, ganoderma extract, gaoben, GATULINE WIHITENING (available from Gatterfosse, located in Saint Priest, France), genísitico acid and its derivatives, alcohol gentisilic, glabridin and its derivatives, glucopyranosyl-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, hydroxy caprylic acid, inositol ascorbate, kojic acid, lactic acid, lemon extract, licorice extract, LICORICE P-TH (available from Barnet Products, located in Englewood, NJ), acid linoleic, magnesium-ascorbyl phosphate, MELFADE (available from Pentapharm, located in Basel, Switzerland), MELAWHITE (available from Pentapharm, located in Basel, Switzerland), extract of morus alba, blackberry root extract, 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), derivatives of 2,4-resorcinol, 3,5-resorcinol derivatives, Russian fruit extract, rucinol, salicylic acid, song-yi extract, SOPHORA POVVDER (available from Barnet Products, located in Englewood, NJ), 4-tioresorein, derivatives of 3,4,5-trihydroxybenzyl, tranexamic acid, TYROSLAT 10,11 (available from Fytokem), vitamin D3 and its analogues, yeast extract or mixtures thereof.

Sebum inhibitors Sebum inhibitors can reduce the production of sebum in the sebaceous glands. Examples of suitable sebum inhibitors include aluminum hydroxychloride, ASEBIOL (available from Laboratorios Serobiologiques, located in Somerville, NJ), BIODERMINE (available from Sederma, located in Brooklyn, NJ), climbazole, COMPLETECH MBAC-OS (available from Lipo, located in Peterson, NJ), corticosteroids, cucumber extracts, dehydroacetic acid and its salts, dichlorophenyl-midazole dioxolan, ketoconazole, LICHOCHALCONE LR 15 (available from Maruzen), niaciinamide, nicotinic acid, and its esters, nicotinyl alcohol, fluoretine, PHLOROGINE (available from Secma, located in Pontrieux, France), pyridoxine and its derivatives, S-carboxymethyl cysteine, SEPINCONTROL AS, spironolactone, thioxolone, tocopherol, UNITRIENOL T27 (available from Unichem, located in Chicago, IL), and ZINCIDONE (available from UCIB, located in Clifton, NJ), and mixtures thereof.

Sebum stimulants Sebum stimulants can increase the production of sebum through the sebaceous glands. Non-limiting examples of sebum stimulants include brionic acid, COMPLETECH MBAC-DS (available from Lipo, located in Paterson, NJ), dehydroepiandrosterone (also known as DHEA), oryzanol, and mixtures thereof.

Skin Perception Agents Non-limiting examples of skin-sensing agents suitable for use in the present invention include agents that impart a cold sensation, such as camphor, thymol, 1 -mentol and derivatives thereof, eucalyptus, carboxamides.; methanéteres, and methanesters; and agents imparting a heat sensation such as cayenne tincture, cayenne extract, cayenne powder, vanillyl amide nonanoate, nicotinic acid derivatives (benzyl nicotinate, methyl nicotinate, phenyl nicotinate, etc.), capsaicin, extract of naturtium officinale, extract Zanthoxylum piperitum and ginger extract, or mixtures thereof.

Protease inhibitors Protease inhibitors are compounds that inhibit the process of proteolysis, that is, the separation of proteins into smaller peptide fractions and amino acids. Examples of suitable protease inhibitors include AE COMPLEX (available from Seporgia Laboratories located in Sophia Antipolis, France), ALE (available from Seporgia Laboratories located in Sophia Antipolis, France), AOSAINE (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 Coliaborative Labs. Inc., located in East Setauket, NY), CENTAURIUM (available from Sederma located in Brooklyn, NY) , CMST (available from Bioética Inc. located in Portland, ME), DERMOPROTECTINE (available from Sederma located in Brooklyn, NY), DISACOSIDE HG 60 (available from Barnet Products located in Englewood, NJ), ELHIBIN (available from Vegetech located in Glendale , CA), HYPOTAURINE (available from Sogo Pharmaceutical Co. Ltd. located in East Setauket, NY), IN CYTE HEATHER (available from Coliaborative Labs. Inc., located in East Setauket, NY), MICROMEROL (d) available from Pentapharm AG located in Basel. Switzerland), PEFABLOC SP (available from Pentapharm AG located in Basel, Switzerland), SEPICONTROL AS (available from Seppic located in Paris, France), SIEGESBECKIA (available from Sederma located in Brooklyn, NY), SOPHORINE (available from Barnet Products located in Englewood, NJ), THIOTAINE (available from Barnet Products located in Englewood, NJ), and mixtures thereof.

Skin Tightening Agents Non-limiting examples of skin tightening agents include BIOCARE SA (available from Amerchol, located in Edison, NJ), egg albumin, FLEXAN (available from National Starch located in Bridgewater, NJ), GATULINE LIFTING (available from Gattefosse located in Saint Priest, France), PENTACARE HP (available from Serobiologiques laboratories located in Somerville, NJ), VEGESERYL (available from Serobiologiques laboratories located in Somerville, NJ), and mixtures thereof.

Anti-pruritus ingredients Non-limiting examples of anti-pruritus agents include STIMUTEX ((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 TRIESTERES (available from Seporgia Laboratories located in Sophia Antipolis, France), and mixtures thereof.

Agents for inhibiting hair growth Non-limiting examples of agents suitable for inhibiting hair growth include 17-estradiol, adamantiguanidines, adamantyl amidines, adenylosuccinate synthase inhibitors, anti-angiogenic steroids, aspartate transcarbamylase inhibitors, betamethasone valerate, bisabolol, copper ions, turmeric extract, cycloxygenase inhibitors, cistern path inhibitors, dehydroacetic acid, dehydroepianandrosterone, diopir extract, epidermal growth factor, epigallocatecin, essential fatty acids, donut herb oil, gamma-transpeptidase inhibitors, ginger oil, glucose metabolism inhibitors, inhibitors of metabolism of glutamine, glutathione, green tea extracts, heparin, KAPILANNE (available from International Sourcing Distributor, located in Upper Saddle River, NJ), L-5-diaminopentanoic acid, synthase inhibitors of L-aspargin, linoleic acid, inhibitors of lipoxygenase, longa extract, mimosinamine dihydrochloride, mimosine, nitric oxide synthase inhibitors, non-steroidal antiinflammatories, ornithine decarboxylase inhibitors, ornithine aminotransferase inhibitors, panthenol, phorhetur, phosphodiesterase inhibitors, leiona extract, kinase inhibitors C protein, 5-alpha reductase inhibitors, compue These reactive sulfhydryl, thioxolone, beta 1 transforming growth factor, urea, zinc ions, and mixtures thereof. 5-alpha reductase inhibitors Non-limiting examples of 5-alpha reductase inhibitors include CLOVE 55 ((available from Barnet Products located in Englewood, NJ), ethinylestradiol, genistein, genistin, Licohalcone LR-15, palmito extracts, SOPHORA EXTRACT ( available from Maruzen located in Morriston, NJ), ZINCIDONE (available from UCIB, located in Clifton, NJ), and mixtures thereof.

Deescamation enzyme enhancers These agents improve the activity of endogenous desquamation enzymes. Non-limiting examples of de-escalation enzyme enhancers include N-methylserine, serine, trimethylglycine and mixtures thereof.

Anti-glycation agents Anti-glycation agents prevent sugar-induced entanglement of collagen. A suitable example of an anti-glycation agent includes AMADORINE (available from Barnet Products located in Englewood, NJ). Preferred examples of beneficial agents useful in the present invention include those selected from the group consisting of salicylic acid, niacinamide, tocopheryl nicotinate, benzoyl peroxide, 3-hydroxybenzoic acid, flavonoids (eg, favonone, chalcone), famesol, phytantriol, glycolic acid, lactic acid, 4-hydroxybenzoic acid, acetylsalicylic acid, 2-hydroxybutanoic acid, 2-hydroxypentanoic acid, 2-hydroxyhexanoic acid, cis-retinoic acid, trans-retinoic acid, retinol, retinyl esters (eg, propionate, retinyl), phytic acid, n-acetyl-n-cysteine, lipoic acid, tocopherol and its esters (eg, tocopheryl acetate), azelaic acid, arachidonic acid, tetracycline, ibuprofen, naproxen, ketoprofen, hydrocortisone, acetaminophen, resorcinol, phenoxyethanol, phenoxypropanol, phenoxyisopropanol, 2,4,4'-trichloro-2'-hydroxy diphenyl ether, 3,4,4'-trichlorocarbanilide, octopirox, lidocaine hydrochloride , clotrimazole, miconazole, ketoconazole, neomycin sulfate, theophylline, and mixtures thereof. For cosmetic methods of treating the skin, hair or nails, the beneficial agent is preferably selected from active anti-wrinkle and anti-atrophy skin, active against acne, artificial bronzing agents and accelerators, skin repair actives, the skin barrier, skin lightening agents, skin permeation agents, skin softening agents, lipids, sebum inhibitors, sebum stimulants, sunscreen agents, protease inhibitors, skin tightening agents, anti-pruritus ingredients, and de-scaling enzyme enhancers or mixtures thereof.

Moisturizers Preferred preformed gel sheet devices comprise at least one humectant. The humectants can be added to achieve a plasticizing effect and to increase the moisture characteristics of the preformed sheet device when applied to the target surface. Certain humectants such as hexylene glycol can also contribute to the antibacterial and characteristic properties of a preformed gel sheet device of the present invention. Furthermore, without wishing to be bound by theory, it is believed that by incorporating humectants into the preformed gel sheet devices of the present invention the stability of the devices is increased so that they are less likely to undergo decomposition under extreme temperature conditions. In general, the preformed gel sheet devices of the present invention comprise about 1.0% to 45%, preferably about 5% to about 40%, most preferably about 10% to about 30%, by weight of a humectant . Suitable humectants for use in the present invention are described in WO98 / 22085, W098 / 18444 and WO97 / 01326, all incorporated herein by reference. In addition, suitable humectants include amino acids and their derivatives such as proline and arginine aspartate, 1,3-butylene glycol, propylene glycol and water and extract of codium tomenstosum, collagen, amino acids or peptides, creatinine, diglycerol, biosaccharide gum-1, glucamine salts, glucuronic acid salts, glutamic acid salts, polyethylene glycol glycerin ethers (eg, glycereth 20) glycerin, glycerol monopropoxylate, glycogen, hexylene glycol, honey, and extracts or their derivatives, hydrogenated starch hydrolyzes, hydrolysed mucopolysaccharides, inositol, keratin amino acids, LAREZ A-200 (available from Larex), glycosaminoglycans, methoxy PEG 10, methyl glucet-10 and 20 (both commercially available from Amerchol located in Edison, NJ), methylglucose, 3-methyl-1,3-butanediol, n-acetylglucosamine salts, panthenol, polyethylene glycol and their derivatives (such as PEG 15 butanediol, PEG 4, PEG 5 pentairitritol, PEG 6, PEG 8, PEG 9, pentaerythritol, 1,2-pentanedioyl, PPG-1 glyceryl ether, PPG-9, 2-pyrrolidone-5-carboxylic acid and its salts such as glyceryl pea, saccharide isomerate, SEACARE (available of Secma), be icine, silk amino acids, sodium acetyluronate, sodium ialuronate, sodium poly-aspartate, sodium polyglutamate, sorbet 20, sorbet 6, sugar and sugar alcohols and their derivatives, such as glucose, mannose and polyglycerol sorbitol, trehalose, triglycerol, trimethylpropane, detris (hydroxymethyl) amino methane salts, and yeast extract, or mixtures thereof. Preferably, the humectants for use herein are selected from glycerin, butylene glycol, hexylene glycol, panthenol and polyethylene glycol and their derivatives and mixtures thereof.

Emulsifiers / surfactants The preformed gel sheet devices of the present invention optionally may also 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 to clean the skin, hair or nails. For convenience, hereinafter emulsifiers will be referred to under the term "surfactants", thus "surfactants" will be used to refer to surface active agents if they are used as emulsifiers or for other surfactant purposes such as like cleaning the skin, hair or nails. Known conventional surfactants can be used in the composition, provided that the selected agent is chemically and physically compatible with the essential components of the composition, and provides the desired characteristics. Suitable surfactants include silicone materials, non-silicone materials, and mixtures thereof. The compositions of the present invention preferably comprise about 0.01% to 15% of a surfactant or mixtures of surfactants. The surfactant or mixture of surfactants selected will depend on the pH of the composition and the other components present. The preferred surfactants are nonionic. Among the nonionic surfactants which are useful herein are the condensation products of alkylene oxides with fatty acids (ie, alkylene oxide esters of fatty acids). These materials have the general formula RCO (X) nOH wherein R is an alkyl group of 10 to 30 carbon atoms, X is -OCH2CH2 (ie, is derived from ethylene glycol or oxide) or -OCH2CHCH3- (ie, it is derived from propylene glycol or oxide), and n is an integer from about 6 to about 200. Other nonionic surfactants from the condensation products of alkylene oxides with two moles of fatty acids (ie, alkylene oxide diesters of fatty acids). These materials have the general formula RCO (X) nOOCR wherein R is an alkyl group of 10 to 30 atom, X is -OCH2CH2 (ie, is derived from ethylene glycol or oxide) or -OCH2CHCH3- (ie, is derived of propylene glycol or oxide), and n is an integer of about 6 to about 100. Other nonionic surfactants are the condensation products of alkylene oxides with fatty alcohols (ie, alkylene oxide ethers of fatty alcohols). These materials have the general formula RCO (X) nOR 'wherein R is an aliphatic group of 10 to 30 atom, X is -OCH2CH2- (ie, is derived from ethylene glycol or oxide) or -OCH2CHCH3- (ie, is derived from propylene glycol or oxide), and n is an integer from about 6 to about 100, and R 'is H or an aliphatic group of 10 to 30 carbon atoms, examples of which include PEG 40 hydrogenated castor oil, available under the tradename "Cremophor RH 40" from BASF (Parsippany, NJ, USA); PEG 60 hydrogenated castor oil, available under the name "Cremophor RH 60" from BASF (Parsippany, NJ, USA); isocetet-20, available under the trade name "Arlasolve 200" from ICI (Wilmington, MA, USA); and olet-20, available under the tradename "Volpo 20" from Croda Chemicals Ltd. (Goole, North Humberside, England). Other nonionic surfactants are the condensation products of alkylene oxides with both fatty acids and fatty alcohols [ie, wherein the polyalkylene oxide moiety is esterified on one end with a fatty acid, and etherified (i.e. , connects through an ether link) on the other end with a fatty alcohol]. These materials have the general formula RCO (X) nOR 'wherein R and R' are an alkyl groups of 10 to 30 atom, X is -OCH2CH2- (ie, is derived from ethylene glycol or oxide) or -OCH2CHCH3- (is derived from propylene glycol or oxide), and 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, stearate of PEG-6, stearate of PEG-10, stearate of PEG- 100, PEG-12 stearate, PEG-20 glyceryl stearate, PEG-80 glyceryl seboate, PEG-10 glyceryl stearate, PEG-30 glyceryl cocoate, PEG-80 glyceryl cocoate, PEG-200 glyceryl seboate, PEG-8 dilaurate, PEG-10 distearate, and mixtures thereof. Other nonionic surfactants which are useful herein are alkyl glucosides and alkyl polyglucosides, which are described in greater detail in W098 / 18444, incorporated herein by reference. Other nonionic surfactants include polyhydroxy fatty acid amide surfactants, which are described in greater detail in WO98 / 04241. Other suitable nonionic surfactants for use herein include sugar esters and polyesters, esters and alkoxylated sugar polyesters, fatty acid esters of 1 to 30 carbon atoms of fatty alcohols of 1 to 30 carbon atoms, alkoxylated derivatives of fatty acid esters of 1 to 30 carbon atoms of fatty alcohols of 1 to 30 carbon atoms, alkoxylated ethers of fatty alcohols of 1 to 30 carbon atoms, polyglyceryl esters of fatty acids of 1 to 30 carbon atoms, esters of polyols of 1 to 30 carbon atoms, polyol ethers of 1 to 30 carbon atoms, alkyl phosphates, polyoxyalkylene ether fatty phosphates, fatty acid amides, acyl lactylates and mixtures thereof. Examples of these surfactants that do not contain silicon include; polysorbate 20, polyethylene glycol 5 sterol sterol, steareth-20, ceteareth-20, methyl glucose diolsterather of PPG-2, polysorbate 80; polysorbate 60, available under the tradename "Tween 60" from ICI (Wilmington, MA, USA); glyceryl stearate, sorbitan monolaurate, sodium stearate of polyoxyethylene 4 lauryl, polyglyceryl-4 isostearate, hexyl laurate, methyl glucose distearate ether of PPG-2, and mixtures thereof. Among the preferred nonionic surfactants are those selected from ceteareth-12, sucrose cocoate, steareth-100, polysorbate-60, hydrogenated castor oil from PEG-60, isoceteth-20, oleth-20, stearate from PEG-100. and mixtures thereof. Other emulsifiers suitable for use herein are polyoxypropylene, polyoxyethylene ethers of fatty alcohols. These materials have the general formula R (CH2CHCH30) x- (CH2CH20)? -H, wherein R is an alkyl group of OC? 0-C3o or an alkyl group of 10 to 30 carbon atoms, x has an average value from 1 to 20 e and has an average value of from 1 to 30, examples of which include PPG-6-Decytetradeceth-30 available under the tradename of "Pen 4630" from Nikko Chemicals Co. Ltd. (Tokyo, Japan); PPG-6-Decytetradeceth-20 available under the tradename "Pen 4620" from Nikko Chemicals Co. Ltd. (Tokyo, Japan); and PPG-5-Ceteth-20, available under the tradename "Procetyl AWS" from Croda Chemicals Ltd. (Goole, North Humberside, England). Another emulsifier useful herein are mixtures of fatty acid which are based on a mixture of sorbitan fatty acid ester or sorbitol and sucrose fatty acid ester, as described in more detail in WO98 / 22085, incorporated herein by reference. Hydrophilic surfactants useful herein alternatively or additionally may include any of a wide variety of cationic, anionic, anionic, amphoteric, and amphoteric surfactants, as is known in the art. See, for example, McCutcheon's Deterqents and Emulsifiers, North American Edition, (1986), published by Allured Publishing Corporation; US-A-5,011, 681 of Ciotti et al., Issued April 30, 1991; patent of E.U.A. 4,421, 769 of Dixon et al., Issued December 20, 1983, and patent of E.U.A. No. 3,755,560 to Dickert et al., Issued August 28, 1973; These four references are incorporated herein by reference in their entirety. A wide variety of cationic surfactants are useful herein, suitable cationic surfactants for use herein are described in W098 / 18444. A wide variety of anionic surfactants are useful herein. See, for example, US patent. 3,929,678 to Laughiin et al., Issued December 30, 1975, which is hereby incorporated by reference in its entirety. Exemplary anionic surfactants include the alkenyl isethionates (eg, from 12 to 30 carbon atoms), alkyl and alkyl ether sulfates and their salts, alkyl and alkyl ether phosphates and their salts, alkyl methyl taurates (eg, from 12 to 30 carbon atoms) and soaps (for example, alkali metal salts, such as potassium or sodium salts) of fatty acids. Amphoteric and zwitterionic surfactants are also useful herein. Examples of amphoteric and switerionic 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, wherein the aliphatic radical can be a straight or branched chain and wherein one of the aliphatic substituents contain from about eight to about 22 carbon atoms (preferably from 8 to 18 carbon atoms), and one contains a group of their anionic solubilization in water, for example, carboxy, sulfonate, sulfate, phosphate or phosphonate. Examples are alkyl imino acetates, iminodialkanoates, and aminoalkanoates, imidazolinyl derivatives and ammonia. Other suitable amphoteric and switerionic agents are those selected from the group consisting of betaines, sultaines, hydroxy sultaines, alkyl sarcosinates (eg, from 12 to 30 carbon atoms), and alkanoisarcosinates. The preformed gel sheet devices of the present invention optionally may contain an emulsifier or surfactant that contains silicone. A wide variety of silicone emulsifiers is useful herein. These silicone emulsifiers are typically organopolysiloxane organopolysiloxanes, also known to those skilled in the art as silicone surfactants. Silicone emulsifiers include dimethicone copolyols. These materials are polydimethylsiloxanes 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 portions derived from both ethylene oxide and polyether oxide. propiieno. Other examples include dimethicone copolyols modified with alkyl, that is to say they contain pendant side chains of 2 to 30 carbon atoms. Other useful dimethicone copolyols include materials that have various cationic, anionic, amphoteric and switerionic pendant options.

Oil-soluble conditioning agents The present invention can also further comprise oil-soluble conditioning agents. Non-limiting examples of conditioning agents useful as oil-soluble conditioning agents include those selected from the group consisting of mineral oil, petrolatum, branched chain hydrocarbons of 7 to 40 carbon atoms, alcohol esters of 1 to 30 carbon atoms of acids carboxylics of 1 to 30 carbon atoms, alcohol esters of 1 to 30 carbon atoms of dicarboxylic acids of 2 to 30 carbon atoms, monoglycerides of carboxylic acids of 1 to 30 carbon atoms, diglycerides of carboxylic acids of 1 to 30 carbon atoms, triglycerides of carboxylic acids of 1 to 30 carbon atoms, monoesters of ethylene glycol of carboxylic acids of 1 to 30 carbon atoms, diesters of ethylene glycol of carboxylic acids of 1 to 30 carbon atoms, monoesters of propylene glycol of carboxylic acids of 1 to 30 carbon atoms, propylene glycol diesters of carboxylic acids of 1 to 30 a carbon monomers, monoesters and polyesters of fatty acid sugar of 1 to 30 carbon atoms, polydialkyl siloxanes, polydiarylsiloxanes, polyalcaryl siloxanes, cyclomethicones having from 3 to 9 silicon atoms, vegetable oils, hydrogenated vegetable oils, alkyl ethers of 4 to 20 carbon atoms of propylene glycol, dialkyl ethers of 8 to 30 carbon atoms, and mixtures thereof. These agents are described in greater detail in W098 / 18444, which is incorporated herein by reference.

Other optional ingredients The compositions of the invention may comprise a wide variety of other optional components. These additional components must be pharmaceutically acceptable. CTFA Cosmetic Ingredient Handbook: Second Edition, 1992, which is incorporated herein by reference in its entirety, discloses a wide variety of non-limiting cosmetic and pharmaceutical ingredients commonly used in the cosmetics industry, which are suitable for use in compositions of the present invention. Non-limiting examples of functional classes of ingredients are described on page 537 of this reference. Examples of these and other functional classes include: abrasives, absorbers, antibiotics, anti-cake agents, anti-dandruff agents, antiperspirant agents, antioxidants, vitamins, biological additives, bleach, bleach activators, brighteners, builders, regulating agents of pH, chelating agents, chemical additives, dyes, cosmetics, cleansers, cosmetic astringents, cosmetic biosides, denaturing agents, dental treatments, deodorants, de-scaling actives, depilators, drug astringents, dyes, color transfer agents, enzymes, external analgesics , flavors, film formers, fragrance components, insect repellents, monosides, opaque agents, oxidizing dyes, oxidizing agents, pest control ingredients, pH adjusters, pH regulators, pharmaceutical actives, plasticizers, preservatives, radical scavengers , whitening agents s skin, hair or nails, conditioners for skin, hair or nails, penetration enhancers in the skin, hair or nails, stabilizers, surface conditioners, reducing agents, temperature depressants and heat generators. Also useful herein are the steric components such as colorants, essential oils and skin, hair or nail healing agents. Other optional materials herein include pigments, suitable pigments for use in the compositions herein may be organic and / or inorganic. Materials that have a low color or luster such as matte finishing agents, and also light diffusing agents are also included within the term pigment. Examples of suitable pigments are iron oxides, iron oxides of aciglutamate, titanium dioxide, ultramarine blue, D and C dyes, carmine and mixtures thereof. Depending on the type of composition, a mixture of pigments will normally be used. Other optional components herein include substrates that are compatible with the properties of the preformed gel sheet devices. Examples of suitable substrates are paper, for example, "Kimwipes EX-L" available from Kimberley-Clark Corp., Roswell, GA, USA, and collagen sheets, for example, "Collagen Fiber Mask" available from Beauté Attica, Inc. Redmond, WA, USA; "Professional Collagen Masks" available from Luminescence, Maple Plain, MN, USA; "Soluble Mash Collagen Lifting Masque" available from Five Star Formulators Inc., Palo Alto, CA, USA; and "Mash Collagen Masks" available from Maybrook Inc., Lawrence, MA, USA: The pH of the sheet devices of the present invention is preferably from about 3 to 9, most preferably from 4 to 8. The sheet devices of Preformed gel of the present invention are patches or masks, which have a size and shape adapted to conform to the desired target area. The exact size and shape will depend on the intended use and the characteristics of the product. The preformed gel sheet devices of the present are suitable for topical application to the nails or cuticles, to the hair or scalp, a human skin or part of it, legs, hands, arms, feet, or human torso. The devices herein may have shapes, for example, box, circular, rectangular, oval, or other shapes that are mixed materials such as shapes that can be described as "semicircles", "donut" or others. The surface area for devices configured to be fixed on the face has a surface area ranging from 0.25 cm2 to approximately 500 cm2, preferably around 1 cm2 to approximately 400 cm2. 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 preformed gel sheet devices of the present invention can also be made and used in the form of use for the hands, use for the feet, or body wrapping. Typically, the use for the hands will comprise a glove for the hand or any portion thereof, and the use for the feet will comprise a sock for the foot or any portion thereof. As used herein, the term "glove" means that it is inclusive of "mitten". Preferably the hand accessory comprises a glove body having an average section from 1 to 4 fingers receptacles connected to the middle section, a thumb receptacle connected to the mid section, a palm side and an opposite back side . Preferably, the accessory for use on the feet comprises a sock body forming a tubular skin portion having a closed end and an open end. The devices of the invention can also be made or used in the form of a body wrap. The body wrap is wrapped radially around any part of the body having a longitudinal axis. Their ends can communicate with each other, or their length can be reduced in order to only partially wrap. In any case, the wrappings must exhibit excellent conformity to the shape of the body part. Typically, said body parts will include the user's back, the upper arm, the lower arm, the upper leg, the lower leg, the neck and the torso. After application of the device, it can be left on the target area for about 3 hours, preferably about one hour, most preferably less than 15 minutes. The preformed gel sheet devices can then be removed in one piece. Depending on the beneficial agent (or beneficial agents) contained therein, the preformed gel sheet devices of the present invention can have at least one of the following uses: moisturizing the skin, hair or nails, smoothing fine lines and wrinkles; treat acne cosmetic mind; firm the skin; give reinforcement; soften exfoliate; improve and / or standardize the tone and / or texture of the skin; rinse skin, hair or nails; condition the skin or hair; tan; reduce the appearance of pores; absorb or control secretions; protect and / or soothe the skin, hair or nails, muscles, headaches or pains; reduce swelling and / or dark circles; stimulate the healing of wounds; heat, cool or cool the skin; mitigate inflammation; clarify the complexion; decongest; reduce swelling; treat dermatological conditions; bulge, purify; provide fragrance; reduce the bacterial growth of microorganisms; healing; repel insects, remove hair, dirt or unwanted makeup and color or whiten the target area where the device is applied. Preferably, the preformed gel sheet devices of the present are used to hydrate the skin, hair or nails; soften fine lines and wrinkles; and improving and / or uniforming the tone and / or texture of the skin.

Methods Exudate Release Test The amount of syneresis of a preformed gel sheet device of the present invention is measured in a gel comprising the device through an exudate release test. Data were generated on the release of exudate from the gels presented herein, by the following method: a gel formulation of interest was prepared as described below. Although still a hot liquid (> 80 ° C), 9 grams (+/- 0.1 g) were emptied into a hollow receptacle with a diameter of 91 mm, for example, the lid of a Falcon-1029 Petri dish. This receptacle was hermetically sealed to reduce evaporative losses. The gel was allowed to solidify without being interrupted with cooling to room temperature. The gel was stored at room temperature overnight before taking the readings. The cover was removed and the receptacle with the sample stopped (+/- 0.005g). Three pieces of filter paper (9.0 cm Whatman-114 Wet Stemgthened) were stacked on the flat gel surface. A load of 200 g of flat bottom with a diameter of 9.0 cm was placed on e! Filter paper to ensure a close contact with the gel surface. After one minute, the filler was removed and the filter paper detached moderately from the gel. The paper must impart a matte surface clearly visible to the gel, which confirms good contact by the filter paper. The sample was reweighed and the loss of mass was calculated by differences. This was reported as grams of exudate released for the gel disk with a diameter of 9 cm described above.

Gel compression rupture test The compression failure test was performed using a Stable Micro Systems (SMS) texture analyzer (TA), model TA-XT2Í available from Stable Micro Systems Ltd. (Godalming, Surrey, UK). The system was controlled through SMS's Texture Expert Exceed software (version 2.03) operating with Windows-98. An aluminum compression plate with a diameter of 100 mm (probe P-100) was attached to a 50 kg load cell.

This was mounted inside the TA Probe Carrier, the extended arm whose vertical path is under the control of the computer. To create test samples, a gel formulation of interest was prepared as described below. Gel discs of a precise cylindrical solid form (diameter of 26 mm by depth of 12 mm) were formed in molds. The molds with the sample were hermetically sealed against evaporation during storage. These gel discs were stored at room temperature overnight. Each gel disk was removed from its mold just before the test and inspected for defects. Any gel discs with defects (eg trapped air bubbles) were dried out since these defects can impact the measured mechanical properties. The flawless gel disc was then centered under the P-100 compression plate. The Expert Exceed Texture software was started in force / compression mode. The compression plate is prefixed to a starting height of 12.0 mm. Its rate of descent was set at 0.8 mm / second and the total fixed distance traveled at 10.8 mm (ie the measurement was stopped when the gel disk was compressed at 90% of its original height). The data was automatically gathered in strength and position of the compression plate at the speed of 200 pps (points per second). The software was prefixed to mark the position of the compression plate at the maximum strength obtained. This maximum force is the resistance to rupture, that is, the force required to break the gel disc. The distance traveled by the plate from its original starting height is the gel break point represents the degree of deformation of the gel. The maximum force at the point of rupture is averaged across the samples (typically 5 samples) and reported in Newtons. The uniaxial deformation (compression) at the gel break point was expressed as a percentage of its original molded height, ie: % compression = distance traveled by the plate (measured in mm) at a maximum force X 100 12 mm (height of the original molded sample) If the gel breakage has not occurred at the end of the 10.8 mm stroke (ie, 90% compression) the gel is classified as "no break" under these test conditions.

EXAMPLES The invention is illustrated through the following examples.

Examples 1-6 • 10 • fifteen twenty 1 Kelgum ™ is a mixture of 1: 1 xanthan gum and locust bean gum supplied by Kelco. The polysaccharide gums were mixed with water to form a uniform dispersion (this can be facilitated by predispersing the polysaccharides in a non-solvent, for example polyhydric alcohol), and any additional components were added. The mixture was heated with stirring to a first temperature above the gel point of the mixture (approximately 90 ° C) to completely hydrate the polysaccharide gums. The liquid gel was then filled into a properly configured mold. Preferably, the gel was dispensed through injection molding. This eliminates any defect that can be introduced when cutting the gel and thus improves the robustness of the device. Injection molding also allows the devices to be easily formed with varying regions of thickness and other structural features. Alternatively, the liquid gel can be cast on a sheet. The liquid gel is then cooled to a second temperature colder than the first temperature a, or below the gel point of the mixture (e.g., room temperature) to fix the gel structure. Then, the device can be removed from the mold or appropriately shaped patches of the gel sheet can be cut. The devices of the present are then packaged in materials having a low water vapor permeability to minimize the drying of the device during storage. Suitable packaging for the devices herein include sealed pouches or trays. If the device is packed in a bag, preferably it is protected before use. This protection can be provided through a release liner such as a plastic film, which provides easy release for the device. If a substrate is to be used, it can be placed in the suitably shaped mold before dispensing the gel or it can be placed on the surface of the liquid gel during the cooling step. In some compositions, metal ions (eg, Ca2 +, K +) may be included in the formulation to increase the gel strength of the device. In this case, the metal ions are added in the form of an aqueous solution and are agitated in the hydrated liquid gel as the final addition to the mixture. The above method can be modified as necessary, depending on the nature of any of the additional components. For example, if non-aqueous components are present, the liquid gel can be homogenized immediately before molding or casting to ensure dispersion of the non-aqueous components. Similarly, if heat-sensitive ingredients are incorporated, the formulation must be cooled to an appropriate temperature (depending on the ingredient) after the hydration step of the gum, and the heat-sensitive ingredient is added at this stage. The liquid gel can be degassed, for example, through vacuum to remove air bubbles dispersed within the liquid. This degassing step, if followed, may be the final step immediately before dispensing the liquid gel. As shown above, the preformed gel sheet devices of the present exhibit desirable amounts of syneresis and have excellent strength and flexibility.

Examples 7-14 Examples 7-14 are comparative examples of gel patches described in the literature, and the gels were prepared according to the methods presented in Examples 1-6 of the present. The measurements were taken on the release of exudate from the gel compositions, the percentage of compression at the point of rupture and the force required to break the gel for each example, and the results obtained from these measurements are shown. As can be seen from these comparative examples, although most of the gels comprising the patches discussed in the literature satisfy one or two of the parameters described by the present invention, none of the gels in the examples have a desirable amount of syneresis, resistance and flexibility. ^ elgum ™ is a 1: 1 mixture of locust bean gum xanthan gum supplied by Kelco, San Diego, CA, USA. 2 OrgasolD ™ is a nylon-12 powder commercially available from ELF Atochem, Paris, France. Example 7: WO90 / 14110, Example 2 - without calcium alginate Example 8: WO90 / 14110, Example 3 - without calcium alginate. GB1,341,999, Example 1 - without silver nitrate. Example 9: JP920649, Example 1. Example 10: EP-A-803245, Gel based on the teaching of the document. Example 11: GB1, 341, 999, example 2 - without silver nitrate. Example 12: EP-A-161681, Example 1. Example 13: EP-A-161681, Gel based on the teaching that the polysaccharide gum may comprise a combination of carrageenan and galactomannan. Example 14: US-A-4,661,475, Example 3.

Claims

NOVELTY OF THE INVENTION CLAIMS

1- A preformed gel sheet device that is a patch or mask for delivering beneficial agents to skin, hair or nails, comprising from about 30% to about 99.5% water and a mixture of at least two gel forming agents polymeric water soluble, characterized in that the gel comprising the device has an exudate release greater than 0.7 grams and less than 1.3 grams; a percentage of. rupture compression greater than 45% and less than 90%; and requires a force for rupture greater than 30 N. 2. A preformed gel sheet device according to claim 1, further characterized in that it has an exudate release greater than 0.8 grams. 3. A preformed gel sheet device according to any of claims 1 or 2, further characterized in that it has an exudate release of less than 1.2 grams. 4. A preformed gel sheet device according to any of claims 1 to 3, further characterized in that it requires a breaking force greater than 60 N. 5. A gel sheet device preformed in accordance with any of claims 1 to 4, further characterized in that it requires a breaking force greater than 80 N. 6. A preformed gel sheet device according to any of claims 1 to 5, further characterized by having a percentage of rupture compression greater than 50%. 7. A preformed gel sheet device according to any of claims 1 to 6, further characterized in that it has a rupture compression percentage of less than 80%. 8. A preformed gel sheet device according to any of claims 1 to 7, further characterized in that the device comprises less than 30% of a mixture of water-soluble polymeric gel forming agents. 9. A preformed gel sheet device according to any of claims 1 to 8, further characterized in that the mixture of water-soluble polymeric gel forming agents comprises at least one polysaccharide. 10. A preformed gel sheet device according to any of claims 1 to 9, further characterized in that the mixture of water-soluble polymeric gel-forming agents is a mixture of a polysaccharide. 11. A preformed gel sheet device according to any of claims 1 to 10, further characterized in that the polysaccharide mixture comprises: (i) at least one polysaccharide of red seaweed; and (ii) at least one fermentation polysaccharide; glucomannan; galactomanana; and derivatives or mixtures thereof. 12. A preformed gel sheet device comprising a polysaccharide mixture characterized in that it consists of: (i) a polysaccharide of red seaweed; (ii) a polysaccharide containing mannose; wherein the device comprises less than 2% total polysaccharide and the ratio of polysaccharides of red seaweed to polysaccharide containing mannose is from about 1: 1 to about 10: 1, and wherein the gel comprising the device requires a force at rupture greater than 60 N. 13.- A preformed gel sheet device according to 12, further characterized in that the polysaccharide ratio of red seaweed to polysaccharide containing mannose is from about 2: 1 to about 7: 1. . 14. A preformed gel sheet device according to any of claim 12 or 13, further characterized in that the red seaweed polysaccharide is selected from agar and agarose or mixtures thereof. 15. A preformed gel sheet device according to any of claims 12 to 14, further characterized in that the polysaccharide containing mannose is selected from a galactomannan, glucomannan and derivatives or mixtures thereof. 16. A preformed gel sheet device according to any of claims 12 or 15, further characterized in that it comprises xanthan gum. 17. A preformed gel sheet device according to any of claims 12 to 16, further characterized in that the gel comprising the device has a percentage of rupture compression greater than 45% and less than 90%. 18. A preformed gel sheet device according to any of claims 1 to 17, further characterized in that it comprises a beneficial agent selected from anti-wrinkle and skin anti-atrophy agents, active against acne, agents and artificial tanning accelerators, active of skin repair, skin barrier repair aids, skin lightening agents, skin perception agents, skin softening agents, antimicrobial and antifungal actives, lipids, sebum inhibitors, sebum stimulants, sunscreen agents, antiseptics, topical anesthetics, steroids, non-steroidal anti-inflammatory agents, protease inhibitors, skin tightening agents, anti-pruritus ingredients, hair growth inhibiting agents, 5-alpha reductase inhibitors, anti-inflammatory agents glycation and de-scaling enzyme enhancers or mixtures thereof. 19. A preformed gel sheet device according to any of claims 1 to 17, further characterized in that it comprises a beneficial agent selected from anti-wrinkle and anti-skin active agents, anti-acne agents, artificial tanning agents and accelerators, skin repair assets, skin barrier repair aids, skin lightening agents, skin perception agents, skin softening agents, lipids, sebum inhibitors, sebum stimulants, sunscreen agents , protease inhibitors, skin tightening agents, and de-scaling enzyme enhancers or mixtures thereof. 20. A preformed gel sheet device according to any of the preceding claims, further characterized in that it comprises from about 1% to about 45% of a humectant. 21, - A preformed gel sheet device according to any of the preceding claims, further characterized by having a thickness of about 0.5 mm to about 20 mm. 22. A cosmetic treatment method, comprising applying to the skin, hair or nails a preformed gel sheet device as claimed in any of claims 1 to 17, 19, 20 or 21. 23.- A device for preformed gel sheet according to any of claims 1 to 21 in the form of a mask or patch having a shape or size adapted to conform to the nails or cuticles, to the hair or scalp, the face of a human or part of it, legs, hands, arms, feet, or human torso. 24. A preformed gel sheet device according to any of claims 1 to 21, further characterized in that it is in a form selected from the group consisting of: use for the hands, use for the feet; and body wrap.