KR100511188B1 - Pre-formed sheet devices suitable for topical application - Google Patents

Abstract

The present invention relates to a preforming device for delivering an adjuvant to skin, hair or nails. The device is a patch or mask for cosmetic or therapeutic use and comprises a single thin film solid gel sheet having at least one surface coated at least partially with a discrete coating composition containing at least one adjuvant for skin, hair or nails. The invention also includes methods of making and using such devices. The coating composition enables adjuvant delivery to the skin more efficiently than conventionally known devices and / or provides greater formulation flexibility.

Description

PREFORMED SHEET DEVICES SUITABLE FOR TOPICAL APPLICATION

Technical Field

The present invention relates to a pre-formed device in the form of a gel sheet for delivering beefit agents to the skin, hair or nails. More specifically, the present invention relates to gel sheets having a coating composition on at least one surface. The coating composition consists of one or more skin adjuvants and allows the aid to be delivered to the skin more efficiently than known uncoated sheets, and / or provides higher tissue flexibility.

Background of the Invention

Instead of creams and lotions, the benefit of using a patch or mask device with a polymeric gel that forms an agent that cosmetically treats skin, hair or nails or promotes the treatment of burns or wounds Known in the art. Various cosmetic patches or devices are commercially available or described as being available for delivering skin care actives such as vitamins, anti-acne actives, moisturizers and the like. Patches are also described in the literature and are commercially available in the medical field as a useful means for transdermal administration of drugs through the skin.

However, many patches or similar devices have drawbacks in the form of physical products that, as perceived by consumers or wearers, result in inappropriate characteristics for use. For example, some patches or devices may be too moist or sticky because the gel formers that make up the patch or device do not form a solid gel structure, resulting in handling the skin or the patch and the device. Difficult to apply on Some are too strong to adhere, snug and inconvenient to detach, and many patches do not provide effective release and absorption of the adjuvant. In addition, some patches or devices are so dry or rigid that they do not conform well to the contour of the surface on which they are used.

WO 97/17944 discloses the formation of organized cosmetic gels, optionally enriched with water-soluble or water-dispersible active ingredients. Optional ingredients are contained during gel formation.

Some applications disclose active agents, such as vitamins, incorporated into pressure sensitive adhesive devices. For example, GB-A-2 265 086 is a skin whitening agent and skin formulated in an adhesive layer in which other ingredients such as permeation enhancers and glycerin are attached to an impermeable backing. Initiate a whitening patch. US-A-5 785 978 describes the incorporation of vitamins, in particular vitamin C, in powder form into an adhesive layer which also has an impermeable backing. US-A-5 965 154 also relates to incorporating an active agent such as vitamin C in powder form into the adhesive layer. WO 98/42303 is another publication dealing with incorporating an active agent, such as vitamin C in powder form, into a product having a layer and substrate comprising an adhesive polymer. In this application, the function of the adhesive layer is to peel off the keratonic plugs. The substrate layer is preferably non-occlusive. US-A-5 723 138 describes a product in which a cosmetic ingredient which prevents, removes or alleviates wrinkles is incorporated into the adhesive and applied to the tape.

EP-A-161 681 discloses polysaccharide gel plates for poultices. The plate may contain medicinal components such as skin irritants, anti-inflammatory agents, analgesics and antibiotics. Such pharmaceutical ingredients may be incorporated into the plates when they are formed, or subsequently coated or soaked with a solution or dispersion of these ingredients. For subsequent addition of the pharmaceutical component, the intervening gel plate product is dried to give high absorbency to the pharmaceutical component.

NZ 329525 discloses a skin treatment method comprising applying a cosmetic preparation to the skin and then applying a dressing thereon. JP 11-130625 discloses an acrylic gel based on a sheet pack for facial wrinkle treatment. Optionally, a separate lotion may be applied to the face before applying the pack. Similarly, products are recommended in Japan, such as Sofina Seraty Wrinkle Device Eye Patch from Kao Corporation, which recommend pre-treatment of the face with gel or lotion before applying the sheet to the face. Such products may be sold in kits and may require separate application of gels / lotions and sheets.

Co-pending PCT application PCT / US99 / 15202 discloses a gel patch containing a cosmetic agent dispersed therein but showing an appropriate amount of syneresis to release the leach onto the surface.

It has been found that by coating discrete preformed gel sheets with discrete discrete coating compositions containing one or more skin adjuvants, the effectiveness of the gel sheets for delivering the adjuvants to the skin, hair or nails can be improved. In addition, this structure for gel devices allows for incorporation of adjuvants such as powders that do not otherwise migrate out of the gel matrix, or for a drier, easier handling or better touch to uncoated areas. Allowing the gel allows for higher tissue flexibility.

The gel device herein is a patch or mask for cosmetic or therapeutic applications.

Summary of the Invention

The present invention relates to a preforming device for delivering an adjuvant to skin, hair or nails, the device comprising a solid gel sheet having opposing first and second surfaces, the gel sheet comprising one or more gelling agents and It is characterized in that it contains at least 10% of a dermatologically acceptable hydrophilic solvent and the first surface is at least partially coated with a discrete coating composition containing at least one adjuvant for skin, hair or nails. Also provided are methods of making and using such coated devices.

The use of a coating composition allows for a more efficient supply of adjuvants to the skin than known devices and provides greater tissue flexibility. The preformed coating apparatus of the present invention provides superior hydration and moisturization benefits for local applications as well as routine advantages by improved delivery of locally effective active agents. In addition, the preforming apparatus of the present invention has a high strength structure that is flexible, elastic, and optically clear, providing excellent use characteristics such as unobtrusiveness and conformability, thereby providing excellent mechanical and optical characteristics. Have The coating composition allows for more efficient delivery of the adjuvant to the skin than known devices and / or provides greater tissue flexibility.

Brief description of the drawings

1 is a cross-sectional view of the device according to the invention, wherein the gel sheets of the device are coated on the first and second surfaces and a coating is applied on the first surface.

2 is a schematic diagram of a setup for measuring device flexibility.

Detailed description of the invention

The preforming apparatus of the present invention comprises a solid gel sheet and a discrete coating composition. Unless otherwise indicated, all levels and ratios of gel sheet components are by weight of gel sheet, and all levels and ratios of coating composition components are by weight of coating composition. Unless otherwise specified, all measurements herein are made at 25 ° C. The present invention relates, in particular, to preforming devices which are manufactured on an industrial scale and which are packaged in protective wrappers for shipment and retail. The device is used to deliver an adjuvant to the skin, hair or nails, preferably to the skin or nails, most preferably to the skin, in particular facial skin.

As used herein, the term "pre-formed" means that the device is manufactured in a shape having a predetermined thickness, shape and size, in which case the associated packaging is carried out with the fingers, without further preparation by the user. It can be removed and the device can be positioned or covered at the target site.

The term "gel sheet" as used herein means a skin or mask, which is a uni-, bi-, or a plurality of continuous thin film sheets for cosmetic or medical applications, the shape of which is to be treated. Predetermined according to a particular area of skin, hair or nails, the mask is designed to cover the face area and has a gap for the eye, nose or mouth. Preferred gel sheets are single membranes, meaning that they consist of a single layer.

"Solid" as used herein in connection with a gel sheet means that when the sheet lies on a flat surface, it substantially retains its shape at 25 ° C. Nevertheless, the sheet can be bent or deformed when applied to a rugged surface or under pressure.

The term "hydrophilic" as used herein in reference to a solvent reference means that the solvent and water can be mixed with a ratio of solvent to water of at least 1:10, preferably 1: 5.

The term "water-soluble" as used herein means that the gel-forming polymer gel former can be dissolved in an aqueous solution at room temperature or when heated to form a continuous phase.

As used herein, the term "syneresis" refers to the process by which the gel shrinks with the release of a liquid. Without being bound by theory, it is believed that the gel compositions herein form a three-dimensional matrix that binds or encapsulates the other components of the composition. Syneresis is thought to be related to the spontaneous separation of the initial homogeneous system into a coherent gel phase and a liquid. The released liquid is a solution whose components depend on the components of the original gel.

As used herein, "polysaccharide" is a naturally occurring or chemically produced linear, branched, or crosslinked polymer of monosaccharide units that expands and disperses in water at low concentrations to thicken aqueous solutions.

"Non-planar topography" means two or more adjacent contour regions of an auxiliary surface arranged on different surfaces such that the surface is textured, and for applying the non-planar structure to the device surface. The texture may be rough, wavy, or stepped, and may be regular or irregular.

As used herein, “periodicity” means a pattern of repeating units and is a measure of the distance between the starting and ending points for the repeating units of the pattern.

Gel sheet

The preforming apparatus of the present invention is provided with a solid gel sheet. The sheet provides the device with a primary structure and form, allowing it to be handled and to handle or appropriately handle specific target areas of the skin, hair or nails. It also functions as a reservoir or delivery means of the adjuvant and utilizes solvent evaporation from the sheet to provide cooling to the device during use.

Gel sheets may be sized and shaped to fit a desired target site, which can be nails or cuticles, hair or scalp, a person's face or portions thereof, legs, hands, arms, feet, or a human torso. Have Generally, the gel sheet has an apparently flat and opposing first and second surface. The device according to the invention is generally sized such that each surface has an area of about 0.25 cm ² to about 1,000 cm ² , preferably about 1 cm ² to about 100 cm ² . Surface area refers to the surface area of a flat plane, ie, the surface area which does not consider the presence of any surface texturing, which has the same boundaries as the surface. In general, the one or more surface dimensions of the device is preferably both, preferably a ratio of the surface dimension (s) to the depth of the device of about 2: 1 to about 100: 1, more preferably about 5 A ratio of from 1 to about 50: 1, greater than the depth of the device. The term "surface dimension" as used herein means the dimension of the x- or y-axis, the depth measured along the z-axis.

The exact size and shape depends on the intended use and product characteristics. For example, the devices herein can be square, round, semicircle, ellipse, rectangular, elliptical, ring, crescents, droplets, or any other combination of these. Apparatus shaped to the face has a surface area in the range of about 0.25 cm ² to about 500 cm ² , preferably about 1 cm ² to about 400 cm ² . Generally the device has an average thickness in the range of about 0.5 mm to about 20 mm, preferably about 0.7 mm to about 5 mm. Preferred devices have a rim that is about 0.1 to about 1.5 mm thick, preferably about 0.2 mm to about 1 mm thicker than the central portion of the patch. Thick edges are known to significantly increase patch strength for handling without significantly reducing the flexibility of the patch.

The first or second surface of the gel sheet may have a non-planar structure. Non-planar structures may be generalized over the surface of the patch, such as surface texturing, or local discontinuities, such as thick borders. Preferably, at least the first surface is textured and has a structure defined by R _a greater than about 10 μm. Texturing can have a regular or irregular pattern. Preferred patterns are sinusoidal, serrated or conical with a periodicity of about 0.1 mm to about 10 mm, preferably about 0.5 mm to about 5 mm. Texturing of the first surface is useful for improving the adhesion of the coating component to the gel sheet. In use, texturing of the second surface, which will be far away for the skin, nails, or hair, reduces the surface brilliance, making it less annoying while wearing the device. The thick rim provides some additional integrity to the device, allowing the device to be handled more easily without tearing. Preferably, a tested surface or a region with two or more contours that do not simultaneously have the same average thickness, or a non-planar structure of both, is applied to both the first and second surfaces of the gel sheet.

The gel sheet contains, as an essential component, at least 10% of one or more gelling agents and a dermatologically acceptable hydrophilic solvent. In addition, the gel sheet may optionally contain various other components, in particular auxiliaries and auxiliary additives which are described in detail following the general description of the coating composition below. Hereinafter, the gelling agent and the hydrophilic solvent will be described in detail.

Gelling agent

In general, the gel sheets of the present invention contain less than 70% of the total weight, preferably less than 50%, more preferably less than 30%, and in particular less than 10% of the gelling agent. Gelants including various types of gelling agents, or particulate based gelants such as polymeric gelants and various clay or other silicate based materials are known in the art. Herein, polymeric gelling agents are very preferred in view of the structure they provide to the gel.

The polymeric gelling agent used herein may be obtained naturally or synthetically and may be self-gelling or combined with other ingredients to form a gel. These can be physically or chemically crosslinked. Some gelling agents combine with substances such as sugars, alcohols, or monovalent or polyvalent salts to form a gel. Here, monovalent or polyvalent salts can additionally be used as gel enhancers to impart additional strength to the gel sheet. Suitable cations for the salts can be selected from potassium, sodium, ammonium, zinc, aluminum, calcium and magnesium ions, or mixtures thereof. Suitable anions combined with these cations may be selected from chloride, citrate, sulfate, carbonate, borate and phosphate anions, or mixtures thereof.

Physical cross linking refers to a polymer having crosslinking, which is a physical property that is not chemically covalent, but has high crystallinity sites or sites with high glass transition temperatures in the device. Chemical crosslinking refers to a polymer linked by chemical bonds. Preferably, the polymer is chemically crosslinked by radiation techniques such as thermal radiation, E-beam radiation, UV radiation, gamma radiation or microwave radiation. In addition, when chemical crosslinking is formed in the system, a polyfunctional cross linker and / or free radical initiator may be present in the premix to initiate crosslinking upon spinning. The components may be present in amounts up to 5% by weight.

Polymeric gelants are either water soluble or water insoluble, preferably water soluble. Alternatively, it may be a non-water soluble polymeric gelant containing a silicone material, such as an organopolysiloxane resin, or a block copolymer thermoplastic elastomer. A more detailed description of the water insoluble polymeric gelant can be found in the concurrent PCT application PCT / US99 / 15201, which is incorporated herein by reference in its entirety.

The water soluble polymeric gelant used in the present invention is selected from synthetic or natural polymers, and mixtures thereof. In general, the preformed gel sheets of the present invention contain less than 50%, more preferably less than 30%, in particular less than 20%, of a water soluble polymeric gelant of the total weight. Suitable synthetic polymers used herein include nonionic water soluble polymers, acrylic acid based polymers, cellulose derivatives, and mixtures thereof. Various materials of this type are known in the art, and exemplary materials can be found in the PCT application PCT / US99 / 15201 simultaneously.

Particularly preferred synthetic polymeric systems are disclosed in WO 00/06215, which is incorporated herein by reference, which describes products suitable for attaching biomedical devices to the skin. In particular, the document discloses bioadhesive, hydrogel compositions containing an aqueous plasticizer, a hydrophilic unsaturated water-soluble acrylamido monomer, in particular one or more monomeric polymers including NaAMPS, and hydrophobic polymers such as ethylene / vinyl acetate copolymers. Doing.

Preferred polymers used herein are natural polymers containing gelatin, polysaccharides, and mixtures thereof. Polysaccharides are preferred. Polysaccharides used in the device herein include red algae polysaccharides; Glucomannan; Galactomannan; Fermented polysaccharides, or derivatives thereof; Brown algae polysaccharides; Extracts of marine invertebrates; Starch, or derivatives thereof; Natural fruit extracts; Plant fiber derivatives; Kelp; Natural plant exudate; And resinous gums; Or a mixture thereof. Here, when the gel sheet contains at least one polysaccharide as a water soluble polymeric gelling agent, the sheet is generally less than 10%, preferably less than 7%, more preferably less than 5% of the total dry weight. Polysaccharides or mixtures thereof. Low concentrations of total polysaccharides are believed to impart an open gel structure that is freely dispersible because other components of the gel do not bind tightly within the gel network.

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

Brown algae polysaccharides are isolated by extraction from various species of phaebophyceae. Suitable brown algae polysaccharides used herein include algin, alginic acid, ammonium alginate, calcium alginate, potassium alginate, sodium alginate, propylene glycol alginate, and mixtures thereof.

Red algae polysaccharides are isolated from marine plant species belonging to the class of Rhodophyceae. Red algae polysaccharides provide mechanical strength to aqueous gels. Red algae polysaccharides suitable for use in the present invention are in the industry under the (CTFA) trademark classification as agar agar flakes derived from a variety of Gelidium plant species or closely related red algae. Known, "Agar Agar 100" or "Agar Agar 150" by TIC Gums (Belcamp, MD, USA), or Gumix International Inc. Agar sold as "Agar Agar K-100" by Fort Lee, NJ, USA; Sea Plaque of FMC (Philadelphia, PA, USA) And agarose sold as "Agarose Type 1-b" by Sigma-Aldrich Co. Ltd. (Poole, UK); as chondrus under the trademark classification (CTFA) known in the industry, and FMC ( Philadelphia, PA, USA) LA "," Seakem 3 / LCM ", or" Viscarin Lambda-, iota- and kappa-fractions, water extracts obtained from various members of Gigartinaceae or Solieriaceae family sold as XLV " Carrageenan, and furcellaran, available from Gum Technology Corporation (Tucson, Arizona, USA) and Continental Colloids Inc. (Chicago, IL, USA), or mixtures thereof. Preferably, the red algae polysaccharides used herein are selected from agar, agarose, kappa-carrageenan and purcellane, or mixtures thereof.

Glucomannan is essentially a polysaccharide containing a linear backbone of glucose and mannose residues. Glucomannan has a short lateral branch attached to the linear backbone, and acetyl groups are randomly present at the C-6 position of the sugar unit. Acetyl groups are generally found between 1 and 20 sugar units per 6 sugar units. Suitable glucomannan or derivatives thereof as used herein have a ratio of mannose to glucose of about 0.2 to about 3. A suitable glucomannan used herein, the common name for the powder formed by crushing the tuber roots of the Amorphophallus konjac plant (elephant yam), is "Nutricol" by FMC (Philadelphia, PA, USA). konjac mannan sold under the name konjac flour "and deacetylated konjac mannan; or mixtures thereof.

Galactomannan is a plant that possesses polysaccharides that occur in the endosperm cells of many seeds of Leguminosae. The collective term "galactomannan" includes all polysaccharides consisting of galactose and mannose residues. Galactomannans comprise a linear backbone of (1 → 4) -linked β-D-mannopyranosyl units. To this ring, as a branch, the isolated galactopyranose residue is attached by α- (1,6) -glucoside bonds. Galactomannans may also contain small amounts of other sugar residues. Suitable galactomannans used herein include fenugreek gums; Lucern; Clover; Locust bean gum, known in the industry under the (CTFA) trademark classification, for example, as a carob bean gum and sold as "Seagul L" by Philadelphia, PA, USA; Tara gum sold by Starlight Products (Rouen, France) or Bunge Foods (Atlanta, GA, USA); Pyramide, marketed as "Burtonite V7E" by TIC Gums (Belcamp, MD, USA), "Jaguar C" by Rhone-Poulenc (Marietta, GA, USA) or "Supercol" by Aqualon (Wilimington, DE, USA) Guar gum derived from milled endosperm of Cyamopsis tetragonolobus; And cassia gums, or mixtures thereof, available from Starlight Products (Rouen, France). Preferably, the galactomannans used herein are substituted with an average of one to about five mannosyl units with (1 → 6) -linked-α-D-galactopyranosyl units, guar gum, locust bean Gum or cassia gum, and mixtures thereof.

Fermented polysaccharides are polysaccharides produced and commercially available by fermentation of microorganisms in a medium containing carbon and nitrogen sources, buffers and trace elements. Suitable fermented polysaccharides, or derivatives thereof, used in the present invention are high molecular weight heteropolysaccharide gums prepared by pure-culture fermentation of carbohydrates with Pseudomonas elodea, as gum gellan (CTFA) Gellan gum known in the industry under the trademark classification and sold as "Kelcogel" by Kelco (San Diego, CA, USA); For example, "Keltrol CG 1000 / BT / F / GM / RD / SF / T / TF" by Calgon (Pittsburgh, PA, USA) or "Kelzan" by Kelco (San Diego, CA, USA) Xanthan gum, a high molecular weight heteropolysaccharide gum prepared by pure-culture fermentation of carbohydrates into Xanthomonas campestris, known in the industry under the (CTFA) trademark classification; Natto gum; Pullulan; Rhamsan gum; Curdlan; Succinoglycans; Welan gum; Dextran sold as "Sephadex G-25" by Pharmacia Fine Chemicals (Piscataway, NJ, USA), and derivatives thereof; And sclerotium gum sold by "Amigel" by Alban Muller International (Montreil, France), and mixtures thereof. Preferred fermented polysaccharides or derivatives thereof are selected from gellan gum and xanthan gum, or mixtures thereof. More preferably the fermented polysaccharide or derivative thereof is xanthan gum.

In addition, extracts of marine invertebrates may be used. Polysaccharides derived from marine invertebrates, in particular the exoskeleton of such invertebrates, consist mainly of N-acetyl-D-glucosamine residues. Examples of such polysaccharides suitable for use herein include, for example, chitosan sold as "Marine Dew" from Ajinomoto (Teakneck, NJ, USA); And hydroxypropyl chitosan and derivatives sold as "HPCH Liquid" by Ichimaru Pharcos (Yamagata Gun Gifu-Pref, Japan); Or mixtures thereof.

Starch is a polysaccharide consisting of two glucose polymers, amylose and amylopectin in various ratios. Suitable materials used herein include starch, amylopectin and dextrin, and derivatives or mixtures thereof, sold as "Nadex 360" by National Starch (Bridgewater, NJ, USA). Examples of natural fruit extracts suitable for use herein include pectin, arabian and mixtures thereof. Suitable examples of plant fiber derivatives used herein are cellulose. Suitable polysaccharides obtained from natural plant exudates used herein include karaya gum, tragacanth gum, arabian gum, tamarind gum, and ghatty gum, or these Obtained in a mixture of Examples of resinous gums suitable for use herein include shellac gums, damar gums obtained from resinous secretions of the insect Lacifer (Tachardia) lacca; Copal gum and rosin gum; Or mixtures thereof.

Preferably, the preformed unilamellar gel sheets herein contain a water soluble polymeric gel former. The mixture may be at least one non-ionic water soluble polymer; One or more acrylic acid based polymers or derivatives thereof; One or more polysaccharides; And mixtures thereof. For example, the preferred water soluble polymeric gel formers herein may contain polysaccharides and non-ionic water soluble polymers, or alternatively, may contain two polysaccharides. More preferably, the water soluble polymeric gel former is a polysaccharide mixture, wherein the polysaccharide mixture comprises (1) one or more red algal polysaccharides; Brown algae polysaccharides; Or mixtures thereof; And (2) one or more fermented polysaccharides; Galactomannan; Glucomannan; Natural plant exudate; Or natural fruit extracts; And derivatives or mixtures thereof. More preferably, the water-soluble polymeric gel former of the device of the present invention comprises: (1) one or more red algae polysaccharides; And (2) one or more fermented polysaccharides; Glucomannan; Or galactomannan; And polysaccharide mixtures containing derivatives or mixtures thereof.

In a preferred embodiment, the water soluble polymeric gel former of the present invention is a polysaccharide mixture containing red algae polysaccharide and glucomannan or galactomannan. The ratio of red algae polysaccharide to glucomannan or galactomannan in the polysaccharide mixture is preferably from about 20: 1 to about 1: 5, more preferably from about 10: 1 to about 1: 2.

If the polymeric gel former is of natural origin, as defined above, the gel undergoes to some extent syneresis. Cineressis provides one mechanism for transporting adjuvant to the target site. The liquid layer exuded to the surface on the coherent gel is readily available for dispersion, facilitating shortening of the wear time of the device.

Hydrophilic solvent

The gel sheet of the device of the present invention contains at least 10% dermatologically acceptable hydrophilic solvent. The solvent acts as a plasticizer or softener for the device, thus providing the desired mechanical properties, in particular flexibility. As used herein, a dermatologically acceptable hydrophilic solvent can be used in sheets applied to the skin without causing inflammation and is miscible with water in a ratio of at least 1 to 10, preferably 1 to 5 solvent: water. . A very preferred hydrophilic solvent is water itself. Other suitable hydrophilic solvents include ethanol, propylene glycol, glycerin, sorbitol; Polyethylene glycols having an MW of less than 30,000, preferably less than 10,000; And polypropylene glycols having an MW of less than 5,000, preferably less than 1,000, which may be used alone or as admixture with water. If necessary, the solvent may be warmed to dissolve them. The use of a hydrophilic solvent not only helps to provide the desired mechanical properties to the device, but can also assist in dispersing the adjuvant into the skin and also provides cooling by evaporation from the gel sheet, making the device more comfortable to wear. do. From the latter point of view, solvents which are liquid at 25 ° C are preferred, and more preferably less than 20% by weight of the solvent mixture consists of solvents that are solid at 25 ° C. Particularly preferred hydrophilic solvents are water, ethanol, propylene glycol, and mixtures thereof. The total hydrophilic solvent content of the gel sheet is preferably from about 15% to about 99% by weight, more preferably from about 20% to about 95% by weight, and even more preferably from about 50% to about 90% by weight of the gel sheet. Weight percent. Preferred gel sheets contain more than about 10% water, more preferably more than about 30% water.

Coating composition

In the preforming device of the present invention, the first surface is coated at least in part with a discrete coating composition containing at least one adjuvant for skin, hair or nails. A "discrete" coating composition is a composition with distinct chemical composition, which is individually prepared from distinctly different compositions, in particular gel sheets, and which is laid down as separate layers before or after the formation of the gel sheets, to the gel sheets. It means to be applied. The coating composition allows for more efficient delivery of the adjuvant to the skin and provides higher formulation flexibility.

The use of the singular “coating composition” herein is not intended to include two or more coating compositions applied to different portions of the same gel sheet. In particular, for devices such as face masks, a composition suitable for oily skin can be applied to the part of the device intended to come into contact with the so-called 'T-zone' and different compositions suitable for dry skin, for example, It is intended to be applied to other areas of the mask intended to contact the cheek. More generally, the coating may comprise two or more different composition regions suitable for different areas of the skin, hair or nails. Alternatively, the coating can be applied in two or more different composition layers to provide sequential release of the components. However, preferably, a single uniform composition is applied. Reference to 'coating composition' herein is intended to include either homogeneous or heterogeneous compositions. Typically, the coating composition coats at least about 20%, preferably at least about 50%, more preferably at least about 75% of the first surface area. The coating composition may help to adhere the patch to the skin, in which case it may be appropriate to coat the entire first surface with the coating composition. Alternatively, optionally, without coating with some areas within the first surface center, for easier or less confusing handling of the device, or to aid in device attachment to the target area of the skin, hair or nails. There may be an area of the first surface, such as a left edge frame.

The coating composition may be a solid, such as a powder, or a liquid comprising a gel. Preferably, the coating composition has a liquid, in particular (viscosity measured on a Brookfield viscometer using a heliopath T-bar C spindle at 5 rpm) with a viscosity greater than about 1000 mPa · s, preferably about 5,000 mPa. liquids greater than s, more preferably greater than about 7,000 mPa · s.

The liquid coating composition may be an aqueous solution comprising a gel, or an emulsion such as an oil-in-water emulsion, a water-in-oil emulsion or a multiple emulsion with an aqueous or oily external phase. In a preferred embodiment herein, the coating composition is an oil-in-water emulsion having one or more internal oil phases which may comprise a silicone oil phase.

The weight ratio of coating to gel sheet is typically in the range of about 1: 100 to about 2: 1, preferably about 1:25 to about 1: 1, more preferably about 1:15 to about 1: 2. Alternatively, the preferred coating composition dosage to the gel patch can be expressed as about 0.001 to about 0.2 gcm ^-2 , preferably about 0.005 to about 0.05 gcm ^-2 .

The coating composition contains one or more adjuvants for skin, hair or nails. Such adjuvants may be specific to the coating composition or may be the same as those that may be present in the gel sheet. Preferably, each of the gel sheet and coating composition contains one or more skin adjuvants in common. In this way, the coating composition can quickly provide the adjuvant to the target site while at the same time inhibiting the gel sheet from acting as a reservoir for the adjuvant or the gel sheet from absorbing the adjuvant from the coating composition.

Supplements

An essential feature of the preforming device of the present invention is that the coating composition contains one or more adjuvants for skin, hair, or nails. Solid gel sheets also preferably contain one or more such adjuvants. As used herein, the term "adjuvant" means an active ingredient that provides a cosmetic and / or therapeutic effect to the site of application. The above definition of adjuvant includes, for example, vitamins and humectants as well as the categories listed below.

Adjuvant is used in a safe effective amount, which is sufficient to deliver efficacy to the desired skin, hair or nails at a ratio of reasonable efficacy to risk within the scope of sound medical judgment, but small enough to avoid serious side effects. Means quantity. The amount by weight of the adjuvant may be determined by the specific formulation, formulation penetration through or to the hair and / or nails, the age of the user, the health of the user, and the condition of the skin, hair or nails, and other factors of the user. Will change accordingly.

Adjuvants herein include pharmaceutically acceptable salts thereof, wherein pharmaceutically acceptable salts are any of the commonly used salts suitable for use in contact with human tissue without excessive toxicity, irritation, incompatibility, allergic reactions, etc. It means anything.

Typically, the coating composition of the present invention comprises from about 0.01 to about 60 weight percent, preferably from about 0.1 to about 40 weight percent, and most preferably from about 0.5 to about 30 weight percent of one or more adjuvants or mixtures thereof in the coating composition. It contains.

Adjuvants useful herein may be categorized by their cosmetic or therapeutic efficacy or their required mode of action. However, it should be understood that in some cases they may provide one or more cosmetic or therapeutic benefits or act by one or more modes of action. Thus, the categorization herein is for convenience and is not intended to limit the adjuvant to any particular application or listed applications. The following exemplary adjuvants are useful for the devices of the present invention. A more complete list of adjuvants can be found in WO 98/18444 and co-pending PCT application PCT / US99 / 15202, both of which are incorporated herein by reference.

Anti-acne: Anti-acne may be effective in treating and preventing acne vulgaris, a chronic impaired acne in fur branch capsules. Preferred antiacne agents include benzoyl peroxide, lactic acid, 4-methoxysalicylic acid, metronidazole, niacinamide, panthenol, retinoic acid and derivatives thereof, salicylic acid, sulfur, triclozan, zinc oxide, and mixtures thereof.

Emollient (Emollient): Examples of emollients useful herein include mineral oil, petroleum jelly (petrolatum), C ₇ -C ₄₀ branched chain hydrocarbons, C ₁ -C ₃₀ carboxylic acid of the C ₁ -C ₃₀ alcohol esters, C ₁ -C _{30-carboxylic} acid of monoglycerides, sugar C ₁ -C ₃₀ carboxylic acid monoesters and polyesters, for example, Sepharose coat carbonate (sefa cottonate) (sucrose polyester cotton when a date (polycottonseedate)), poly dialkyl siloxane ; Silicone gums, resins and elastomers; Cyclomethicones having 3 to 9 silicon atoms, vegetable oils, hydrogenated vegetable oils and mixtures thereof. Preferred emollients are selected from straight and branched chain hydrocarbons, sugar polyesters and silicones, in particular dimethicone and dimethiconol.

Nonsteroidal anti-inflammatory agents (NSAIDS): Examples of NSAIDS and esters thereof suitable for use herein are described in WO 98/18444.

Local Anesthetics: Examples of suitable local anesthetics for use herein are benzocaine and bupivacaine.

Artificial Tanning Agents and Tanning Promoters: Artificial tanning agents can help to simulate natural tanning by increasing melanin in the skin or by revealing increased melanin in the skin. Non-limiting examples of artificial tanning agents and tanning promoters include dihydroxyacetone, glucose tyrosinate and acetyl tyrosine, braziline, caffeine, coffee extracts, DNA fragments, isobutyl methyl xanthine, methyl xanthine, PHOTOTAN (NJ, Somerville to Commercially available from Laboratoires Serobiologiques), prostaglandins, tea extracts, theophylline, UNIPERTAN P2002 (available from IL, Unichem in Chicago) and UNIPERTAN P27 (commercially available from Unichem, Chicago); And mixtures thereof.

Preservatives Preservatives suitable for use herein include alcohols, benzoates, sorbic acid, and mixtures thereof.

Antibacterial and Antifungal Agents: Antibacterial and antifungal agents can be effective in preventing the growth and growth of bacteria and fungi. Non-limiting examples of antibacterial and antifungal agents include ketoconazole, benzoyl peroxide, tetracycline, benzalkonium chloride, benzoic acid and salts thereof, butyl paraben, cinnamon oil, citronella oil, echinacea, ethyl paraben, GLYDANT PLUS ( NJ, commercially available from Lonza in Fairlawn), grape seed oil, iodopropyl butyl carbamide lemon balm oil, salicylic acid, sodium metabisulfite, sodium sulfite, sorbic acid and its salts, and tea tree oil. .

Skin Soothing Agent: Skin Soothing Agents may be effective in preventing or treating skin inflammation. Such sedatives enhance the skin appearance efficacy of the present invention, for example, such agents contribute to a more uniform and acceptable skin tone or color. Examples of skin sedatives include allantoin, aloe, bisabolol, borage oil, chamomile, evening primrose oil, panthenol, and tocopherol.

Sunscreens: Sunscreens useful herein include both commercially available UVA and UVB absorbing organic sunscreens, as well as inorganic sunscreens such as titanium oxide and zinc oxide.

Skin Barrier Repair Aid: Skin Barrier Repair Aid is a skin care agent that can help restore and replenish the natural moisturizing barrier function of the epidermis. Non-limiting examples of skin barrier repair aids include ceramide, cholesterol, lanolin, lanolin alcohol, n-acetyl cysteine, n-acetyl-L-serine, niacinamide, nicotinic acid and esters thereof, nicotinyl alcohol, panthenol, phosphodiesterase inhibitors, Trimethyl glycine, tocopheryl nicotinate, and vitamin D3 and analogs or derivatives thereof.

Anti Wrinkle and Skin Atrophy Agents: The anti wrinkle and skin atrophy agents may be effective to replenish or regenerate the epidermal and / or dermal layers. These active agents typically provide the desired skin care efficacy by promoting or maintaining the natural process of formation and / or peeling of skin matrix components (eg, collagen and glycosaminoglycans). Examples of anti-wrinkle and anti-skin atrophy agents include niacinamide, nicotinic acid and esters thereof, nicotinyl alcohol, estrogen and estrogen-based compounds, or mixtures thereof.

Skin Repair Agents : Skin repair agents may be effective in restoring the epidermal and / or dermal layers. Non-limiting examples of skin repair agents include adenosine, aloe-induced lectins, ascorbyl palmitate, azaleic acid, biotin, blackberry bark extract, catecholamines, chalcones, cis retinoic acid, citric acid esters, coenzyme Q10 (ubiquinone), dehydro Cholesterol, dehydroepiandrosterone, dehydroascorbic acid and derivatives thereof, dehydroepiandrosterone sulfate, estrogens and derivatives thereof, farnesol, ginkgo bilboa extract, ginseng extract, lactate dehydrogenase Inhibitors, magnesium ascorbyl phosphate, melatonin, N-acetyl cysteine, panthetin, phytic acid and salts thereof, retinal, retinol, retinyl acetate, retinyl propionate and vitamin K.

Lipids: Examples of suitable lipids include cetyl ricinoleate and phytanetriol.

Skin Lightening Agents: Skin lightening agents can actually reduce the amount of melanin in the skin or provide such effects by other mechanisms. Skin lightening agents suitable for use herein are described in EP-A-758,882 and EP-A-748,307, both of which are incorporated herein by reference. Other skin lightening agents include arbutin, ascorbic acid, ascorbyl palmitate, azelaic acid, butyl hydroxy anisole, gallic acid and derivatives thereof, glycyrrhizinic acid, hydroquinine, inositol ascorbate, kojic acid, Niacinamide and vitamin D ₃ and analogs thereof.

Sebum Inhibitors: Sebum inhibitors can reduce the production of sebum in the sebaceous glands. Examples of suitable sebum inhibitors include dichlorophenyl imidazoledioxolane, aluminum hydroxy chloride, corticosteroids and cucumber extracts.

Sebum Stimulant: The sebum stimulant can increase sebum production by sebaceous glands. Non-limiting examples of sebum irritants include brinolic acid, dehydroepiandrosterone, and orizol.

Skin Sensor: Non-limiting examples of skin sensor suitable for use herein include agents that impart cool feeling, such as camphor, thymol, 1-menthol and derivatives thereof, eucalyptus, carboxamide; Mentan ether and mentan ester; And cayenne tinctures, cayenne extracts, cayenne powders, vanylamide nonanoates, nicotinic acid derivatives (benzyl nicotinate, methyl nicotinate, phenyl nicotinate, etc.), capsaicin, watercress extracts, bark extract And agents that impart a warm feeling, such as ginger extract, or mixtures thereof.

Protease Inhibitors: Protease inhibitors are compounds that inhibit proteolytic processes, ie, the process of splitting proteins into smaller peptide fragments and amino acids. Examples of suitable protease inhibitors include AE COMPLEX (NJ, available from Barnet Products, Englewood), BLUE ALGAE EXTRACT (NY, available from Collaborative Labs Inc., East Setauket), and SEPICONTROL AS (available from Seppic, Paris, France). This includes.

Skin tightening agents: Examples of skin tightening agents include sodium polystyrene sulfonate, BIOCARE SA (available from Amerchol, Edison, NJ), and egg whites.

Anti-itch ingredients: Examples of anti-itch ingredients include ichthyol and OXYGENATED GLYCERYL TRIESTERS (available from Laboratoires Seporgia, Sophia Antipolis, France).

Hair Growth Inhibitors: Suitable agents for inhibiting hair growth include, but are not limited to, 17 beta estradiol, anti-angiogenic steroids, turmeric extract, cycloxygenase inhibitors, evening primrose oil, linoleic acid and ethynylestradiol, and genistin Alpha reductase inhibitors are included.

Dermabrasion Enzyme Enhancers: These agents enhance the activity of endogenous dermabrasion enzymes. Non-limiting examples of dermabrasion enzyme enhancers include N-methyl serine, serine, trimethyl glycine, and mixtures thereof.

Antiglycosylating Agents: Antiglycosylating agents prevent the crosslinking of sugar-induced collagen. Suitable examples of antiglycosylating agents include AMADORINE (NJ, sold by Barnet Products Distributor, Englewood).

Examples of preferred auxiliaries useful herein include ascorbic acid and derivatives thereof, salicylic acid, niacinamide, panthenol, tocopheryl nicotinate, benzoyl peroxide, 3-hydroxy benzoic acid, flavonoids (eg flavanones, chalcones), farnesol, Phytantriol, glycolic acid, lactic acid, 4-hydroxy benzoic acid, acetyl salicylic acid, 2-hydroxybutanoic acid, 2-hydroxypentanoic acid, 2-hydroxyhexanoic acid, cis-retinoic acid, trans-retinoic acid, Retinol, retinyl esters (e.g. retinyl propionate), phytic acid, N-acetyl-L-cysteine, lipoic acid, tocopherol and esters thereof (e.g. tocopheryl acetate), azelaic acid, arachidonic acid, tetracycline, Ibuprofen, naproxen, ketoprofen, hydrocortisone, acetominophene, resorcinol, phenoxyethanol, phenoxypropanol, phenoxyisopropanol, 2,4,4'-trichloro-2'-hydroxy diphenyl ether , 3,4,4'-trichlorocarbanilide, octopyrrox, lidocaine hydrochloride, clotrimazole, myconazole, ketoconazole, neomycin sulfate, theophylline, and mixtures thereof. .

For cosmetic methods of skin, hair or nail treatments, beauty aids are anti-wrinkle and skin atrophy agents, antiacne, artificial tanning and tanning accelerators, emollients, wetting agents, skin repair agents, skin barrier repair aids, skin lightening agents, It is preferably selected from skin sensitizers, skin sedatives, lipids, sebum inhibitors, sebum irritants, sunscreens, protease inhibitors, skin tightening agents, anti-itch ingredients, and dermabrasion enzyme enhancers, or mixtures thereof.

Humectant

Preferred coating compositions and gel sheets contain one or more wetting agents. Wetting agents increase the moisturizing properties of the device when applied to a target surface. Some humectants, such as glycerin, may also act as a solvent for plasticizing the gel sheet. Certain wetting agents, such as hexylene glycol, may also contribute to the antibacterial properties of the preforming apparatus of the present invention.

Wetting agents suitable for use in the present invention are described in WO 98/22085, WO 98/18444 and WO 97/01326, all of which are incorporated herein by reference. Preferably the humectant for use herein is selected from glycerin, butylene glycol, hexylene glycol, panthenol, polyethylene glycol, and mixtures thereof.

In general, the coating compositions and gel sheets of the present invention contain from about 1.0 to about 50 weight percent, preferably from about 5 to about 45 weight percent, more preferably from about 10 to about 40 weight percent wetting agent.

Emulsifiers / Surfactants

Gel sheets and coating compositions of the invention optionally contain one or more surfactants and / or emulsifiers. Emulsifiers and / or surfactants generally help to disperse and suspend the discontinuous phase in a continuous phase. Surfactants may also be useful when the product is intended for skin, hair or nail cleaning. For the sake of convenience below, emulsifiers will be referred to by the term 'surfactant', and therefore 'surfactant (s)', whether used as an emulsifier or for other surfactant purposes such as skin, hair or nail cleansing, Will be used to refer to the surface active agent. Known or customary surfactants can be used in the composition, provided that the selected active agent is chemically and physically compatible with the essential ingredients of the composition and provides the desired characteristics. Suitable surfactants include silicone materials, non-silicone materials, and mixtures thereof.

The composition of the present invention preferably contains about 0.01% to about 15% of a surfactant or surfactant mixture. The exact surfactant or surfactant mixture selected will depend on the pH of the composition and other components present. Preferred surfactants are nonionic.

Nonionic surfactants useful herein include condensation products of alkylene oxides with fatty acids (ie, alkylene oxide esters of fatty acids); Condensation products of alkylene oxides with 2 moles of fatty acids (ie, alkylene oxide diesters of fatty acids); Condensation products of alkylene oxides with fatty alcohols, for example PEG 40 hydrogenated castor oil, steareth-2, isosethetsu-20, and oleeth-20. Other nonionic surfactants include condensation products of alkylene oxides with both fatty acids and fatty alcohols (i.e., polyalkylene oxide moieties are esterified with fatty acids at one end and fatty alcohols at the other end). )

Other nonionic surfactants useful herein include alkyl glucosides and alkyl polyglucosides, which are described in more detail in WO 98/18444. Still other useful nonionic surfactants include the polyhydroxy fatty acid amide surfactants described in WO 98/04241.

Other nonionic surfactants suitable for use herein include optionally alkoxylated sugar esters and polyesters, fatty acid amides.

Preferred nonionic surfactants are laureth-4, laureth-23, ceteareth-12, sucrose cocoate, steareth-100, polysorbate 60, PEG-60 hydrogenated castor oil, isosetetsu- 20, oleth-20, PEG-100 stearate, and mixtures thereof.

Other emulsifiers useful herein include fatty acid ester formulations based on mixtures of sorbitan or sorbitol fatty acid esters and sucrose fatty acid esters described in more detail in WO 98/22085, which is incorporated herein by reference.

Hydrophilic surfactants useful herein may alternatively or additionally include any of a wide variety of cationic, anionic, zwitterionic and amphiphilic surfactants, as known in the art. See, eg, McCutcheon's Cleaners and Emulsifiers, North American Edition (1986), Allured Publishing Corporation; US-A-5,011,681 to Ciotti et al. On April 30, 1991; US-A-4,421,769 to Dixon et al. On December 20, 1983; And US-A-3,755,560, issued to Dickert et al. On August 28, 1973; These four references are hereby incorporated by reference in their entirety.

A wide range of cationic surfactants are useful herein. Suitable cationic surfactants for use herein are disclosed in WO 98/18444. Exemplary anionic surfactants include alcoholic isethionates (eg, C ₁₂ -C ₃₀ ), alkyl and alkyl ether sulfates and salts thereof, alkyl and alkyl ether phosphates and salts thereof, alkyl methyl taurate (eg C ₁₂ -C ₃₀ ), and soaps of fatty acids (eg, alkali metal salts such as sodium or potassium salts). Examples of amphiphilic and zwitterionic surfactants include betaine, sultine, hydroxysultine, alkyl sarcosinates (eg, C ₁₂ -C ₃₀ ), and alkanoyl sarcosinates.

Gel sheets and coating compositions in the devices of the present invention may optionally contain a silicone containing emulsifier or surfactant. A wide range of silicone emulsifiers are useful herein. These silicone emulsifiers are typically organically modified organopolysiloxanes, also known to those skilled in the art as silicone surfactants. Useful silicone emulsifiers include dimethicone copolyols. These materials are polydimethyl siloxanes modified to include polyether side chains such as polyethylene oxide chains, polypropylene oxide chains, mixtures of these chains, and polyether chain containing moieties derived from both ethylene oxide and propylene oxide. . Other examples include alkyl-modified dimethicone copolyols, ie compounds containing C ₂ -C ₃₀ pendant side chains. Still other useful dimethicone copolyols include materials having various cationic, anionic, amphiphilic, and zwitterionic pendant moieties.

Other optional ingredients

The device of the present invention may contain a wide variety of other optional components. These additional ingredients must be dermatologically acceptable. [CTFA Cosmetic Ingredient Handbook: 2nd Edition, 1992], which is hereby incorporated by reference in its entirety, describes various types of non-limiting cosmetic and medicinal components commonly used in the cosmetic industry suitable for use in the compositions of the present invention. It is. Non-limiting examples of functional classification of ingredients are described on page 537 of the above reference. Examples of these and other functional classes include: absorbents, antibiotics, anti-dandruff agents, anti-perspirant agents, antioxidants, biological additives, bleach activators, brighteners, buffers, chelating agents, chemicals Additives, colorants, cosmetics, cleaners, deodorants, active peeling agents, depilatory agents, drug astringents, dyes, dye transfer agents, enzymes, external analgesics, film formers, fragrance components, insect repellents, fungicides, opacifiers, oxidizing dyes, oxidants , Control ingredients, pH adjusters, pH buffers, medicinal active ingredients, preservatives, radical scavengers, skin, hair or nail bleaches, skin, hair or nail conditioners, skin, hair or nail penetration enhancers, stabilizers, Surface conditioners, reducing agents, temperature lowering agents, and warmth generators.

Also useful herein are cosmetic ingredients such as colorants, essential oils, and therapeutic agents for skin, hair or nails.

Other optional materials herein include pigments and other particulates that can provide visual or tactile benefits. Pigments suitable for use in the compositions of the present invention may be organic and / or inorganic. The term pigment also includes lightly colored or glossy materials, such as matte finishing agents, and light scattering agents. Examples of suitable pigments are iron oxide, acylglutamate iron oxide, titanium dioxide, ultramarine blue, D & C pigments, carmine, and mixtures thereof. Depending on the type of composition, a mixture of pigments is usually used. Other microparticles useful herein include nylon-12, polymethylsilsesquioxane and dimethicone / vinyl dimethicone cross polymers.

The pH of the gel sheet and coating composition herein is preferably about 3 to about 9, more preferably about 4 to about 8.

Method of producing gel sheet

Gel sheets are formed by applying a mixture of one or more gelling agents and hydrophilic solvents to the gelling step with any additional additives such as plasticizers or auxiliaries to form a self-supporting gel sheet. The nature of the gelling step depends on the nature of the gelling agent (s) used. For example, the step may include the addition of metal ions for the crosslinking of the polymer solution, or may include ultraviolet irradiation for the generation of a self-supporting gel.

In many cases, the gelling step is through cooling. It mixes the solvent and the gelling agent (s), and any other ingredients and heats it to a first temperature above the gel point of the mixture; Putting the mixture into a mold of the appropriate form; And gelling the gel-forming mixture at a second temperature below the first temperature and at or below the gelling point of the mixture to produce a solid gel sheet. Alternatively, the mixture may be prepared directly in the mold.

In forming the gel sheet, the components may be added simultaneously or sequentially in any order. The order of ingredient addition may depend on its physical properties and properties. Preferably, the gelling agent (s) and any auxiliaries are sufficiently dissolved in the solvent before any other optional ingredients are added. "Fully dissolved" means that the mixture appears substantially or completely transparent. The temperature of the mixture is usually kept above the gel point until all ingredients are added. In some cases, it may be advantageous to start lowering the temperature of the mixture before adding certain components.

In a preferred embodiment, the gel sheet is produced via injection molding. The sheets thus produced are considered to be high in strength due to the smooth finish of the surface which provides greater resistance to tearing. An injection molding manufacturing method of a gel sheet includes the steps of injecting a gel-forming mixture into a mold of a suitable form, wherein the mixture is maintained at a first temperature above the gel point of the gel-forming mixture; And cooling the gel-forming mixture to a second temperature below the gel point of the gel-forming mixture in a mold of a suitable form to form a solid sheet. Prior to gelation, the mixture is kept sufficiently fluid in order to be easily supplied to the mold by any conventional means, in addition to the injection molding process. Lubricants may be added to assist in feeding the gel-forming mixture along the lumen of the extrusion barrel.

The gel-forming mixture may be supplied to the mold in any suitable form by any known technique, including gravity feeding systems and pneumatic or mechanical injection systems. Injection molding is the most preferred technique because of the fluidity and low processing temperature of the mixture. A very wide range of molding pressures can be used. Generally, the molding pressure is about 0.1 to about 5 MPa (about 1 to about 50 atmospheres), although higher or lower pressures may be used depending on the molding technique used.

When gelling is carried out via cooling, the forming temperature must naturally be at or below the gelling point of the gel-forming mixture to form a solid sheet. Appropriate molding temperatures can be achieved before, during or after the mixture is fed into the mold. After the sheet is molded and cooled to a temperature below the gel point, the sheet is removed from the mold. No special handling is required while the sheet is removed from the mold.

In a gel sheet having a non-planar structure on at least one, preferably both, of the first and second surfaces, the mold is formed by a surface corresponding to the negative image of the first and second surfaces of the sheet itself. Have The non-planar structure is of a freely selectable form. If the non-planar structure is periodic, the mold surface has a negative periodicity of the same periodicity.

Preferred methods of manufacturing the device according to the invention comprise the following steps:

a) providing a solid gel sheet;

b) at least partially coating its first surface with a coating composition containing one or more skin adjuvants; And

c) packaging the coated gel sheet in a sealed protective wrapper.

The packaged device is optionally provided with a release liner to prevent the device from drying out or to facilitate handling. The release liner is removed before use.

Board

The preform apparatus of the present invention does not require support or reinforcement by occlusive or non-occlusive backing materials, often referred to as substrates. However, when worn by the user, the substrate intended as part of the device may be combined with a gel sheet and will impart additional support or reinforcement. In addition, the substrate may be made to make the handling of the device more comfortable or easier when the device is wet or sticky to touch; To prevent evaporation of the active ingredient; Or may be used to function as a means of adhering the device to the skin when the adhesive is coated along the edge. The substrate may be impregnated, adhered or laminated to one surface of the device. If the device has a large surface area such as a front mask, the substrate is particularly useful.

If the substrate is used to impart additional support or reinforcement, the substrate will be compatible with the device of the present invention so as not to peel off from the device. It may be difficult to align the substrate with the gel sheet. The combination of flexible substrates and flexible gels does not necessarily result in flexible patch or mask devices. In addition to the problem of delamination, many flexible substrates often exhibit some degree of porosity such that the wettable gel penetrates into the substrate and forms a strong gel network within the fiber. Such a network can reduce the flexibility of the resulting device. In addition, the substrate may not provide a patch or mask device with an unobstrusive appearance on the skin, hair, or nails. This often depends on the choice of substrate and its properties.

However, various kinds of materials can be used as the substrate. The following properties are desirable: (i) sufficient wet strength for use, (ii) sufficient flexibility, (iii) sufficient thickness and porosity, (iv) sufficient hydrophilicity for the gel mixture to diffuse and penetrate into the substrate, (v) Sufficient compatibility with the mixture to prevent delamination, (vi) sufficient transparency or translucency, and (vii) appropriate size. The substrate is preferably non-closed. Suitable substrate types that meet the above conditions include woven and nonwoven materials; Polymeric sheet materials such as molded films; And paper substrates.

Alternatively, a substrate-like material can be used as the textured surface. When such a substrate like material is used as a textured surface, it is desirable to easily peel off from the device in the same manner as the release liner.

How to use

After applying the device to a target site of skin, hair or nails, the device is generally left at the target site for at least 1 minute, preferably at least 5 minutes, 12 hours or less, preferably 3 hours or less, more preferably 1 It may be left for a period of time or less, most preferably less than 15 minutes. The device can then be removed at once.

Depending on the adjuvant (or auxiliaries) contained therein, the preformed device may have one or more of the following uses: hydrating skin, hair or nails, relieving fine lines and wrinkles; Cosmetic treatment of acne; Firming, strengthening of the skin; softening; Peeling; Improving and / or homogenizing skin tone and / or feel; Skin, hair or nail whitening; Tanning; Reduction in the appearance of pores; Absorption or regulation of secretions; Protection or relief of muscles, aches or pains of the skin, hair or nails; Swelling and / or reduction of black lines around the eyes; Promotion of wound healing; Warming, refreshing or cooling the skin, hair or nails; Relief of inflammation; Whitening of the skin; Prevention of congestion; Anti-expansion; Treatment of dermatological conditions; Shock mitigation; refine; Flavor; Reduced growth of bacteria or microorganisms; cure; Insect repellent; Removal of unwanted hair, dirt or makeup; And coloring or bleaching of the target area to which the device is applied. Preferably, the preforming device herein comprises hydration of skin, hair or nails; Relief of fine lines and wrinkles; And cosmetically used for the improvement and / or homogenization of skin tone and / or texture.

Example

The invention is illustrated by the following examples.

Gel Sheet Examples 1-4

The polysaccharide gum is mixed with water to form a uniformly dispersed mixture (which can be facilitated by predispersing the polysaccharide in a nonsolvent, for example polyhydric alcohol), and any additional ingredients are added. The mixture is heated to a first temperature above the gel point of the mixture (about 90 ° C.) with stirring to fully hydrate the polysaccharide gum. The liquid gel is then placed in a suitably shaped mold. Injection molding is the preferred method of injection. This eliminates any defects that may be introduced by cutting the gel, thereby improving the robustness of the sheet. Injection molding also allows the sheet to be easily formed into a three-dimensional structure. The liquid gel is then cooled to a second temperature (room temperature) below the first temperature below the gel point of the mixture to make up the gel structure. The sheet is then removed from the mold and coated with the coating composition shown below.

If a substrate is used, it may be placed in a suitably shaped mold prior to injecting the gel or placed on the surface of the liquid gel during the cooling step.

In some compositions, metal ions (eg Ca ²⁺ , K ⁺ ) may be included in the formulation to increase the gel strength of the sheet. In this case, metal ions are added in the form of an aqueous solution and stirred into the liquid gel just before the injection step.

The method may be modified as necessary according to the kind of any additional component. For example, if a non-aqueous component is present, the liquid gel can be homogenized immediately before molding or casting, to ensure dispersion of the non-aqueous component. Likewise, if a heat sensitive component is incorporated, the formulation should be cooled to a suitable temperature (depending on the component) after the hydration step of the gum, in which the heat sensitive component is added.

The liquid gel is degassed, for example by vacuum, to remove air bubbles dispersed in the liquid. This degassing step, if subsequent, will be the last step just before injecting the liquid gel. Another suitable gel sheet can be prepared by Examples 1-15 of WO 00/06215 below.

Coating Composition: Examples 6-10

The method of preparing the coating composition depends on the nature of the composition, for example, aqueous solutions, o / w emulsions, and the like, and follows procedures known to those skilled in the art. The gum is predispersed in a nonsolvent for the gum (eg polyhydric alcohol) and then dispersed in some water phase. Water soluble components (eg niacinamide, panthenol) are dissolved in some water phase and thickener premix is then added with stirring to prepare a thickened coating composition. Heating may be necessary for complete dissolution of poorly soluble components (eg ethyl parabens) or for complete hydration of the thickener. Components that are not water soluble (eg tocopheryl acetate) may be predispersed in a solubilizer (eg PEG-60 hydrogenated castor oil) prior to addition to the coating composition. Particulate materials can be dispersed in the coating through conventional mixing techniques.

Application of the coating to the gel sheet

Various methods are suitable for applying the coating to the gel sheet to form the final device. For example, the coating can be applied directly to the gel sheet, such as, for example, injecting through a pipette to provide a "dots" coating or spreading with a brush to provide a uniform layer. . Alternatively, the coating can be applied using screen printing techniques or through an extrusion process. It is also possible to apply the coating to the gel sheet by an indirect method. For example, after applying a coating to the surface of a packaging material (e.g. , plastic tray , release liner sheet), the gel sheet is placed on top of this coating layer. Various methods can be used to apply the coating to the packaging material. These include point deposition of the coating via molecular spraying of the coating, electrofluidizing coating methods of the type used in nozzle devices or inkjet printing. A preferred method is to use a nozzle to deposit the coating composition into the packaging tray, rotate the nozzle to provide a uniform coating layer, and then compress the gel sheet on top of the coating composition.

The device herein is then packaged in a material having low water vapor permeability to minimize drying of the device during storage. Suitable packaging for the device herein includes disposable bags or sealed trays. Any suitable material can be used for packaging, such as plastic material and foil lamination. If the device is packaged in a disposable bag, it should preferably be additionally mechanically protected prior to use. This protection may be provided by a release liner or substrate, such as a plastic film, which provides for easy release of the device.

An embodiment of the device seen from the side is shown in FIG. 1. The apparatus 1 comprises a gel sheet 2 and a coating composition 4 on the first surface 12 of the gel sheet. The device is generally flat with raised outer edges 18 which provide greater mechanical strength to the device in handling. In the plan view, the device will show a nearly new moon shape, with dimensions of an abstract rectangle of 4 cm x 2 cm surrounding the new moon shape. The gel sheet has a second upper surface 16 opposite the first surface 12. The thinner portion 22 in the center of the gel sheet has an average thickness of 1.2 mm and is textured on the first and second surfaces. The tusks on the first and second surfaces are different patterns, reducing gloss from the patch. Make it less noticeable when used. Texturing of the first surface 12 helps the coating 4 adhere to the gel sheet.

Evaluation method of the device

Device transparency

The transparency of the device is measured by evaluating the visibility of the printed version through the device. Printed versions are printed by printing the English alphabet (uppercase) on a transparent film (Universal Office Supplies) using a LaserJet 4 Plus printer (Hewlett Packard) with a black ink cartridge and Microsoft Word Ariel font. The printed transparent film is produced in a font size ranging from 4 points to 28 points. The printed transparent film is then placed on a sheet of white paper to ensure a uniform background and all samples are evaluated under normal room lighting conditions.

A sample of the gel of interest was molded to prepare a 7 mm thick (depth) disc shaped gel. This gel disc is evenly coated with the coating composition at a rate of 0.015 gcm ^-2 and placed face up onto the transparent film printed on a 4 font size. The visibility of the printed version is evaluated via a disc shaped gel. If the edition is not discernible through the gel disc, the gel disc is transferred to the next larger font size and the evaluation is repeated. Repeat this method until the font size is discernible through the gel. The smallest font size identifiable through the gel sample is then set to the "transparency threshold" of the device.

The preferred "transparency threshold" of the device of the invention is preferably about 10 points or less, preferably about 7 points or less and particularly preferably about 4 points or less.

Device flexibility

When the device spans an edge, the flexibility of the device of the present invention can simply be evaluated by measuring how much the device bends under its own weight. Prepare a 4 cm × 2 cm rectangular test strip of the material used to make the device. The specimen should have a rectangular cross section of thickness equal to the average thickness of the device of interest, with the average weighted for the largest area of the first and second surfaces. In the case of the device of the present invention, flexibility is predominantly determined by the gel sheet, but in order to address the question, the specimen should be evenly coated with the coating composition of the device at a rate of 0.015 gcm ⁻² . Likewise, if a substrate intended to be part of a device worn by a user is included in the subject device, the test should be performed with the included substrate. The specimen is supported on a flat surface with the coated side up and the flat surface has a square edge that can be unobstructed by 2 cm of the 4 cm length of the specimen. This arrangement is schematically shown in FIG. A strip of gel 30 (coating not shown) spans the vertical edge of the solid support 40, and the surface thereof is horizontal. The angle θ of the overhang from vertical is measured by drawing a straight line from the end of the gel sheet to the edge of the support (indicated by the dashed line in FIG. 2). This can be conveniently done with a photo.

The angle θ of the protrusion is the flex angle of the device. In general, the device according to the invention should have a bending angle of about 15 to about 80 degrees, preferably about 25 to about 75 degrees, and more preferably about 40 to about 60 degrees.

Claims (13)

In the preforming device 1 for delivering a beefit agent to the skin, hair or nails, A solid gel sheet 2 having opposing first and second surfaces 12, 16, and The gel sheet contains at least one gelling agent and at least 10% dermatologically acceptable hydrophilic solvent, Said first surface is at least partly coated with a discrete coating composition (4) containing one or more adjuvants for skin, hair or nails. The method of claim 1, The coating composition is a preforming apparatus, characterized in that the liquid having a viscosity of greater than 1000 mPa.s. The method according to claim 1 or 2, The coating composition is a preforming apparatus, characterized in that in the form of an oil in water emulsion (oil in water emulsion). The method according to claim 1 or 2, Wherein said hydrophilic solvent is selected from water, ethanol, propylene glycol, glycerin, and mixtures thereof. The method according to claim 1 or 2, And wherein the gel sheet is a single thin film (unilamellar). The method according to claim 1 or 2, Wherein said gel sheet contains one or more skin adjuvants. The method according to claim 1 or 2, Wherein said gel sheet and said coating composition each contain one or more skin adjuvants in common. The method according to claim 1 or 2, And a substrate disposed on said gel sheet. The method according to claim 1 or 2, And the device is packaged in a sealed protective wrapper. The method according to claim 1 or 2, And the device has a transparency threshold of 10 points or less. The method of claim 10, And the device has a transparency threshold of 7 points or less. a) providing a solid gel sheet; b) at least partially coating the first surface of the solid gel sheet with a coating composition containing one or more skin supplements; And c) packaging the coated gel sheet in a sealed protective wrapper. A method of delivering one or more cosmetic supplements to the skin, hair, or nails, Applying the device according to claim 1 to a target site of skin, hair or nails, such that the coated first surface is in contact with the target site, and Leaving the device at the target site for a period of 1 minute to 12 hours.