CZ200236A3 - Sheet-like means - Google Patents

Abstract

The present invention relates to pre-formed, unilamellar, sheet-like devices (10, 110, 210, 310, 410, 510, 610, 710, 810) for delivering benefit agents to the skin, hair or nails. The devices are patches or masks for cosmetic or therapeutic use. The devices have a non-planar topography on at least one surface (14, 114, 214, 314, 414, 514, 614, 714, 814; 16, 116, 216, 316, 416, 516, 616, 716, 816) and are less obtrusive. The present invention also encompasses methods of producing such devices.

Description

The present invention relates to novel preformed, uniformly lamellar, unilamellar film-like compositions. In particular, the present invention relates to preformed, unilamellar, film-like compositions which are in the form of patches or masks comprising at least one polymeric gel-forming agent for the purpose of delivering agents that are beneficial to skin, hair or nails. Said compositions are suitable for the local delivery of at least one beneficial agent and exhibit improved mechanical properties such as strength and flexibility. Furthermore, the compositions of the present invention are inconspicuous and adaptable to the contours of the selected target surface when applied.

BACKGROUND OF THE INVENTION

The benefits of using patch or mask compositions that contain a gel-forming agent instead of creams and lotions and the like for cosmetic treatment of skin, hair or nails, or to promote burn healing or burns or injuries have been known in the art. A variety of cosmetic patches or compositions are commercially offered for sale or described as being useful for delivering skin-treating active ingredients such as vitamins, anti-acne agents, moisturizers and the like. The patches and compositions are also described in the literature and offered in the medical field as useful methods for transdermal delivery of drug substances. However, many of these patches or

The formulations suffer from deficiencies in their physical product forms, resulting in undesirable performance as perceived by the consumer or wearer. For example, some patches or compositions may be too moist or sticky if the agents contained in the patch or composition do not form a rigid gel structure; as a result, such patches or compositions make it difficult to handle and apply to the skin. Others are strongly adherent, too tight and tight and uncomfortable to wear and remove, and many patches do not provide effective release and permeation of beneficial agents.

Some patches or compositions require in situ formation on the skin and are therefore complicated and delicate to be applied. For example, US-A-4,291,025 relates to a thermally reversible agar gel topical dressing comprising 5% to 12% by weight agar, 20% to 75% by weight diethylene glycol and water to 100%; and methods of preparing the dressing. Such compositions may additionally contain gel-enhancing agents and ingredients intended for particular purposes (e.g., vitamins, antibiotics). According to one aspect of the invention US-A-4,291,025, solid, high strength agar gels are prepared which are then subdivided into smaller beads or chunks. In another aspect, the agar gel is then converted to a sol by heating, and the sol is then applied to a designated area of the skin and cooled in situ to form a removable gel form.

Furthermore, some patches or devices are too dry or inflexible and therefore cannot adapt well to the surface to which they are applied. For example, EP-A-161 681 discloses gel flat layers comprising a polysaccharide and an aqueous solution of a polyhydric alcohol. Preferred polysaccharides for these gel layers are mixtures of carrageenan and galactomannan, or carrageenan itself. These compositions optionally contain medical ingredients such as skin stimulants, anti-inflammatory drugs, analgesics and antibiotics. Such gel layers are said to be transparent or inconspicuous, giving a refreshing feel and being well adhered and reasonably elastic, elastic and firm.

Flexibility and strength are other important properties of gel formulations. WO97 / 17944 discloses cosmetic formulations made from a gel material consisting of an equilibrium mixture of polysaccharides containing soluble alginate (0.1% to 5% by weight), agar (0.01% to 0.5% by weight), pectin (0.01% to 0.5%), xanthan (0.05% to 1%), and an equilibrium amount of water. This gel material is optionally enriched with water-soluble or water-soluble active ingredients. Such a gel material can be processed into a structured gel, which is described as being easy to handle and very adaptable to the skin surface.

WO90 / 14110 discloses pharmaceutical compositions which can take the form of a self-supporting wafer or wafer, pad or pad under a bandage or circular stickers, and the size, shape and thickness can be adapted as desired. Said pharmaceutical compositions comprise water-insoluble alginate and suspending agents such as xanthan alone or xanthan in association with gelatin of locust bean. Gelan gelatin is mentioned as another other material useful as a suspending agent. These suspending agents in the compositions may also act as gel-forming agents. The compositions may optionally also contain an anti-inflammatory agent or an antiseptic, iodine. Formulation forms such as slices or circular stickers may be resilient and applied to a plastic backing in the form of an integral surgical bandage with a gel that is either applied to the gauze or covered with gauze.

US-A-4 318 746 relates to a gel comprising at least 0.5% by weight of a first polymer which disperses, dissolves or hydrates in hot water and forms or can form a solid gel upon cooling, furthermore at least 2% by weight of a second polymer which is insoluble in hot water and thus dissolves or hydrates upon cooling and is compatible with the first gel and with water. The document further describes a gel as solid, coherent and adhesive and useful, for example, as an electrode or for topical administration of drug substances. The document states that one of the advantages of this gel is that it is relatively coherent and adherent at temperatures below 60 ° C to 65 ° C.

JP-A-200760 discloses a two-layer patch comprising a gel matrix and a backing layer (or pad). It is stated in the description that it is preferred that the skin adhering surface of the gel matrix is flat. Alternatively, the skin-adhering surface may comprise net-like grooves or grooves (Figure 3), logo designation or the like (Figure 2), a substantially parallel groove or groove grouping (Figure 5) or grooves shown (Figure 7). The gel metrics comprise a protein (gelatin, casein, albumin or serecin) or a water-soluble polymer to which an inorganic filter, a wetting agent, a binder and / or a crosslinking agent can be added. The two-layer patch is made by casting into a mold of the desired shape.

WO98 / 17287 is directed to hollow flexible silicone pads for the treatment of keloids (hyper-tumorous scars) and hypertrophic scars, by developing a negative electrical charge near the scars. These pads may be made of a textured silicone surface, with the term "textured" being defined as an irregular surface containing, for example, spikes or corners that are the same or similar in respect of textured fabric properties, which may be

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0 0000 00 · 0 ·· 00 ·· Regularly uniform or irregular in shape and appearance. Texturing is said to be related to uneven charge distribution. No way of texturing the mat is given.

US-A-4,289,125 discloses polymer layers for use as facial burn wraps which are textured. It is reported that it is recommended to provide some margin with respect to wound-related cellular waste and due to adhesion to the injured surface. Burnt dressings with a teturated surface on one surface or on both surfaces are described. Figure 1D shows a unilamellar composition in which both surfaces are textured. The woven textured layer acts as a base layer for the polymer, which is then cured. Then, the base woven layer is removed by solvent leaching and the integral unilamellar self-supporting polymer layer is removed. Figures 5F to 51 show a laminated composition having a single "textured" surface. It comprises a smooth surface polymeric membrane in which a material is embedded to impart a woven texture to the surface. The material that is anchored may be applied to the gauze or may not be applied to the gauze or netting or the aforementioned woven layer (either with or without leaching the base layer). The woven material is stretched on a suitable surface and acts as a base layer supporting a polymer membrane layer which forms a continuous phase with the polymer deposited on the woven material (see Figure 6C). The woven material can then be infused.

WO94 / 02674 is directed to a dual medical pad comprising a synthetic fiber laminate paper layer, a nonwoven layer having a repeating pattern that comprises at least two contiguous areas of contour that are not of equal thickness or have regular or irregularly spaced apertures. Dual textured allows for both fine and strong cleaning with the same pad.

WO98 / 50085 relates to a product which is intended, for example, for dressing wounds or for disposable stripes. This product includes a substrate and a textured, matt, low tack backing. This document states that the matt surface of the wound dressing can be achieved by 'mechanical action', making the dressing less visible when applied to the skin.

US-A-5,026,446 relates to a physically abraded disposable strip. Physical grinding improves the adhesion of the adhesive tabs to the target strips.

While the above cosmetic and medical patches or layers provide advantages in terms of the physical and utility properties achieved, i

these documents do not disclose self-supporting, preformed, film-like compositions which are unilamellar and have the desired mechanical properties in terms of strength, stiffness and elasticity, as well as desirable performance properties for ease of handling, unobtrusiveness and adaptability to the contours of the target surface when applied.

It has now surprisingly been found that preformed film-like unilamellar compositions can be formulated as self-supporting, high-strength structures that are sufficiently flexible to conform to the contours of the target surface upon application. The compositions of the first aspect do not have a planar, planar (two-dimensional) topography, their topography is selected according to the target surface upon application to facilitate handling and application. For example, thicker joints around the periphery of the device facilitate handling and strength, while thinner joints are better suited to target surfaces in areas of increased curvature. In addition, or alternatively, a distal textured surface on the surface of the composition, such as when used on a user's skin, hair or nails, makes the composition less noticeable. The desired physical properties are achieved by selecting the chemical composition and theological properties of these gel compositions with respect to the strength-elasticity dependence and the desired performance properties are achieved by selecting a suitable non-planar topography, wherein at least two contiguous regions do not simultaneously have the same mean thickness and / or suitable textured surface. or surfaces.

Preferred preformed, unilamellar, film-like compositions of the present invention exhibit a low level of syneresis, which makes the compositions wet to the touch and thereby aids a cooling feeling. The liquid surface may facilitate adherence of the composition to the target surface, thereby eliminating the need for either an additional gel-shaped adhesive or application of the adhesive composition to the backing layer.

The unilamellar film-like compositions herein do not require support or reinforcement with an occlusive or non-occlusive material, often referred to as a substrate. However, the substrate, if present, may be combined with the unilamellar composition and could exhibit additional support, support or reinforcement. In addition, the substrates may also be used in the case of preventive evaporation of the active ingredients, or act as an auxiliary method for adhering the composition to the skin when the adhesive composition is applied around its periphery. The substrate may be impregnated, adhered, or laminated to one of the surfaces of the composition.

EP-B-507 160 relates to an exterior preparation for application to the skin, comprising a drug substance that retains the layer placed on the substrate, wherein the drug layer-retardant comprises lidocaine, and an adhesive gel base containing 0.5% by weight up to 50% by weight of a high molecular weight water-soluble substance, from 20% to 70% by weight of water and from 1% to 70% by weight of a water retention agent. Suitable substrates are described as resilient materials such as nonwovens.

The substrate or substrate, if present, means additional support or reinforcement must be compatible with the gel. The substrate is not compatible with the gel when the gel is delaminated from the substrate. Even when it is found that the gel composition has the desired elasticity and strength, there may still be difficulties due to the corresponding gel and substrate due to their compatibility with the corresponding gel properties. Combining the elastic substrate with the elastic gel is not necessary to produce the elastic composition in the form of a patch or mask. Despite the problem of delamination, many resilient substrates often show a degree of porosity that the moisture of the gel infiltrates the substrate and forms strong gel networks in its fibers. Such nets are then able to reduce the flexibility of the resulting composition. In addition, the substrate also need not provide a composition in the form of a patch or mask with an unobtrusive appearance to the skin, hair or nails. However, this depends on the choice of the substrate and its properties.

The film-like compositions herein are preferably patches or masks for cosmetic or therapeutic applications.

SUMMARY OF THE INVENTION

The present invention relates to a first aspect of a preformed, unilamellar film-like composition for delivering agents that are beneficial to skin, hair or nails, the perimeter of said composition defined by first and second surfaces separated from each other; the composition comprising at least one beneficial agent and at least one polymer gel forming agent; and further, the composition has at least one of the first and second surfaces non-planar, non-planar topography.

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According to a second aspect, the present invention provides a preformed, unilamellar, film-like composition for delivering an agent beneficial to the skin, hair or nails, wherein the perimeter of the composition is defined by first and second surfaces separated from each other; the composition comprising at least one beneficial agent and at least one polymer gel forming agent; and further comprising at least one non-planar topography on at least one of the first and second surfaces, wherein the non-planar topography comprises at least two contiguous areas that are not of the same mean thickness.

According to a third aspect, the present invention provides a preformed, unilamellar, film-like composition for delivering an agent beneficial to the skin, hair or nails, the composition comprising at least one beneficial agent and at least one polymer gel forming agent; and wherein the perimeter of the device is defined by first and second surfaces separated from each other, the first surface in use adjacent to skin, hair or nails, and the second surface having a non-planar topography, the non-planar topography comprising a textured surface having a negative appearance the textured surface and the textured surface has the appearance of a negative texture defined by R _and whose value is greater than 10 microns.

The compositions of the present invention having textured surfaces are advantageous in that it is not obvious that they are textured, but also that they are textured on contact.

The compositions of the invention are suitable for topical application to the skin, hair or nails. They provide excellent performance features such as inconspicuousness, comfort, visual appearance, strength, ease of handling and adaptability for topical application. Moreover, the compositions described herein have excellent mechanical properties and form a high strength structure that is resilient and has a high degree of elasticity. Preferred compositions of the present invention exhibit a low level of syneresis and thus further provide utility properties related to the moisturizing and moisturizing benefits of topical application of the compositions.

According to a fourth aspect, the present invention provides a process for preparing a preformed, unilamellar film-like composition according to the first or second aspect of the invention, the method comprising providing a gel-forming composition comprising at least one beneficial agent and at least one gellable polymeric agent , in a form having at least ·· ··· «

4444 one surface that has a negative appearance in relation to the other surface, a non-planar topography, this one nonplanar topography includes at least two adjacent drawn by areas that do not simultaneously the same mean thickness or textured surface that has a negative appearance of the textured surface and the textured surface of the negative appearance of a texture defined by a parameter _{R, and} whose value is greater than 10 microns, or is equal to this value; and then (accordingly) gelling the gel forming composition. In a preferred embodiment, the mold has opposing texturing surfaces, the texture of which is defined by Ra, greater than 10 µm so that the textured surfaces are printed opposite to the first and second surfaces of said composition. More preferably, the mold is additionally formed to provide a non-planar topography that comprises at least two contiguous plotted regions that at the same time do not have the same mean thickness on at least one surface of said composition, and preferably is a second surface that is from the skin, hair or nails. I use this device more distant.

According to a fifth aspect, the present invention provides a process for preparing a preformed, unilamellar, film-like composition according to the first or third aspect of the invention, the method comprising providing a gel-forming composition comprising at least one beneficial agent and at least one gelable polymeric gel forming agent in a form whose first surface has a topography having a negative appearance relative to the first surface of said composition; further comprising contacting the second texturing surface with the second surface of said composition of the gel-forming composition; gelling the gel-forming composition; and removing the textured surface from the composition.

According to a sixth aspect, the present invention provides a method of delivering at least one skin, hair or nail benefit agent comprising contacting the skin, hair or nails with the composition of the first, second or third aspects of the invention, the composition comprising at least a cosmetically beneficial agent and at least one polymer gel forming agent.

Description of the picture

Figures 1a, 1b and 1c are plan views, sectional views, and perspective views of a first embodiment of a device according to the first or second aspect of the present invention.

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Figures 2 and 3 are sectional views of the second and third embodiments of the device according to the first or second aspect of the present invention.

Figure 4 is a cross-sectional perspective view, partial view of a fourth embodiment of a device according to the first, second or third aspect of the present invention.

Figure 5 is a cross-sectional perspective view, partial view of a second embodiment of the device according to the first or third aspect of the present invention.

Figure 6 is a schematic view of a fifth embodiment of a preformed, unilamellar, film-like composition according to the first or second aspect of the present invention, in situ on a user's face.

Figures 7a and 7b are plan and cross-sectional views of the embodiment of the device of Figure 6.

Figure 8 is a schematic view of a sixth embodiment of the device according to the first or second aspect of the present invention, in situ on a user's face.

Figure 9 is a plan view of a preformed unilamellar film-like composition of Figure 8.

Figure 10 is a schematic view of a seventh embodiment of the device according to the first or second aspect of the present invention, in situ on a user's face.

In the figure, there is a plan view of a preformed, unilamellar film-like composition of Figure 10.

Fig. 12 is a cross-sectional view of an eighth embodiment of the device of the present invention according to the third aspect wherein the device is textured on the first and second surfaces.

DETAILED DESCRIPTION OF THE INVENTION

The preformed, unilamellar, film-like compositions of the present invention, having at least one beneficial agent and at least one polymer gel forming agent, as well as other miscellaneous optional ingredients as set forth below. All amounts and ratios are by weight unless otherwise indicated. When a substrate is used in addition to said composition, the total weight of the composition is calculated so that the weight of the substrate is not included in the total weight.

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As used herein, the term "preformed" means that the composition is made in a product form having a predetermined thickness, shape and size, which composition can be removed from any package and placed on the target surface by without the need to lubricate, paint or glue the target surface on which this product form is intended. The compositions herein are preferably packaged in sealed protective containers.

The term "film-like" as used herein means that the composition is a patch or mask for cosmetic or medical application, wherein the patch is a continuous thin layer or area whose shape is predetermined according to the specific skin surface, hair or nails to be treated, and wherein the mask is a discontinuous thin layer or area covering the facial portion with openings for the eyes, nose or mouth.

As used herein, the term "unilamellamic" means that the composition is a single layer that is self-supporting.

As used herein, the term " non-planar topography " means that at least two contiguous regions do not simultaneously have the same mean thickness. Alternatively or additionally, then the term "non-planar topography" as used herein means the texture Vanya surface having a negative pattern textured surface and the textured surface of the negative appearance of a texture defined by a parameter _{R, and} whose value is greater than 10 pm . As used herein, the term "parameter R _a " means the average (mean) deviation from the best fit plane of the surface points as described in detail below in the section entitled "Evaluation Methods".

As used herein, the term "contoured areas not having the same mean thickness" as used herein refers to contoured areas that are visually different and, if the thickness variations are only to a small extent, such changes correspond to the textures described herein, and are aligned to a certain average value, their mean thickness being different.

As used herein, the term "water-soluble" refers to the ability of a polymeric gel-forming agent to dissolve in an aqueous solution at either room temperature or with heating to form a continuous phase.

As used herein, the term "syneresis" refers to a process whereby the gel gradually shrinks or contracts (ages) while standing, expelling the liquid. Without wishing to be bound by theory,

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444 4444 44 44 49 4944 gel formulations are believed to form three-dimensional matrices, binding or encapsulating other materials in the formulation. Syneresis is believed to spontaneously separate the initial homogeneous system into a coherent gel phase and into a liquid. The released sweat liquid is a solution whose composition depends on the composition of the original gel. In a preferred embodiment of the composition of the present invention, the composition is applied to a target region, the composition losing part of its volume as the individual ingredients bind in the gel matrices, particularly water or beneficial agents, as they are released and penetrated relative to the target areas.

The term "polysaccharide" as used herein refers to a naturally occurring or synthetically prepared, linear, branched or crosslinked polymer of monosaccharide units that swells when dispersed in water at low anhydrous concentrations and gelatinizes in the aqueous phase.

As used herein, the term "percent burst compression" as used herein refers to the result of a gel elasticity measurement. This method is described in detail in the section entitled 'Measurement methods'.

As used herein, the term "rupture force" refers to the result of a gel strength measurement. This method is described in detail in the section entitled 'Measurement methods'.

The term "periodicity" as used herein refers to the characteristic elements (model) of the repeating units and is determined by measuring the distance between the start and end points of the repeating unit with the characteristic elements.

The non-planar topography of said compositions of the present invention may demonstrate periodicity or may not demonstrate periodicity. Preferred periodic characteristic elements are sinusoidal, sawtooth or conical. The preferred periodicity is 0.1 mm to 10 mm, preferably 0.5 mm to 5 mm. If the compositions comprise a textured first and second surfaces, then the feature elements on each surface may be the same or different, and each feature may be periodic or non-periodic. If the characteristic elements on both surfaces are periodic, then the periodicity may be the same or different. In those embodiments where the periodicity is the same, the characteristic elements developed periodically on both surfaces may be aligned such that peaks on one surface are directly opposite peaks or recesses on the other surface, or alternately (checkerboard). It is preferred that the characteristic elements are alternately arranged and it is found that the alternating arrangement means are less visually apparent.

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In the figures, similar numbering is given to correspond to the individual parts.

Figures 1a, 1b and 1c illustrate a first embodiment of a preformed, unilamellar, film-like composition of the invention, generally referred to herein as JO. The cross-sectional perspective view of Figure 1b is taken along line lb-1b of Figure 1a. The device 10 has a circuit 12 defined by first and second separated surfaces 14, 16. The device 10 has a non-planar topography on the second surface 16. The non-planar topography comprises a plotted thickened region 18 adjacent to the perimeter 12 and a plotted crest-like region 20 between the perimeter 12 as well as the thinner region 22.

In use, it relates to a substantially planar first surface 14 that will abut the skin, hair or nails of the wearer. However, it would be better and more valuable if both the first and second surfaces 14, 16 were made with a non-planar topography (not shown here). Similarly, a non-planar topography could be performed on the first surface 14 (not shown here). Said composition 10 may be suitable, for example, for delivering a beneficial agent in the skin area under or around the user's mouth.

The composition 10 in Figures 1a, 1b and 1c may be of any suitable size, depending on the intended use and product characteristics. Such a means is shaped approximately to a crescent shape with overall dimensions as defined by theoretical rectangles bounding the shape, the dimensions being 60 mm to 27 mm. This substantially crescent-like shape is curved by the first and second vertices of the proximal first longitudinal side of the theoretical rectangle (not shown here). Said means 10 has dimensions of 13 mm, 17 mm, 20 mm, 23 mm and optionally 21 mm, at angles of 22.5 °, 45 °, 90 °, 135 ° and 157.5 ° from the connection of the transverse center bar (diagonal) of the theoretical rectangle with the first longitudinal side of the theoretical rectangle.

Figure 2 illustrates a second embodiment of a preformed, unilamellar film-like composition according to the first or second aspect of the present invention, generally referred to herein as 110. The composition 110 has a circuit 112 defined by first and second spaced surfaces 114, 116, said composition 110 having a non-planar a topography comprising a contoured thickened flange-shaped region 118 adjacent to the perimeter 112 on the second surface 116 and a thinner region 122, a thicker and thinner region 118, 122, but not having the same mean thickness simultaneously. The flange 118 helps to prevent tearing of the device 110 during handling, and the thinner region 122 acts better when using the " 9 "

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999 9999 99 99 ·· · * »· to the user's skin in areas of greater curvature. It is preferred that at least the thinner region 122 should furthermore a non-planar topography on the second surface 116 comprising a textured surface which has a negative pattern textured surface, wherein the negative appearance of the textured surface having a texture is defined so that the value of the parameter _{R, and} was greater than 10 microns ( not shown here).

Figure 3 illustrates a third embodiment of a device according to the first or second aspect of the present invention, generally referred to herein as 210. Said device 210 has a circuit 212 defined by first and second spaced surfaces 214, 216, said device 210 having a non-planar topography comprising a plotted thickening region. The ridge 222 imparts greater rigidity and flexibility for handling, and the thinner region 222 performs better in use relative to the target surface with greater curvature.

Figure 4 shows a cross-sectional perspective view, a partial view of a fourth embodiment of a preformed, unilamellar, film-like composition according to the first, second or third aspect of the present invention, generally referred to herein as 310. Said composition 310 has first and second spaced surfaces 314, 316. wherein said device 310 has a non-planar topography comprising a plurality of plotted thickened regions in the form of spaced apart ridges 320 lying between the perimeter (not shown here) and plurality of plotted thinner regions 322. As shown, although said composition could alternatively be considered that it could be textured transversely to the ridges, there is no texturing along the length of the ridges. Nevertheless, however, this illustrates a nonplanar topography may also comprise a textured surface, which might be negative the appearance of the textured surface, wherein the texture has been defined so that the value of parameter _{R, and} was greater than 10 microns.

Figure 5 shows a cross-sectional perspective view, a partial view of a second embodiment of a preformed, unilamellar, film-like composition according to the first or third aspect of the present invention, generally referred to herein as 410. Said composition 410 has first and second spaced surfaces 414, 416, the first surface 414 in use adjacent the skin, hair or nails and the second surface 416 has a non-planar topography comprising a textured surface that has the appearance of a negative textured surface wherein texture should be defined so that the value of parameter _{R, and} was greater than 10 microns. The value would be increased if the first and / or second surface 414, 416 could additionally have a non-planar topography to include at least two plotted regions that would not have the same mean thickness (not shown here). It would also increase the value if the first surface 414 could possibly have a 4 * 4 * 4 * 4 * 4 * 4 * 4 * 4 * 4 * 4 * 4 * 4 * 4 * 4 * 4 * 4 * 4 * 4 * 4 * ¹⁴ *. :. :: ··

4 4 4 4 · 4 4 4 • ••••• 44 «4 44 44 · 4 <· non-planar topography containing a textured surface that would be negative to the textured surface, the texture being defined so that the value of R _and was greater than 10 µm (not shown).

Figures 6, 7a and 7b is a schematic view of a fifth embodiment of a preformed unilamellar film-like composition according to the first or second aspect of the present invention, generally referred to herein as 510. The section in Figure 7b is taken along line 7b-7b in Figure 7a. Said means 510 has an irregular circuit 512 defined by first and second spaced surfaces 514,516. Said means 510 has a non-planar topography comprising two contiguous regions, namely a thinner and thickened region 522, 524, which at the same time do not have the same mean thickness. In this embodiment, the non-planar topography is on the second surface 516.

Figures 8 and 9 illustrate a sixth embodiment of a preformed, unilamellar, film-like composition according to the first or second aspect of the present invention, generally referred to herein as 610. The device 610 herein is a mask shaped and sized substantially to cover the face of a user. having first and second spaced surfaces 614, 616, said means 610 having a non-planar topography on the second surface 616 comprising two contiguous areas of drawing, namely a thinner and thickened area 622, 624, which at the same time do not have the same mean thickness. Said means 610 also has openings 626 that are shaped and sized to fit the eyes, nose, and mouth of the wearer. The thicker region 622 is separated at the periphery by adjacent cut-off regions 628. In use, as shown in Figure 8, the thicker regions are separated so that the preformed, unilamellar, film-like masking means 610 substantially covers the face of the user and thus allows delivering at least one beneficial skin agent on the face.

Figures 10 and 11 show a seventh embodiment of a preformed, unilamellar, film-like composition according to the first or second aspect of the present invention, generally referred to herein as 710. The composition 710 herein is a mask shaped and sized substantially to cover the face of a user. The circumferential slits 730 are formed so that their location is adjacent to the periphery 712. The device has a non-planar topography on the second surface 716, the non-planar topography comprising at least two contoured plotted areas, namely a thinner and thickened area 722, 724, medium thickness. The thinner areas 722 adhere to the eye and nose / mouth areas of the wearer in use to provide greater comfort to the wearer. Said composition 710 also comprises:

the slits 732 and the apertures 726, each of which is shaped and sized to fit the nose, mouth, and optionally the eyes of the user. In use, the face portions of the surface of the circumferential slots 730 may be superposed so that said preformed, unilamellar, film-like mask-like means 710 substantially covers the face of the user.

Figure 12 illustrates an eighth embodiment of a device according to the invention, in accordance with a third aspect of the invention, generally referred to herein as 810. The device 810 has a circuit 812 defined by first and second spaced surfaces 814, 816, said device 810 having a non-planar topography including a contoured thickened rim-shaped region 818 adjacent to the periphery 812 on the second surface 816 and a thinner region 822 drawn by thicker and thinner regions 818, 822 but not having the same mean thickness at the same time. Furthermore, he said means for both the first and on the second surface 816. The textured surface 814 that has the appearance of a negative textured surface wherein the textured surface negative pattern texture has been defined to the value of the parameter _{R, and} was greater than 10 microns.

Alternatively, or in addition to the above, the non-optional topography of the composition may be in the form of a patch or mask in the form of a composition designated 10, Π0, 210, 310, 410, 510, 610, 710, 810. ). For example, this symbol may take the form of a trademark, trademark, protected name, a device logo, and / or a series of alphanumeric characters.

Preferably, the non-planar topography is formed by either a textured surface or at least two plotted areas that do not simultaneously have the same mean thickness, or both, on a second surface (distal, in use, relative to the user's skin, hair or nails). More preferably, the non-planar topography is comprised of a textured surface and at least two plotted regions that do not have the same mean thickness or both at the same time (distal, in use, relative to the user's skin, hair or nails), in addition, the non-planar topography is formed by a textured surface which is provided on the first surface of said device.

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Polymeric gel forming agents

An essential component of the preformed, unilamellar, film-like compositions described herein is a composition comprising at least one polymer gel forming agent. Generally, said preformed, unilamellar, film-like compositions of the present invention comprise less than 70% by weight, preferably less than 50% by weight, more preferably less than 30% by weight, and particularly preferably less than 10% by weight of polymeric agent gel, based on the total weight

The at least one polymer gel forming agent may be a naturally occurring substance or prepared synthetically. The at least one polymer gel forming agent may form a gel by itself or may form a gel only in combination with other substances. Alematively, the at least one polymer gel forming agent may be physically or chemically crosslinked.

Polymeric gel forming agents can either form a gel on its own or can form a gel in combination with other substances such as sugar, alcohol, or mono- or multivalent salts. In addition, the mono- or multi-valent salts may act as gel-reinforcing agents and thus impart strength to the preformed, unilamellar, film-like compositions described herein. Suitable cations which may be selected from mono- or multi-valent cations include, for example, those selected from the group consisting of potassium, sodium, ammonium, zinc, aluminum, calcium and magnesium, or mixtures thereof. Suitable anions associated with the above cations include those selected from the group consisting of choride, citrate, sulfate, carbonate and phosphate anions, or mixtures thereof.

Physical cross-linking refers to polymers having cross-links that are not chemical covalent bonds but are of a physical nature such that there are regions of high crystallinity or regions of high glass transition temperature in the composition. Chemical crosslinking refers to polymers that are linked by chemical bonds. Preferably, the polymer is chemically crosslinked by radiation methods such as thermal radiation, ultraviolet radiation, gamma radiation or microwave radiation. In addition, if chemical cross-linking occurs in the system, the polyfunctional cross-linking agent and / or free radical initiator may be present in the premixed mixture to initiate cross-linking by radiation. Such components are preferably present in an amount of up to 5% by weight.

• · · · · · ·

9

The polymer gel forming agents are water soluble or water insoluble. Preferably, the at least one polymer gel forming agent is water-soluble. The polymer gel forming agents may alternatively comprise water-insoluble polymer gel forming agents, further may comprise polymeric gel / silicone (organopolysiloxane resin) forming silicone agents or a block copolymer of a thermoplastic elastomer.

Water-insoluble polymer gel forming agents

Silicones can be described as soluble, hydroxyl-functional organopolysiloxane resins containing a R ₃ SiO _1/2 siloxane unit and S 10 O 4/2 wherein R is a monovalent radical selected from the group of hydrocarbon and halogenated hydrocarbon radicals having 1 to 20 carbon atoms. In the nomenclature R3S1O1 / 2 and S1O4 / 2, 1/2 and 4/2 mean the number of half-bonds shown in the molecule. For example, in R ₃ SiO _1/2 , the 1/2 bond is bound to one oxygen atom and the other half of the bond is bound to another atom. This group can also be described in this manner

R - Si - O -

Similarly, SiO 4/2 has shown four 1/2 bonds in a molecule, with the other half of each bond being bound to some other molecule. This group can also be described in this way - Si-O - ········

The term "soluble resin" as used herein means that the gellable organopolysiloxane can be dissolved substantially completely, either in a hydrocarbon liquid such as benzene, toluene, xylene, heptane and the like, or in a silicone liquid such as cyclic or linear polydiorganoosiloxanes. Preferably, the resin is soluble in a silicone fluid.

In the formula for a silicone resin, R is a monovalent radical selected from the group consisting of hydrocarbon and halohydrocarbon radicals, preferably having less than 20 carbon atoms, and most preferably having 1 to 10 carbon atoms. Suitable R radicals include, for example, those selected from the group consisting of alkyl radicals such as methyl, ethyl, propyl, pentyl, octyl, undecyl, octadecyl and others; cycloaliphatic radicals such as phenyl, tolyl, xylyl, benzyl, alpha-methylstyryl, 2-phenylethyl and others; alkenyl radicals such as vinyl; and chlorinated hydrocarbon radicals such as 3-chloropropyl, dichlorophenyl and others.

To achieve the solubility of the silicone resin in the silicone fluid, it is desirable to select such predominant organic silicone resin radicals to match the predominant organic silicone liquid radicals. Preferably, at least every third and more preferably, substantially all of the R radicals in the silicone resin formula are methyl radicals. Preferred include, for example, R ₃ SiO _1/2 siloxane units including Me ₃ SiO _1/2 and PhMe ₂ SiO _1/2 and Ph ₂ MeSiO _1/2 wherein Me is methyl and Ph is phenyl.

It is preferred that the molar ratio R _{3 of} SiO _1/2 siloxane units to SiO _4/2 units is 0.5 or even 1.2. It is further preferred that the molar ratio of all R ₃ SiO ₂ / siloxane units to SiO _4/2 units is 0.6 to 0.8.

The silicone resin can be prepared by well known methods. It is preferred to prepare by the hydrosol capping process of US-A-2,676,182 (Daudt et al.) As well as modified according to US-A-3,627,851 (Brady) and US-A-3,772,247 (Flannigan). ; each patent is incorporated herein by reference to show how soluble oragnopolysiloxanes can be prepared which are useful for a preformed, unilamellar, film-like composition of the invention. The resulting resin can be used without further modification or can be capped with trialkylsilyl groups to reduce the silanol content. This can be done by well known methods, such as reacting such a resin with a compound such as trimethylchlosilane or hexamethyldisilanzane.

• · · · · · · · · · · · · · · · · · · · ·

The silicone fluid is preferably a hydroxyl-terminated diorganopolysiloxane polymer. Repeating units of such silicone fluids are R ₂ SiO _2/2 siloxy units wherein R is independently selected from the same hydrocarbon and halogenated radicals as defined above for the silicone resin. Generally, these silicone fluids may comprise the polymer or copolymer alone or may be a blend of two or more such polymers. The silicone fluid may be a liquid or resin in a liquid state at 25 ° C. It is preferred that at least 50% and preferably at least 85% of the organic radicals along the silicone fluid chain are methyl radicals which can be distributed in any manner in the silicone fluid. Further, the silicone fluid may contain up to 10 mol% of siloxane branched sites.

Silicone resins are preferably used in amounts of 40 parts by weight to 70 parts by weight in said preformed unilamellar film-like composition, and the silicone fluid is used in amounts of 30 parts by weight to 60 parts by weight, the total sum of all parts of silicone resin and liquid being 100 parts. Usually, it is preferred that the silicone resin is used in an amount of 50 parts by weight to 60 parts by weight, and accordingly the silicone liquid is used in an amount of 40 parts by weight to 50 parts by weight, the total sum of all parts being 100. and the silicone fluid may be mixed together or condensed together to form a preformed, unilamellar, film-like composition. Methods of condensing silicone resin and silicone fluid are well known in the art.

Another preferred group of silicone resins consists of a mixture of trimethylsilyl groups of end-blocked polysilicate resins, such as a silicone resin consisting of a water-soluble resin copolymer containing silicone-bonded hydroxyl radicals and consisting essentially of triorganosiloxy units of the general formula R 6 SiO 2, - and tetrafunctional units SiO _4/2 in a ratio of 0.6 to 0.9 triorganosiloxy units for each tetrafunctional siloxyl unit present in the copolymers, wherein R ¹ is a monovalent organic radical selected from hydrocarbon radicals having 1 to 6 carbon atoms; and silanol-terminated polydiorganosiloxane fluids such as polydimethylsiloxane liquid. US-A-2,736,721 to Dexter et al., And US-A-2,814,601 to Curie et al., Which are also incorporated herein by reference, disclose such or similar resins.

Μ ·· ·· · · · · ····

Another preferred group are those disclosed in US-A-2,857,356, Goodwin, Jr., which is incorporated herein by reference, or resins similar to those disclosed by Goodwin. US-A-2 857 356 discloses a silicone consisting of a mixture of components comprising (i) the hydrolyzed products of a trialkyl hydrolysable silane and an alkyl silicate, the latter containing a large amount of silicone-bonded hydroxyl groups; and (ii) a linear, highly viscous organopolysiloxane liquid that contains hydroxyl-bonded silicone groups.

Said silicone resin (i) and silicone fluid (ii) may optionally be condensed with each other according to the method described for example in CA-A-711 756, Pail, which patent is incorporated herein by reference. In this condensation reaction, the silicone resin (i) and the silicone fluid (ii) are mixed together in the presence of a catalytic amount of a silanol condensation catalyst, and thereafter said silicone resin (i) and said silicone fluid (ii) are condensed , for example by heating under reflux for 1 to 20 hours. Examples of silanol condensation catalysts include primary, secondary and tertiary amines, carboxylic acids of these amines, and quaternary ammonium salts.

Another group consists of the compositions described in US-A-4,591,622 and 4,584,355 to Blizzard et al., US-A-4,585,836 to Homan et al., And US-A-4,655,767 to Woodard et al. et al., incorporated herein by reference. In general, these compositions consist of mixtures of (i) silicone resins and (ii) silicone fluids that are chemically treated to reduce the content of the silicone-linked hydroxyl groups in the mixture. These can then optionally be condensed, as previously described, prior to chemical treatment.

Silicone polymer gel forming agents may not be confused with silicone rubbers that are not useful in these applications herein. Silicone polymer gel forming agents usually do not contain fillers or contain only small amounts (less than 5% by weight) of fillers. In contrast, silicone rubbers typically contain from 15% to 35% by weight of fillers. Fillers are generally not required in high amounts in silicone polymer gel forming agents, as these high amounts often result in a loss of tack and adhesion and an increase in dynamic viscosity for silicone polymer gel forming agents, making it more difficult to apply and apply silicone polymer gel forming agents.

4 4

4 • ·

4 ·· 4 ·

Other additional classes of suitable silicone polymer gel forming agents are those described in FR-A-2 735 024 and EP-A-0 764 441, which are incorporated herein by reference.

Other alternative water-insoluble polymer gel forming agents may be block copolymer thermoplastic elastomers such as ABA block copolymers such as styrene-olefin-styrene block copolymers or ethylene-propylene block copolymers. More preferred are those polymers that comprise the hydrogenated Styrene / Ethylene-Butylene / Styrene (SEBS), Styrene / Isoprene / Styrene (SIS) and Styrene / Ethylene-Propylene / Styrene (SEPS) grades.

Water-soluble polymer gel forming agents

The water-soluble polymer gel forming agents for use in the present invention are selected from synthetic or naturally occurring polymers and mixtures thereof. Generally, preformed, unilamellar, film-like compositions of the present invention contain less than 50% by weight, more preferably less than 30% by weight, and particularly preferably less than 20% by weight of the total weight of the water-soluble polymer gel forming agents.

Synthetic polymers

Suitable synthetic polymers for use herein include nonionic water-soluble polymers; acrylic acid polymers or derivatives thereof; or cellulose derivatives; and mixtures thereof. Synthetic polymers suitable for use herein may be categorized according to their charge or constituting monomers. However, it is understood that the classification made here serves a certain convention and goes beyond individual categories.

Non-ionic water-soluble polymers

Suitable nonionic water-soluble polymers for use herein include polydimethylacrylamide, polyvinylpyrrolidones, polyethylene glycol monomethacrylate, poly-2-ethyl-2-oxazoline, polyvinyl alcohol, polyethylene oxide, polyvinyl ethers, polyvinyl ether copolymers and polyvinylpyrrolidinone and their derivatives, methylvinylpyrrolidine and their derivatives, and their ·· ·· • · · ·· * • · ·

9999 mixture. The non-crosslinked polymers contain repeating units which are derived from vinyl alcohols, vinyl ethers and copolymers thereof, carboxyvinyl monomers, vinyl ester monomers, carboxyvinyl monomer esters, vinylamide monomers, hydroxyvinyl monomers, amine-containing cationic vinyl monomers, or amine-containing N-quaternary monomers and sulfonated polymers such as acrylamide sulfonated polymers and mixtures thereof. Alternatively, the uncrosslinked polymer may be a homopolymer or a copolymer of polyvinyl ether, or a copolymer derived from a half ester of a maleic ester. Similarly, any other compatible polymer units can be used as copolymers such as polyvinyl alcohol or ethylene and vinyl acetate.

Polymers based on acrylic acid or derivatives thereof

Suitable acrylic acid-based polymers or derivatives thereof include polymers of acrylic acid, methoxydiethoxyethyl methyl acrylate and hydroxydiethoxyethyl methacrylate; polyacrylic acid salts such as ammonium polyacrylate and sodium polyacrylate; polymers of 2-acrylamido-2-methylpropanesulfonic acid or its salts (AMPS); copolymers of acrylamide and Ν, Ν'-methylenebisacrylamide, or mixtures thereof.

Other polymers suitable for use herein include copolymers based on 2-hydroxyethyl methacrylate ("HEMA"), including copolymer "HEMA" and one or more comonomers as described in US-A-5 804 107 , paragraph 14, lines 36 to 67, and further paragraph 15, lines 1 to 34, which is incorporated herein by reference.

Cellulose derivatives

Cellulose derivatives suitable for use herein include, for example, carboxymethylhydroxyethylcellulose, carboxymethylcellulose, sodium carboxymethylcellulose, cellulose acetate propionate carboxylate, hydroxyethylcellulose, hydroxyethylethylcellulose, hydroxypropylcellulose, methylcellulose, sodium methylmethylcellulose, hydroxypropylmethylcellulose, hydroxypropylmethylcellulose, hydroxypropylmethylcellulose, and mixtures thereof. Alkyl substituted celluloses are also suitable for use herein. In these polymers, the hydroxyl groups of the cellulosic polymer are hydroxyalkylated (preferably hydroxyethylated or hydroxypropylated) to form hydroxyalkylated cellulose, which is then further modified with an alkyl group having an alkyl group having a φφ φφφφ φφ φφ φ φφφφφ

ΦΦ · • * · • • • • • • • φ φ φ φ φ φ φ φ φ · φ φ φ φ

C10-C30 straight or branched chain connected via ether. Typically, these polymers are straight or branched chain alkyl esters of C ₁₀ -C ₃₀ hydroxyalkyl celluloses. Alkyl groups useful for use herein include, for example, those selected from the group consisting of stearyl, isostearyl, layl, myristyl, cetyl, isocetyl, cocoyl (i.e., alkyl groups derived from coconut alcohols), pamityl, oleyl, linoleyl, ricinoleyl, behenyl and mixtures thereof. A preferred substance of the alkylhydroxyalkylcellulose ethers is the CTFA designated cetylhydroxyethylcellulose, which is cetyl alcohol ether and hydroxyethylcellulose. This substance is sold under the trade name Natrosol® CS Plus by Aqualon Corporation.

Naturally occurring polymers

Naturally occurring polymers suitable for use herein include gelatin, polysaccharides, and mixtures thereof. The polysaccharides suitable for use herein are preferably selected from the group consisting of red seaweed polysaccharides; glucomannans; galactomannans; fermentation polysaccharides, or derivatives thereof; brown seaweed polysaccharides; extracts of marine invertebrates; starches, or derivatives thereof; natural fruit extracts; vegetable fiber derivatives; natural plant exudates; resin vegetable gums; and mixtures thereof. Where the compositions herein comprise one or more polysaccharides as water-soluble polymer gel forming agent (s), these compositions comprise less than 10% by weight, preferably less than 5% by weight, and more preferably less than 3% by weight of the total dry weight of this saccharide or a mixture of saccharides.

Gelatine

When gelatin is used in the compositions of the present invention, high molecular weight gelatin is combined with low molecular weight gelatin to control or control solubility. Low molecular weight gelatin, having a molecular weight of 20,000 or less, is weak to be able to gel.

Brown seaweed polysaccharides

Polysaccharides, which are classified as brown seaweed polysaccharides, are isolated by extraction from a variety of Phaebophyceae species.

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9 9 9 9 9 9 9 9 9 9 · 9 · 9 9 9

999 99 99 99 99 99 999

Brown seaweed polysaccharides suitable for use herein include those selected from the group consisting of algin, alginic acid, ammonium alginate, calcium alginate, potassium alginate, sodium alginate, propylene glycol alginate, and mixtures thereof.

Red seaweed polysaccharides

Polysaccharides, which are classified as red seaweed polysaccharides, are isolated from marine plant species belonging to the Rhodophyceae class. Red seaweed polysaccharides provide mechanical strength to the water gel. Red seaweed polysaccharides suitable for use herein include those selected from the group consisting of agar known in the industry under (CTFA) trade designation as agar slices derived from a variety of gelidium plant species or very close to red algae that are commercially available as "Agar Agar 100" or "Agara 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 contained in the lambda-, iota-, and kappa- fractions, which are aqueous extracts, obtained from a variety of members of the genus Gigartinaeceae or Solieriaceae, known in the industry under the trade name (CTFA) commercially available as chodrus, commercially available as "Gelcarin® LA "," Seakem® 3 / LCM ", or" Viscarin® XLV ", all from FCM (Philadelphia, PA, USA); and furcellaran available from Gum Technology Corporation (Tucson, Arizona, USA) and Continental Colloids Inc. (Chicago, IL, USA) or mixtures thereof. Preferably, the red seaweed polysaccharides are selected from the group consisting of agar, agarose, kappa-carrageenan and furcellaran, or mixtures thereof.

Glukomannan

Glucomannans are polysaccharides that contain a backbone linear chain of glucose and mannose residues. Glocomannans have short side branches attached to a linear backbone and acetyl groups are randomly presented at the C-6 positions of the sugar unit. Acetyl groups are generally found in a number of one group per six sugar units to one group per twenty sugar units. Suitable glucomannanates or derivatives thereof for use herein have a mannose to glucose ratio of 0.2 to 3. Among the preferred glucomannanates for fc fcfc fcfc fcfc fcfc fcfc fcfc The uses disclosed herein include, for example, Konjac Mannan, which is a generic term for powder, obtained by crushing the roots of Amorphophallus konjac (sweet potato) roots, and is commercially available under the trade name "Nutricol". ® from FMC (Philadelphia, PA, USA); and deacetylated konjac mannan; or mixtures thereof.

Galaktomannan

Galactomannans are plant storage polysaccharides that occur in the endosperm of many Leguminosae seed cells. The collective name 'galactomannan' encompasses all polysaccharides that are built up of galactose and mannose residues. Galactomannans contain a linear backbone of (1,4) -linked β-D-mannopyranosyl units. Isolated galactopyranose residues are attached to these rings by α- (1,6) -glucoside bonds. The galactomannans may furthermore also contain small amounts of other sugar residues. Preferred galactomannans for use herein include those selected from the group consisting of gelatin of fenugreek; lucerne; Clover; locust bean gelatin, known for example in the industry under the (CTFA) trade name as corn bean gelatin, available as "Seagul L from FMC (Philadelphia, PA, USA); tara gelatin available from Starlight Products (Rouen, France) or guar gum derived from the base endosperm of Cyamopsis tetragonolobus, available as "Burtonite V7E from TIC Gums (Belcamp, MD, USA)," Jaguar C "from Rhone-Poulenc (Marietta, GA, USA) or "Supercol" from Aqualon (Wilmington, DE, USA); and cassia gums available from Starlight Products (Rouen, France), or mixtures thereof. Preferably, the galactomannans for use herein have on average one for each 1 to 5 mannosyl units of a substituted (1,6) -linked-αD-galactopyranosyl unit and are selected from the group consisting of guar gum, locust bean gelatin and cassia gum or mixtures thereof.

Fermentation polysaccharides or derivatives thereof

Fermentation polysaccharides are polysaccharides that are commercially produced by fermentation of microorganisms in an environment containing a carbon and nitrogen source, a buffering agent, and trace elements. Suitable fermentation of polysaccharides or derivatives thereof suitable for use in the present invention include gelatin gum known in the industry under (CTFA) trade name as gum gellan, wherein the high molecular weight polysaccharide gelatin is a high molecular weight polysaccharide. 4 4

4 4 · 4444 44 4 • 4444 444

444 4444 44 44 44 4444 produced by fermentation of a pure carbohydrate culture with Pseudomonas elodea, and commercially available as "Kelcogel" from Kelco (San Diego, CA, USA); xanthan, a high molecular weight polysaccharide gelatin produced by fermentation of a pure carbohydrate culture with Xanthomonas campestris, known in the industry under the trade name ("CTFA") as "Keltrol CG 1000 / BT / F / GM / RD / SF / T / TF" Calgon (Pittsburg, PA, USA), or "Kelzan" from Kelco (San Diego, CA, USA); natto gelatin; pullulan; rhamsan gelatin; curdlan; succinoglyka; welan gelatine; 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 (Montreil, France), or mixtures thereof. Preferred fermentation polysaccharides or derivatives thereof suitable for use in the present invention include gelatin gum and xanthan, or mixtures thereof. The most preferred fermentation polysaccharide or derivatives thereof is xanthan.

Extracts from marine invertebrates

Polysaccharides derived from marine invertebrates, in particular from the exoskeleton of such marine invertebrates, mainly consist of N-acetyl D-glucosamine residues. Such polysaccharides suitable for use herein include, for example, chitosan, available as "Marien Dew" from Ajinomoto (Teakneck, NJ, USA); and hydroxypropyl chitosan, available, for example, as "HPCH Liquid" from Ichimaru Pharcos (Yamagata Gun Gifu-Pref, Japan) and derivatives thereof; or mixtures thereof.

Starches or their derivatives

V _t

Starches are polysaccharides that consist of multiple proportions of two glucose polymers, amylose and amylopectin. Suitable materials for use herein include starch; amylopectin; and dextrin, commercially available as "Nadex 360" from National Starch (Bridgewater, NJ, USA) and derivatives thereof; or mixtures thereof.

Natural fruit extracts

Suitable natural fruit extracts suitable for use herein include, for example, pectin; and Arabic gelatin; or mixtures thereof.

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Derivatives of vegetable fibers

An example of a suitable plant fiber derivative for use herein is cellulose.

Natural plant exudates

Polysaccharides obtained from natural plant exudates suitable for use herein include karaya gelatin, tragacanth, arabic gelatin, tamarind gelatin, and ghatty gums, or mixtures thereof.

Resin plant gums

Suitable resin vegetable gums suitable for use herein include, for example, shellac, which is obtained from Laccifcr (Tachardia) lacccr resin insect excreta, damar gum; zopal resins and natural rosin resins; or mixtures thereof.

The preformed, unilamellar, film-like compositions herein herein preferably comprise a mixture of water-soluble polymer gel forming agents. Such a blend may be selected from one or more nonionic water-soluble polymers; one or more acrylic acid-based polymers or derivatives thereof; one or more polysaccharides; and mixtures thereof. For example, a preferred mixture of water-soluble gel forming agents may comprise a polysaccharide and a non-ionic water-soluble polymer or, alternatively, may comprise two polysaccharides. More preferably, the water-soluble gel forming agent is a mixture of polysaccharides, wherein the mixture of polysaccharides comprises (1) at least one red seaweed polysaccharide; brown seaweed polysaccharide; or mixtures thereof; and (2) at least one fermentation polysaccharide; galactomannan; glucomannan; natural plant exudate; natural fruit extract; and derivatives or mixtures thereof. Even more preferably, the water-soluble gel forming agent for the compositions of the present invention is a mixture of polysaccharides, wherein the mixture of polysaccharides comprises (1) at least one red seaweed polysaccharide; a 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4

4444 4444 44 94 44 4444 (2) at least one fermentation polysaeharide; glucomannan; or galactomannan; and derivatives or mixtures thereof.

In a preferred embodiment, the water-soluble gel forming agent of the present invention is a mixture of polysaccharides, the mixture comprising a red seaweed polysaeharide and glucomannan or galactomannan. Without wishing to be bound by or in any way limited by theory, it is likely that incorporation of glucomannan or galactomannan in such a polysaccharide composition may contribute to the mechanical strength of the preformed, unilamellar, film-like compositions of the present invention by supplementing the red seaweed polysaccharides herein.

Further, in order to provide improved mechanical properties and, preferably, a low level of syneresis in the preformed, unilamellar film-like composition of the present invention, it is preferred that the ratio of red seaweed polysaccharides to glucomannan or galactomannan in the polysaccharide mixture is 20; 1 to 1: 5, and more preferably 5: 1 to 1: 2.

When the gel-forming agents are water-soluble of natural origin, all such gels always undergo synergies, as defined herein, to some degree. Syneresis provides a mechanism for delivering a beneficial agent to a selected target surface. The liquid layer exudes to the surface of the coherent gel phase, which is readily available for diffusion and thus affects the wear time of the composition. For said preformed, unilamellar, film-like compositions of the present invention, it is desirable to have a low level of syneresis, and preferably the compositions herein are wet to the touch. However, excessive amounts due to syneresis are not suitable and effective and make the product unattractive.

Applicants have also found that, in order to achieve a gel having desirable mechanical properties in terms of strength and elasticity, it is desirable to combine gel-forming polysaccharide agents selected for their strength with agents that contribute to impart a plasticizing effect, wherein: it is possible to keep the total amount of polysaccharide gel forming agents as low as possible without compromising mechanical strength and elasticity. It is likely that a low total amount of polysaccharides aids in open gel structure, so that other components of the original gel are not too tightly bound in the gel within the gel network and are thus freely available for diffusion.

In the preformed, unilamellar, film-like compositions herein, it is preferred that they exhibit a low level of syneresis and are wet to the touch. As mentioned above, the gel-containing composition will always undergo some synergy to some extent, but if applied to an excessive extent, the effects of the product will be reduced and the product will become unattractive. .

Water

In a preferred embodiment of the present invention, wherein the at least one water-soluble gel forming agent, said preformed, unilamellar, film-like compositions of the present invention comprises water. The total water content, if present, in said preformed unilamellar film-like composition of the invention is 20% to 99.5% by weight, preferably 30% to 95% by weight, more preferably 40% to 85% by weight of the device.

Substrate

The preformed, unilamellar, film-like compositions of the present invention are self-supporting and do not require reinforcement or reinforcement with an occlusive or non-occlusive backing material, often referred to as a substrate. However, if such a substrate is present, it may be combined with said preformed, unilamellar, film-like compositions and thus confer additional support or strength to them. Preferably, such a substrate is non-occlusive. In addition, the substrate is particularly useful when the composition of the invention has a large surface area. When a substrate is used to enhance further support or strength, such a substrate is reasonably compatible with the composition of the invention so that it does not break into layers.

A wide variety of materials can be used as a substrate. The following properties are desirable: (i) adequate strength under humidity ph usage, (ii) adequate flexibility, (iii) adequate porosity, (iv) adequate hydrophilicity so that the gel composition can diffuse and infiltrate into the substrate, (v) measured compatibility with mixtures having a preventive effect on the possibility of grafting into layers; (vi) adequate transparency or translucence; and (vii) reasonable size.

β ·

Alternatively, the substrate may be used as a texturing surface. When the substrate is used as a texturing surface, the substrate can then be readily cleaved from the composition.

Examples of suitable substrates meeting one or more of the above criteria and useful herein include, for example, woven and nonwoven fabrics; polymeric film materials such as shaped films; and paper substrates.

Permeable agents

As an essential ingredient of the present invention, the preformed, unilamellar, film-like compositions herein comprise a safe and effective amount of at least one beneficial agent. The term "beneficial agent" as used herein refers to an active ingredient that provides the cosmetic and / or therapeutic effect of the area to which it is applied. Included in this definition are beneficial agents, which are listed herein by category, such as vitamins and wetting agents.

The term "safe and effective amount" as used herein means an amount of a beneficial agent that is high enough to modify the conditions for treating the skin or imparting the desired effect to the skin, hair, or nails, but low enough Avoid serious adverse side effects, while maintaining a reasonable risk in terms of medical judgment. What can be considered a safe and effective amount of a beneficial agent is highly dependent on the specific agent, the ability of the agent to penetrate through the skin or into the skin, hair and / or nails, the age of the user, his condition, the skin, hair or nails of the user and other factors.

Beneficial agents also include pharmaceutically acceptable salts thereof, and the term "pharmaceutically acceptable salts" refers to any generally used salts that are suitable for use in contact with human tissue without exhibiting any undesirable and excessive toxicity, irritation, incompatibility, instability, allergic response and the like.

• * • · · · ·

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4444 4444 44 44 44 4444

In general, said preformed unilamellar film-like compositions of the present invention comprise from 0.01% to 60% by weight, preferably from 0.05% to 30% by weight, and most preferably from 0.1% to 20% by weight of said composition of at least one or a mixture thereof.

Beneficial agents can be categorized according to their cosmetic or therapeutic effect or their postulated mode of action. However, it is understood that these beneficial agents may, in certain circumstances, provide more than one cosmetic or therapeutic effect, or exert more than one mode of action. Therefore, the classification herein is also made for the purposes herein, but is not intended to limit or restrict certain application lists. The following beneficial agents are useful for the preformed, unilamellar, film-like compositions herein.

Agents active against acne

Agents active against acne can be effective in the treatment and prevention of acne vulgaris, a chronic disorder of the hair follicles and sebaceous glands. These conditions are characterized by inflammation of the hair follicles and sebaceous glands and the result is skin damage, such as small pimples, blisters, cysts, comedones, pimples, and sometimes severe scarring. Corynebacterium acnes and Staphylococcus epidermis are usually present in these ulcer areas. Useful anti-acne agents include, for example, keratolytics as described in WO98 / 18444, which is incorporated herein by reference. Other useful anti-acne agents include retinoids such as retinoic acid (e.g., cis and / or trans) and derivatives thereof (e.g., esters); retinol and its esters (e.g. retinyl propionate, retinyl acetate); abietic acid, adapalene, tazarotene, allantoin, zaloe extracts, arbietic acid and its salts, ASEBIOL (from Laboratories Serobiologiques, Somerville, NJ), azaleic acid, barberry extracts, belamcanda chinesis, benzoquinolines, benzoylperoxide, berberine, berberine, berberine Brooklyn, NY), bioflavonoids as a class, bisabolol, sec. Carboxymethyl, cysteine, carrot extracts, cassia oil, colt oil, citral, citronellal, climazole, COMPLETECH MBAC-OS (from Lipo, Paterson, NJ), CREMOGEN M82 (from Dragoco, Totowa, NJ), cucumber extracts, dehydroacetic acid and its salts, dehydroepiandrosterone and its sulphate derivatives, dihydrophenylimidazole dioxolane, d, l-valine and its esters, DMDM hyndantoin, erythromycin, escinol, ethylhexyl monoglycerylether, ethyl-2-ethyl acetate, 2-ethyl acetate Famesol, famesyl acetate, geraniol, geranylgeraniol, glabridin, gluconic acid, gluconolactone, glycine eryl monocapinate, glycolic acid, grapefruit seed extract, gugu lipid, HEDERAGENIN (from Maruzen, Morristown, NJ), hesperitin, hinokitol, hop extracts, hydrogenated rosin, natural resin, 10-hydroxydecanoic acid, ichtyol, interleukin 1 alpha, KAPILARINR (from Greentech, Saint Beauzire, France), ketoconazole, lactic acid, East Indian grass oil, LOCHOCHALCONE LR15 (from Maruzen, Morristown, NJ), linoleic acid, LIPACEDE C8CO (from Seppic, Paris, Fracie), lovastatin, acid 4 -methoxysalicylic, metronodazole, minocycline, mucurossi, oil seed oil, niacinamide, nicotinic acid and its esters, nisin, panthenol, 1-pentadecanol, peonium extract, peppermint extract, phelladendron extract, derivatives

2-phenylbenzothiophene, floretine, PHLOROGINE (from Secma, Pontrieux, France), phosphatidylcholine, proteolytic enzymes, quercetin, red sandalwood extract, rosemary extract, rutin, sage extract, salicin, salicylic acid, sisib extract lomicamene, silicol, sodium laulyl sulphate, sodium sulphoacetamide, SOPHORA EXTRACT (from Maruzen, Morristown, NJ), sorbic acid, sulfur, sunder extract, oily oil extract, tetrahydroabietic acid, threonine, thyme extract, thyme extract , tocopherol and its esters, trehalose 6-undecylenoate, 3-tridecen-2-ol, triclosan, troplolone, UNITRIENOL T27 (from Unichem, Chicago, IL), vitamin D ₃ and its analogues, white thyme oil, willow extract, wogonin, ylang ylang, zinc glycerolate, zinc linoleate, zinc oxide, zinc pyrithione, zinc sulfate, zwitterionic surfactants (e.g. cetyldimethylbeta) in) and mixtures thereof.

Emollients

Emollients useful herein include, for example, mineral oil, petrolatum, C 7 -C 40 branched hydrocarbons, C 1 -C ₃₀ alcohol esters of C ₁ -C ₃₀ carboxylic acids, C ₁ -C ₃₀ alcohol esters of C ₂ -C ₃₀ dicarboxylic acids, monoglycerides of C _r C ₃₀ carboxylic acids, diglycerides of _Cl-C30 carboxylic acids, triglycerides of _Ci-C30 carboxylic acids, ethylenglykolmonoestery _Ci-C30 carboxylic acids, ethylenglykoldiesteiy -C ₃₀ carboxylic acids, propylene C _r C ₃₀ carboxylic acids, as well as propylene glycol diesters of C-C ₃ of the carboxylic acid , C 1 -C ₃₀ monoesters of carboxylic acids, and sugar polyesters, for example, sepha cottonate (sucrose polyvalve oil), polyalkyl alkyl siloxanes, polydiarylsiloxanes, polyalkaryl siloxanes, cyclomethicones having 3 to 9 silicon atoms, vegetable oils and hydrogenated vegetable oils, C4-C20 alkylene glycol -C ₂₀ alkyl ethers, and mixtures thereof si. These reagents are described in more detail in WO 98/18444, which is incorporated herein by reference. These agents are described in more detail in WO 98/18444.

Non-steroidal anti-inflammatory active substances (NSAIDS)

Examples of suitable NSAIDS and their esters for use herein are described in WO98 / 18444, which is incorporated herein by reference. Further, suitable examples include, but are not limited to, those selected from the group consisting of non-steroidal anti-inflammatory actives (NSAIDS), including flufenamic acid; panthenols and ethers and derivatives thereof, for example ethyl ether panthenol, panthenyl triacetate; pantothenic acid and its derivatives, salts and esters thereof, especially calcium pantothenate; aloe vera, bisabolol; alantoin, and compounds from liquorice plants (plant species / genus Glycyrrhiza glabra), including glycyrrhetic acid, glycyrrhizinic acid and derivatives thereof and, for example, salts such as ammonium glycyrrhizinate and their esters such as stearyl glycyrrhetinate.

Local anesthetics

Suitable topical anesthetics for use herein include, for example, benzocaine and bupivacaine. Other other suitable examples are described in WO98 / 18444, which is incorporated herein by reference.

Artificial tanning agents and tanning accelerators

Artificial tanning and accelerating tanning agents may assist in simulating natural sunburn by increasing melanin in the skin or assisting in the appearance of an increased melanin content in the skin. Examples of such tanned skin formers and tanned skin accelerators include, but are not limited to, glucose tyrosinate and acetyityrosine, braziline, caffeine, caffeine extracts, DNA fragments, and isobutylmethylxanthine, methylxanthine, PHOTOTAN (from Laboratories Serobiologiques Somerville, NJ), prostraglandins, tea extracts, theophylline, UNIPERTAN P2002 and UNIPERTAN P27 (from Unichem, Chocago, IL); and mixtures thereof. Other useful artificial means of acting «

Tanned appearance and tanned appearance accelerators for use herein are disclosed in WO98 / 18444, which is incorporated herein by reference.

Antiseptics

Suitable antiseptics for use herein include, for example, alcohols, benzoates, sorbic acid, and mixtures thereof.

Antimicrobial and antifungal active substances

Antimicrobial and antifungal active substances can effectively act to prevent the growth and growth of bacteria and fungi. Examples of such compounds include, but are not limited to, those selected from the group consisting of ketoconazole, cyclopirox, benzoyl peroxide, tetracycline, azelaic acid and derivatives thereof, ethyl acetate, allantolactone, isoalantolactone, alkanet extract (alaninine), anise, arnica extract (helenalin acetate and 11,13-dihydrohelenalin), aspidium extract (chlorine, lucinol containing extract), barberry extract (berberin chloride), laurel sweet extract, laurel berry extract (myricitrin), benzalkonium chloride, benzethonium chloride and its salts, benzoin, benzyl alcohol, benedict extract, tuber bletilla extract, root vegetable tuber extract, rose oil, burdock extract, butylparaben, cade oil, CAE (from Ajinomoto, Teaneck, NJ), oil extract from tea tree, cangzhu, cumin oil, cascarilla bark (sold under the trade name ESSENTIAL OH), silos cedar leaves, chamomile, evergreen shrub extracts, chlorphenisin, chlorxylenol, cinnamon oil, clove oil, dehydroacetic acid and its salts, dill seed oil, DOWICIL 200 (from Dow Chemical, Midland, MI), echinacea, elenolic acid , epimedium, ethylparaben, FO-TI, galbanum (galvanic locust bean gum), toten borer, GERMALL 115 and GERMALL II (from ISP-Sutton Labs, Wayne, NJ), German camomile essential oil, gigantic linen GLYDANT and GLYDANT PLUS from Lonza, Fairlawn, NJ), grapefruit seed essential oil, haxamidine diisethionate, hinokitiol, honey, honeysuckle flowers, hops extract, immortelle, iodopropylbutylcarbamide (available from Lonza, Fairlawn, NJ), isobutylparaben, from JM ACTICAREting International (JM ACTICAREting) , UK), juniper berries, KATHON CG (from Rohm and Haas, Philadelphia, PA, USA), labdanum, lavender, lemon balsamic essential oil, green lemongrass, methylpara ben, mint, mume, mustard, myrrh, neem seed oil, o-phenylalcohol, OLIVE LEAF EXTRACT (from Bio Botanica, Haupauge, NY), parsley, patchouli essential oil, root 9 9 9 9 999 9 peonies, PHENONIP (from Nipa Labs, Wilmington, DE), phytosphingosine, pine needles essential oil, plansERVATIVE (from Campo Research, Raffles Quay, Singapore), propylparaben, purslane, portula, quillaira, rhubarb, pink essential oil, spelargonium essential oil, rosemary, sage, salicylic acid, sassafras, garden savory, wood marigold, lovage, sodium metabisulfite , SOPHOLIANCE (from Soliance, Compiegne, France), sorbic acid and its salts, sphingosina, stevia, witch hazel, ambergris, rasamala, starax, tarax balsam, tannin, tannic acid, tea tree, tea tree, thyme, thyme, triclos , triclokarban, tropolone, turpentine, umbelliferone (antifungal) and yucca or mixtures thereof. Further examples of antimicrobial and antifungal active agents useful for the purposes herein are disclosed in WO98 / 1844, which is incorporated herein by reference.

Agents having a cooling soothing effect on the skin

Agents having a cooling soothing effect on the skin, may act to prevent or treat inflammation of the skin. These agents improve the appearance of the skin by enhancing the beneficial effects of the present invention, since, for example, they contribute to make the skin more uniform, have a more uniform surface, and have an adequate color tone. Examples of such substances include, but are not limited to, those selected from the group consisting of wormwood, acacia, black locust, aescin, alder extract, allantoin, aloe (from Centerchem, Stamford, CT). , arnica, goat-goat root, azulene, BAICALIN SR 15 (from Bamet Products Dist., Engelwood, NJ), biscuit, baizhu, Canadian balm, bee pollen, BIOPHYTEX (from Laboratories Serobiologiques, Somerville, NJ), bisabolol , black cohosh, black cohosh extract, blue cohosh, blue cohosh extract, boneset, borage, borage essential oil, borage seed oil, bromelain, marigold, marigold extract, CANADIAN WILLOWBARK EXTRACT (by Fytokem), candelilla wax, cangzhu, canola phytosterols, pepper, carboxypeptidase, celery seeds, celery stalk extract, CENTAURIUM (from Sederma, Brooklyn, NY), Centaurea plant extract, cornflower, rost Centaurium lineage, chamazulen, chamomile, chamomile extract, chickweed, chicory root, chicory extract, chirata, chishao, colloidal oatmeal or oat flour, comfrey, comfrey extract, Cippany CM GLUCAN ), darutoside, angelica cannons, DEVII / S CLAW (from MMP Plainfield, NJ), divalent metals (such as magnesium, strontium, manganese), ryegrass, bloody dogwood, EASHAVE (from Pentapharm, Basel, Switzerland), eleuterophyll plants, ELHIBIN (from Pentapharm, Basel Switzerland), ENTELINE 2 (from Secma, Pontrieux, • <4 4 ♦ · *

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France), ephedra, epimedium, esculoside, evening primrose, EXTRACT LE-100 (from Sino Lion, World Center, NY), fangfeng, marguerite, ficin, forsythia, forsythia, forsythia fruit, ganoderma, gaoben, GATULINE A (from Gattefosse , Saint Priest, France), gentian, gentian, germanium extract, ginkgo bilboa, ginkgo, ginsehg extract, vodka, american plant of buttercup family, gorgonium extract, gotu round, grapefruit extract, guajac oil, guggal ester extract , henna, honeysuckle, mallow extract, horse chestnut, horsetail, huzhang, hypericum, ichtyol, immortelle, ipecac, job's tears, jujujba cicimek, cola extract, LANACHRYS 28 (from Lana Tech, Paris, France), lemon essential oil, lianqiao, licorice root, ligusticum, lovage root, loofah, mace, magnolia flower, manistha extract, margaspidin, chamomile, matricin, MICROAT IRC (from Nurture, M Assyla (MT), mint, white mistletoe, Loranthaceae plants, MODULENE (from Seporga, Sophia Antipolis, France), mung bean extract, muskrat, musk, oat extract, orange, panthenol, papain, peony root, peony root , PHYTOPLENOLIN (from Bio Botanica, Hauppauge, NY), PREREGEN (from Pehtapharm, Basel, Switzerland), cabbage, portula, QUENCH T (from Centerchem, Stamford, CT), quillaia, sage red, rehmannia, rhubarb, rosemary rosmarinic acid, royal jelly, rue, routine, sandalwood, sanqi, dried roots of transfer, palmetto, dwarf palm, SENSILINE (from Silab, Brive, France), SIEGESBECKIA (from Sederma, Brooklyn, NY), stearyl-gly -cylrhettinate, STEMUTEX (from Pentapharm, Basel, Switzerland), witch-tree species, sweetgum, rasamala, sweet birch essential oil, sweet fragrance, marsupial, tea tree extract, thyme extract, tienchi ginseng, tocopherol, tocopheryl acetate, triclosan, maize long, urimei, ursolic acid, bark of pines, witch peanut, xinyi, yarrow, yeast extract, yucca and mixtures thereof.

Sunscreen optical agents

Sunscreen optical agents suitable for use herein include those described in WO98 / 18444, which is incorporated herein by reference. Preferred sunscreen optical agents useful in the present invention are those selected from the group consisting of diethanolamine-p-methoxycinnamate, dioxybenzone, ethyldihydroxypropyl PABA, glycerylaminobenzoate, lawsome and dihydroxyacetone, menthyl- anthranilate, methyl anthranilate, octyldimethyl PABA, red petrolatum, sulisobenzone, triethanol salicylate, and mixtures thereof.

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Means for improving skin protection, health and skin regeneration

Agents that actively work to improve skin protection, health and regeneration are those skin care active ingredients that can help improve skin protection and supplement the natural protective function of the epidermis as a barrier to moisture and hydration. Without limiting the choice of such agents that actively improve skin protection, health and regeneration, examples are those selected from the group consisting of brassicasterol, caffeine, campesterol, canol-derived sterols, CERAMAX (from Quest, Ashford, England), CERAMIDE H03TM (from Sederm, Brooklyn, NY), CERAMIDE II and CERAMIDE III (from Quest, Ashford, England), CERAMEDE IIIB (available from Cosmoferm, Delft, The Netherlands), CERAMIDE IS 3773 ( from Laboratories Serobiologiques, Somerville, NJ), CERAMIDOL (from Inocosm, Chatenay Malabry, France), CERASOL and CEPHALIP (from Pantapharm, Basel, Switzerland), cholesterol, hydroxystearate, cholesterol isostearate, 7-dehydrocholesterol DERMATEIN BRC and DERMATEIN GSC Hormel, Austin, MN), ELDEW CL 301 (from Ajinomoto, Teaneck, NJ), ELDEW PS 203 (from Ajinomoto, Teaneck, NJ), FITROBROSIDE (from Pentapharm, Basel, Switzerland), GENEROL 122 (from Henkel, Hoboken, NJ) ), glycerylserinamide, acids and lactic, LACTOMEDE (from Pentapharm, Basel, Switzerland), lanolin, lanolin alcohols, lanosterol, lauric acid, laurylglukaid, lipoic acid, n-acetyl-cysteine, serine, n-acetyl-L-serine, NET STERO-ISO (from Barnet Products, Englewood, NJ), niacinamide, nicotinic acid and its esters, nicotinyl alcohol, palmitic acid, panthenol, panthetin, phosphine esterase inhibitors, PHYTO / CER (from Intergen, Purchaser, NY), PHYTOGLYCOLIPIDE MILLET EXTRACT (from Barnet Products Distributor, Engle , NJ), PHYTOSPHINGOSINE (from Brocades, King of Prussia, PA), PSENDOFILAGGRIN (from Brooks Industries, South Plainfiedel, NJ), QUESTAMIDE H (from Quest, Ashford, England), serine, stigmasterol, sitosterol, stigmastanol, soy derived sterols, sphingosine, s-lactoylglutathione, stearic acid, SUPER STEROL ESTERS (from Croda, Parsippany, NJ), lipoic acid, THSC CERAMIDE OIL (from Campo RESEARCH, Raffles Quay, Singhapur), trimethylglycine, tocopheryl nicotinate, vitamin D3 and its analogues or its derivatives, and Y2 (from Ocean Pharmaceutical), or mixtures thereof.

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Active ingredients against wrinkles and skin atrophy

Active substances that counteract wrinkle formation and skin atrophy can effectively assist in replenishment or rejuvenation in relation to epidermal and / or dermal layers of the skin. These active ingredients generally provide those desired skin care benefits that are beneficial in promoting or achieving a natural process of peeling damaged and / or building components in the skin matrix (e.g., collagen and glycosaminoglycans). Anti-wrinkle and skin atrophy agents which can be used in the compositions of the invention include, but are not limited to, nicotinic acid and its esters, nicotinyl alcohol, estrogens and estrogenic compounds, or mixtures thereof. Other anti-wrinkle and skin atrophy agents that can be used in the compositions of the present invention are described in WO98 / 18444, which is incorporated herein by reference.

Active substances to improve health and skin regeneration

Compositions that actively act to improve the health of the skin are those active substances that can help in improving the health of the epidermal and / or dermal layer of the skin. While not limiting the choice of such agents that actively improve skin health, examples include those selected from the group consisting of actein 27 deoxyactein cimicifugoside (cimigoside), adapalene, tazarotene, ademethionine, adenosine, aletris extract, aloe-derived lectins, 3-aminopropyldihydrogephosphate, AMADORINE (from Bamet Products, Englewood, NJ), anise extracts, AOSINE (from Secma, Pontrieux, France), arginine aminobenzoate, ASCIII (from E. Merck, Darmstadt, Germany) ), ascorbic acid and its derivatives, ascorbyl palmitate, asiatic acid, asiaticosides, ARLAMOL GEO (from ICI, Wilmington, DE), azelaic acid, benzoic acid derivatives, bertholletia extracts, betulinic acid, BIOCHANINA, BIOPEPTIDE CL and BIOPEPTIDE EL (from Sederma, Brooklyn, NY), biotin, blackberry bark extract, blackberry blossom extract, blue cohosh extract, butanoylbetulinic acid, catecholamines , chalcones, chaste tree extract, c-retinoic acid, citric acid esters, clover extracts, coenzyme Q10 (ubiquinone), cumestrol, CPC PEPTIDE (Bamet Products, based in Englewod, NJ), daidzein, dang gui extract, darutoside, debromo laurinterol followed by an acid

1-decanoylglycerophosphoric acid, dehydrocholesterol, dehydrodicresol, dehydrodieugenol, dehydroepiandrosterone, DERMOLECTINE (from Sederma, Brooklyn, NY), dehydroascorbic acid and its derivatives, dehydroepiandrosterone sulphate, dianethol, ί:

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2,4-dihydroxybenzoic, diosgenin, disodium ascorbyl phosphate, dodecanedioic acid, EDERLINE (from Seporga, Sophia Antipolis, France), ELESERYL SH (from Laboratories Serobiologiques, Somerville, NJ), ENDONUCLEINE (from Laboratories Serobiologiques, Somerville, Nerville, Nerve) , ergosterol, eriodictyol, estrogen and its derivatives, ethocyn, erythrobic acid, famesol, famesyl acetate, fennel extract, FIBTRASTEL (from Sederma, Brooklyn, NY), FIBROSTIMULINES A AND P (from Sederma, Brooklyn, MY), Firmogen IS 8445 (from Laboratories Serobiologiques, Somerville, NJ), flavonoids (in particular flavanones such as unsubstituted flavanone and chalcones such as unsubstituted chalcone and monohydroxy and dihydroxy chalcones), formononetine, fortymy extract, gallic acid esters, gammaATININEButanoic acid Gattlefosse, Saint Priest, France), genistein, genistic acid, gentisic acid, gentisyl alcohol, ginkgo biloba extracts, ginsehg extracts, ginsenoside, Ro, Re. ,, R ₆ . _2, R ₆ _ _3, Rc, _Rd, Re, Rf, R 2, R q-i, Rg 2, glucopyranosyl-L-ascorbate, as well as glutathione and its esters, glycitein acid eptyloxy-4-salicylic acid, hesperitin , hexahydrocurcumin, hmg-coenzyme A reductase inhibitors, hop extracts, 11-hydroxyundecanoic acid, 10-hydroxy decanoic acid, 25-hydroxycholesterol, ISOFLAVONE SG 10 (from Barnet Products, Englewood, NJ), kinetin, esters of 1-2-oxo-thiazolidine- 4-carboxylic, lactate dehydrogenase inhibitors, 1-laylyl-lysophosphatidylcholine, lectins, LICHOCHALCONE LR15 (from Maruzen, Morristown, NJ), liquorice extracts, lipoic acid, lumisterol, luteoline, magnesium-ascorbyl phosphate, melatonone phosphate, melatinose phosphate, melatinose phosphate, melatine methprene, methoprene acid, 4-methoxysalicylic acid, mevalonic acid, MPC COMPLEX (from CLR, Berlin, Germany), N-acetylcysteine, N-methylserine, N-methyltaurine, N, N'-bis (lactyl) cysteine, naringenin, neotigogein 5-octanoylsalicylic acid, followed by O-desme thylangoiensin, oleanolic acid, pantethin, phenylalanine, photoanethone, phytic acid and its salts, piperidine, placenta extracts, pratensein, pregnenolone, pregnenolone acetate, pregnenolone succinate, premarin, quilic acid, raloxifene, REPAerma FACTOR 1 (from Seda, FACTOR 1, NY), REPAIR FACTOR SPC (pd Sederma, Brooklyn, NY), retinal, retinoates (esters C ₂ . ₂₀ alcohols), retinol, retinyl acetate, retinyl glucoronate, retinyl linoleate, retinyl palmitate, retinyl propionate, REV1TALIN BT (from Pentapharm, Basel, Switzerland), sec.carboxymethycysteines, salicylic acid, SEANAMIDE FP (from Laboratories Serobiologiques , Somerville, NJ), ascorbyl phosphate, soy extracts, spleen extracts, tachysterol, taurine, tazarotene, thymulene, thymus extract, thyroid hormones, tigogenin, tocopherol retinoate, toxifoline, and / or retinoic acid , traumic acid, tricholine citrate, trifoside, uracil derivatives, ursolic acid, vitamin D ₃ , and its 004 00 00 00 00 00 00

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• 0 0 0 0 0 0 analogues, vitamin K, vitex extracts, sweet potato extract, jamogenin and zeatin or mixtures thereof.

Lipids

Suitable lipids include, for example, cetyl ricinoleate, cholesterol hydroxystearate, cholesterol isostearate, CREMEROL (from Amerchol, Edison, NJ), ELDEW 0301 (from Ajinomoto, Teaneck, NJ), lanolin, MODULAN (from Amerchol, Edison, NJ), CARBON (from Amerchol, Edison, NJ), petrolatum, phytantriol, and SUPERSTEROL ESTERS (from Crod, Parsippany, NJ), or mixtures thereof.

Skin-lightening agents

The skin lightening agents can actually reduce the amount of melanin in the skin, or provide such an effect by another mechanism. 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 those belonging to the group consisting of adapalene, aloe extract, aminotyrosine, ammonium lactate, anethole derivatives, apple extract, arbutine, ascorbic acid and its derivatives, ascorbyl palmitate, acid azelain extract, bamboo extract, bearberry extract, tuber of bletilla tuber, bupleurum falcatum extract, totene rumen extract, BURNET POWDER (from Bamet Products, Englewood, NJ), butylhydroxyanisole, butylhydroxytoluene, chuanxiong, danggui, 1,3-deoxyarbutin diphenylpropane, 2,5-dihydroxybenzoic acid and its derivatives, 2- (4-acetoxyphenyl) -1,1-3dithane, 2- (4-hydroxyphenyl) -1,3-dithane, ellagic acid, escinol, eskuletter, FADEOUT (from Pentapharm , Basel, Switzerland), fangfeng, fennel extract, gallic acid and its derivatives, ganoderm extract, gaoben, GATULINE WHITENING (from Gattefosse, Saint Priest, France), genistic acid and its derivatives, gentis alcohol, 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-hydroxybenzoic acid derivatives, hydroxycaprylic acid, inisitol ascorbate, koji acid, lactic acid, lemon extract, liquorice extract, LICORICE P-TH (from Bamet Products, Englewood, NJ), linoleic acid, magnesium-ascorbyl- phosphate, MELFADE (from Pentapharm, Basel, Switzerland), MELAWHITE (from Pentapharm, Basel, Switzerland), morus alba extract, mulberry root extract, niacinamide, nicotinic acid and its esters, nicotinyl alcohol, • 4 ♦ · ♦ · * 44 * * · * «· * 4 9 * 44

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4 4 * * 4 44 4 5-octanoylsalicylic acid, parsley extract, phellinus linteus extract, placental extract, pyrogallol derivatives, retinoic acid, retinol, retinyl esters (acetate, propionate, palmitate, linoleate), 2,4-resorcinol derivatives, derivatives 3,5-resorcinol, rose fruit extract, rucinol, salicylic acid, song-yi extract, SOPHORA POWDER (from Bamet products, Englewood, NJ), 4-thioresorein, 3,4,5-trihydroxybenzyl derivatives, tranexamic acid, TYROSLAT 10,11 (from Fytokem), vitamin D ₃ and its analogue, yeast extract, or mixtures thereof.

Skin fat inhibitors

Skin fat inhibitors can reduce skin fat production in the fat glands. Suitable skin fat inhibitors may be, for example, those selected from the group consisting of aluminum-hydroxy chloride, ASEBIOL (from Laboratories Serobiologiques, Somerville, NJ), BIODERMINE (from Sederm, Brooklyn, NY), climbazole, COMPLETECH MBAC-OS ( from Lípo, Peterson, NJ), corticosteroids, cucumber extracts, dehydroacetic acid and its derivatives, dichlorophenylimidazole dioxolane, ketoconazole, LICHOCHALCONE LR 15 (available from Maruzen), niacinamide, nicotinic acid and its esters, nicotinyl alcohol, florentine, from PHLOROGINE , France), pyridoxine and its derivatives, sec. Carboxymethylcysteine, SEPICONTROL AS, spironolactone, thioxolone, tocopherol, UNITR1ENOL T27 (from Unichem, Chicago IL), and ZINCIDONE (from UCIB, Clifton, NJ), or mixtures thereof.

Skin fat stimulators

Skin fat stimulators can cause an increase in skin fat production in the fat glands. Without limiting their choice, suitable skin fat stimulators may be, for example, those selected from the group consisting of bryonolic acid, COMPLETECH MBAC-DS (from Lípo, Peterson, NJ), dehydroepiandrosterone (also known as DHEA), orizanol, and mixtures thereof.

Substances affecting the sensory perception of the skin

Without limiting their choice, suitable skin sensitizing agents may be, for example, those selected from the group consisting of agents that provide a cooling sensation such as camphor, thymol,

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1-methanol and their derivatives, further eucalyptus, carboxamides; menthane ethers and menthane esters; and heat sensitizing agents such as cayenne tincture, cayenne extract, cayenne powder, vanillylamide nonanoate, nicotinic acid derivatives (benzyl nicotinate, methyl nicotinate, phenyl nicotinate, etc.), capsaicin, watercress extract, Zanthoxylum piperitum extract, and ginger extract, or mixtures thereof.

Protease inhibitors

Protease inhibitors are compounds that inhibit the proteolysis process, i.e., cleavage of proteins into smaller peptide fractions and amino acids. Suitable protease inhibitors include, for example, those selected from the group consisting of AE COMPLEX (from Bamet products, Englewood, NJ), ALE (from Laboratories Seporgia, Sophia Antipolis, France), allicin, AOSAINE (from Secma Biotechnologies Marina, Pontrieux , France), APROTININ (from Pentapharm AG, Basel, Switzerland), Areca palm extract, thickened extract of East Indian acacia, BLUE ALGAE EXTRACT (from Collaborative Labs Inc., East Setauket, NY), CENTAURIUM (from Sederma, Brooklyn, NY) , CMST (from Bioethica Inc., Portland, ME), DERMOPROTECTINE (from Sederma, Brooklyn, NY), DISACOSIDE HF (from Bamet Products, Englewood, NJ), ELHIBIN (from Pentapharm AG, Basel, Switzerland), FLUID OUT COLLOID ( from Vegetech, Glendale, CA), HYPOTAURINE (from Sogo Pharmaceutical Co. Ltd., Chiroda-ku Tokyo, Japan), IN CYTE HEATHER (from Collaborative Labs Inc., East Setauket, NY), MICROMEROL (from Collaborative Labs Inc., East Setauket, NY), PEFABLOC SP (from Pentapharm AG, Basel, Switzerland), SEPICONTROL AS (from Seppic, Paris, France), SIEGEBECKIA (from Sederm located in Brooklyn, NY), SOPHORINE and THIOTAINE (from Bamet Products, Englewood, NJ), and mixtures thereof.

Agents to improve skin tension

Suitable skin tension enhancers include, for example, those selected from the group consisting of BIOCARE SA (from Amerchol, Edison, NJ), egg white, FLEXAN 130 (from National Starch, Bridgewater, NJ), GATULINE (from Gattefosse) , Saint Priest, France), PENTACARE HP (from Pentapharm AG, Basel, Switzerland), VEGESERYL (from Laboratories Serobiologiques, Somerville, NJ), and mixtures thereof,

♦♦ • ί ·:

• 4 * 4 • 4 4 4 ·· · ♦

44

4 4 4.: Ι. *

4 4

4444

Ingredients against itching

Examples of suitable anti-itch ingredients include STIMU-TEX (from Pentapharm AG, Basel, Switzerland), TAKANAL (from Ikeda-Distributor, Tokyo, Japan), ICHTHYOL (from International Sourcing-Distributor, Upper Saddle River, NJ) , OXYGENATED GLYCERYL TRIESTERS (from Laboratories Seporgia, Sophia Antipolis, France), and mixtures thereof.

Hair growth retardants

Suitable hair growth retardants are, for example, those selected from the group consisting of oestradiol beta, adamantylguanidines, adamantylamidines, adenylosuccinate synthase inhibitors, anti-angiogenic steroids, aspartate transcarbamylase inhibitors, betamethasone valerate, bisabolol, bisabolol cucumber extract, cycloxygenase inhibitors, cysteme patchway inhibitors, dehydroacetic acid, dehydroepiandrosterone, diopyros leak extract, epidermal growth factor, epigalocatechin, essential fatty acids, evening primrose essential oils, gamma glutamyl transpeptidase inhibitors, glutamate metabolic inhibitors, glucose inhibitors, glutathione, green tea extracts, heparin, KAPILANNE (from International Sourcing Distributor, Upper Saddle River, NJ), L-2-diaminopentanoic acid, L-asparginic synthase inhibitors, linoleic acid, l ipogenase inhibitors, longa extract, mimosinamine hydrochloride, mimosin, oxidative synthase inhibitors, nonsteroidal anti-inflammatory agents, omithine decarboxylase inhibitors, omithine aminotransferase inhibitors, panthenol, phorhetur, phosphodiesterase inhibitors, extract, pleione extract C, protein extract, pleione extract red, protein mercapto reactive compounds, thioxolone, transforming growth factor beta 1, urea, zinc ions, and mixtures thereof.

5-alpha reductase inhibitors

5-alpha reductase inhibitors include, for example, CLOVE 55 (from Bamet Products Distributor, Englewood, NJ), ethynylestradiol, genistein, genistin, Licochalcona LR-15, sawtooth dwarf palm extract, SOPHORA EXTRACT (from Maruzen, Morristown, NJ), ZINCIDONE (from UCIB, Clifton, NJ), and mixtures thereof.

· «

9 9 · 9

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99 ♦ 0 ♦ · «• 9 9 9

9 9 9 9 • 9 9 9 • 999999

Enzyme compositions acting to improve cell shedding and release

Said compositions improve the activity of endogenous enzymes which act to exfoliate and release cells. Without limiting the choice of such substances, examples thereof include N-methylserine, serine, trimethylglycine, and mixtures thereof.

Antiglycan reagents

Said agents prevent the sugar from inducing collagen cross-linking. Suitable examples of such agents include, for example, AMADORINE (from Barnet Products Distributor, Englewood, NJ).

Preferred blowing agents suitable for use herein include, for example, those selected from the group consisting of ascorbic acid and derivatives thereof, salicylic acid, niacinamide, tocopherol nicotinate, benzoyl peroxide, 3-hydroxybenzoic acid, flavonoids (e.g. flavanone, chalcone), famesol, phytanetriol, glycolic acid, 4-hydroxybenzoic acid, acetylsalicylic acid, 2-hydroxybutanoic acid, 2-hydroxypentanoic acid, 2-hydroxyhexanoic acid, cis -retinoic acid, and / or trans -retinoic acid, retinol, retinyl esters (e.g. retinyl propionate), phytic acid, N-acetyl-L-cysteine, lipoic acid, tocopherol and its esters (e.g. tocopherol acetate), azelaic acid, arachidonic acid, tetracycline, ibuprofen, naproxen, ketoprofen, hydrocortisone, acetominophen, resorcinol, phenoxyethanol, phenoxypropanol, phenoxyisopropanol, 2,4,4'-trichloro-2'-hydroxydiphenyl ether, 3,4,4'-trichlorocarboxylic acid banilide, octopirox, lidocaine hydrochloride, clotrimazone, miconazole, ketoconazole, neomycin sulfate, theophylline, and mixtures thereof.

For cosmetic skin, hair and / or nail treatment methods, the cosmetically beneficial agents are preferably selected from such agents as anti-wrinkle and skin atrophy agents, anti-acne agents, tanning agents and tanning agents, emollients, furthermore substances having a cooling soothing effect on the skin, substances for hydrating the skin, substances active for improving the health of the skin and its regeneration, means for protection and regeneration of the skin, skin lightening agents, substances affecting skin sensation, lipids, inhibitors skin fat, skin fat stimulators, substances φφ φφ φ φ φ φ

Jako φ • působ působ působ působ působ působ působ působ působ působ působ působ působ působ působ působ působ působ prote prote prote prote prote prote prote prote prote prote prote prote prote prote prote prote prote prote prote prote prote prote prote prote prote prote prote prote prote prote prote or mixtures thereof.

Moisturizing substances

Preferred preformed, unilamellar, film-like compositions comprise at least one wetting agent. Moisturizing agents are added to provide a plasticizing effect and to enhance the moisturizing and moisturizing properties of said preformed, unilamellar, film-like composition for application to the intended target surface. Certain humectants, such as hexylene glycol, may also contribute to the antibacterial properties and characteristics of a given preformed, unilamellar, film-like composition of the present invention. Furthermore, without being bound by theory, it is believed that by incorporating wetting agents into the preformed, unilamellar, film-like compositions of the present invention, the stability of such compositions is increased so that they are not subject to any damage or are not even under extreme temperature conditions. Generally, the preformed, unilamellar, film-like compositions of the present invention comprise 1.0% to 45% by weight, preferably 5% to 40% by weight, more preferably 10% to 30% by weight of the wetting agent.

Suitable humectants for use in the present invention are described in WO98 / 22085, WO98 / 18444 and WO97 / 01326, all of which are incorporated herein by reference. Other suitable wetting agents are, for example, those selected from the group consisting of amino acids and derivatives thereof such as proline and arginine aspartate, 1,3-butylene glycol, propylene glycol and water and codon tomentosum extract, collagen amino acids or peptides, creatinine , diglycerol, biosaccharide gum-1, glucamine salts, glucuronic acid salts, glutamic acid salts, polyethylene glycol ethers of glycerin (e.g. glycereth 20), glycerin, glycerol monopropoxylate, glycogen, hexylene glycol, honey and extracts of honey or derivatives thereof, hydrogenated starch hydrolysates, hydrolyzed mucopolysaccharides, inositol, keratin amino acids, LAREX A-200 (available from Larex), glycosaminoglycans, methoxy PEG 10, methyl gluceth-10, and methyl gluceth-20 (both commercially available from Amerchol, located in Edison, NJ), methylglucose , · · * * 00 00 00 00 00 00 0 0000 0 0 0 0 0 00 * 0 »0

0 0 0

3-methyl-1,3-butanediol, N-acetylglucosamine salts, panthenol, polyethylene glycol and derivatives thereof (such as PEG 15 butanediol, PEG 4, PEG 5 pentaerythritol, PEG 6, PEG 8, PEG 9), pentaerythritol , 1,2-pentanediol, PPG-1 glyceryl ether, PPG-9, 2-pyrrolidone-5-carboxylic acid and its salts such as glyceryl PCA, saccharide isomerate, SEACARE (available from Secma), sericin, silk amino acids, sodium acetyl - hyaluronate, sodium hyaluronate, sodium polyaspartate, sodium polyglutamate, sorbeth 20, sorbeth 6, sugar and sugar alcohols and their derivatives such as glucose, mannose and polyglycerol sorbitol, trehalose, triglycerol, trimethyolpropane, tris (hydroxymethyl) and yeast extracts or mixtures thereof.

More preferably, the humectants for use herein include those selected from the group consisting of glycerin, butylene glycol, hexylene glycol, panthenol and polyethylene glycol and derivatives thereof, or mixtures thereof.

Emulsifiers / surfactants

Said preformed, unilamellar, film-like compositions of the invention may also optionally contain one or more surfactants and / or emulsifiers. Emulsifiers and / or surfactants generally help to disperse and suspend the discontinuous phase into the continuous phase. The surfactant may also be further useful when the product is intended to clean skin, hair or nails. For the purposes of the conventions introduced herein, emulsifiers are referred to as "surfactant" or "surfactants", which refers to surfactants that are used as emulsifiers or for other purposes for which surfactants such as surfactants are used. cleaning of skin, hair or nails. Known or customary surfactants may be used in the compositions herein, provided that the selected agent is compatible with the basic ingredients of the composition, as well as having the desired properties. Suitable surfactants include, for example, silicone materials, non-silicone materials, and mixtures thereof.

The compositions of the present invention preferably comprise from 0.01% to 15% by weight of a surfactant or surfactant mixture. The precise specific choice of surfactant or surfactant mixture is dependent upon the pH of the composition and other components present. Nonionic surfactants are preferred.

· • 4 • r # 4

4 4

4 4

4 4

4 4 ·

4 ·

44

4 4 · 4 · ··· 4

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4444

Nonionic surfactants useful herein include the condensation products of alkylene oxides with fatty acids (i.e., alkylene oxide fatty acid esters). These materials have the general formula RCO (X) _n OH wherein R is a C _1O -3o alkyl group, X is _{-OCH2 CH2} - (i.e. derived from ethylene glycol or oxide) or -OCH ₂ CHCH ₃ - (i.e. derived from propylene glycol or oxide; and n is an integer from 6 to 200. Other nonionic surfactants are the condensation products of alkylene oxides with 2 fatty acid molecules (i.e., alkylene oxide diesters of fatty acids). These materials have the general formula RCO (X) _n OOCR wherein R is a _{C] 0} -3o alkyl group, X is -OCH ₂ CH ₂ - or -OCH ₂ CHCH ₃ - n is an integer from 6 to about 100. Other nonionic surfactants The substances are the condensation products of alkylene oxides with fatty alcohols (ie alkylene oxide ethers of fatty alcohols). These compounds have the general formula R (X) _n OR ', where R is a C10-30 aliphatic group, X is -OCH ₂ CH ₂ - or -OCH ₂ CHCH ₃ - and n is an integer from 6 to 100 and R' is H or A C10-30 aliphatic group, which may be, for example, PEG 40 hydrogenated castor oil and optionally PEG 60 hydrogenated castor oil, available under the trade names "Cremophor RH 40" and "Cremophor RH 60" from BASF (Parsippany, NJ, USA); isoceteth-20, available under the tradename "Arlasolve 200" from ICI (Wilmington, MA, USA); and oleth-20, available under the tradename "Volpo N20" from Croda Chemicals Ltd. (Goole, North Humberside, England). Still other other nonionic surfactants are the condensation products of alkylene oxides with both fatty acids and fatty alcohols [i.e. wherein the polyacylene oxide moiety is esterified at one end with a fatty acid and etherified (i.e., attached via an ether bond) at the other end with a fatty alcohol]. These compounds have the general formula RCO (X) "OR ', where R and R' are C 10-30 aliphatic groups, X is -OCH ₂ CH ₂ - or -OCIFCHCH, and is an integer from 6 to 100, and examples are ceteth-6, ceteth-10, ceteth-12, ceteareth-6, then ceteareth-10, ceteareth-12, steareth-6, steareth-10, steareth-12, PEG-6 stearate, further PEG-10 stearate, PEG- 100 stearate, PEG-12 stearate, PEG-20 glyceryl stearate, PEG-80 glyceryl stearate, PEG-10 glyceryl stearate, PEG-30 glyceryl cocoate, PEG-80 glyceryl cocoate, PEG-200 glyceryl stearate, PEG-8 dilaurate, PEG-10 distearate, and mixtures thereof.

Other nonionic surfactants useful for the purposes herein include, for example, alkylglucosides and alkylpolyglucosides, which are more fully described in WO98 / 18444, which is incorporated herein by reference. Yet other nonionic surfactants useful herein include polyhydroxy fatty acid amide surfactants as described in more detail in WO98 / 04241.

fc · fcfc fcfc fcfcfc · fcfcfc • fcfcfc fcfc fc fcfcfcfc • fcfcfcfc fc ··· · · · ··· ··· • fcfcfc fcfcfcfc fcfc fcfc fcfc

Other nonionic surfactants suitable for use herein include, for example, sugar esters and polyesters, alkoxylated sugar esters and polyesters, C1-esters. _3O fatty acids and C ₃₀ fatty alcohols, alkoxylated derivatives of C-fatty acids and C). _3O fatty alcohols, alkoxylated ethers of C ₃₀ fatty alcohols, polyglyceryl esters of C ₃₀ fatty acids, C. ₃₀ esters of polyols, Ci. ₃₀ polyol ethers, alkyl phosphates, polyalkylenes phosphate fatty ethers, fatty acid amides, acyl lactylates, and mixtures thereof. Such silicone-free surfactants include, for example, polysorbate 20, polyethylene glycol 5 soya sterol, steareth-20, ceteareth-20, PPG-2 methyl glucose ether distearate, polysorbate 80; polysorbate 60, available under the tradename "Tween 60" from ICI (Wilmington, MA, USA); glyceryl stearate, sorbitan monolaurate, polyoxyethylene 4 lauryl ether sodium stearate, polyglyceryl-4 isostearate, hexyl laurate, PPG-2 methyl glucose ether distearate, and mixtures thereof.

Preferred nonionic surfactants are those selected from the group consisting of ceteareth-12, sucrose cocoate, steareth-100, polysorbate 60, PEG-60 hydrogenated castor oil, isoceteth-20, oleth-20, PEG-100 stearate, and mixtures thereof.

Other suitable emulsifiers for use herein are polyoxypropylene, polyoxyethylene fatty alcohol ethers. These compounds have the general formula R (CH ₂ CHCH ₃ O) _{X -} (CH ₂ CH ₂ O) _V J 1, where R is OC ₁₀ -C ₃₀ alkyl or C ₁₀ -C ₃₀ alkyl, x has an average value of 1 to 20, ay has an average value of 1 to 30, and examples include PPG-6-Decyltetradeceth-30, available under the trade name "Pen 4630" from Nikko Chemicals Co. Ltd. (Tokyo, Japan); PPG-6-Decyltetradeceth-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 suitable emulsifier for use herein is a mixture of sorbitan or sorbitol fatty acid ester and sucrose fatty acid ester as described in more detail in WO98 / 22085, which is incorporated herein by reference.

The hydrophilic surfactants suitable for use herein may alternatively or additionally comprise a wide variety of cationic, anionic, zwitterionic and amphoteric surfactants known in the art. See, for example, McCutcheon: Detergents and Emulsifiers, North American Edition (1986), edited by AI Publishing Company; US-A-5 011 681 to Ciotti et al.

ΦΦ ΦΦ

Φ Φ Φ Φ

Φ Φ • Φ φ φ Φ Φ φ φ φφ

Φ 9 9 Φ • Φ φφ φφφφ released on April 30, 1991; US-A-4,421,769, Dixon et al., Issued Dec. 20, 1983; and US-A-3,755,560, Dickert et al., issued Aug. 28, 1973; all four of which are incorporated herein by reference in their entirety.

A very wide range of cationic surfactants can be used herein. Suitable cationic surfactants for use herein are described in WO98 / 18444, which is incorporated herein by reference.

Furthermore, a very wide range of anionic surfactants can be used herein. See, for example, US-A-3 929 678, Laughlin et al., Issued Dec. 30, 1975; which is incorporated herein by reference in its entirety. Examples of suitable anionic surfactants include alkoyl isethionates (e.g., C ₁₂ -C ₃₀ ), alkyl sulfates and alkyl ether sulfates and salts thereof, alkyl phosphates and alkyl ether phosphates and salts thereof, alkyl methyltaurates (e.g. C ₁₂ -C ₃₀ ), and soaps (e.g. alkali salts) metals (e.g., sodium salts or potassium salts) of fatty acids.

Amphoteric and zwitterionic surfactants can also be used herein. Examples of amphoteric and zwitterionic surfactants suitable for use in the compositions herein are those widely described as derivatives of aliphatic secondary and tertiary amines in which the aliphatic radical may have a straight or branched chain, and wherein one among aliphatic substituents, it contains 8 to 22 carbon atoms (preferably C ₈ -C ₁₈ ), and one contains an anionic water-soluble group, for example a carboxy, sulfonate, sulfate or phosphonate. Examples are alkyliminoacetates and iminodialkanoates and aminoalkanoates, imidazolinium and ammonium derivatives. Suitable amphoteric and zwitterionic surfactants include those selected from the group consisting of betaines, sultains, hydroxysultains, alkyl sarcosinates (e.g., C ₁₂ -C ₃₀ ), and alkanoyl sarcosinates.

The preformed, unilamellar, film-like compositions of the present invention may also optionally contain an emulsifier or surfactant. A very wide range of silicone emulsifiers can be used herein. Such silicone emulsifiers are typically organically modified organopolysiloxanes, so are known to those skilled in the art as silicone surfactants. Useful silicone emulsifiers include dimethicone copolyols. Such materials are polydimethylsiloxanes which are modified to include polyether side chains such as polyethylene oxide chains, polypropylene oxide chains, mixtures of these chains, and polyether chains containing moieties derived from both ethylene oxide and propylene oxide. Other examples include alkyl modified dimethicone

9 *

• »· * *

9 • 9

9 9

9 9 9

99

9999 copolyols, i.e. compounds containing C ₂ -C 3 _O- chains. Other examples of dimethicone copolyols suitable for use herein are those having a variety of cationic, anionic, amphoteric, and zwitterionic pendant moieties in their molecules.

Other additional excipients

The compositions of the present invention may also advantageously contain other adjuvants within a very wide range. However, these additives 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 cosmetic and pharmaceutical ingredients that are generally used in the cosmetic industry and which are suitable for use in the compositions of the invention. Without limiting its choice in any way, it is noted that examples of functional groups of such ingredients are described on page 537 of this referenced publication. Examples of such and other functional groups include: abrasives, absorbents, antibiotics, anti-caking agents, anti-dandruff agents, antiperspirants, antioxidants, biological additives, bleach activators, brighteners, fillers, buffers and buffering agents, chelating agents, chemical agents additives, dyes, cosmetics, cleansing ingredients, denaturates, dental care agents, deodorants, active agents for improved peeling and cell release, depilators, medicinal astringents, colorants, dye transfer agents, transfer agents, enzymes, external analgesics, flavors, film-forming agents, fragrance ingredients, insecticidal repellents, antifungal agents, opacifiers, opacifying agents, oxidizing dyes, oxidizing agents, pesticide pests, pH adjusting agents, pH buffering solutions, farm aceutically active substances, plasticizers, radical scavengers, skin, hair or nail lightening agents, skin, hair or nail conditioners, skin, hair or nail penetration enhancers, stabilizers, surface-active conditioners, reducing agents, temperature suppressants and agents generating heat.

Aesthetic components such as color shades, essential oils, and healing agents on the skin, hair or nails are also useful for the purposes herein. Other optional substances are pigments. The pigments suitable for use herein in the compositions of this invention may be organic and / or inorganic. Included in the term pigment are also materials that have a low level.

4 9 9 4 9 4

9 4 4 4 4 4 5

4 49 4444 color intensity, shine or shimmer, materials such as matt finishes as well as light scattering agents. Such suitable pigments include, for example, those selected from the group consisting of titanium dioxide, ultramarine blue, D&C dyes, carmine, and mixtures thereof. Depending on the formulation, a mixture of pigments is usually used.

The pH of the preformed, unilamellar, film-like compositions of the present invention herein is preferably 3 to 9, more preferably 4 to 8.

The preformed, unilamellar, film-like compositions herein are patches or masks having a size and shape selected to conform to a desired target surface. Accordingly, the compositions of the invention may range in size from a surface area of 0.25 cm ² to a surface area of 1000 cm ² . It is preferred that at least one surface dimension of the device, preferably both surface dimensions of the device, is / is greater than the depth of the device, with ratios between the surface dimension (or surface dimensions) to the depth of the device 2 being preferred; 1 to 100: 1, and more preferably 5: 1 to 50: 1.

The term &quot; surface dimension &quot; as used herein refers to the x-axis or y-axis dimension, and the depth is measured along the z-axis. The exact specific size and shape then depends on the intended use and product characteristics. Said preformed, unilamellar, film-like compositions are suitable for topical application to the nail or cuticle under the nail, hair or scalp, human face or part of the face, legs, hands, arms, feet, or torso. For example, the compositions herein may have square, circular, oval, or other shapes composed thereof, such as shapes that can be described in various ways, such as "hemispherical" and the like. Compositions which are shaped to fit the face have a surface area in the range of 0.25 cm ² to 500 cm ² , preferably it is in the range of 1 cm ² to 400 cm ² . The patch or mask compositions of the third aspect of the invention have a thickness of 0.05 mm to 20 mm, preferably 1 mm to 5 mm. The patch or mask compositions according to the second aspect of the invention have a thickness of 0.05 mm to 20 mm, preferably 0.5 mm to 3 mm, as measured in their densified thickened region (s) and have a thickness in the range of 0.5 mm to 3 mm. 17.5 mm, preferably 0.5 mm to 2.5 mm, in their thinner region (s).

The preformed, unilamellar, film-like compositions of the present invention may also be made and used in a form covering hands (various types that are similar to gloves), feet (various types that are similar to socks, shoes, stockings), or in such form so that he can take them 4 * 4 * 4 * 4 * 4 · 4 · 4 · 4 ·· * · <44 ·· ·· «· person directly on the body, on the torso. Typically, such a certain coverage of the hands may be gloves on the whole hand or on any part thereof, and the types on the legs may then mean the socks on the legs or on any part thereof. As used herein, the term "glove" is intended to include long-fingered gloves or mittens. Preferably, such hand coverage comprises a glove portion comprising a central portion, with one to four finger portions connected to the central portion, a thumb portion connected to the central portion, further comprising a palm side and an opposing side on the back of the hand. It is preferred that the foot cover comprises a sock portion formed by a round foot portion having a closed end and an open beginning. The compositions of the invention may also be manufactured or used in the form of a body-covering composition. Such body torso coverage is formed radially around the body torso and has a longitudinal axis. Its ends are connected to each other, or its length may be shortened to cover only part of the body around the body. In both cases, however, this coverage (or wrap) shows excellent adaptability to the shape of the body part. Typically, these parts can then be applied to different body parts, such as the user's back, upper arm, lower arm, upper leg, lower leg, neck and torso.

Subsequent applications of the compositions herein may be on the target surface for 3 hours, preferably for 1 hour, more preferably for 15 minutes. The preformed unilamellar film-like compositions can all be removed in one piece.

Depending on the benefit agent (s) mentioned herein, the compositions of the invention may have at least one of the following uses: hydrating skin, hair or nails; smoothing fine lines and wrinkles; cosmetic acne treatments; skin firming; strengthening; refinement; peeling; improving and / or balancing skin tone and / or skin surface character; lightening of skin, hair or nails; tan; reducing the occurrence of dilated pores; absorbing or controlling excreta; protection and / or cooling soothing effect on skin, hair or nails, muscles, pain, strain; reducing swelling and / or dark circles (under the eyes); effects on faster wound healing and injury; exposure to a warm, refreshing or cooling effect on the skin, hair or nails; inflammation relief; skin brightening; reducing swelling; treatment of dermatological health problems; alleviation and control; cleaning; better skin breathing; reducing the growth of bacteria or microorganisms; healing; insecticidal effects; removing unwanted hair, dirt or makeup; and dyeing or bleaching the target surface to which said composition is applied. Preferably, said preformed, unilamellar, film-like compositions are cosmetically used to hydrate skin, hair or nails;

smoothing fine lines and wrinkles; and to improve and / or align skin tone and / or skin surface character.

Methods of preparation

Preformed, unilamellar, film-like compositions that are self-supporting are prepared by subjecting at least one beneficial agent and at least one polymer gel forming agent to gelling. The nature of the gelling step depends on the nature of the polymer gel forming agent used. For example, this gelling step may comprise adding metal ions to the solution to be crosslinked by the polymer, or it may include irradiation with ultraviolet rays to form a self-supporting gel.

In many cases, gelling is achieved by cooling. The method comprises heating the liquid, the at least one beneficial agent, and the at least one gellable polymer gel forming agent together with any other additional excipients, if any (or gel forming mixture), first to a temperature above the point of the point. gelling said gel-forming composition to dissolve said gel-forming composition; the mixture is then placed in a suitably shaped mold; and then gelling said gel-forming composition at a second temperature below said first temperature or below a gel point temperature to form a unilamellar self-supporting composition. In an alternative embodiment, the at least one beneficial agent and the at least one gellable polymer gel forming agent are heated together with any other additional excipients and placed in a suitably shaped mold.

In forming the self-supporting composition, the individual components may be added together or sequentially in some order. The order of addition of the components may depend on their properties and characteristics. Preferably, the at least one beneficial agent and the at least one gellable polymer gel forming agent are appropriately dissolved in the liquid before any other components are added. By &quot; reasonably dissolved &quot; it is meant herein that the appearance of the gel-forming composition is substantially transparent or completely transparent. The temperature of this gel forming mixture is maintained above the gel point temperature until all components are added. In alternative embodiments, it may be beneficial to start at a lower temperature of the gel-forming composition before the final ingredients are added.

The at least one beneficial agent and the at least one gellable polymer gel forming agent are maintained at elevated temperature for a reasonably effective period of time. By "reasonably effective" a long time is meant a time sufficient to allow at least one gellable polymer gel forming agent to dissolve completely (or substantially) in the liquid over a reasonable period of time.

In a preferred embodiment, it is possible to prepare said self-supporting composition by injection molding. The composition so produced is believed to be stronger due to the smoother final surface, providing greater resistance to cracking. The injection molding method for producing the self-supporting means comprises sequential steps of injecting the gel-forming composition into a suitably shaped mold, maintaining the composition at a first temperature above the gel point temperature of the gel-forming composition prior to injection; and cooling said gel-forming composition, in a suitably shaped form, to a second temperature that is lower than the gel point temperature of said gel-forming composition, thereby forming a unilamellar self-supporting composition.

In an alternative injection molding method, the at least one beneficial agent and the at least one polymer gel forming agent and any other additional excipients, if present, are all added sequentially in some order. For injection molding, it is important that the at least one beneficial agent and the at least one gellable polymer gel forming agent can be adapted to be fluidly fluid enough to be readily loaded in a conventional manner, as is the case with injection molding processes. . For example, it is possible to add lubricants to assist in filling the gel-forming composition into the opening of the extrusion barrel.

Said gel-forming composition can be delivered to a suitably shaped mold by any of a variety of well known methods, including gravity filling systems and pneumatic or mechanical injection systems. Injection molding is the most preferred method because of the fluidity and low temperatures of the mixtures in these methods. Pressures can be used over a very wide range of values. Generally, a compression pressure of 10 ⁵ Pa (1 atmosphere) to 5 x 10 ⁶ Pa (50 atmospheres) may be used, although higher or lower pressures may be used at these pressures.

injection molding processes. An advantage of the present invention is the ability to mold by the compositions of the present invention using low pressures.

If the gel is achieved by cooling, then the pressing temperature must be at or below the gel point of the gel-forming composition or below the gel point of the gel-forming composition to form a self-supporting composition. A suitable compression temperature must be reached before, during, or after the delivery of said mixture to the mold. After the composition is shaped and cooled to a temperature below the gel point temperature, the composition is removed from the mold. This composition is self-supporting and therefore does not require any special handling during removal from the mold.

In a composition according to the first or second or fourth aspect of the invention, the composition has a non-planar topography on at least one of the first and second surfaces, preferably on the second surface of the composition, wherein the non-planar topography comprises at least two contiguous areas. The mold has at least one of the first and second surfaces of the mold having a negative surface appearance relative to at least one of the first and second surfaces of the composition itself and at least one of the first and second surfaces of the mold has a negative non-planar topography. This non-planar topography is of freely selectable shape, including but not limited to, as shown in Figures 1 to 4, 6 to 7, 8 to 9, and 10 to 12 shown in the accompanying drawings. If the non-planar topography has a periodicity, then at least one of the first and second surfaces of the mold has a periodicity that shows a negative appearance of the periodicity on at least one of the first and second surfaces of the composition itself.

According to the first and third aspects of the invention, said composition has at least one of the first and second surfaces, preferably the second surface, a non-planar topography, the non-planar topography comprising a textured surface having a textured surface negative appearance and the textured negative surface having a texture defined by Ra having a value greater than 10 pm. If the non-planar topography has a periodicity, then the textured surface has a periodicity that demonstrates a negative appearance of the periodicity on at least one of the first and second surfaces of the composition itself. The method comprises preparing a gel-forming composition comprising at least one beneficial agent and at least one polymeric gel-forming agent, and optionally other ingredients, if present, and heating said composition to a first temperature that is higher than the gel point temperature of said composition for dissolving the gel-forming mixture; placing said mixture in a

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A suitably shaped mold having at least one surface having a negative appearance to at least one of the first and second surfaces of the composition itself; on at least one of the first and second mold surfaces, a textured surface having a negative appearance is positioned and the textured surface of the negative appearance has a texture defined by the Ra parameter greater than 10 µm; gelling said mixture at a second temperature colder than or below the gel point temperature of said gel-forming mixture; and finally removing the textured surface from the composition. The removal step may be positioned so as to occur during or after the gelling step. The textured surface is selected from substrates which have been described above, with said negative pattern on the outer surface of the substrate has an R value _and greater than 10 microns. The formed films are preferably textured surfaces.

In a preferred embodiment, the mixture is heated upon insertion into the mold. In another alternative embodiment, at least one of the first and second mold surfaces is textured to a textured surface shape by an etching method or any other method known in the art.

If the non-planar topography has a periodicity on both the first and second surfaces of the composition, either as a result of the mold surface or has a textured surface periodicity, then the periodicity pattern on both surfaces may be assembled in a single row or alternate (zigzag) . Preferably, the sample has an alternating configuration.

The method also comprises preparing a preformed, unilamellar, film-like composition according to the first, second and third or fourth aspects of the present invention, the method comprising preparing a gel-forming composition comprising at least one beneficial agent and at least one polymer gel-forming agent, and optionally additional excipients, if any; further heating said mixture to a first temperature that is higher than the gel point temperature of said mixture to dissolve the gel forming mixture; placing said mixture in a suitably shaped mold having at least one of the first and second surfaces having a negative appearance to at least one of the first and second surfaces of the device itself, wherein the topography on at least one of the first and second surfaces of the non-planar topography device comprises at least two contiguous areas which at the same time do not have the same mean thickness; on at least one of the first and second surfaces of the mold is

4 · • · Repositioning textured surface, which has a negative appearance, and the textured surface of the negative appearance, the texture defined by a parameter R _and whose value is greater than 10 pm; gelling said mixture at a second temperature colder than or below the gel point temperature of said gel-forming mixture; and finally removing the textured surface from the composition.

In a preferred embodiment, the mixture is heated upon insertion into the mold. In another alternative embodiment, at least one of the first and second mold surfaces is textured to a textured surface shape by an etching method or any other method known in the art.

Evaluation methods

Gel burst pressure test

The mechanical properties of the preformed, unilamellar, film-like compositions of the present invention are determined by a method using pressure testing of a gel to damage it (cracking). Interesting parameters include gel strength (determined by the compressive force required to rupture the shaped gel roll) and gel elasticity (determined as the amount of gel compression at the rupture point). A detailed description of this testing method will now follow.

Testing the gel for damage (cracking) under pressure is performed using a Stable Micro Systems (SMS) Texture Analyzer (TA), model TA-XT21, available from Stable Micro Systems Ltd. (Godalming, Surrey, UK). This system is controlled by SMS 'Texture Expert Exceed software (version 2.03) running under Windows-98. A 100 mm aluminum pressure plate (P-100 probe) is attached to a 50 kg cartridge. This merges with the TA Probe Carrier, whose extended arm moves vertically under control and according to computer control.

The preparation of test samples and formulation of the gel of interest is described below. The disc-shaped gel samples of a precision cylindrical solid shape (26 mm in diameter and 12 mm depth) are formed in correspondingly shaped molds. These sample molds are hermetically sealed to prevent evaporation during storage · 4 · 4 · 4 · 4 · 4 · 4 · 4444 Said gel discs are stored at ambient temperature overnight. Each disc is removed from its mold just prior to testing and visually inspected for defects. Discs with defects (such as air bubbles) are discarded as these defects affect their mechanical properties. Discs with no defects found are then placed in the center of the P-100 compression plate.

Texture Expert Exceed software is a file in Force / Compressive mode. Said compression plate is set to an initial starting height of 12.0 mm. Its descent speed is set to 0.8 mm / second and the total distance is 10.8 mm (ie the measurement ends when the disc is compressed to 90% of its original height (or, as noted, depth). Data is automatically collected, recorded; it is the strength and position of the compression pad at 200 pps (points per second). The software records the position of the compression plate when the maximum is reached. This maximum force is the breaking strength of the gel disc, i.e. the force required to break the gel disc. The distance traveled by said plate from its original starting point of gel breakage represents the extent of deformation of the test gel. The maximum force at the rupture point is determined as the average of the samples (typically 5 duplicates) and recorded in Newtons.

The one-dimensional deformation (compression) at the point of gel breakage is expressed as a percentage of its original shaped height, i.

plate distance (mm) at maximum compression% ---------------- x 100 (original sample height in mm)

If the gel does not break at the end of the 10.8 mm (ie 90% compression) path, then such a gel is classified as "non-cracking" under these conditions herein.

9 • · ·

98 99 9 9

Surface roughness

Surface topography is determined using a CADEYES Surface Analysis System (Medar, USA) using a moiré interferometric method, with a configuration such that the resolution is 30.7 µm in the x-axis, the resolution is 35.8 µm in the y-axis, and the resolution 1.6 pm vose x. A textured surface representative of the composition of the first or third aspect of the present invention is prepared using manufactured negative silicone castings (Silflo Silicone Impression Material; Flexico Developments, UK) of textured surfaces useful for preparing preformed, unilamellar, film-like compositions of the first or third aspect of the present invention. . Silicone castings are used instead of current preformed, unilamellar, film-like compositions, as the optical properties of these silicone molding materials are more suitable for optical surface analysis.

Silicone castings are prepared as follows.

1. A 1 inch diameter circle of silicone paste is mixed with 1 drop of catalyst for 1 minute.

2. Using a spatula, this silicone mixture is applied to a given textured surface, followed by curing at room / ambient temperature for 7 minutes.

3. After curing, the silicone cast is removed from the textured surface and analyzed.

The data recorded to describe the surface roughness of a given silicone casting represents the textured surface of the composition according to the first and second aspects of the invention, including the parameter R _a , the surface related average deviation from the best fit, where R _a = 1 / n Σ Zi where z, v at any point, is the absolute value of the calculated best fit elevation at the point, minus the measured elevation at that same point; the calculated best fit elevation at the same point is the elevation of the best fit plane when measuring the surface at the same point. Data taken for a description of the surface roughness, R also include _<(, relative to the surface of the root mean square deviation from the best fit plane, and R _of 10-point roughness.

R _q is the square root of the mean square deviation of IM ' ₂ ' of the best-fit plane R _q = J / l / n Σ z _; ,

R _z is a 10-point roughness averaged over all scanned lines in the x-mix,

R _z ⁼ ((Si + S ₃ + S ₅ + S ₇ + S ₉ ) - (S ₂ + S ₄ + S ₆ + S ₈ + S ₁₀ )) / 5

Where Si, S ₃ , S5, S7, S ₉ is the 5 highest peaks from the best fit plane along the scan line and S ₂ , S ₄ , S ₆ , S ₈ , S ₁₀ is the 5 lowest depressions (downward curved peaks) of best fit planes along the scan line. The best fit plane as described herein is automatically calculated using the CADEYES Surface Analysis System, i is the index related to the particular point analyzed and and the total number of points analyzed, for example, for a surface area of 1 cm ^2, is 90,987.

Although surface topographies of these samples are obtained using the moiré interferometric method, other suitably configured (x-axis and y-resolution of less than 40 pm; z-axis of less than 2 µm) can be used, surface profiling methods (e.g., touch profilometry, laser profilometry) , or interference projection) to obtain a surface topography to obtain such data. An alternative method of measuring Rg and Rq is described by line-based method in ISO4287 (1997), where R _{a is} defined as the arithmetic mean of the deviation from the determined profile and Rq is defined as the square root of the mean square deviation from the determined profile.

Surface gloss

The texturing surface is placed on a gel-forming composition comprising 0.83% agarose, 0.3% Kelgum® (1: 1 mixture of xanthan and locust bean gelatin supplied by Kelco, San Diego, CA, USA). % glycerin, 10% niacinamide, 1% panthenol, 5% butylene glycol, 0.15% Nipagine A (ethylparaben, supplied by Nipa Laboratories, Inc., Wilmington, DE, USA), 0.1% Hampene Na ² (disodium-EDTA, supplied by Hampshire Chemical, Lexington, MA, USA), 62.62% by weight of deionized water. After removing the texturing surface

A gel structure is obtained which is evaluated. The gloss (i.e. surface reflectance) is determined by measuring on the textured surface of a preformed, unilamellar, film-like composition of the invention, on the opaque matt (black) Leneta Card portions available from The Leneta Company. The reflectance surface area% value is measured using a BYK-Gardner Micro Tri-Gloss meter (BYK Gardner, Siiver Spring, MD) for reading at 20 degrees (20 °), 60 degrees (60 °) and 85 degrees (85 °). .

Gel transparency

The transparency of the gel is determined by evaluating the visibility of the printed text through the composition of the invention. Printed text is prepared by printing in English alphabet (capital letters) on a transparent film (Unníersal Office Supplies) using a Microsoft Word Arial font on a LaserJet 4 Plus (Hewlett Packard) laser printer with a black ink cartridge. Printed transparencies are prepared in font sizes from 4 to 28 points. The printed transparent films are then backed with a sheet of white paper to ensure uniformity of the background and all samples are evaluated under normal indoor lighting conditions.

The gel samples of interest are formed into a gel disc having a thickness (depth) of 7 mm. Such a gel disc is placed on a transparent film printed with a font size of 4 and the visibility of the printed alphabet is determined through the gel disc under investigation. If the text is not readable through the gel disc, then the disc is printed with the next larger font size. This process is repeated until a font size is achieved in which the printed text is readable through the gel of interest. The smallest font size that is readable through the gel sample is then referred to as the "transparency threshold" for the gel. A preferred "threshold of transparency" for the gels used for the compositions of the present invention is a font size of 10, more preferably a font size of 7, and a particularly preferred font size of 4.

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DETAILED DESCRIPTION OF THE INVENTION

The following are examples of preferred embodiments that fall within the scope of the present invention. These examples are provided for illustrative purposes only, in order to illustrate the invention in more detail, but are not intended to limit the invention in any way; various variations and variations of the present invention are possible without limiting its scope or scope.

Examples 1 to 3

Component 1 % w / h 2 % w / h 3 % w / h Agarose - 0.4 0.8 Gelatin from the carob pod - 0.27 - Konjac-mannan 0.3 - - Xanthan 0.1 0.13 - Kelgum ™ ¹ - - 0.3 Gelan gum 1.0 0.4 - Glycerine 20.0 20.0 15.0 Butylene glycol 5.0 - 8.0 Panthenol 1.0 2,0 2,0 Niacinamide - 5.0

Sucrose-poly-cotton ester

5.0

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9 9 · 9 9

9 99 9999 (continued table)

Polysorbate 60 - - 0.2 Dimethikonkopolyol 0.02 0.02 - Benzyl alcohol - 0.3 0.2 Ethylparaben 0.2 0.1 - Propylparaben - 0.05 - Disodium-EDTA - 0.1 - Calcium chloride 0.1 0.08 - Water to 100 to 100 to 100 Bursting force / N 82 73 102 % Compression 26 44 58 Substrate Paper ² - -

% w / h are relative% by weight, ie% by weight / weight ¹ Kelgum ™ ¹ is a 1: 1 mixture of xanthan: carob gelatin, supplied by Kelco, San Diego, CA, USA ^{2 The} paper is "Kimwipes EX- L "from Kimberley-Clark Corp., Roswell, GA, USA.

Said polysaccharide gums or gums are mixed with water to form a uniform dispersion mixture (which can be facilitated by pre-dispersing the polysaccharides in a non-solvent, e.g., polyhydric alcohol), and optionally adding other excipients. The mixture is heated with stirring to a temperature above the gel point of the mixture (90 ° C) to completely hydrate the polysaccharide gums. This liquid gel is then placed in a suitably shaped mold (Example 3). The compositions 1 and 2 are injection molded into a suitably shaped mold. Injection molding is preferred. It eliminates the defects that may occur during the processing of the gel and increase the robustness ·· • 4 4 4

4 · <♦

4 4 4 ♦ · ♦

4 ·

4 4 • 45 4

4 9 4

4 4 · of the resource. Injection molding also helps make the composition easier to shape into a three-dimensional structure. The liquid gel is then cooled to a second temperature that is cooler, i.e. lower than the first temperature, i.e., to a gel point temperature or below a gel point temperature (ambient temperature), and the resulting gel structure is formed. The composition can then be removed from the mold. The compositions of Examples 1 to 3 are illustrated in Figures 1 to 3, which are attached as accompanying drawings. The compositions herein are then packaged in materials having low water permeability to minimize the possibility of drying of the composition during storage. Suitable types of packaging include, for example, sachets, which is the preferred packaging in terms of how to protect the composition before it is used. The desired protection is provided by the substrate or, for example, by a thin layer of plastic film that provides easy handling.

When using a substrate (Example 1), the substrate may be placed in a suitably shaped mold before the gel is loaded, or placed on the surface of the liquid gel during cooling.

Metal ions (e.g. Ca ²⁺ , K ⁺ ) may be included in some compositions to improve the gel strength of the composition (Examples 1 and 2). In this case, the metal ions are added in the form of a liquid solution and mixed into the liquid gel immediately prior to loading.

The above process may be modified, but this also depends on the nature of any other additive. For example, if anhydrous components are present, the liquid gel may be homogenized immediately before casting or molding to ensure that the anhydrous components are dispersed. Similarly, if heat-sensitive components are incorporated, it is possible to cool to a suitable temperature (depending on the component) after hydration of the gum or gelatin and the heat-sensitive component is added at this stage.

The liquid gel may be degassed, for example by means of very reduced pressure (vacuum), to remove air bubbles that are dispersed in the liquid. This degassing step, if used, may be the final step immediately prior to dispensing the liquid gel.

As can be seen from the above, these preformed, unilamellar, film-like compositions have excellent strength and flexibility.

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Example 4

A preformed, unilamellar film-like formulation is prepared containing 50/50 (w / w) silicone gel forming agent and ascorbic acid and derivatives thereof as a beneficial agent. The formulation is prepared by condensing at 115-120 ° C, in the presence of 0.025 parts anhydrous ammonia, 67 parts 70% (by weight) xylene solution of a siloxane resin copolymer consisting essentially of (CH 2 SiO 2 # units and SiO _4/2 units in a molar ratio of 0.75: 1 and containing 2.7% by weight of solid hydroxyl, as determined by FT1R (ASTM E-168), 31 parts of hydroxyl-terminated polydimethylsiloxane having a viscosity of 13,500 cP (mP.s) at 25 ° C, and 2 parts of xylene, followed by a condensation reaction, the mixture was heated to 140 ° C for 1 hour, removing excess ammonia.

This silicone mass was then mixed with an equal portion of ascorbic acid and its derivatives (ultrafine powder, Hoffman-La Roche) for 17 minutes using a Lee stainless steel reaction vessel and a built-in Eppinbach stirrer for intensive stirring.

The silicone solution is converted to a suitably shaped mold and subjected to air-drying overnight, evaporating the solvents. The resulting formulation is removed from the mold and packaged. It has been found that this silicone-containing preformed, unilamellar, film-like composition is suitable for delivering ascorbic acid and its derivatives as a beneficial agent for the skin, hair or nails.

Example 5 parts (dry weight) of a pressure sensitive acrylic adhesive of medical grade (Draize 0 to 1 scale) dissolved in ethyl acetate and toluene are mixed with 50 parts ascorbic acid and its derivatives and sodium ascorbate, both in the form of anhydrous powder (1: 22 (w / w)) to form a cosmetically effective adhesive matrix. This is then converted into a suitably shaped mold and then cured at 121.2 ° C. It was found that this preformed,

4 · 44

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4 4 · · 4 4

4444

44

The unilamellar, film-like composition is suitable for delivering at least one beneficial agent for the skin, hair or nails.

Example 6

% Weight / weight component

Agar 0.6 Agarose 0.3 Gelatin from the carob pod 0.1 Konjac-mannan 0.2 Xanthan 0.1 Glycerine 15.0 Panthenol 3.0 Polysorbate 60 0.08 Benzyl alcohol 0.3 Ethylparaben 0.1 Propylparaben 0.05 Water to 100 NW / and to burst / N 78 % Compression 58

Said polysaccharide gums or gums are mixed with water to form a homogeneous dispersion mixture and any additional auxiliaries are added. The process can be facilitated by pre-dispersing the polysaccharides in a non-solvent, e.g., polyhydric alcohol. The mixture was heated to 90 ° C with stirring to fully hydrate the polysaccharide gums. This liquid gel is then φφ φφ φ φφφφ

Odp φ φ φ odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp odp za za za odp The liquid gel is then placed in a suitably shaped mold and cooled to ambient temperature, resulting in the formation of a gel structure. The composition is then removed from the mold. Alternatively, the liquid gel may be cast onto a surface and the desired shape may then be cut from the resulting gel layer. The composition of Example 6 is shown in Figure 4, which is included as part of the accompanying drawings. The composition herein is then packaged in a material having low water permeability to minimize the possibility of drying of the composition during storage.

Duplicates of this composition are then evaluated for surface roughness (Table 1) and surface gloss (Table 2) using a variety of textured surface types. Said textured surfaces are contacted with the composition, either before or during the gel of the liquid gel.

Table 1

Surface roughness of silicone castings

Texturing surface R " R _a R, None 4.85 6.32 14.13 60 mesh, X-7189 ² 21.10 34.37 93.93 40 hex, X-2S137 ² 92.27 133.51 353.78 VFE, 3.4M, X-15928 ² 160.22 189.26 441.45 DRI-WEAVE, pat # 35/7 171.18 206.07 527.44 Hydroformed film ¹ 315.26 360.85 786.01

^A hydroformed film having both microscopic and macroscopic apertures (slits) is described in US-A-4 609 518, Curro et al., Issued September 2, 1986. It is preferred that a sample with macroscopic apertures is in the form of drops with 12% open surface located in a sample having 24 microscopic holes / cm ² , • • φφ φ φ φ φ

Φ φ • «« · · · φ φ φ φ φ φ φ φ φ φ φ φ φ φ φ φ φ φ · ·

Wherein the base of each macroscopic aperture is 1.54 mm, the tip is 0.3 mm in diameter, and the microscopic apertures are formed using a sieve having a sample of 100 apertures.

² From Tredegar Film Products, 1100 Boulders Parkway, Richmond, VA, USA

23225.

Negative pattern of said suitable texturujících surface as defined herein is a value parameter R _a greater than 10 .mu.m, preferably greater than 20 microns, when measured as herein described above. A preferred range for the negative appearance of the texturizing surface for the compositions of the present invention is for a parameter of R _{a of} greater than 10 µm, and less than 316 µm, as measured herein above. The negative appearance of all said suitable texturing surfaces as defined herein has a R _q value greater than 7 µm, preferably greater than 30 µm, and / or most preferably less than 375 µm. The negative appearance of all said suitable texturing surfaces as defined herein then has an R value _of greater than 15 µm, preferably greater than 75 µm, more preferably greater than 90 µm and / or most preferably, this value is less than 800 pm.

Table 2% surface reflectance for texturing surfaces

Textured surface 20 ° 60 ° 85 ° None 48 64.8 72.8 60 mesh, X-7189 ² 0.9 4.0 4.3 40 hex, X-2S137 ² 1,8 7.2 4.3 DRI-WEAVE, pat # 35/7 2.5 14.3 17.2 Hydroformed film ¹ 0.3 0.8 0.35 VFE, 3.4M, X-15928 ² 2.7 23.6 19.2

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4 • 4,444

9 «94

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4494 ¹ hydroforming film which has both a microscopic and macroscopic openings (slits) is disclosed in US-A-4,609,518, Curro et al., Issued September 2, 1986. It is preferred that the sample used to macroscopic shaped holes drops with 12% open surface placed in a sample having 24 microscopic holes / cm ² , the base of each macroscopic hole being 1.54 mm ² , the tip being 0.3 mm ² in diameter and the microscopic holes formed by a sieve having a sample with 100 otvoiy.

² From Tredegar Film Products, 1100 Boulders Parkway, Richmond, VA, USA

23225.

For all suitable texturing surfaces as defined herein, a gloss level in the range of < 40, < 58, and < 65 for a geometry of 20 °, 60 ° and optionally 85 ° is preferred. Preferred gloss ranges for the compositions of the present invention are then 0 to 10, 0 to 30 and 0 to 25 for 20 °, 60 ° and optionally 85 ° geometry. The most preferred gloss ranges for the compositions of the invention are 0-5, 0-25 and 0-20 for 20 °, 60 ° and optionally 85 ° geometry.

Example 7

% Weight / weight component

Agarose 0.9 Glycerine 20.0 Butylene glycol 5.0 Ethylparaben 0.15 Disodium-EDTA 0.1 Water to 100

Said polysaccharide gums or gums are mixed with water to form a uniform dispersion mixture and any additional excipients are added. The process can be facilitated by pre-dispersing the polysaccharides in a non-solvent, for example

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0004 in a polyhydric alcohol. This gel-forming mixture is heated to 90 ° C with stirring to completely hydrate the polysaccharide gums. The liquid gel-forming mixture is then degassed, for example at very low pressure (vacuum), to remove air bubbles from the fluid, and then the mixture is converted into a suitably shaped mold (for example, a mold that is shaped to obtain a composition). 6 and 7, which are part of the accompanying drawings).

The transparency of the composition thus obtained is then evaluated in the manner as described above, the detected threshold being at a font size of 4.

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Industrial applicability

The preformed, unilamellar, film-like compositions of the present invention are in the form of patches or masks intended for cosmetic or therapeutic use, and are applicable to the chemical industry, to the consumer, cosmetic and pharmaceutical manufacturing section, and further to the service sector.

Claims (27)

A preformed, unilamellar, film-like means (10, 110, 210, 310, 410, 510, 610, 710, 810) for delivering beneficial agents to the skin, hair or nails, having a perimeter (12, 112, 212, 512, 612, 712, 812), which defines a first and second spaced apart surfaces (14, 114, 214, 314, 414, 514, 614, 714, 814; 16, 116, 216, 316, 416,516,616,716,816); wherein the composition comprises at least one beneficial agent and at least one polymer gel forming agent; and has a non-planar topography on at least one of the first and second surfaces. A preformed, unilamellar, film-like means (10, 110, 210, 310, 510, 610, 710, 810) for delivering beneficial agents to the skin, hair or nails, having a perimeter (12, 112, 212, 512, 612, 712, 812) defining a first and second spaced apart surfaces (14, 114, 214, 314, 514, 614, 714, 814; 16, 116, 216, 316, 516, 616, 716, 816); wherein the composition comprises at least one beneficial agent and at least one polymer gel forming agent; and the device has a non-planar topography on at least one of the first and second surfaces, the non-planar topography comprising at least two adjacent plotted regions (22, 122, 222, 322, 522, 622, 722, 822; 18,118, 818; 20, 220,320; 524,624, 724), which do not simultaneously have the same mean thickness. The preformed, unilamellar, film-like composition of claim 2, wherein at least one of the two contiguous areas comprises a flange (18, 118, 818) adjacent the periphery (12, 112, 822). 49 44 »444 4 # 44 4 ··· 44 4,444 4,444 44 · 4444 4444 4 4 · 4444 444 4444 4444 44 44 4 «4444 A preformed unilamellar film-like composition according to claim 2 or 3, wherein at least one of the two contiguous areas comprises at least one ridge (20, 220, 320) within the perimeter (12,212). . A preformed, unilamellar film-like composition according to any one of claims 2 to 4, wherein at least one of the two contiguous areas comprises an imprinted symbol. A preformed unilamellar film-like composition according to any one of claims 2 to 5, wherein the second surface is distal to the skin, hair or nails, the second surface (16, 116, 216, 316). , 516, 616, 716, 816) has a non-planar topography and includes a textured surface that has the appearance of a negative textured surface wherein texture has been defined to the value of the parameter _{R, and} was greater than 10 microns. A preformed unilamellar film-like composition according to claim 6, wherein the first surface abuts the user's skin, hair or nails, wherein the first surface (14, 114, 214, 314, 514, 614, 714, 814 ) has a non-planar topography that includes a textured surface that has the appearance of a negative textured surface wherein texture has been defined to the value of the parameter _{R, and} was greater than 10 microns. A process for preparing a preformed, unilamellar, film-like composition according to any one of the preceding claims, characterized in that a gel-forming composition is used which comprises at least one beneficial agent and at least one gellable polymer gel-forming agent, in a form having at least one surface that has a negative appearance to the other, I • r ·· * · ·· ** · <99 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 · · 9 9 9 9 9 9 9 · 9 9 9 9 9 9999 9999 99 99 99 9999 non-planar topography, wherein the non-planar topography comprises at least two contiguous areas having not the same mean thickness or textured surface having a textured surface negative appearance and the textured negative surface having a texture defined by the parameter R _a , having a value greater than or equal to 10 µm; and then gelling the gel-forming composition. A process for the preparation of a preformed unilamellar film-like composition according to claim 12, characterized in that injection molding is carried out. Method for preparing a preformed unilamellar film-like composition according to claim 12 or 13, characterized in that the non-planar topography on the second surface (16, 116, 216, 316, 516, 616, 716, 816) comprises at least two plotted regions (16). 22, 122, 222, 322, 522, 622, 722, 822; 18, 118, 818; 20, 220, 320; 524, 624, 724, 824), which simultaneously do not have the same mean thickness and textured surface in at least one of at least two outlined areas. A method of preparing a preformed unilamellar film-like composition according to claims 12 to 14, wherein the composition additionally comprises a non-planar topography on the first surface (14, 114, 214, 314, 514, 614, 714, 814), topography comprises a textured surface that has a negative appearance and textured surface of the textured surface has the appearance of a negative texts defined by the parameter _{R, and} whose value is greater than 10 microns. A preformed, unilamellar, film-like composition (410, 810) for delivering benefit agents to skin, hair or nails, comprising at least one benefit agent and at least one polymer gel forming agent; and the device has a perimeter that defines a first and second spaced apart surfaces (414, 814; 414, 816), the first surface (414, 814) abutting the skin, hair or nails and the second surface (416, 816) ) has a non-planar topography that includes a textured surface that has the appearance of a negative textured surface wherein texture has been defined to the value of the parameter _{R, and} was greater than 10 microns. Preformed unilamellar film-like composition according to any one of claims 1 to 7 or 12, characterized in that the composition is combined with a substrate. A preformed, unilamellar, film-like composition according to any one of claims 1 to 7, 12 or 13, wherein the at least one polymer gel forming agent is a water-soluble polymer gel forming agent. Preformed unilamellar film-like composition according to any one of claims 1 to 7 or 12 to 14, characterized in that the second surface (316, 416, 816) has a gloss value of 20 ° for the geometry less than 40, preferably less than 10 and most preferably less than 5. Preformed unilamellar film-like composition according to claim 15, characterized in that the second surface has a gloss value of less than 58, preferably less than 30 and most preferably less than 25, for a 60 ° geometry. Preformed unilamellar film-like composition according to claims 15 or 16, characterized in that the second surface has a gloss value of less than 65, preferably less than 25, and most preferably less than 20, for a geometry of 85 °. AND A preformed, unilamellar, film-like composition according to any one of claims 12 to 17, wherein at least one of the first and second surfaces has at least two contoured regions that do not have the same mean thickness simultaneously. Preformed unilamellar film-like composition according to any one of claims 1 to 7 or 12 to 18, characterized in that it has no transparency threshold greater than the font size 10, more preferably no greater than the font size 7 and most preferably no greater than the font size 4 . A preformed unilamellar film-like composition according to any one of claims 1 to 7 or 12 to 18, in the form of a patch. A preformed unilamellar film-like composition according to any one of claims 1 to 7 or 12 to 20, which is packaged in a sealed, protective container. A process for the preparation of a preformed, unilamellar film-like composition according to any one of the preceding claims 1 to 21, characterized in that a gel-forming composition is used which comprises at least one beneficial agent and at least one gellable polymer gel-forming agent in a form having a topography which has a negative appearance relative to the first surface (814); the texturizing surface is contacted with a second surface (816) of the gel-forming composition; gelling the gel-forming composition; and the textured surface is removed from the mold. • • • A method for preparing a preformed unilamellar film-like composition according to claim 22, wherein the mold surface has a negative appearance to the first surface defined by at least two plotted regions (822; 824). which also have the same average thickness and / or a textured surface which has a negative appearance and textured surface of the textured surface has the appearance of a negative texture defined by _a parameter R whose value is greater than 10 microns. A method for preparing a preformed unilamellar film-like composition according to any one of claims 8 to 11 or 22 or 23, further comprising wrapping it in a sealed, protective container. A method of delivering at least one cosmetic benefit agent to the skin, hair or nails, comprising contacting the skin, hair or nails with the composition of any one of claims 1 to 7 and 12 to 21, wherein the composition comprises at least one cosmetic benefit agent and at least one polymer gel forming agent. A preformed, unilamellar film-like composition according to any one of claims 1 to 7 or 12 to 21, characterized in that it is in the form of a mask or patch having a size and shape that adapts to the nails or cuticle of the nails, hair or skin on top of head, human face or part of it, legs, arms, hands, feet or human torso. φφ ·· ·· Φ ··· ·· ·· · · · · · · · · · · φ φφφφ φφ * A preformed unilamellar film-like composition according to any one of claims 1 to 7 or 12 to 21, characterized in that its shape is selected from the group consisting of: a hand wrap, a foot wrap and a body wrap.