HK40007691A

HK40007691A - Barrier patch with soluble film and methods of improving skin appearance

Info

Publication number: HK40007691A
Application number: HK19131115.8A
Authority: HK
Inventors: E·C·博斯韦尔; J·A·亨特; M·J·罗迪; E·A·怀尔德
Original assignee: 宝洁公司
Priority date: 2017-01-09
Filing date: 2018-01-09
Publication date: 2020-06-05

Description

Barrier patch with dissolvable film and method of improving the appearance of skin

Technical Field

The present invention relates to products comprising a barrier patch and a soluble film region comprising a skin active agent for improving the appearance of skin. The present invention also relates to a method of delivering a cosmetic composition to a target area of skin via the use of such products.

Background

The use of a patch or mask device containing a skin agent to cosmetically treat the benefit of skin has been recognized in the art. A variety of cosmetic patches or devices are marketed or described as being useful for delivering skin actives. Patches have been described in the literature and are marketed in the medical field as a useful means of transdermal drug delivery.

However, many patches or devices suffer from drawbacks, including ineffective release of the active ingredient to the skin. Other patches are dry, rough and inflexible, and therefore are tight and uncomfortable to wear. Many existing cosmetic patches typically include a planar two-dimensional substrate. These substrates retain this inflexible configuration during wear and do not conform well to the three-dimensional surface of the skin. Existing patches are not conformable because facial skin can bend and change during movement and changing facial expressions. Thus, in such dynamic environments, these patches generally do not conform well to the contours of the skin surface to which they are applied. A gap between the skin surface and the patch may be formed or the patch may simply be uncomfortable to wear, especially over extended periods of time. Thus, many patches have undesirable use characteristics.

Certain beauty care patch systems comprise an active contained in a reservoir, wherein the active is present in solid, liquid or dissolved form. These systems may also have a layer of pressure sensitive adhesive through which the system can be brought into intimate contact with the skin. These systems are limited when the active substance does not diffuse through the reservoir or adhesive layer, when a chemical reaction occurs between the active substance and the reservoir material or adhesive, or when the active substance is insoluble or only poorly soluble in the reservoir or adhesive.

Thus, an improved multi-layer cosmetic care product is provided. The product includes a soluble film region comprising an active agent and a water-soluble film-forming polymer. When the soluble film-forming polymer is dissolved, the active is released. The soluble film region or polymer or product provides a dynamic modulus, wherein the modulus decreases during use of the product to improve comfort and conformability around the curved surface of the skin, even in low water environments. Thus, the comfort of the product during wear is improved. The product also contains a pressure sensitive adhesive that is substantially separated from the active ingredient such that any interaction between the two is minimized.

Disclosure of Invention

The present invention addresses at least one of these issues by incorporating at least one soluble film region into a cosmetic care product, and soluble films are directed, in part, to having a suitable degree of modulus and/or solubility in water when hydrated.

In one aspect, there is provided a multi-layered cosmetic care product for applying skin active agents to skin, the product comprising:

a barrier patch, the barrier patch comprising:

a backing layer having a first surface and a second surface; about 1g/m²24h to about 500g/m²24h, preferably about 1g/m²24h to about 250g/m²24h, more preferably about 2g/m²24h to about 20g/m²WVTR of/24 h;

a pressure sensitive adhesive zone having an upper surface and a lower surface, the lower surface of the pressure sensitive adhesive zone being in contact with the first surface of the backing layer;

a water-soluble film region comprising:

a water-soluble film-forming polymer;

a cosmetic composition comprising an effective amount of a skin active agent;

the dissolvable film region is in contact with the first surface of the backing layer, the upper surface of the adhesive region, or both;

wherein the water-soluble film region preferably has an initial modulus in the dry state of from about 30MPa to about 600MPa, preferably from about 75MPa to about 500MPa, more preferably from about 100MPa to about 450 MPa; and is

The% weight gain of the water-soluble film region or product, preferably at 1 hour, or 6 hours or 24 hours, can be from about 10% to about 80%, preferably from about 20% to about 80%.

In another aspect, a method of improving the appearance of skin is provided, the method comprising the steps of:

a. identifying a target portion of skin in need of improvement, preferably the ground skin surface;

b. topically applying a multi-layered cosmetic care product to a target portion of skin, the product comprising:

a barrier patch, the barrier patch comprising:

a water-soluble film region comprising:

a water-soluble film-forming polymer;

a cosmetic composition comprising an effective amount of a skin active agent;

Wherein the product is administered for a treatment period.

In one aspect, the treatment period is a period of time sufficient for the product to improve the appearance of skin. In one aspect, the target portion of skin is healthy skin. In one aspect, the pressure sensitive adhesive region is continuous and the water-soluble film region can be continuous or discontinuous. The beauty care product may be applied to any keratinous tissue.

Drawings

While the specification concludes with claims particularly pointing out and distinctly claiming the invention, it is believed that the present invention will be better understood from the following description taken in conjunction with the accompanying drawings in which:

fig. 1 is a top plan view of a beauty care product comprising a discontinuous water-soluble film region and a continuous adhesive region, as shown and described herein.

Fig. 2A is a cross-section taken along 2A-2A of fig. 1.

Fig. 2B is an alternative cross-section of a beauty care product as shown and described herein.

Fig. 3 is a top plan view of a beauty care product comprising a discontinuous water-soluble film region and a discontinuous pressure-sensitive adhesive region, as shown and described herein.

Fig. 4 is a section taken along 4-4 of fig. 3.

Fig. 5 shows a product showing an alternative pattern of discrete water-soluble film regions.

Fig. 6 shows a product showing an alternative pattern of discrete water-soluble film regions.

Fig. 7 is a bar graph illustrating the effect of blocking on percent weight gain at 1 hour, 6 hours, and 24 hours for certain water-soluble film regions as described herein.

FIG. 8 shows a bar graph representing Franz cell permeation of active substances.

Detailed Description

While the specification concludes with claims particularly pointing out and distinctly claiming the invention, it is believed that the present invention will be better understood from the following description.

All percentages and ratios used herein are by weight of the total composition. All numerical ranges are narrower ranges including the endpoints; the upper and lower limits of the ranges described are interchangeable to further form ranges not explicitly described. All ratios are weight ratios unless otherwise specifically noted. All ranges are inclusive and combinable. The number of significant figures indicates that neither a limitation of the indicated quantity nor a limitation of the accuracy of the measurement is expressed. All numerical values should be understood as modified by the word "about" unless otherwise specifically indicated. Unless otherwise indicated, all measurements are understood to be made at about 25 ℃ and at ambient conditions, where "ambient conditions" refers to conditions at about 1 atmosphere of pressure and at about 50% relative humidity.

As used herein, "molecular weight" refers to weight average molecular weight unless otherwise specified. Molecular weight was measured using industry standard methods, gel permeation chromatography ("GPC").

The compositions of the present invention may comprise, consist essentially of, or consist of the essential components described herein, as well as optional ingredients. As used herein, "consisting essentially of means that the composition or component may include additional ingredients, so long as the additional ingredients do not materially alter the basic and novel characteristics of the claimed compositions or methods.

The term "application" as used in reference to a composition means applying or spreading the composition onto a substrate such as the surface or epidermis of human skin.

As used herein, the term "dermatologically acceptable" means that the composition or components thereof are suitable for use in contact with mammalian keratinous tissue without undue toxicity, incompatibility, instability, allergic response, and the like.

As used herein, the term "facial skin surface" refers to one or more of the forehead, periorbital, cheek, perioral, chin, and nose skin surfaces. Although facial skin surfaces are contemplated and exemplified herein, other skin surfaces may be treated with the compositions and methods of the present invention, for example, surfaces not normally covered by clothing, such as facial skin surfaces, hand and arm skin surfaces, foot and leg skin surfaces, and neck and chest skin surfaces (e.g., meconium breast).

As used herein, "healthy skin" means that the physical barrier function of the epidermis and dermis remains intact, e.g., the stratum corneum of the skin is intact and not physically disrupted, removed, subjected to reduction, injured, altered, or ablated using mechanical, optical, or thermal methods.

As used herein, the term "keratinous tissue" refers to stratum corneum-containing layers that are the outermost protective covering for mammals (e.g., humans, dogs, cats, etc.) and include, but are not limited to, skin, mucous membranes, lips, hair, toenails, fingernails, cuticles, hooves, etc.

As used herein, the terms "topically apply", "topically", and "topical" refer to the application (e.g., spreading, spraying) of the compositions of the present invention onto the surface of keratinous tissue.

As used herein, the term "effective amount" refers to an amount of a compound or composition sufficient to significantly produce a positive keratinous tissue benefit, including benefits that are independent or combined with other benefits disclosed herein. This means that the amount and/or concentration of the agent in the formulation is sufficiently large that the formulation can provide treatment for one or more undesirable keratinous tissue conditions (e.g., skin wrinkles) when the formulation is applied at normal frequency and in conventional amounts. For example, the amount may be an amount sufficient to inhibit or enhance certain biochemical functions present within the keratinous tissue. The amount of the skin care agent may vary depending on the type of product, the type of keratinous tissue condition to be treated, and the like.

As used herein, the term "safe and effective amount" means an amount of a compound or composition sufficient to significantly produce a positive benefit, preferably a positive keratinous tissue appearance, including benefits that are independent or in combination with the benefits disclosed herein, while being low enough to avoid serious side effects, i.e., to provide a reasonable benefit to risk ratio, within the scope of sound judgment of the skilled artisan.

As used herein, the term "water-impermeable" includes materials or objects through which water cannot pass in its liquid state.

The term "substantially free" refers to an amount of material that is less than 2%, 1%, 0.5%, 0.25%, 0.1%, 0.05%, 0.01%, or 0.001% by weight of the product, barrier patch, water-soluble film region, water-soluble film-forming polymer, or backing layer of the barrier patch. By "free" is meant no detectable amount of the ingredient or substance.

"biobased content" refers to the carbon content from renewable resources in a material as a percentage of the total organic carbon mass in the material as determined by ASTM D6866-10 method B. It is noted that in determining the biobased content of the material, any carbon from inorganic sources such as calcium carbonate is not included.

"biodegradation" refers to the process of chemical dissolution of a material by microorganisms or other biological processes.

"bioehomogeneous polymer" refers to a polymer made from monomers wherein at least one monomer is derived from a renewable resource. For example, bio-homogeneous polyolefins are made from olefins derived from renewable resources, whereas petroleum-based polyolefins are made from olefins typically derived from non-renewable oils or gases.

"Bionovel polymer" refers to a polymer that is directly derived (i.e., without intermediate compounds in the derivation process) from renewable resources. Such renewable resources include cellulose (e.g., pulp fiber), starch, chitin, polypeptides, poly (lactic acid), polyhydroxyalkanoates, and the like.

"monomeric compound" refers to an intermediate compound that can be polymerized to form a polymer.

As used herein, the term "nonwoven" refers to a porous fibrous material made from continuous (long) filaments (fibers) and/or discontinuous (short) filaments (fibers) by processes such as, for example, spunbonding, meltblowing, carding, and the like. The nonwoven web does not have a woven or knitted filament pattern.

"petrochemicals" refers to organic compounds derived from petroleum, natural gas, or coal.

"Petroleum" refers to crude oil and its constituents of paraffinic, naphthenic and aromatic hydrocarbons. Crude oil may be obtained from tar sands, bitumen fields, and oil shale.

"Polymer directly derived from renewable resources" refers to a polymer derived from renewable resources without intermediates. Typically, these types of polymers will generally be "bio-new".

"post-consumer recycled polymer" refers to a synthetic polymer that is recovered after consumer use and includes recycled polymers from plastic bottles (e.g., laundry bottles, milk bottles, and soda bottles).

"renewable resource" refers to a natural resource that can be replenished within a 100 year period. The resource may be replenished naturally or via agricultural techniques. Renewable resources include plants, animals, fish, bugs, insects, bacteria, fungi, and forestry products. They may be naturally occurring, hybrid, or genetically engineered organisms. Natural resources such as crude oil, coal and peat that take longer than 100 years to form are not considered renewable resources.

Water soluble film zone

The water-soluble film region comprises a water-soluble film-forming polymer and a cosmetic composition comprising an effective amount of a skin active agent. The water-soluble film-forming polymer forms a water-soluble film. As used herein, "water-soluble film" refers to a film that dissolves according to the dissolution method herein.

In one aspect, the water-soluble film region comprises from about 30% to about 99% or from about 40% to about 90%, more preferably from about 50% to about 75%, of the water-soluble film-forming polymer.

As used herein, the "low water environment" of the skin refers to the moisture or water provided under occlusion from one or more endothelial layers of healthy skin to the surface of the skin via pores in the skin. This may include components of sweat, sebum or oil. For example, a low water environment includes moisture that accumulates on the skin when the products herein are applied to the skin for about 1 to 8 hours or more, the products including a backing layer having low breathability (e.g., low WVTR, suitable thickness, etc.) as provided herein.

Thus, when applied to the skin, the water-soluble film region or product can add weight as water/moisture accumulation occurs beneath the product. In one aspect, the% weight gain of the water-soluble film region, water-soluble film or product at 1 hour, 6 hours and/or 24 hours can be from about 10% to about 80%, or from about 20% to about 70%, or from about 20% to about 60%, or from about 25% to about 50%, according to the percent weight gain method herein. When this transition occurs, the skin active agent can be released from the product to the user's skin and absorbed into the skin to have the desired effect. To approximate the weight change of the water-soluble film region, water-soluble films made from water-soluble film-forming polymers can also be used in the process.

Fig. 7 is a bar graph illustrating the effect of blocking on percent weight gain at 1 hour, 6 hours, and 24 hours for certain water-soluble film regions or water-soluble films as described herein. Once the soluble film or product is exposed to a low water environment and/or closed on the skin as described herein, it has a weight change above the initial weight.

The water-soluble film region or product is also capable of reducing modulus as water/moisture build-up occurs under the product when applied to the skin. Thus, the product or water-soluble film region provides a "dynamic" modulus, wherein the modulus decreases during wear to improve the comfort of the product. In one aspect, the water-soluble film, water-soluble film region, or product can have a reduction in modulus of at least 90%, or preferably at least about 95%, or from about 90% to about 100%, preferably from about 96% to about 100%, more preferably from about 97% to about 99%, according to the modulus test herein. When this transition occurs, the skin active agent can be released from the product to the skin to have the desired effect.

Without being bound by theory, the soluble film region or soluble film dissolves, disintegrates and/or loses its physical integrity when exposed to a low water environment. The active substance is released when the water-soluble film region or water-soluble film softens and/or dissolves. Prior to exposure to a low water environment, the soluble film region or water-soluble film is a dry film comprising a water-soluble polymer. In this dry state, it has a first modulus and the water-soluble film region, water-soluble film or product also has a specific weight, such as an initial weight. In one aspect, once the dissolvable film or product is exposed to a low water environment and/or applied to the skin to occlude the skin, it has a second modulus that is lower than the first modulus, and also has a second weight that is higher than the initial weight, as described herein.

Table 1 shows the effect on the modulus of a product or water-soluble film region or water-soluble film when exposed to different temperatures and humidity.

TABLE 1

Methocel E5LV is hydroxypropyl methylcellulose available from Dow Chemical.

In table 1, 25 ℃ represents the approximate temperature before the consumer places the product on the skin, and 37 ℃ represents the approximate temperature when the consumer wears the product on the skin.

In one aspect, the water-soluble film region (at 25 ℃ and 40% RH) has an initial modulus of from about 30MPa to about 600MPa, preferably from about 75MPa to about 500MPa, more preferably from about 100MPa to 450 MPa.

As shown in table 1, the percent reduction in modulus at 37 ℃ for polyethylene oxide with 37% glycerol (PEO with Mw of 200,000) at both 75% RH and 90% RH was 100% compared to the modulus at 25 ℃/40% RH. The same film material without glycerol in sample No. 3 had a percent reduction in modulus at 37 ℃ at 90% RH of 99.2% as compared to the modulus at 25 ℃/40% RH.

The percent reduction in modulus at 37 ℃ at 90% RH for sample number 2 with Methocel and 37% glycerol was 98.80% compared to the modulus at 25 ℃/40% RH.

As can be seen in table 1, foamed EVA, a material that can be used for the backing layer, shows a 36.36% lower modulus at 90% RH at 37 ℃ compared to the modulus at 25 ℃/40% RH. In one aspect, the backing layer comprises one or more layers of ethyl vinyl acetate, wherein the reduction in modulus of the backing layer can be from about 25% to about 50% when the conditions are changed from 25 ℃/40% RH to 37 ℃/90% RH.

In one aspect, the water-soluble film region or water-soluble film has a first modulus that is higher than the modulus of the backing layer or barrier patch. For example, after being worn on the skin at 37 ℃ and 90% RH, the water-soluble film region or water-soluble film has a second modulus that is lower than the modulus of the backing layer or barrier patch. In one aspect, this provides a product that is more comfortable to wear and more easily conforms around the curved surface of the skin, especially when the skin surface is in motion. Thus, in one aspect, the ratio of the modulus of the dissolvable film to the modulus of the backing layer or barrier patch is greater than 1 at 25 ℃/40% RH, where the ratio is less than 1 at 37 ℃/90% RH. In another aspect, the ratio of the modulus of the dissolvable film to the modulus of the backing layer or barrier patch is from about 0.2 to about 2 at 37 ℃/90% RH, or from about 0.2 to about 1 at 37 ℃/90% RH.

In one aspect, when the conditions are changed from 25 ℃/40% RH to 37 ℃/90% RH, the ratio of the modulus of the water-soluble film region (or water-soluble film) to the modulus of the EVA film backing layer is changed from 5.7 (for PEO/37% glycerin) or 19 (methocel/37% glycerin) to < 0.5.

In one aspect, the soluble film region comprises a skin active agent. In one aspect, the skin active agent is only minimally released (if at all) from the soluble film region in dry form prior to use and/or prior to exposure to a low water environment and/or in the absence of moisture or water. When low levels of water contact the soluble film region, softening, dissolution or disintegration begins to occur, thereby enabling the skin active to migrate out of the soluble film region and/or penetrate to the skin surface or into the skin. In one aspect, in the presence of water, it is believed that skin active agents present in the soluble membrane region are more readily available to the skin due to the faster diffusion rate through the soluble membrane region.

In one aspect, the water-soluble film region is substantially free of water, or can comprise less than about 15%, 12%, or 10% water, or can comprise from about 0.001% to about 15% water, or from about 0.05% to about 10% water, by weight of the soluble film region, prior to use by a consumer.

Preferred water-soluble materials for the soluble film region are polymeric materials, preferably polymers that can be formed into films or sheets. As is known in the art, for example, the water-soluble film region may be obtained by casting, blow molding, extrusion or blown extrusion of a polymeric material.

Preferred water-soluble materials for the soluble film region may be selected from polyethylene oxide polymers, polyvinyl alcohol, polyvinyl pyrrolidone, acrylamide, acrylic acid, cellulose ethers, cellulose esters, cellulose amides, polyvinyl acetate, polycarboxylic acids and salts, polyaminoacids or peptides, polyamides, polyacrylamides, copolymers of maleic/acrylic acid, polysaccharides (including starch) and gelatin, natural gums (such as xanthan and carrageenan), polyacrylate and water-soluble acrylate copolymers, polymethacrylates, methylcellulose, carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose, dextrin, maltodextrin, salts thereof, and combinations thereof.

Additional water-soluble materials for the soluble film region may be selected from polyethylene glycol, pullulan, carbohydrate polymers such as natural polysaccharides or derivatives (including pectin and derivatives), sodium alginate, methyl methacrylate copolymers, carboxyvinyl polymers, amylases, pectin, chitin, chitosan, levan, elsinan, collagen, gelatin, zein, gluten, soy protein isolate, whey protein isolate, casein, gums (such as guar gum, gum arabic, tragacanth gum, xanthan gum, gellan gum sodium salt, ghatti gum, okra gum, karaya gum, locust bean gum, tara gum, quince seed gum, fenugreek seed gum, scleroglucan, psyllium seed gum, tamarind gum, oat gum, quince seed gum, rhizobium gum, biosynthetic gums, carapa gum, pectin, arabic, konjac glucomannan, soy protein isolate, whey protein isolate, casein, gums, gum, xanthan gum, quince seed gum, rhizobium gum, biosynthetic gums, xanthan gum, carrageenan gum, pectin, konjac, Galactomannans, funorans, acetans, welan gum, rhamnella gum, furcellaran, succinoglycan, scleroglucan and dextran, flaxseed gum, propylene glycol, alginates, starches (such as amylose, amylopectin, modified starches, hydroxyethyl starch, carboxymethyl starch, high amylose starch, hydroxypropylated high amylose starch, biosynthetic processed starches, starches such as rice, corn, potato and wheat), dextrans, dextrins and maltodextrins, konjac, acetylated mannans from aloe vera, carrageenans, scleroglucans, succinoglycan, xyloglucans, chondroitin sulfate, hyaluronic acid, curdlan, deacetylated konjac, water-soluble non-gelling polypeptides or proteins (such as gelatin, albumin, milk proteins, soy proteins and whey proteins), hydrocolloids (such as synthetic hydrocolloids exemplified by polyethylene-imine), Hydroxyethyl cellulose, sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, ethyl cellulose, polyacrylic acid, low molecular weight polyacrylamides and their sodium salts (carbomers), polyvinyl pyrrolidone, polyethylene glycol, polyethylene oxide, polyvinyl alcohol, pluronics, tetronic acids and other block copolymers, carboxyvinyl polymers and colloidal silica, soluble polyesters, natural seaweed, natural seeds, natural plant secretions, natural fruit extracts, glycyrrhizic acid, polyacrylic acid, vinyl polymers, cationic polymers, acrylic polymers (such as sodium polyacrylate, polyethyl acrylate, and polyacrylamide), and combinations.

In one aspect, the water-soluble film region comprises a polymer selected from the group consisting of polyethylene oxide polymers, polyvinyl alcohol copolymers, starch, methyl cellulose, sodium carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, and combinations.

Preferred polymers, copolymers or derivatives thereof suitable for use as the water-soluble film region are selected from polyethylene oxides, and combinations thereof.

Preferred polymers, copolymers or derivatives thereof suitable for use as the water-soluble film region of the soluble film are selected from methylcellulose, and combinations thereof.

Preferred water-soluble film-forming polymers are made from polyethylene oxides such as polyethylene oxide films or polyethylene glycols, and include Polyox, sold by Dow Chemical Company. Polyethylene oxides include Polyox WSR N-10 (having a molecular weight of 10,000), WSR N-80 (having a molecular weight of about 200,000), WSR N750 (having a molecular weight of about 300,000) with corresponding solubility characteristics. In one aspect, the water-soluble film comprises polyethylene oxide having a molecular weight of from about 500 to about 10,000,000, or from about 10,000 to about 1,000,000, or from about 100,000 to about 300,000, or from about 150,000 to about 250,000.

Another preferred water-soluble film-forming polymer is Methocel E5LV, a low viscosity water-soluble cellulose ether available from Dow/Coloron LTD.

The polyethylene oxide polymer or cellulose ether may be combined with additional polymers, such as polymers, copolymers or derivatives thereof which may be other water soluble film forming polymers. The additional polymer may be selected from the group consisting of polyvinyl alcohol, polyvinyl pyrrolidone, polyalkylene oxides, acrylamide, acrylic acid, cellulose ethers, cellulose esters, cellulose amides, polyvinyl acetate, polycarboxylic acids and salts, polyaminoacids or peptides, polyamides, polyacrylamides, copolymers of maleic/acrylic acid, polysaccharides (including starch) and gelatin, natural gums (such as xanthan and carrageenan), polyacrylates and water-soluble acrylate copolymers, polymethacrylates, methylcellulose, carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose, dextrin, maltodextrin, salts thereof, and combinations thereof. In one aspect, the water-soluble film region comprises a polyethylene oxide polymer and an additional polymer selected from the group consisting of polyvinyl alcohol, polyvinyl alcohol copolymers, starch, methyl cellulose, sodium carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, and combinations.

Also suitable are mixtures of polyethylene oxide polymers having different molecular weights. The additional polymer may have a molecular weight of preferably about 1,000 to 1,000,000, more preferably about 50,000 to 300,000, still more preferably about 20,000 to 150,000.

Preferably, the level of polymer in the water-soluble film region in the dry state is from about 20% to about 90%, or from about 45% to about 85%, or from about 50% to about 70%, by weight of the water-soluble polymer region.

In another aspect, the cosmetic composition may comprise a water-in-oil or oil-in-water emulsion to be combined with a water-soluble film-forming polymer. For example, an oil-in-water emulsion composition such as Olay skin care product can be combined with methylcellulose or hydroxypropyl methylcellulose such as Methocel E5LV (available from Dow Chemical) and used as a water-soluble film region. A water-soluble film-forming polymer (such as Methocel) can be used in excess of a composition comprising an oil-in-water emulsion and a skin active agent. Thus, in one aspect, the water-soluble film region can comprise:

a.) from about 40% to about 70%, by weight of the soluble film region, of a water-soluble film-forming polymer;

b.) from about 30% to about 60%, by weight of the dissolvable film region, of a cosmetic composition comprising a water-in-oil or oil-in-water emulsion, and an effective amount of a skin active agent and optionally a safe and effective amount of a plasticizer.

In one aspect, the ratio of b) to a) in the soluble film region, whether in the wet or dry state, is from about 30:70 to about 70:30, or from about 40:60 to about 60:40, or from about 45:55 to about 55: 45.

Plasticizer

The water-soluble film region herein may further comprise one or more plasticizers. For example, it may be beneficial to add the plasticizer at a level of from about 2% to about 80% or from about 2% to about 60% by weight of the soluble film region or water-soluble film-forming polymer, or from about 10% to about 50% or from about 20% to about 45% by weight. The plasticizer may be, for example, glycerol, ethylene glycol, diethylene glycol, hexylene glycol, triethylene glycol, propylene glycol, polyethylene glycol, polypropylene glycol, alkyl citrates, sorbitol, pentaerythritol, glucosamine, N-methylglucamine, sodium cumene sulfonate, and mixtures thereof. In one aspect, the plasticizer is glycerin. Other plasticizers may include vegetable oils, polysorbates, polyethylene oxides, polydimethylsiloxanes, mineral oils, paraffin waxes, C1-C3 alcohols, dimethyl sulfoxide, N-dimethylacetamide, sucrose, corn syrup, fructose, dioctyl-sodium sulfosuccinate, triethyl citrate, tributyl citrate, 1, 2-propanediol, monoacetates, diacetates, or triacetates of glycerol, natural gums, citrates, and mixtures thereof.

Optional ingredients of the soluble film region

The water-soluble film region or water-soluble film-forming polymer herein may further comprise one or more optional ingredients. Optional ingredients include extenders, fillers, diluents, surfactants, stabilizers, emulsifiers, thickeners, preservatives, binders, colorants, pigments, solubilizers, wetting agents, water-soluble inert fillers, buffering agents, penetration enhancers, and combinations. Thickeners may include gum arabic, carrageenan, karaya gum, tragacanth gum, carob gum, cedar seed or quince, casein, dextrin, gelatin, sodium pectate, sodium alginate, methyl cellulose, ethyl cellulose, CMC, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl alcohol, PVM, PVP, sodium polyacrylate, carboxyvinyl polymers, locust bean gum, guar gum, tamarind gum, cellulose dialkyl dimethyl ammonium sulfate, xanthan gum, magnesium aluminum silicate, bentonite, hectorite, AIMg silicate or begum, laponite and silicic anhydride.

Surfactants may include mono-and diglycerides of fatty acids and polyoxyethylene sorbitol esters, such as, for example, Atmos 300 and polysorbate 80, pluronic acid and sodium lauryl sulfate.

The stabilizer may include xanthan gum, locust bean gum and carrageenan, guar gum, sugar, polyol, amino acid or methylamine. The emulsifier can include triethanolamine stearate, quaternary ammonium compounds, gum arabic, gelatin, lecithin, bentonite, colloidal magnesium aluminum silicate, and sodium benzoate.

Permeation enhancers may include azones, alcohols, dimethyl-sulfoxide, monovalent saturated and unsaturated aliphatic and alicyclic alcohols having 6 to 12 carbon atoms, such as cyclohexanol, lauryl alcohol, and the like; aliphatic and alicyclic hydrocarbons such as mineral oil; alicyclic and aromatic aldehydes and ketones such as cyclohexanone; n, N-di (lower alkyl) acetamides such as N, N-diethylacetamide and N, N-dimethylacetamide, N- (2-hydroxyethyl) acetamide, and the like; aliphatic and alicyclic esters such as isopropyl myristate and dihydroxypropyl laurate; n, N-di (lower alkyl) sulfoxides such as decylmethyl sulfoxide; essential oils, nitrated aliphatics, aliphatic and alicyclic hydrocarbons such as N-methyl-2-pyrrolidone and azone; salicylates, polyalkylene glycol silicates; fatty acids such as oleic acid and lauric acid, terpenes such as eucalyptol, siloxanes such as hexamethylsiloxane; and mixtures thereof.

Detailed description of the drawings

Exemplary aspects of the product 1 are shown in fig. 1, 2A, 2B, 3 and 4. Fig. 1, 2A and 2B show a product 1 comprising a barrier patch 2 with a pressure sensitive adhesive 3 and a backing layer 4. Fig. 2A is a cross-section of fig. 1 taken along fig. 2A-2A. Figure 1 shows a plurality of soluble film regions 6 to create a series of parallel strips offset to the longitudinal axis of the product 1. The product 1 thus has an alternative row of strips of the soluble film region 6 applied to the upper surface 16 of the pressure sensitive adhesive 3.

The product 1 also includes a soluble film region 6 having an effective amount of a skin active agent 8. The backing layer 4 also includes a first surface 10 and a second surface 12. The pressure sensitive adhesive 3 is contacted with at least a portion of the first surface 10 of the backing layer 4 to form a pressure sensitive adhesive coated area 14 of the first surface 10. Product 1 may also comprise a cosmetic composition comprising an effective amount of a skin active agent 8. In one aspect, the pressure sensitive adhesive 3 further comprises a cosmetic composition. In other aspects, the cosmetic composition and the skin active agent 8 are distributed to some extent and/or uniformly throughout the soluble film region 6. The product 1 has a skin-facing surface 5. The skin-facing surface 5 of the product 1 may comprise the upper surface 16 of the pressure sensitive adhesive, the top surface 22 of the water-soluble film region and/or the first surface 10 of the backing layer.

In the aspects of fig. 1, 2A, 2B and 3, the products 1 and 40 are crescent-shaped. However, this shape is not intended to limit the invention.

FIG. 2B is an alternative cross-section of the product of FIG. 1, also taken along 2A-2A. Figure 2B shows a product 1 comprising a barrier patch 2 with a pressure sensitive adhesive 3 and a backing layer 4. The product 1 also includes a soluble film region 6 having an effective amount of a skin active agent 8. The backing layer 4 also includes a first surface 10 and a second surface 12. The pressure sensitive adhesive 3 is contacted with at least a portion of the first surface 10 of the backing layer 4 to form a pressure sensitive adhesive coated area 14 of the first surface 10. The backing layer 4 comprises 3 layers: a non-foamed first layer 26, a foamed second layer 28, and a non-foamed third layer 30. The pressure sensitive adhesive includes an upper surface 16 and a lower surface 18. The soluble film region 6 also includes a top surface 22 and a bottom surface 24. As shown in fig. 2B, the bottom surfaces 24 of the plurality of dissolvable film regions 6 are in contact with the upper surface 16 of the pressure sensitive adhesive 3. As shown in fig. 1, 2A and 2B, the dissolvable film region 6 and the pressure sensitive adhesive 3 are substantially separate, and the pressure sensitive adhesive region 6 is continuous.

Fig. 3 and 4 show a product 40 comprising a barrier patch 42 having a pressure sensitive adhesive 43 and a backing layer 44. Fig. 4 is a section of fig. 3 taken along 4-4. The product also includes a plurality of discrete soluble film regions 46 having an effective amount of a skin active agent 48. The backing layer 44 also includes a first surface 50 and a second surface 52. The pressure sensitive adhesive 43 is contacted with at least a portion of the first surface 50 of the backing layer 44 to form a plurality of pressure sensitive adhesive coated areas 54 of the first surface 50 of the backing layer 44. The product 40 may also include a cosmetic composition that includes an effective amount of a skin active agent 48. In one aspect, the skin active agent 48 is distributed to some extent and/or uniformly distributed in each of the plurality of soluble film regions 46. As shown in fig. 3 and 4, the plurality of soluble film regions 46 and adhesive regions 43 are substantially separated. In fig. 4, the dissolvable film region 46 is in contact with the first surface 50 of the backing layer 44. As shown in fig. 4, in one aspect, the top surface 62 of the dissolvable film region and the upper surface 66 of the pressure sensitive adhesive region 43 are coplanar or collinear. Additionally, the bottom surface 64 of the dissolvable film region and the lower surface 68 of the pressure sensitive adhesive region can be coplanar or collinear.

Fig. 5 shows a product showing an alternative pattern of discontinuous soluble film regions 70, wherein the soluble film regions 70 are configured as a series of repeating diamonds.

Fig. 6 shows a product showing an alternative pattern of discontinuous soluble film regions 72, where the soluble film regions 72 are a series of repeating curved strips.

Fig. 8 shows Franz cell permeation for the following data: (A) in an oil-in-water emulsion applied without blocking; (B) an oil-in-water emulsion closed by a polyethylene terephthalate (PET) film; (C) methocel e5LV film applied without blocking; and (D) Methocel E5LV film blocked with PET film. Both the emulsion and Methocel membranes each contained 2% inositol. These data indicate that Methocel E5LV in the form of a dry film, which is not blocked via the backing layer, releases myo-inositol either not or only minimally, but when it is blocked, Methocel E5LV film dissolves and releases myo-inositol. This is also the case with emulsions. Thus, the backing layer herein provides a seal via, for example, a low WVTR, increasing the delivery of the active to the skin. The Franz cell device can be used to assess in vitro the penetration of an active substance, such as inositol, through a skin mimic after pretreatment with a protective composition, after application of the sample. The permeated active substance such as inositol can be quantified using reverse phase high performance (or pressure) liquid chromatography (RP-HPLC), with external standard quantitation at 240 nm. See, for example, the Franz cell procedure in EP2561856a1 to P & G.

Barrier patch

In one aspect, the barrier patch may include: a backing layer having a first surface and a second surfaceFlour, and about 1g/m²24h to about 500g/m²WVTR of/24 h; and a pressure sensitive adhesive zone having an upper surface and a lower surface, and the pressure sensitive adhesive being contactable with the first surface of the backing layer.

The backing layer may be a coextruded film laminate comprising at least two layers, but may comprise 3,4, 5,6 or more layers. In one aspect, the backing layer or product or non-foamed first layer is substantially free of open cells.

As used herein, "open cell" refers to a membrane having openings of a size and shape that allow liquid molecules to pass through the membrane.

The barrier patch of the present invention may comprise a solid sheet material. The sheet provides the product with a primary structure and shape allowing it to be treated and applied to treat a specific target area of skin.

In certain aspects, the backing layer is generally made of a flexible film material that is capable of remaining conformable and bending during human body movements and particularly movements associated with facial expressions or gestures. By "flexible" is meant that the product, barrier patch and/or backing layer can be substantially bent or folded without breaking, tearing, ripping, etc.

In one aspect, the product or barrier patch does not collapse or fold under gravity or when handled and applied by the user. It is desirable for the product to conform to the targeted area of the skin surface to which it is applied, but not fold, wrinkle or cause more wrinkling of the targeted area of skin. Thus, as the user moves during the wearing period, the product or barrier patch readily conforms to the skin and remains flexible throughout use.

In certain aspects, the products of the invention are characterized by barrier patches, adhesive regions, and/or backing layers that are substantially free of, contain only a non-effective amount of, or contain no or no skin active agents. Thus, the barrier patch, adhesive region, and/or backing layer of the present invention can be characterized as a "blank" backing layer, adhesive region, or barrier patch. In this regard, in one aspect, the effective amount of skin active agent employed in the products herein is substantially separate from the barrier patch, the adhesive zone, and/or the backing layer. In one aspect, the pressure sensitive adhesive region and the water-soluble film region are substantially separate. As used herein, the term "substantially separate" means that one component is substantially free of another component.

In one aspect, the backing layer may be a laminate comprising a film and a nonwoven material (e.g., cotton, rayon, acrylic, polypropylene, polyester, and combinations), with the proviso that the laminate has about 1g/m²24h to about 500g/m²WVTR of/24 h.

One or more layers of the barrier patch may comprise at least one material including, but not limited to, polypropylene (PP); polyethylene (PE), metallocene plastomers, metallocene elastomers, High Density Polyethylene (HDPE), rubber modified LDPE, rubber modified LLDPE, acid copolymers, polystyrene, cyclic polyolefins, polyethylene terephthalate (PET); polyvinyl chloride (PVC); polyamide (PA); a polycarbonate; a polyurethane; cellulose acetate; polychloroprene; polysulfones; polytetrafluoroethylene (PTFE); polyvinyl acetate (PVA); a polyethylene terephthalate film; polystyrene; polyphenylene Oxide (PPO); acrylonitrile Butadiene Styrene (ABS); acrylic acids; acrylonitrile Styrene Acrylate (ASA); ethylene vinyl alcohol, natural rubber, latex, nylon, nitrile, silicone and thermoplastic elastomers (TPE), Ethylene Vinyl Acetate (EVA), Ethylene Acrylic Acid (EAA), copolymers of PE and PP, bimodal resins, any of which may be derived from homopolymers or copolymers, and blends and combinations of these materials. The blend may be a physical blend or a reactor blend. The layer may comprise a single polymer or a mixture of polymers or copolymers. Laminates of these layer materials may also be used.

One or more of the backing layers herein may comprise polyethylene. The term "polyethylene" or "PE" is used herein in the broadest sense to include PEs, copolymers, blends, catalysts, etc. having any of a variety of resin grades, densities, branch lengths. The layer may comprise a blend of different grades of polyethylene, which may include LLDPE, LDPE, VLDPE, HDPE, or MDPE, or combinations thereof; made using Ziegler-Natta (Ziegler-Natta) catalysts, chromium catalysts, metallocene-based catalysts, single site catalysts, and other types of catalysts. The polymer may comprise a homopolymer or a copolymer. The blend may be a physical blend or a reactor blend. These materials may be bio-based, petroleum-based, and recycled/reground. The LLDPE copolymers can be made from any one or more of butene, hexene and octene comonomers. The ratio of the different levels may be different.

Preferred materials for one or more layers of the backing layer include ethylene vinyl acetate, EVA (CAS number 24937-78-8) copolymer. Different grades of EVA tend to have different ethylene to vinyl acetate monomer ratios and/or different melt indices (molecular weights). For example, the percentage of VA monomers can range from about 20% to about 50%, or from about 25% to about 40% VA, or from about 25% to about 30% VA. For example, the melt flow index can be in a range from about 0.7dg/min to about 60dg/min, and/or from about 2dg/min to about 6dg/min, and/or from about 2dg/min to about 4 dg/min. EVA grades useful herein include DupontGrade: 260 (28% VA; melt flow index MFI 6dg/min, measured via ASTM D1238); grade 250 (28% VA; MFI 25 dg/min); grades 150 and 150W (32% VA; MFI 43 dg/min); grade 40W (40% VA; MFI 52 dg/min); and Celanese2803G (28% VA; MFI 3dg/min, measured via ASTM D1238) and1807EG(18％VA；MFI 0.7dg/min)。

another preferred material for the backing layer or barrier patch is a polyethylene film sold under the trade name 1525L available from 3M, st. 3M 1525-L has a backing of approximately 3 mil thick polyethylene film, a 1.4 mil thick hypoallergenic pressure sensitive acrylate adhesive layer, and a paper release layer coated with polyethylene and silicone (3M 1525L can be used without the release layer).

A color masterbatch comprising pigments and/or slip/antiblock agents and/or liquid colorants may also be added to the backing layer to provide certain aesthetics and functionality.

If present, the pigment can generally be used at a concentration of about 0.5 wt% to about 15 wt%, and/or about 1 wt% to about 10 wt%, or about 1.5 wt% to about 7 wt%, based on the total weight of the polymer (e.g., backing layer).

Other additives are further detailed in U.S. patent publications including U.S. patent application serial No. 13/924983(P & G US 2014/0376835; case No. 12966Q), filed 24.6.2013; and us patent application serial No. 13/924999(P & G No. 12967Q), filed 24/6/2013, and the references cited therein.

For example, the backing layer of the barrier patch may contain additives such as slip agents or antistatic agents (e.g., erucamide, stearamide), fillers (e.g., talc, clay, pulp, titanium dioxide, thermoplastic starch, raw starch wood flour, diatomaceous earth, silica, inorganic glass, inorganic salts, pulverized plasticizers, pulverized rubber), pigments (e.g., mica, titanium dioxide, carbon black), UV inhibitors, anti-colorants, mold release agents, flame retardants, conductive agents, antioxidants, impact modifiers, stabilizers (e.g., UV absorbers), wetting agents, carbon, graphene, and biodegradable reinforcing additives (e.g., oxidatively degradable additives or organic materials). The oxo-degradable additive is often compounded into the polymer at a concentration of about 1 wt% to about 5 wt%, based on the total weight of the polymer, and comprises at least one transition metal that is capable of promoting oxidation and chain scission in plastics when exposed to heat, air, light, or mixtures thereof. Organic materials (e.g., cellulose, starch, ethylene vinyl acetate, and polyvinyl alcohol) can also be used as biodegradable-enhancing additives, although they are not capable of promoting degradation of the non-degradable portion of the polymer matrix.

In a preferred aspect, the multilayer coextruded backing layer has at least three layers, and is preferably an ethylene vinyl acetate ("EVA") containing film. In a preferred aspect, the foamed layer is located between layers of the non-foamed layer, e.g., a non-foamed first layer and a non-foamed third layer on either side.

In one aspect, the barrier patch comprises a backing layer comprising:

(i) a non-foamed first layer comprising a non-foamed polymeric film having a first surface;

(ii) a foamed second layer comprising a foamed polymer film having an average void volume percentage of 45% to 80%, preferably 50% to 75%, more preferably 55% to 73%, and a thickness of 10 microns to 250 microns, preferably 40 microns to 160 microns.

Techniques for measuring average void volume percent are described in U.S. serial No. 62/257,341; 62/257,347 and 62/257,351. The degree of foaming of the foamed layer can be characterized by the average void volume percent as determined by X-ray microcomputer tomography or simply "micro CT".

In one aspect, the foamed layer comprises an average void volume percentage (relative to the overall volume of the foamed layer) of from 45% to 80%, preferably from 50% to 75%, more preferably from 55% to 73%.

In one aspect, the backing layer of the barrier patch comprises three layers, for example a foamed second layer optionally comprising EVA and a non-foamed EVA layer, i.e. a first non-foamed EVA layer and a third non-foamed EVA layer, on either side, with the foamed EVA layer located between the first and third non-foamed layers.

In one aspect, the multilayer barrier patch and/or backing layer is substantially free of fibers, nanofibers, or nonwoven materials, such as cotton, rayon, acrylic, polypropylene, polyester.

In another aspect, the barrier patch and/or backing layer includes a corona treatment. For example, the backing layer or barrier patch may be additionally treated, for example by corona discharge or coated with an adhesion promoter which acts as a primer to influence the anchoring of the active substance and the adhesive.

The material composition and/or polymer resin used in the foamed layer may be different than those used in the non-foamed layer or layers, as the material composition and/or resin may be optimized for foam formation or other film layer properties. Additives may be included, in particular small amounts selected from CaCO₃Clay, talc, and combinations thereof, for rapid foam formation during the foaming process.

The resin used to make the backing layer or layers of the barrier patch may include renewable materials, "bio-homogeneous" or "bio-new" materials, or combinations thereof. Some non-limiting options for suitable bio-homogeneous and/or bio-new materials are further detailed in the following U.S. patent publications: U.S. patent application serial No. 13/924983 (P) filed 24/6/2013&G US 2014/0376835), pages 15-22; and us patent application 13/924999 filed 24.6.2013 (P)&G US 2014-0377512 A1；P&G case No. 12967Q), pages 12-20. For example, the barrier patch may include at least one layer made of a plastic resin. The resin may be a conventional petroleum-based polyolefin, or it may be a renewable-based polyolefin, or blends thereof. Alternatively, it may be a blend comprising a petroleum-based or renewable-based polyolefin blend mixed with a renewable "bio-new" material that is chemically different from traditional petroleum-based polyolefins. The film layer may consist of a material or a mixture of materials, which has a useASTM D6866-10, total biobased content of about 10% to about 100% of method B. In one aspect, the layer may comprise from about 5 wt% to about 99 wt% of a polymer (a) comprising at least one or possibly more of: low Density Polyethylene (LDPE), polar copolymers of polyethylene such as Ethylene Vinyl Acetate (EVA), Linear Low Density Polyethylene (LLDPE), high density polyethylene homopolymer/high density polyethylene copolymer, medium density polyethylene, Very Low Density Polyethylene (VLDPE), plastomers, polypropylene/copolypropylene/heterophasic polypropylene, polyethylene terephthalate (PET), PLA (e.g. from Natureworks), Polyhydroxyalkanoates (PHA), poly (ethylene 2, 5-furandicarboxylate) (PEF), cellulose (e.g. from Innovia), NYLON 11 (i.e. from Arkema)) Starch (thermoplastic starch or starch fillers), biobased polyesters (e.g., those made from biological glycerol, organic acids and anhydrides, as described in U.S. patent application 2008/0200591, which is incorporated herein by reference), polybutylene succinate, polyglycolic acid (PGA), and polyvinyl chloride (PVC). At least one of the components of polymer (a) may be at least partially derived from renewable resources. Recycled materials may also be added. In particular cases, biodegradable materials may be utilized.

Some of the "bio-new" materials may also contribute to the reflection of the film, as the presence of this additional material within the film layer structure may lead to additional light reflection due to its typical incompatibility with the polyolefin matrix.

Adhesive zone

The barrier patch may include a backing layer and a pressure sensitive adhesive region. Typically, the pressure sensitive adhesive region comprises a Pressure Sensitive Adhesive (PSA) which is suitable for long term skin contact and should be physically and chemically compatible with the backing layer and/or additives present. Examples of suitable binder materials include, but are not limited to, the following: acrylate and methacrylate homopolymers or copolymers, butyl rubber based systems, silicones, urethanes, vinyl esters and amides, olefin copolymer materials, natural or synthetic rubbers, hot melt adhesives (see, e.g., U.S. Pat. No. 5,387,450); polyethylene; a polysiloxane; polyisobutylene; a polyacrylate; polyacrylamide; a polyurethane; plasticized ethylene vinyl acetate copolymer; and adhesive rubbers such as polyisobutylene, polybutadiene, polystyrene-isoprene copolymers, polystyrene-butadiene copolymers, and neoprene (polychloroprene), and combinations thereof.

According to one aspect, the adhesive is a hot melt adhesive comprising an adhesive selected from the group consisting of ethyl vinyl acetate, metallocene poly α -olefins, polyolefins including atactic poly α olefins, block copolymers such as diblock copolymers and triblock copolymers, polyurethane hot melts, polyamides, and combinations thereof.

The high viscosity triblock copolymer is useful as an adhesive and has a configuration a-B-a, where polymer block a is a non-elastomeric polymer block having a glass transition temperature greater than 20 ℃ as a homopolymer. The elastomeric polymer block B is generally isoprene or butadiene, or a mixture thereof, which may be partially or substantially hydrogenated. In addition, the copolymers may be linear or branched.

The diblock copolymer may generally have an A-B configuration, wherein A and B are as previously described.

A liquid diluent may be added to the adhesive composition. The adhesive composition may comprise from about 60% to about 99% by weight of the diluent. In one aspect, the majority of the liquid diluent is oil. Preferably the liquid diluent comprises, or consists essentially of, an oil such as a highly refined white petroleum mineral oil. Useful diluents are primarily characterized as being aliphatic and compatible with the polymer midblock. Plasticizers may also be included, for example, paraffinic and naphthenic petroleum oils, highly refined non-aromatic paraffinic and naphthenic food and technical grade oils, highly refined white petroleum mineral oils, and liquid tackifiers, synthetic liquid oligomers such as polybutylenes, polypropylenes, polyterpenes, and the like. Synthetic process oils can be high viscosity oligomers, which can be permanent fluid/liquid mono-olefins, isoparaffins, or medium to high molecular weight paraffins.

In one aspect, the binder is selected from HenkelAnd DERMA-Brands, e.g. TECHNOMET PSM 154AThe DERMA-TAK product is a pressure sensitive adhesive and includes both solvent based acrylic pressure sensitive adhesives and formulated rubber (liquid and hot melt) pressure sensitive adhesives. Useful adhesives may also be selected from those described in U.S. Pat. Nos. 6,448,303 and 5,559,165.

In one aspect, the pressure sensitive adhesive region is continuous, discontinuous, or a combination thereof. The product may also include a plurality of discrete adhesive regions.

Thickness of

In one aspect, the overall total thickness of the barrier patch or product is from 20 microns to 500 microns, preferably from 50 microns to 200 microns, more preferably from 70 microns to 180 microns, still more preferably from 75 microns to 150 microns, and combinations thereof.

In another aspect, the water-soluble film region (in the dry state) has a total thickness of from about 2 microns to about 200 microns, preferably from 50 microns to about 175 microns, more preferably from about 75 microns to about 170 microns. In one aspect, the water-soluble film region in the dry state has a thickness of from about 5 microns to about 50 microns, or from about 15 microns to about 30 microns.

In one aspect, the pressure sensitive adhesive region typically has an average thickness in a range of from about 5 microns to about 350 microns, and in an alternative aspect, from about 10 microns to about 120 microns.

In one aspect, typical basis weights for the products herein range from about 40gsm to about 190gsm, for example from about 45gsm to about 170gsm and/or from about 50gsm to about 140 gsm.

Continuous or discontinuous zones

The pressure sensitive adhesive region and the water-soluble film region can be continuous or discontinuous such that they comprise a continuous or discontinuous pattern. In one aspect, the adhesive region and the soluble film region can both be continuous. In some aspects, a portion of the adhesive region and the soluble film region are continuous, while another portion may be discontinuous. By applying the dissolvable film region and the adhesive region to the backing layer in a discontinuous pattern, a portion of the skin-facing surface of the product and the adhesive region remain exposed to the skin to allow for adequate adhesion to the skin via the pressure sensitive adhesive. In one aspect, the dissolvable film region should be applied to the adhesive region such that it covers from about 1% to about 99% of the skin-facing surface area of the adhesive region or product, or from about 10% to about 90%, and/or from about 20% to about 80% of the skin-facing surface area of the adhesive region or product.

In one aspect, the pressure sensitive adhesive zones are applied to the backing layer in a pattern to define a pattern of discrete adhesive-free areas, and the dissolvable film zone is applied to the adhesive-free areas of the backing layer. In another aspect, the pressure sensitive adhesive zones are applied to the backing layer in a series of rows or stripes to define a pattern of adjacent adhesive free areas that are stripes or rows, and the dissolvable film zone is applied to the adhesive free areas/stripes of the backing layer.

The dissolvable film region can be applied to the adhesive region or backing layer in a regular pattern, a random pattern, and combinations thereof. For example, the soluble film region may be configured in a regular or random pattern of elements, such as straight lines, angled lines, curved lines, intersecting lines, dots, circles and geometric shapes, amorphous shapes, and the like, or combinations of these elements.

Size and shape of the product

The product may have a size and shape suitable to conform to a desired target area of skin, which may be a human face or a portion thereof, legs, hands, arms, feet, or a human torso. Which is generally flat in appearance.

The exact size and shape of the product will depend on the intended use and product characteristics. The products herein may be, for example, square, circular, semi-circular, rectangular, triangular, oval, annular, crescent with rounded corners, teardrop, or other more complex and irregular shapes. The shape of the barrier patch may be selected from circular, square, rectangular, triangular, and/or irregular shapes that conform to the contours of the forehead, perioral, and/or periorbital regions of a human face.

In certain other aspects, the product includes a size and shape for treating different areas of the face, such as the forehead, the under-eye area, and the under-eye area in combination with the crow's feet area around the eyes. Thus, the size of the product may be determined by the size of the target area of skin to be treated. Thus, the product is shaped to fit the target area of the face or skin, and the surface area may be about 0.25cm²To about 50cm²And/or about 1cm²To about 30cm²And/or about 1cm²To about 20cm²And/or about 1cm²To about 15cm²And/or about 5cm²To about 15cm²Within the range of (1). Surface area refers to the surface area of a flat plane having the same boundaries as the surface, i.e. ignoring the presence of any surface texture.

WVTR

According to one aspect, the backing layer or barrier patch has about 1g/m²24h to about 500g/m²A WTVR value of/24 h, and in another aspect about 1g/m²24h to about 250g/m²24h, and/or about 1g/m²24h to about 180g/m²24h, and/or about 2g/m²24h to about 150g/m²24h, and/or about 2g/m²24h to about 20g/m²WVTR of/24 h. The term WTVR denotes "water vapor transmission rate", i.e. the amount of vapor that can pass per unit area during a certain period of time.

In certain aspects, the backing layer or barrier patch is non-porous or water impermeable. In certain other aspects, the multilayer barrier patch or backing layer is impermeable to cosmetic compositions, dissolvable film regions, skin care actives employed, and fluids, wherein the WVTR is about 2g/m²24h to about 100g/m²And/24 h. While not being bound by theory, the use of a backing layer or barrier patch that minimizes water loss from the dissolvable film or cosmetic composition while in contact with the keratinous tissue and skin, once hydrated, prevents the water-soluble film region or cosmetic composition from drying out. This drying out can lead to a reduction or loss of efficacy and/or irritation of the skin.

Such relative water impermeability and lower water vapor permeability of the barrier patch may increase the effectiveness and efficiency of the cosmetic composition. For example, without being bound by theory, the relative water impermeability and lower vapor permeability of the barrier patches employed may serve to enhance or increase the penetration of the skin care active into the skin.

In certain aspects, the backing layer or barrier patch may, for example, consist of a perforated polyolefin film, wherein the size of the holes is selected such that air and vapor can pass through but liquid molecules cannot. One example of such ｃA membrane is described in us patent 5,628,737, and/or ｃA microporous plastic film, as described for example in EP- ｃA-0238200. However, these laminates and films are not preferred herein due to their relatively high WVTR and higher level of breathability.

Peeling layer

The products herein can also optionally include a protective release layer removably attached to the consumer-facing side of the pressure sensitive adhesive or soluble film region of the product. The release layer provides protection from the environment to the pressure sensitive adhesive region and/or the soluble film region prior to application by the user.

The protective release layer may comprise a material including a polymeric resin such as a polyolefin, for example polypropylene (including layered biaxially oriented polypropylene (SBOPP)), polyethylene (including LDPE; LLDPE; HDPE; metallocene) or polyethylene terephthalate, polyester, and combinations thereof. Alternative materials that may be used include polyvinyl chloride, polyamides, acetyl, acrylonitrile butadiene styrene, acrylic, acrylonitrile styrene acrylate, ethylene vinyl alcohol, ethylene vinyl acetate, nylon, latex, natural or synthetic rubber, polycarbonate, polystyrene, silicone or thermoplastic elastomers, thermoplastic vulcanizates or copolymers of the materials, and combinations thereof. Where appropriate, the protective release layer may comprise one or more laminates, combinations of layers. In one aspect, the protective release layer may comprise a coating of a non-stick material. Exemplary non-stick coatings include waxes, silicones, fluoropolymers such asAnd fluorosilicones.

In one aspect, the protective release layer covers the entire aforementioned area of the pressure sensitive adhesive region of the coated barrier patch. In another aspect, the protective release layer is water impermeable. In another aspect, the release layer has an average thickness of at least about 50 microns, or at least about 85 microns, or from about 50 microns to about 150 microns, and/or from about 90 microns to about 120 microns.

The release layer may optionally extend fully or partially beyond the pressure sensitive adhesive region to provide a removal tab that facilitates removal of the release layer.

Cosmetic composition

Skin active agent

In one aspect, the product provides an effective amount of a drug to be delivered toA skin active agent of a target area of the skin. In another aspect, the product provides about 0.5mg/cm to a target area of skin²To about 3mg/cm2, and/or from about 1mg/cm2 to about 2mg/cm 2. In one aspect and without being bound by theory, the use of an appropriate amount of the cosmetic composition will minimize the interaction of the cosmetic composition with the pressure sensitive adhesive. The compositions of the present invention may comprise skin active agents that provide specific skin care benefit characteristics in the use of skin care products. Skin care benefit agents may include benefits relating to the appearance of skin or color cosmetics. Skin care actives can provide short-term (immediate and short-lived) benefits or long-term (long-term and long-lasting) benefits.

As used herein, the term "skin active agent" refers to an active ingredient that can provide a cosmetic and/or therapeutic effect to an application area on the skin. Skin actives useful herein include skin lightening agents, anti-acne agents, emollients, non-steroidal anti-inflammatory agents, local anesthetics, artificial tanning agents, antimicrobial and antifungal actives, skin soothing agents, sunscreens, skin barrier repair agents, anti-wrinkle agents, anti-skin atrophy actives, lipids, sebum inhibitors, skin sensates, protease inhibitors, anti-itch agents, desquamation enzyme enhancers, anti-glycation agents, diaper rash agents, anti-eczema agents, botanicals, and mixtures thereof. When included, the compositions of the present invention comprise a safe and effective amount of a skin active agent, and/or from about 0.0001% to about 20%, and from about 0.01% to about 10% of at least one skin active agent in another aspect.

The cosmetic composition may comprise from about 0.00001% to about 10%, or from about 0.01% to about 8%, or from about 0.05% to about 5%, by weight, of the plant active. "botanical drug" herein refers to a substance, extract or derivative of a plant, and may also be described as "herb". Botanicals can include water-soluble or oil-soluble active materials extracted from specific plants, including materials extracted from: echinacea, yucca, willow herb, basil leaf, turkey oregano, carrot root, grapefruit fruit, anise fruit, rosemary, thyme, blueberry, bell pepper, black tea, blackberry, blackcurrant fruit, chinese tea, coffee seed, dandelion root, date palm fruit, ginkgo leaf, green tea polyphenols (such as epicatechin gallate and epigallocatechin 3-O-gallate), hawthorn berry, licorice, oolong tea, sage, strawberry, sweet pea, tomato, vanilla fruit, neohesperidin, quercetin, rutin, morin, myricetin, chlorogenic acid, glutathione, glycyrrhizin, wormwood, arnica, centella asiatica, chamomile, violacean, cornflower, horse chestnut, ivy (ivy) (Hederahelix), magnolia, mimosa, oat extract, pansy, scutellaria, sea buckthorn, buckthorn (hippophae), sage, olive, black currant, olive, white nettle, witch hazel and any combination thereof.

The type and amount of skin active agent is selected such that the inclusion of a particular agent does not affect the stability of the composition. For example, the hydrophilic agent may be incorporated in an amount soluble in the aqueous phase while the lipophilic agent is incorporated in an amount soluble in the oil phase.

Other skin active agents are intended to exhibit expression line relaxation benefits for use in the present invention, including but not limited to Lavandox, available from Barnet Products Corporation; thallnasine 2 from BiotechMarine; argiline NP from Lipotec; gatuline In-Tense and Gatuline expression from Gattefosse; myoxinol LS 9736 available from BASF Chemical Company, Syn-ake available from DSM Nutritional products, Inc.; and available from Silab, IncSesaflash from Seppic Inc^TM。

Skin lightening agents useful herein refer to active ingredients that are capable of ameliorating hyperpigmentation as compared to prior treatment. Useful skin lightening agents herein include ascorbic acid compounds, vitamin B₃Compound, azelaic acid, butyl hydroxy anisole, gallic acid and its derivatives, glycyrrhizic acid, hydroquinone, kojic acid, arbutin, mulberry extract, and mixture thereof. It is believed that the use of a combination of skin lightening agents is advantageous because they can provide skin lightening benefits through different mechanisms.

The ascorbic acid compounds useful herein include ascorbic acid, ascorbic acid salts, and derivatives thereof, which are L-forms per se. Ascorbate salts useful herein include sodium, potassium, lithium, calcium, magnesium, barium, ammonium and protamine salts. Ascorbic acid derivatives useful herein include, for example, esters of ascorbic acid and ester salts of ascorbic acid. Particularly preferred ascorbic acid compounds include 2-o-D-glucopyranosyl-L-ascorbic acid (which is an ester of ascorbic acid and glucose and is commonly referred to as L-ascorbic acid 2-glucoside, or ascorbyl glucoside) and metal salts thereof, and L-ascorbic acid phosphate salts such as sodium ascorbyl phosphate, potassium ascorbyl phosphate, magnesium ascorbyl phosphate, and calcium ascorbyl phosphate. Commercially available ascorbic acid compounds include magnesium ascorbyl phosphate from Showa Denko, 2-o-D-glucopyranosyl-L-ascorbic acid from Hayashibara, and sodium L-ascorbyl phosphate from Roche under the trade name STAY C.

Vitamin B useful herein₃Compounds include, for example, those having the formula:

wherein R is-CONH₂(e.g., nicotinamide) or-CH₂OH (e.g., nicotinyl alcohol); derivatives thereof; and salts thereof. The aforementioned vitamin B₃Exemplary derivatives of the compounds include nicotinic acid esters, including non-vasodilating nicotinic acid esters, nicotinyl amino acids, nicotinyl alcohol esters of carboxylic acids, nicotinic acid N-oxide, and nicotinamide N-oxide. Preferred vitamin B₃The compounds are niacinamide and tocopherol nicotinate, and on the other hand niacinamide. In a preferred aspect, vitamin B₃The compounds comprise limited amounts of salt forms and more preferably are substantially free of vitamin B₃Process for preparing compoundsAnd (3) salt. Preferably vitamin B₃The compounds comprise less than about 50% of such salts, and more preferably are substantially free of salt forms. Commercially available vitamin B compounds highly useful herein₃The compounds include nicotinamide USP available from Reilly.

Other hydrophobic skin lightening agents useful herein include ascorbic acid derivatives such as ascorbyl tetraisopalmitate (e.g., VC-IP from Nikko Chemical), ascorbyl palmitate (e.g., from Roche Vitamins), ascorbyl dipalmitate (e.g., NIKKOL CP from Nikko Chemical); undecylenoylphenylalanine (e.g., SEPIWHITE MSH from Seppic); octadecenedioic acid (e.g., arlatondioic DCA available from Uniquema); evening primrose seed extract, and apple (apple) fruit extract, water and Myritol 318 and butylene glycol and tocopherol and sscorbil tetraisopalmitate and paramben and Carbopol 980 and DNA/smart vector UV (from colorica), magnesium ascorbyl phosphate in hyaluronic acid filled spheres (from colorica), and mixtures thereof.

Other skin active agents useful herein include those selected from N-acetyl D-glucosamine, panthenol (e.g., DL panthenol, available from Alps Pharmaceutical Inc.), tocopherol nicotinate, benzoyl peroxide, 3-hydroxybenzoic acid, flavonoids (e.g., flavanone, chalcone), farnesol, phytantriol, glycolic acid, lactic acid, 4-hydroxybenzoic acid, acetyl salicylic acid, 2-hydroxybutyric acid, 2-hydroxyvaleric acid, 2-hydroxycaproic acid, cis-retinoic acid, trans-retinoic acid, retinol, retinyl esters (e.g., retinol propionate), phytic acid, N-acetyl-L-cysteine, lipoic acid, tocopherol and esters thereof (e.g., tocopherol acetate: DL- α -tocopherol acetate, available from Eisai), azelaic acid, arachidonic acid, tetracycline, naproxen, ketoprofen, hydrocortisone, acetaminophen, resorcinol, phenoxyethanol, phenoxypropanol, phenoxyisopropanol, 2,4,4 '-trichloro-2' -hydroxydiphenyl ether, 3,4 '-hydroxychlorobenzene, 4,4' -meconazole, propiconazole, doxyconazole, pivaloin, and mixtures thereof.

In various aspects, the compositions of the present invention can comprise an N-acyl amino acid compound. Suitable N-acyl amino acid compounds include, but are not limited to, N-acyl phenylalanine, N-acyl tyrosine, isomers thereof (including D and L isomers thereof), salts, derivatives, and mixtures thereof. An example of a suitable N-acylamino acid is N-undecylenoyl-L-phenylalanine, which is commercially available from Seppic (France) under the trade name SEPIWHITE (registered trade Mark).

Skin care agents are also disclosed in U.S. publication 2007/0020220a1, published on month 1 and 25 of 2007, wherein the components/ingredients are incorporated herein by reference in their entirety.

The cosmetic composition may comprise one or more peptides. Herein, "peptide" refers to peptides comprising ten or fewer amino acids, their derivatives, isomers, and complexes with other substances such as metal ions (e.g., copper, zinc, manganese, and magnesium). As used herein, peptide also refers to both naturally occurring peptides and synthetic peptides. In one aspect, the peptides are di-, tri-, tetra-, penta-, and hexapeptides, their salts, isomers, derivatives, and mixtures thereof. Examples of useful peptide derivatives include, but are not limited to, peptides derived from soy protein, palmitoyl-lysine-threonine (pal-KT), and palmitoyl-lysine-threonine-lysine-serine (pal-KTTKS, present in what is known asIn the composition of (a)), palmitoyl-glycine-glutamine-proline-arginine (pal-GQPR, present in what is called a pal-GQPROf (e), commercially available from sederma (france), and Cu-histidine-glycine (Cu-HGG, also known as). At each sideThe cosmetic composition may comprise about 1 × 10^-7% to about 20%, alternatively about 1X 10^-6% to about 10%, and alternatively about 1X 10^-5% to about 5% peptide.

In one aspect, the skin active agent is niacinamide. In one aspect, the agent is a combination of niacinamide, glycerol, tocopherol acetate, and d-panthenol. Niacinamide may be included in the composition in an amount of from about 1% to about 30% by weight, in another aspect, from about 2% to about 28% by weight, in another aspect, from about 5% to about 25% by weight, and in another aspect, from about 10% to about 20% by weight. When d-panthenol is included, it may be present in an amount of about 0.5 wt% to about 5 wt%, or about 0.5 wt% to about 3 wt%, and/or about 0.5 wt% to about 2 wt%. Glycerin may be included as an active in an amount of about 6 wt% to about 20 wt%, and/or about 8 wt% to about 15 wt%, and/or about 10 wt% to about 15 wt%.

In various aspects, the skin active agent is selected from niacinamide, alone or in combination with one or more of the following: palmitoyl-lysine-threonine, palmitoyl-lysine-threonine-lysine-serine, N-undecyl-10-enoyl-L-phenylalanine, retinol propionate, N-acetyl glucosamine, vitamin C, tretinoin, salicylic acid, benzoic acid, benzoyl peroxide, tretinoin, and combinations thereof.

In one aspect, the cosmetic compositions herein may be aqueous solutions or emulsions, such as oil-in-water emulsions, water-in-oil emulsions, or multiple emulsions with aqueous or oily outer phases. In another aspect, the cosmetic compositions herein are oil-in-water emulsions.

In one aspect, to avoid adverse interaction with the pressure sensitive adhesive, the cosmetic composition or water-soluble film region comprises only about 0.5% to about 10% and/or about 1% to about 5% of a low level of silicone and/or the cosmetic composition is substantially free of silicone. As used herein, "silicone" may refer to those disclosed in US 2007/0020220a1 (e.g., paragraphs [0226] to [0258 ]) to Osborne, published on 25/1/2007.

In one aspect, the cosmetic composition is substantially free of depilatory agents.

The cosmetic composition or water-soluble film region can comprise an effective amount of a skin active agent having activity to improve the visual or aesthetic appearance of skin, such as an agent effective to reduce or eliminate the appearance of fine lines and/or wrinkles on the skin of a human face or an agent effective to treat existing acne lesions, reduce redness associated with acne lesions, and/or prevent the formation of acne lesions.

In another aspect, a method of treating skin is provided that includes applying a product to a target area of skin, the product including an effective amount of a skin active agent.

The methods of treating, applying, modulating, or improving disclosed herein can utilize the aforementioned products and/or multilayer barrier patches. Application of the product of the invention may occur on any target area of the skin surface of the body. The most interesting skin surfaces are mostly those not normally covered by clothing, such as facial skin surfaces, hand and arm skin surfaces, foot and leg skin surfaces, and neck and chest skin surfaces (e.g. tegilletage). In particular, it may be applied to facial skin surfaces, including forehead, perioral, chin, periorbital, nose and/or cheek skin surfaces.

The step of applying the product to a target area of the skin may be performed by topical application to the target area, for example an area comprising wrinkles. For purposes of this application, the terms "topical", "local", or "locally" refer to delivery to a target area of skin (such as an area of skin that includes wrinkles) while minimizing delivery to the surface of the skin that does not require treatment.

One or more products of the present invention may be applied broadly to one or more facial skin surfaces to reduce the appearance of wrinkles in those facial skin areas.

The methods of treating skin herein can optionally begin with a cleansing step. The consumer may wash his or her face with a suitable cleanser (e.g., overlay Purifying Mud heating cleaner available from The Procter & Gamble Company, Cincinnati, OH) and gently dry his or her skin.

The product can be applied to at least one target portion of skin selected from the group consisting of: forehead, perioral, chin, periorbital, nose, cheek, skin surface, and combinations thereof. The product may be applied to a target portion of skin for a treatment period. The treatment period may comprise at least once daily for at least four weeks, preferably at least twice daily for at least four weeks, more preferably at least once daily for at least eight weeks, and more preferably at least twice daily for at least eight weeks, preferably the length of the treatment period is at least 2 weeks, preferably at least 4 weeks, and more preferably at least 8 weeks. The product may remain on the targeted portion of skin for about 1 minute to about 24 hours or about 2 hours to about 10 hours prior to removal from the skin. In one aspect, the target portion of the skin includes pigmented spots, wrinkles, fine lines, dryness, skin laxity, and combinations thereof.

Test method

Tensile/modulus testing method

The tensile (modulus) properties were measured using a load cell on a constant rate elongation tensile tester with a computer interface (a suitable instrument is an MTS instrument using Testworks 4.0 software, such as that available from MTS Systems Corp. (Eden Prairie, MN)), with the measured force being within 1% to 99% of the limit of the sensor. Both the movable (upper) and fixed (lower) fixtures are equipped with a light vise action clamp having a width greater than the width of the test specimen. The tensile tester is equipped with a sample humidity and temperature control chamber, and the environment of the sample can be maintained at a set temperature between 23 ℃ and 40 ℃ (with an accuracy of 0.5 ℃) and a set relative humidity between 35% and 95% (with an accuracy of 0.5%) throughout the tensile test. All tests were conducted in a conditioning chamber maintained at about 23 ℃ ± 2 ℃ and about 50% ± 2% relative humidity.

After the initial gauge adjustment is performed, the tensile tester is programmed to perform an elongation test. To perform gauge adjustment, the grips were first lowered 5.0mm at a rate of 7.5mm/s to increase the slack in the sample. The chuck was then lifted at 7.5mm/s until 0.1N was measured on the load cell and the current gauge at that time was set to the adjusted gauge. The chuck was continued to be lifted at 7.5mm/s until the specimen broke, i.e. the force dropped to <0.05N after the maximum peak force. Force and chuck travel data were collected at 200Hz throughout the experiment. The collet is restored to the original gauge.

Prior to testing, the samples were conditioned at about 23 ℃ ± 2 ℃ and about 50% ± 2% relative humidity for at least 2 hours. The samples were measured in the Machine Direction (MD) and the Cross Direction (CD). Eighteen (18) samples 80mm long by 25.4mm + -0.1 mm wide are cut in the transverse direction using a JDC cutter (available from Thwing-Albert) or other suitable device. Next, eighteen (18) samples 80mm long by 25.4mm ± 0.1mm wide were cut in the machine direction. The thickness of each sample was measured using a digital linear caliper (e.g., Ono SokkiGS-503 or equivalent instrument) fitted with a foot 25mm in diameter that can apply a pressure of 0.69 kPa. The caliper foot was zeroed to the anvil. The foot was lifted and the sample laid flat against the anvil with the sample width under the foot press and the foot was lowered onto the sample at about 5 mm/sec avoiding any creases, folds or obvious defects. Calipers (mm) were read and recorded to the nearest 0.01mm after 5.0 seconds of placing the foot on the specimen. The cross-sectional area of each sample was calculated as the sample width multiplied by the caliper and recorded to 0.01mm²。

The initial gauge was set to exactly 75.0mm and the collet and load cell were zeroed. The sample is inserted into the upper clamp, aligned vertically within the upper and lower clamps, the upper clamp is closed and tightened. The other end of the sample was inserted into the lower grip and tightened. The sample should have minimal sag with a force measured at the load cell of less than 0.1N. The environmental chamber was sealed and the temperature and humidity were allowed to reach the set target values and then these conditions were maintained for 10 minutes before testing. A test procedure is initiated.

Force (N) is plotted against elongation (mm). Elongation herein is the stroke length corrected for the adjusted gauge. The maximum peak force was read and recorded and reported to the nearest 0.1N. The energy to break was calculated as the area under the curve between the onset of elongation and the ultimate elongation to break. The recording was accurate to 0.01N mm.

And (3) constructing an engineering stress (MPa) and engineering strain curve by using the force (N) and the elongation data (mm). Herein, the engineering stress s is defined as the force (N) divided by the initial cross-sectional area of the sample (mm)²). The engineering strain e is the change in length (from the adjusted gauge) divided by the adjusted gauge. The failure stress (MPa) was read as the maximum stress of the curve from the curve and recorded to the nearest 0.01 MPa. Before 10% strain, the modulus (MPa) was calculated from the curve as the maximum slope of the linear segment of the curve, where the length of the segment included a strain increment of 0.01 mm/mm. The recording was accurate to 0.01 MPa.

Three replicate CD and three replicate MD samples were analyzed under each of the following target environmental conditions:

	temperature (. degree.C.)	Relative humidity (%)
			1	25	40
2	25	75
			3	25	90
4	37	40
			5	37	75
6	37	90

The arithmetic mean of the three replicate CD results for each environmental condition was calculated. The arithmetic mean of the three replicate MD results at each environmental condition was calculated separately, reporting a modulus to the nearest 0.1MPa, a failure stress to the nearest 0.1MPa, a peak force to the nearest 0.01N, and a fracture energy to the nearest 0.1N x mm for each of the environmental conditions. The initial modulus was determined as the modulus at 40% RH at 25 ℃. The decrease/decrease in modulus was calculated by comparing the modulus at 37 ℃ and 75% RH with the modulus at 25 ℃ and 40% RH or by comparing the modulus at 37 ℃ and 90% RH with the modulus at 25 ℃ and 40% RH.

Percent weight gain

In one aspect, the soluble film region or product has a weight change once it is exposed to a low water environment as described herein and/or closed on the skin (e.g., by using a backing layer with the requisite low WVTR). This weight change was quantified using the following method. To approximate the weight change of the water-soluble film region, water-soluble films made from water-soluble film-forming polymers can also be used in the process.

124 oz glass jars are provided having a screw cap on the bottom including a grid tray and a weighing boat suspended from the grid tray. Cans No. 1 to 12 are labeled. A saturated aqueous solution of potassium chloride was provided under the weigh boat to produce a chamber humidity of 85% at ambient conditions. An 3/4 "x 3/4" sample of the cut film/product. The sample was then added to each of the cans and placed into a weigh boat. Each of the weigh boats was weighed with the sample in the boat. This is the initial weight.

The time was started after the sample was added to the tank, starting with tank No. 1. At specific time intervals outlined below, the sample and the weighing boat were removed from the designated canister (starting with No. 1) and weighed together. This is the subsequent weight. The% weight gain was then calculated.

Sample number/time interval：

1/10min

2/20min

3/30min

4/40min

5/50min

6/1h

7/2h

8/3h

9/4h

10/5h

11/6h

12/24h

Each of the samples was measured 3 times, and then averaged. The average of 1 hour, 6 hours and 24 hours of the sample was recorded.

WVTR

The WVTR of the barrier patch or backing layer is measured according to ASTM F124913 at 37 ℃ and 35% RH. Samples can be analyzed on a MOCON Permatran-W3/33 water vapor permeameter using ASTM F1249. For a material with a higher WVTR (e.g., about 300 g/m)²24h to 500g/m²24h) which can be analyzed according to ASTM E-96, with a desiccant placed inside the test cup and 35% RH around the outside of the cup. Samples of the barrier patch were prepared and did not contain a pressure sensitive adhesive.

Basis weight

Basis weight was calculated as follows. Sample preparation: the samples were allowed to equilibrate under TAPPI conditions for 100 hours (50% RH, 23 ℃). The samples were cut into 25.4mm wide strips using a JDC 1 "slitter. The sample was cut to 80mm length using a measuring block. Each sample was weighed using a 4-position analytical balance. Basis weight was calculated as sample mass/area, where mass was measured on a balance and area 25.4mm x 80mm 2032mm 0.002032 meters. In grams per meter²Basis weight is reported as a unit.

Thickness (Caliper/Thickness)

Thickness measurements can be made using ASTM D5729, which typically uses a pad caliper with a known pressure (0.1psi) and gauge sensor. A Qualitest thickness tester, model CHY-C2, available fromwww.WorldofTest.com。

Dissolution method

The water-soluble film was aged at 21 ℃ (+/-1.5 ℃) and 50% relative humidity (+ 1-1.5% relative humidity) for 24 hours. Three samples of water-soluble film were cut to a size of 3.8cm by 3.2 cm. Each sample was locked in a separate 35mm carriage. A suitable beaker was filled with 500mL of distilled water and maintained at a constant temperature of 20 ℃. The height of the water column is marked. Place the beaker on a magnetic stirrer, add a magnetic stir bar to the beaker, turn on the stirrer, and adjust the stirring speed until a vortex emerges that is approximately one-fifth the height of the water column. The depth of the vortex is marked. The 35mm carriage was secured in the alligator clip of the carriage holder so that the long end of the carriage was parallel to the water surface. The depth setter of the holder should be set so that when dropped, the end of the clamp will be 0.6cm below the water surface. One of the short sides of the carriage should be immediately adjacent to the side of the beaker and the other short side positioned directly on the center of the stir bar so that the membrane surface is perpendicular to the flow of water. In one movement, the fixed slide and clamp drop into the water and start the timer. When all visible film is released from the carriage, the carriage is lifted out of the water while continuing to monitor the solution for undissolved film fragments. For each sample, the time at which all the film fragments of each sample were no longer visible to the naked eye was recorded and the solution became clear. The time values of the 3 samples were averaged, and if the average time was 15 minutes or less, the samples constituted a water-soluble film.

Examples

The following are non-limiting examples of the products and methods of the present invention. The examples are given solely for the purpose of illustration and are not to be construed as limitations of the present invention, as many variations thereof are possible without departing from the spirit and scope of the invention, which will be recognized by those of ordinary skill in the art.

In the examples, all concentrations are listed in weight percent, and minor substances such as diluents, fillers, and the like may be excluded, unless otherwise specified. Thus, the listed formulations include the listed components as well as any minor materials associated with such components. It will be apparent to those of ordinary skill in the art that the selection of these minor components will vary depending on the physical and chemical characteristics selected to make the particular compositions of the present invention as described herein.

A. Preparation of beauty care products：

The following formulation and procedure were used：

	Components	By weight%
			Solution A
	PEG 100 stearate (surfactant)	1％
				Emulgade PL 68-50¹(surfactant)	1％
	Eutanol G 16²(hexyldecanol)	10％
			Solution B
	Sepiwhite MSH (undecylenoyl phenylalanine)³	0.4％
				1N sodium hydroxide solution	1.26％
Solution C
				Water (W)	52.34％
	Nicotinamide	10％
				Glycerol	20％
	Inositol	4％

The ingredients of solution a were mixed and heated to 80 ℃ with stirring. The solution B ingredients were then placed in a small beaker and stirred until the solution became clear to deprotonate the Sepiwhite MSH to make it water soluble. The contents of solution C were then heated to 80 ℃ with stirring.

Solution B was added slowly to solution C over 10 minutes with rapid stirring. Then slowly added to solution a over 15 minutes with rapid stirring at 80 ℃ and stirred for 30 minutes, and then ground with a hand-held grinder at 80 ℃ for 2 minutes. The solution was stirred and allowed to cool to room temperature. Once at room temperature, the solution was placed in a jar and labeled. After 96 hours, the solution was stable, no separation, and no solids formed.

Once the above emulsion was obtained, a 20% aqueous solution of Methocel E5LV water soluble polymer was mixed with the emulsion in a ratio (polymer solution to emulsion) of 60: 40. The film was then cast onto a transfer sheet using a Gardo Draw Down table and a number 44 Draw Down rod. Methocel E5LV is a low viscosity water soluble cellulose ether available from Dow/Coloron LTD.

Backing and adhesive layer

A backing layer according to sample 3 of provisional U.S. patent application serial No. 62/257,341 filed 11/19/2015 is provided. Specifically, sample 3 is a 3-layer film having a foamed core layer and a non-foamed outer layer. All layers are made of EVA. The outer layers each have a thickness of about 20 μm, and the core foam layer has a thickness of about 130 μm. The total thickness of the backing layer was about 170 μm. A basis weight of about 99gsm and a WVTR of 82g/m²And/24 hours. The backing layer has a first surface. Alternatively, the backing layer may comprise a low density polyethylene film or a non-foamed EVA laminate. The backing layer or barrier patch may also include a polyethylene film sold under the trade name 3M 1525L, available from 3M, st. paul, Minn (without a release layer), having a backing of about 3 mil thick polyethylene film and a 1.4 mil thick layer of hypoallergenic pressure sensitive acrylate adhesive.

Pressure sensitive adhesives (if no adhesive is present in the backing layer), such as for example those available from HenkelAnd DERMA-Brands (e.g. TECHNOMET PSM 154A DERMA-) At a rate of about 50g/m²To about 160g/m²Or especially about 95g/m²Coated on the first surface of the backing layer. The pressure sensitive adhesive is slit coated as a continuous layer across the first surface of the backing layer.

After the completion of the application of the pressure-sensitive adhesive, the above-mentioned skin-active agent-containing soluble film is applied to the upper surface of the pressure-sensitive adhesive layer/zone by bringing the soluble film side of the transfer sheet into contact with the upper surface of the pressure-sensitive adhesive. The dissolvable film is applied as a discontinuous layer on the upper (outer) surface of the pressure sensitive adhesive layer/zone. The soluble film had a density of about 30g/m²To about 200g/m²Coating basis weight of (a).

Assembly of the barrier patch can also be accomplished by the methods described in: U.S. serial No. 62/257,341; 62/257,347 and 62/257,351, each filed 11/19/2015, assignee Procter & Gamble.

Exemplary products for treating periorbital skin aging, such as the products of the above-described embodiments, are attached to the periorbital area via the adhesive side. The product is applied and worn for an extended period of time, such as overnight, for about 7 to 8 hours, and then removed. The products herein deliver an effective amount of a skin active agent in a manner that achieves penetration of the skin active agent into the stratum corneum, and/or other layers of the epidermis, and in many aspects, into the basal cortex and/or dermis.

The dimensions and values disclosed herein are not to be understood as being strictly limited to the exact numerical values recited. Rather, unless otherwise specified, each such dimension is intended to mean both the recited value and a functionally equivalent range surrounding that value. For example, a dimension disclosed as "40 mm" is intended to mean "about 40 mm".

Each document cited herein, including any cross referenced or related patent or patent application and any patent application or patent to which this application claims priority or its benefits, is hereby incorporated by reference in its entirety unless expressly excluded or otherwise limited. The citation of any document is not an admission that it is prior art with any disclosure of the invention or the claims herein or that it alone, or in combination with any one or more of the references, teaches, suggests or discloses any such invention. Further, to the extent that any meaning or definition of a term in this document conflicts with any meaning or definition of the same term in a document incorporated by reference, the meaning or definition assigned to that term in this document shall govern.

While particular aspects of the present invention have been illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention.

Claims

1. A method of improving the appearance of skin, the method comprising the steps of:

identifying a target portion of skin;

topically applying a multi-layered cosmetic care product to the target portion of skin, the product comprising:

a barrier patch, the barrier patch comprising:

a backing layer having a first surface and a second surface; 1g/m²24h to 500g/m²24h, preferably 1g/m²24h to 250g/m²WVTR of/24 h;

a pressure sensitive adhesive zone having an upper surface and a lower surface, the lower surface of the pressure sensitive adhesive zone in contact with the first surface of the backing layer;

a water-soluble film region comprising:

a water-soluble film-forming polymer;

a cosmetic composition comprising an effective amount of a skin active agent;

the water-soluble film region is in contact with the first surface of the backing layer, the upper surface of the adhesive region, or both;

wherein the water-soluble film region has an initial modulus of from 30MPa to 600MPa, preferably from 75MPa to 500 MPa; and is

Wherein the product is administered for a treatment period; preferably the water-soluble film region or product has a weight gain of 20% to 80% at 1 hour, 6 hours, or 24 hours, and preferably the water-soluble film region and the adhesive region are substantially separate, and wherein preferably the pressure sensitive adhesive region is selected from the group consisting of acrylate and methacrylate homopolymers or copolymers, butyl rubber based systems, silicones, urethanes, vinyl esters and amides, olefin copolymer materials, and combinations thereof.

2. The method of claim 1 wherein the water-soluble film region or product has a reduction in modulus of from 90% to 100% compared to the initial modulus.

3. The method according to any preceding claims, wherein the water-soluble film region comprises from 30% to 99% of a water-soluble film-forming polymer, wherein the water-soluble film-forming polymer is selected from polyethylene oxide polymers, polyvinyl alcohol copolymers, starch, methylcellulose, sodium carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose, and combinations thereof, preferably the water-soluble film-forming polymer comprises methylcellulose, hydroxypropylmethylcellulose, polyethylene oxide, and combinations thereof, more preferably the water-soluble film-forming polymer is selected from polyethylene oxide having a molecular weight of from 500 to 10,000,000, preferably from 100,000 to 300,000.

4. The method of any preceding claim, wherein the water-soluble film region further comprises from 2% to 80% by weight of the soluble film region of a plasticizer, preferably the plasticizer is selected from the group consisting of glycerol, ethylene glycol, diethylene glycol, propylene glycol, sorbitol, pentaerythritol, glucosamine, N-methylglucamine, sodium cumene sulfonate, and combinations thereof.

5. The method of any one of the preceding claims, wherein the backing layer comprises one or more layers of ethylene vinyl acetate, wherein the backing layer has a 25% to 50% decrease in modulus when conditions are changed from 25 ℃/40% RH to 37 ℃/90% RH.

6. The method of any preceding claim further comprising a ratio of the modulus of the water-soluble film region to the modulus of the backing layer or barrier patch, wherein the modulus ratio is greater than 1 at 25 ℃/40% RH and less than 1 at 37 ℃/90% RH.

7. The method of any preceding claim, wherein the product comprises a plurality of discrete soluble film regions.

8. The method of any preceding claim wherein the soluble film region further comprises a top surface and a bottom surface, and wherein the bottom surface of the soluble film region is in contact with the upper surface of the adhesive region, and the adhesive region is continuous.

9. The method of any preceding claim wherein the top surface of the soluble film region and the upper surface of the adhesive region are coplanar or collinear, or the bottom surface of the soluble film region and the lower surface of the adhesive region are coplanar or collinear.

10. The process of any preceding claim wherein the water-soluble film region has a total thickness of from 2 microns to 150 microns, and preferably the barrier patch or product has a total thickness of from 20 microns to 500 microns.

11. The method of any of the preceding claims, wherein the product, barrier patch or backing layer is substantially free of fibrous absorbent materials, superabsorbent materials, nonwoven materials, cotton, rayon, acrylics, polypropylene fibers and polyester fibers.

12. The method of any preceding claim, wherein the adhesive region, backing layer, or barrier patch is substantially free of an effective amount of a skin active agent.

13. The method of any preceding claim, wherein the target portion of skin is healthy skin and is selected from forehead skin, perioral skin, chin, periorbital skin, nose, cheek, skin surface, pigmentation spots, wrinkles, fine lines, dryness, skin laxity, and combinations thereof.

14. The method of any preceding claim, wherein the treatment period comprises once or twice daily application to the skin for at least two weeks or at least eight weeks, and the product remains on the target portion of skin for 1 minute to 24 hours before removal from the skin.