JP6728425B2 - Cream, lotion or gel composition for treating psoriasis - Google Patents

Description

The present invention relates to methods and compositions for treating psoriasis and other skin disorders similar to psoriasis, such as eczema, sunburn and wounds and scars. The method includes topical administration of a composition containing a sterol ester.

Psoriasis is a skin disorder that occurs as a result of skin cells regenerating faster than normal. Psoriasis causes erythema, which is sometimes referred to as plaque, and dry gray-white or silvery scales on the patient's skin.

Many different methods are currently used to treat the development of psoriasis. One of the more common treatments is the topical application of corticosteroids to the affected area to reduce inflammation. Its use is often limited because patients may gradually develop resistance to corticosteroids.

Other common treatments include topical application of anthralin, also known as dithranol, topical application of vitamin D such as calcipotriene or calcitriol, or topical application of vitamin A such as tazarotene. Anthralin, Vitamin D and Vitamin A are believed to slow the rate of skin cell renewal. Anthralin stains the patient's skin and clothes, and is unlikely to be effective in developing superactive psoriasis. Topical application of Vitamin D and/or A is at risk of increased sensitivity to sunlight.

Coal tar has also been used to treat psoriasis. Coal tar may be applied directly to the affected area or added to the bath. Coal tar is effective but has a strong unpleasant odor.

Topical application of salicylic acid has been applied to some patients with psoriasis. Salicylic acid is believed to function as a dermabrasion agent that exfoliates the outer layers of the skin. Leaving salicylic acid on the skin for extended periods of time can cause irritation and/or hair loss.

Some patients have used ultraviolet light to treat psoriasis. Such ultraviolet light may include sunlight (irradiating the exposed area while adjusting the amount) or artificial light that irradiates the affected area.

In other patients, oral administration of psoralen (Psoralen or Psoralen) has been combined with UV treatment.

Still other psoriasis patients have been given oral retinoids, high levels of vitamin A, or drugs that reduce immune function, such as methotrexate or cyclosporine.

Patients with psoriasis are also advised to moisturize their skin with moisturizing creams, lotions and soaps and to use bath oils and bath salts to reduce the redness and itching associated with the development of psoriasis.

Although there are many possible options for treating psoriasis, none of the above methods are 100% curative or have no potential side effects.

It is an object of the present invention to provide a method for treating psoriasis and to provide a composition effective in treating psoriasis that does not cause an unpleasant odor or inflammation of the skin of the patient.

The present invention achieves the above objects by providing a method for treating psoriasis, which comprises a topical application of a composition containing a sterol ester, preferably a C ₁₀ -C ₃₀ carboxylic acid sterol ester, to the psoriatic area of a patient. To do. The application of the composition is performed as needed, but should be performed at least once a day, preferably immediately or immediately after washing and drying the affected area, that is, within 5, 10 or 15 minutes. Application of the composition to psoriatic areas should be continued on a regular basis until psoriatic plaques and scales are cleared.

The composition may be applied to the psoriatic area in a non-occlusive or occlusive manner. In one embodiment of the invention, the composition should be in contact with the psoriatic area for at least 20 minutes or longer, preferably at least 30 minutes or longer.

The composition may be a gel, cream, paste, lotion, ointment, salve, serum, spray, aerosol, mousse or foam. The composition is preferably a serum, aerosol, mousse or foam.

In one embodiment of the present invention, the present compositions, 25 percent or more sterol esters, based on the total weight of the composition excluding the solvent, it is preferably contained in C ₁₀ -C ₃₀ carboxylic acid sterol ester It should be contained in an amount of 30% or more based on the total weight of the composition excluding the solvent, and most preferably of 40% or more based on the total weight of the composition excluding the solvent. ..

In another embodiment of the present invention, the composition according to the present invention, sterol esters, preferably contains a mixture of C ₁₀ -C ₃₀ carboxylic acid sterol ester and penetration enhancer.

The compositions according to the invention are also believed to be useful in the treatment of eczema, sunburn and skin disorders and pain such as wounds and scars.

As used herein, the phrase "psoriasis" refers to a skin condition thought to be caused by the body of a patient producing excessive skin cells. The condition is accompanied by erythema on the patient's skin, wide white/silver scales and often swelling, typically on the arms, scalp, ears and genitals. It is believed that psoriasis does not cure but can be treated.

The terms “treatment” or “treating” as used herein refer to the alleviation of any one or more symptoms associated with psoriasis, or the reduction or reduction of one or more symptoms associated with psoriasis.

As used herein, the terms "enhancement," "permeation enhancement," and "permeation enhancement" refer to increasing the permeability of a drug or biologically active agent through biological membranes (eg, skin or mucous membranes). It is meant to improve the permeability of the membrane to drugs or biologically active substances. "Permeation enhancer," "enhancer," "penetration enhancer" or similar terms refers to a substance that enables such permeation enhancement.

"Transdermal" as used herein means to penetrate into and through the skin or mucosal tissue to deliver a drug or biologically active agent. For this reason, the terms "transdermal" and "transmucosal" are used interchangeably unless otherwise noted. Similarly, “skin”, “dermis”, “epithelium”, “mucosa” and the like are also used interchangeably unless otherwise specified.

The term "topical" as used herein refers to the patient's integument or dermis. Thus, the expression "topical application" refers to applying the composition according to the invention and its various embodiments to the outer surface of the skin or dermis of a patient.

As used herein, the terms "occluded", "occluded", "occlusive" and the like refer to a transdermal formulation that is applied to the skin using a support structure or other related structure. In other words, the topical formulation may be applied to the patient's skin using a structure such as a backing member, bandage or cover. An example of an obturator is a matrix patch. Conversely, "non-occlusive" and "non-occlusive" may be used interchangeably and applied to the skin without the use of support structures, backing members, covers or other related structures. Shows a transdermal formulation. In other words, the transdermal formulation is in a free form as long as it can transdermally deliver the drug or biologically active substance without using a structure such as a backing member. Applied to the skin. Gel formulations are one example of forms of non-occlusive compositions, other non-occlusive compositions include ointments, lotions, pastes, mousses, aerosols and creams.

The terms “combination” and “mixture” are synonyms that can be used interchangeably. These terms should not be construed as under-inclusive as appropriate, but should always be over-inclusive.

Concentrations, weight percents and other numerical data may be presented herein in a range format. Since we use such range formats solely for convenience and brevity, it goes without saying that each number and subrange is explicitly referred to, not just those numbers explicitly referred to as the range's boundary values. Thus, the individual numerical values falling within the range or all subranges should be construed flexibly. For example, a percentage range of 1% to 20% does not include only explicitly mentioned boundary values of 1% and 20%, but rather 1.5%, 3%, 4.75%, 8.34%, etc. It should be construed to include the individual percentages as well as subranges such as 1% to 5%, 10% to 15%, 4.7% to 11.9%.

The present invention relates to methods for treating psoriasis and compositions useful in treating psoriasis.

The method comprises topical application of the composition to the psoriatic area of a patient suffering from the development of psoriasis. The composition, sterol ester preferably contain a _C 10 _{-C 30} carboxylic acid sterol esters. The composition can be a gel, cream, paste, lotion, ointment, salve, serum, spray, aerosol, mousse or foam.

Furthermore, the method comprises the steps of washing the psoriatic area, drying the psoriatic area and optionally exfoliating the skin in the psoriatic area before application of the composition. Topical application of the method or composition should be applied directly to the psoriatic area at least once a day or twice a day. Depending on the severity of psoriasis development and the site of onset, the composition may be applied to the psoriatic area three, four, five or more times.

Depending on the form to which the composition is applied (i.e. gel, serum or cream), it may adhere to the patient's clothing, furniture or a third party after the composition has been applied to the psoriatic area. To prevent this, the composition and the psoriatic area may be covered with a protective cloth, bandage, gauze or wrap. Protective cloths, bandages, gauze or wraps may also be applied for the purpose of protecting psoriatic areas from dirt, bacteria and bacteria.

The method according to the present invention is repeatedly applied to a part of the day or a part of the day as needed until the occurrence of psoriasis converges or ends.

The composition according to the present invention, sterol esters, preferably _C 10 _{-C 30} carboxylic acid sterol esters, and most preferably Croda Chemicals Europe Ltd. UK East Yorkshire Containing tradename SUPER Sterol ESTER (TM) available in a _C 10 _{-C 30} carboxylic acid cholesterol / lanosterol mixture. _C 10 _{-C 30} cholesterol / lanosterol ester mixtures Croda Chemicals is sold, Koresawa other U.S. Patent No. 4,138,416 by the method described in (the content of which is incorporated herein by reference in its entirety.) It is believed to be made from wool wax. Examples of other sterol esters that may be used in the composition according to the invention include stearates, palmitates, acetates, lanolates, macadamates, nonanoates, oleates, butyrates, hydroxystearates, isostearates, sulphates, isosteres of cholesterol. Included, but not limited to, rate carbonates and other sterols.

The amount of sterol ester contained in the composition according to the present invention should be 25% or more based on the weight of the composition excluding the solvent, based on the total weight of the composition excluding the solvent. It is preferably 30% or more, and most preferably 40% or more based on the total weight of the composition excluding the solvent. Since many excipients in transdermal formulations have the ability to serve multiple functions depending on concentration and method of use, the amount of solvent present in the composition formulated in accordance with the present invention should be subtracted to determine the amount of sterol ester. When quantifying, the solvent present in the composition but deducted when calculating the weight percent of sterol ester is liquid at room temperature and has a boiling point of less than 150° C., preferably less than 125° C., most of the boiling points under standard atmospheric conditions. Preferably, the compound has a boiling point of less than 105°C. Examples of typical solvents to be subtracted when calculating the weight percent of sterols are water, low molecular weight alcohols such as C ₁ -C ₆ branched or straight chain alcohols (eg methanol, ethanol and isopropanol), C ₁ -C. Low molecular weight ketones such as ₆ branched or linear ketones (eg, acetone, aromatic compounds) and low molecular weight alkanes such as C ₁ -C ₁₀ branched or linear alkanes.

The composition according to the present invention may further contain a penetration enhancer. The amount of penetration enhancer used in the compositions of the present invention will depend on the particular composition embodiment or transdermal formulation (ie, serum, cream or foam) and the particular penetration enhancer selected. The amount of penetration enhancer used in the compositions of the present invention is typically from about 0.001% to about 25%, preferably about 0.005% by weight, based on the total weight of the composition. It should be between about 15% and about 15%, most preferably between about 0.01% and about 10%. Examples of penetration enhancers that may be used in the composition according to the invention are fatty acids, fatty acid esters, fatty alcohols, fatty acid esters of lactic or glycolic acid, glycerol tri, di and monoesters, triacetin, Including but not limited to short chain alcohols, amine oxides and mixtures thereof. More specific examples of permeation enhancers include oleyl alcohol, lauryl alcohol, isopropyl myristate, oleyl oleate, levulinic acid, ethanol, glycerol monooleate, methyl laurate, sorbitan monooleate, triacetin, aloe vera oil, benzotonium chloride, Cetyl dimethyl amine oxide, cetyl alcohol, cetyl lactate, cocamidopropyl betaine, coco amine oxide diethanol amine, dimethyl octyl amine oxide, 2-dodecoxyethyl dimethyl amine oxide, dimethyl-decyl amine oxide, dimethyl hexadecyl amine oxide, dimethyl- Tetradecylamine oxide, dimethylisosorbide, dipropylene glycol, ethylhexyl lactate, glycolic acid, 3-dodecoxy-2-hydroxypropyldi(3-hydroxypropyl)amine oxide, lactic acid, lauramine oxide, lauryl betaine, lauryl lactate, lauryl laurate Rate, isopropyl palmitate, macrogol 15 hydroxystearate (Solutol HS 15), menthol, menthyl lactate, myristyl alcohol, myristal lactate, octyldodecanol, octyl salicylate, oleamine oxide, oleic acid, Oleyl betaine, oleyl di(2-hydroxyethyl)amine oxide, PEG1000, pentadecalactone, propylene glycol, salicylic acid, stearyl alcohol, stearyl lactate, 3,6,9-trioxaheptadecyldiethylamine oxide, di(2-hydroxyethyl) Includes tetradecylamine oxide, triethanolamine triacetate and mixtures thereof. Other permeation enhancers useful in the present invention can be found in US Patent Application Publication No. 2007/0269379, the contents of which are incorporated herein by reference in their entirety. Preferred permeation enhancers include oleyl alcohol, lauryl alcohol, isopropyl myristate, oleyl oleate, levulinic acid, glycerol monooleate, methyl laurate, sorbitan monooleate, triacetin, cetyl alcohol, cetyl lactate, dimethyl isosorbide, dipropylene glycol, Ethylhexyl lactate, glycolic acid, lauramine oxide, lauryl betaine, lauryl lactate, lauryl laurate, isopropyl palmitate, myristyl alcohol, myristal lactate, octyl salicylate, oleamine oxide, oleic acid, oleyl betaine, Includes salicylic acid, stearyl alcohol, stearyl lactate, triethanolamine triacetate and mixtures thereof.

Depending on the particular mode of composition or transdermal formulation (ie, serum, cream or foam), compositions according to the present invention may include solvents, film-forming/polymeric agents, viscosity enhancers, emulsifiers, antioxidants. Additional additives such as agents, preservatives, pH adjusters, propellants and mixtures of the foregoing may be included.

The composition according to the present invention may contain any suitable solvent. Preferably, the solvent is water and/or one or more organic compounds such as esters, terpenes, alcohols, ketones, aldehydes, fatty acids, partially or fully esterified fatty acids, Those in which the structure is cyclic, acyclic (eg, alkyl), alicyclic (that is, bridged cyclic compound) or aromatic, and organic compounds having a combination of these functional groups can also be included. Specific examples of the solvent that can be used include water, methanol, ethanol, isopropyl alcohol, acetone, hexane, butyl alcohol, ethyl acetate, polyethylene glycol, propylene glycol, ethylene glycol, triethylene glycol, glycerin, 1,3-propanediol. , 2-methyl-1,3-propanediol, glycerol ricinoleate, mineral oil, peanut oil, corn oil, cottonseed oil, sesame oil or mixtures thereof. The solvent can be used in any suitable amount. The amount of solvent present in the composition is typically about 1.0% to about 95.0% by weight, based on the total weight of the composition, and preferably about 1.0% by weight based on the total weight of the composition. 3.0 wt% to about 85 wt%, most preferably about 5.0 wt% to about 75 wt% based on the total weight of the composition.

The composition according to the invention may also contain film-forming/polymeric agents. Applicants do not wish to be bound by any particular theory, but the presence of film-forming/polymeric agents in the compositions made in accordance with the present invention renders the compositions more spreadable on the skin. It is also believed that the ability to form a protective layer coating allows the sterol ester to penetrate the skin in the psoriatic area and/or keep the sterol ester in contact with the skin in the psoriatic area. The film forming/polymeric agent may also increase the adhesion of the composition to the patient's skin and improve the resistance of the composition to washout or wiping.

The film-forming/polymeric agent preferably has solubility or miscibility with the sterol ester and/or the penetration enhancer. Compositions according to the invention will typically contain from about 0.001% to about 25%, preferably from about 0.005% to about 15%, most preferably by weight of the composition. Preferably, the content is about 0.010% by weight to about 10% by weight. Some examples of film-forming/polymeric agents that can be used in the compositions of the present invention are polyalkenes, lipophilic vinylpyrrolidone copolymers, acrylic copolymers, polyethylene glycol derivatives, polyolefins, polyurethanes. And mixtures thereof.

Examples of polyalkenes that may be included in the compositions of the present invention include polyethylenes in the molecular weight range of about 300 to 3000 (available from PERFORMALENE® from New Phase Technology, Piscataway, NJ), polyisobutylenes ( Available from VISTANEX™ from Exxon Chemical Company, Houston, Texas), polyisobutenes (available from PRESPERSE™ from Sumitomo Corp.), polydecenes (available from Amoco to SILKFLO™), and hydrogenated. Polyisobutenes (available as PANALANE® from Lipo Chemicals, Patterson, NJ).

Lipophilic copolymers of vinylpyrrolidone suitable for use in the compositions of the present invention are copolymers of polyvinylpyrrolidone (PVP) and long chain alpha olefins, including those from Ashland (previously Wayne, NJ). Examples include, but are not limited to, PVP/eicosene copolymers (GANEX® V-220 and V-220F) and tricontanyl PVP copolymers (GANEX®), which are commercially available from International Specialty Products. I can't.

Examples of the acrylic copolymers which can be used in the compositions according to the present invention include acrylic copolymers having a long alkyl chain (C 8 _{-C 30)} enhancing lipophilicity, such as acrylate / octylacrylamide copolymers (Akzo (Available from Nobel as DERMACRYL®). An example of a polyethylene glycol derivative that may be used as a film-forming agent for the composition of the present invention is a polyethylene glycol derivative of beeswax (formerly from Unichema, Wilmington, Del. from ESTOL® E04BW-3752, E06BW-3753 or E03BW-3751, which is currently available from Croda under the trademark CITHOL®). Examples of polyolefins which may be used as a film-forming agent in the composition according to the present invention is a fatty acid ester / fatty acid anhydride grafted Porirefin, esters and anhydrides derived from C ₁₂ -C ₂₂ fatty acid moieties shall, for example, _C 30 _{-C 38} olefin / isopropyl maleate / maleic anhydride copolymer (available from New Phase Technologies of Piscataway, NJ at PERFORMA (TM) V1608) and the like.

A preferred group of film-forming/polymeric agents that can be used in the composition according to the invention includes polyurethanes derived from isophorone diisocyanate, for example US Pat. Nos. 5,051,260 and 6,613. , 866, Alzo International Inc. Polyisobutene/polybutene, hydrogenated polydecene and hydrogenated C ₆ -C ₁₄ olefin polymers sold under the trade name POLYDERM® by ExxonMobil Chemical under the trade name PURESYN®. The following table shows examples of preferred film forming/polymeric agents.

The film-forming/polymeric agent preferably has water insolubility, lipophilicity and/or water resistance.

The composition according to the present invention may contain a viscosity enhancer which concentrates, gels or solidifies the composition. The composition according to the invention typically contains from about 0.001% to about 50% by weight of a viscosity enhancing agent, based on the total weight of the composition, preferably from about 0.005% by weight. It contains from about 40% by weight, most preferably from about 0.01% to about 25% by weight of a viscosity enhancing agent. Representative The viscosity enhancing agent, an organic material, for example, natural or synthetic _waxes, C 12 _{-C 60 alcohols,} C 12 _{-C 60} acids, alpha - hydroxy fatty acids, polyhydroxy fatty acid esters, polyhydroxy fatty acid Included are amides and inorganic/organic materials such as metal ester complexes containing zinc, calcium, aluminum or magnesium, fumed silica and organoclays. Other viscosity enhancers include polyol polyesters, glyceryl esters, polyglyceryl esters and polysiloxanes that are solid or semi-solid at ambient temperature.

Examples of specific viscosity enhancing agents which may be included in the compositions according to the present invention, C ₁₂ -C ₆₀ alcohols, preferably C ₁₆ -C ₂₂ fatty alcohols, e.g., cetyl alcohol, stearyl alcohol, behenyl alcohol And mixtures thereof. Other suitable viscosity enhancing _agents, C 12 _{-C 60} acids, preferably _C 16 _{-C 22} fatty acids, such as palmitic acid, stearic acid, behenic acid, oleic acid, linoleic acid, myristic acid, ricinoleic acid, Includes auric acid, lauric acid, isostearic acid and mixtures thereof. Further preferred viscosity enhancing agents that can be used herein are alpha-hydroxy fatty acids including 12-hydroxystearic acid, 12-hydroxylauric acid, 16-hydroxyhexadecanoic acid and mixtures thereof. Examples of other suitable fatty acids include Klofta et al., US Pat. No. 7,449,613, Hofrichter et al., US Pat. No. 5,429,816, and Motley, US Pat. No. 5,552,136. Further disclosure in the specification, the disclosures of each are incorporated herein by reference in their entirety.

Waxes are also suitable for use as the viscosity enhancer of the composition of the present invention. Natural waxes can include, but are not limited to, carnauba, ozokerite, beeswax, candelilla, paraffin, ceresin, esparto, auricuri, resowax and other known mining and mineral waxes. Synthetic waxes can include, but are not limited to, paraffin wax and microcrystalline wax.

Other viscosity enhancing agents that can be used herein include polyhydroxy fatty acid esters, polyhydroxy fatty acid amides and mixtures thereof. Preferred esters and amides have 3 or more free hydroxyl groups in the polyhydroxy moiety and typically have nonionic character. These esters and amides should be relatively non-irritating and non-irritating to the skin, as the skin of the person using the article to which the composition is applied may be hypersensitive. Is. Suitable polyhydroxy fatty acid esters and polyhydroxy fatty acid amides are disclosed in US Pat. No. 5,643,588 to Roe et al., the contents of which are incorporated herein by reference in their entirety.

Further, the viscosity enhancer that may be contained in the composition according to the present invention may be a gelling agent. Gelling agents are materials that can swell or swell upon contact with water. Examples of gelling agents that may be used in the present invention include swellable polymers, also known as osmopolymers or hydrogels. The swellable polymer may be non-crosslinked or lightly crosslinked. The crosslinks may be covalent or ionic with a polymer that has the ability to swell in the presence of a liquid, which in the case of crosslinks does not dissolve in the liquid. The polymer may be of plant, animal or synthetic origin. Polymeric materials useful for the purposes of the present invention include polyhydroalkyl celluloses having a molecular weight greater than 50,000, such as hydroxypropylmethyl cellulose (available from Dow Chemical at METHOCEL® K 100M), from 5,000 to Poly(hydroxyalkylmethacrylate) having a molecular weight of 5,000,000, poly(vinylpyrrolidone) having a molecular weight of 100,000 to 3,000,000, anionic and cationic hydrogels, poly(electrolytic) composites A poly(vinyl alcohol) with a low acetate residue, a swellable mixture of agar and carboxymethylcellulose, a swellable composition comprising methylcellulose mixed with a sparingly soluble cross-linked agar, a molecular weight of 10,000 to 6,000,000. And a water-swellable copolymer produced by dispersing a fine powder copolymer of maleic anhydride and styrene, ethylene, propylene or isobutylene, and a water-swellable polymer of N-vinyllactam.

Other gelling agents useful in the present invention include pectins having a molecular weight range of 30,000 to 300,000, polysaccharides (such as agar, acacia, karaya, tragacanth, algin and guar), CARBOPOL®, Acrylic acid polymers, sometimes referred to as carboxypolymethylene, carboxyvinyl polymers, described in US Pat. Nos. 2,798,053 and 2,909,462 and CARBOPOL®. Acrylic acid polymers cross-linked with sucrose polyallyl ethers and their salt derivatives, polyacrylamides, water-swellable indene-maleic anhydride polymers, 80,000-200,000, available as 934, 940 and 941. Polyacrylic acid with a molecular weight (GOOD-RITE®), polyethylene oxide polymers with a molecular weight of 100,000 to 7,000,000 (POLYOX®), starch graft copolymers, of the original weight Acrylate polymers having a water absorption of 400 times (AQUA-KEEP (registered trademark)), diesters of polyglucan, a mixture of crosslinked polyvinyl alcohol and poly(N-vinyl-2-pyrrolidone), 4,000 to 100,000 Poly(ethylene glycol) having a molecular weight of is included. Representative polymers having gelling properties are US Pat. Nos. 6,419,954, 4,915,949, 4,327,725, 4,207,893. And Scott and Roff, "Handbook of Common Polymers," Cleveland Rubber Company, Cleveland, Ohio.

Examples of inorganic viscosity enhancing agents that may be included in the compositions of the present invention include treated and untreated fumed silica, examples of which are Cabot Corp. of Tacosla, Illinois. Commercially available under the trade names CAB-O-SIL M5 and MS-55. An exemplary surface treated fumed silica is also available from Cabot Corp. of Tacosla, Illinois. Available under the trade names TS-720 and TS-610.

Suitable clays such as hectorite and smectite can also be used as viscosity enhancers in the composition according to the invention.

Hydrogenated vegetable oils such as cocoa butter, shea butter and mixtures thereof can likewise be used as viscosity enhancing agents in the compositions according to the invention.

Suitable petroleum-based emollients may likewise be used as viscosity enhancers in the compositions according to the invention. Suitable examples of petroleum-based emollients that may be used, petrolatum, i.e. contains a mixture of hydrocarbons or hydrocarbons, hydrocarbons having a chain length of C ₁₀ -C ₁₀₀ is particularly preferred. Petroleum emollients having a chain length within this range include mineral oils and petrolatum. Mineral oil usually refers to a low viscosity mixture of hydrocarbons having 10 to 30 carbon atoms, but the hydrocarbons have different molecular weight distributions. Mineral oils with a low proportion of low molecular weight hydrocarbons are preferred because low molecular weight hydrocarbons can cause inflammation in some individuals. Petrolatum is usually a mixture of high molecular weight hydrocarbons and is highly viscous. Petrolatum and mineral oils are preferred as skin conditioning agents in the compositions of the present invention because of their ability to protect the skin from harmful or irritation causing inflammation. Petrolatum is particularly preferred because it has a good barrier function.

The composition according to the present invention may also contain a humectant. The compositions according to the invention typically contain from about 0.001% to about 30% by weight of humectant, based on the total weight of the composition, preferably from about 0.005% by weight. It contains about 20% by weight, and most preferably about 0.01% to about 10% by weight moisturizer. Examples of compounds that can be used as humectants in the composition according to the invention include esters of polyhydroxy alcohols. Esters of this type include glyceryl esters, including glycerides and derivatized glycerides, polyglyceryl esters and glycol esters. Glyceryl esters are derived from glycerin, its derivatives and one or more carboxylic acid moieties. Non-limiting examples include glycerin and various C ₁ -C ₃₀ mono derivatives thereof, di-, tri- - esters, such as mono-, - di -, tri - glycerides, acetoglycerides acids and ethoxylated glycerides Is included. Representative glyceryl esters include glyceryl behenate, glyceryl oleate, glyceryl stearate, glyceryl palmitate, glyceryl distearate, glyceryl dipalmitate, and the like. Polyglyceryl esters having an acid moiety of C ₁₂ -C ₂₂ are also suitable for use herein. Non-limiting examples include polyglyceryl-4 isostearate, polyglyceryl-3 oleate, diglyceryl monooleate, tetraglyceryl monooleate and the like. Glycol esters, ethylene glycol, propylene glycol induction, butylene glycol, from one or more carboxylic acid moieties with a C ₂ -C ₆ glycols containing hexylene glycol and derivatives thereof, a chain of C ₁ -C ₃₀ To be done. Specific examples of glycol esters include polyethylene glycols (PEGs) such as PEG-2, PEG-3, PEG-30 and PEG-50, and polypropylene glycols (PPGs) such as PPG-. 9, PPG-12, PPG-15, PPG-17, PPG-20, PPG-26, PPG-30 and PPG-34.

The composition according to the invention may also contain emulsifiers or dispersants, examples of which include anionic, cationic and nonionic surfactants. The composition according to the invention typically contains from about 0.001% to about 15% by weight of emulsifier or dispersant, based on the total weight of the composition, preferably about 0. It contains from 005% to about 10%, most preferably from about 0.01% to about 5% by weight of an emulsifier or dispersant. Nonionic surfactants are preferred because of their low skin irritation. Typical nonionic surfactants include monoglycerides such as glyceryl monostearate, sorbitan fatty acid esters such as sorbitan monolaurate, sucrose fatty acid esters, and polyoxyethylene fatty acid esters such as polyoxyethylene stearate. And polyoxyethylene higher alcohol ethers such as polyoxyethylene cetyl ether, polyoxyethylene oleyl ether, and polyoxyethylene fatty ether.

The composition according to the invention may contain antioxidants to minimize or prevent the oxidation process and increase the shelf life of the composition. The composition according to the invention typically contains from about 0.001% to about 25% by weight of antioxidants, based on the total weight of the composition, preferably about 0.005%. % To about 15 wt. %, most preferably about 0.01 wt.% to about 10 wt.% antioxidant is included. Antioxidants useful herein should preferably be mild and non-irritating. Naturally occurring antioxidants are preferred, for example vitamin E and its containing tocopherols, tocopherol acetates, and mixed tocopherols (available from COVI-OX T-50 or T-70 from Henkel Corp., Amber, PA). Examples thereof include derivatives, butylated hydroxytoluene, butylated hydroxyanisole, sodium pyrosulfate, and acetone sodium bisulfate. Some of these antioxidants are useful as skin antioxidants, minimizing wrinkles and dullness of the skin as well as providing a youthful appearance and tightening of the texture of the skin.

The compositions according to the invention may contain preservatives to control bacterial growth and their odor, especially when the composition has a relatively high water content. The composition according to the invention typically contains from about 0.001% to about 10% by weight of preservative, based on the total weight of the composition, preferably about 0.005. % To about 5%, and most preferably about 0.01% to about 2.5% by weight preservative. Suitable preservatives include propylparaben, methylparaben, benzyl alcohol, benzalkonium chloride, calcium triphosphate, phenoxyethanol, or acids such as citric acid, tartaric acid, maleic acid, lactic acid, malic acid, benzoic acid, salicylic acid and the like. Be done.

The composition according to the present invention may contain an acid or base in order to adjust the pH of the composition to a desired or optimum range. Examples of typical compounds used to adjust the pH of topically used compositions include oleic acid, hydrochloric acid, citric acid, lactic acid, tartaric acid, glacial acetic acid, sodium hydroxide and the like. The final desired pH value of the composition may vary depending on the form (ie, gel, serum, or cream) and location to which the composition is applied, but generally the pH of the composition is The range is preferably about 5.0 to about 8.5, more preferably about 6 to about 8.0, most preferably about 6.5 to about 7.5.

It may be necessary to add a chelating agent in order to increase the stability of the composition according to the invention. Chelating agents can include ethylenediaminetetraacetic acid (EDTA) and its derivatives, thioglycolic acid, thiolactic acid, thioglycerol, and the like.

A fragrance can also be added to the composition according to the present invention, if necessary.

When the composition according to the invention is an aerosol, foam or mousse, the composition requires a propellant for dispensing the composition from the container. The propellant may be of any type commonly used in the cosmetic/pharmaceutical industry, eg nitrogen, carbon dioxide, dimethyl ether, hydrocarbons (ie methane, ethane, propane, butanes and pentanes). , halogenated hydrocarbons _{(i.e., CH 2 ClF, CClF 2 CHClF} , CF 3 CHClF, CHF 2 CClF 2, CHClFCHF 2, CF 3 CH 2 Cl, CClF 2 CH 3, CHF 2 CHF 2, CF 3 CH 2 F (HFC 134a), CHF ₂ CH ₃ (HFC152a), CF ₃ CHFCF ₃ (HFC227), CF ₃ CF ₃ and CF ₃ CF ₂ CF ₃ ). Among the more commonly used hydrocarbon propellants are A-46 (15.2% propane/84.8% isobutene), and NP-46 (25.9% propane/74.1% n-). Butane) and NIP-46 (21.9% propane/31.3% isobutene/46.8% n-butane). The amount of propellant may be the type of container used in the composition according to the invention, the amount of the composition in the container, the amount of composition dispensed per actuation, and the form in which the composition is dispensed ( That is, it depends on the mist or form). Optimization of propellants and containers is well within the capabilities of those skilled in the art, examples of which are US Pat. No. 6,946,120 to Wai-Chi So So et al. and Remington, “Science and Practice of Pharmacy. (Science and Practice of Pharmacy), 21st Edition, p. 1000-1017, the contents of which are hereby incorporated by reference in their entirety. Propellants are generally only made in accordance with the present invention because they are only part of the dispensing tool, and once the composition is dispensed and applied to the psoriatic area of a patient, it does not normally remain in the composition. It is not included in the calculation of the weight percentage of the composition.

Aerosol according to the present invention, foams and mousses, the solvent, preferably in an amount of C ₁ -C ₆ alcohols such as water and / or a lower alcohol i.e. methanol, ethanol, isopropanol, or mixtures thereof. The aerosol, foam or mousse may also be from one or more of the group consisting of aromatic and polyhydric alcohols such as 1,3-butylene glycol, propylene glycol, polyethylene glycol 400, hexylene glycol and dipropylene glycol or glycerol. A cosolvent of choice may be included. When present, the cosolvent may be present in an amount of about 10% or less, preferably about 5% or less, based on the total weight of the composition.

The composition according to the invention may also contain anti-inflammatory agents, local anesthetics or mixtures thereof. Typical local anesthetics include, but are not limited to, lidocaine, xylocaine, buprenorphine and fentanyl. Suitable local anesthesia is known to those skilled in the art, for example Goodman Gilman, Alfred, Goodman, Luis S, Gilman, Alfred by Goodman Gilman, Alfred, Goodman, Louis S, Gilman, Alfred. Basis of Therapeutics (Goodman and Gilman's The Pharmaceutical Basis of Therapeutics), 9th Edition, p. 331-347.

Any suitable topical corticosteroid can be used as an anti-inflammatory agent. Suitable corticosteroids are known to those skilled in the art and are described, for example, in Goodman Gilman, Alfred, Goodman, Louis S, Gilman, Alfred, “Goodman and Gilman, Theman,” by Goodman Gilman, Alfred, Goodman, Lewis S, Gilman, Alfred. "Pharmacologic Basis of Therapeutics", 9th edition, p.o., Goodman and Gilman's The Pharmacological Basis of Therapeutics. 1459-1483. Representative and suitable corticosteroids include cortisol (hydrocortisone), tetrahydrocortisol, prednisone (cortisone), prednisolone (cortisol), 6α-methylprednisolone, fludrocortisone (9α-fluorocortisol), 11-desoxycortisol, Cortisone (11-dehydrocortisol), corticosterone, triamcinolone (9α-fluoro-16α-hydroxyprednisolone), parameterzone (6α-fluoro-16α-methylprednisolone), betamethasone (9α-fluoro-16β-methylprednisolone), dexamethasone (9). 9α-fluoro-16α-methylprednisolone), desoxycorticosterone acetate (doca acetate, percorten acetate), desoxycorticosterone pivalate (percorten pivalate), fludrocortisone acetate (fluorine) Acetate (florine acetate), cortisol (hydrocortisone) (cortef, hydrocorton), cortisol acetate (cortef acetate, hydrocorton acetate), cortisol cypionate (cortef), sodium cortisol phosphate (hydrocorton phosphate), cortisol succinate Sodium (Sol-Cortef), Beclomethasone Dipropionate (Vanceryl), Betamethasone (Cerestone), Phosphate and Betamethasone Acetate Sodium (Cerestone Solspan), Betamethasone Dipropionate (Diprozone), Betamethasone Valerate (Varizone) , Betamethasone benzoate (benison, flurodate), cortisone acetate (corton acetate), dexamethasone (decadron, gammacorten), dexamethasone sodium phosphate (decadron phosphate, hexadolol phosphate), dexamethasone acetate (decadron-LA. ), fuprednisolone (alphadrol), meprednisone (betapa), methylprednisolone (medrol), methylprednisolone acetate (depo-medrol, medrol acetate), methylprednisolone sodium succinate (sol-medrol), parametazone acetate (sol-medrol). Hardron), Prednisolone (Delta-Cortef), Prednisolone Acetate (Methicorterone Acetate), Li Prednisolone sodium acid salt (Hydertrazol), Prednisolone sodium succinate (Methylcorterone soluble), Prednisolone tebutate (Hydelta-T. B. A. ), prednisone (deltazone, paracort), triamcinolone (Aristocort, Kenacolt), triamcinolone acetonide (Aristoderm, Kenalog), triamcinolone diacetate (Aristocort diacetate, kenacort diacetate), triamcinolone hexasacotonid Aristopan), Desonide (Tridecylone), Desoxymethasone (Topicote), Flumethasone Pivalate (Locorten), Fluocinolone Acetonide (Fluonide, Sinaler), Fluocinonide (Redex, Topsin), Fluorometron (Oxylone), Fluland Includes lenolid (Cordran), halcinonide (Halogue) and medolizone (HMS liquifilm, medrocort).

A suitable amount of local anti-inflammatory or local anesthetic may preferably be from about 0.1% to about 99.9% by weight of the composition. Typically, the amount of anesthetic and/or anti-inflammatory agent present can be determined by the particular anesthetic and anti-inflammatory agent used in the composition. In some embodiments of the invention, the anesthetic and/or anti-inflammatory agent is at most about 10%, at most about 5%, at most about 2%, at most about 1% or at most about 1% by weight of the composition. It may be 0.1% by weight. Further, the nature and amount of anesthetic and/or anti-inflammatory agent present in the composition complies with all national and/or federal guidelines (eg, FDA regulations) that regulate the use of such compounds. Should be.

The composition according to the invention may also contain a psoriasis therapeutic agent such as anthralin, also known as dithranol, vitamin D such as calcipotriene or calcitriol, and vitamin A such as tazarotene. Some of the known remedies for psoriasis are described by Goodman Gilman, Alfred, Goodman, Louis S, Gilman, Alfred by Goodman Gilman, Alfred, Goodman, Louis S, Gilman, Alfred. Therapeutic (Goodman and Gilman's Pharmacological Basis of Therapeutics), 9th Edition, p. 1591-1613 for further details.

The following table outlines some representative compositions that can be formulated according to the invention, but the invention is not limited thereto.

(Example)
The following are provided by way of illustration and are not intended to be limiting.

Example 1
A beauty essence having the following composition is prepared.

The above serum was prepared by adding SUPER STEROL LIQUID, shea butter, POLYDERM PPI-SA, oleic acid and lauryl laurate to a suitable mixer and heating the mixture at 75-85°C for about 30 minutes until a clear solution was obtained. Be prepared. SUPER Sterol LIQUID _is a mixture of C 10 _{-C 30} cholesterol and lanosterol esters, Croda Chemicals Europe Ltd. UK East Yorkshire It can be purchased from. POLYDERM PPI-SA is a di-PEG-2 soyamine/IPDI copolymer available from Alzo International Inc. It can be purchased from.

Stop heating the resulting composition and continue stirring. When the temperature of the composition is below 50° C., add vitamin A palmitate, vitamin E acetate and phenoxyethanol to the composition with continued stirring. When the temperature of the composition reaches room temperature, the serum composition is filled in a pump bottle.

Example 2
A salve having the following composition is prepared.

The plaster is prepared by mixing the ingredients in a suitable mixer according to the procedure outlined in Example 1 and filling the plaster in a suitable tube for distribution by the patient.

Example 3
A cream having the following composition is prepared.

The cream is prepared by adding the serum of Example 1, POLAWAX™, water and cetyl alcohol to a suitable mixer and heating the mixture at 75-85°C for about 20-30 minutes. POLAWAX™ is a higher fatty alcohol self-emulsifying wax and is available from Croda Chemicals Europe Ltd. of East Yorkshire, England. It can be purchased from. DOWICIL™-200 is a 1-3-chloroallyl-3,5,7-triaza-1-azonia adamantan chloride antiseptic/antibacterial compound available from Dow Chemical Co. It can be purchased from. Stop heating the resulting composition and continue stirring. Once the solution is at room temperature, DOWICIL™-200 is added and the cream is packaged in tubes, bottles, bottles or other suitable containers.

Example 4
A foam having the following composition is prepared.

The foam composition described above is prepared by adding the serum of Example 1, GLYCEROX 767, and water to a suitable mixer and heating the mixture at 75°C for about 10 minutes. GLYCEROX 767 is a PEG-6 capric/caprylic glyceride and is available from Croda Chemicals Europe Ltd. of East England, United Kingdom. It can be purchased from. Stop heating the resulting composition and stir until room temperature is reached. The composition is packaged in a closed aerosol container with A-46 propellant (15.2% propane/84.8% isobutene) available from Diversified CPC International. The final aerosol container contains about 96.5% foam composition as described above and 3.5% at 75°F and a pressure of about 46 PSIG propellant.

Example 5
The cosmetic solution prepared in Example 1 was applied to 14 patients suffering from psoriasis. The treatment plan and results are summarized in Table 10.

Example 6
In one male patient, it was reported that sunburn pain was alleviated after the cosmetic solution prepared in Example 1 was applied once. According to the patient's report, when the beauty essence was applied to the sunburned area before going to bed at night, it was relieved when waking up in the morning.

While described with the purpose of disclosing preferred and alternative embodiments of the invention, those skilled in the art will be able to modify aspects of the disclosure. Therefore, the appended claims are intended to cover all embodiments of the invention and modifications thereof without departing from the spirit and scope of the invention.

All journal articles, patents, and other references mentioned herein are incorporated by reference in their entirety.

The word "comprising" as used in the following claims is an open-ended transitional phrase intended to include additional elements not specifically recited in the claim. As used in the following claims, the phrase "consisting essentially of" is a partially closed transitional expression that, in addition to the recited elements, is essential to the basic and novel characteristics of the claim. Is intended to include any unspecified elements that do not affect For example, an adhesive laminate with embossed or printed indicia (outermost layer of applied patch) is included in the meaning of "consisting essentially of" even though it is not specifically listed. The phrase "consisting of" as used in the following claims is intended to indicate that the claims are limited to the elements listed.

(Cross-reference of related applications)
It should be noted that all features or elements positively identified herein are also considered to be specifically excluded as features or elements of embodiments of the present invention.

(Appendix)
(Appendix 1)
A composition for topical administration, comprising:
(A) 25% or more sterol ester based on the weight of the composition, excluding all possible solvents, having a boiling point of 150° C. or less,
(B) a penetration enhancer, and
(C) optionally an additional addition selected from the group consisting of solvents, film-forming/polymeric agents, viscosity enhancers, emulsifiers, antioxidants, pH adjusting agents, preservatives, vitamins, propellants and mixtures thereof. Agent,
A composition comprising:

(Appendix 2)
The composition according to Appendix 1, which contains the sterol ester in an amount of 30% or more based on the total weight of the composition excluding any solvent that may have a boiling point of 150° C. or less.

(Appendix 3)
The composition according to Appendix 1, which contains the sterol ester in an amount of 40% or more based on the total weight of the composition excluding all solvents that may be present and has a boiling point of 150°C or less.

(Appendix 4)
The composition according to Appendix 1, wherein the sterol ester is a C ₁₀ -C ₃₀ carboxylic acid sterol ester.

(Appendix 5)
The composition of statement 4 wherein the sterol ester is C ₁₀ -C ₃₀ carboxylic acid cholesterol / lanosterol mixture.

(Appendix 6)
The composition according to Appendix 1, which is a gel, cream, lotion, salve, beauty essence, aerosol, mousse or foam, and which contains a film-forming agent.

(Appendix 7)
The composition according to Appendix 1, which is a gel, cream, lotion, salve, beauty essence, aerosol, mousse or foam, and which contains a film-forming agent and a viscosity enhancer.

(Appendix 8)
The composition according to appendix 1, which is a gel, cream, lotion, aerosol, mousse or foam, containing a film forming agent, a viscosity enhancer and a solvent.

(Appendix 9)
The composition according to Appendix 1 which is an aerosol, mousse or foam and contains a film forming agent, a viscosity enhancer, a solvent and a propellant.

(Appendix 10)
A method for treating psoriasis comprising topically administering at least once daily a composition to a psoriatic area of a patient, said composition comprising:
(A) 25% or more sterol ester based on the weight of the composition, excluding all possible solvents, having a boiling point of 150° C. or less,
(B) a penetration enhancer, and
(C) optionally an additional addition selected from the group consisting of solvents, film-forming/polymeric agents, viscosity enhancers, emulsifiers, antioxidants, pH adjusting agents, preservatives, vitamins, propellants and mixtures thereof. Agent,
A method comprising:

(Appendix 11)
11. The method according to appendix 10, wherein the sterol ester is contained in an amount of 30% or more based on the total weight of the composition excluding all solvents that may be present and has a boiling point of 150°C or less.

(Appendix 12)
The method according to appendix 10, wherein the sterol ester is contained in an amount of 40% or more based on the total weight of the composition excluding all solvents that may be present and has a boiling point of 150°C or less.

(Appendix 13)
Note 1 wherein the sterol ester is a C ₁₀ -C ₃₀ carboxylic acid sterol ester.
The method described in 0.

(Appendix 14)
The sterol esters method of statement 13 is _C 10 _{-C 30} carboxylic acid cholesterol / lanosterol mixture.

(Appendix 15)
11. The method according to appendix 10, wherein the composition is a gel, cream, lotion, salve, serum, aerosol, mousse or foam and contains a film-forming agent.

(Appendix 16)
11. The method according to Appendix 10, wherein the composition is a gel, cream, lotion, salve, serum, aerosol, mousse or foam and contains a film-forming agent and a viscosity enhancer.

(Appendix 17)
11. The method according to Appendix 10, wherein the composition is a gel, cream, lotion, aerosol, mousse or foam and contains a film-forming agent, a viscosity enhancer and a solvent.

(Appendix 18)
11. The method of appendix 10 wherein the composition is an aerosol, mousse or foam and contains a film forming agent, a viscosity enhancing agent, a solvent and a propellant.

(Appendix 19)
The method of claim 10 wherein the composition is applied to the psoriatic area more than once a day.

(Appendix 20)
11. The method of claim 10 further comprising washing and drying the psoriatic area prior to applying the composition.

(Appendix 21)
11. The method of claim 10 further comprising the step of covering the composition and the psoriatic area with a protective cloth, bandage, gauze or wrap after applying the composition.

(Appendix 22)
A composition for topical administration, comprising:
(A) 25% or more sterol ester based on the weight of the composition, excluding all possible solvents, having a boiling point of 150° C. or less,
(B) solvent,
(C) propellant,
(D) penetration enhancer,
(E) a viscosity enhancer, and
(F) optionally an additional additive selected from the group consisting of cosolvents, film-forming/polymeric agents, emulsifiers, antioxidants, pH adjusting agents, preservatives, vitamins and mixtures thereof,
Containing
A composition which is an aerosol, mousse or foam.

(Appendix 23)
23. The composition according to Appendix 22, which contains the sterol ester in an amount of 30% or more based on the total weight of the composition excluding any solvent that may have a boiling point of 150°C or less.

(Appendix 24)
23. The composition according to Appendix 22, which contains the sterol ester in an amount of 40% or more based on the total weight of the composition excluding any solvent that may have a boiling point of 150° C. or less.

(Appendix 25)
The composition of statement 22 wherein the sterol ester is _C 10 _{-C 30} carboxylic acid sterol esters.

(Appendix 26)
The composition of statement 22 wherein the sterol ester is _C 10 _{-C 30} carboxylic acid cholesterol / lanosterol mixture.

Claims (10)

A composition of a cream, lotion or gel for the treatment of psoriasis, which is administered topically to the psoriatic area of a patient at least once a day, comprising:
(A) 30 wt% -80 wt% _C 10 _{-C 30} carboxylic acid cholesterol / lanosterol mixture,
(B) 0.01 wt%-15 wt% penetration enhancer,
(C) 0.1 wt%-10 wt% film-forming polymer agent,
(D) 1 wt%-40 wt% viscosity enhancer,
(E) 5 wt%-85 wt% solvent,
(F) 0.1 wt%-20 wt% emulsifier,
(G) 0 wt%-10 wt% antioxidant,
(H) 0 wt%-10 wt% preservative,
(Provided that the amount of the C ₁₀ -C ₃₀ carboxylic acid cholesterol / lanosterol mixture based on the weight of the composition excluding the solvent, the amount of the other components based on the weight of the composition including the solvent)
A cream, lotion, or gel composition comprising. The penetration enhancer is oleyl alcohol, lauryl alcohol, isopropyl myristate, oleyl oleate, levulinic acid, glycerol monooleate, methyl laurate, sorbitan monooleate, triacetin, cetyl alcohol, cetyl lactate, dimethyl isosorbide, dipropylene glycol, ethylhexyl. Lactate, glycolic acid, lauramine oxide, lauryl betaine, lauryl lactate, lauryl laurate, isopropyl palmitate, myristyl alcohol, myristal lactate, octyl salicylate, oleamine oxide, oleic acid, oleyl betaine, salicylic acid. A cream, lotion or gel composition according to claim 1 selected from the group consisting of:, stearyl alcohol, stearyl lactate, triethanolamine triacetate and mixtures thereof. The cream, lotion, or gel composition of claim 1 or 2, wherein the film-forming polymeric agent is water soluble. The cream, lotion, or gel composition according to claim 1 or 2, wherein the film-forming polymer is water-insoluble. The viscosity enhancing agent, natural waxes, synthetic _waxes, C 12 _{-C 60 alcohols,} C 12 _{-C 60} acids, alpha - hydroxy fatty acids, polyhydroxy fatty acid esters, polyhydroxy fatty acid amides, metal ester complexes , fumed silica, organic clays, polyols polyesters, glyceryl esters, polyglyceryl esters, polysiloxanes, gelling agents, hydrogenated vegetable oils, petroleum-based emollients having a chain length of C ₁₀ -C _100, and their A composition of cream, lotion or gel according to any one of claims 1 to 4, selected from the group consisting of the mixture of: 6. The cream, lotion, or lotion according to any one of claims 1 to 5, wherein the preservative is selected from the group consisting of propylparaben, methylparaben, benzyl alcohol, benzalkonium chloride, calcium triphosphate, and phenoxyethanol. Gel composition. The solvent is water, a C ₁ -C ₆ alcohol, an aromatic alcohol, a polyhydric alcohol, methanol, ethanol, isopropanol, 1,3-butylene glycol, propylene glycol, polyethylene glycol 400, hexylene glycol, dipropylene glycol, dipropene. 7. A cream, lotion or gel composition according to any one of claims 1 to 6 selected from the group consisting of prene glycerol and mixtures thereof. (A) the _C 10 _{-C 30} carboxylic acid cholesterol / lanosterol mixture 40 wt% -70 wt%,
(B) 0.1 wt%-10 wt% of the penetration enhancer,
(C) 0.5% to 5% by weight of the above film-forming polymer agent,
(D) 3 wt%-20 wt% of the viscosity enhancer,
(E) 10 wt%-75 wt% of the solvent,
(F) 1% to 10% by weight of the emulsifier,
(G) 0.5 wt%-5 wt% of said antioxidant,
(H) 0.5 wt% - 5 wt% of the preservative,
(Provided that the amount of the C ₁₀ -C ₃₀ carboxylic acid cholesterol / lanosterol mixture based on the weight of the composition excluding the solvent, the amount of the other components based on the weight of the composition including the solvent)
8. A cream, lotion or gel composition according to any one of claims 1 to 7, which comprises: A composition of a cream, lotion or gel for the treatment of psoriasis, which is administered topically to the psoriatic area of a patient at least once daily
(A) 30 wt% -80 wt% _C 10 _{-C 30} carboxylic acid cholesterol / lanosterol mixture,
(B) 0.01% to 15% by weight of penetration enhancer (provided that the penetration enhancer is oleyl alcohol, lauryl alcohol, isopropyl myristate, oleyl oleate, levulinic acid, glycerol monooleate, methyl laurate, sorbitan Monooleate, triacetin, cetyl alcohol, cetyl lactate, dimethyl isosorbide, dipropylene glycol, ethylhexyl lactate, glycolic acid, lauramin oxide, lauryl betaine, lauryl lactate, lauryl laurate, isopropyl palmitate, myristyl alcohol, myristal lactate (myristal) lactate), octyl salicylate, oleamine oxide, oleic acid, oleyl betaine, salicylic acid, stearyl alcohol, stearyl lactate, triethanolamine triacetate and mixtures thereof),
(C) 0.1 wt%-10 wt% film-forming polymer agent,
(D) 1% to 40% by weight of viscosity enhancer (provided that the viscosity enhancer is natural wax, synthetic wax, C ₁₂ -C ₆₀ alcohol, C ₁₂ -C ₆₀ acid, alpha-hydroxy fatty acid) , Polyhydroxy fatty acid esters, polyhydroxy fatty acid amides, metal ester complexes, fumed silica, organic clay, polyol polyesters, glyceryl esters, polyglyceryl esters, polysiloxanes, gelling agents, hydrogenated vegetable oils, C petroleum emollient having a chain length of ₁₀ -C _100, and is selected from the group consisting of mixtures),
(E) 5 wt%-85 wt% solvent (provided that the solvent is water, C ₁ -C ₆ alcohol, aromatic alcohol, polyhydric alcohol, methanol, ethanol, isopropanol, 1,3-butylene glycol, propylene) Selected from the group consisting of glycol, polyethylene glycol 400, hexylene glycol, dipropylene glycol, dipropylene glycol, and mixtures thereof),
(F) 0.1 wt%-20 wt% emulsifier,
(G) 0 wt%-10 wt% antioxidant,
(H) 0% to 10% by weight of preservative (wherein the preservative is selected from the group consisting of propylparaben, methylparaben, benzyl alcohol, benzalkonium chloride, tribasic calcium phosphate, and phenoxyethanol),
(Provided that the amount of the C ₁₀ -C ₃₀ carboxylic acid cholesterol / lanosterol mixture based on the weight of the composition excluding the solvent, the amount of the other components based on the weight of the composition including the solvent)
A composition of cream, lotion, or gel consisting essentially of: (A) the _C 10 _{-C 30} carboxylic acid cholesterol / lanosterol mixture 40 wt% -70 wt%,
(B) 0.1 wt%-10 wt% of the penetration enhancer,
(C) 0.5% to 5% by weight of the above film-forming polymer agent,
(D) 3 wt%-20 wt% of the viscosity enhancer,
(E) 10 wt%-75 wt% of the solvent,
(F) 1% to 10% by weight of the emulsifier,
(G) 0.5 wt%-5 wt% of said antioxidant,
(H) 0.5 wt% - 5 wt% of the preservative,
(Provided that the amount of the C ₁₀ -C ₃₀ carboxylic acid cholesterol / lanosterol mixture based on the weight of the composition excluding the solvent, the amount of the other components based on the weight of the composition including the solvent)
10. The cream, lotion or gel composition of claim 9, consisting essentially of: