COMPOSITIONS FOR TREATING SKIN DISORDERS

INTRODUCTION

Aspects of the present invention relate to topical cream compositions comprising various butters in a delivery vehicle. Aspects of the present invention also relate to topical compositions comprising squalene. Additional aspects of the invention relate to processes for preparing such compositions or formulations. Further aspects of the invention relate to methods of use and treatment with the compositions.

Psoriasis is generally a skin disease evidenced by the presence of skin elevations and scales, which may be silvery in appearance. Psoriasis in general is a disease involving acceleration of epidermal proliferation and proliferation of capillaries in the dermal region. In addition, psoriasis frequently results in the exfoliation of the dermis and epidermis by inflammation of the affected cells.

Dry skin frequently occurs on the hands. It is more common during the winter months, when humidity is low. Dry skin is defined as flaking or scaling which may or may not be itchy when there is no evidence of dermatitis, or inflammation, of the skin. Some flaking along with redness, dermatitis of the palms, also called eczema keratoticum, is a chronic, sometimes disabling condition in middle-aged persons. Eczema as often used as being synonymous with dermatitis that simply means inflammation of skin. There are different types of dermatitis such as seborrheic dermatitis, allergic contact dermatitis, atopic dermatitis, athlete's foot, etc., which lead to excessive scaling or keratinisation. Eczema may be exogenous, such as dermatitis resulting from external factors, or endogenous, such as dermatitis resulting from internal factors.

U.S. Patent Application Publication No. 2004/0137089 A1 describes a skin treatment having the components alcohol spirit, glycerine, and an extract of aloe vera or kiddachi aloe. Alternatively, the treatment includes alcohol spirit and a source of vitamin B17. Preferably, the alcohol spirit is chosen from the group including barley, rice, potato spirit or sake. Preferably, it is a low class distilled spirit. Additional preferred ingredients include seed and/or leaf extract, citrus fruit extract, and tea leaf extract.

International Application Publication No. WO 2007/075597 describes a topical composition comprising: a mixture of dimethicone and cyclomethicone, mineral oil,

Aloe vera gel, and a vitamin E source. The composition may be used to treat burns, particularly minor burns, sunburns, eczema, psoriasis, dry or bleeding cuticles, dry or rough skin, athletes foot, razor rash or razor burn, cold sores, dry or chapped lips, dry or frayed hair, and/or combinations thereof.

U.S. Patent Application Publication No. 2003/0157050 A1 describes a cosmetic lotion comprising 16-76% by weight cocoa butter and having a solid rather than liquid form. Also described is a method of manufacturing a cosmetic lotion having an oil based component and a water based component, characterized by selecting the oil based component to comprise cocoa butter so that the cocoa butter constitutes 16-76% by weight of the final form of the lotion, heating the cocoa butter to a temperature in the range 55-70°C, cooling the cocoa butter to a temperature in the range 35-25°C, and at a temperature in that range adding the water based component.

U.S. Patent Application Publication No. 2008/0241202 A1 describes a multifunctional cosmetic composition, being particularly an oil-in-water emulsion, characterized by comprising a silicone system and an emollient system composed of at least one component selected from cupuacu butter, murumum butter, and Shea butter.

U.S. Patent Application Publication No. 2007/160548 A1 discloses a sunless tanning composition comprising a tanning active system; and a moisturizing system, wherein the moisturizing system comprises of naturally occurring fats and oils are selected from the group consisting of shea butter, shea butter oil, cocoa butter, jojoba butter, aloe butter, olive butter, coconut oil, jojoba, and combinations thereof.

U.S. Patent No. 7,625,575 discloses a dermatological composition comprising urea, glycine soja (soybean) sterol, shea butter, hybrid sunflower oil, disodium EDTA, sodium polyacrylate, and triethanolamine. Apart from shea butter, it discloses use of cocoa butter, mango butters, and modified vegetable butters.

U.S. Patent No. 7,736,632 discloses a topical deodorant composition comprising: unrefined Shea butter; sodium bicarbonate; cornstarch; cocoa butter; Clary sage oil; benzoin gum tincture; coconut oil; lavender oil; and optionally, vitamin E and optional oil extracts.

Many hand creams, lotions, and gels for human skin, and preferably for the hands, are well known, for example, the brands Lindesa O Hand Cream, Logona -Daily Care Hand Cream, and Eucerin pH 5 Hand Cream.

The hand creams are suitable for application after work on dry and defatted skin, for intensive care for rough and damaged hands.

The known emulsion based hand creams contain, besides water, often glycerin, cetearyl alcohol, and glyceryl stearate.

There is a long felt need to provide emulsion products that can be applied to the skin, which produce an immediate appearance improvement for rough, chapped, or dry skin. It would be a significant advance in the art to provide improved topical compositions for the treatment of skin disorders.

SUMMARY OF THE INVENTION

Aspects of the present invention relate to topical compositions comprising butters in a cream base for improved moisturizing effect. The cream bases may be in any of a large spectrum of suitable forms, including but not limited to creams, moisturizing creams, ointments, oils, waxes, gels, lotions, liquid suspensions or dispersions, emulsions, emulsions comprising oil in water, and the like, provided the emollient base is suitable for topical application on skin. A properly chosen emollient base may provide a certain amount of relief itself for mild outbreaks of psoriasis or dermatitis.

In embodiments, the topical compositions of the present invention are useful in the treatment of portions of skin of persons afflicted with psoriasis or other skin disorders such as dry skin, eczema, itchy skin, red skin, itchy eczema, inflamed skin, and/or cracked skin for the removal of itch and the restoration of the affected areas of skin to a normal condition.

In an aspect, the present invention provides methods for treating psoriasis and other skin disorders, which include applying topical treatments completely formed from natural ingredients especially suitable for severe dryness or scaling of palms.

In embodiments, the present invention provides topical compositions for the treatment of eczema by administering the topical compositions.

In an aspect, the present invention relates to topical composition for the treatment of eczema, comprising any combinations of butters such as shea butter, aloe butter, mango butter, and cocoa butter, in a cream base.

In an aspect, the present invention relates to topical pharmaceutical compositions, comprising: shea butter in the range from about 2% to about 4.5% w/w; aloe butter in a range from about 1% to about 4% w/w; mango butter in a range from about 1% to about 4% w/w; cocoa butter in a range from about 1% to about 4% w/w; and other pharmaceutically acceptable excipients.

In a further aspect, the present invention provides topical compositions for treating dry skin, comprising squalene, aloe vera and vitamin E in an emulsifying base. The composition may be any form, not limited to lotions, liquids, creams, gels, and the like.

In an aspect, the invention includes oil-in-water (O/W) emulsions, comprising a base formed by fatty alcohol and/or fatty alcohol mixtures, at least one glycerol ester of a fatty acid, and at least one humectant.

In an aspect, the present invention includes O/W emulsions, comprising a base formed by fatty alcohol and/or fatty alcohol mixtures with waxes.

Embodiments of the present invention include butters that result in an elegant, easy to apply therapeutic preparation that can effectively treat eczematous conditions. As various natural butters are rich moisturizers it would especially be useful in a remission period for prevention of recurrence and as palms are the most exposed area of the body they are very vulnerable for dryness or eczematous changes.

Further aspects of the invention relate to methods for treating skin disorders that minimize complications encountered by individual exposed to topical and/or systemic medications during treatment received for a skin disease.

In an aspect, the present invention relates to methods for treating eczema disorders that minimize relapse or recurrence of the disorders following completion of a treatment regime.

Embodiments of the present invention include treating psoriasis or other skin disorder to naturally return moisture to areas of the skin affected with the skin diseases.

Embodiments of the present invention provide processes for preparing topical compositions of the present invention, embodiments comprising:

a) Preparing an oil phase by combining the oil soluble ingredients;

b) Preparing an aqueous phase by combining water soluble ingredients in warm water, followed by addition of a preservative;

c) Combining the aqueous phase of step (b) and the oil phase of step (a), followed by homogenization.

Further aspects of the invention relate to the preparation of topical compositions, involving forming emulsions by combining an aqueous phase and an oil phase, followed by homogenization.

DETAILED DESCRIPTION OF THE INVENTION

In aspects, the present invention relates to topical compositions for the treatment of psoriasis or other skin disorders such as dry skin, eczema, itchy skin, red skin, itchy eczema, inflamed skin, and/or cracked skin. The compositions comprise various butters such as aloe butter, Shea butter, mango butter, and cocoa butter, in a cream base. As hands are the most exposed area of the body they are very vulnerable to dryness or eczematous changes. Hand dermatitis is a separate dermatological disorder. Various natural butters are rich moisturizers. The compositions are especially useful in remission periods for prevention of recurrence. Hand eczema/dryness is one of the most prevalent conditions which requires intensive moisturization.

Aspects of the present invention include topical compositions in the form of oil-in-water emulsions for the treatment of portions of skin of a person afflicted with psoriasis or other skin disorders such as dry skin, eczema, itchy skin, red skin, itchy eczema, inflamed skin, and/or cracked skin, for the relief of itching and the restoration of the affected areas of skin to a normal condition.

In aspects of the invention, the emulsions produce immediate care, beautification, and/or treatment of brittle, cracked and/or inflamed skin, such as the hands, for which they are particularly suitable. Embodiments of the invention provide rapid action against very dry skin or brittle/cracked skin.

Aspects of the present invention provide topical compositions comprising a combination of butters in a cream base as a first line therapy for dry palms.

Embodiments of the present invention include topical compositions comprising one or more butters such as aloe butter, mango butter, cocoa butter, and shea butter, in a cream base.

Aspects of the present invention provide topical compositions comprising a combination of aloe vera, vitamin E, and squalene for the management of dry skin associated with conditions such as psoriasis and dermatitis.

Embodiments of the present invention include uses of the compositions of the present invention for the treatment of psoriasis or other skin disorders such as dry skin, eczema, itchy skin, red skin, itchy eczema, inflamed skin, and/or cracked skin, as disclosed herein.

Embodiments of the present invention include the application of a topical composition to an affected area of an individual's skin for treatment of skin conditions such as psoriasis associated with dry skin and dermatitis.

Embodiments of the present invention include topical compositions comprising a combination of butters for the treatment of severe dryness or scaling of palms.

Embodiments of the present invention include elegant, easy to apply therapeutic preparations that can effectively treat eczematous conditions. As various natural butters are rich moisturizers, the preparations are especially useful for remission and prevention of recurrences, such as for palms, which are more exposed areas of the body and are very vulnerable to dryness or eczematous changes.

Embodiments of the present invention result in elegant, easy to apply therapeutic preparations that can effectively treat eczematous conditions. Including the component squalene, being a natural constituent of sebum, results in effectively moisturizing the skin.

Embodiments of the present invention include oil-in-water emulsions comprising a base formed by a fatty alcohol and/or fatty alcohol mixtures, at least one glycerol ester of a fatty acid, and at least one humectant.

Embodiments of the present invention include oil-in-water emulsions comprising a base formed by a fatty alcohol and/or fatty alcohol mixtures, with waxes.

In an aspect, the present invention provides topical compositions formulated as, but not limited to, creams, liquids, lotions, gels, ointments, and the like.

Aspects of the present invention include treatment of psoriasis or other skin disorders, by replacing moisture losses to areas of skin affected with a skin disease.

Squalene is natural constituent of sebum (a secretion by sebaceous glands), thus is physiologically effective in moisturizing the skin. Aloe vera is an established moisturizing factor with some benefits for complexion and texture. Vitamin E has also been shown in reports to benefit the skin. Their combinations, in the form of emulsions, will enhance the ease of application because of better spreadability. A lotion or cream form will also extend its application for many xerotic conditions where the affected area is large.

Shea butter has a unique fatty acid profile and the high content of vitamins E and A contributes to its protective and hydrating properties. Clinical trials have shown that Shea butter provides natural ultraviolet (UV) radiation protection, is an effective skin moisturizer, and visibly reduces the appearance of fine lines and wrinkles. It may be used in concentrations ranging from about 2% to about 4.5% w/w.

Cocoa butter is the cream-colored fat extracted from cacao seeds (cocoa beans) and used to add flavor, scent, and smoothness to chocolate, cosmetics, tanning oil, soap, and a multitude of topical lotions and creams. Cocoa butter has been called the "ultimate moisturizer," and has been used to keep skin soft and supple. It is one of the most stable, highly concentrated natural fats known, and melts at body temperature so that it is readily absorbed into the skin. Cocoa butter is often recommended for treatment of skin conditions such as eczema and dermatitis. When applied topically, it creates a barrier between sensitive skin and the environment and also helps retain moisture. In addition, cocoa butter contains cocoa mass polyphenol (CMP), a substance that inhibits the production of the immunoglobulin IgE, known to aggravate symptoms of both dermatitis and asthma. It may be used in concentrations ranging from about 1% to about 4% w/w.

Mango butter has natural emollient properties, high oxidative ability, wound healing, and regenerative activity. Mango butter has been traditionally used in the rainforests and tropics for its skin softening, soothing, moisturizing and protective properties, and to restore flexibility and reduce degeneration of skin cells. It has a protective effect against UV radiation. It is used to treat eczema and dermatitis. It may be used in concentrations ranging from about 1% to about 4% w/w.

Aloe butter is a soft solid butter at room temperature, which melts on contact at skin temperatures. Aloe butter may be used for cutaneous dryness, to assist in moisturization after exposure to sun and other harsh elements. It may be used in concentrations ranging from about 1% to about 4% w/w.

Butters play a main role in healing the conditions, due to their unique fatty acid profiles and high contents of vitamins E and A that contribute to its protective and hydrating properties. Some butters also have natural UV protection which helps in effective skin moistunzation and visibly reduces the appearance of tine lines and wrinkles. They will help to nourish and rejuvenate skin cells making the skin feel soft, silky and smooth. Use of the products to soften rough skin, smooth marks, for toning, and as a moisturizer will help maintain a youthful appearance.

The term "pharmaceutically acceptable" refers to substances that are useful in preparing a pharmaceutical composition that are generally non-toxic and not biologically undesirable, and includes materials acceptable for veterinary use and/or human pharmaceutical use.

The term "excipient" or "pharmaceutically acceptable excipient" means a component of a pharmaceutical product that is not a pharmacologically active ingredient, such as filler, diluent, carrier, preservative, etc. The excipients that are useful in preparing pharmaceutical compositions are generally safe, non- toxic, and neither biologically nor otherwise undesirable, and are acceptable for veterinary use as well as human pharmaceutical use. The term includes both one and more than one such excipients.

The term "composition" is intended to encompass a combination including active ingredients and pharmaceutically acceptable excipients, as well as any product which results, directly or indirectly, from combination, complexation, or aggregation of any two or more of the ingredients, or from dissociation of one or more of the ingredients, or from other types of reactions or interactions involving one or more of the ingredients.

The terms "formulation" or "dosage form" or "composition" refers to finished pharmaceutical products that are suitable for administration, including, but not limited to, gels, creams, lotions, liquids, etc.

The term "optional" or "optionally" means that the subsequently described element, component or circumstance may or may not be present, so that the description includes instances where the element, component, or circumstance is included and instances where it is not.

The term "stability" as used herein includes both physical and chemical stability. The term "physical stability" refers to maintenance of the form of active agents, such as crystalline or amorphous, and the term "chemical stability" relates to a limited formation of impurities.

The term "topical administration" is used in its conventional sense to mean delivery of a topical drug or pharmacologically active agent to the skin or mucosa, as in, for example, the treatment of various skin disorders. Topical administration, in contrast to transdermal administration, primarily provides a local rather than a systemic effect.

"Carrier" or "vehicle" as used herein refers to pharmacologically inert materials that provide a more or less fluid matrix, suitable for topical drug administration. Carriers and vehicles useful herein include any such materials known in the art, which are nontoxic and do not interact with other components of a pharmaceutical formulation or drug delivery system in a deleterious manner. The topical formulations of the present invention are particularly suitable for topical administration. Formulations suitable for topical administration include liquid or semi-liquid preparations. Examples of liquid and semi-liquid preparations include, but are not limited to, topical solutions, liniments, lotions, creams, ointments, pastes, and gels. Other topical ingredients used in the topical formulation are generally those commonly used and recognized by persons skilled in the art of topical formulations.

Useful pharmaceutical^ acceptable excipients of the present invention include, but are not limited to viscosity enhancing agents, plasticizers, vehicles or diluents, film forming agents, chelating agents, thickening or gelling agents, wetting agents, surfactants, neutralizers, anti-tacking agents, emulsifying agents, emollients, humectants, preservatives, antioxidants, solvents, protectives, fragrance imparting agents, and the like, including any combinations of two or more thereof.

The topical formulations may be prepared with the aid of suitable equipment. The fluid matrix may contain hydrocarbons. Examples of hydrocarbons include, but are not limited to, hard, soft, or liquid paraffins, glycerol, beeswax, metal soaps, mucilages, oils of natural origin (such as almond, corn, arachis, castor or olive oil), wool fat or its derivatives, fatty acids (such as stearic acid or oleic acid), and any combinations of two or more thereof.

Representative examples of the butters that are usable in the context of present invention include, but are not limited to, cocoa butter, Shea butter, mango butter, aloe butter, pumpkin seed butter, coconut lime verbena body butter, cranberry butter, etc.

Representative examples of emulsifying agents that are useful for preparing compositions of the invention include, but are not limited to, fatty acids having 12-18 carbon atoms, such as undecylenic acid, lauric acid, myristic acid, palmitic acid, stearic acid, cetostearyl alcohol, isostearic acid, aracel, emulsifying wax, oleic acid, hydroxyoleic acid, linoleic acid, and their derivatives. Useful emulsifying agents further include cetyl alcohol, acacia, carbomers, carrageenan, cetostearyl alcohol, ceresin wax, and any combinations thereof.

Representative examples of emollients that are useful in the context of present invention include, without limitation thereto, C12-C15 alkyl benzoates, cetyl palmitate, ethylhexyl palmitate, glyceryl monostearate, isopropyl palmitate, cyclomethicones, dimethicones, isostearyl benzoate, myristyl myristate, isostearyl behenate, isostearyl isostearate, caprylic/capric triglyceride, butyrospermum parkii, cholesterol, cetostearyl alcohol, cetearyl isononanoate, and the like.

Representative examples of humectants that are useful in the context of the present invention include, but are not limited to, glycerin, propylene glycol, cyclomethicones, dimethicones, sorbitol, xylitol, urea, sugars and starches, sugar and starch derivatives (e.g., alkoxylated glucose), D-panthenol, hyaluronic acid, lactamide monoethanolamine, acetamide monoethanolamine, 2-pyrrolidone-5-carboxylic acid, urea, and any mixtures thereof.

Examples of chelating agents useful in the invention include, but are not limited to, salts of EDTA, such as disodium EDTA and calcium disodium EDTA.

Examples of neutralizers useful in the invention include, but are not limited to, triethanolamine and other pharmaceutically acceptable neutralizing agents.

Examples of film forming agents that are useful in the invention include, but are not limited to, vinyl polymers, eicosene co-polymers, butylated polyvinylpyrrolidones, vinylpyrrolidone-dimethylaminoethylmethacrylate copolymers, triacontanyl PVP, polyquaternium-55, and any mixtures thereof.

Representative examples of preservatives that are useful in the invention include, but are not limited to, methylparaben, propylparaben, benzoic acid, sodium benzoate, benzethonium chloride, boric acid, bronopol, cetylpyridinium chloride, chlorocresol, chloroxylenol, phenol or its salts, propionate salts, sorbic acid, benzyl alcohol, imidazolidinyl urea, sodium dehydroacetate, pentylene glycol, 0-phenylphenol, sodium o-phenylphenol, chlorocresol, salicylic acid, sodium salicylate, magnesium salicylate, resorcin, chloroxylenol, thymol, triclosan, cresols, benzalkonium chloride, benzethonium chloride, cetylpyridium chloride, benzoic acid, sodium benzoate, sorbic acid, dehydroacetic acid, sodium dehydroacetate, chlorhexidine, chlorhexidine gluconate, chloramine T, triclocarban, iodopropynyl butylcarbanate, chlorobutanol, chlorphenesin, hinokitol, silver chloride, zinc pyrithione, alkyldiaminothylglycine hydrochloride, glycerol caprylate, and any mixtures thereof. Appropriate preservatives can be chosen to satisfy a preservative challenge test and to provide product stability.

Suitable examples of antioxidants that are useful in the invention include, but are not limited to, alpha-tocopherol, ascorbic acid, butylated hydroxyanisole, butylated hydroxytoluene, citric acid, edetic acid and edetates such as disodium EDTA, erythorbic acid, fumaric acid, malic acid, phenolic derivatives such as thymol, sulphite derivatives such as potassium metabisulphite, sodium metabisulphite, and sodium sulphite, monothioglycerol, alkyl gallates such as propyl gallate, and the like.

Representative examples of solvents that are useful in the context of the invention include, but are not limited to propylene glycol, alcohol, water, glycerin, isopropyl alcohol, polyethylene glycols, and any combinations thereof.

Some of the optional excipients that are useful in the context of the invention include, but are not limited to, zinc oxide, buffering agents, viscosity imparting agents, and the like. Suitable fragrance imparting agents can also be included.

In an aspect, the present invention provides processes for making stable topical compositions. The processes for manufacturing formulations of present invention are not limited to the processes described herein, and the formulations can be prepared using any processes known to one skilled in the art.

In embodiments, topical compositions of the present invention can be manufactured using a method comprising:

a) preparing an oil phase by combining the oil soluble ingredients;

b) preparing an aqueous phase by combining water soluble ingredients in warm water, and adding a preservative; and

c) combining the aqueous phase of step b) and the oil phase of step a), followed by homogenization.

Topical formulations of the present invention can be part of a kit or device and may be filled into tubes, jars, bottles, aerosol containers, and any other forms of packaging that facilitate application topically, such as to the face, hands, ears, torso, legs, and any other such superficial locations. The formulations are meant to be applied topically, either manually or by using a convenient applicator, for patient compliance and ease of application. The dose, number, and frequency of applications can be determined by a person skilled in the art of treating conditions, such as a physician, a dermatologist, and the like.

Laminated tubes may be used for packaging. The features and advantages of laminated tubes include ability to retain smoothness, flexibility and softness, increase in product shelf life, excellent barrier properties, excellent sealability, resistance to print bleeding, tamper evident closures with nozzle seals available, and hot foil stamping.

HDPE tubes may also be used for packaging. Examples are pre-printed monolayer plastic tubes made of LDPE/LLDPE blends by extrusion processes and fitted with snap-on flip caps made up of polypropylene.

In embodiments, the invention provides topical formulations, in packages suitable for commercial sale that provide stability during storage or transportation. The topical formulations of the present invention are intended to provide rich moisturizing effects for prevention and treatment of dryness and hand eczema for extended durations of time. They will be especially useful in producing remission periods, and for preventing recurrence of a condition.

Certain specific aspects and embodiments of the invention will be explained in more detail with reference to the following examples, being provided only for purposes of illustration, and it is to be understood that the present invention should not be considered to be limited thereto.

EXAMPLES EXAMPLE 1: Topical composition with butters.

Manufacturing procedure:

A) Preparation of oil phase:

1. Shea butter, mango butter, cocoa butter, aloe butter, beeswax, cetyl alcohol, stearic acid and emulsifying wax were mixed and heated to 75°C to produce a melt.

2. Cyclomethicone and dimethicone were mixed and added to step 1.

3. Methylparaben and propylparaben were dissolved in step 2 with mixing.

B) Preparation of aqueous phase:

4. Water was heated to 75°C.

5. Zinc oxide was dispersed in warm water (60°C).

6. Disodium EDTA was added to step 4 and dissolved.

7. Propylene glycol and glycerin were mixed and added to step 6.

8. Step 7 was mixed with the oil phase and homogenized for 10 minutes, maintaining the temperature at 60°C.

9. Step 5 was mixed with step 8 and homogenized for 10 minutes.

10. The final formulation was cooled and filled into tubes, followed by sealing and labeling.

Double-Blind Human Study of the Topical Composition:

The composition prepared in Example 1 was subjected to a double-blinded human study, using a commercially available moisturizing cream as a comparative product.

In a double-blinded, placebo-controlled study in humans, 24 female volunteers in the age group of 18-55 years of age were included in the study. The forearms of each volunteer were cleaned with alcohol swabs and the volunteers were acclimatized for 1 hour under controlled temperature and humidity conditions. The relative humidity was kept at 50±5% and temperature at 20±2°C for the entire study duration. A clinical examination was performed to verify inclusion and exclusion criteria. Two sites of 3x5 cm were marked on each of the inner forearms via randomization (2 sites on the inner forearm about 3 cm away from wrist, elbow, and each other). Baseline measurements were carried out before treatment using a Moisturemeter SC. On each inner forearm, either one of the two test products was applied either of the sites and one site was kept as a control. On each forearm, either one of the test products (0.05 g) was massaged into the skin for 30 seconds, on any one site, using a covered finger. There was no product application at the control site. Vapometer readings were taken at the time of administration, 4 hours, and 8 hours. The total duration of the study was 9 hours.

A vapometer is the instrument used to evaluate the transepidermal water loss (TEWL) after application of the 2 test products over a span of 8 hours. Water loss rate through the skin is a good indicator of the integrity of the barrier function of the skin. With the vapometer, one can assess the effect of trauma, irritation, or disease on the skin and monitor repair rates and response to treatment.

The following observations were made, based on the study:

(i) There was a significant decrease observed in the TEWL readings at 4 hours (19.2%) and hence demonstrating an improvement in skin barrier function on the test site as compared to baseline.

(ii) There was no significant change observed in the TEWL readings at 4 hours and hence no improvement in skin barrier functions on the control site as compared to baseline.

(iii) It was observed that even at 8 hours (at the end of the study), the TEWL readings were significantly lower (14.5%) as compared to baseline on the test site.

(iv) It was observed that even at 8 hours (at the end of the study), there was no significant change in the TEWL readings as compared to baseline on the control site.

(v) On comparing the test site with the control site, it was observed that there was a significant improvement in skin barrier function on the test site as compared to the control site at the 2 time points until the end of the study.

Comparison with commercially available moisturizing cream:

(i) There was a significant decline observed in the TEWL readings at 4 hours (19.2%), and at 8 hours (14.5%), and hence an improvement in skin barrier function on the test site as compared to baseline with the Example 1 composition.

(ii) There was a significant decline observed in the TEWL readings at 4 hours (17.0%), and at 8 hours (14.2%), and hence an improvement in skin barrier function on the test site as compared to baseline with commercially available moisturizing cream.

(iii) On comparing the test site 1 (Example 1 composition) with the test site 2 (commercially available moisturizing cream), it was observed that there was no significant difference in TEWL readings between the Example 1 composition and the commercially available moisturizing cream at the 2 time points summarized in Table 1 and figure 1.

Hence, Example 1 composition significantly affects the skin barrier function by reducing the trans-epidermal water loss of skin and sustains it for at least 8 hours, as compared to baseline and the control side (where no product was applied).

On comparing the Example 1 composition with the commercially available moisturizing cream, it was observed that both products have a similar effect on trans-epidermal water loss of the skin.

Table 1

Tubes containing the Example 1 composition were stored under various accelerated stability testing conditions, for times up to 9 months (9 M). Samples of the initial product and stored product were analyzed for percentage of preservatives remaining, viscosity, and pH, and the results are summarized in Table 2.

Table 1

EXAMPLE 2: Topical composition with butters.

Manufacturing procedure:

A) Preparation of oil phase:

1. Shea butter, mango butter, cocoa butter, aloe butter, white beeswax, cerecin wax, Arlacel 165, and cetostearyl alcohol were mixed and heated to 75°C to form a melt.

2. Cyclomethicone and dimethicone were mixed and added to the melted mixture of step 1.

3. Methylparaben and propylparaben were dissolved in the mixture of step 2.

B) Preparation of aqueous phase:

4. Water was heated to 75°C.

5. Zinc oxide was dispersed in warm water (60°C).

6. Step 5 was mixed with the oil phase and homogenized for 10 minutes.

7. The final formulation was cooled and filled into tubes, followed by sealing and labeling.

EXAMPLE 3: Topical composition with squalene.

Manufacturing process:

A) Preparation of oil phase:

1. Cetyl alcohol, stearic acid, and emulsifying wax were mixed and heated at 75°C to form a melt.

2. Butylated hydroxytoluene and butylated hydroxyanisole were dissolved in step 1.

3. Squalene was mixed with D-ct-tocopheryl and the mixture was added to step 2.

4. Cyclomethicone and dimethicone were mixed and added to step 3.

B) Preparation of aqueous phase:

5. Water was heated to 75°C and sodium methylparaben, sodium propylparaben, and disodium EDTA were dissolved in it.

6. Propylene glycol, trolamine, and glycerin were mixed and added to step 5.

7. Step 6 was mixed with step 4 and homogenized for 15 minutes.

8. Aloe vera was added to step 7 and homogenized for 15 minutes.

9. The final formulation was filled into tubes, followed by sealing and labeling.

EXAMPLE 4: Formulation of topical composition with squalene.

Manufacturing procedure:

A) Preparation of oil phase:

1. Cetyl alcohol, stearic acid, and emulsifying wax were mixed and heated to 75°C to form a melt.

2. Butylated hydroxytoluene and butylated hydroxyanisole were dissolved in step 1.

3. Squalene was mixed with D-a-tocopheryl acetate and the mixture was added to step 2.

4. Cyclomethicone and dimethicone were mixed uniformly and added to step 3.

B) Preparation of aqueous phase:

5. Water was heated to 75°C and sodium methylparaben, sodium propylparaben, and disodium EDTA were dissolved in it.

6. Propylene glycol, trolamine, and glycerin were mixed and added to step 5.

7. Step 6 was mixed with step 4 and homogenized for 15 minutes.

8. Aloe vera was added to step 7 and further homogenized for 15 minutes.

9. The final formulation was cooled and filled into tubes, followed by sealing and labeling.

EXAMPLE 5: Topical composition with squalene.

Manufacturing procedure:

A) Preparation of oil phase:

1. Cetyl alcohol, stearic acid, and emulsifying wax were mixed and heated to 75°C to form a melt.

2. Butylated hydroxyanisole was dissolved in step 1.

3. Squalene was mixed with Vitamin E acetate and the mixture was added to step 2.

4. Cyclomethicone and dimethicone 10 est were mixed uniformly and added to step 3.

B) Preparation of aqueous phase:

5. Water was heated to 75°C and sodium methylparaben, sodium propylparaben, and disodium EDTA were dissolved in it.

6. Propylene glycol, trolamine, and glycerin were mixed and added to step 5.

7. Step 6 was mixed with step 4 and homogenized for 15 minutes.

8. Aloe vera was added to step 7 and further homogenized for 15 minutes.

9. The final formulation was cooled and filled into tubes, followed by sealing and labeling.

CLAIMS:

1. A topical pharmaceutical composition comprising shea butter, aloe butter, mango butter, cocoa butter, and one or more pharmaceutically acceptable excipients.

2. A topical pharmaceutical composition comprising squalene, aloe vera, vitamin E acetate, and one or more pharmaceutically acceptable excipients.

3. The topical composition according to either of claims 1 or 2, wherein the excipients include at least one emulsifying agent, at least one emollient, at least one solvent, at least one preservative, at least one antioxidant, at least one humectant.

4. The topical composition according to claim 3, wherein: an emulsifying agent is lauric acid, myristic acid, stearic acid, emulsifying wax, or cetyl alcohol; an emollient is cetyl palmitate, glyceryl palmitate or isopropyl palmitate; a solvent is an alcohol, propylene glycol, water, glycerin, or polyethylene glycol; a preservative is methylparaben, propylparaben, benzoic acid, or sodium benzoate; an antioxidant is butylated hydroxyanisole, citric acid, or ascorbic acid; and a humectant is glycerin, propylene glycol, cyclomethicone, dimethicone, sorbitol, or xylitol.

5. The topical composition according to any of the preceding claims in the form of a solution, a cream, a lotion, a gel, an emulsion, or a suspension.

6. A process for preparing the topical composition according to claim 1, comprising the steps of:

a) preparing an oil phase by melting shea butter, aloe butter, mango butter, cocoa butter with one or more pharmaceutically acceptable excipients;

b) preparing an aqueous phase by dispersing zinc oxide in warm water, adding methylparaben, propylparaben, disodium EDTA, propylene glycol, glycerin, and adding a preservative; and

c) combining the aqueous phase of step b) and the oil phase of step a), followed by homogenization.

7. A process for preparing the topical composition according to claim 2 the process comprising the steps of:

a) preparing an oil phase by mixing squalene, vitamin E acetate and melting squalene, aloe vera, vitamin E acetate with one or more pharmaceutically acceptable excipients;

b) preparing an aqueous phase by adding methylparaben, propylparaben, disodium EDTA, propylene glycol, glycerin, and adding a preservative; and

c) combining the aqueous phase of step b) and the oil phase of step a), followed by homogenization.

8. The topical composition substantially as described and illustrated herein.