IL105296A - Emollient and moisturizing pharmaceutical composition for topical application useful fro very dry skin - Google Patents

Description

105296/3 ¾>η> Ί Ο *nyn D">.< n ,·ρ_>>·η jnnt? >ηρ·η i vyDn EMOLLIENT AND MOISTURIZING PHARMACEUTICAL COMPOSITION TOPICAL APPLICATION USEFUL FOR VERY DRY SKIN EMOLLIENT AND MOISTURIZING PHARMACEUTICAL COMPOSITION FOR TOPICAL APPLICATION USEFUL FOR VERY DRY SKIN Field of the Invention The present invention relates to a pharmaceutical formulation for topical application in the treatment of dry skin and extremely dry skin. More specifically the presen invention relates to emollient and moisturizer pharmaceutical composition for topical application for use on brittle skin after severe burns prior to investing pressure garments, and for all types of dry skin.

Background of the Invention The need for an emollient that would be compatible for use on ultra-dry skin, especially on brittle skin after severe burns, has been apparent. Particularly lacking is a pharmaceutical composition that if applied to brittle skin (after severe burns) would have no interaction and/or adverse effect on the pressure suit itself.

Existing emollient preparations were either too greasy and insufficient in their skin softening properties, and/or were too perfumed, and/or were too coloured, and/or their active ingredients attacked the rubber pressure suit.

Emollient preparations, such as the known Vaseline intensive care hand cream, and the stable anhydrous and pharmaceutical emulsions described in German Patent No. 3,938,901, contain Hydrocarbon Wax and Tocophe¾yl Acetate both of which have adverse effects on the rubber of the pressure suit. These preparations also contain perfume and coloring substances, which are potential allergens.

The pharmaceutical composition according to the present invention, as opposed to the described preparations, fulfills simultaneously the following requirements: (a) The formulation is an excellent emollient. (b) The emollient easily penetrates the skin surface while leaving the skin supple without the feeling of the greasiness. (c) The emollient does not attack or interact in any way with rubber pressure suits. (d) The emollient has little, if any, odor. (e) The emollient has no artificial colouring.

Brief Description of the Invention The present invention relates to an emollient and moisturizing pharmaceutical' composition for topical application and useful for very dry skin comprising of anhydrous lanolin, cetyl stearyl alcohol, stearic acid, polyethylene glycol, triethanolamine, sodium lauryl sulphate, glycerin, purified water and optionally preservatives .

Detailed Description of the Invention The present, invention relates to an emollient and moisturizing pharmaceutical composition comprising of the following ingredients: 1. Anhydrous Lanolin B.P.; (melting point 38°-42°C.) 2. Cetyl Stearyl Alcohol B.P. (synonym Lanette "0" DAB 9); melting point 49°C. 3. Stearic Acid DAC 79 (synonym Purified Stearic Acid V.S.N.F.); melting point 69°-70°C. 4. Polyethylene Glycol (PEG) 4000 B.P.; solidifying point 50°-55°C. 5. Triethanolamine B.P. 6. Sodium Lauryl Sulphate B.P. 7. Glycerin B.P. 8. Purified Water B.P.

Optional ingredients as preservative: 9. Sodium Methyl Hydroxybenzoate (methylparaben sodium) 10. Sodium Propyl Hydroxybenzoate (propylparaben sodium) Solvent for preservatives: 11. Propylene Glycol ~ The preferred concentration of the above mentioned ingredients is as follows: 1. Anhydrous Lanolin 5.0% w/v 2. Stearic Acid 2.0% W/V 2. Cetyl Stearyl Alcohol 1.0% W/V 4. Polyethylene Glycol 4000, 5 .0% w/v 5. Triethanolamine 0.4% V/V 6. Sodium Lauryl Sulphate 0.3% w/v 7. Glycerin 5.0% V/V 8. Purified Water to 100.0% Optional : 9. Preservative solution 1.0% 9.1 Sodium Methyl Hydroxybenzoate 10.0% W/V 9.2 Sodium Propyl Hydroxybenzoate 3.3% W/V 9.3 Propylene Glycol to 100.0%.

Variations of concentrations can be as follows: 1. Anhydrous Lanolin 2.5%-7.5% W/.V 2. Stearic Acid 1.0%-3.0% w/v 2. Cetyl Stearyl Alcohol 0.5%-1.5% w/V 4. Polyethylene Glycol 4000, 2.5%-7.5% W/V 5. Glycerin 2.5%-7.5% V/V 6. Triethanolamine 0.2%-0.6% v/v 7. Sodium Lauryl Sulphate 0.1%-0.5% W/V 8. Purified Water up to 100.0% 9. Optional: Preservative solution 0.5%-1.5% W/V (a) Sodium Methyl Hydroxybenzoate 5-15%% W/V 9.2 Sodium Propyl Hydroxybenzoate 2-5% W/V 9.3 Propylene Glycol up: to 100.0%.

In experiments with various patients it was found that the combination of the ingredients of the above emulsion was very effective in softening very dry skin and relieving the itchiness of dry skin while simultaneously leaving a feeling of suppleness.

Although varying concentrations of the ingredients were tried it was found that the optimum concentrations were as expounded above .

A clear advantage of the emulsion according to the present invention is that it does not leave the skin feeling greasy.

In a number of experiments with people who were wearing pressure clothing after severe burns it was found that the emulsion had the same softening effect on their skin while not affecting in any way the pressure suit.

The emulsion according to the present invention is easily absorbed into the skin via gentle massage and does not in any way require hard rubbing.

The emulsion according to said invention is stable in types of weather and there is no apparent change in consistency at 5° or at 25°C.

Though allergy tests have not been performed, no allergic reactions have been reported. Preservatives can allergens and therefore most: of the experiments were carried out using the emulsion without the preservative option. For storage purposes the addition of the preservative is imperative.

Mode of Application The emulsion is applied to the skin in small (thin) layers and by slow gentle circular motion massage is absorbed into the skin. The massage is continued until all the emulsion has penetrated the skin, leaving the skin looking shiny.

Application may be as often as required, though usually when the skin feels brittle or when there is a tingling sensation as a result of skin dryness.

Application is also recommended prior to wearing rubber pressure suits and again whenever the patient subjectively feels the need of an emollient.

Preparation 1. Simultaneously; (a) Melt together by gentle heating on a water bath, Anhydrous lanolin 5.0% w/V with Stearic Acid 2.0% w/V with Cetyl Stearyl Alcohol 1.0% W/V, to a temperature of 65°(+5°)C (just above the collective melting point ) . (b) Gently heat and dissolve together, Polyethylene Glycol 4000, 5.0% W/V with Triethanolamine 0.4% V/V with Sodium Lauryl Sulphate 0.3% W/V with Glycerin 5.0% V/V in Purified Water to 100.0% to a temperature of 65° (+5°).

At this stage the preservative solution whose total concentration is 1.0% V/V of the total volume may be added to solution (b) above. 2. Mix together solutions (a) and (b) (solution (b) with or without preservative solution) above in an homogenizer (blender) with gentle heating of the baffles to prevent frothing until resulting emulsion is lukewarm and still fluid.

Pour the semi-liquid into suitable containers and allow to cool .

Suitable containers for the emulsion are usually wide mouthed plastic squeeze bottles, which facilitate easy filling after which are sealed by small hole adapters prevent spillage. ?

Claims (2)

Claims :

1. An emollient and moisturizing pharmaceutical composition for topical application and useful for very dry skin comprising of anhydrous lanolin, cetyl stearyl alcohol, stearic acid, polyethylene glycol, triethanolamine , sodium lauryl sulphate, glycerin, purified water and optionally preservatives.

2. An emollient and moisturizing pharmaceutical composition according to claim 1 wherein the preservative solution comprising of sodium methyl hydroxybenzoate , sodium propyl hydroxybenzoate and propylene glycol. An emollient and moisturizing pharmaceutical composition according to claims 1 and 2 comprising of anhydrous lanolin 2.5%-7.5% W/V, cetyl steary alcohol 0.5-1.5% W/V, stearic acid 1.0%-3.0%- W/V, polyethylene glycol 2.5%-7.5% W/V, triethanolamine 2.0%-0.6% V/V, sodium lauryl sulphate 0.1%-0.5% W/V, optionally preservative solution 0.5%-1.5% W/V and purified water up to 100%. An emollient and moisturizing pharmaceutical composition according to claim 3 comprising of anhydrous lanolin 5.0% W/V, stearic acid 2.0% W/V, cetyl stearyl alcohol 10% W/V, polyethylene glycol 5.0%, triethanolamine 0.4% V/V, sodium lauryl sulphate 0.3% W/v, glycerin 5.0 v/v, optionally preservative solution 1.0% W/V, and purified water up to 100.0%. An ' emollient and moisturizing pharmaceutical composition according to claim 4 wherein the preservative solution comprises of sodium methyl hydroxybenzoate 10% W/V, sodium propyl hydroxybenzoate 3.3% W/V, and propylene glycol up to 100.0%.