Patent information
IP India · live recordAbstract
The present application relates to topical compositions. In particular the present application relates to a topical composition comprising retinoid as active agent and pharmaceutically acceptable excipient(s) and a process of preparing such compositions. Further the present application relates to method of using topical compositions for the treatment of skin disorders such as acne rosacea psoriasis etc.
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What is claimed is: 1. A topical composition comprising: a) a retinoid compound; b) at least one foaming agent; c) at least one anti-irritant; and d) one or more dermatologically acceptable excipients, wherein said anti-irritant is selected from polyhydroxy acids in the range of from about 0.01% to about 3% of the total weight of the composition. 2. The topical composition of claim 1, wherein the polyhydroxy acid is gluconolactone. 3. The topical composition of claim 1, and further comprising tocofersolan. 4. The topical composition of claim 1, wherein the foaming agent is selected from disodium laureth sulfosuccinate, cocobetaine, sodium lauryl sarcosinate, and sodium lauryl sulfate, or mixtures thereof. 5. The topical composition of claim 1, wherein a retinoid compound is selected from tretinoin, isotretinoin, acitretin, tazarotene, and adapalene. 6. The topical composition of claim 5, wherein the retinoid compound is tazarotene. 7. The topical composition of claim 1, wherein the polyhydroxy acid is gluconolactone; the foaming agent is selected from disodium laureth sulfosuccinate, cocobetaine, sodium lauryl sarcosinate, and sodium lauryl sulfate, or mixtures thereof; and the retinoid compound is selected from tretinoin, isotretinoin, acitretin, tazarotene, and adapalene. 8. The topical composition of claim 7, wherein the retinoid compound is tazarotene. 9. The topical composition of claim 7 or 8, further comprising tocofersolan. 10. A method of treating skin disorders by topically applying to a skin in need thereof, a topical composition according to any one of claims 1-8, comprising the steps of a) shaking the composition; b) topically applying the wash composition to the affected area of the skin for a period of about 0 seconds to about 15 minutes; and c) rinsing-off said composition from the affected area with water or a suitable solvent.
11. The method according to claim 10, wherein the composition is rinsed-off within 5 minutes. 12. The method according to claim 10, wherein the skin disorder is selected from acne vulgaris, rosacea, atopic dermatitis, skin wrinkles, facial mottle, hyperpigmentation, hypopigmentation, photo aging, papule, pustule, psoriasis, nodulocystic acne lesion and lentigo. 13. An aqueous-based topical composition comprising: a) a retinoid compound; b) at least one foaming agent; c) at least one anti-irritant; and d) one or more dermatologically acceptable excipients, wherein said anti-irritant is selected from polyhydroxy acids in the range of from about 0.01% to about 3% of the total weight of the composition, and wherein said topical composition comprises at least about 60% of water based on final weight of the composition. 14. The aqueous-based topical composition of claim 13, and further comprising tocofersolan. 15. The aqueous-based topical composition of claim 10, wherein the polyhydroxy acid is gluconolactone. 16. The aqueous-based topical composition of claim 10, wherein the foaming agent is selected from disodium laureth sulfosuccinate, cocobetaine, sodium lauryl sarcosinate, and sodium lauryl sulfate, or mixtures thereof. 17. The aqueous-based topical composition of claim 10, wherein a retinoid compound is selected from tretinoin, isotretinoin, acitretin, tazarotene, and adapalene. 18. An aqueous-based topical composition comprising: a) from about 0.01% to about 1% of tazarotene or pharmaceutically acceptable salts, esters thereof; b) from about 0.1 % to about 7% of foaming agents selected from disodium laureth sulfosuccinate, cocobetaine, sodium lauryl sarcosinate, and sodium lauryl sulfate, or mixtures thereof; c) from about 0.01% to about 3% of an anti-irritant selected from polyhydroxy acids or tocofersolan or mixtures thereof; and d) one or more dermatologically acceptable excipients, wherein said topical composition comprises at least about 60% of water based on final weight of the composition. 19. The aqueous-based topical composition of claim 18, wherein tazarotene is in micronized form.
20. The aqueous-based topical composition of claim 18, comprising tazarotene in suspended form. 21. A process of preparing topical composition comprising steps of: 1) preparing a retinoid-containing dispersion comprising: mixing a retinoid compound with a foaming agent and water to prepare a dispersion; 2) preparing an emulsion by mixing an aqueous phase and an oil phase under homogenization; 3) preparing the composition by mixing retinoid-containing dispersion and emulsion together under homogenization; and 4) adjusting the pH of the retinoid-containing topical composition using a suitable pH adjusting agent, in the range of about 4 to about 7, wherein said emulsion of step 2 is pre-neutralized using a suitable pH adjusting agent, in the range of about 4 to about 7. 22. A method of treating acne comprising: administering retinoid-containing topical composition of claim 1,13 and 18 to a patient in need thereof, wherein said composition administers an effective amount of retinoid compound(s) to the skin.