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Claims for Patent: 4,247,547

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Claims for Patent: 4,247,547

Title: Tretinoin in a gel vehicle for acne treatment
Abstract:An acne treatment gel composition, effective at low concentrations of tretinoin, is provided for topical application. The composition is highly effective in treating acne conditions and is capable of being stored without refrigeration for long periods of time without losing therapeutic effectiveness and while maintaining the uniformity and stability of the gel.
Inventor(s): Marks; Alan M. (East Brunswick, NJ)
Assignee: Johnson & Johnson (New Brunswick, NJ)
Application Number:06/022,022
Patent Claims: 1. A gel formulation for topical application comprising from about 0.01% to about 0.025% by weight of said formulation of tretinoin; and a vehicle system consisting essentially of (a) from about 84 to about 99% by weight of said formulation of an organic solvent selected from the group consisting of ethanol, isopropanol, and propylene glycol; (b) an effective amount to inhibit oxidation of said tretinoin of a pharmaceutically acceptable antioxidant soluble in said organic solvent; and (c) an effective amount to cause gelling of hydroxypropyl cellulose.

2. The product of claim 1 wherein the antioxidant is selected from the group consisting of butylated hydroxyanisole, butylated hydroxytoluene, .alpha.-tocopherol, ascorbic acid, and propyl gallate.

3. The product of claim 2 which contains from about 0.01 to about 0.10% by weight of said antioxidant and from about 0.5 to about 5.0% by weight of said hydroxypropyl cellulose.

4. The product of claim 1 wherein said organic solvent comprises a mixture selected from the group consisting of ethanol and propylene glycol; isopropanol and proplyene glycol; and ethanol and isopropanol.

5. The product of claim 1 further comprising a dye.

6. The product of claim 1 further comprising a perfume oil.

7. The product of claim 1 further comprising a sunscreen.

8. The product of claim 1 further comprising an antimicrobial.

9. The product of claim 1 further comprising a topical corticosteroid.

10. A gel formulation for topical treatment of acne vulgaris consisting essentially of:

from about 0.01 to about 0.025% by weight of tretinoin;

from about 84 to about 99% by weight of an organic solvent selected from the group consisting of ethanol, isopropanol, propylene glycol and mixtures thereof;

from about 0.025 to about 0.075% by weight of an antioxidant selected from the group consisting of butylated hydroytoluene, butylated hydroxyanisole, ascorbic acid, propyl gallate, and .alpha.-tocopherol;

and from about 0.5 to about 3.0% of hydroxypropyl cellulose.
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