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Claims for Patent: 5,670,547

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Claims for Patent: 5,670,547

Title: Moisturizing vehicle for topical application of vitamin A acid
Abstract:A formulation containing tretinoin, a gelling agent, proteinaceous material, and water is provided for the uniform topical application of tretinoin. The water-based formulation is oil- and fat-free, alcohol-free, and rich in proteinaceous material. The formulation is stable over time and is comedogenic and less irritating and drying to the skin.
Inventor(s): Milstein; Elliott A. (West Bloomfield, MI), Milstein; Nathan (Hazel Park, MI)
Assignee: Dow Pharmaceutical Sciences (Petaluma, CA)
Application Number:08/430,154
Patent Claims: 1. A stable aqueous gel formulation comprising:

a) from about 0.001% to about 1% by weight tretinoin;

b) from about 0.05% to about 15% by weight of a gelling agent for uniformly delivering said tretinoin to the surface of the skin in a way which makes it readily absorbable;

c) from about 0.001% to about 50% by weight of a proteinaceous material, wherein said proteinaceous material comprises a protein, polypeptide, amino acid, mucopolysaccharide, or a mixture thereof, wherein said proteinaceous material is in sufficient quantity to stabilize said gelling agent and tretinoin formulation; and

d) water;

wherein said formulation is free of fat and oil and substantially free of alcohol as a carrier for the tretinoin, said weight percentages being based on 100 weight percent of the formulation, and wherein said formulation is a stable aqueous gel.

2. The formulation of claim 1, wherein said tretinoin is present from about 0.001% to about 0.5% by weight.

3. The formulation of claim 1, wherein said tretinoin is present at approximately 0.05% by weight.

4. The formulation of claim 1, wherein the gelling agent is an acidic carboxy polymer which is partially neutralized with a neutralizing agent so as to maintain the pH of said formulation between approximately 5.2 and approximately 5.5.

5. The formulation of claim 1, and further comprising an antioxidant.

6. The formulation of claim 1, and further comprising a preservative.

7. The formulation of claim 1, and further comprising a surfactant.

8. The formulation of claim 1, and further comprising glycerin.

9. The formulation of claim 1, wherein said water is present from about 35 to about 95% by weight.

10. The formulation of claim 1, wherein the formulation comprises substantially no organic solvent so that the tretinoin remains substantially in suspension.

11. The formulation of claim 1, wherein the proteinaceous material comprises collagen, elastin, or sodium hyaluronate.

12. The formulation of claim 1, wherein the gelling agent is water soluble.

13. A stable aqueous gel formulation comprising:

a) from about 0.001% to about 1% by weight tretinoin;

b) from about 0.05% to about 15% by weight of an acidic carboxyl polymer gelling agent for uniformly delivering said tretinoin to the surface of the skin in a way which makes it readily absorbable;

c) from about 0.001% to about 50% by weight of a proteinaceous material, wherein said proteinaceous material comprises a protein, polypeptide, amino acid, mucopolysaccharide, or a mixture thereof, wherein said proteinaceous material is in sufficient quantity to stabilize said acidic carboxyl polymer and tretinoin formulation; and

d) water;

wherein the pH of said formulation is between approximately 5.2 and approximately 5.5 and wherein said formulation is free of fat and oil and substantially free of alcohol as a carrier for the tretinoin, said weight percentages being based on 100 weight percent of the formulation, and wherein said formulation is a stable aqueous gel.

14. The formulation of claim 13, wherein said tretinoin is present from about 0.001% to about 0.5% by weight.

15. The formulation of claim 13, wherein said tretinoin is present at approximately 0.05% by weight.

16. The formulation of claim 13, wherein said acidic carboxy polymer is partially neutralized with an organic amine.

17. The formulation of claim 13, and further comprising an antioxidant.

18. The formulation of claim 13, and further comprising a preservative.

19. The formulation of claim 13, and further comprising a surfactant.

20. The formulation of claim 17, and further comprising glycerin.

21. The formulation of claim 13, wherein the proteinaceous material comprises collagen, elastin, or sodium hyaluronate.

22. The formulation of claim 13, wherein said water is present from about 35 to about 95% by weight.
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