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Claims for Patent: 5,635,497

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Claims for Patent: 5,635,497

Title: Topical application compositions
Abstract:A stable topical application composition in the form of a fatty cream comprising 50 to 80% by weight of fatty components, 1.5 to 5% by weight of at least one hydrophilic non-ionic surfactant, a therapeutically effective amount of at least one topically active therapeutic agent and water and a novel method of administering a topically active therapeutic agent.
Inventor(s): Molenaar; Adrianus P. (As Delft, NL)
Assignee: Yamanouchi Europe B.V. (Leiderdorp, NL)
Application Number:08/414,040
Patent Claims: 1. An oil-in-water, fatty cream composition for topical administration comprising from 60 to 80 percent by weight of fatty components, from 1.5 to 5 percent by weight of at least one non-ionic, hydrophilic surfactant having an HLB of at least 14, about 6% of fatty alcohols and esters, a therapeutically effective amount of at least one topically active therapeutic agent, and water, provided the topically active therapeutic agent is not dithranol or its derivatives.

2. An oil-in-water, fatty cream composition for topical administration comprising from 60 to 80 percent by weight of fatty components, from 1.5 to 5 percent by weight of at least one non-ionic, hydrophilic surfactant having an HLB of at least 14, about 6% of fatty alcohols and esters, and water, provided the composition does not contain a therapeutically effective amount of dithranol or its derivatives.

3. A composition of claim 1 wherein the amount of fatty composition is 60% to 70% by weight of the composition.

4. A composition of claim 1 wherein the fatty materials included in the composition are a mixture of cetyl/stearyl alcohol, liquid paraffin and white soft paraffin.

5. A composition of claim 1 wherein the amount of surfactant is from 1.5 to 3.5% by weight of the composition.

6. A composition of claim 1 wherein the hydrophilic nonionic surfactant is cetomacrogrol 1000.

7. A composition of claim 1 wherein the amount of water present is from 20% to 35% by weight of the composition.

8. A composition of claim 7 wherein the amount of water is about 30% by weight.

9. A composition of claim 1 wherein the therapeutic agent is an anti-inflammatory steroid.

10. A composition of claim 9 in which the steroid is hydrocortisone-17.alpha.-butyrate.

11. A composition of claim 1 containing a buffering agent to maintain a desired pH value in the composition.

12. A composition of claim 11 wherein the buffering agent is a combination of citric acid and sodium citrate.

13. A composition of claim 11 which contains a preservative.

14. A method of topically administering a therapeutic agent to a warm-blooded animal comprising applying to the skin of a warm-blooded animal a composition of claim 1.

15. The method of claim 14 wherein the amount of fatty component is 60 to 70% by weight of the composition.

16. The method of claim 14 wherein the fatty component is a mixture of cetyl alcohol, stearyl alcohol, liquid paraffin and white soft paraffin.

17. The method of claim 14 wherein the therapeutic agent is an anti-flammatory steroid.

18. The method of claim 17 wherein the steroid is hydrocortisone-17.alpha.-butyrate.
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