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Claims for Patent: 7,378,405

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Claims for Patent: 7,378,405

Title:Stabilized steroid composition and method for its preparation
Abstract:Stabilized 17-substituted hydrocortisone containing compositions and methods of manufacture. Isomerization of the hydrocortisone component of topical steroid compositions is markedly reduced by introducing an omega-6. acid in the form of linoleic acid into the skin preparation. Preferably, the linoleic acid is added as a component of refined safflower oil. The omega-6 acid has been found to be an effective way of preventing the isomerization of hydrocortisone 17-butyrate into the undesirable isomer HC21-B.
Inventor(s): Patel; Pravin M. (Bloomfield Hills, MI)
Assignee: Triax Pharmaceuticals, LLC (Cranford, NJ)
Application Number:10/762,652
Patent Claims: 1. A method for stabilizing a composition including hydrocortisone 17-butyrate therein, said method comprising the step of: adding an omega-6 acid to said composition.

2. The method of claim 1, wherein said step of adding an omega-6 acid comprises adding linoleic acid to said composition.

3. The method of claim 1, wherein said step of adding an omega-6 acid to said composition comprises adding safflower oil to said composition.

4. The method of claim 1, wherein the step of adding an omega-6 acid further comprises adding said acid in an amount at least equimolar to a quantity of said hydrocortisone 17-butyrate.

5. The method of claim 4, wherein said amount of acid is substantially greater than said quantity of hydrocortisone 17-butyrate.

6. A method for inhibiting the isomerization of hydrocortisone 17-butyrate to hydrocortisone 21-butyrate, said method comprising the step of: disposing said hydrocortisone 17-butyrate in a composition which includes an omega-6 acid therein.

7. The method of claim 6, wherein the step of disposing said omega-6 acid comprises disposing linoleic acid.

8. The method of claim 6, wherein the step of disposing said omega-3 acid comprises disposing omega-3 acid as a component of safflower oil.

9. The method of claim 6, wherein the step of adding an omega-6 acid further comprises adding said acid in an amount at least equimolar to a quantity of said hydrocortisone 17-butyrate.

10. The method of claim 6, wherein said amount of acid is substantially greater than said quantity of hydrocortisone 17-butyrate.

11. A method for stabilizing a hydrocortisone compound having an ester linkage at the 17 position, said method comprising the step of: disposing said hydrocortisone compound in a composition which includes an omega-6 acid therein.

12. The method of claim 11, wherein the step of disposing said omega-6 acid comprises disposing linoleic acid.

13. The method of claim 11, wherein the step of disposing said omega-6 acid comprises adding omega-6 acid as a component of safflower oil which is present in said composition.

14. The method of claim 13, wherein the step of adding an omega-6 acid further comprises adding said acid in an amount at least equimolar to a quantity of said hydrocortisone 17-butyrate.

15. The method of claim 13, wherein said amount of acid is substantially greater than said quantity of hydrocortisone 17-butyrate.

16. In a composition which includes hydrocortisone 17-butyrate therein, the improvement comprising in composition: said composition having an omega-6 acid therein in an amount sufficient to stabilize said hydrocortisone 17-butyrate.

17. A method for stabilizing a composition including a 17-substituted hydrocortisone, said method comprising the step of: adding an omega-6acid to said composition.

18. The method of claim 17, wherein said 17-substituted hydrocortisone is a hydrocortisone ester.
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