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Details for Patent: 8,389,502

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Details for Patent: 8,389,502

Title:Stabilized steroid composition and method for its preparation
Abstract: Stabilized, 17-substituted hydrocortisone containing compositions and methods of manufacture are disclosed. Isomerization of the hydrocortisone component of topical steroid compositions is markedly reduced by including an omega-6 acid component in the form of a free acid or as a compound such as an ester. Specifically disclosed are methods for preventing the isomerization of hydrocortisone 17-butyrate into hydrocortisone 21-butyrate through the use of safflower oil.
Inventor(s): Patel; Pravin M. (Bloomfield Hill, MI)
Assignee: Precision Dermatology, Inc. (Cumberland, RI)
Filing Date:Jun 08, 2011
Application Number:13/155,493
Claims:1. A method for stabilizing a composition including a 17-substituted hydrocortisone therein, said method comprising the step of: adding a stabilizer to said composition, said stabilizer comprising an omega-6 acid or an ester of an omega-6 acid.

2. The method of claim 1, wherein said step of adding said stabilizer comprises adding linoleic acid to said composition.

3. The method of claim 1, wherein said step of adding said stabilizer to said composition comprises adding a triglyceride which includes an ester of said omega-6 acid to said composition.

4. The method of claim 3, wherein said triglyceride comprises safflower oil.

5. The method of claim 1, wherein the step of adding said stabilizer further comprises adding said stabilizer in an amount so that the omega-6 acid component thereof is at least equimolar to a quantity of said 17-substituted hydrocortisone.

6. The method of claim 5, wherein the molar amount of the omega-6 acid component is substantially greater than the molar amount of said 17-substituted hydrocortisone.

7. A method for stabilizing a 17-substituted hydrocortisone compound, said method comprising the step of: disposing said hydrocortisone compound in a composition which includes a stabilizer comprising an omega-6 acid or an ester of an omega-6 acid.

8. The method of claim 7, wherein the stabilizer comprises safflower oil.

9. The method of claim 7, wherein the step of adding said stabilizer comprises adding said stabilizer in an amount so that the omega-6 acid component thereof is at least equimolar to a quantity of said 17-substituted hydrocortisone compound.
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