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Details for Patent: 8,546,364

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Details for Patent: 8,546,364

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:Jul 21, 2010
Application Number:12/840,487
Claims:1. A composition of matter comprising: (a) About 0.1% (w/w) hydrocortisone 17-butyrate; (b) About 60% to about 80% (w/w) of a lipid system, (i) Said lipid system comprising at least one omega-6 fatty acid or omega-6 acid ester; (ii) Said lipid system comprising up to about 24% (w/w) of a fatty alcohol (and/or ester formable by condensing said fatty alcohol with a fatty acid); (c) Quantum sufficit of water; (d) Surfactant having a hydrophilic:lipophilic balance of less than about 12; (i) said surfactant present in an amount sufficient to emulsify said lipid system and said water to form an emulsion suitable for topical application; (ii) said emulsion having a pH of less than about 5; (iii) said omega-6 acid or omega-6 acid ester present in an amount whereby said composition of matter contains not more than about 0.05% (w/w) of hydrocortisone 21-butyrate.

2. The composition of claim 1, wherein said lipid system comprises not more than about 5% of the fatty alcohol and/or ester formable by condensing the fatty alcohol with a fatty acid.

3. The composition of claim 1, wherein said lipid system comprises at least about 10% of the fatty alcohol and/or ester formable by condensing the fatty alcohol with a fatty acid.

4. The composition of claim 1, said emulsion selected from the group consisting of: an oil-in-water emulsion; a water-in-oil emulsion; and a complex emulsion.

5. The composition of claim 4, wherein said emulsion comprises an oil-in-water emulsion.

6. The composition of claim 4, wherein said emulsion comprises a complex emulsion.

7. The composition of claim 1, wherein said surfactant comprises a surfactant system comprised of at least two surfactants, wherein said surfactant system has a hydrophilic:lipophilic balance of less than about 14.

8. The composition of claim 1, wherein said Omega-6 acid or omega-6 acid ester comprises safflower oil.

9. The composition of claim 1, wherein said composition contains not more than about 0.02% (w/w) of hydrocortisone 21-butyrate.

10. A composition of matter comprising: (a) Hydrocortisone 17-butyrate in an amount sufficient to treat the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses; (b) About 60% to about 80% (w/w) of a lipid system, (i) Said lipid system comprising at least one omega-6 fatty acid or omega-6 acid ester; (ii) Said lipid system comprising up to about 24% (w/w) of a fatty alcohol (and/or ester formable by condensing said fatty alcohol with a fatty acid); (c) Quantum sufficit of water; (d) Surfactant having a hydrophilic:lipophilic balance of less than about 12; (i) said surfactant present in an amount sufficient to emulsify said lipid system and said water to form an emulsion suitable for topical application; (ii) said emulsion having a pH of less than about 5; (iii) said omega-6 acid or omega-6 acid ester thereof present in an amount whereby said composition of matter contains not more than about 0.05% (w/w) of hydrocortisone 21-butyrate.

11. The composition of claim 10, wherein said lipid system comprises not more than about 5% of the fatty alcohol and/or ester formable by condensing the fatty alcohol with a fatty acid.

12. The composition of claim 10, wherein said lipid system comprises at least about 10% of the fatty alcohol and/or ester formable by condensing the fatty alcohol with a fatty acid.

13. The composition of claim 10, said emulsion selected from the group consisting of: an oil-in-water emulsion; a water-in-oil emulsion; and a complex emulsion.

14. The composition of claim 13, wherein said emulsion comprises an oil-in-water emulsion.

15. The composition of claim 13, wherein said emulsion comprises a complex emulsion.

16. The composition of claim 10, wherein said surfactant comprises a surfactant system comprised of at least two surfactants, wherein said surfactant system has a hydrophilic:lipophilic balance of less than about 14.

17. The composition of claim 10, wherein said Omega-6 acid or omega-6 acid ester comprises safflower oil.

18. The composition of claim 10, wherein said composition contains not more than about 0.02% (w/w) of hydrocortisone 21-butyrate.

19. A composition of matter comprising: (a) About 0.1% (w/w) hydrocortisone 17-butyrate; (b) About 60% to about 80% (w/w) of a lipid system, (i) Said lipid system comprising at least one omega-6 fatty acid or omega-6 acid ester; (c) Quantum sufficit of water; (d) At least one surfactant; (i) said surfactant present in an amount sufficient to emulsify said lipid system and said water to form an emulsion suitable for topical application; (ii) said emulsion having a pH of less than about 5; (iii) said omega-6 acid or omega-6 acid ester present in an amount whereby said composition of matter contains not more than about 0.05% (w/w) of hydrocortisone 21-butyrate.
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