Details for Patent: 8,546,364
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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. |