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Last Updated: October 23, 2020

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Claims for Patent: 8,809,307

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Summary for Patent: 8,809,307
Title:Pharmaceutical formulations containing corticosteroids for topical administration
Abstract: The potency of a topical corticosteroid in a pharmaceutical formulation is maintained even when the concentration of the corticosteroid is substantially reduced by providing the corticosteroid in a formulation containing a liquid oil component that includes a dicarboxylic acid ester and/or a monocarboxylic acid ester.
Inventor(s): Angel; Arturo (Santa Rosa, CA), Dow; Gordon (Santa Rosa, CA)
Assignee: Dow Pharmaceutical Sciences, Inc. (Petaluma, CA)
Application Number:13/287,176
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,809,307
Patent Claims: 1. A pharmaceutical composition for topical application to the skin of an individual comprising halobetasol propionate at a concentration of 0.04% or less and a liquid oil component comprising one or more dicarboxylic acid esters, wherein the dicarboxylic acid esters are selected from diethyl sebacate, diisopropyl adipate, and dibutyl sebacate and wherein at least 25% of the halobetasol propionate is solubilized in the liquid oil component at 22.degree. C.

2. The pharmaceutical composition of claim 1 wherein the concentration of the halobetasol propionate is 0.025% or less.

3. The pharmaceutical composition of claim 2 wherein the concentration of the halobetasol propionate is 0.01% or less.

4. The pharmaceutical composition of claim 1 wherein the concentration of the liquid oil component is sufficient to dissolve the amount of halobetasol propionate in the composition at a temperature of 22.degree. C..+-.2.degree. C.

5. The pharmaceutical composition of claim 4 wherein the concentration of the liquid oil component is between 1.5 and 3 tunes that required to completely solubilize the amount of halobetasol propionate in the composition at a temperature of 22.degree. C..+-.2.degree. C.

6. The pharmaceutical composition of claim 5 wherein the concentration of the liquid oil component is between 1.75 and 2.75 times that required to completely solubilize the amount of halobetasol propionate in the composition at a temperature of 22.degree. C..+-.2.degree. C.

7. The pharmaceutical composition of claim 1 wherein the concentration of the esters in the liquid oil component is at least 30% of the concentration of the liquid oil component in the composition.

8. The pharmaceutical composition of claim 7 wherein the concentration of the esters in the liquid oil component is at least 50% of the concentration of the liquid oil component in the composition.

9. The pharmaceutical composition of claim 8 wherein the concentration of the esters in the liquid oil component is at least 70% of the concentration of the liquid oil component in the composition.

10. The pharmaceutical composition of claim 9 wherein the concentration of the esters in the liquid oil component is at least 90% of the concentration of the liquid oil component in the composition.

11. The pharmaceutical composition of claim 10 wherein the concentration of the esters in the liquid oil component is 100% of the concentration of the liquid oil component in the composition.

12. The pharmaceutical composition of claim 1 wherein the dicarboxylic acid ester is diethyl sebacate.

13. The pharmaceutical formulation of claim 1 wherein the halobetasol propionate is at a concentration of 0.025% or less, the liquid oil component comprises diethyl sebacate, and wherein at least 50% of the halobetasol propionate is solubilized in the liquid oil component at room temperature.

14. The pharmaceutical formulation of claim 13 wherein the concentration of the liquid oil component is between 1.5 and 3 times that required to completely solubilize the amount of halobetasol propionate in the composition at a temperature of 22.degree. C..+-.2.degree. C.

15. A method for treating a disorder of the skin that is amenable to treatment with a topical corticosteroid comprising providing a pharmaceutical composition of claim 1 and applying an amount to the skin that is effective in ameliorating the signs or symptoms of the disorder.

16. A method for treating a disorder of the skin that is amenable to treatment with a topical corticosteroid comprising providing a pharmaceutical composition of claim 4 and applying an amount to the skin that is effective in ameliorating the signs or symptoms of the disorder.

17. A method for treating a disorder of the skin that is amenable to treatment with a topical corticosteroid comprising providing a pharmaceutical composition of claim 13 and applying an amount to the skin that is effective in ameliorating the signs or symptoms of the disorder.

18. The pharmaceutical composition of claim wherein the concentration of the halobetasol propionate is 0.035%.

19. The pharmaceutical composition of claim 1, wherein the liquid, oil component further comprises light mineral oil.

20. The pharmaceutical composition of claim 19, wherein the liquid oil component comprises diethyl sebacate and light mineral oil.

21. The pharmaceutical composition of claim 1, wherein the liquid oil component comprises diethyl sebacate and isopropyl myristate.

22. A pharmaceutical composition for topical application to the skin of an individual comprising halobetasol propionate at a concentration of 0.04% or less and a liquid oil component comprising one or more dicarboxylic acid esters, wherein the dicarboxylic acid esters are selected from diethyl sebacate, diisopropyl adipate, and dibutyl sebacate and wherein the concentration of the liquid oil component is between 1.5 and 3 times that required to completely solubilize the amount of halobetasol propionate in the composition at a temperature of 22.degree. C..+-.2.degree. C.

23. The pharmaceutical composition of claim 22, wherein the concentration of the esters in the liquid oil component is at least 30% of the concentration of the liquid oil component in the composition.

24. The pharmaceutical composition of claim 22, wherein the concentration of the esters in the liquid oil component is at least 50% of the concentration of the liquid oil component in the composition.

25. The pharmaceutical composition of claim 22, wherein the concentration of the esters in the liquid oil component is at least 70% of the concentration of the liquid oil component in the composition.

26. The pharmaceutical composition of claim 22, wherein the concentration of the esters in the liquid oil component is at least 90% of the concentration of the liquid oil component in the composition.

27. The pharmaceutical composition of claim 22, wherein the concentration of the esters in the liquid oil component is 100% of the concentration of the liquid oil component in the composition.

28. The pharmaceutical composition of claim 22, wherein the liquid oil component further comprises light mineral oil.

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Moodys

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