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Claims for Patent: 8,715,624

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Claims for Patent: 8,715,624

Title:Stable liquid desoximethasone compositions with reduced oxidized impurity
Abstract: The present invention relates to a stable liquid formulation comprising desoximetasone, isopropyl myristate, a C.sub.2-C.sub.4 alcohol and a stabilizing agent. Specifically, the present invention provides a liquid formulation comprising: a) about 0.01 wt % to about 2.5 wt % desoximetasone; b) about 10 wt % to about 70 wt % isopropyl myristate; c) about 20 wt % to about 70 wt % C.sub.2-C.sub.4 alcohol; and d) a stabilizing agent selected from the group consisting of an oleaginous vehicle and a propellant, wherein the stabilizing agent is in an amount sufficient to reduce the formation of less than about 1 wt % 17-carboxy-9.alpha.-fluoro-11.beta.-hydroxy-16.alpha.-methyl-androsta-1,4- -diene-3-one under an accelerated storage condition.
Inventor(s): Rao; Srinivasa (Valley Stream, NY), Dixit; Suresh (Ft. Worth, TX), Yacobi; Avraham (Englewood, NJ), Bailey; Arthur (Bethel, CT)
Assignee: Taro Pharmaceuticals North America, Inc. (Grand Cayman, KY)
Application Number:13/605,622
Patent Claims: 1. A liquid formulation comprising: a) about 0.01 wt % to about 2.5 wt % desoximetasone; b) about 10 wt % to about 70 wt % isopropyl myristate; c) about 20 wt % to about 70 wt % C.sub.2-C.sub.4 alcohol; and d) a stabilizing agent comprising a mixture of (1) an oleaginous vehicle selected from the group consisting of mineral oil and light mineral oil and (2) a skin conditioning agent selected from one or more of the group consisting of (i) a C.sub.15-C.sub.25 fatty alcohol present in the amount of about 0.5 wt % to about 10 wt %, and (ii) an ester of glycerin and a C.sub.15-C.sub.25 fatty acid present in the amount of about 0.5 wt % to about 10 wt %.

2. The liquid formulation of claim 1, wherein the desoximetasone is present in an amount of about 0.1 wt % to about 1 wt %.

3. The liquid formulation of claim 1, wherein the desoximetasone is present in an amount of about 0.25 wt %.

4. The liquid formulation of claim 1, wherein the isopropyl myristate is present in an amount of about 25 wt % to about 55 wt %.

5. The liquid formulation of claim 1, wherein the isopropyl myristate is present in an amount of about 40 wt %.

6. The liquid formulation of claim 1, wherein the C.sub.2-C.sub.4 alcohol is ethyl alcohol.

7. The liquid formulation of claim 1, wherein the C.sub.2-C.sub.4 alcohol is isopropanol.

8. The liquid formulation of claim 1, wherein the C.sub.2-C.sub.4 alcohol is present in an amount of about 30 wt % to about 60 wt %.

9. The liquid formulation of claim 1, wherein the C.sub.2-C.sub.4 alcohol is present in an amount of about 40 wt %.

10. The liquid formulation of claim 1, wherein the oleaginous vehicle is mineral oil.

11. The liquid formulation of claim 1, wherein the skin conditioning agent comprises a ester of a glycerin and a C.sub.15-C.sub.25 fatty acid.

12. The liquid formulation of claim 11, wherein the ester is glyceryl oleate.

13. The liquid formulation of claim 11, wherein the ester is present in the amount of about 1 wt % to about 8 wt %.

14. The liquid formulation of claim 11, wherein the ester is present in the amount of about 0.9 wt %.

15. The liquid formulation of claim 1, wherein the skin conditioning agent comprises a C.sub.15-C.sub.25 fatty alcohol selected from the group consisting of lauryl alcohol, myristyl alcohol, palmityl alcohol, stearyl alcohol, linoleyl alcohol, and oleyl alcohol.

16. The liquid formulation of claim 15, wherein the C.sub.15-C.sub.25 fatty alcohol is present in the amount of about 1 wt % to about 8 wt %.

17. The liquid formulation of claim 15, wherein the C.sub.15-C.sub.25 fatty alcohol is present in the amount of about 5 wt %.

18. The liquid formulation of claim 1, wherein the propellant is selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane, butane, isobutane, propane, and dimethyl ether.

19. The liquid formulation of claim 1, wherein the propellant is present in an amount of about 20 wt % to about 95 wt %.

20. The liquid formulation of claim 1, wherein the propellant is present in an amount of about 20 wt % to about 75 wt %.

21. The liquid formulation of claim 1, further comprising a surfactant selected from the group consisting of sodium lauryl sulfate, and polysorbate 80.

22. The liquid formulation of claim 21, wherein the surfactant is present in the amount of about 0.5 wt % to about 5 wt %.

23. The liquid formulation of claim 1, wherein the liquid formulation is stable after storage at 50.degree. C. for 4 weeks.

24. A dosage form comprising the liquid formulation of claim 1, and further comprising a pump delivery system.

25. A dosage form comprising the liquid formulation of claim 1, and further comprising an aerosolized delivery system.

26. The dosage form of claim 25, wherein the aerosolized delivery system contains a can equipped with a continuous valve.

27. The dosage form of claim 25, wherein the aerosolized delivery system contains a can equipped with a metered-dosed valve.

28. The liquid formulation of claim 1, wherein the liquid formulation is a foam.

29. The dosage form of claim 27, wherein the foam is a quick-break foam.

30. A method of treating a corticosteroid responsive dermatosis in a mammal comprising the step of topical administering the aerosolized formulation of claim 1.

31. The method of claim 30, wherein the corticosteroid responsive dermatosis is selected from the group consisting of plaque psoriasis, and atopic dermatitis.

32. A process for preparing a liquid formulation comprising: a) mixing desoximetasone in a C.sub.2-C.sub.4 alcohol to from a mixture; b) adding isopropyl myristate in the mixture; and c) adding a stabilizing agent comprising a mixture of (1) an oleaginous vehicle selected from the group consisting of mineral oil and light mineral oil and (2) a skin conditioning agent selected from one or more of the group consisting of (i) a C.sub.15-C.sub.25 fatty alcohol present in the amount of about 0.5 wt % to about 10 wt %, and (ii) an ester of glycerin and a C.sub.15-C.sub.25 fatty acid present in the amount of about 0.5 wt % to about 10 wt %.

33. A process for preparing an aerosolized formulation of desoximetasone comprising the step of filling an aerosol formulation into a container equipped with a continuous valve, wherein said aerosol formulation contains: a) about 0.01 wt % to about 2.5 wt % desoximetasone; b) about 10 wt % to about 70 wt % isopropyl myristate; c) about 20 wt % to about 70 wt % C.sub.2-C.sub.4 alcohol; and d) a stabilizing agent comprising a mixture of (1) an oleagenous vehicle selected from the group consisting of mineral oil and light mineral oil and (2) a skin conditioning agent selected from one or more of the group consisting of (i) a C.sub.15-C.sub.25 fatty alcohol present in the amount of about 0.5 wt % to about 10 wt %, and (ii) an ester of glycerin and a C.sub.15-C.sub.25 fatty acid present in the amount of about 0.5 wt % to about 10 wt %.
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