IP Library Granted Patent US 9,642,912
Granted Patent B2
US 9,642,912 · App. 14/578,812 · Granted May 9, 2017

Topical formulations for treating skin conditions

Inventors: Edward T. Kisak (San Diego, CA); John M. Newsam (La Jolla, CA); Dominic King-Smith (San Diego, CA); Pankaj Karande (Troy, NY); Samir Mitragotri (Santa Barbara, CA); Wade A. Hull (Kaysville, UT); Ngoc Truc-Chi Vo (Longueuil, CA)
Assignee: Crescita Therapeutics Inc.
A61K47/183A61F7/03A61K9/0014A61K9/06A61K31/573A61K47/12A61K47/14A61K47/20A61F2007/0261
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Quick Facts
Patent No.
US 9,642,912
App. No.
14/578,812
Granted
May 9, 2017
Kind
B2
Abstract

The present disclosure is drawn to topical formulations and related methods. In one embodiment, a topical formulation is provided that includes at least one corticosteroid, a first compound, and a second compound. The first compound and second compound are different and each is selected from the group consisting of N-lauroyl sarcosine, sodium octyl sulfate, methyl laurate, isopropyl myristate, oleic acid, glyceryl oleate, and sodium lauryl sulfoacetate.

Claims (54)

1. A topical formulation, comprising:

at least one corticosteroid,

a first compound, and

a second compound,

wherein the first compound and the second compound are different, and each is selected from the group consisting of N-lauroyl sarcosine, sodium octyl sulfate, methyl laurate, isopropyl myristate, oleic acid, glyceryl oleate, and sodium lauryl sulfoacetate.

2. The topical formulation of claim 1 , wherein the first compound and the second compound are each selected from the group consisting of methyl laurate, isopropyl myristate, oleic acid, glyceryl oleate, and sodium lauryl sulfoacetate.

3. The topical formulation of claim 1 , wherein the at least one corticosteroid is a pharmaceutically acceptable salt of a corticosteroid.

4. The topical formulation of claim 1 , wherein the at least one corticosteroid is a pharmaceutically acceptable base of a corticosteroid.

5. The topical formulation of claim 1 , wherein the at least one corticosteroid is selected from the group consisting of clobetasol, halobetasol, betamethasone, triamcinolone acetonide, and combinations thereof.

6. The topical formulation of claim 1 , wherein the at least one corticosteroid is halobetasol propionate.

7. The topical formulation of claim 6 , wherein the halobetasol propionate is present at about 0.01 wt % to about 20 wt % of the formulation.

8. The topical formulation of claim 7 , wherein the halobetasol propionate is present at about 0.05 wt % of the formulation.

9. The topical formulation of claim 1 , wherein the first compound comprises methyl laurate and the second compound comprises isopropyl myristate.

10. The topical formulation of claim 1 , wherein the first compound comprises methyl laurate and the second compound comprises oleic acid.

11. The topical formulation of claim 1 , wherein the first compound comprises methyl laurate and the second compound comprises glyceryl oleate.

12. The topical formulation of claim 1 , wherein the first compound comprises methyl laurate and the second compound comprises sodium lauryl sulfoacetate.

13. The topical formulation of claim 1 , wherein the first compound comprises isopropyl myristate and the second compound comprises oleic acid.

14. The topical formulation of claim 1 , wherein the first compound comprises isopropyl myristate and the second compound comprises glyceryl oleate.

15. The topical formulation of claim 1 , wherein the first compound comprises isopropyl myristate and the second compound comprises sodium lauryl sulfoacetate.

16. The topical formulation of claim 1 , wherein the first compound comprises oleic acid and the second compound comprises glyceryl oleate.

17. The topical formulation of claim 1 , wherein the first compound comprises oleic acid and the second compound comprises sodium lauryl sulfoacetate.

18. The topical formulation of claim 1 , wherein the first compound comprises glyceryl oleate and the second compound comprises sodium lauryl sulfoacetate.

19. The topical formulation of claim 1 , further comprising one or more biologically acceptable excipients.

20. The topical formulation of claim 19 , further comprising polyoxyl 35 castor oil.

21. The topical formulation of claim 1 , wherein the formulation further comprises water.

22. The topical formulation of claim 1 , wherein the total concentration of the first compound and the second compound is in the range from about 1 wt % to about 5 wt %, per unit volume of the formulation.

23. The topical formulation of claim 1 , wherein the total concentration of the first compound and the second compound is up to about 10 wt %, per unit volume of the formulation.

24. The topical formulation of claim 1 , wherein the weight ratio of the first compound to the second compound is in the range from about 1:9 to about 9:1.

25. The topical formulation of claim 1 , wherein the weight ratio of the first compound to the second compound is in the range of from about 1:3 to about 3:1.

26. The topical formulation of claim 1 , wherein the weight ratio of the first compound to the second compound is in the range of from about 1:2 to about 2:1.

27. The topical formulation of claim 1 , wherein the weight ratio of the first compound to the second compound is about 1:1.

28. The topical formulation of claim 1 , wherein the topical formulation provides for improved flux of the drug as compared to a comparative formulation devoid of the first compound and the second compound and replaced with an equivalent wt % of water.

29. The topical formulation of claim 1 , wherein the topical formulation has improved chemical and/or physical stability as compared to a comparative formulation devoid of the first compound and the second compound and replaced with an equivalent wt % of water.

30. A method of treating a skin condition, comprising:

applying a topical formulation of a corticosteroid to a skin surface of a subject at a site of the skin condition, said formulation comprising:

at least one corticosteroid,

a first compound, and

a second compound, wherein the first compound and second compound are different and each is selected from the group consisting of N-lauroyl sarcosine, sodium octyl sulfate, methyl laurate, isopropyl myristate, oleic acid, glyceryl oleate, and sodium lauryl sulfoacetate.

31. The method of claim 30 , wherein the at least one corticosteroid is selected from the group consisting of a clobetasol, halobetasol, betamethasone, triamcinolone acetonide, and combinations thereof.

32. The method of claim 30 , wherein the at least one corticosteroid is halobetasol propionate.

33. The method of claim 30 , wherein the first compound comprises methyl laurate and the second compound comprises isopropyl myristate.

34. The method of claim 30 , wherein the first compound comprises methyl laurate and the second compound comprises oleic acid.

35. The method of claim 30 , wherein the first compound comprises methyl laurate and the second compound comprises glyceryl oleate.

36. The method of claim 30 , wherein the first compound comprises methyl laurate and the second compound comprises sodium lauryl sulfoacetate.

37. The method of claim 30 , wherein the first compound comprises isopropyl myristate and the second compound comprises oleic acid.

38. The method of claim 30 , wherein the first compound comprises isopropyl myristate and the second compound comprises glyceryl oleate.

39. The method of claim 30 , wherein the first compound comprises isopropyl myristate and the second compound comprises sodium lauryl sulfoacetate.

40. The method of claim 30 , wherein the first compound comprises oleic acid and the second compound comprises glyceryl oleate.

41. The method of claim 30 , wherein the first compound comprises oleic acid and the second compound comprises sodium lauryl sulfoacetate.

42. The method of claim 30 , wherein the first compound comprises glyceryl oleate and the second compound comprises sodium lauryl sulfoacetate.

43. The method of claim 30 , wherein the formulation further comprises polyoxyl 35 castor oil.

44. The method of claim 30 , wherein the skin condition is caused by eczema, dermatitis, allergy, or a skin rash.

45. The method of claim 30 , wherein the skin condition is caused by psoriasis.

46. The method of claim 30 , wherein the skin condition is plaque psoriasis.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 8, 2016
From: KISAK, EDWARD T.; NEWSAM, JOHN M.; KARANDE, PANKAJ; MITRAGOTRI, SAMIR; VO, NGOC TRUC-CHI
To: NUVO RESEARCH INC.
Reel/Frame 039370/0401 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 8, 2016
From: KING-SMITH, DOMINIC; HULL, WADE A.
To: ZARS PHARMA, INC.
Reel/Frame 039370/0595 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 8, 2016
From: ZARS PHARMA, INC.
To: NUVO RESEARCH INC.
Reel/Frame 039370/0709 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 8, 2016
From: NUVO RESEARCH INC.
To: CRESCITA THERAPEUTICS INC.
Reel/Frame 039370/0799 →
Continuity (6)
Continuation In Part 13791460 · Mar 8, 2013
Continuation In Part 13680623 · Nov 19, 2012
Continuation 12848792 · Aug 2, 2010
Continuation In Part 12281561
Provisional Application 60778847 · Mar 6, 2006
Related Publication 20150297723A1 · Oct 22, 2015