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Claims for Patent: 6,387,383

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Claims for Patent: 6,387,383

Title: Topical low-viscosity gel composition
Abstract:A composition is provided that has a viscosity of less than about 15,000 cP and a pH of about 3.0 to 9.0 for treating a skin disorder in a human subject. The composition consists essentially of (a) a therapeutically-effective amount of at least one compound useful for treating such disorder, (b) a pharmaceutically-acceptable, lightly cross-linked polyacrylic acid polymer compatible with the compound, (c) optionally a water miscible solvent, (d) optionally a preservative, (e) optionally an oil phase component and suitable surfactant, and (f) water. The composition is useful for treating an inflammatory skin disorder, acne, or rosacea. The low viscosity composition has an advantage of being administered more accurately when combined with a container that administers the composition as drops.
Inventor(s): Dow; Gordon J. (Santa Rosa, CA), Lathrop; Robert W. (Novato, CA), Dow; Debra A. (Petaluma, CA)
Assignee: Dow Pharmaceutical Sciences (Petaluma, CA)
Application Number:09/632,508
Patent Claims: 1. A topical aqueous gel composition having a pH of about 3 to about 9 and a viscosity of less than about 15,000 cP for treating a skin disorder in a human subject, which composition consists essentially of

(a) a therapeutically-effective amount of at least one compound useful for treating such disorder,

(b) a hydrophilic pharmaceutically-acceptable, lightly cross-linked polyacrylic acid polymer compatible with the compound,

(c) a pharmaceutically-acceptable base to adjust pH,

(d) optionally a water miscible solvent,

(e) optionally a preservative, and

(f) water.

2. The composition of claim 1, wherein the compound is an antibiotic, imidazole, retinoid, corticosteroid, or a non-steroidal anti-inflammatory drug (NSAID).

3. The composition of claim 2, wherein the compound is an antibiotic alone or in combination with a corticosteroid or a retinoid.

4. The composition of claim 3, wherein the compound is an antibiotic alone.

5. The composition of claim 4, wherein the antibiotic is clindamycin phosphate.

6. The composition of claim 5 having a pH of about 4.0 to 7.0, which composition consists essentially of

(a) about 0.5% to 2.0% w/w clindamycin phosphate,

(b) about 0.1% to 0.4% w/w of the polymer,

(c) the base to adjust pH,

(d) about 15.0% to 25.0% w/w of a water miscible solvent,

(e) less than about 0.2% ww of a preservative, and

(f) purified water in a quantity sufficient to make (QSAD) 100% w/w.

7. The composition of claim 6 having a pH of about 5.0 to 6.0, which composition consists essentially of:

(a) about 1.0 to 1.5% w/w clindamycin phosphate,

(b) about 0.2% w/w of the polymer,

(c) the base to adjust pH,

(d) about 15.0% w/w propylene glycol and about 5.0% w/w polyethylene glycol 400

(e) about 0.1-0.15% w/w methylparaben, and

(g) QSAD purified water to 100% w/w.

8. The composition of claim 3, wherein an antibiotic is combined with a corticosteroid, the antibiotic is clindamycin phosphate, and the corticosteroid is desonide, hydrocortisone valerate, fluocinolone acetinide, hydrocortisone butyrate, or triamcinolone acetonide.

9. The composition of claim 3, wherein an antibiotic is combined with a retinoid, the antibiotic is clindamycin phosphate, and the retinoid is tretinoin.

10. The composition of claim 9 having a pH of about 4 to 7, which composition is a gel consisting essentially of

(a) (i) about 0.5% to about 2.0% w/w clindamycin phosphate, and (ii) about 0.01% to about 0.05% w/w tretinoin;

(b) about 0.1% to about 0.5% w/w of the polymer;

(c) the base to adjust pH;

(d) about 10% to about 30% w/w of a water-miscible solvent;

(e) less than about 0.2% of a preservative; and

(g) QSAD purified water 100% w/w.

11. The composition of claim 1, wherein the compound is a non-steroidal anti-inflammatory drug.

12. The composition of claim 11, wherein the compound is naproxen or diclofenac or a pharmaceutically-acceptable salt thereof.

13. The composition of claim 2, having a corticosteroid as the sole active agent.

14. The composition of claim 13, wherein the corticosteroid is diflorasone diacetate, fluticasone propionate, halobetasol propionate, or budesonide.

15. The composition of claim 14, wherein the corticosteroid is halobetasol propionate.

16. The composition of claim 1 in combination with a container that accurately administers a portion of the composition for topical administration to a patient.

17. The composition of claim 16 in combination with labeling instructions for use in treating the skin disorder.

18. A method for treating a skin disorder in a human subject, which method comprises topically administering an aqueous gel composition having a pH of about 3 to about 9 and a viscosity of less than about 15,000 cP to an affected area of the subject's skin having such disorder in an amount and for a period of time sufficient to improve the skin disorder, wherein the composition consists essentially of

(a) a therapeutically-effective amount of at least one compound useful for treating such disorder,

(b) a hydrophilic, pharmaceutically-acceptable lightly cross-linked polyacrylic acid polymer compatible with the pharmaceutical active material,

(c) a pharmaceutically-acceptable base to adjust pH

(d) optionally a water miscible solvent,

(e) optionally a preservative, and

(f) water.

19. The method of claim 18, wherein the skin disorder is an inflammatory skin disorder, acne, or rosacea.

20. The method of claim 19, wherein the composition is administered once a day for the period of time sufficient to improve the skin disorder.

21. The method of claim 19, wherein the skin disorder is acne.

22. The method of claim 19, wherein the compound of the composition is an antibiotic, imidazole, retinoid, corticosteroid, or NSAID.

23. The method of claim 22, wherein the compound is an antibiotic alone or in combination with a corticosteroid, or a retinoid.

24. The method of claim 23, wherein the compound is an antibiotic alone.

25. The method of claim 24, wherein the antibiotic is clindamycin phosphate.

26. The method of claim 18, wherein the composition has a pH of about 4.0 to 7.0 and consists essentially of

(a) about 0.5% to 2.0% w/w clindamycin phosphate,

(b) about 0.1% to 0.4% w/w of the polymer,

(c) a base to adjust pH,

(d) about 15% to 25.0% w/w of a water miscible solvent,

(e) less than about 0.2% w/w of a preservative,

(f) QSAD purified water to 100% w/w.

27. The method of claim 26, wherein the composition has a pH of about 5.0 to 6.0 and has the following components:

(a) about 1.0 to 1.5% w/w clindamycin phosphate,

(b) about 0.2% ww of the polymer,

(c) a base to adjust pH,

(d) about 15% w/w % propylene glycol and 5 w/w % polyethylene glycol 400,

(e) about 0.1-0.15% w/w methylparaben, and

(f) QSAD purified water to 100% w/w.

28. The method of claim 22, wherein the compound is an antibiotic in combination with a corticosteroid.

29. The method of claim 28, wherein the antibiotic is clindamycin phosphate and the corticosteroid is desonide, hydrocortisone valerate, fluocinolone acetonide, hydrocortisone butyrate, or triamcinolone acetonide.

30. The method of claim 23, wherein the antibiotic is clindamycin phosphate and is combined with tretinoin.

31. The method of claim 30, wherein the composition is a gel having a pH of about 4 to 7, consisting essentially of

(a) (i) about 0.5% to about 2.0% w/w clindamycin phosphate, and (ii) about 0.01% to about 0.05% w/w tretinoin;

(b) about 0.1% to about 0.5% w/w of the polymer;

(c) the base to adjust pH;

(d) about 10% to about 30% w/w of a water-miscible solvent;

(e) less than about 0.2% of a preservative; and

(g) QSAD purified water 100% w/w.

32. The method of claim 18, wherein the compound is an NSAID.

33. The method of claim 32, wherein the compound is diclofenac or naproxen or a pharmaceutically acceptable salt thereof.

34. The method of claim 19, wherein composition contains a corticosteroid as the sole active agent.

35. The method of claim 34, wherein the corticosteroid is diflorasone diacetate, fluticasone propionate, halobetasol propionate, or budesonide.

36. The method of claim 35, wherein the corticosteroid is halobetasol propionate.

37. A method of preparing an aqueous gel composition having a viscosity of less than about 15,000 cP and a pH of about 3 to 9 useful for treating a skin disorder in a human subject, which method comprises

(a) combining water with a therapeutically-effective amount of at least one compound useful for treating such disorder and a hydrophilic, pharmaceutically-acceptable, lightly cross-linked polyacrylic acid polymer compatible with the compound,

(b) adjusting the pH to about 3 to 9, and

(c) optionally combining a water-miscible solvent and a preservative to form the composition.

38. The method of claim 37, wherein the compound is an antibiotic, imidazole, retinoid, corticosteroid, or a NSAID.

39. The method of claim 38, wherein the compound is an antibiotic alone or in combination with a corticosteroid or a retinoid.

40. The method of claim 39, wherein the compound is an antibiotic alone.

41. The method of claim 40, wherein the antibiotic is clindamycin phosphate.

42. The method of claim 41, wherein the composition has a pH of about 4 to 7, and consists essentially of

(a) about 0.5% to 2.0% w/w clindamycin phosphate,

(b) about 0.1% to 0.4% w/w of the polymer,

(c) the base to adjust pH,

(d) about 15.0% to 25.0% w/w of a water miscible solvent,

(e) less than about 0.2% ww of a preservative, and

(f) QSAD purified water to 100% w/w.

43. The method of claim 42, wherein the composition has a pH of about 5 to 6, and consists essentially of:

(a) 1.0 to 1.5% w/w clindamycin phosphate,

(b) 0.2% w/w of the polymer,

(c) the base to adjust pH,

(d) 15.0% w/w propylene glycol and 5.0% w/w polyethylene glycol 400

(e) 0.1-0.15% w/w methylparaben, and

(f) QSAD purified water to 100% w/w.

44. The method of claim 39, wherein the antibiotic is combined with a corticosteroid, the antibiotic is clindamycin phosphate, and the corticosteroid is desonide, hydrocortisone valerate, fluocinolone acetinide, hydrocortisone butyrate, or triamcinolone acetonide.

45. The method of claim 39, wherein the antibiotic is combined with a retinoid, the antibiotic is clindamycin phosphate, and the retinoid is tretinoin.

46. The method of claim 45, wherein the composition is a gel having a pH of about 4 to 7 and consists essentially of

(a) (i) about 0.5% to about 2.0% w/w clindamycin phosphate, and (ii) about 0.01% to about 0.05% w/w tretinoin;

(b) about 0.1% to about 0.5% w/w of the polymer;

(c) the base to adjust pH;

(d) about 10% to about 30% w/w of a water-miscible solvent;

(e) less than about 0.2% of a preservative; and

(f) QSAD purified water 100% w/w.

47. The method of claim 38, wherein the compound is a NSAID.

48. The method of claim 47, wherein the compound is naproxen or diclofenac or a pharmaceutically-acceptable salt thereof.

49. The method of claim 38, wherein the composition has a corticosteroid as the sole active agent.

50. The method of claim 49, wherein the corticosteroid is diflorasone diacetate, fluticasone propionate, halobetasol propionate, or budesonide.

51. The method of claim 50, wherein the corticosteroid is halobetasol propionate.

52. The method of claim 37, which method further comprises placing the composition in a container from which drops are accurately administered for topical administration to a patient.

53. The method of claim 52, which method further comprises combining the container with labeling instructions for use in treating the skin disorder.

54. The composition of claim 13, wherein the corticosteroid is desonide.

55. The composition of claim 54, wherein the desonide is present at about 0.01% w/w to about 1 0% w/w.

56. The method of claim 34, wherein the corticosteroid is desonide.

57. The method of claim 56, wherein the desonide is present at about 0.01% w/w to about 1.0% ww.

58. The method of claim 49, wherein the corticosteroid is desonide.

59. The method of claim 58, wherein the desonide is present at about 0.01% w/w to about 1.0% ww.
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