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Claims for Patent: 5,733,886

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Claims for Patent: 5,733,886

Title: Compositions of clindamycin and benzoyl peroxide for acne treatment
Abstract:Compositions suitable for the treatment of acne by topical application comprise clindamycin and benzoyl peroxide. Kits for preparing the compositions include a solution of clindamycin in a first container and a gel suspension of benzoyl peroxide in a second container. Each component is stored at a pH which promotes stability, and the combination of the two components provides a final composition having a pH which promotes stability and enhances viscosity.
Inventor(s): Baroody; Lloyd J. (Scotch Plains, NJ), Dow; Gordon J. (Santa Rosa, CA), Dow; Debra A. (San Rafael, CA), Lathrop; Robert (Novato, CA)
Assignee: Baroody; Lloyd J. (Scotch Plains, NJ) Dow; Gordon J. (Santa Rosa, CA)
Application Number:08/235,125
Patent Claims: 1. A topical therapeutic gel composition which is stable at room temperature for at least one month comprising a combination of a pharmaceutically acceptable fluid carrier, and as a first active component, benzoyl peroxide in suspension in a gelling agent, and as a second active component, a solution of a pharmaceutical grade of a clindamycin selected from the group consisting of clindamycin phosphate and clindamycin hydrochloride, the resulting composition having a concentration of benzoyl peroxide from 1% to 20% by weight, a concentration of clindamycin from 0.2% to 4% by weight, a pH of about 4 to less than 7.0 and a viscosity which is higher than the viscosity of the benzoyl peroxide suspension, and the solution of clindamycin before combination with the first active component having an adjusted pH in the range from about 5.9 to 6.9.

2. A kit for preparing a topical therapeutic gel composition which is stable at room temperature for at least one month after mixture of the components of the composition, said kit comprising:

a first container holding a suspension of benzoyl peroxide in a gelling agent at a pH in the range from about 3.5 to 7.0,

a second container holding an aqueous solution of a clindamycin selected from the group consisting of clindamycin phosphate and clindamycin hydrochloride at an adjusted pH in the range from about 5.9 to 6.9 and

instructions associated with the kit to combine the benzoyl peroxide suspension with the clindamycin solution, whereby the resulting composition is a gel having a pH in the range of 4 to less than 7 and having enhanced viscosity in comparison with that of the benzoyl peroxide suspension or the clindamycin solution and the instructions associated with the kit do not call for or require storage of the composition under refrigeration after combination of the benzoyl peroxide suspension and the clindamycin solution.

3. The topical composition of claim 1 wherein the gelling agent is a carboxylated polymer.

4. The topical therapeutic composition of claim 3 wherein the carboxylated polymer is a carboxy vinyl polymer.

5. The topical composition of claim 4 wherein the concentration of the carboxy vinyl polymer in the resulting composition is in the range from 0.1% to 5% by weight.

6. The topical therapeutic composition of claim 4 wherein the pH of the resulting composition is in the range of 4.5 to 5.5.

7. A method for preparing a topical therapeutic gel composition which is stable at room temperature, said method comprising combining (a) an aqueous suspension of benzoyl peroxide initially at a pH of 3.5 to 7.0 in a gelling agent with (b) a stable aqueous solution of a pharmaceutical grade of a clindamycin selected from the group consisting of clindamycin phosphate and clindamycin hydrochloride at an adjusted pH in the range from about 5.9 to 6.9 and selected to provide a pH of the composition in the range from 4.5 to below 7, obtaining the resulting therapeutic gel composition which is stable at room temperature for at least one month, and which has a viscosity greater than that of either the benzoyl peroxide suspension or the clindamycin solution.

8. The topical therapeutic composition of claim 1 wherein the resulting composition has a uniform consistency and has a viscosity in the range from 7.times.10.sup.4 cp to 12.times.10.sup.4 cp.

9. The topical therapeutic composition of claim 8 wherein the resulting composition has a viscosity in the range from 8.times.10.sup.4 cp to 10.times.10.sup.4 cp.

10. The topical therapeutic composition of claim 9 which is aqueous.

11. The composition of claim 7 in which after admixing the benzoyl peroxide and the clindamycin 97% of the benzoyl peroxide remains after 3 months when the resulting composition is stored at room temperature.

12. The composition of claim 7 in which after admixing the two components, the pH of the composition is between about 4.03 and about 4.85 and no more than about 20% of the clindamycin is lost after 1 month when the composition is stored at 40.degree. C.

13. The composition of claim 7 wherein the benzoyl peroxide component, prior to combining with the clindamycin component, retains 95% of its original concentration of benzoyl peroxide when the benzoyl peroxide component is stored at 40.degree. C. for 3 months.

14. The composition of claim 7 wherein the clindamycin component, prior to combining with the benzoyl peroxide component, retains 89% of its original concentration of clindamycin when the clindamycin component is stored at 40.degree. C. for 3 months.

15. The kit of claim 2 wherein the gelling agent is a carboxylated polymer.

16. The kit of claim 15 wherein the carboxylated polymer is a carboxy vinyl polymer.

17. A method for treating acne which comprises applying to affected skin areas of a patient a therapeutically effective amount of a gel composition which is stable at room temperature for at least a month, the composition having a pH in the range of about 4 to less than 7, comprising a combination of a pharmaceutically acceptable fluid carrier containing a mixture of a first active component, benzoyl peroxide in suspension in a gelling agent, and as a second active component, a solution of a pharmaceutical grade of a clindamycin selected from the group consisting of clindamycin phosphate and clindamycin hydrochloride, the resulting composition having a concentration of benzoyl peroxide from 1% to 20% by weight, a concentration of clindamycin from 0.2% to 4% by weight, a pH of about 4 to less than 7.0 and a viscosity which is higher than the viscosity of the benzoyl peroxide suspension, and the solution of clindamycin before combination with the first active component having an adjusted pH in the range from about 5.9 to 6.9.

18. The kit of claim 16 wherein the pH of the benzoyl peroxide suspension is in the range from 4.0 to 5.0.

19. The kit of claim 2 wherein the amount of benzoyl peroxide suspension in the first container and the amount of clindamycin solution in the second container are selected to provide a pH of the composition in the range from 4.5 to 5.5 and an increased viscosity when the total contents of each container are combined.

20. The kit of claim 19 wherein the benzoyl peroxide suspension has a pH in the range from 4.0 to 5.0, wherein the clindamycin is in a concentration from 2% to 15% by weight and at a pH from 6.0 to 6.5, and wherein the written instructions for use with the kit provide for combining the benzoyl peroxide suspension with the clindamycin solution at a weight ratio selected to provide a stable gel product having a pH in the range from 4.5 to 5.5 and of enhanced viscosity in comparison with that of the benzoyl peroxide suspension and the clindamycin solution.

21. The kit of claim 20 wherein the volume ratio of clindamycin solution to benzoyl peroxide suspension is in the range from 1 to 9 or 2 to 9.

22. The kit of claim 2 wherein the viscosity of the resulting composition is in the range of 7.times.10.sup.4 cp to about 12.times.10.sup.4 cp.

23. The kit of claim 22 wherein the viscosity of the resulting composition is in the range from 8.times.10.sup.4 cp to 10.times.10.sup.4 cp.

24. The kit of claim 23 wherein the amount of benzoyl peroxide suspension is from 2.5 g to 100 g and the amount of clindamycin solution is from 0.5 g to 60 g and the clindamycin is clindamycin phosphate.

25. The kit of claim 2 wherein the viscosity of the benzoyl peroxide in the gelling agent is less than about 9.times.10.sup.4 cp.

26. The topical therapeutic composition of claim 1 wherein the clindamycin is clindamycin phosphate.

27. The topical therapeutic composition of claim 26 wherein the adjusted pH of the clindamycin solution is in the range of about 6.0 to 6.5.

28. The topical therapeutic composition of claim 27 wherein the clindamycin solution is chemically stable for two months, measured by the potency of the clindamycin.

29. The kit of claim 22 wherein the clindamycin is clindamycin phosphate.

30. The kit of claim 29 wherein the adjusted pH of the clindamycin solution is in the range of about 6.0 to 6.5.

31. The kit of claim 30 wherein the clindamycin solution is chemically stable for two months, measured by the potency of the clindamycin.

32. The method of preparation of claim 7 wherein the clindamycin is clindamycin phosphate.

33. The method of preparation of claim 32 wherein the adjusted pH of the clindamycin solution is in the range of about 6.0 to 6.5.

34. The method of preparation of claim 33 wherein the clindamycin solution is chemically stable for two months, measured by the potency of the clindamycin.

35. The method of treatment of claim 17 wherein the clindamycin is clindamycin phosphate.

36. The method of treatment of claim 35 wherein the adjusted pH of the clindamycin solution is in the range of about 6.0 to 6.5

37. The method of treatment of claim 36 wherein the clindamycin solution is chemically stable for two months, measured by the potency of the clindamycin.

38. A topical therapeutic gel composition which is stable at room temperature for at least one month comprising a combination of a pharmaceutically acceptable fluid carrier, and as a first active component, benzoyl peroxide in suspension in a gelling agent, and as a second active component, a solution of a pharmaceutical grade of a clindamycin selected from the group consisting of clindamycin phosphate and clindamycin hydrochloride, the resulting composition having a concentration of benzoyl peroxide from 1% to 20% by weight, a concentration of clindamycin from 0.2% to 4% by weight, a pH of about 4 to less than 7.0 and a viscosity which is higher than the viscosity of the benzoyl peroxide suspension, the composition being free of dioctyl sodium sulfosuccinate, and the solution of clindamycin before combination with the first active component having an adjusted pH in the range from about 5.9 to 6.9.

39. A kit for preparing a topical therapeutic gel composition which is stable at room temperature for at least one month after mixture of the components of the composition, the composition being free of dioctyl sodium sulfosuccinate, said kit comprising:

a first container holding a suspension of benzoyl peroxide in a gelling agent at a pH in the range from about 3.5 to 7.0,

a second container holding an aqueous solution of a clindamycin selected from the group consisting of clindamycin phosphate and clindamycin hydrochloride at an adjusted pH in the range from about 5.9 to 6.9, and

instructions associated with the kit to combine the benzoyl peroxide suspension with the clindamycin solution, whereby the resulting composition is a gel having a pH in the range of 4 to less than 7 and having enhanced viscosity in comparison with that of the benzoyl peroxide suspension or the clindamycin solution and the instructions associated with the kit do not call for or require storage of the composition under refrigeration after combination of the benzoyl peroxide suspension and the clindamycin solution.

40. A method for preparing a topical therapeutic gel composition which is stable at room temperature, the composition being free of dioctyl sodium sulfosuccinate, said method comprising combining (a) an aqueous suspension of benzoyl peroxide initially at a pH of 3.5 to 7.0 in a gelling agent with (b) a stable aqueous solution of a pharmaceutical grade of a clindamycin selected from the group consisting of clindamycin phosphate and clindamycin hydrochloride at an adjusted pH of about 5.9 to 6.9 and selected to provide a pH of the composition in the range from 4.5 to below 7, obtaining the resulting therapeutic gel composition which is stable at room temperature for at least one month, and which has a viscosity greater than that of either the benzoyl peroxide suspension or the clindamycin solution.

41. A method for treating acne which comprises applying to affected skin areas of a patient a therapeutically effective amount of a gel composition which is stable at room temperature for at least a month, the composition having a pH in the range of about 4 to less than 7 comprising a combination of a pharmaceutically acceptable fluid carrier containing a mixture of a first active component, benzoyl peroxide in suspension in a gelling agent, and as a second active component, a solution of a pharmaceutical grade of a clindamycin selected from the group consisting of clindamycin phosphate and clindamycin hydrochloride at an adjusted pH of about 5.9 to 6.9, the resulting composition having a concentration of benzoyl peroxide from 1% to 20% by weight, a concentration of clindamycin from 0.2% to 4% by weight, and a viscosity which is higher than the viscosity of the benzoyl peroxide suspension, the composition being free of dioctyl sodium sulfosuccinate.

42. The topical therapeutic gel composition of claim 38 wherein the solution of clindamycin before combination with the first active component, has an adjusted pH in the range from about 6.0 to 6.5.

43. The topical therapeutic gel composition of claim 42 wherein the clindamycin is clindamycin phosphate.

44. The topical therapeutic gel composition of claim 43 wherein the adjusted pH of the clindamycin solution is in the range of about 6.0 to 6.5.

45. The topical therapeutic gel composition of claim 44 wherein the clindamycin solution is chemically stable for two months, measured by the potency of the clindamycin.

46. The kit for preparing a topical therapeutic gel composition of claim 39 wherein the solution of clindamycin before combination with the first active component, has an adjusted pH in the range from about 6.0 to 6.5.

47. The kit of claim 46 wherein the clindamycin is clindamycin phosphate.

48. The kit of claim 47 wherein the adjusted pH of the clindamycin solution is in the range of about 6.0 to 6.5.

49. The kit of claim 48 wherein the clindamycin solution is chemically stable for two months, measured by the potency of the clindamycin.

50. The method for preparing a topical therapeutic gel composition of claim 40 wherein the solution of clindamycin before combination with the first active component, has an adjusted pH in the range from about 6.0 to 6.5.

51. The method for preparing a topical therapeutic gel composition of claim 50 wherein the clindamycin is clindamycin phosphate.

52. The method for preparing a topical therapeutic gel composition of claim 51 wherein the adjusted pH of the clindamycin solution is in the range of about 6.0 to 6.5.

53. The method for preparing a topical therapeutic gel composition of claim 52 wherein the clindamycin solution is chemically stable for two months, measured by the potency of the clindamycin.

54. The method for treating acne of claim 41 wherein the solution of clindamycin before combination with the first active component, has an adjusted pH in the range from about 6.0 to 6.5.

55. The method of treating acne of claim 54 wherein the clindamycin is clindamycin phosphate.

56. The method of treating acne of claim 55 wherein the adjusted pH of the clindamycin solution is in the range of about 6.0 to 6.5.

57. The method of treating acne of claim 56 wherein the clindamycin solution is chemically stable for two months, measured by the potency of the clindamycin.
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