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Claims for Patent: 6,096,331

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Claims for Patent: 6,096,331

Title: Methods and compositions useful for administration of chemotherapeutic agents
Abstract:In accordance with the present invention, there are provided compositions and methods useful for the in vivo delivery of a pharmaceutically active agent, wherein the agent is associated with a polymeric biocompatible material.
Inventor(s): Desai; Neil P. (Los Angeles, CA), Soon-Shiong; Patrick (Los Angeles, CA)
Assignee: Vivorx Pharmaceuticals, Inc. (Santa Monica, CA)
Application Number:08/926,155
Patent Claims: 1. A method for the administration of a taxane to a subject in need thereof, said method comprising systemically administering a dose in the range of about 30 mg/m.sup.2 to about 1000 mg/m.sup.2 of said taxane to said subject in a pharmaceutically acceptable formulation substantially free of cremophor, over an administration time of less than 3 hours, without the use of premedication.

2. The method of claim 1, wherein said dose is at least 135 mg/m.sup.2.

3. The method of claim 1, wherein said pharmaceutically acceptable formulation is administered as a bolus injection.

4. The method of claim 3, wherein said dose is at least 135 mg/m.sup.2.

5. The method of claim 1, wherein said administration period is less than 2

hours.

6. The method of claim 1, wherein said dose is at least 175 mg/m.sup.2.

7. A method for the administration of a taxane to a subject in need thereof, said method comprising systemically administering a dose in the range of about 30 mg/m.sup.2 to about 1000 mg/m.sup.2 of said taxane to said subject in a pharmaceutically acceptable formulation substantially free of cremophor without the use of premedication, with a treatment cycle of no greater than 2 weeks.

8. The method of claim 7, wherein said dose is at least 135 mg/m.sup.2.

9. The method of claim 7, wherein said dose is at least 175 mg/m.sup.2.

10. The method of claim 7, wherein said administration period is less than 2 hours.

11. The method of claim 7, wherein said pharmaceutically acceptable formulation is administered as a bolus injection.

12. The method of claim 11, wherein said dose is at least 135 mg/m.sup.2.

13. The method of claim 11, wherein said dose is at least 175 mg/m.sup.2.

14. The method of claim 11, wherein said dose is at least 250 mg/m.sup.2.

15. A method for reducing the hematologic toxicity of a taxane in a subject undergoing treatment with taxane, said method comprising systemically administering a dose in the range of about 30 mg/m.sup.2 to about 1000 mg/m.sup.2 of said taxane to said subject in a pharmaceutically acceptable formulation, wherein said pharmaceutically acceptable formulation is substantially free of cremophor.

16. The method of claim 15, wherein said pharmaceutically acceptable formulation further comprises albumin.

17. A method for reducing the cerebral or neurologic toxicity of taxane in a subject undergoing treatment with taxane, said method comprising systemically administering a dose in the range of about 30 mg/m.sup.2 to about 1000 mg/m.sup.2 of said taxane to said subject in a pharmaceutically acceptable formulation, wherein said pharmaceutically acceptable formulation is substantially free of cremophor.

18. The method of claim 17, wherein said pharmaceutically acceptable formulation further comprises albumin.

19. A method for treatment of primary tumors in a subject by achieving high local concentration of taxane at the tumor site, said method comprising systemically administering a dose in the range of about 30 mg/m.sup.2 to about 1000 mg/m.sup.2 of said taxane to said subject in a pharmaceutically acceptable formulation substantially free of cremophor.

20. The method of claim 19, wherein said primary tumors are selected from cancers of prostate, testes, lung, kidney, pancreas, bone, spleen, liver or brain.

21. The method of claim 20, wherein said pharmaceutically acceptable formulation further comprises albumin.

22. A pharmaceutically acceptable formulation of taxane for treatment of primary tumors in a subject which achieves high local concentration of said taxane at the tumor site, said formulation being substantially free of cremophor and comprising taxane in a dose in the range of about 30 mg/m.sup.2 to about 1000 mg/m.sup.2.

23. The formulation of claim 22, wherein said primary tumors are selected from cancers of prostate, testes, lung, kidney, pancreas, bone, spleen, liver or brain.

24. The formulation of claim 22 further comprising albumin.

25. A pharmaceutically acceptable formulation of taxane according to claim 22, wherein said formulation shows reduced cerebral or neurologic toxicity.

26. A method for treatment of metastatic tumors in a subject by achieving high local concentration of taxane at the site of metastases, said method comprising systemically administering a dose in the range of about 30 mg/m.sup.2 to about 1000 mg/m.sup.2 of said taxane to said subject in a pharmaceutically acceptable formulation substantially free of cremophor.

27. The method of claim 26, wherein said site of metastases are selected from lung, bone, liver or brain.

28. The method of claim 26, wherein said pharmaceutically acceptable formulation further comprises albumin.

29. A method for treatment of prostatic cancer in a subject by inducing a medical orchiectomy by administering a dose of taxane in the range of about 30 mg/m.sup.2 to about 1000 mg/m.sup.2 to said subject in a pharmaceutically acceptable formulation substantially free of cremophor.

30. The method of claim 29, wherein said pharmaceutically acceptable formulation further comprises albumin.

31. A unit dosage form comprising a vessel containing a sufficient quantity of taxane to allow systemic administration at a dose in the range of about 30 mg/m.sup.2 to about 1000 mg/m.sup.2 over an administration period of less than 3 hours.

32. A unit dosage form according to claim 31, wherein said taxane is administered as a non-aqueous formulation, wherein said non-aqueous formulation is substantially free of cremophor.

33. A unit dosage form according to claim 31, wherein said taxane is administered as a dry powder formulation.

34. A lyophilized taxane-containing formulation characterized by the ability to be reconstituted at concentrations greater than 1.3 mg/ml, and remaining stable for at least 3 days.

35. A taxane-containing formulation suitable for administration using standard intravenous infusion tubing, wherein said taxane-containing formulation has a concentration of greater than 1.3 mg/ml.

36. A taxane-containing formulation suitable for delivery of a dose in the range of about 30 mg/m.sup.2 to about 1000 mg/m.sup.2 with an administration period of less than 3 hrs.

37. A formulation according to claim 36 wherein said dose comprises about 250-300 mg/m.sup.2.

38. A formulation according to claim 31 wherein said dose is delivered in a volume of <200 ml.

39. A pharmaceutically acceptable formulation of taxane comprising in the range of about 30 mg/m.sup.2 to about 1000 mg/m.sup.2 of taxane, wherein said formulation is useful for the reduction of serum testosterone levels in a subject.

40. The method of claim 1, wherein said dose is greater than 80 mg/m.sup.2 and up to 700 mg/m.sup.2.

41. A unit dosage form according to claim 31, wherein said quantity of taxane is sufficient to allow systemic administration of a taxane dose of greater than 80 mg/m.sup.2 and up to 700 mg/m.sup.2 over an administration period of less than 3 hours.

42. A formulation according to claim 36, wherein said dose is greater than 80 mg/m.sup.2 and up to 700 mg/m.sup.2.

43. The method of claim 1 wherein said formulation is free of cremophor.

44. The method of claim 7 wherein said formulation is free of cremophor.

45. The method of claim 15 wherein said formulation is free of cremophor.

46. The method of claim 17 wherein said formulation is free of cremophor.

47. The method of claim 18 wherein said formulation is free of cremophor.

48. The formulation of claim 22, wherein said formulation is free of cremophor.

49. The method of claim 26 wherein said formulation is free of cremopor.

50. The method of claim 29 wherein said formulation is free of cremophor.

51. The unit dosage form of claim 32 wherein said non-aqueous formulation is free of cremophor.

52. The method of claim 1, wherein said administration period is less than 1 hour.

53. The method of claim 7, wherein said administration period is less than 1 hour.

54. The method of claim 1, wherein said dose is at least 250 mg/m.sup.2.

55. The method of claim 7, wherein said dose is at least 250 mg/m.sup.2.

56. The method of claim 1, wherein said formulation is free of agents which aid recovery from hematologic toxicity of taxane.

57. The method of claim 7, wherein said formulation is free of agents which aid recovery from hematologic toxicity of taxane.
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