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Claims for Patent: 8,138,229

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Claims for Patent: 8,138,229

Title:Compositions and methods of delivery of pharmacological agents
Abstract: The present invention relates to a pharmaceutical composition comprising a pharmaceutical agent and a pharmaceutically acceptable carrier, which carrier comprises a protein, for example, human serum albumin and/or deferoxamine. He human serum albumin is present in an amount effective to reduce one or more side effects associated with administration of the pharmaceutical composition. The inventor also provides methods for reducing on or more side effects of administration of the pharmaceutical composition, and methods for enhancing transport and binding of a pharmaceutical agent to a cell.
Inventor(s): Desai; Neil P. (Los Angeles, CA), Soon-Shiong; Patrick (Los Angeles, CA), Trieu; Vuong (Calabasas, CA)
Assignee: Abraxis Bioscience, LLC (Los Angeles, CA)
Application Number:12/910,693
Patent Claims: 1. A liquid pharmaceutical composition for injection comprising paclitaxel and a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier comprises albumin, wherein the albumin and the paclitaxel in the composition are formulated as particles, wherein the particles have a particle size of less than about 200 nm, wherein the weight ratio of albumin to paclitaxel in the composition is about 1:1 to about 9:1, wherein the liquid pharmaceutical composition comprises about 0.5% to about 5% by weight of albumin, and wherein the liquid pharmaceutical composition further comprises saline.

2. The liquid pharmaceutical composition of claim 1, wherein the albumin is human serum albumin.

3. The liquid pharmaceutical composition of claim 1, wherein the liquid pharmaceutical composition is free of Cremophor.

4. The liquid pharmaceutical composition of claim 1, wherein the weight ratio of albumin to the paclitaxel in the pharmaceutical composition is 1:1 to 9:1.

5. The liquid pharmaceutical composition of claim 1, wherein the weight ratio of albumin to the paclitaxel in the pharmaceutical composition is about 9:1.

6. The liquid pharmaceutical composition of claim 1, wherein the liquid pharmaceutical composition comprises about 5% by weight of albumin.

7. The liquid pharmaceutical composition of claim 1, wherein the pH in the composition is about 5.0 to about 8.0.

8. The liquid pharmaceutical composition of claim 7, wherein the albumin is human serum albumin.

9. The liquid pharmaceutical composition of claim 7, wherein the weight ratio of albumin to the paclitaxel in the pharmaceutical composition is 1:1 to 9:1.

10. The liquid pharmaceutical composition of claim 7, wherein the weight ratio of albumin to the paclitaxel in the pharmaceutical composition is about 9:1.

11. The liquid pharmaceutical composition of claim 4, wherein the albumin is human serum albumin.

12. The liquid pharmaceutical composition of claim 5, wherein the albumin is human serum albumin.

13. The liquid pharmaceutical composition of claim 9, wherein the albumin is human serum albumin.

14. The liquid pharmaceutical composition of claim 10, wherein the albumin is human serum albumin.

15. A sealed container comprising a pharmaceutical composition for injection comprising paclitaxel and a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier comprises albumin, wherein the albumin and the paclitaxel in the composition are formulated as particles, wherein the particles have a particle size of less than about 200 nm, and wherein the weight ratio of albumin to paclitaxel in the composition is about 1:1 to about 9:1.

16. The sealed container of claim 15, wherein the albumin is human serum albumin.

17. The sealed container of claim 15, wherein the weight ratio of albumin to the paclitaxel in the pharmaceutical composition is 1:1 to 9:1.

18. The sealed container of claim 15, wherein the weight ratio of albumin to the paclitaxel in the pharmaceutical composition is about 9:1.

19. The sealed container of claim 15, wherein the container is a unit dose container.

20. The sealed container of claim 15, wherein the container is a multi-dose container.

21. The sealed container of claim 15, wherein the pharmaceutical composition is a liquid composition.

22. The sealed container of claim 15, wherein the pharmaceutical composition is a dry composition.

23. The sealed container of claim 15, wherein the pharmaceutical composition is lyophilized.

24. The sealed container of claim 23, wherein the albumin is human serum albumin.

25. The sealed container of claim 23, wherein the weight ratio of albumin to the paclitaxel in the pharmaceutical composition is 1:1 to 9:1.

26. The sealed container of claim 23, wherein the weight ratio of albumin to the paclitaxel in the pharmaceutical composition is about 9:1.

27. The sealed container of claim 25, wherein the albumin is human serum albumin.

28. The sealed container of claim 26, wherein the albumin is human serum albumin.

29. A method of treating a cancer in a human individual, comprising injecting into the human individual an effective amount of the liquid pharmaceutical composition of claim 1.

30. The method of claim 29, wherein the albumin is human serum albumin.

31. The method of claim 29, wherein the ratio (w/w) of albumin to the paclitaxel in the pharmaceutical composition is 1:1 to 9:1.

32. The method of claim 29, wherein the weight ratio (w/w) of albumin to the paclitaxel in the pharmaceutical composition is about 9:1.

33. The method of claim 29, wherein the pH in the composition is about 5.0 to about 8.0.

34. The method of claim 29, wherein the cancer is lung cancer.

35. The method of claim 34, wherein the albumin is human serum albumin.

36. The method of claim 34, wherein the weight ratio of albumin to the paclitaxel in the pharmaceutical composition is 1:1 to 9:1.

37. The method of claim 34, wherein the weight ratio of albumin to the paclitaxel in the pharmaceutical composition is about 9:1.

38. The method of claim 29, wherein the cancer is breast cancer.

39. The method of claim 38, wherein the albumin is human serum albumin.

40. The method of claim 38, wherein the weight ratio of albumin to the paclitaxel in the pharmaceutical composition is 1:1 to 9:1.

41. The method of claim 38, wherein the weight ratio of albumin to the paclitaxel in the pharmaceutical composition is about 9:1.

42. The method of claim 29, wherein the liquid pharmaceutical composition is injected intravenously.

43. The method of claim 30, wherein the liquid pharmaceutical composition is injected intravenously.

44. The method of claim 31, wherein the liquid pharmaceutical composition is injected intravenously.

45. The method of claim 32, wherein the liquid pharmaceutical composition is injected intravenously.

46. The method of claim 33, wherein the liquid pharmaceutical composition is injected intravenously.

47. The method of claim 34, wherein the liquid pharmaceutical composition is injected intravenously.

48. The method of claim 38, wherein the liquid pharmaceutical composition is injected intravenously.
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