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Last Updated: March 29, 2024

Claims for Patent: 8,034,765


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Summary for Patent: 8,034,765
Title:Compositions and methods for preparation of poorly water soluble drugs with increased stability
Abstract: The present invention provides stable pharmaceutical compositions of poorly water soluble pharmaceutical agents and stabilizing agents which function to increase stability of the compositions. The use of stabilizing agents provide extended stability of nanoparticle suspensions and other formulations of poorly water soluble pharmaceutical agents such as docetaxel under certain conditions, for example upon dilution for administration.
Inventor(s): De; Tapas (Los Angeles, CA), Desai; Neil P. (Los Angeles, CA), Yang; Andrew (Rosemead, CA), Yim; Zachary (Los Angeles, CA), Soon-Shiong; Patrick (Los Angeles, CA)
Assignee: Abraxis BioScience, LLC (Los Angeles, CA)
Application Number:11/513,756
Patent Claims:1. A pharmaceutical composition comprising nanoparticles comprising docetaxel, wherein the nanoparticles comprise docetaxel coated with albumin, and wherein the docetaxel used for preparation of the composition is in an anhydrous form.

2. The pharmaceutical composition according to claim 1, wherein the weight ratio of the albumin and docetaxel in the composition is about 18:1 or less.

3. The composition according to claim 1, further comprising a stabilizing agent.

4. The composition according to claim 3, wherein the stabilizing agent is a citrate.

5. The composition of claim 1, wherein the nanoparticles in the composition have an average or mean particle size of no greater than about 200 nm.

6. The composition of claim 5, further comprising a stabilizing agent.

7. The composition of claim 6, wherein the stabilizing agent is citrate.

8. The composition of claim 7, wherein the composition comprises about 200 mM sodium citrate and about 300 mM sodium chloride.

9. The composition of claim 1, wherein at least some of the docetaxel in the composition is in anhydrous form.

10. The composition of claim 4, wherein at least some of the docetaxel in the composition is in anhydrous form.

11. The composition of claim 7, wherein at least some of the docetaxel in the composition is in anhydrous form.

12. The composition according to claim 5, wherein the weight ratio of the albumin and docetaxel in the composition is about 18:1 or less.

13. The composition according to claim 5, wherein the albumin is human serum albumin.

14. The composition according to claim 5, wherein the pharmaceutical composition is sterile.

15. The composition according to claim 5, wherein the pharmaceutical composition is sterile filterable.

16. The composition according to claim 4, wherein the pharmaceutical composition further comprises sodium chloride.

17. The composition according to claim 7, wherein the pharmaceutical composition further comprises sodium chloride.

18. The composition according to claim 1, wherein the pharmaceutical composition is a liquid suspension.

19. The composition according to claim 17, wherein the composition is a liquid suspension of docetaxel at a concentration of at least about 1 mg/ml.

20. The pharmaceutical composition according to claim 5, wherein the pharmaceutical composition is a liquid suspension.

21. The composition according to claim 20, wherein the composition is a liquid suspension of docetaxel at a concentration of at least about 1 mg/ml.

Details for Patent 8,034,765

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Grifols Therapeutics Llc ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5 albumin (human) For Injection 101138 10/21/1942 ⤷  Try a Trial 2025-08-31
Baxalta Us Inc. BUMINATE, FLEXBUMIN albumin (human) Injection 101452 03/03/1954 ⤷  Try a Trial 2025-08-31
Csl Behring Ag ALBURX albumin (human) Injection 102366 07/23/1976 ⤷  Try a Trial 2025-08-31
Grifols Biologicals Llc ALBUTEIN albumin (human) Injection 102478 08/15/1978 ⤷  Try a Trial 2025-08-31
Instituto Grifols, S.a. HUMAN ALBUMIN GRIFOLS albumin (human) Injection 103352 02/17/1995 ⤷  Try a Trial 2025-08-31
Instituto Grifols, S.a. HUMAN ALBUMIN GRIFOLS albumin (human) Injection 103352 06/11/2003 ⤷  Try a Trial 2025-08-31
Csl Behring Llc ALBUMINAR, ALBUMINAR-20, ALBUMINAR-25, ALBUMINAR-5 albumin (human) Injection 103955 03/17/2000 ⤷  Try a Trial 2025-08-31
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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