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Claims for Patent: 6,753,006

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Claims for Patent: 6,753,006

Title: Paclitaxel-containing formulations
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: American BioScience, Inc. (Santa Monica, CA)
Application Number:09/629,501
Patent Claims: 1. A unit dosage form of paclitaxel comprising a sealed vial containing a quantity of non-crystalline, cremophor-free paclitaxel suitable for administration to a human over an administration period no greater than about 3 hours, wherein said quantity is sufficient to deliver a dose between 30-1000 mg/m.sup.2 over said administration period.

2. A unit dosage form according to claim 1, wherein said dose is between 50-300 mg/m.sup.2.

3. A unit dosage form according to claim 1, wherein said dose is between 175-700 mg/m.sup.2.

4. A unit dosage form of paclitaxel comprising a sealed vial containing a quantity of non-crystalline, cremophor-free paclitaxel suitable for administration to a human with a treatment cycle less than about 3 weeks, wherein said quantity is sufficient to deliver a dose between 30-1000 mg/m.sup.2.

5. A unit dosage form according to claim 4, wherein said dose is between 50-300 mg/m.sup.2.

6. A unit dosage form according to claim 4, wherein said dose is between 175-700 mg/m.sup.2.

7. A unit dosage form of paclitaxel comprising an article of manufacture, wherein said article comprises a sealed vial containing a quantity of non-crystalline, cremophor-free paclitaxel suitable for administration to a human over an administration period no greater than about 3 hours, wherein said quantity is sufficient to deliver a dose between 30-1000 mg/m.sup.2 over said administration period.

8. A unit dosage form according to claim 7, wherein said dose is between 50-300 mg/m.sup.2.

9. A unit dosage form according to claim 7, wherein said dose is between 175-700 mg/m.sup.2.

10. A unit dosage form according to claim 7, wherein said administration is accomplished as a single dose.

11. A stable, sterile, nonpyrogenic, nonaqueous formulation of paclitaxel wherein the formulation contains a sufficient quantity of non-crystalline, cremophor-free paclitaxel to allow systemic administration at a dose in the range of about 30 mg/m.sup.2 to about 1000 mg/m.sup.2.

12. A formulation according to claim 11, wherein said dose is between 175-700 mg/m.sup.2.

13. A formulation according to claim 11, wherein said dose is between 50-300 mg/m.sup.2.

14. A formulation according to claim 11, wherein said administration is accomplished as a single dose.
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