Taxane particles and their use

Patent metadata

Field	Value
Publication number	US-10729673-B2
Application number	US-202016776919-A
Country	US
Kind code	B2
Filing date	Jan 30, 2020
Priority date	Jun 4, 2015
Publication date	Aug 4, 2020
Grant date	Aug 4, 2020

Abstract

Compositions are provided that include having at least 95% by weight of a taxane, or a pharmaceutically acceptable salt thereof, where the particles have a mean bulk density between about 0.050 g/cm 3 and about 0.15 g/cm 3 , and/or a specific surface area (SSA) of at least 18 m 2 /g, 20 m 2 /g, 25 m 2 /g, 30 m 2 /g, 32 m 2 /g, 34 m 2 /g, or 35 m 2 /g. Methods for making and using such compositions are also provided.

First claim

We claim:

1. A method for treating a bladder tumor, comprising administering to a subject with a bladder tumor an amount effective to treat the tumor of a composition comprising particles including at least 95% by weight of a taxane, or a pharmaceutically acceptable salt thereof, wherein the particles have a specific surface area (SSA) of at least 18 m 2 /g, and wherein the taxane particles include both agglomerated taxane particles and non-agglomerated taxane particles.

2. The method of claim 1 , wherein the taxane is selected from the group consisting of paclitaxel, docetaxel, and cabazitaxel, or a pharmaceutically acceptable salt thereof.

3. The method of claim 2 , wherein the taxane is paclitaxel or a pharmaceutically acceptable salt thereof.

4. The method of claim 3 , wherein the paclitaxel particles have a mean bulk density between about 0.050 g/cm 3 and about 0.12 g/cm 3 .

5. The method of claim 3 , wherein the paclitaxel particles have a specific surface area (SSA) of at least 20 m 2 /g.

6. The method of claim 3 , wherein the paclitaxel particles have a SSA of between about 18 m 2 /g and about 40 m 2 /g.

7. The method of claim 3 , wherein the paclitaxel particles have a SSA of between about 20 m 2 /g and about 40 m 2 /g.

8. The method of claim 2 , wherein the taxane is docetaxel or a pharmaceutically acceptable salt thereof.

9. The method of claim 8 , wherein the docetaxel particles have a mean bulk density between about 0.050 g/cm 3 and about 0.12 g/cm 3 .

10. The method of claim 8 , wherein the docetaxel particles have a SSA of between about 18 m 2 /g and about 50 m 2 /g.

11. The method of claim 8 , wherein the docetaxel particles have a SSA of at least 20 m 2 /g.

12. The method of claim 8 , wherein the docetaxel particles have a SSA of between about 20 m 2 /g and about 50 m 2 /g.

13. The method of claim 8 , wherein the docetaxel particles have a SSA of between about 25 m 2 /g and about 50 m 2 /g.

14. The method of claim 1 , wherein the particles have a mean particle size of between about 0.4 μm to about 3 μm.

15. The method of claim 3 , wherein the particles have a mean particle size of between about 0.4 μm to about 3 μm.

16. The method of claim 8 , wherein the docetaxel particles have a mean particle size of between about 0.4 μm to about 3μm.

17. The method of claim 1 , wherein the particles have a mean particle size of between about 0.4 μm to about 1.2 μm.

18. The method of claim 3 , wherein the particles have a mean particle size of between about 0.4 μm to about 1.2 μm.

19. The method of claim 8 , wherein the docetaxel particles have a mean particle size of between about 0.4 μm to about 1.2 μm.

20. The method of claim 1 , wherein the composition comprises a suspension further comprising a pharmaceutically acceptable aqueous carrier.

21. The method of claim 3 , wherein the composition comprises a suspension further comprising a pharmaceutically acceptable aqueous carrier.

22. The method of claim 8 , wherein the composition comprises a suspension further comprising a pharmaceutically acceptable aqueous carrier.

Assignees

• Crititech Inc

Inventors

• Baltezor Michael
• Farthing Joseph
• Sittenauer Jake
• Espinosa Jahna
• Campbell Samuel
• Mcclorey Matthew
• Fischer Julia K
• Williams Mark D
• Clapp Gary E

Classifications

• A61K9/10 Primary

  Dispersions; Emulsions · CPC title

• B05B1/341

  before discharging the liquid or other fluent material, e.g. in a swirl chamber upstream the spray outlet · CPC title

• B01J2204/002

  the feeding side being of particular interest · CPC title

• B01J19/10

  employing sonic or ultrasonic vibrations · CPC title

• B01J3/02

  Feed or outlet devices therefor · CPC title