Taxane Particles and Their Use

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/cm3 and about 0.15 g/cm3, and/or a specific surface area (SSA) of at least 18 m2/g, 20 m2/g, 25 m2/g, 30 m2/g, 32 m2/g, 34 m2/g, or 35 m2/g. Methods for making and using such compositions are also provided.

We claim: 
     
         1 . A method for treating a lung tumor, comprising administering to a subject with a lung 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 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 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 3 μm. 
     
     
         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. 
     
     
         23 . The method of  claim 1 , wherein the taxane is paclitaxel or a pharmaceutically acceptable salt thereof, the paclitaxel particles have a SSA of between 18 m 2 /g and about 40 m 2 /g, the paclitaxel particles have a mean bulk density between about 0.050 g/cm 3  and about 0.12 g/cm 3 , and the paclitaxel particles have a mean particle size of between about 0.4 μm to about 3 μm. 
     
     
         24 . The method of  claim 23 , wherein the composition comprises a suspension further comprising a pharmaceutically acceptable aqueous carrier. 
     
     
         25 . The method of  claim 1 , wherein the taxane is docetaxel or a pharmaceutically acceptable salt thereof, the docetaxel particles have a SSA of between 18 m 2 /g and about 50 m 2 /g, the docetaxel particles have a mean bulk density between about 0.050 g/cm 3  and about 0.12 g/cm 3 , and the docetaxel particles have a mean particle size of between about 0.4 μm to about 3 μm. 
     
     
         26 . The method of  claim 25 , wherein the composition comprises a suspension further comprising a pharmaceutically acceptable aqueous carrier.