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 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 a mean bulk density between about 0.050 g/cm 3  and about 0.15 g/cm 3 . 
     
     
         2 . The composition 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 composition of  claim 2 , wherein the taxane is paclitaxel or a pharmaceutically acceptable salt thereof, wherein the paclitaxel particles have a specific surface area (SSA) of at least 20 m 2 /g. 
     
     
         4 . The composition of  claim 2 , wherein the taxane is paclitaxel or a pharmaceutically acceptable salt thereof, wherein the paclitaxel particles have a SSA of between 18 m 2 /g and about 40 m 2 /g. 
     
     
         5 . The composition of  claim 2 , wherein the taxane is paclitaxel or a pharmaceutically acceptable salt thereof, wherein the paclitaxel particles have a SSA of between 20 m 2 /g and about 40 m 2 /g. 
     
     
         6 . The composition of  claim 2 , wherein the taxane is docetaxel or a pharmaceutically acceptable salt thereof, wherein the docetaxel particles have a SSA of at least 20 m 2 /g. 
     
     
         7 . The composition of  claim 2 , wherein the taxane is docetaxel or a pharmaceutically acceptable salt thereof, wherein the docetaxel particles have a SSA of between 18 m 2 /g and about 50 m 2 /g. 
     
     
         8 . The composition of  claim 2 , wherein the taxane is docetaxel or a pharmaceutically acceptable salt thereof, wherein the docetaxel particles have a SSA of between 20 m 2 /g and about 50 m 2 /g. 
     
     
         9 . The composition of  claim 1 , wherein the particles have a mean particle size of between about 0.4 μm to about 3 μm. 
     
     
         10 . The composition of  claim 2 , wherein the particles have a mean particle size of between about 0.4 μm to about 3 μm. 
     
     
         11 . The composition of  claim 3 , wherein the particles have a mean particle size of between about 0.4 μm to about 3 μm. 
     
     
         12 . The composition of  claim 4 , wherein the particles have a mean particle size of between about 0.4 μm and about 1.2 μm. 
     
     
         13 . The composition of  claim 5 , wherein the particles have a mean particle size of between about 0.4 μm and about 1.2 μm. 
     
     
         14 . The composition of  claim 6 , wherein the particles have a mean particle size of between about 0.4 μm and about 1.2 μm. 
     
     
         15 . The composition of  claim 7 , wherein the particles have a mean particle size of between about 0.4 μm and about 1.2 μm. 
     
     
         16 . The composition of  claim 8 , wherein the particles have a mean particle size of between about 0.4 μm and about 1.2 μm. 
     
     
         17 . The composition of  claim 1 , wherein the particles have a mean particle size of between about 0.2 μm to about 5 μm. 
     
     
         18 . The composition of  claim 1 , wherein the particles are uncoated and exclude polymer, protein, polyethoxylated castor oil and polyethylene glycol glycerides composed of mono-, di- and triglycerides and mono- and diesters of polyethylene glycol.