Taxane particles and their use
AssigneeCrititech, Inc.
InventorsMichael Baltezor, Joseph Farthing, Jake Sittenauer, Jahna Espinosa, Samuel Campbell, Matthew McClorey, Julia K. Fischer, Mark D. Williams, Gary E. Clapp
Life of this patent
Estimating the term…
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.
Claims18
A composition, comprising particles including at least 95% by weight of a taxane selected from the group consisting of paclitaxel and docetaxel, or a pharmaceutically acceptable salt thereof, wherein the particles have one or both of the following characteristics:
- (i) a mean bulk density between about 0.050 g/cm3 and about 0.15 g/cm3, and/or
- (ii) have a specific surface area (SSA) of at least 18 m2/g;
- and
- wherein the taxane particles include both agglomerated taxane particles and non-agglomerated taxane particles.
A composition, comprising:
- (a) particles including at least 95% by weight of paclitaxel, wherein at least 40% (w/w) of the paclitaxel is dissolved in 30 minutes or less in a solution of 50% methanol/50% water (v/v) at 37° and pH 7.0 in a USP II paddle apparatus operating at 75 RPM, wherein the particles include both agglomerated paclitaxel particles and non-agglomerated paclitaxel particles;
- or
- (b) at least 95% by weight of docetaxel, wherein at least 20% (w/w) of the docetaxel is dissolved in 30 minutes or less in a solution of 15% methanol/85% water (v/v) at 37° and pH 7.0 in a USP II paddle apparatus operating at 75 RPM, wherein the particles include both agglomerated paclitaxel particles and non-agglomerated paclitaxel particles.
Dependencies are inferred from the claim text.