| CPC A61K 47/34 (2013.01) [A61K 9/0019 (2013.01); A61K 31/426 (2013.01); A61L 2/0017 (2013.01); A61L 2/0029 (2013.01)] | 15 Claims |
|
1. A kit for preparing an injectable depot composition, the kit comprising PLA (polylactic acid) particles, solvent for PLA, and drug particles, wherein prior to mixing the PLA particles, solvent for PLA, and drug particles, the drug has a particle size distribution that approximates the PLA's particle size distribution, and after mixing the PLA, solvent for PLA, and drug, the PLA is dissolved in the solvent, wherein the solvent is dimethyl sulfoxide (DMSO), and said drug is selected from the group consisting of letrozole, anastrozole, salt of either thereof, and metabolite of either thereof, and further wherein prior to mixing the PLA particles with said solvent for PLA, the particle size distribution of the PLA particles is defined as follows:
a) particle size mass distribution with not more than 10% above 300 microns when measured by analytical sieving according to USP<786>;
b) particle size mass distribution with not more than 10% above 250 microns when measured by analytical sieving according to USP<786>;
c) particle size volume distribution with a D90 not above 330 microns when measured by laser diffraction analysis;
d) particle size volume distribution with a D90 not above 280 microns when measured by laser diffraction analysis;
e) particle size mass distribution where not more than 80% of the particles have a particle size below 125 microns, when measured by analytical sieving according to USP<786>;
f) a particle size volume distribution with a D80 not below 135 microns when measured by laser diffraction analysis;
g) particle size mass distribution with not more than 10% above 300 microns, and where not more than 80% of the particles have a particle size below 125 microns, when measured by analytical sieving according to USP<786>; and/or
h) particle size volume distribution with a D90 not above 330 microns, when measured by laser diffraction analysis and with a D80 not below 135 microns when measured by laser diffraction analysis.
|