| 摘要 |
PROBLEM TO BE SOLVED: To provide a method for preventing substantial aggregation of particles in a pharmaceutical nanoparticle composition, the method comprising adding sugar and salt to a lyophilized product in order to prevent the aggregation of the nanoparticles in reconstitution.SOLUTION: The invention provides a lyophilized pharmaceutical composition comprising polymeric nanoparticles, wherein upon reconstitution of the lyophilized pharmaceutical composition, in less than or about 100 mL of an aqueous medium, the reconstituted composition suitable for parenteral administration comprises: less than 6000 microparticles of greater than or equal to 10 microns; and less than 600 microparticles of greater than or equal to 25 microns.SELECTED DRAWING: None |
