PROCESS FOR INCREASING PARTICLE SIZE OF CRYSTALLINE DRUG MICROPARTICLES

a first suspension prepared from crystalline microparticles of active substance with a first d50 value of 0.5-5 μm, solvent and antisolvent for the active substance, wherein the solubility of the active substance in the solvent-antisolvent mixture of the first suspension is 0.001-0.5 wt. %, such tha...

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Hauptverfasser: GLIESING, SABINE, GRAWE, DETLEF
Format: Patent
Sprache:eng ; fre ; ger
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Zusammenfassung:a first suspension prepared from crystalline microparticles of active substance with a first d50 value of 0.5-5 μm, solvent and antisolvent for the active substance, wherein the solubility of the active substance in the solvent-antisolvent mixture of the first suspension is 0.001-0.5 wt. %, such that the average particle diameter (d50 value) at the end or the method is at least 0.03 μm larger than the starting d50 value. The d50 values of a first batch can also serve to control the particle coarsening of a second batch. In addition, particles of fluticasone propionate having an average particle size d50 of 1.0-1.5 μm and simultaneously a narrow particle size distribution with a span