Preparation of Ultra-Fine Clarithromycin Particles by Anti-Solvent Recrystallization

摘要

Ultrafine drug powders have higher bioavaibability than the larger signed particles. Ultrafine powders of clarithromycin were produced by anti-solvent recrystallization with the acetone - water solvent systems. The effects of volume ratio of clarithromycin acetone solution to anti-solvent, stirring speed, precipitation temperature and precipitation time on the preparation process were investigated. The results show that ultrafine powders can be yielded and well-controlled under the following optimal conditions: the volume ratio of clarithromycin acetone solution to anti-solvent 1:10, stirring speed 900 r/min, precipitation temperature 20°C, and precipitation time 10 min. The ultrafine powders with the rod-shape and the mean diameter of 1.8 urn with the narrow distribution were successfully obtained. The yield of drug powders is more than 83%. The powders were analyzed with FT-IR and metalloscope. The purity of drug powders is more than 98%, according with Chinese Pharmacopoeia. The operation of the experiment was very simple, and the powders were separated easily.