Azithromocin monohydrate with lower hygroscopicity, preparation method and pharmaceutical compositions which include it

摘要

The improved form of azitromycin monohydrate of lower hydroscopicity and greater density and hardness that presents values of: apparent filling density not lower than 0.35 g/ml; and apparent knocked density not lower than 0.50 g/ml. The method for preparation of an improved form of azitromycin monohydrate is characterised in that the hydroscopic azitromycin monohydrate is subjected to a procession of compaction by pressure. The invention also refers to a pharmaceutical composition that includes a therapeutically effective quantity of improved form of azitromycin monohydrate in association with at least one pharmaceutically acceptable suitable inert diluent.