Process of preparing a crystalline azithromycin monohydrate
AssigneeTaro Pharmaceutical Industries Ltd.
InventorsDaniella Gutman, Lea Shachal
Life of this patent
Estimating the term…
Abstract
The present invention provides a process of preparing a crystalline azithromycin monohydrate. The process involves dissolving azithromycin in a solution containing ethanol, adding the dissolved azithromycin into water to precipitate the crystals, isolating and drying the precipitate to a water content of about 5% (w/w) to about 7% (w/w). The resulting azithromycin monohydrate is stable, exhibiting less than 2% degradation, and non-hydroscopic.
Claims7
A process for preparing a crystalline azithromycin monohydrate, comprising the steps of:
- (a) dissolving azithromycin in a first solution comprising 95% (v/v) of ethanol at 70° C.;
- (b) adding the dissolved azithromycin to a second solution comprising about 100% water to form a precipitate;
- (c) isolating the precipitate;
- and,
- (d) drying the isolated precipitate and providing crystalline azithromycin monohydrate having a water content of about 5% (w/w) to about 7% (w/w).
A process for preparing a crystalline azithromycin monohydrate, comprising the steps of:
- (a) dissolving azithromycin in a 95% (v/v) solution of ethanol at about 70° C.;
- (b) filtering the dissolved azithromycin through diatomaceous earth;
- (c) adding the dissolved azithromycin to water to form crystalline azithromycin monohydrate;
- (d) isolating crystalline azithromycin monohydrate;
- (e) slurrying the isolated crystalline azithromycin monohydrate;
- and,
- (f) drying the isolated crystalline azithromycin monohydrate to a water content of about 5% (w/w) to about 7% (w/w).
Dependencies are inferred from the claim text.