SOLID PHARMACEUTICAL COMPOSITION COMPRISING AN ANTIBIOTIC FROM THE QUINOLONE FAMILY AND METHOD FOR THE PRODUCTION THEREOF

摘要

The present invention is designed to provide a solid pharmaceutical composition comprising: (a) an antibacterially effective amount of an antibiotic of the quinolone family, preferentially moxifloxacin or a pharmaceutically acceptable salt thereof; and (b) a vehicle or excipients that are pharmacologically acceptable and compatible with the active ingredient, said excipient being lactose-free. The invention also includes a method for producing a solid pharmaceutical composition comprising, as active principle, an antibiotic of the quinolone family, said method comprising the steps of (a) in a granulator, mixing and homogenizing the active principle and the dry excipients, i.e. either at least one diluent or at least one disintegrant; (b) dissolving the at least one binder in an organic solvent selected from the group comprising isopropyl alcohol, acetone, ethanol, dichloromethane or mixtures thereof; (c) granulating the dry mixture from step (a) with the solution of step (b); (d) at a suitable temperature, grading and drying the granulate from step (c); (e) grading the dry granulate; and (f) mixing and homogenizing the granulate from step (e) with an additional amount of disintegrant in order to produce the composition of the invention.