Composicion de liberacion sostenida inyectable por via intramuscular, que comprende un farmaco, un copolimero biocompatible a base de acido lactico y acido glicolico, con un peso molecular entre 30 y 46 kda y una viscosidad inherente entre 0,25 y 0,31 dl/g, y dmso como disolvente; kit farmaceutico; y metodo para su elaboracion.

摘要

The present invention is directed to an injectable intramuscular depot composition suitable for forming an in situ solid implant in a body, comprising a drug which is risperidone and/or paliperidone or any pharmaceutically acceptable salt thereof in any combination, a biocompatible copolymer based on lactic and glycolic acid having a monomer ratio of lactic to glycolic acid of about 50:50 and a DMSO solvent, wherein the composition releases the drug with an immediate onset of action and continuously for at least 4 weeks and wherein the composition has a pharmacokinetic profile in vivo that makes it suitable to be administered each 4 weeks or even longer periods.