Composition of sustained Release injection intramuscularly, comprising a Drug, a biocompatible based Copolymer of lactic acid and Glycolic Acid, with a Molecular weight between 30 and 46 kDa and an inherent viscosity between 0.25 and 0.31 g / dl, and DMSO as Solvent Kit; pharmacist; And Method for its preparation.

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.