Pharmaceutical composition containing goserelin for in-situ implant

摘要

The present invention provides a pharmaceutical composition capable of forming in-situ implant comprising goserelin or its pharmaceutically acceptable salts thereof, biodegradable polymer and a biocompatible organic solvent wherein the biocompatible organic solvent is miscible to dispersible in aqueous medium or body fluid. The present invention further provides a process for the preparation of pharmaceutical composition capable of forming in-situ implant. A kit containing composition for in-situ implant is provided comprising a first vial comprising a composition comprising a biodegradable polymer and a biocompatible organic solvent; wherein the biocompatible organic solvent is miscible to dispersible in aqueous medium or body fluid; and a second vial comprising goserelin acetate.

主权项

1. A pharmaceutical product comprised of components capable of forming an in-situ implant comprising:
a) a first component comprised of goserelin acetate in lyophilized powder form; b) a second component comprised of a solution comprising
a mixture of at least a high or medium weight average molecular weight biodegradable polymer and a low weight average molecular weight biodegradable polymer, anda biocompatible organic solvent present in 20% to 80% by weight of the composition; wherein the low weight average molecular weight biodegradable polymer has a weight average molecular weight of from 4,000 to 20,000 Da wherein the in-situ implant comprised of a mixture of the first and second components has an in vivo burst index that is less than an in situ implant comprised of goserelin acetate and at least a high or medium weight average molecular weight biodegradable polymer.