Sustained release composition and manufacturing method thereof

摘要

A sustained release composition comprising a polymer and manufacturing method thereof. The sustained release composition comprises a polymer, a bioactive agent, and a release rate determined agent, wherein the release rate determined agent is dispersed in the sustained release composition to control the release rate of the bioactive agent. The method comprises providing an oil phase comprising a bioactive agent, a polymer, and a release rate determined agent; providing an aqueous phase comprising a surfactant; mixing the oil phase with the aqueous phase to form the sustained release composition having a controlled release effect.

主权项

1. A sustained release composition without lag phase comprising a polymer, a bioactive agent, and a release rate determined agent, wherein the bioactive agent and the release rate determined agent are dispersed in the sustained release composition, the release rate determined agent is vitamin E-TPGS present in amounts of 7%-42% by weight of the total weight of the sustained release composition for controlling the release rate of the bioactive agent,
wherein the polymer is polylactide-co-glycolide (PLGA) and the bioactive agent is olanzapine, and wherein the sustained release composition is produced by an emulsion process comprising an oil phase including the bioactive agents, the polymer and the release rate determined agent before mixing with an aqueous phase.