EP4606371A1 — Lumateperone pharmaceutical composition, and long-acting microsphere sustained-release formulation and preparation method therefor

USPTO Abstract

The present invention relates to the field of pharmaceutical formulations. Disclosed are a composition containing Lumateperone active ingredients, and a long-acting sustained-release formulation and a preparation method therefor. A composition containing Lumateperone active ingredients capable of achieving long-acting sustained release is obtained by means of a specific definition on medicinal polymer auxiliary materials; and preparation process conditions are further controlled to obtain a long-acting sustained-release formulation containing Lumateperone active ingredients, so that the sustained release of Lumateperone is implemented in one week to two months, and compared with general formulations (for example: capsules), the compliance of patients can be effectively improved; and clinical requirements of stable drug release are satisfied while the drug safety and effectiveness are ensured.