EP4678165A1 — Long-acting and sustained-release preparation composition of lumateperone and preparation method therefor

USPTO Abstract

Disclosed in the present application is a long-acting and sustained-release preparation composition of lumateperone, the composition comprising lumateperone or a salt thereof and a polymer material, wherein the mass ratio of lumateperone to the polymer material is 0.5 : 9.5 to 5 : 5; the polymer material comprises a main material, i.e. polylactide, and an optional release regulator; the mass of the release regulator is 0% to 95% of the mass of the main material, i.e. polylactide; and the release regulator is selected from one of or a mixture of more than one of polylactide or polylactide-glycolide. The long-acting and sustained-release preparation of the present invention can achieve a sustained-release effect ranging from one week to three months, can improve the compliance of a patient, and has no obvious burst release in the early stage and no release lag phase, has stable release of the preparation, and ensures the safety and effectiveness of drug release.