Patent ID: 11957791
Assignee: INTRA-CELLULAR THERAPIES, INC.
Field: Pharmaceuticals (Chemistry)
Classification: CPC A  C | IPC A

Claim 0:
1. A solid oral dosage form, comprising lumateperone:, wherein the dosage form is an immediate release dosage form;
wherein the dosage form is a tablet formulated for oral (gastrointestinal) administration;
wherein the dosage form comprises the lumateperone in mono-tosylate salt form;
wherein the lumateperone mono-tosylate is in solid crystal form; and
wherein the composition further comprises one or more pharmaceutically acceptable diluents or carriers comprising at least:
(a) 60-90% by weight of a diluent/filler selected from cellulose, microcrystalline cellulose, mannitol, lactose monohydrate, dicalcium phosphate, and isomalt,
(b) 1-10% by weight of a binder selected from hydroxypropyl cellulose, hydroxypropyl methyl cellulose, and copovidone,
(c) 1-10% by weight of a disintegrant selected from sodium starch glycolate, crospovidone, and croscarmellose sodium,
(d) 0.1-5% by weight of a lubricant selected from magnesium stearate and glyceryl monostearate, and
(e) 0.1-5% by weight of a glidant selected from silicon dioxide and talc.