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US 11,957,791 B2Granted
Methods
AssigneeIntra-Cellular Therapies, Inc.
InventorsPeng Li, Robert Davis, William Paul Findlay
Life of this patent
Estimating the term…
Abstract
The present disclosure relates to solid oral dosage forms comprising lumateperone, in free, or pharmaceutically acceptable salt form, optionally in combination with one or more additional therapeutic agents, processes for manufacture thereof and methods of use in the treatment or prophylaxis of disease.
Claims17
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.
8 more elements
Dependencies are inferred from the claim text.