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US 11,690,842 B2Granted
Pharmaceutical capsule compositions comprising lumateperone mono-tosylate
AssigneeIntra-Cellular Therapies, Inc.
InventorsPeng Li, Robert Davis
Life of this patent
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Abstract
The present disclosure relates to pharmaceutical capsules 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.
Claims20
A pharmaceutical capsule for oral administration, comprising lumateperone:
- in mono-tosylate salt form, wherein the lumateperone mono-tosylate is in solid crystal form;
- and
- wherein the capsule comprises a blend of 10 to 30% by weight of lumateperone mono-tosylate in solid crystal form, 60 to 90% by weight of mannitol, 0.5 to 10% by weight of croscarmellose sodium, 0.1 to 1% by weight of talc, and 0.1 to 3% by weight of magnesium stearate, filled into a gelatin capsule, and
- wherein a single capsule dissolves in 500 mL of 0.1N aqueous hydrochloric acid to the extent of at least 85% after 15 minutes, and/or to the extent of at least 92% after 30 minutes, and/or to the extent of at least 94% after 45 minutes.
1 more element
Dependencies are inferred from the claim text.