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US 12,734,167 B2Granted
Naltrexone formulation
AssigneeIntas Pharmaceuticals Ltd.
InventorsAlkeshkumar Narayanbhai Patel, Manish Mavjibhai Patel, Manishkumar Jayantibhai Chauhan, Venkataramana Naidu
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Abstract
A lactose free, stable pharmaceutical composition having naltrexone or its pharmaceutically acceptable salt thereof. Also disclosed is a process for the preparation of the composition and its use in a method for the treatment of Crohn's disease.
Claims4
A lactose free, stable pharmaceutical composition comprising naltrexone or its pharmaceutically acceptable salt thereof and pharmaceutically acceptable excipients,
- wherein the amount of naltrexone or its pharmaceutically acceptable salt thereof in the pharmaceutical composition is from about 1.5 mg to about 5 mg, the content uniformity of the composition is in between 95% and 105%, wherein the pharmaceutical composition is in the form of a tablet, wherein the pharmaceutically acceptable excipients are:
- mannitol and microcrystalline cellulose as diluents, present in an amount from about 20% w/w to about 80% w/w of the pharmaceutical composition;
- sodium starch glycolate as disintegrant, present in an amount from about 1% w/w to about 10% w/w of the pharmaceutical composition;
- hydroxypropyl cellulose as binder, present in an amount from about 0.5% w/w to about 5% w/w of the pharmaceutical composition;
- and
- magnesium stearate as lubricant, present in an amount from about 0.2% w/w to about 2% w/w of the pharmaceutical composition;
- and wherein the pharmaceutical composition is devoid of any stabilizer or chelating agent.
4 more elements
Dependencies are inferred from the claim text.