Sustained release formulation of naltrexone

摘要

A sustained-release oral dosage form of naltrexone or a pharmaceutically acceptable salt thereof is provided. The oral dosage form may be administered with another compound. Administration of the oral dosage form may reduce a side effect, which may be a side effect at least partially attributable to a weight-loss treatment. The oral dosage form may be administered to treat a weight-loss condition.

主权项

1. A method of treating overweight or obesity having reduced adverse effects comprising:
selecting for treatment a subject in need of a treatment for obesity or overweight; and orally administering at least daily about 4 mg to about 32 mg of naltrexone and about 90 mg to about 360 mg of bupropion, or pharmaceutically acceptable salts thereof to said subject, wherein the bupropion or pharmaceutically acceptable salt thereof is administered as a sustained-release formulation, wherein the naltrexone or pharmaceutically acceptable salt thereof is administered as a sustained-release formulation having an in vitro naltrexone dissolution profile in a dissolution test of USP Apparatus 2 Paddle Method at 100 rpm in a dissolution medium of water at 37° C. of: a) 67% to 80% of naltrexone released in 1 hour; and b) 85% to 96% of naltrexone released in 2 hours; whereby at least one adverse effect associated with administration of the same amount of an immediate-release naltrexone formulation and said sustained-release formulation of bupropion or a pharmaceutically acceptable salt thereof is reduced.