Naltrexone hydrochloride compositions

Details Naltrexone hydrochloride compositions Naltrexone hydrochloride compositions

A - Human Necessities

61

K

A61K 31/485 (2006.01) A61K 9/20 (2006.01) B60R 13/06 (2006.01)

Patent

CA 2748620

The invention relates to a pharmaceutical composition comprising an inert core coated with a first layer and a second layer, the first layer being between the core and the second layer, the first layer comprising a mixture of naltrexone hydrochloride and a stabilizer, and the second layer comprising a hydrophobic material, wherein one or more coated cores are included in a dosage form to provide a total of about 20 mg or less naltrexone hydrochloride, said stabilizer is in an effective amount to inhibit the formation of the degradation product of naltrexone hydrochloride such that at least about 95% of the naltrexone hydrochloride remains in undegraded form after storage for 1 month at 40 2° C and 75 5% relative humidity.

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