Sustained release formulations containing acetaminophen and...

Details Sustained release formulations containing acetaminophen and... Sustained release formulations containing acetaminophen and...

2008-05-20

2008-05-20

Tran, S. (Department: 1618)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Capsules

C424S457000, C424S458000, C424S459000

Reexamination Certificate

active

10664451

ABSTRACT:
A sustained release formulation as a unit dose contains 100 mg-1000 mg of Acetaminophen and 15 mg-150 mg of tramadol hydrochloride, which comprises of 1) an immediate release portion comprising of 25%-75% of the total effective amount of drug in the dosage form and 2) a sustained release portion comprising of a) 25%-75% of the total effective amount of drugs in the dosage form; b) 6%-50% of gelling polymers of the total formulation, and c) optionally an enteric coating at a level of 5%-40% of the total formulation. The set forth formulation dissolves 25%-60% of the total drug in the first hour, 50%-90% of the total drug in the first four hours and not less than 80% of the total drug in the first 12 hours using USP dissolution method II at 50 rpm.

REFERENCES:
patent: 5336691 (1994-08-01), Raffa et al.
patent: 6375957 (2002-04-01), Kaiko et al.
patent: 6491949 (2002-12-01), Faour et al.

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