Shuyi Zhang - Parsippany NJ, US Jin Wang - Cedar Grove NJ, US Shaoling Li - Sunnyvale CA, US
International Classification:
A61K 9/52 A61K 31/135 A61K 9/14 A61K 9/32
US Classification:
424457, 514646, 424497, 424468
Abstract:
The present invention provides a pharmaceutical dosage form for sustained release of a combination of acetaminophen and tramadol or its salts. The dosage form has an immediate release portion and a sustained release portion. The immediate release portion has about 16%-75% of the drugs. The sustained release portion includes: a. about 25%-84% of the drugs, at least one gelling polymer in an amount by weight of the total formulation of about 6% to 50%. The dosage form releases about 25% to about 60% of the drugs in the first hour, and not less than about 80% of the drugs in the first 24 hours in an intestinal fluid dissolution media using USP dissolution method II with the paddle speed between 50 rpm and 100 rpm.
