DIRECTLY COMPRESSIBLE HIGH LOAD ACETAMINOPHEN FORMULATIONS

摘要

Direct compressed solid pharmaceutical dosage forms containing: a) from about 40 to about 95 % by weight acetaminophen; b) from about 1 to about 60 % by weight of a direct compression vehicle comprising microcrystalline cellulose; and c) from about 0.01 to about 4.0 % by weight of a pharmaceutically-acceptable lubricant are disclosed. The acetaminophen and direct compression vehicle are combined under high shear conditions which are sufficient to transform acetaminophen and direct compression vehicle into a homogenous granulate without degradation. In preferred aspects of the invention, the lubricant is also combined with the acetaminophen and direct compression vehicle under high shear conditions. Methods of preparing the directly compressed solid pharmaceutical dosage forms and methods of treatment with the dosage forms are also disclosed. The methods are particularly well suited for preparing directly compressed dosage forms containing high load (i.e., up to 80 % or greater) amounts of acetaminophen based on the weight of the total tablet.