NOVEL COMPOSITION OF LAPATINIB OF ORAL SOLID DOSAGE FORM AND METHOD OF MANUFACTURING THEREOF

摘要

The present invention discloses a novel pharmaceutical composition of lapatinib or a pharmaceutically acceptable salt thereof preferably oral solid dosage form of a tablet with pharmaceutically acceptable excipients and method of preparation thereof. The pharmaceutical composition of present invention comprises lapatinib ditosylate monohydrate with one or more pharmaceutically acceptable excipients selected from the group comprising of at least one diluent, at least one disintegrant, at least one binder, at least one lubricant, wherein the composition does not comprise microcrystalline cellulose and sodium starch glycolate. The pharmaceutical composition according to the present invention is economical and advanced dosage form over existing dosage form, with less side effects and time efficient, especially for large scale production, whereby the pharmaceutical composition shows a desired dissolution profile and higher stability with minimum use of excipients.