SPHERICAL PARTICLE OF CLOPIDOGREL BISULFATE, PHARMACEUTICAL COMPOSITION COMPRISING THE SAME AND METHOD OF PREPARATION THEREOF

摘要

PURPOSE: A spherical particle of clopidogrel hydrogenosulphate and a pharmaceutical composition containing the same are provided to remarkably improve physiochemical stability and to be used as a therapeutic agent for treating stroke, myocardial infarction and sterosclerosis. CONSTITUTION: A pharmaceutical composition contains a spherical particle of clopidogrel hyrogenosulphate, an excipient, low substitution hydroxypropyl cellulose as a disintegrant, a colloidal silicon dioxide, and sodium stearyl fumarate as a lubricant. The clopidogrel hyrogenosulphate is crystalline type I, type II, or a mixture thereof. The pharmaceutical composition does not contain a binder. A method for preparing a tablet containing spherical particle of clopidogrel hyrogenosulphate comprises: a step of mixing the spherical particles, an excipient, low substitution hydroxypropyl cellulose, colloidal silicon dioxide, and sodium stearylfumaric acid; and a step of forming a tablet by a direction powder compression method.