Clopidogrel is an oral antiplatelet agent (thienopyridine class) used to inhibit blood clots in coronary artery disease, peripheral vascular disease, and cerebrovascular disease.

The aim of this work was to develop stable formulation containing the crystalline form I of clopidogrel bisulfate as an active substance, with appropriate pharmaceutical bioavailability.

Core tablets were covered by two kinds of coating – Opadry II and AMB. The finished tablets were packed into blisters manufactured from two kinds of packaging materials Alu/Alu and Alu/PVDC. The stability study was conducted in different temperature and humidity conditions during 6 month. An RP-HPLC method was developed for the study of assay, quantity of the active substance released from the drug form, and the purity study of the preparation, whereas stability of Clopidogrel bisulfate I polymorphic form was carried on by FT-IR method. The results show the stability of the active substance in the investigated tablets coated with Opadry II and packed into blisters Alu/Alu after 6 month storage in 40^oC temperature and 75% humidity.

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