Abstract

PREFORMULATION AND CHARACTERIZATION STUDIES OF CLOPIDOGREL ACTIVE INGREDIENT FOR ORODISPERSIBLE TABLETS DEVELOPMENT

Maged Alwan Noman, Mahmoud Mahyoob Alburyhi* and Mohammed A. Alqubati

ABSTRACT

Clopidogrel is used to prevent heart attack and stroke in people who are at high risk of these events, including those with a history of myocardial infarction and other forms of acute coronary syndrome, stroke, and those with disease. The objective of this study was to investigate some of the important physicochemical properties of Clopidogrel Bisulfate powder before the development of Orodispersible tablets. Several tests should be performed to rule out any potential physical or chemical interactions between the active pharmaceutical ingredient and the various excipients that might be utilized in the manufacturing of the drug formula. Thus, before the selection of excipients the preformulation study should be completed evalution for successes of the formulation. Preformulation studies, like melting point stability, bulk density, flow properties FT-IR, HPLC assay and any potential physical or chemical interactions between the active pharmaceutical ingredient and the various excipients that might be utilized in the development of the drug formulations. In this study, Compatibility study between Clopidogrel Bisulfate as an active
ingredient and many candidates of pharmaceutical excipients supposed to be used in the formulation of Orodispersable tablets has been investigated by two approaches: Fourier Transform infrared Spectroscopy (FT-IR), for the most important excipients and high-performance liquid chromatography HPLC assay after storage in humidity and high temperature condition (40°C-75%RH, for 30days). It was concluded there are no notable interactions between API and the various selected excipients that could be employed to development Clopidogrel Orodispersible tablets as drug delivery system.

Keywords: Pre-formulation, Clopidogrel, Orodispersible tablets, Development, Oral anticoagulant, HPLC assay.