Abstract

COMPATIBILITY STUDIES WITH PHARMACEUTICAL EXCIPIENTS OF CLOPIDOGREL FOR THE DEVELOPMENT OF NOVEL DELIVERY SYSTEMS

Mahmoud Mahyoob Alburyhi*, Abdalwali Ahmed Saif and Maged Alwan Noman

Abstract

In the present study that the Clopidogrel bisulfate was chosen to be the active pharmaceutical ingredient (API) in Orodispersible tablets ODTs formulations. Clopidogrel bisulfate is thieno pyridine class antiplatelet agent used to inhibit blood clots in coronary artery disease, peripheral vascular disease and cerebrovascular disease, its solubility is very low and has very low bioavailability. A total of nine formulations of Orodispersible tablets ODTs of Clopidogrel bisulfate with Superdisintegrants like; croscarmellose sodium, sodium starch glycolate, and/or crospovidone in different ratios were prepared with a view to increase its effect by decreasing the time required for the drug to be released. Preformulation, formulation and evaluation of Clopidogrel to avoid problems associated with conventional delivery system such as limited permeation, low dissolution and bioavailability and also to improve bioavailability were evaluated for preformulation studies parameters and one of the most recent antiplatelet agents. It was concluded that the drug Clopidogrel was found to be compatible with various excipients which were selected for the formulation development of the Clopidogrel ODTs. Formulation scientist from his experience and knowledge have to significantly in the preformulation study stage and is an important factor in the ADDS (Advanced Drug Delivery Systems) product development process.

Keywords: Clopidogrel, Compatibility, Excipients, Development, Preformulation, Formulation, Antiplatelet agent.