Abstract

FORMULATION DEVELOPMENT AND EVALUATION OF GASTRORETENTIVE FLOATING TABLET OF CILNIDIPINE

Chetan Varade*, Smita Aher and Rushikesh Bachhav

ABSTRACT

The present research work was an attempt to formulate and evaluate floating tablet containing Cilnidipine in the form of tablets using polymers like HPMC K4M, carbopol 934, NaHCO3 and citric acid as gas generating agent. Cilnidipine, an antihypertensive drug, with an oral bioavailability 13%, short half life (2.5 hr) and largely present in unionized form in acidic pH, have been designed to increase gastric residence time and therapeutic efficacy. This can be achieved by fabricating floating tablets which retain in stomach for prolonged time to release the drug. The tablets were formulated by direct compression method. The effect of sodium bicarbonate and citric acid on drug release profile and floating properties were investigated. The tablets were characterized for the pre and post compression parameters such as friability, hardness, thickness, drug content, weight variation, in-vitro buoyancy studies and in-vitro drug release studies and the results were within the limits. The in-vitro drug release studies were carried out in a USP type-II apparatus in 0.1N HCL. Among all the formulation (F1 to F9) prepared, batch F3 was the best formulation which showed buoyancy lag time 82 sec. and the tablet remained buoyant for >12 hr. The in-vitro drug release data is fitted in to different kinetic models and the best-fit was achieved with the zero order models. The optimized formulation F3 followed zero order release kinetics by non-fickian diffusion.

Keywords: Cilnidipine, HPMC K4M, Carbopol 934, Direct compression method.