COMBINATIONAL THERAPY OF ROSUVASTATIN CALCIUM AND FENOFIBRATE AS BILAYER TABLET: A POTENTIAL APPROACH TO CONTROL HYPOLIPIDAEMIA

The present investigation studied a novel bilayer tablet having extended release of rosuvastatin calcium (RSTCa) and immediate Release of fenofibrate (FB) in different polymers using wet granulation techniques. Granules were characterized by fourier-transformed Infrared Spectroscopy (FT-IR), differential Scanning Calorimetry (DSC), as well as by content uniformity, in-vitro dissolution studies and release kinetics. Selected granular system was subjected to bilayer tablet preparation by direct compression. Compressed tablets were evaluated for drug content, weight variation, friability, hardness, thickness, %assay and in-vitro dissolution studies. Prepared tablets were then coated and coated bilayer tablets were evaluated for the same. Functional groups of RSTCa and FB were retained in respective granules, suggesting absence of chemical interaction with any of the excipients used in the preparation of granules. Absence of specific peaks in physical mixtures revealed that FB has been completely converted to molecular form. Among the polymers used to improve drug release, MCC and HPMC K4M showed better control over drug release.  Formulated bilayer tablets gave satisfactory results for various physicochemical evaluations and best fitted to Korsemeyer peppas and First-order model rate kinetics.  In – vitro study showed that optimized bilayer tablet formulation released immediate dose of FB and then sustained release of RSTCa for more than twelve hours. Stability studies conducted for optimized formulation did not show any change in physical properties, drug content, and in-vitro drug release. The present study concluded that bilayer tablets of FB and RSTCa can be used as an alternative to the conventional dosage form.