Formulation and Evaluation of Controlled Release Formulations of Anti-Hypertensive Drugs Clevidipine

Abstract

The main objective of the Study was to develop the control release of the tablets of Clevidipine. A standard calibration curve was developed by measuring absorbance at 263 nm. Pre-formulation studies revealed similar bulk and tapped densities, with Carr’s index, Hausner’s ratio, and angle of repose (11.03° to 18.23°) confirming good flow properties. Post-formulation assessments demonstrated acceptable weight variation, tablet thickness (3.66 to 5.26 mm), hardness (5.89 to 6.98 kg/cm²), friability (<1.0%), and drug content (98% to 102%). In vitro dissolution studies showed significant drug release over 12 hours, with formulation F2 exhibiting the most favorable release profile. Kinetic analysis suggested non-Fickian diffusion mechanisms for formulation F2, with an "n" value between 0.45 and 0.89. FTIR spectroscopy confirmed no significant interactions between Clevidipine and the excipients, indicating successful molecular dispersion in the polymer matrix. This study established Clevidipine CR tablets with favorable physicochemical properties and release profiles, making them suitable for clinical use in blood pressure management.