Formulation, Evaluation and Assessment of Bilayered Tablet of Candisertan Cilexetil Manufactured by Direct Compression Technique Quantitative Evaluation and Assessment

A Sustained-Release Drug Delivery System is specially designed to provide a drug in the human body at a predetermined and constant rate (zero order dissolution). The primary objective of sustained-release drug delivery is to ensure safety and to improve the efficacy of drugs as well as patient compliance. Conventional dosage forms are accused of repetitive dosing and unpredictable absorption windows that cause a wide range of fluctuations in drug concentration in the bloodstream and tissues with subsequent undesirable toxicity and poor therapeutic efficiency. Bi-layer tablet is suitable for the sequential release of two drugs in combination, separating two incompatible substances and also for sustained release tablets in which one layer is immediate release as the initial dose and the second layer is the maintenance dose. The goal of the present investigation was to formulate and evaluate bilayered tablets of Candisartan Cilexetil for an extended period of time. The tablets were prepared by using different polymers (Sodium Alginate, Ethyl Cellulose, HPMC K100M) in various proportions by using (Direct compression method technique). The tablets were evaluated for Angle of Repose, Bulk Density, Taped Density, Weight Variation, Thickness, Hardness, Friability, Determination of drug content, Scanning Fourier transform- infrared spectroscopic analysis (FT- IR), In vitro Disintegration time Studies, In-vitro drug release studies, Stability studies of tablets and ex-vivo residence time. Nine formulations were developed by using different polymers in different proportion. The formulation F7 shows an in vitrodrug release of 96.28% in 12 h along with satisfactory results. From the experimental results, it was concluded that F7 was the best formulation based on dissolution profile and physical characteristics. Formulation (F7) showed total drug release in 12 hours and showed fair flow properties when compared to other formulations.