Formulation Development and Evaluation of Taste Masked Oral Disintegrating Films of Atenolol by Using Natural Polymers

Abstract

Fast dissolving/disintegrating films/tablets have received ever-increasing demand during the last decade, and the field has become a rapidly growing area in the pharmaceutical area. Particularly the fast dissolving drug delivery systems formulated with natural polymers have more demand because natural materials like gums and mucilages have been extensively used in the field of drug delivery for their easy availability, ease administration, non toxicity, non irritant nature etc. Atenolol is β1-selective adrenergic blocking agent and widely used in the treatment of hypertension and angina pectoris. It has a bioavailability of 40-50%. The main objective of the study was to formulate taste masked oral fast disintegrating films of Atenolol to achieve a better dissolution rate by improving the bioavailability of the drug and providing quick onset of action thereby enhancing patient compliance. Oral FDF prepared by solvent casting method using water and 95% ethanol as solvents and HPMC as film forming polymer. PEG 400 was the selected plasticizers, Natural and synthetic superdisintegrants such as croscarmellose sodium (CCS), sodium starch glycolate (SSG) and fenugreek mucilage alone and also in combinations was incorporated to achieve quick onset of action, is to increase the water uptake with in shortest wetting time and there by decrease the disintegration time. The prepared films were evaluated for the drug content, weight variation, film thickness, disintegration time, folding endurance, percentage of moisture content and in vitro dissolution studies and taste mask studies on healthy human volunteers. Among all, the formulation F5 was found to be best formulation which releases 98.89% of the drug within 15 min and disintegration time is 59 sec. which was significantly high when compared to other formulation. When the regression coefficient values compared, it was observed that ‘r’ values of formulation F5 was maximum i.e 0.890 hence indicating drug release from formulations was found to follow zero order drug release kinetics.