FORMULATION AND EVALUATION OF MOUTH DISSOLVING FILMS OF LOSARTAN POTASSIUM USING 32 FACTORIAL DESIGN

The objective of the present study was to develop mouth dissolving films (MDF) of Losartan potassium for the treatment of hypertension, with fast disintegration, optimum morphological properties, and mechanical strength. Losartan is an anti-hypertensive drug which undergoes extensive first-pass metabolism that results in low bioavailability of the drug. Through buccal route, the drug directly enters blood circulation and hence bioavailability of the drug increases. Hydroxypropylmethyl-cellulose, sodium carboxymethylcellulose, sodium alginate, and gelatin were used as the hydrophilic film-forming polymeric bases and glycerol as plasticizer. Films were prepared by solvent casting technique. Parameters like in-vitro disintegration time, tensile strength, content uniformity, folding endurance, swelling index, and in-vitro drug release were evaluated. 3² factorial design was used to optimize the amounts of the polymer and the plasticizer. In-vitro dissolution studies showed that 99% of Losartan potassium was released within 5 min with an average disintegration time of 38 sec. UV and FTIR spectrophotometry were used to identify drug-excipient interactions. Accelerated stability studies were performed as per ICH guidelines wherein the MDFs were stable for 2 months at 40 ± 2 °C and 75 ± 5% relative humidity.