Formulation and Evaluation of Fast Dissolving Sublingual Films of Labetalol Hydrochloride

Fast dissolving sublingual film is the type of drug delivery systems which when placed in the sublingual cavity disintegrates or dissolves within few seconds due to presence of saliva in mouth. The present study was undertaken with the objective of formulating and evaluating fast dissolving sublingual films of Labetalol hydrochloride to enhance the patient convenience and compliance specifically elderly and paediatric patients. Fast dissolving sublingual films of Labetalol hydrochloride were prepared by solvent casting method using different concentrations of water-soluble film forming polymers such as HPMC K4M, HPMC and NaCMC. PEG 400 was used as plasticizer. Six formulations were prepared and evaluated for physicochemical parameters such as weight uniformity, thickness, surface pH, tensile strength, swelling index, drug content, disintegration time, in vitro dissolution studies and stability studies. All the formulations showed satisfactory results for the tested parameters. The formulation F3 containing 3wv of HPMC was found to show maximum drug release i.e., 97.711.18 at the end of 300 seconds and found to disintegrate in 191.24 seconds. Thus, fast dissolving sublingual films of Labetalol hydrochloride was an effective approach whenever immediate onset of action is required.