European Journal of Biomedical and Pharmaceutical Sciences

FORMULATION AND EVALUATION OF GLIBENCLAMIDE ORAL FAST DISSOLVING FILMS

Lakshmi Swapna Sai Mekapothula*, Jyothi Kamarajugadda, Keerthi Jenya Nettum, Gulshan Mohammad,
Rama Rao Nadendla.

ABSTRACT

The ultimate goal of any drug delivery system is the successful delivery of the drug, in which almost 90% of the drugs are administered to the body for the treatment of various disorders and diseases as it is regarded as the safest, most convenient and most economical method of drug delivery having the highest patient compliance. In this the drug is dissolved or swallowed and then enters into the systemic circulation to produce the desired effect. Despite of astounding advancement in drug delivery the oral route of drug administration is considered as the most important method of administration of drug for systemic effect because of self-medication, ease of administration and avoidance of pain compared to parenteral route. The aim of the present study is to formulate fast dissolving films of glibenclamide using HPMC K4M, propylene glycol as a plasticizer, tween 80 as a surfactant, peppermint oil as flavouring agent and aspartame as sweetening agent. Glibenclamide solid dispersion of PEG 6000 is dispersed in the polymer solution. Films are prepared by solvent casting method and found to satisfy the mouth dissolving time and other film parameters. 2 x 2 cm of film is required to be placed on to patient tongue. Film instantly gets wet by saliva, rapidly hydrates, adheres to tongue and rapidly disintegrates and dissolves to release the drug for the oro – mucosal absorption or allow for gastrointestinal absorption to be achieved when swallowed. The formulated films exhibited acceptable film endurance. Time required for the film to dissolve and release 26 seconds and 2 minutes respectively. It can be concluded from the study that the oro – flash release film can be a potential novel drug dosage form for poorly water – soluble drugs.

Keywords: Fast dissolving drug delivery, fast dissolving oral films (FDOFs), oral thin film (OTF), oro– flash release films, Glibenclamide, HPMC K4M, solvent casting oro-mucosal absorption, poorly water soluble drugs.