Formulation and evaluation of carvedilol fast dissolving sublingual films

Abstract

Carvedilol, a non selective beta blocker is an antihypertensive drug which has oral bioavailability of 25-35% with
conventional dosage forms due to first pass metabolism. The present study investigated the possibility of developing
carvdilol fast dissolving sublingual films allowing fast, reproducible drug dissolution in the oral cavity, thus bypassing
first pass metabolism to provide rapid onset of action of the drug. The fast dissolving films were prepared by solvent
casting method. Low viscosity grades of HPMC E3 and HPMC E5 were used as film forming polymers. In this study
Tween 80 was used as solubilising agent as well as plasticizer. All the film formulations (F1-F9) were evaluated for their
thickness, weight variation, tensile strength, percentage elongation, folding endurance, in-vitro disintegration, drug
content, in-vitro drug release and ex-vivo permeation studies. Disintegration time showed by the formulations was found
to be in range of 25-50 sec. Formulation F7 was chosen as the best formulation which showed 96.65% in-vitro drug
release within 5 min and 62.36% ex-vivo drug permeation within 60 min. The film showed an excellent stability at least
for 45 days when stored at 400 C and 75% relative humidity.