Formulation and evaluation of carvedilol fast dissolving sublingual films


Volume :

4

Issue :

2

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.
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