Formulation and invitro evaluation of bisprolal fumarate as buccal films

Abstract

Bisoprolol is a drug belonging to the group of beta-blockers, a class of medicines used primarily in cardiovascular diseases. More specifically, it is a selective type β1 adrenergic receptor blocker. The U.S. Food and Drug Administration (FDA) approved an application by Duramed Pharmaceutical for Zebeta Oral Tablets (bisoprolol fumarate) as a new molecular entity on July 31, 1992. In current work buccal drug delivery of Bisoprolol was developed to overcome the first pass metabolism and to reduce frequency of dosing compared to oral route. buccal patches was prepared  by using polymers Eudragit-L100, HPMCk4M and HPMCk15M. by employing solvent casting method. Propylene glycol and Tween80 were selected as permeation enhancer and plasticizer. all the formulations prepare (F1-F9)were evaluated for various physical parameters Physical appearance, Flatness, Weight variation, Thickness, Folding endurance, Drug content, Moisture uptake, Moisture content and Swelling study and all the results were found to be were found to be with in the pharmacopeial limits, invitro drug release studies by using dialysis membrane. Among all the 9 formulations F6 formulation which contain HPMC K4M 300mg and Eudragit L -100 60mg had shown 94% cumulative drug release with in 12 hours. And compared to HPMC K15M, HPMC K4M showed better drug release profile. Drug excipient compatibility studies were carried out by using FTIR, and it was observed that there were no interactions.