Abstract

FORMULATION AND EVALUATION OF BUCCOADHESIVE FILMS OF HYDRALAZINE HYDROCHLORIDE

Gamal M. Mahrous*

Abstract

The present study was an effort to develop a mucoadhesive buccal delivery system for hydralazine hydrochloride, a hypotensive agent that was formulated onto buccoadhesive films to overcome the limitations in the currently available dosage and routes of administration which in sequence will increase its bioavailability and patientsʼ compliance. Films were cast from aqueous solvents using various bioadhesive polymers namely: sodium carboxymethyl cellulose (CMC), hydroxypropylmethyl cellulose (HPMC) and Carbopol 934. The prepared films were subjected to investigations for their physical and mechanical properties, swelling behaviors, in vitro bioadhesion, in vitro drug release and drug permeation via bovine buccal mucosa. These properties were found to vary depending on the type of the polymers. Formula number F4 containing carbopol0.5% and HPMC 0.5% was found to be the best film as it shows good adhesion, acceptable pH, and gives a reasonable drug release (about 86 % at 6 h). The amount permeated through bovine buccal membrane reached about 17% after 6 hours.

Keywords: Hydralazine – Buccoadhesive – Swelling – Film casting – Tensile strength – In vitro release- Permeation.