FORMULATION AND EVALUATION OF MUCOADHESIVE BUCCAL FILMS OF PROPRANOLOL FOR IMPROVED SYSTEMIC DELIVERY

Nirmal Puri*, Prof. Dr. Pankaj Kumar Sharma, Prof. Dr. Jaya Sharma, Ravisha Mathur

ABSTRACT

Propranolol hydrochloride is a non-selective beta-adrenergic receptor blocker widely prescribed for the management of hypertension, angina pectoris, cardiac arrhythmias, migraine prophylaxis, and anxiety disorders. However, its oral administration is associated with extensive first-pass hepatic metabolism, resulting in low and variable bioavailability of approximately 25–35%. Buccal drug delivery offers a promising alternative route by facilitating direct absorption through the buccal mucosa into the systemic circulation, thereby bypassing hepatic first-pass metabolism and improving therapeutic efficacy. The present study aims to formulate and evaluate mucoadhesive buccal films of propranolol hydrochloride for enhanced systemic drug delivery and improved patient compliance. Mucoadhesive buccal films were prepared using the solvent casting technique by incorporating suitable hydrophilic and mucoadhesive polymers such as hydroxypropyl methylcellulose (HPMC), Carbopol 934P, sodium carboxymethyl cellulose (NaCMC), or chitosan in different ratios. Appropriate plasticizers, including glycerol or polyethylene glycol 400 (PEG 400), were added to enhance flexibility and mechanical strength. The prepared films were evaluated for various physicochemical and pharmaceutical parameters, including appearance, thickness, weight uniformity, surface pH, folding endurance, tensile strength, percentage moisture absorption, moisture loss, swelling index, drug content uniformity, and in vitro residence time. Mucoadhesive strength was determined using suitable biological membranes, while in vitro drug release studies were performed using phosphate buffer (pH 6.8) to simulate buccal conditions. Ex vivo permeation studies were conducted using porcine or goat buccal mucosa to assess the drug permeation characteristics. Stability studies of the optimized formulation were carried out according to International Council for Harmonisation (ICH) guidelines.

Keywords: Propranolol Hydrochloride, Mucoadhesive Buccal Film, Buccal Drug Delivery, Systemic Drug Delivery, Bioavailability Enhancement, First-Pass Metabolism, Controlled Drug Release.