Design and Evaluation of Instant Release Buccal Films of Empagliflozin: A Statistical Approach

The buccal cavity may serve as a promising area to deliver the drug instantly. The route of drug administration helps to bypass the first-pass effect and hence to increase the drug bioavailability. Different types of dosage forms are available to deliver the drug through this route, and among them, instant release buccal films are of great interest when the rapid release of the drug and faster onset of action are required. This current study aimed to implement a statistical approach, Central Composite Rotatable Design (CCRD) to design and optimize immediate release buccal films of empagliflozin. HPMC E-5 and PVP K-30 were used as polymers, PEG 400 was used as a plasticizer, and Tween 80 was used as a surfactant. The drug was physically complexed with β-cyclodextrin to form a homogeneous mixture of the drug and other excipients. The films were prepared using an easy approach of the solvent casting method, followed by their physicochemical characterizations. The dissolution and permeation studies have been conducted using the USP-Dissolution apparatus II and Franz diffusion cell, respectively. The outcomes of the studies have suggested that the films were of uniform thickness and smooth texture and transparent in nature and exhibited good mechanical strength. The disintegration and dissolution tests assured rapid disintegration and dissolution of the films, leading to immediate release (approximately 90% within 10 min) of the drug, leading to rapid absorption and faster onset of action. The optimized formulation met all of the required parameters, ensuring reproducibility. Overall, the results concluded that the empagliflozin-β-cyclodextrin complex produced buccal films with good mechanical strength, uniform morphology, and immediate drug release via the buccal mucosa, fulfilling the study's objectives.