Formulation and Evaluation of Mucoadhesive Buccal Films of Glimepiride Using HPMC–Carbopol Polymer Blend for Enhanced Drug Release and Patient Compliance
Keywords:
Glimepiride, Mucoadhesive Buccal Films, HPMC K15M, Carbopol 934P, Buccal Drug Delivery, Solvent Casting Technique, Drug Release KineticsAbstract
The present study aimed to formulate and evaluate mucoadhesive buccal films of Glimepiride using a polymer blend of Hydroxypropyl Methylcellulose (HPMC K15M) and Carbopol 934P for enhanced drug release and improved patient compliance. Glimepiride, a third-generation sulfonylurea antidiabetic drug, exhibits limitations such as poor aqueous solubility and first-pass metabolism, which may reduce its therapeutic effectiveness following conventional oral administration. Buccal drug delivery was selected as an alternative route to bypass hepatic first-pass metabolism and improve systemic bioavailability. Mucoadhesive buccal films were prepared by solvent casting technique using HPMC K15M, Carbopol 934P, Polyvinyl Alcohol (PVA), and Chitosan. Prepared formulations were evaluated for physicochemical properties including thickness, weight variation, folding endurance, surface pH, drug content, tensile strength, percentage elongation, mucoadhesive strength, swelling index, and in-vitro drug release. Drug–excipient compatibility studies were performed using Fourier Transform Infrared Spectroscopy (FTIR) and Differential Scanning Calorimetry (DSC). Ex-vivo permeation studies were conducted using goat buccal mucosa and Franz diffusion cell. Stability studies were carried out under accelerated conditions according to ICH guidelines. Among all formulations, formulation F6 exhibited optimum physicochemical and mechanical properties, high mucoadhesive strength, controlled swelling behavior, and sustained drug release profile. Drug release kinetics followed the Korsmeyer–Peppas model, indicating a non-Fickian diffusion mechanism. Stability studies confirmed the stability of the optimized formulation under accelerated storage conditions.The study concluded that mucoadhesive buccal films of Glimepiride prepared using HPMC–Carbopol polymer blend offer a promising alternative to conventional oral dosage forms by improving drug release characteristics, reducing dosing frequency, and enhancing patient compliance.
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