Polymeric oral fast dissolving films of metformin: fabrication, optimization, in vitro, and in vivo evaluation
Abstract
Abstract Background Metformin is gold standard for polycystic ovary syndrome (PCOS), but associated with gastrointestinal side effects, leading to poor patient adherence. Present oral fast-dissolving films (OFDFs) offer rapid disintegration, improving drug delivery, therapeutic outcomes, and patient compliance. Objective This project aimed to fabricate metformin-loaded OFDFs to enhance patient compliance and drug efficacy in treatment of PCOS. Methods Metformin-loaded OFDFs were prepared using solvent casting method with hydroxypropyl methylcellulose (HPMC) and gelatin as film-forming polymers and propylene glycol as a plasticizer. The Box–Behnken experimental design was utilized for optimization. Various physico-chemical characterization tests, including thickness, weight, folding endurance, percent elongation, water content, and moisture uptake, were conducted. In vitro drug release, disintegration time, and mechanical strength were analyzed. Additionally, a pharmacokinetic study in rats was conducted to compare plasma concentrations of optimized formulation with those of metformin intragastric solution. Results A stable drug-loaded formulations with a uniform surface and an amorphous nature of drug were prepared in OFDFs. The optimized formulation demonstrated significant drug release at 5 min (98.9%), a rapid disintegration time (19.2 sec), and good mechanical strength (7.4 MPa) (ANOVA, p < .05). Furthermore, increased values of Cmax as well as AUC0-t were also observed…
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