Drug development and industrial pharmacy · 2025
Polymeric oral fast dissolving films of metformin: fabrication, optimization, in vitro, and in vivo evaluation.
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Imtiaz Malik Muhammad, Rashid Sheikh Abdur, Naseem Faiza, Khan Nauman Rahim, Ullah Kalim, Khan Muhammad Khalid, Shah Pervaiz Akhtar, Butt Farooq Bashir, Riaz Amina, Alzahrani Khalid J, Alsharif Khalaf F, Azad Abul Kalam
Аннотация
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 in plasma of rats treated with optimized formulation (MF7) as compared to those administered with metformin intragastric solution (Student t-test, p < .05).
CONCLUSION: Results cemented a very rapid disintegration and dissolution of OFDF, suggesting a promising substitute to enhance patient adherence and reduce metformin onset time in treating PCOS.
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 in plasma of rats treated with optimized formulation (MF7) as compared to those administered with metformin intragastric solution (Student t-test, p < .05).
CONCLUSION: Results cemented a very rapid disintegration and dissolution of OFDF, suggesting a promising substitute to enhance patient adherence and reduce metformin onset time in treating PCOS.