Chinese Journal of Pharmacovigilance ›› 2014, Vol. 11 ›› Issue (7): 394-397.

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Full-factorial Design for Optimizing Formulation of Metformin Hydrochloride Extended-release Tablets and Investigation of Release Mechanism in Vitro

CHEN Ye-ming1, ZHOU Zhi-liang2, ZHANG Xue-nong1, *, LI Xian-jun2   

  1. 1Soochow University, Jiangsu Suzhou 215123,China;
    2Runze Pharmaceutical Co.Ltd, Jiangsu Suzhou 215126, China
  • Received:2016-02-03 Revised:2016-02-03 Online:2014-07-08 Published:2016-03-02

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Abstract: ObjectiveTo obtain an optimized formulation of metformin hydrochloride extended-release tablets, and investigate the release mechanism of the optimized formulation. MethodsMetformin hydrochloride extended-release tablets were prepared by high shear wet granulation route. The formulation was optimized using full-factorial design by Design Expert software. Responses were measured in this study, including the f2 factor of drug release profiles in vitro and the cumulative release percentages of 10 hours(Q10). The release mechanism of optimized formulation was investigated. ResultsOptimal prescription contained metformin hydrochloride 100 g, chitosan 2.5 g, HPMC(K100 M)47.5 g, magnesium stearate 1.5 g. The predicted value of deviation was less than 4%. The drug release followed the first-order kinetics, via mechanism of Fickian diffusion. ConclusionFull-factorial design by Design Expert software is an effective and feasible method for screening metformin hydrochloride extended-release tablets formulation. The drug release follows the mechanism of Fickian diffusion.

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