Effect of ethanol on release behavior of glipizide controlled release tablets by HPLC

doi:10.19803/j.1672-8629.20230412

Abstract

Abstract: Objective To comparatively study the alcohol-induced dose dumping in glipizide controlled-release tablets from different manufacturers and their reference formulation according to the National Medical Products Administration (NMPA) guidelines. Methods The in vitro release of glipizide from generic and reference formulations at different concentrations of ethanol was examined using high-performance liquid chromatography (HPLC). Dissolution profiles were meticulously generated, and the relative change in the rate of dissolution due to ethanol was used as an index to assess its effect on drug release kinetics. Additionally, the similarity in in vitro release patterns across various formulations was quantitatively evaluated by calculating the similarity factor (f₂). Results It was observed that the in vitro release profiles of generic formulations and the reference formulation underwent minimal changes at ethanol concentrations of 5% and 20%, with a noticeable increase at 40% ethanol, much like the release observed in a hydrochloric acid medium without ethanol (f₂>50), indicating that the in vitro release behavior of the generic formulations closely paralleled that of the reference formulation. Conclusion The generic formulations meet the quality standards for consistency evaluation. Ethanol concentrations ranging from 0% to 40% do not significantly affect the in vitro release behavior of glipizide controlled-release tablets. The presence of hydrophilic excipients and the unique push-pull osmotic pump structure within the formulation may play critical roles in mitigating the risk of alcohol-induced dose dumping. These findings can help predict appropriate dosing and assess the safety risk associated with consuming glipizide alongside alcoholic beverages.

Key words: dose dumping, glipizide, controlled-release tablets, ethanol, high-performance liquid chromatography, dissolution profile, safety, reference formulation, generic formulation

CLC Number:

R917

SU Hai, ZAN Mengqing, NIU Jianzhao, MA Lingyun, LIU Qian. Effect of ethanol on release behavior of glipizide controlled release tablets by HPLC[J]. Chinese Journal of Pharmacovigilance, 2024, 21(6): 638-643.

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URL: https://www.zgywjj.com/EN/10.19803/j.1672-8629.20230412

https://www.zgywjj.com/EN/Y2024/V21/I6/638

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