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KMID : 0380020170320020108
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Korean Journal of Biotechnology and Bioengineering
2017 Volume.32 No. 2 p.108 ~ p.116
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Stability Improvement of Esomeprazole Magnesium Dihydrate Enteric-Coated Tablet by Adding Alkalizing Agents
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Cho Young-Ho
Jeon Hyo-Bin
Lee Jong-Hwa
Lee Gye-Won
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Abstract
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Omeprazole, a benzimidazole derivative, suppresses gastric acid secretion by inhibiting H+/K+ ATPase in gastric parietals cells, and by reducing H+ concentration. To improve stability of esomeprazole magnesium dihydrate (ESMD), enteric-coated preperation was composed of core tablet, subcoating and enteric coating layer. We were evaluated in vitro dissolution characteristics between test and reference ESMD preparation and stability. We could prepare enteric-coated formulation of ESMD by controlling disintegrating agent and coating ratio which could rapidly dissolved in neutral or alkali medium. The formulation D5 with crospovidone of 1.25% and coating ratio of 16.25% had a similar dissolution behavior compare to reference preparation. Difference factor (f1) and similarity factor (f2) were 0~15 and 50~100 and there was no significant difference in bioequivalence between formulations. The content and dissolution rate of formulation D5 were 96.54±0.21 and 78.56±0.87% without change of color in accelerated condition (40oC, RH 75%, high density polyethylene (HDPE) container) for 6 months. This study concluded that our enteric coated preparation of ESMD could be an useful method to improve stability of unstable drug without direct contact with coating material.
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KEYWORD
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Alkalizing agent, Enteric coating, Esomeprazole Magnesium Dihydrate, Stability, High density polyethylene
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