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KMID : 0043320160390040508
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Archives of Pharmacal Research
2016 Volume.39 No. 4 p.508 ~ p.515
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The solid state of rebamipide: preparation, characterization, and dissolution
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Jeon Seong-Hyeon
Sohn Young-Taek
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Abstract
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Rebamipide is marketed as a peptic ulcer agent under the trade name MucostaR. The objective of this work was to investigate the existence of polymorphs and pseudopolymorphs of rebamipide. Two crystal forms of rebamipide were isolated by recrystallization and characterized by differential thermal analysis (DTA), thermogravimetric analysis (TG), powder X-ray diffractometry, infrared spectrometry, and nuclear magnetic resonance. The DTA curve of Form 1 showed one endothermic peak at 305.2 °C, and that of Form 2 showed one endothermic peak at 307.3 °C. The TG curve of Form 1 showed a single weight loss at 305.2 °C, which corresponded to melting. The TG curve of Form 2 also showed a single weight loss at 307.3 °C, which corresponded to melting. The melting point of Form 2 was higher than that of Form 1. In the dissolution studies in pH 6.8 buffer at 37 ± 0.5 °C, the two crystal forms showed no significant differences in dissolution. After 3 months of storage at 0, 52, and 95 % RH, the two crystal forms were not transformed. After milling with a Specamill for 2 h, the two crystal forms were not transformed.
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KEYWORD
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Rebamipide, Crystal form, DTA, PXRD, Dissolution, Transformation
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