The Stability of a Novel Carbapenem Antibiotic, Meropenem (SM-7338), in a Solid State Formulation for Injection
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概要
- 論文の詳細を見る
A formulation of meropenem, a novel carbapenem antibiotic for injection, was developed as a vial filled with a mixture of meropenem and dried sodium carbonate. During the design phase, we studied the effect of water in the formulation on the stability of meropenem in the solid state.Meropenem is obtained as trihydrate, whose moisture content is 12.35% and is nonhygroscopic. Dehydrated meropenem, whose moisture content was 3.4%, took up moisture quickly even under low humidity (33% RH). Also, the chemical stability of dehydrated meropenem was poor compared with that of untreated meropenem, which is quite stable. Degradation of meropenem by free water was considered as a possible cause of the poor stability. Degradation of meropenem due to liberation of its crystal water to free water was also observed when meropenem was micronized by pneumatic pulverization.Crystal water of meropenem was found to stay bound and to be almost inert in the formulation. Thus, meropenem injection formulation is stable for long time at room temperature.
- 社団法人日本薬学会の論文
- 1993-11-15
著者
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野口 哲男
Formulation Research Department Pharmaceutical Division Sumitomo Chemical Co. Ltd.
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野口 哲男
Research Center Sumitomo Pharmaceuticals Co. Ltd.
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竹内 洋文
50周年誌編集小委員会
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竹内 豊
Research Center, Sumitomo Pharmaceuticals Co., Ltd.,
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砂川 洵
Research Center, Sumitomo Pharmaceuticals Co., Ltd.,
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濱詰 ゆかり
住友製薬総合研究所製剤技術研究所
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竹林 淑明
Research Laboratories, Sumitomo Pharmaceuticals Co., Ltd.,
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五十部 穣
Formulation Development Department, Sumitomo Pharmaceuticals Co., Ltd.,
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浜詰 ゆかり
Formulation Development Department, Sumitomo Pharmaceuticals Co., Ltd.,
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上村 明
Formulation Development Department, Sumitomo Pharmaceuticals Co., Ltd.,
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浜詰 ゆかり
Research Center Sumitomo Pharmaceuticals Co. Ltd.
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Takeuchi Yoshikazu
Lab. Of Clinical Pharmaceutics Fac. Of Pharmaceutical Sciences Kobe Gakuin Univ.
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竹内 豊
Research Center Sumitomo Pharmaceuticals Co. Ltd.
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Isobe Y
Research Division Discovery Research Laboratories Ii Sumitomo Pharmaceuticals Co. Ltd.
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上村 明
Formulation Development Department Sumitomo Pharmaceuticals Co. Ltd.
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砂川 洵
Research Center Sumitomo Pharmaceuticals Co. Ltd.
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Takeuchi Y
Faculty Of Pharmaceutical Sciences Okayama University
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Yamaoka Takashi
Pharmacology Research Laboratories Dainippon Sumitomo Pharma Co. Ltd
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Takeuchi Y
Research Center Sumitomo Pharmaceuticals Co. Ltd.
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Isobe Y
Japan Energy Corp. Saitama Jpn
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五十部 穣
Research Center Sumitomo Pharmaceuticals Co. Ltd.
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竹林 淑明
Research Laboratories Sumitomo Pharmaceuticals Co. Ltd.
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