カプセル開封により調製した粉末製剤の安定性II : クロラゼプ酸二カリウムカプセル内容物の包装時における吸湿および変色に関する検討

概要

論文の詳細を見る
The hygroscopicity of the contents of clorazepate dipotassium (Mendon^<[○!R]>) capsule (CM) divided in packages made of polyethylene laminated glassine was investigated by storing the capsules at various relative humidities (RHs) The CM capsules were found to significantly absorb water vapor at an RH of more than 61.5%. The hygroscopicity of CM decreased after placing the CM capsules into air-tight containers, e.g., polyethylene laminated glassine. At the same time, a marked discoloration of CM was also observed during storage, in which the color changed from white to yellow. The discoloration of the CM capsules accelerated at high RH levels and after expose to fluorescent light. As a result, when Mendon^<[○!R]> capsules must be prepared in a powdered dosage form. CM should be stored below an RH of 31.3% and be protected from light to avoid any adsorption of water vapor and/or discoloration.
日本医療薬学会の論文
2000-06-10