YAKUGAKU ZASSHI
Online ISSN : 1347-5231
Print ISSN : 0031-6903
ISSN-L : 0031-6903
ノート
エビデンスに基づく臨床製剤の品質管理:錠剤粉砕物を用いて調製した散剤の長期安定性の検討
堤 きく江土屋 千佳子花輪 和己鈴木 正彦花輪 剛久小口 敏夫
著者情報
ジャーナル フリー

2008 年 128 巻 6 号 p. 965-970

詳細
抄録

  Beraprost sodium (BPS) is often used for pediatric patients with pulmonary hypertension. The purpose of this study was to determine the expiration date of the powdered medicine prepared by grinding tablets. In the present study, the hygroscopicity and stability of the beraprost tablet (DORNER® tablet), ground Dorner tablet and powder formulation (Doener powder) consisting of the ground DORNER® tablet and lactose (EFC® lactose) were investigated after storage at various relative humidities (RHs) and light exposures. While the DORNER® tablets and ground DORNER® tablets were found to adsorb significant amounts of water vapor at an RHs of greater than 51.0%, Dorner powder scarcely adsorbed water. The stability of BPS in the Dorner powder decreased after storage under 3000 lux for 90 days. From these results, the expiration date and storage conditions of Dorner powder were determined to “90 days without exposure to light.” We also investigated the stability of BPS in solutions of various pH values on the assumption that Dorner powder may be given to pediatric patients after dissolving in soft drinks. Because BPS degraded significantly below pH 2, pharmacists should alert patients not to take Dorner powder with acidic soft drinks.

著者関連情報
© 2008 by the PHARMACEUTICAL SOCIETY OF JAPAN
前の記事 次の記事
feedback
Top