技術報告
内服固形製剤の混合工程における含量の均一性に関するバリデーション
キーワード:
mixing process,
oral solid medicine,
validation,
content uniformity,
mixing time,
sampling method
2000 年 60 巻 3 号 p. 215-222
詳細
2000 年 60 巻 3 号 p. 215-222
We examined the mixing process of oral solid medicines and considered the method of validation for content uniformity: 1) the suitability of mixing time, 2) the mixing degree in the multi-step mixing processes and 3) the differences in sampling methods. The data were obtained from two manufacturing factories (Model I and Model II). Model I utilizes about one-step mixing operation for powder preparation, while Model II utilizes multi-step mixing processes required prior to tablet preparation. While the validation of manufacturing pharmaceutical preparations is generally invested in each manufacturer, the results of this study may offer useful information of the mixing operation of medicinal powders in terms of the mixing time, selection of container, and sampling tools.
