一般論文
標準処方における造粒法と含量均一性―流動層造粒法―
キーワード:
standard formulation,
fluidized bed granulation,
content uniformity,
blend uniformity,
particle size
2003 年 63 巻 4 号 p. 218-227
詳細
2003 年 63 巻 4 号 p. 218-227
We investigated the content and blend uniformity of drugs in granules and tablets made by the fluidized bed-granulation method using three active ingredients, ascorbic acid, ethenzamide and acetaminophen, as model drugs. They were used at concentrations of 0.1% and 1%, with lactose/corn starch in a 7/3 mixture and hydroxypropylcellulose as the standard formulation, as recommended by the Standard Formulation Research Association. Consequently, good content uniformity was confirmed for all three model drugs under suitable manufacturing conditions in this study. However, care must be taken when the particles of active ingredients are fine, because the loss of drugs by passing through the bag-filter or adhering to the wall of the granulator during the granulation process is possible.
