The Study of the Applicability of Content Uniformity and Weight Variation Test : The State of Commercial Tablets and Capsules in Japan

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概要

• 論文の詳細を見る

• This study intends to determine the rational criteria (e.g., threshold value) for applying the weight variation test and to investigate the adequacy of the acceptance value for existing commercial products in Japan. The studied products were 489 lots (3 lots×163 products) of compressed tablets (plain, film-coated, sugar-coated) and 42 lots (3 lots×14 products) of hard capsules marketed in Japan. The individual drug content and the weight of 10 units in a lot were determined for each product and the acceptance values were calculated according to the Japanese Pharmacopoeia thirteenth edition (JP13) Content Uniformity Test (M=100.0, k=2.2). Product-specificintra-lot relative standard deviation of content (RSD_D), weight (RSD_W) and concentration (RSD_C) were calculated by analysis of variance (ANOVA) using three lots of data per product. The RSD_D and RSD_C tended to increase with the decrease of the label strength for plain tablets, but not for film-coated and sugar-coated tablets, and hard capsules. A good correlation was found between RSD_D and RSD_C but not between RSD_D and RSD_W. These findings indicate that 1) it is difficult to rationally set the threshold level for weight variation, especially regarding the dosage forms except for plain tablets, 2) the application of weight variation tests should, in principle, be deciede on the mixing homogeneity that is RSD_C. 3) Most (99.6%) of the tablets and all the capsules investigated met the requirement of content uniformity test of JP13. Therefore the criteria of the JP13 content uniformity test are considered acceptable from the viewpoint of manufacturing capability.

• 公益社団法人日本薬学会の論文
• 2001-11-01

著者

• Nishio Kazuto

  Shien-laboratory National Cancer Center Hospital

• Aoyagi Nobuo

  National Institute Of Health Sciences

• Aoyagi Nobuo

  国立医薬品食品衛生研究所

• Aoyagi N

  National Institute Of Health Sciences

• Kojima Shigeo

  National Institute Of Health Sciences

• KATORI Noriko

  National Institute of Health Sciences

• Kojima S

  National Institute Of Health Sciences

• Katori N

  National Cancer Center

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