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首页> 外文期刊>PDA journal of pharmaceutical science and technology >Evaluation of the discrepancy between the European pharmacopoeia test and an adopted United States pharmacopoeia test regarding the weight uniformity of scored tablet halves: Is harmonization required?
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Evaluation of the discrepancy between the European pharmacopoeia test and an adopted United States pharmacopoeia test regarding the weight uniformity of scored tablet halves: Is harmonization required?

机译：评估欧洲药典测试与美国采用的药典测试之间关于计分的片剂半份的重量均匀性之间的差异：是否需要统一？

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The aim of this study was to evaluate whether there exists any discrepancy between the European Pharmacopoeia (Ph. Eur.) and adopted United States Pharmacopeia (USP) tests concerning the weight uniformity measurements of tablet halves after splitting. The USP method does not contain provisions to evaluate split tablets, so here we adopt their whole tablet weight uniformity method. Twenty-nine different commercial scored tablets (local and imported) were divided. The split units were individually weighed and the relative standard deviation (RSD) for each product was calculated and then evaluated according to both the adopted USP and the Ph. Eur. tests of weight uniformity. Twenty out of the 29 products tested failed the USP test, while 14 of them failed the Ph. Eur. test. Nine products passed both the USP and Ph. Eur. tests. Six products passed the Ph. Eur. test but failed the USP test, with all of these products having an RSD greater than 6%. The correlation coefficient between the weight and content of split halves for three randomly selected products-corotenol 100 mg, corotenol 50 mg, and lorazepam 2.5 mg-was found to be 0.986, 0.998, and 0.72, respectively. A clear difference can be seen between outcomes obtained by the two compendial tablet splitting methods with regard to weight uniformity. Results from the USP test showed that tighter measures are needed to pass the test. Our results argue that the Ph. Eur. should revise the existing weight uniformity test on scored tablets to include the RSD parameter in it. The USP should include this adopted test as a specific test for scored tablet halves, not just whole tablets. Manufacturers in some cases will need to improve the quality of the produced scored tablets in order to pass the USP test, especially those with low therapeutic indices. Finally, harmonization between the pharmacopoeias regarding the weight uniformity testing of split tablets is warranted.
机译：这项研究的目的是评估欧洲药典（Ph。Eur。）和采用的美国药典（USP）测试之间是否存在关于片剂半份重量均匀性测量的差异。 USP方法不包含评估分割片剂的规定，因此这里我们采用其整体片剂重量均匀性方法。共划分了29种不同的商业评分片（本地和进口）。分别称量拆分单位的重量，计算每种产品的相对标准偏差（RSD），然后根据采用的USP和Ph.Eur进行评估。重量均匀性测试。在测试的29种产品中，有20种未通过USP测试，而其中14种未通过Ph.Eur测试。测试。九种产品通过了美国药典和欧洲药典认证。测试。有六种产品通过了欧洲博士学位。测试，但未通过USP测试，所有这些产品的RSD均大于6％。三种随机选择的产品（可乐宁醇100 mg，可乐宁醇50 mg和劳拉西m 2.5 mg）的重量和两半含量的相关系数分别为0.986、0.998和0.72。在重量均匀度方面，可以看到两种药典片剂拆分方法获得的结果之间存在明显差异。 USP测试的结果表明，通过测试需要采取更严格的措施。我们的研究结果表明，欧洲博士。应该修改刻痕片剂的现有重量均匀性测试，以在其中包含RSD参数。 USP应将此采用的测试作为对计分的片剂半数的特定测试，而不仅仅是整个片剂。在某些情况下，制造商将需要提高生产的计分片剂的质量，以通过USP测试，尤其是那些治疗指数较低的片剂。最后，必须保证药典之间就分割片剂的重量均匀性测试进行协调。

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