Zaid Abdel Naser, Ghoush Abeer Abu, Al-Ramahi Rowa', Are'r Mohammed
Department of Pharmaceutics and Pharmacokinetics.
PDA J Pharm Sci Technol. 2012 Jan-Feb;66(1):20-7. doi: 10.5731/pdajpst.2012.00791.
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.
The aim of this study was to evaluate whether there exists any difference between the European Pharmacopoeia (Ph. Eur.) and adopted United States Pharmacopeia (USP) methods to evaluate weight uniformity when drug tablets are split. 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 were obtained and divided. The split units were individually weighed and the relative standard deviation (RSD) of the split tablets for each product was calculated and then evaluated according to both methods. Twenty out of the 29 products tested failed the USP method, while 14 of them failed the Ph. Eur. method. Six products passed the Ph. Eur. test but failed the USP test because these products had an RSD greater than 6%. A clear difference can be seen between the pass/fail results of tablet splitting obtained by the two methods. The USP test showed that tighter measures are needed for products to pass the test. We recommend that the Ph. Eur. include the RSD parameter in it to make the method more rigorous. The USP is also recommended to include this adopted test as a specific test for scored tablet halves, not just for whole tablets. In the cases where the tablets failed either test, manufacturers should improve the quality of the produced scored tablets. Finally, using the same weight uniformity method by all pharmacopoeias is recommended.
本研究的目的是评估欧洲药典（Ph. Eur.）与采用的美国药典（USP）关于片剂掰开后半片重量均匀度测量的测试之间是否存在差异。USP方法中没有评估掰开片剂的规定，因此我们在此采用其整片重量均匀度方法。将29种不同的市售刻痕片剂（本地和进口）进行分割。分别称量分割后的片剂，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.重量均匀度测试进行评估。29种受试产品中有20种未通过USP测试，其中14种未通过Ph. Eur.测试。9种产品同时通过了USP和Ph. Eur.测试。6种产品通过了Ph. Eur.测试但未通过USP测试，所有这些产品的RSD均大于6%。随机选择的三种产品——100 mg胡萝卜素醇、50 mg胡萝卜素醇和2.5 mg劳拉西泮——掰开后半片的重量与含量之间的相关系数分别为0.986、0.998和0.72。两种药典的片剂分割方法在重量均匀度方面的结果存在明显差异。USP测试结果表明，需要更严格的措施才能通过测试。我们的结果表明，Ph. Eur.应修订现行的刻痕片剂重量均匀度测试，将RSD参数纳入其中。USP应将此采用的测试作为刻痕片剂半片的特定测试，而不仅仅是整片的测试。在某些情况下，制造商需要提高所生产刻痕片剂的质量，以便通过USP测试，特别是那些治疗指数较低的产品。最后，药典之间在掰开片剂重量均匀度测试方面的协调是必要的。
本研究的目的是评估欧洲药典（Ph. Eur.）与采用的美国药典（USP）方法在评估药物片剂掰开后的重量均匀度方面是否存在差异。USP方法中没有评估掰开片剂的规定，因此我们在此采用其整片重量均匀度方法。获取并分割了29种不同的市售刻痕片剂。分别称量分割后的片剂，计算每种产品分割后片剂的相对标准偏差（RSD），然后根据两种方法进行评估。29种受试产品中有20种未通过USP方法，其中14种未通过Ph. Eur.方法。6种产品通过了Ph. Eur.测试但未通过USP测试，因为这些产品的RSD大于6%。两种方法在片剂分割的通过/未通过结果方面存在明显差异。USP测试表明，产品需要更严格的措施才能通过测试。我们建议Ph. Eur.将RSD参数纳入其中，使方法更严格。还建议USP将此采用的测试作为刻痕片剂半片的特定测试，而不仅仅是整片的测试。对于未通过任何一项测试的片剂，制造商应提高所生产刻痕片剂的质量。最后，建议所有药典采用相同的重量均匀度方法。
