The accuracy, precision and sustainability of different tec"hniques for tablet subdivision: Breaking by hand and the use of tablet splitters or a kitchen knife
The accuracy, precision and sustainability of different tec"hniques for tablet subdivision: Breaking by hand and the use of tablet splitters or a kitchen knife
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DOI：
10.1016/j.ijpharm.2014.02.031
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发表时间：
2014-05-15
影响因子：
5.8
通讯作者：
van den Bemt, Bart J. F.
中科院分区：
文献类型：
--
作者：
van Riet-Nales, Diana A.;Doeve, Myrthe E.;van den Bemt, Bart J. F.
简介：片剂经常被细分以降低剂量，以便于吞咽。G.儿童或老年人或节省成本。方法：采用手工碎药法、碎药器法、菜刀法三种碎药方法进行片剂的分碎。应用最佳病例药物（扑热息痛）、片剂（圆形、扁平、无包衣，500 mg）和操作员（24岁学生）。用手和以下每种类型的三种装置细分百片片剂：Fit & Healthy、Health Care Logistics、Lifetime、PillAid、PillTool、Pilomat片剂分割器; Blokker菜刀。研究了设备内和设备间的准确度、精密度和可持续性。结果：手撕片的准确度和精密度分别为104/97%。2.8/3.2%（每片考虑一个部件;部件右侧/左侧操作员）。劈裂装置的右/左准确度在60%和133%之间变化;精确度为4.0%和29.6%。器械在使用100次后未发生劣化。只有手破片剂符合所有的监管requires.Conclusion：卫生保健专业人员应该认识到，片剂分裂可能会导致不准确的剂量。主管部门应采取适当措施，确保片剂拆分器功能良好，并在可行的情况下减少其使用需求。(C)2014作者由ELSEVIERCOMPANY出版。这是CC BY许可下的开放获取文章（http：//creativecommons.org/licenses/by-nc-nd/3.0/）。
Introduction: Tablets are frequently subdivided to lower the dose, to facilitate swallowing by e. g. children or older people or to save costs. Splitting devices are commonly used when hand breaking is difficult or painful.Methods: Three techniques for tablet subdivision were investigated: hand breaking, tablet splitter, kitchen knife. A best case drug (paracetamol), tablet (round, flat, uncoated, 500 mg) and operator (24-year student) were applied. Hundred tablets were subdivided by hand and by three devices of each of the following types: Fit & Healthy, Health Care Logistics, Lifetime, PillAid, PillTool, Pilomat tablet splitter; Blokker kitchen knife. The intra and inter device accuracy, precision and sustainability were investigated. The compliance to (adapted) regulatory requirements was investigated also.Results: The accuracy and precision of hand broken tablets was 104/97% resp. 2.8/3.2% (one part per tablet considered; parts right/left side operator). The right/left accuracies of the splitting devices varied between 60 and 133%; the precisions 4.0 and 29.6%. The devices did not deteriorate over 100-fold use. Only hand broken tablets complied with all regulatory requirements.Conclusion: Health care professionals should realize that tablet splitting may result in inaccurate dosing. Authorities should undertake appropriate measures to assure good function of tablet splitters and, where feasible, to reduce the need for their use. (C) 2014 The Authors. Published by ELSEVIERCOMPANY. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by-nc-nd/3.0/).