Breaking of scored tablets: a review

被引:98
作者
van Santen, E
Barends, DM
Frijlink, HW
机构
[1] Natl Inst Publ Hlth & Environm, NL-3720 BA Bilthoven, Netherlands
[2] Univ Groningen, Dept Pharmaceut Technol & Biopharm, Groningen, Netherlands
关键词
scored tablets; score lines; breaking tablets; splitting tablets; subdivision of tablets; tablet-splitters;
D O I
10.1016/S0939-6411(01)00228-4
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The literature was reviewed regarding advantages, problems and performance indicators of score lines. Scored tablets provide dose flexibility, ease of swallowing and may reduce the costs of medication. However, many patients are confronted with scored tablets that are broken unequally and with difficulty, reducing compliance and reliance on the drug. Possibilities to reduce breaking difficulties are breaking instructions, tablet-splitters and breaking in advance. Factors influencing the performance of score lines are shape, size, curvature and thickness of the tablet and the form and deepness of the score line. Performance of score lines can be defined by breaking ease, uniformity of mass of subdivided tablets and loss of mass by the subdivision. For breaking case, an in-vivo reference test and a routinely applicable in-vitro test need to be established. For the uniformity of mass of subdivided tablets a requirement has recently been set by the European Pharmacopoeia. Loss of mass upon breaking can be limited to not more than 1%. (C) 2002 Elsevier Science B.V. All rights reserved.
引用
收藏
页码:139 / 145
页数:7
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