Review article
Breaking of scored tablets: a review

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Abstract

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 ease, 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%.

Introduction

Very recently, the European Pharmacopoeia (Ph.Eur.) [1] included a test on the subdivision of scored tablets, being the first Pharmacopoeia to do so. Therefore, it is now clear that badly performing score lines are a quality defect. This review summarises the literature on tablet score lines, focussing on their advantages and problems. Possibilities to overcome the problems associated with scored tablets are discussed. Finally requirements for the performance of score lines are proposed. The databases searched were Medline, Embase, Biosis, International Pharmaceutical Abstracts, Scisearch, Chemical Abstracts and the Derwent ringdoc files up to January 2001.

Section snippets

Advantages of scored tablets

The advantages of score lines are summarised in Table 1. Dose flexibility is the most important advantage of scored tablets. This was reported to be particularly important for tablets with a dose schedule that has to be dosed up or down, like for instance ACE-inhibitors [2]. In paediatrics and geriatrics, doses are used which may not be available in marketed strengths [3], [4], [5]. Footitt [3] considers for small dosage requirements a well breakable tablet preferable to a reformulation into a

Problems with scored tablets

Reported problems with scored tablets are difficulty of breaking, unequally breaking and loss of mass upon breaking, see Table 2.

Possibilities to overcome problems with scored tablets

Possibilities and limitations to cope with score line problems are shown in Table 2.

Requirements for breaking accuracy

Kristensen et al. [12] proposed requirements on mass uniformity of tablet parts: from 40 subdivided tablets with an average mass of up to 250 mg not more than four parts should deviate more than 15% of the average mass and none more than 30%. For subdivided tablets with an average mass of 250 mg and more, deviations of 10%, resp. 20% were proposed. The authors showed that about 50% of the investigated scored tablets would fail to meet these criteria. A Ph.Eur. draft monograph for the mass

Formulation aspects of score lines

Some tablets have been designed to be broken easily, e.g. the so-called ‘Snap-Tab’ tablets [2], [13]. Snap-Tabs are curved on one side, see Fig. 3 and a special breaking method should be used, see Fig. 1b. Oblong tablets appear to be better breakable than round tablets regarding breaking ease as well as uniformity of mass, also when using a splitter [4], [13], [19]. Spang [13] states that scored tablets should be at least of 8 mm diameter to be well manageable. This is in line with the finding

Breakability as a batch to batch release test of versus a development item

The EU Note for Guidance on Development Pharmaceutics suggests that accuracy of breaking is a development matter [36]. Also the inclusion of requirements for uniformity of mass of subdivided tablets under PRODUCTION in the monograph TABLETS of the Ph.Eur. indicates that this is a development parameter. However, Stimpel et al. [17] found for one brand that 86% of the tablets could be divided by hand, whereas 14% could not. This suggests that within one brand the breakability can differ, i.e.

Discussion

Scored tablets bring added value to solid dosage forms both with respect to their possibility for flexibility of dosing and for cost savings of medication. It may be worthwhile to quantitatively assess these advantages.

Most problems encountered with scored tablets come from bad functioning score lines. Although score lines can be designed to break well, not every patient will always be able to break a scored tablet himself, even with a very good score line design. However, the pharmacist has a

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    This paper does not necessarily reflect the opinion of the Medicines Evaluation Board in The Netherlands.

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