Review articleBreaking of scored tablets: a review☆
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.