Breaking of scored tablets: a review.

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%.