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Breaking of scored tablets: a review
E van Santen1, D M Barends, H W Frijlink
1National Institute of Public Health and the Environment, Bilthoven, The Netherlands.
Summary
Scored tablets offer dose flexibility but can break unevenly, impacting patient compliance. Improving score line design and using tools like tablet splitters can enhance tablet breaking performance.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
Background:
- Scored tablets offer advantages like dose flexibility and ease of swallowing.
- However, uneven breaking can lead to reduced patient compliance and drug efficacy.
Purpose of the Study:
- To review the advantages, problems, and performance indicators of score lines on tablets.
- To identify factors influencing score line performance and methods to improve tablet breaking.
Main Methods:
- Literature review on scored tablet properties and patient-reported issues.
- Analysis of factors affecting score line performance (tablet shape, size, score depth).
- Evaluation of methods to improve tablet breaking (instructions, splitters, pre-breaking).
Main Results:
- Scored tablets can be difficult to break uniformly, affecting medication reliability.
- Tablet characteristics and score line design significantly influence breaking performance.
- Breaking ease, mass uniformity, and mass loss are key performance indicators.
Conclusions:
- Optimizing score line design and utilizing breaking aids can improve tablet subdivision.
- Standardized testing methods (in-vivo and in-vitro) are needed to assess breaking ease.
- European Pharmacopoeia has set standards for mass uniformity of subdivided tablets, with mass loss ideally below 1%.