Abstract

Aloka Sampath Piyasena*, M. A. Siriwardhene, Pubuduni Dantanarayana and W. Pathirana

ABSTRACT

Performance assessment of tablet division using break lines has evaded at all levels by the personnel involved in the drug industry. No test for the measurement of tablet divisibility strength is available. Specifications for the divided parts of a tablet in the European Pharmacopoeia are not implemented by the industry. Studies are wanting on the performance of tablet division in the hands of consumers, many of whom are senior citizens with multiple morbidities. In this study experiments were designed in relation to divisibility contributing parameters of a tablet. New attachment part, the Tablet Divisibility Chuck was designed to be fitted in to the electronic tablet hardness tester facilitating the measurement of the new parameter, the Tablet Divisibility Strength. The availability of this quantified test will greatly facilitate the industry to monitor and address the tablet divisibility issues. A model ‘tablet divisibility dash board’ displaying all of the tablet divisibility contributing parameter was introduced. It facilitates the industry to manipulate the multiple parameters associated with the tablet divisibility to favorable values. In the tableting operation, the compression pressure adjustment together with excessive pressure release mechanism should be judiciously fine- tuned with tablet divisibility in mind. The Tablet Divisibility Strength and the pharmacopoeia Uniformity of Weight requirements for the divided tablet parts should be an integral part of a tablet product dossier. Since an acceptable validated tablet divisibility strength of a given product is both mechanical and community based, it has a good prospect of replacing the current tablet hardness test.