Abstract

TABLET SPLITTING AND DOSAGE UNIFORMITY ISSUES: A REVIEW

Hemangi Parekh, Jitesha Patel, Parth Patel and Rajashree Mashru*

ABSTRACT

Tablet splitting provides variety of reason such as dose flexibility, ease of swallowing and may minimize the costs of medication. There are risks associated with this process like breaking difficulty, loss of mass, unequal part of tablet. Patient characteristics and medication characteristics are main two type of factor which influence dosage uniformity of split tablet. Patient may experience difficulty in splitting tablet especially if their dexterity, cognitive or eyesight is impaired. And tablet related factor include inaccuracy in splitting, degradation of drug as result of exposure to air, alteration in dissolution rate, size, shape, thickness and depth of groove of tablet. FDA introduced draft guidance on tablet scoring to advise manufacturers in order to provide criteria needed to support applications for scored tablet. The splitting can be typically achieved by manually using hand or mechanically using tablet splitter. Accuracy of scored tablet can be assured by weight variation method, dose uniformity and assay. In this review, author have compiled information from currently available literature on tablet splitting.

Keywords: Tablet splitting, Weight variation, Dosage uniformity, Score tablet, Assay.