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JOURNAL OF ASIAN ASSOCIATION OF SCHOOLS OF PHARMACY - Volume 8, January - December, 2019

Pages: 7-14

Date of Publication: 30-May-2019


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The effect of tablet splitting on the mass loss, uniformity, and stability: by hand or splitter?

Author: Sil Seong , Ju-Young Shin , Daejin Kim, Inmyung Song, Sangouk Sun, Inok Kim, Sun-Kyeong Park, Dongmun Ha

Category: Pharmacy

Abstract:

This study aimed to analyze and compare differences by split methods for scored tablets of different strengths and shapes. Five tablets with different strengths were subdivided using splitter, and by hand. The loss of weight, friability, the uniformity of dosage units, and stability were tested for whole tablets and tablets broken by hand and a splitter. All drug products showed greater weight loss and friability and smaller uniformity of dosage when broken by hand compared with the splitter. One mg tablets broken by hand and 8 and 16 mg rounded tablets subdivided by both hand and splitter did not satisfy content uniformity. All the products, except 8 and 16 mg rounded tablets, met the stability test criteria. Tablet subdividing by splitter is more appropriate, and these trends were more pronounced for nonrounded tablets with low strength. Hence, the lower-strength tablets require subdividing by a splitter.

Keywords: splitting tablet, split methods, weight loss, content uniformity, stability