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Key Technical Aspects Influencing the Accuracy of Tablet Subdivision

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Abstract

Tablet subdivision is a common practice used mainly for dose adjustment. The aim of this study was to investigate how the technical aspects of production as well as the method of tablets subdivision (employing a tablet splitter or a kitchen knife) influence the accuracy of this practice. Five drugs commonly used as subdivided tablets were selected. For each drug, the innovator drug product, a scored-generic and a non-scored generic were investigated totalizing fifteen drug products. Mechanical and physical tests, including image analysis, were performed. Additionally, comparisons were made between tablet subdivision method, score, shape, diluent composition and coating. Image analysis based on surface area was a useful tool as an alternative assay to evaluate the accuracy of tablet subdivision. The tablet splitter demonstrates an advantage relative to a knife as it showed better results in weight loss and friability tests. Oblong, coated and scored tablets had better results after subdivision than round, uncoated and non-scored tablets. The presence of elastic diluents such as starch and dibasic phosphate dehydrate conferred a more appropriate behaviour for the subdivision process than plastic materials such as microcrystalline cellulose and lactose. Finally, differences were observed between generics and their innovator products in all selected drugs with regard the quality control assays in divided tablet, which highlights the necessity of health regulations to consider subdivision performance at least in marketing authorization of generic products.

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ACKNOWLEDGMENTS

This research was supported by Brazilian agency FAP-DF project number 0193.001023/2015.

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Authors and Affiliations

  1. Laboratory of Food, Drugs and Cosmetics (LTMAC), University of Brasília (UnB), 70910-900, Brasília, DF, Brazil

    Maíra T. Teixeira, Taís Gratieri, Guilherme M. Gelfuso & Marcílio S. S. Cunha-Filho

  2. Faculty of Ceilândia, University of Brasília (UnB), 72220-900, Brasília, DF, Brazil

    Lívia C. L. Sá-Barreto & Izabel C. R. Silva

Authors
  1. Maíra T. Teixeira
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  2. Lívia C. L. Sá-Barreto
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  3. Taís Gratieri
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  6. Marcílio S. S. Cunha-Filho
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Correspondence to Marcílio S. S. Cunha-Filho.

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Teixeira, M.T., Sá-Barreto, L.C.L., Gratieri, T. et al. Key Technical Aspects Influencing the Accuracy of Tablet Subdivision. AAPS PharmSciTech 18, 1393–1401 (2017). https://doi.org/10.1208/s12249-016-0615-y

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  • DOI: https://doi.org/10.1208/s12249-016-0615-y

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