title: Key Technical Aspects Influencing the Accuracy of Tablet Subdivision.
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.
authors: Laboratory of Food, Drugs and Cosmetics (LTMAC), University of Brasília (UnB), 70910-900, Brasília, DF, Brazil.
authors: Maíra T
authors: MT
authors: Teixeira
authors: Faculty of Ceilândia, University of Brasília (UnB), 72220-900, Brasília, DF, Brazil.
authors: Lívia C L
authors: LCL
authors: Sá-Barreto
authors: Laboratory of Food, Drugs and Cosmetics (LTMAC), University of Brasília (UnB), 70910-900, Brasília, DF, Brazil.
authors: Taís
authors: T
authors: Gratieri
authors: Laboratory of Food, Drugs and Cosmetics (LTMAC), University of Brasília (UnB), 70910-900, Brasília, DF, Brazil.
authors: Guilherme M
authors: GM
authors: Gelfuso
authors: Faculty of Ceilândia, University of Brasília (UnB), 72220-900, Brasília, DF, Brazil.
authors: Izabel C R
authors: ICR
authors: Silva
authors: Laboratory of Food, Drugs and Cosmetics (LTMAC), University of Brasília (UnB), 70910-900, Brasília, DF, Brazil. marciliofarm@hotmail.com.
authors: Marcílio S S
authors: MSS
authors: Cunha-Filho
mesh_terms: D002482:Cellulose / Q000737:chemistry; D016568:Drugs, Generic; D007785:Lactose / Q000737:chemistry; D013607:Tablets / Q000737:chemistry*; D013678:Technology, Pharmaceutical
chemical_list: D016568:Drugs, Generic; D013607:Tablets; D002482:Cellulose; D007785:Lactose; C109691:microcrystalline cellulose
keywords: generic product; image analysis; score; tablet subdivision; tablets subdivision method