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Materials 2017, 10(7), 845; doi:10.3390/ma10070845

On Identification of Critical Material Attributes for Compression Behaviour of Pharmaceutical Diluent Powders

Department of Chemical and Process Engineering, University of Surrey, Guildford GU2 7XH, UK
School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou 510006, Guangdong, China
Author to whom correspondence should be addressed.
Received: 6 April 2017 / Revised: 14 June 2017 / Accepted: 20 July 2017 / Published: 23 July 2017
(This article belongs to the Special Issue Materials for Drug Delivery and Biomedical Consideration)
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As one of the commonly-used solid dosage forms, pharmaceutical tablets have been widely used to deliver active drugs into the human body, satisfying patient’s therapeutic requirements. To manufacture tablets of good quality, diluent powders are generally used in formulation development to increase the bulk of formulations and to bind other inactive ingredients with the active pharmaceutical ingredients (APIs). For formulations of a low API dose, the drug products generally consist of a large fraction of diluent powders. Hence, the attributes of diluents become extremely important and can significantly influence the final product property. Therefore, it is essential to accurately characterise the mechanical properties of the diluents and to thoroughly understand how their mechanical properties affect the manufacturing performance and properties of the final products, which will build a sound scientific basis for formulation design and product development. In this study, a comprehensive evaluation of the mechanical properties of the widely-used pharmaceutical diluent powders, including microcrystalline cellulose (MCC) powders with different grades (i.e., Avicel PH 101, Avicel PH 102, and DG), mannitol SD 100, lactose monohydrate, and dibasic calcium phosphate, were performed. The powder compressibility was assessed with Heckel and Kawakita analyses. The material elastic recovery during decompression and in storage was investigated through monitoring the change in the dimensions of the compressed tablets over time. The powder hygroscopicity was also evaluated to examine the water absorption ability of powders from the surroundings. It was shown that the MCC tablets exhibited continuous volume expansion after ejection, which is believed to be induced by (1) water absorption from the surrounding, and (2) elastic recovery. However, mannitol tablets showed volume expansion immediately after ejection, followed by the material shrinkage in storage. It is anticipated that the expansion was induced by elastic recovery to a limited extent, while the shrinkage was primarily due to the solidification during storage. It was also found that, for all powders considered, the powder compressibility and the elastic recovery depended significantly on the particle breakage tendency: a decrease in the particle breakage tendency led to a slight decrease in the powder compressibility and a significant drop in immediate elastic recovery. This implies that the particle breakage tendency is a critical material attribute in controlling the compression behaviour of pharmaceutical powders. View Full-Text
Keywords: pharmaceutical materials; diluent powder; mechanical property; compressibility; particle arrangement; elasticity; hygroscopicity pharmaceutical materials; diluent powder; mechanical property; compressibility; particle arrangement; elasticity; hygroscopicity

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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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Zhang, J.; Wu, C.-Y.; Pan, X.; Wu, C. On Identification of Critical Material Attributes for Compression Behaviour of Pharmaceutical Diluent Powders. Materials 2017, 10, 845.

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