AI Article Synopsis

  • - This study utilized advanced synchrotron-based X-ray imaging to explore the drying process of individual pharmaceutical granules during tablet manufacturing, overcoming challenges in quantifying internal changes through traditional methods.
  • - Two excipients, lactose monohydrate and microcrystalline cellulose, were tested both alone and in combination with active ingredients acetaminophen and carbamazepine, focusing on how moisture content affected drying properties.
  • - Findings indicated that drying time and composition significantly affect pore volume and moisture removal, while active ingredient nature (hydrophilicity vs. hydrophobicity) plays a crucial role in the drying behavior of certain mixtures, particularly influencing acetaminophen more than carbamazepine.

Article Abstract

Drying time, velocity, and temperature are important aspects of the drying process for pharmaceutical granules observed during tablet manufacturing. However, the drying mechanism of single granules is often limited to modelling and simulation, with the internal and physical changes difficult to quantify at an experimental level. In this study, in-situ synchrotron-based X-ray imaging techniques were used for the first time to investigate the dynamic drying of single pharmaceutical granules, quantifying internal changes occurring over the drying time. Two commonly used excipients (lactose monohydrate (LMH) and microcrystalline cellulose (MCC)) were used as pure components and binary mixtures with one of either two active pharmaceutical ingredients of differing hydrophilicity/hydrophobicity (acetaminophen (APAP) and carbamazepine (CBZ)). Water was used as a liquid binder to generate single granules of 25 % to 30 % moisture content. Results showed that for most samples, the drying time and composition significantly influences the pore volume evolution and the moisture ratio, with the velocity and temperature of the drying air possessing mixed significance on increasing the rate of pore connectivity and moisture removal depending on the sample composition. Effects of active ingredient loading resulted in minimal influence on the drying of CBZ and generated binary mixtures, with APAP and its respective mixtures' drying behaviour dominated by the material's hydrophilic nature.

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http://dx.doi.org/10.1016/j.ijpharm.2024.124664DOI Listing

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