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Open AccessArticle

Application of Box–Behnken Design to Investigate the Effect of Process Parameters on the Microparticle Production of Ethenzamide through the Rapid Expansion of the Supercritical Solutions Process

Department of Chemical Engineering and Biotechnology, National Taipei University of Technology, Taipei 10608, Taiwan
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Pharmaceutics 2020, 12(1), 42; https://doi.org/10.3390/pharmaceutics12010042 (registering DOI)
Received: 10 November 2019 / Revised: 25 December 2019 / Accepted: 28 December 2019 / Published: 3 January 2020
(This article belongs to the Special Issue Supercritical Fluid and Pharmaceutical Applications)
In this study, the rapid expansion of the supercritical solutions (RESS) process was used to produce microparticles of a commonly used anti-inflammatory drug, ethenzamide. The effects of process parameters in RESS including the extraction temperature, pre-expansion temperature, and post-expansion temperature were investigated using the Box–Behnken design. According to the results of the analysis of variance (ANOVA), the effect of pre-expansion temperature is the most significant parameter on the mean size of RESS-produced ethenzamide. A higher pre-expansion temperature benefits the production of smaller crystals. In addition, a quadratic effect of the post-expansion temperature was also identified. Through RESS, ethenzamide microparticles with a mean size of 1.6 μm were successfully produced. The solid-state properties including the crystal habit, crystal form, thermal behavior, and spectrometric property were characterized by scanning electron microscopy (SEM), Fourier-transform infrared spectrometer (FTIR), differential scanning calorimeter (DSC), and powder X-ray diffraction (PXRD). These analytical results show that the rod-like crystals were generated through RESS, and the crystal form, thermal behavior, and spectrometric property of RESS-produced crystals are consistent with the unprocessed ethenzamide. View Full-Text
Keywords: supercritical; RESS; microparticle; ethenzamide; Box–Behnken design supercritical; RESS; microparticle; ethenzamide; Box–Behnken design
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Hsu, Y.-T.; Su, C.-S. Application of Box–Behnken Design to Investigate the Effect of Process Parameters on the Microparticle Production of Ethenzamide through the Rapid Expansion of the Supercritical Solutions Process. Pharmaceutics 2020, 12, 42.

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