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Title: Improved understanding of the high shear wet granulation process under the paradigm of quality by design using salvia miltiorrhiza granules
Authors: Zhang, Y
Cheng, BCY 
Zhou, WJ
Xu, B
Gao, XY
Qiao, YJ
Luo, G
Issue Date: 2019
Source: Pharmaceutics, 9 Oct. 2019, v. 11, no. 10, 519, p. 1-18
Abstract: Background: High shear wet granulation (HSWG) is a shaping process for granulation that has been enhanced for application in the pharmaceutical industry. However, study of HSWG is complex and challenging due to the relatively poor understanding of HSWG, especially for sticky powder-like herbal extracts. Aim: In this study, we used Salvia miltiorrhiza granules to investigate the HSWG process across different scales using quality by design (QbD) approaches. Methods: A Plackett-Burman experimental design was used to screen nine granulation factors in the HSWG process. Moreover, a quadratic polynomial regression model was established based on a Box-Behnken experimental design to optimize the granulation factors. In addition, the scale-up of HSWG was implemented based on a nucleation regime map approach. Results: According to the Plackett-Burman experimental design, it was found that three granulation factors, including salvia ratio, binder amount, and chopper speed, significantly affected the granule size (D-50) of S. miltiorrhiza in HSWG. Furthermore, the results of the Box-Behnken experimental design and validation experiment showed that the model successfully captured the quadratic polynomial relationship between granule size and the two granulation factors of salvia ratio and binder amount. At the same experiment points, granules at all scales had similar size distribution, surface morphology, and flow properties. Conclusions: These results demonstrated that rational design, screening, optimization, and scale-up of HSWG are feasible using QbD approaches. This study provides a better understanding of HSWG process under the paradigm of QbD using S. miltiorrhiza granules.
Keywords: High shear wet granulation
Quality by design
Salvia miltiorrhiza granules
Scale-up
Regime map
Publisher: Molecular Diversity Preservation International (MDPI)
Journal: Pharmaceutics 
EISSN: 1999-4923
DOI: 10.3390/pharmaceutics11100519
Rights: © 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
The following publication Zhang, Y.; Cheng, B. .-Y.; Zhou, W.; Xu, B.; Gao, X.; Qiao, Y.; Luo, G. Improved Understanding of the High Shear Wet Granulation Process under the Paradigm of Quality by Design Using Salvia miltiorrhiza Granules. Pharmaceutics 2019, 11, 519, 1-18 is available at https://dx.doi.org/10.3390/pharmaceutics11100519
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