Real-Time Assessment of Granule Densification in High Shear Wet Granulation and Application to Scale-up of a Placebo and a Brivanib Alaninate Formulation

2015 ◽  
Vol 104 (3) ◽  
pp. 1019-1034 ◽  
Author(s):  
Ajit S. Narang ◽  
Valery A. Sheverev ◽  
Vadim Stepaniuk ◽  
Sherif Badawy ◽  
Tim Stevens ◽  
...  
Keyword(s):  
Real Time ◽  
Scale Up ◽  
Wet Granulation ◽  
High Shear ◽  
Brivanib Alaninate ◽  
High Shear Wet Granulation ◽  
Time Assessment

scholarly journals Real-time monitoring of granule properties during high shear wet granulation by near-infrared spectroscopy with a chemometrics approach

RSC Advances ◽  
2017 ◽  
Vol 7 (61) ◽  
pp. 38307-38317 ◽  
Author(s):  
F. Shikata ◽  
S. Kimura ◽  
Y. Hattori ◽  
M. Otsuka
Keyword(s):  
Infrared Spectroscopy ◽  
Real Time ◽  
Near Infrared Spectroscopy ◽  
Near Infrared ◽  
Wet Granulation ◽  
High Shear ◽  
Monitoring Method ◽  
Granulation Process ◽  
High Shear Wet Granulation ◽  
Granule Properties

An in-line near-infrared spectroscopy monitoring method was developed for analyzing granule properties during a high shear wet granulation process.

scholarly journals Scale-Up Studies on High Shear Wet Granulation Process from Mini-Scale to Commercial Scale

2008 ◽  
Vol 56 (10) ◽  
pp. 1431-1435 ◽  
Author(s):  
Shouhei Aikawa ◽  
Naomi Fujita ◽  
Hidetoshi Myojo ◽  
Takashi Hayashi ◽  
Tadatsugu Tanino
Keyword(s):  
Scale Up ◽  
Wet Granulation ◽  
High Shear ◽  
Granulation Process ◽  
Commercial Scale ◽  
High Shear Wet Granulation

Evaluating Scale-Up Rules of a High-Shear Wet Granulation Process

2015 ◽  
Vol 104 (7) ◽  
pp. 2323-2333 ◽  
Author(s):  
Jing Tao ◽  
Preetanshu Pandey ◽  
Dilbir S. Bindra ◽  
Julia Z. Gao ◽  
Ajit S. Narang
Keyword(s):  
Scale Up ◽  
Wet Granulation ◽  
High Shear ◽  
Granulation Process ◽  
High Shear Wet Granulation

scholarly journals Improved Understanding of the High Shear Wet Granulation Process under the Paradigm of Quality by Design Using Salvia miltiorrhiza Granules

Pharmaceutics ◽  
2019 ◽  
Vol 11 (10) ◽  
pp. 519 ◽  
Author(s):  
Yi Zhang ◽  
Brian Chi-Yan Cheng ◽  
Wenjuan Zhou ◽  
Bing Xu ◽  
Xiaoyan Gao ◽  
...  
Keyword(s):  
Experimental Design ◽  
Quality By Design ◽  
Salvia Miltiorrhiza ◽  
Scale Up ◽  
Granule Size ◽  
Quadratic Polynomial ◽  
Wet Granulation ◽  
High Shear ◽  
Validation Experiment ◽  
High Shear Wet Granulation

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 (D50) 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.

Scale-up of a high shear wet granulation process using a nucleation regime map approach

Particuology ◽  
2017 ◽  
Vol 31 ◽  
pp. 87-94 ◽  
Author(s):  
Gan Luo ◽  
Bing Xu ◽  
Yi Zhang ◽  
Xianglong Cui ◽  
Jianyu Li ◽  
...  
Keyword(s):  
Scale Up ◽  
Wet Granulation ◽  
High Shear ◽  
Granulation Process ◽  
Regime Map ◽  
High Shear Wet Granulation ◽  
Map Approach
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