Empirical prediction model based process optimization for droplet size and spraying angle during pharmaceutical fluidized bed granulation.

Pharmaceutical Development and Technology
Jia ZengYi Feng

Abstract

The objective of this study was to predict the droplet size and the spraying angle during the process of binder atomization in pharmaceutical fluidized bed granulation using an empirical model. The effects of the binder viscosity, the atomization pressure, and the spray rate on the droplet size and the spraying angle were investigated using a response surface central composite design and analysis of variance. Prediction models for droplet size and spraying angle were then established using stepwise regression analysis and were validated by comparing the measured and predicted values. The results showed that the droplet size model and the spraying angle model were well established, with an R2 of 0.93 (p < 0.0001) and a root mean square error (RMSE) of 10.10, and an R2 of 0.82 (p < 0.0001) and an RMSE of 3.69, respectively. The error between the measured and predicted values of the droplet size and the spraying angle were less than 10%, indicating that the established models were accurate. The results of the present study were significant in predicting the droplet size and spraying angle in the process of pharmaceutical fluidized bed granulation.

References

Dec 22, 1999·International Journal of Pharmaceutics·S H SchaafsmaN W Kossen
Mar 29, 2003·Journal of Biomaterials Science. Polymer Edition·Fang-Jing Wang, Chi-Hwa Wang
Apr 2, 2008·Pharmaceutical Development and Technology·Pia ThyboJesper Saederup Lindeløv
May 19, 2009·International Journal of Pharmaceutics·Chandra VemavarapuSherif Badawy
Mar 10, 2010·International Journal of Pharmaceutics·Henrik EhlersJouko Yliruusi
Feb 7, 2017·International Journal of Pharmaceutics·Saeed ShirazianGavin M Walker
Jul 27, 2017·International Journal of Pharmaceutics·Ronghua LiuHengchang Zang

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