Study on spray drying technology of Fengke Granule based on QbD concept / 中草药

ABSTRACT

Objective: To establish and validate the design space of spray drying process of Fengke Granule using the concept of quality by design (QbD). Methods: Using Fengke Granule formula to extract the concentrated solution as model drug, the risk assessment and Plackeet-Burmann design on influence factors of screening, to determine the liquid inlet velocity and pressure of atomization is the critical process parameters. Then, the central composite design was used to optimize the key parameters and establish the process design space. Finally, four experimental points were selected to test the predictive power of the model. Results: Analysis of variance results showed that regression model P values were less than 0.01, which showed that the model had a good prediction, and the optimal range of key parameters of inlet velocity was determined and pressure of atomization were 11%-14% and 41.3-45.0 mmHg, the process parameters in this range could meet the target requirements. Conclusion: The design space of spray drying process is established based on QbD, which could improve the flexibility and stability of spray drying process, and provide reference for the pilot study in the future.