Continuous twin screw granulation: Impact of the starting material properties and various process parameters

The purpose of this study is to confirm the correlation between the formulation factors and the process parameters using multivariate analysis (MVA) during twin screw granulation.

Various grades of lactose and MCC were used as starting materials and the characteristics of final granules were investigated by varying the L/S ratio and feed rate. The size distribution, friability, and various flow properties of granules using powder rheometer were evaluated. When the effect of formulation factors and process parameters were investigated, it was confirmed that the characteristics of granules change largely according to L/S ratio.

MVA also showed that the influence of formulation factors on characteristics of granules was significant as L/S ratio. The feed rate had few effects on the characteristics of the granules. MVA is a useful tool to confirm the correlations of various factors.

The properties of the starting materials are important in the continuous twin screw granulation process. More on excipient impact on continuous twin screw granulation