Tablet Quality-Prediction Model Using Quality Material Attributes: Toward Flexible Switching Between Batch and Continuous Granulation
Contributor(s):: Arai, H, Nagato, TKoide, T, Yonemochi, E, Yamamoto, H, Sugiyama, H
Purpose The purpose of the study was to develop a model to predict the critical quality attribute (CQA) of tablets during continuous and batch manufacturing using only critical material attributes (CMAs). Methods Experiments were performed using ethenzamide as the active pharmaceutical ingredient...
Assessment of Robustness for a Near-Infrared Concentration Model for Real-Time Release Testing in a Continuous Manufacturing Process
Contributor(s):: Colon, Yleana, Vargas, Jenny, Sánchez, Eric, Navarro, Gilfredo, Romañach, Rodolfo
This study describes the robustness test of a transmission near-infrared spectroscopic (NIRS) model for prediction of drug concentration in core tablets as part of real-time release testing (RTRt) efforts for a continuous manufacturing process. Seven calibration blend samples were prepared...