Model predictive in vitro dissolution testing in pharmaceutical continuous manufacturing: An equivalence study
| Contributor(s):: Atul Dubey, Su Qinglin, Paul Hermant, Federica Casati, Bhakti Halkude, Wei Wu, Anjana Ramnath, Stephen Born, Salvatore Mascia, Bayan Takizawa
A predictive mathematical model for tablet dissolution was developed and implemented in an end-to-end integrated continuous manufacturing pilot plant. The tablets were produced for immediate release with a proprietary extrusion-molding-coating (EMC) unit operation. Besides the mass balance of...
Enabling real time release testing by NIR prediction of dissolution of tablets made by continuous direct compression (CDC)
| Contributor(s):: Pawar, Pallavi, Wang, Yifan, Keyvan, Golshid, Callegari, Gerardo, Cuitino, Alberto, Muzzio, Fernando
A method for predicting dissolution profiles of directly compressed tablets for a fixed sustained release formulation manufactured in a continuous direct compaction (CDC) system is presented. The methodology enables real-time release testing (RTRt). Tablets were made at a target drug...