Robustness Optimization of an Existing Tablet Coating Process Applying Retrospective Knowledge (rQbD) and Validation

• Main Authors: Albert Galí (Author), Magda Ascaso (Author), Anna Nardi-Ricart (Author), Marc Suñé-Pou (Author), Pilar Pérez-Lozano (Author), Josep M. Suñé-Negre (Author), Encarna García-Montoya (Author)
• Format: Book
• Published: MDPI AG, 2020-08-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

The objective of these studies is to verify and validate the improvement in the inter-tablet coating uniformity for an industrially commercialized coated tablet, without involving changes in the approved registration dossier. Using the CPP (critical process parameters) determined from previous retro...