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

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

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...

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Bibliographic Details
Main Authors: Albert Galí, Magda Ascaso, Anna Nardi-Ricart, Marc Suñé-Pou, Pilar Pérez-Lozano, Josep M. Suñé-Negre, Encarna García-Montoya
Format: Article
Language:English
Published: MDPI AG 2020-08-01
Series:Pharmaceutics
Subjects:
retrospective data
design of experiments
critical process parameters
coating optimization
coating defects
process validation
Online Access:https://www.mdpi.com/1999-4923/12/8/743

Internet

https://www.mdpi.com/1999-4923/12/8/743

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