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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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Detalles Bibliográficos
Autores principales: Galí, Albert, Ascaso, Magda, Nardi-Ricart, Anna, Suñé-Pou, Marc, Pérez-Lozano, Pilar, Suñé-Negre, Josep M., García-Montoya, Encarna
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7465942/
https://www.ncbi.nlm.nih.gov/pubmed/32784621
http://dx.doi.org/10.3390/pharmaceutics12080743