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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...

Whakaahuatanga katoa

I tiakina i:
Ngā kaituhi matua: Albert Galí, Magda Ascaso, Anna Nardi-Ricart, Marc Suñé-Pou, Pilar Pérez-Lozano, Josep M. Suñé-Negre, Encarna García-Montoya
Hōputu: Artigo
Reo:Inglês
I whakaputaina: MDPI AG 2020-08-01
Rangatū:Pharmaceutics
Ngā marau:
retrospective data
design of experiments
critical process parameters
coating optimization
coating defects
process validation
Urunga tuihono:https://www.mdpi.com/1999-4923/12/8/743
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