Process Analytical Technologies (PAT) in freeze-drying of parenteral products
Authors:
- 3 November 2009
- journal article
- review article
- Published by Taylor & Francis in Pharmaceutical Development and Technology
- Vol. 14 (6) , 567-587
Abstract
Quality by Design (QbD), aims at assuring quality by proper design and control, utilizing appropriate Process Analytical Technologies (PAT) to monitor critical process parameters during processing to ensure that the product meets the desired quality attributes. This review provides a comprehensive list of process monitoring devices that can be used to monitor critical process parameters and will focus on a critical review of the viability of the PAT schemes proposed. R&D needs in PAT for freeze-drying have also been addressed with particular emphasis on batch techniques that can be used on all the dryers independent of the dryer scale.Keywords
This publication has 56 references indexed in Scilit:
- Physical Characterization of Pharmaceutical Formulations in Frozen and Freeze-Dried Solid States: Techniques and Applications in Freeze-Drying DevelopmentPharmaceutical Development and Technology, 2006
- Practical Formulation and Process Development of Freeze-Dried ProductsPharmaceutical Development and Technology, 2005
- Formulation Characterization2004
- Glimpses into the Realm of Freeze-Drying2004
- Heat and mass transfer scale-up issues during freeze-drying, I: Atypical radiation and the edge vial effectAAPS PharmSciTech, 2003
- Freeze‐drying using vacuum‐induced surface freezingJournal of Pharmaceutical Sciences, 2002
- Research and Development Needs and Opportunities in Freeze DryingDrying Technology, 1996
- Measurement of Glass Transition Temperatures of Freeze-Concentrated Solutes by Differential Scanning CalorimetryPharmaceutical Research, 1994
- Applications of DSC in the development of improved freeze-drying processes for labile biologicalsJournal of Thermal Analysis and Calorimetry, 1991
- New Therapeutic Uses for Well-Known Chemicals**Read before Philadelphia Branch, A. Ph. A., November meeting, 1919.The Journal of the American Pharmaceutical Association (1912), 1920