Editorial: Freeze-Drying and Process Analytical Technology for Pharmaceuticals
نویسندگان
چکیده
منابع مشابه
Freeze-drying Process Development for Protein Pharmaceuticals
This chapter provides an overview of the impact of protein formulation variables on different stages of the protein freeze-drying process and offers guidance for selection of critical process parameters during protein freeze-drying cycle development, optimization, and scale-up. There is particular focus on practical considerations including large-scale process development, scale-up challenges, ...
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1. Freezing: the product to be dried is put over shelves in a chamber and its temperature is lowered so that the water (or the other solvent) is frozen. Unfortunately, not all the solvent freezes forming ice crystals, but a certain amount (sometimes significant) remains bonded to the product and must be finally desorbed. In some cases the product (the drug and the excipients) does not crystalli...
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Freeze-drying has been considered as a good technique to improve the long-term stability of colloidal nanoparticles. The poor stability in an aqueous medium of these systems forms a real barrier against the clinical use of nanoparticles. This article reviews the state of the art of freeze-drying nanoparticles. It discusses the most important parameters that influence the success of freeze-dryin...
متن کاملProcess analytical technology for chromatography.
A major United States Food and Drug Administration effort is devoted to process analytical technology (PAT), which is emerging as the likely "surprise" of the second half of the decade. PAT is an approach to monitoring, manufacturing, and other processes on a continuous rather than discrete basis. It carries the future promise of new methods of production. Building PAT into a chromatography sys...
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ژورنال
عنوان ژورنال: Frontiers in Chemistry
سال: 2018
ISSN: 2296-2646
DOI: 10.3389/fchem.2018.00622