Emerging Freeze-Drying Process Development and Scale-up Issues
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, ...
متن کاملFreeze-drying of nanoparticles: formulation, process and storage considerations.
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 کاملPAT Tools for the Optimization of the Freeze-Drying Process
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...
متن کاملCirculating-Gas Freeze Drying
WAGMAN, JACK (U.S. Army Biological Laboratories, Frederick, Md.) AND EDWARD J. WENECK. Preservation of bacteria by circulating-gas freeze drying. Appl. Microbiol. 11:244-248. 1963.-Water-washed Serratia marcescens and Escherichia coli were freeze dried in a circulating-gas system at atmospheric pressure. This convective procedure resulted in a substantially higher survival of organisms than cou...
متن کاملFreeze-drying process monitoring using a cold plasma ionization device.
A cold plasma ionization device has been designed to monitor freeze-drying processes in situ by monitoring lyophilization chamber moisture content. This plasma device, which consists of a probe that can be mounted directly on the lyophilization chamber, depends upon the ionization of nitrogen and water molecules using a radiofrequency generator and spectrometric signal collection. The study per...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: AAPS PharmSciTech
سال: 2011
ISSN: 1530-9932
DOI: 10.1208/s12249-011-9599-9