Droplet-Stream Freeze-Drying for the Production of Protein Formulations: From Simulation to Production

Autor: Matthias Dietzel, Sören N. Eggerstedt, Matthias Kuschel, Markus Jäger, Richard Süverkrüp, Ali Darvan, Alf Lamprecht, Martin Sommerfeld, Stefan Wanning
Rok vydání: 2016
Předmět:
Zdroj: Process-Spray ISBN: 9783319323688
DOI: 10.1007/978-3-319-32370-1_10
Popis: The objective of this interdisciplinary project was to develop a continuous atmospheric freeze-drying process for the production of lyophilized powder aerosols as pulmonary drug delivery systems in cooperation between an experimental and formulation group at the University of Bonn and a modelling and imaging team at the University of Halle (Saale). Observation and simulation results indicated deficiencies in the initial concept, which were eliminated by stepwise modifications of the freezing and drying system. Collisions and coalescence of droplets in fast streams exiting from piezoelectric generators were recorded by high-speed imaging and analyzed. Both the mean and the spread of the particle size distributions were reduced by a novel vortex-jet freezing technique. The fine particle fraction of the powder, which is suited to alveolar deposition in lungs, was increased to more than 40 %. In spite of the small size and low density of spherical and highly porous particles, the flowability of the powders is very good. Besides the powder aerosols envisaged in the initial concept, the method can be adapted to the production of other pharmaceutical dosage forms and may contribute to lowering the expenses and energy requirements for the manufacture of freeze-dried parenteral products.
Databáze: OpenAIRE