Design and Process Considerations in Spray Freeze Drying

Design and Process Considerations in Spray Freeze Drying

Bernhard Luy, Matthias Plitzko, Howard Stamato

Abstract

Dynamic spray freeze drying combines spray freezing and rotary freeze drying to generate homogeneous, free-flowing lyophilized beads as a bulk intermediate product. This allows for filling on demand, with choices in dose strength and combinations of multiple active materials. Thus, the supply chain becomes highly flexible. This feature of handling bulk intermediate can significantly reduce time to market.

Production efficiency is enabled by using higher concentrated liquids yet maintaining fast reconstitution. Further processing with established solid dosage form technologies is possible, for example film coating for light or oxygen protection in diagnostic applications. The technology is built and tested in lab, pilot and production scale including its use for the manufacture of parenteral products, which is done in a fully contained process line. Industrial uses of the technology are in the areas of pharmaceuticals, diagnostics and medical devices, and specialty chemicals applications.