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Pharmaceutical companies often use lyophilisation (or freeze-drying) to increase the shelf life of the products, such as live virus vaccines, biologics and other injectables. By removing the water from the material and sealing the material in a glass vial, the material can be easily stored, shipped, and later reconstituted to its original form for injection. Another example from the pharmaceutical industry is in tablet or wafer production, the advantage of which is less excipient as well as a rapidly absorbed and easily administered dosage form.
Lyophilisation is also used in manufacturing of raw materials for pharmaceutical products. Active Pharmaceutical Product Ingredients (APIs) are lyophilised to achieve chemical stability under room temperature storage. Bulk freeze-drying of APIs is typically conducted using trays instead of glass vials.
Dry powders of probiotics are often produced by bulk lyophilisation of live microorganisms such as Lactic acid bacteria and Bifidobacteria.
Over the last decade, the development of new drug delivery methods and devices for dry powder inhalation1, needle-free intradermal powder injection2 or sustained parenteral drug delivery3 has led to an increasing demand for powder formulations incorporating an active pharmaceutical ingredient (API)4,5.
25 January 2007 | By Dr. Henning Gieseler, PhD., Department of Pharmaceutics, University of Erlangen-Nuremberg
Freeze drying is generally known to be a time consuming and therefore expensive process. In order to lower costs during manufacturing, the effective cycle time must be reduced. This goal can be achieved by optimising a freeze drying cycle in the laboratory – in particular the primary drying phase. Applying…
23 May 2006 | By Prof. Louis Rey, Scientific Advisor and Head, Laboratory of Experimental Freeze-Drying AERIAL – CRT, and Dalal Aoude-Werner, Head of Project, AERIAL – CRT
Almost 60 years have elapsed since freeze-drying/lyophilization was introduced on an industrial scale. Developed initially for the rapid delivery of human blood plasma on the World’s battle fields, lyophilization gained its credentials with the massive production of penicillin under the guidance of the late Nobel Laureate Sir Ernst Boris Chain.
11 November 2005 | By Michael Wiggenhorn, Gerhard Winter, Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics, Ludwig-Maximilians-University and Ingo Presser, Boehringer Ingelheim
Freeze drying is a widely used method to stabilise protein pharmaceuticals. The stability of proteins and the biological activity can be influenced by several factors, which may lead to conformational changes and to denaturation, aggregation or absorption to surfaces1.
