Lyophilization - Articles and news items

Primary packaging materials for pharmaceutical freeze-drying: Moulded vs. serum tubing vials

Issue 4 2010 / 19 August 2010 / Susanne Hibler and Dr. Henning Gieseler, University of Erlangen-Nuremberg, Division ofPharmaceutics, Freeze Drying Focus Group

Pharmaceutical freeze-drying is used to stabilise delicate drugs which are typically unstable in solution over a longer shelf life. The liquid formulation is converted into a solid, highly porous cake which can be easily reconstituted prior to administration. The majority of freeze-dried products in the pharmaceutical industry are used for parenteral application. This route of administration demands high quality for both the drug product and the primary packaging material. Today, glass vials are routinely used for freeze-dried products as they provide some indispensable characteristics. Depending on glass composition, surface treatment, processing and geometry, a vast number of different glass vials are commercially available for customers. Selection of the optimum vial for a given product seems to become more and more difficult as manufacturers of moulded and tubing glass have refined their products over the last decades to fulfil market needs. (more…)

Lyophilization: cycle robustness and process tolerances, transfer and scale up

Issue 3 2008, Past issues / 19 June 2008 /

During the past 10-15 years, close attention has been paid to the development of optimal lyophilization cycles for different types of pharmaceuticals[1-4]. Recent advances in process control, such as the Smart Freeze-Dryer^TM technology or similar approaches,[5-7] make cycle development a routine procedure. The attention of many researchers has shifted to the aspects of cycle transfer and scale up that still require significant investment in understanding the differences in lyophilization processes between laboratory and commercial dryers[8-14]. Conducting numerous experiments in an attempt to demonstrate that a laboratory cycle is not only optimal but also robust, requires significant material and time investment. Mathematical modelling of lyophilization processes proved to be a very useful tool, not only for cycle development[15-19] but also for cycle transfer and scale up[11,14]. The same mathematical approach (as discussed in experiment[14]) was applied to the process tolerances design and estimation of cycle robustness in regard to the product temperature. (more…)

An ever-evolving technology

Issue 3 2006, Past issues / 23 May 2006 / 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.

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The current state of PAT in freeze drying

Issue 4 2005, Past issues / 11 November 2005 / 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.

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