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Dr. Henning Gieseler

 

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The obstacle to developing an optimum placebo formulation for pharmaceutical freeze drying

Scale-up of pharmaceutical freeze-drying processes is cost and time consuming…

18 January 2019 | By ,

Scale-up of pharmaceutical freeze-drying processes is cost and time consuming due to Quality by Design (QbD) requirements and novel compound costs or availability. The application of placebo formulations offers a promising way to improve drug development activities and save resources. Furthermore, placebos are used as a reference in clinical trials.…

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Controlled nucleation in freeze-drying

The stochastic nature of nucleation during the freezing step of…

22 October 2012 | By Henning Gieseler, Associate Professor at the Division of Pharmaceutics, University of Erlangen & CEO, GILYOS GmbH and Peter Stärtzel, Pharmaceutical Scientist, GILYOS GmbH

The stochastic nature of nucleation during the freezing step of the freeze-drying process has been regarded as a demerit in a process which is considered under rigorous control. The freezing performance of a product can impact its subsequent drying behaviour and the final product quality attributes. Hence, the idea to…

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

Pharmaceutical freeze-drying is used to stabilise delicate drugs which are…

19 August 2010 | By 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…