Channels

 

Special Offers & Promotions

 

 

Latest News

 

 

View Channel

New Products

 

 

View Channel

Video Presentations

 

 

View Channel

Separation Science

 

 

View Channel

Microscopy & Image Analysis

 

 

View Channel

Laboratory Automation & IT Solutions

 

 

View Channel

 

Linkam Highlights the Work of Dr Henning Gieseler from the Division of Pharmaceutics at the Friedrich-Alexander University Erlangen-Nuremberg in the Field of Pharmaceutical Freeze Drying

publication date: Jan 29, 2018
 | 
author/source: Linkam Scientific Instruments Limited

Linkam FDCS196 stageMarket leaders in temperature controlled microscopy and established manufacturers of advanced freeze drying microscopes, Linkam Scientific Instruments, report on the work of Dr Henning Gieseler from the Friedrich-Alexander University (FAU) Erlangen-Nuremberg on his research and development activities in the field of freeze drying for the pharmaceutical industry.

Dr Henning Gieseler leads the Freeze Drying Focus Group (FDFG) in the Division of Pharmaceutics at the Friedrich-Alexander University (FAU) Erlangen-Nuremberg. He started his research in this area in 2006 after first coming across freeze drying microscopy (FDM) during his post doc at the University of Connecticut in the USA where he used a Linkam FDSC196 stage. This led in the following years to a collaboration with Linkam on the development of innovative instrumentation dedicated to improve freeze drying characterisation methods. The pharmaceutical industry demands as much knowledge on formulation behaviour as possible to design optimum and robust freeze drying cycles. Most recent analysis approaches tend towards miniaturization of the freeze drying process, with the ultimate goal to minimize the amount of drug used for development.

The main research goal is to have a representative measure of the temperature point (or region) where the product starts to undergo structural (morphological) changes during primary drying of a freeze drying cycle. These changes can be visually detected, in form of “shrinkage” or “collapse”. It is essentially the point where a (rigid) glassy system starts to flow (decrease in viscosity). This temperature point is specific for every single formulation in the world. Product defects or imperfections, such as collapse, are of regulatory concern and might impede pharmaceutical quality parameters. Conventional FDM allows the determination of the so called “onset of collapse temperature, Toc.” This measurement is performed using 2-3 µL of liquid placed between two glass cover slips. This experimental setup reflects a 2D measurement, i.e. on the pore size level. In other words, during freeze drying, the product would not show the expected level of collapse when exposed to the same process temperatures applied during the FDM measurement. In order to get a more complete understanding of product behaviour, a scale-up of the measurement was required to cover the full perfomance range and test product behaviour at larger volumes when in a commercial vial. This would then be a 3D experiment which would be more reflective of a typical freeze drying cycle. Together, these complementary techniques allow a better understanding of formulation in the frozen state and of the scale up factors (from 2µL to 5 mL) which allow improved process optimization.

The work over the last two years has led to the production of Linkam’s Freeze Drying Vial System (FDVS). This development came in part from the excellent work of one of Dr Gieseler's PhD students, Zixin Huang. Dr Gieseler comments on the collaboration: “Our work with Linkam has enabled the release of a cost-effective solution with a small footprint for freeze drying optimisation. We have also seen that Linkam’s new Optical DSC performs a complementary role in the process.”

For information on Linkam’s range of freeze drying characterisation products along with other temperature and environmental control materials characterisation solutions, visit the web site. 


more about linkham


more news from linkham


 


If you have not logged into the website then please enter your details below.



 

News Channels

 

 

Subscribe to any of our newsletters for the latest on new laboratory products, industry news, case studies and much more!

Newsletters from Lab Bulletin

 

Request your free copies HERE

 

 

 

Popular this Month

Top 10 most popular articles this month

 

 

Today's Picks

 

 

 

 

Looking for a Supplier?

Search by company or by product

 


Company Name:

Product:


 

 

 

 

Please note Lab Bulletin does not sell, supply any of the products featured on this website. If you have an enquiry, please use the contact form below the article or company profile and we will send your request to the supplier so that they can contact you directly.

Lab Bulletin is published by newleaf marketing communications ltd.


 

Media Partners

 

Exhibitions & Events