List view / Grid view

Issue 4 2010



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

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…


Article 4: The implementation of rapid microbiological methods

19 August 2010 | By Michael J. Miller, President, Microbiology Consultants, LLC

This is the fourth in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010. Believe it or not, today’s regulatory authorities encourage the use of rapid microbiological methods (RMMs), and when applicable, they have put policies in place that provide guidance on…


Raman spectroscopy and cancer cells

19 August 2010 | By Andrew Riches, Professor of Experimental Pathology, School of Medicine, University of St. Andrews and Co-authors: C. Simon Herrington, School of Medicine Kishan Dholakia, Elisabetta Canetta, Antonia Carruthers, Michael Mazilu, Anna Chiara de Luca, School of Physics & Astronomy Chris Goodman, Greg Kata, Nabi Ghulam, Kadi Nourdin, Department of Urology, Ninewells Hospital & Medical School, Dundee

Raman spectroscopy has the potential to provide diagnostic information to the clinician. The technique has a number of advantages allowing individual cells to be interrogated without staining. With further developments in technology, the surgeon will be able to rapidly acquire accurate diagnostic information at the time of operation using fibre…


Polymorph screening in pharmaceutical development

19 August 2010 | By Professor Alastair J. Florence, Solid-State Research Group, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde

The majority of active pharmaceutical ingredients (APIs) are produced by crystallisation and so the phenomenon of polymorphism, whereby an organic molecule can adopt more than one crystalline form (Figure 1), is of considerable importance when trying to achieve consistent product quality during the manufacture of pharmaceutical solids and solid dosage…


Towards a comprehensive open source platform for management and analysis of High Content Screening data

19 August 2010 | By Karol Kozak, Angela Bauch, Gabor Csucs,Tomasz Pylak & Bernd Rinn, ETH Zurich

As High Content Screening (HCS) has moved into the mainstream for biological and pharmaceutical investigations, a lag of well integrated pipelines for automated acquisition, management and analysis of HCS results turns out to be a bottleneck for fully leveraging the wealth of information contained in a screen and moving to…


Indirect modulation of cardiac ion channels and implications for preclinical safety assessment

19 August 2010 | By Gül Erdemli & Dmitri Mikhailov, Center for Proteomic Chemistry, Novartis Institutes for BioMedical Sciences and Albert M Kim, Translational Medicine, Novartis Institutes for BioMedical Sciences

The preclinical assessment of a small molecule’s liability for QT interval prolongation is an essential part of the drug discovery process. Patch clamp assays for heterologously expressed recombinant cardiac ion channels are widely used in the pharmaceutical industry to evaluate potential drug-channel interactions. These assays are generally acute assessments and…


Process Analytical Technology: An industry perspective

19 August 2010 | By Uwe Kirschner, General Manager, Sentronic GmbH, Rick E. Cooley, Market Development Manager - Process Analytics, Dionex Corporation, Rebecca Vangenechten, Business Development, Siemens Headquarters Pharma and Kjell François, Project Leader in PAT

Process Analytical Technology (PAT) is a system for designing, analysing and controlling pharmaceutical manufacturing processes through measurements of critical quality and performance attributes of raw and processed materials to ensure final product quality, the idea of which is to become more efficient while reducing over-processing, enhancing efficiency and minimising waste.…


Toxicology and Pharmaceutical Industry Advanced Training (PIAT)

19 August 2010 | By Brian Lockwood, Director of PIAT, School of Pharmacy & Pharmaceutical Sciences, University of Manchester

Toxicology is the study of the harmful interactions between chemicals and biological systems. Man, as well as other animals and plants, is increasingly exposed to a huge variety of chemicals. These range from metals to large complex organic molecules, all of which are potentially toxic. A toxicologist must understand pathology,…


Applying systems biology and computer simulations to predicting idiosyncratic DILI

19 August 2010 | By David Cook, Associate Director, Global Safety Assessment, AstraZeneca

Idiosyncratic drug-induced liver injury (DILI) is a rare adverse drug reaction which accounts for a significant amount of patient suffering, including death. Currently, idiosyncratic DILI is unpredictable and as a result arises late in the drug development process or even post-marketing. The prediction of idiosyncratic DILI based on preclinical or…