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Issue 2 2014

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Mass Spectrometry: In-Depth Focus 2014

15 April 2014 | By

In this free-to-view Mass Spectrometry In-Depth Focus: Some tricks and tools for structural characterisation of natural products using Electrospray mass spectrometry, Mass spectrometry in the biopharmaceutical industry: from the mundane to the cutting edge, and Mass Spectrometry roundtable...

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Is risk in the eye of the beholder?

15 April 2014 | By

An effective quality risk management (QRM) process provides a key mechanism for the proactive identification and control of potential issues that may arise during product development and subsequent commercialisation1. In this context, risk is defined as the combination of the probability of occurrence of harm (or unwanted outcome) and the…

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Microbiology Series: Antimicrobial delivery

15 April 2014 | By Joshua Boateng and Harshavardhan Pawar, Department of Pharmaceutical Chemical and Environmental Sciences, Faculty of Engineering and Science, University of Greenwich

Antimicrobial drugs form a significant aspect of disease therapy and are a major means of treating bacterial, fungal and viral infections. The issue of antimicrobial therapy is of current interest and clinical concern. This is mainly due to two key reasons; (i) persistent emergence of microbial resistant strains and (ii)…

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Product Hub: Eurofins BioPharma Product Testing

15 April 2014 | By European Pharmaceutical Review

Timothy S. Oostdyk, PhD, President of Eurofins Lancaster Laboratories; Sr. Vice President, Eurofins BioPharma Product Testing Group, discusses harmonising policies, quality and services among 14 global facilities.

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Hot melt extrusion processing for the development of sustained release products

15 April 2014 | By Dennis Douroumis, Reader in Pharmaceutical Sciences at the University of Greenwich and the Director of Centre for Innovation in Process Engineering and Research

Hot Melt Extrusion (HME) has attracted increased interest for the development of pharmaceutical dosage forms over the last decade. It is a versatile processing technology which produces extrudates in the form of solid dispersions and solid solutions. Among the various applications, HME has been adopted for the development of sustained…

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PAT for packaging: review of applications for expeditious, nondestructive quality testing

15 April 2014 | By Jose Montenegro-Alvarado, Bradley Diehl, Jean-Maxime Guay, Steve Hammond, Hiwot Isaac, Ben Lyons, Conor McSweeney, Seamus O’Neill, Jean-Sébastien Simard and Joep Timmermans, Pfizer Inc.

This article reviews some emerging applications of Process Analytical Technologies (PAT) for packaging quality testing. Specifically, four commercially-available packaging applications are explored in further detail: Raman spectroscopy for rapid material identification testing of polymeric packaging materials; vision-based elastic deformation for non-destructive blister integrity testing; X-ray monitoring for inline blister fill…

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Excipients in medicines for children: scientific and regulatory paradigms

15 April 2014 | By Ali Al-khattawi, Postdoctoral Research Associate, Aston University / Afzal R. Mohammed, Senior Lecturer in Pharmaceutics, Aston University

There is an ongoing debate over the use of pharmaceutical excipients in medicines for children, triggered by the increased number of formulations suitable for this target patient population. Pharmaceutical excipients can be regarded as essential / necessary enablers in formulation development. These are materials other than the ‘active pharmaceutical ingredient’…

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Product Hub: Rigaku Raman Technologies

15 April 2014 | By European Pharmaceutical Review

Bree Allen, Vice President and General Manager at Rigaku Raman Technologies, discusses their new handheld Progeny™ raw material analyser.