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Pharmaceutical powders characterisation – the need for a multivariate approach

3 July 2014 | By Brian Armstrong and Katrina Brockbank, Freeman Technology

Powders and bulk materials are widely used in industry as raw materials, intermediates and finished products. Indeed, over 60% of the value of pharmaceutical sales worldwide is accounted for by powder formulations, typically as tablet/capsule/sachet or in the form of an inhalable powder. Whilst they are used extensively, they are…

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...

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…

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)…

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…

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…

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’…

Raman Spectroscopy In-Depth Focus 2014

10 April 2014 | By

In this Raman Spectroscopy In-Depth Focus 2014: Raman spectroscopy in the study of pharmaceuticals: the problems and solutions to sub-sampling and data analysis; Conformational state analysis of proteins by Raman spectroscopy: univariate and multivariate methods; Raman Roundtable...

Excipient selection in biologics and vaccines formulation development

19 February 2014 | By M. Babu Medi and Ramesh Chintala, Vaccine Drug Product Development, Merck & Co, Inc and Akhilesh Bhambhani, Novel Adjuvants, Formulation and Delivery Technologies, Merck & Co, Inc.

Excipients are an integral part of pharmaceutical products and play an important role in the formulation development of both small and large molecule pharmaceuticals. The type and extent of excipient use depends on several factors, including the type of active ingredient, route of administration, dosage form, target population and indication…

Mitigating the common pitfalls of LIMS implementation

19 February 2014 | By Cindy Novak-DeLaurell, Systems Application Consultant, Allergan

Over the past 20 years, I have participated in numerous LIMS implementation projects in a variety of roles. I have participated as a subject matter expert (SME), validation coordinator, programmer, System Administrator and technical representative, and have worked both in the laboratories and IS during these projects; gaining an insight…