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Latest issue / 19 August 2010 / 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 parenteral application. This route of administration demands high quality for both the drug product and the primary packaging material. Today, glass vials are routinely used for freeze-dried products as they provide some indispensable characteristics. Depending on glass composition, surface treatment, processing and geometry, a vast number of different glass vials are commercially available for customers. Selection of the optimum vial for a given product seems to become more and more difficult as manufacturers of moulded and tubing glass have refined their products over the last decades to fulfil market needs. (more…)
Tagged with: Dr. Henning Gieseler, Freeze Drying, Lyophilization, Susanne Hibler, Tubing Vials
Latest issue / 19 August 2010 / 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 how to get a RMM approved. Because there are different regulatory perspectives on RMM implementation, a company should understand what each regulatory body expects with regard to validation, submission and implementation strategies. In my last article, I discussed a number of RMM implementation perspectives from the U.S. Food and Drug Administration (FDA). In this article, I will focus on the European Medicines Agency (EMA) and their expectations on the introduction of new RMM technologies. (more…)
Tagged with: LLC, Michael J. Miller, Microbiology
Latest issue / 19 August 2010 / 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 optic Raman probes. Improvements in signal detection and data analysis, like modulated Raman spectroscopy, will allow the rapid acquisition and analysis of spectra. There is also considerable potential in screening tissue fluids for cancer cells in order to facilitate early detection and for follow up after surgery for cancer. Collaborations between clinicians, pathologists and physicists are opening up new areas in this rapidly developing field. (more…)
Tagged with: Andrew Riches, Anna Chira de Luca, Antonia Carruthers, C. Simon Herrington, Chris Goodman, Elisabetta Canetta, Greg Kata, Kadi Nourdin, Kishan Dholakia, Michael Mazilu, Nabi Ghulam, Ninewells Hospital & Medical School, Raman Spectroscopy, Scotland, University of St. Andrews
Latest issue / 19 August 2010 / 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 forms. Although morphology and particle size-distribution are important solid-state characteristics, the uncontrolled occurrence of multiple physical forms (polymorphs, solvates, salts, co-crystals or amorphous) of an API can have significant effects on the performance of the material during processing, manufacture, storage and administration. For example, the solubility difference between some polymorphs has been shown to be over four times that of the least soluble form1 and can vary by significantly more for amorphous forms2. (more…)
Tagged with: Alistair J. Florence, HTS (High Throughput Screening), Polymorphism Screening, Raman Spectroscopy, United Kingdom, University of Strathclyde
Latest issue / 19 August 2010 / 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 higher throughput. For many applications, monolithic pipelines cannot deliver the flexibility and versatility needed. Laboratories and scientific service providers instead usually look into integrating components from both the open source world and the commercial software world into best-of-breed data pipelines. In this article, we will present two open source components that can be used as flexible and powerful building blocks for such a pipeline. (more…)
Tagged with: Angela Bauch, Bernd Rinn, ETH Zurich, Gabor Csucs, HCS (High Content Screening), Karol Kozak, Switzerland, Tomasz Pylak
Latest issue / 19 August 2010 / 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 are not designed to detect indirect channel modulations that may result in QT prolongation. Despite the abundant literature demonstrating potential transcriptional, translational and post-translational mechanisms for indirect ion channel modulation, contribution of these mechanisms to drug-induced QT prolongation and/or arrhythmia propensity is not well understood. In this brief review, we discuss some potential mechanisms through which indirect ion channel modulation can produce QT prolongation and strategies for their early detection and mitigation. (more…)
Tagged with: Albert Kim, Dmitri Mikhailov, Drug discovery, Gül Erdemli, Ion Channels, Novartis, Novartis Institutes for BioMedical Research
Latest issue / 19 August 2010 / 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. In this roundtable, three leading pharmaceutical PAT companies offer their opinions on why PAT is becoming more and more essential to the pharmaceutical industry. (more…)
Tagged with: Kjell François, PAT, Rebecca Vangenechten, Rick E. Cooley, Uwe Kirschner
Latest issue / 19 August 2010 / 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, biochemistry, chemistry and physiology as these disciplines all contribute to the impact of a given chemical’s toxicity. Indeed the multidisciplinary nature of toxicology makes the area of toxicology a challenging yet rewarding area for research and learning. To gain a true understanding of how a chemical can disrupt a biological system and cause toxic consequences is no easy matter. (more…)
Tagged with: Brian Lockwood, Pharmaceutical Industry Advanced Training (PIAT), Toxicology, United Kingdom, University of Manchester
Latest issue / 19 August 2010 / 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 early clinical data is a formidable challenge and this short review will discuss why and how new initiatives in systems biology and dynamic computational simulations can meet this challenge and predict the ‘unpredictable’. (more…)
Tagged with: AstraZeneca, Dr David Cook, Drug discovery, Idiosyncratic Drug-Induced Liver Injury (DILI), Toxicology
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