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University of London - Articles and news items
The fluorescence-based quantitative real-time polymerase chain reaction (qPCR)1,2,3 has become firmly established as the preferred technology for the detection and quantification of nucleic acids in molecular diagnostics, life sciences, agriculture and medicine4,5.
The emergence of next generation sequencing technology has brought the prospect of digital analyses closer, technology that will allow not just the quantification of nucleic acids, but will result in the fine-tuning of this information with respect to tissue- and cell-specific transcription, the identification of new transcriptional units, e.g. the detection of new splice variants and their overall correlation with genomic elements. Until that time, the real-time quantitative polymerase chain reaction (qPCR) continues as the enabling technology par excellence offering an unrivalled combination of simplicity, cost-efficiency, accuracy and availability, with application in every area of life sciences and medicine1. Its sensitivity, specificity, and wide linear dynamic range makes qPCR today’s method of choice for any research and diagnostic application that aims to detect and measure nucleic acids2.
Differential scanning calorimetry (DSC) is a widely used technique within the pharmaceutical industry because the range of phase transitions it can measure usually allows near complete physical characterisation of a new active principal early during preformulation. In addition, because DSC measures a property change that is ubiquitous† (heat) there are very few samples that cannot be investigated.
Issue 3 2007 / 23 May 2007 / Simon Gaisford PhD and Rita Ramos PhD, School of Pharmacy, University of London
In the previous article (European Pharmaceutical Review, Issue 2, 2007) an introduction to calorimetry was given and its application to polymorph characterisation, discussed. Another area of application of growing importance is quantification of (usually small) amorphous contents. A requirement to demonstrate the presence or absence of amorphous material is becoming more important in regulatory documentation and calorimetric techniques are emerging as major tools in this arena. This article focuses on the use of various calorimetric techniques for quantifying amorphous content.
Characterising the properties of a material, understanding how these properties change in relation to local environment and quantifying potential interactions with other species are facets central to any drug development programme. Not understanding and, more importantly, not controlling these factors can have serious consequences for a pharmaceutical, from irreproducible processing to poor bioavailability, product instability and, worse, patentability. Properties that may be characterised include solubility, dissolution rate, stability (in combination with other excipients and as a function of relative humidity and temperature) and per cent crystallinity (or amorphous content).
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