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UCL School of Pharmacy - Articles and news items

Foreword: New guidelines for breakmarks on tablets

Issue 3 2013, Manufacturing & Packaging / 13 June 2013 / Tony Moffat, UCL School of Pharmacy and Joint Pharmaceutical Analysis Group

The US Food and Drugs Administration (FDA) produced their guidance for industry on tablet scoring in March 2013 to ensure that tablet scoring (breakmarks or breaklines) on generic tablets would enable them to be split in the same effective way as their reference listed products (RLD). These breakmarks on tablets were originally developed to allow tablets to be split into two or four equal parts to help the ingestion of large tablets or to allow a reduction in dose, e.g. for children or the elderly. However, some generic drugs have included breakmarks just so that they look like the RLD without the breakmarks being functional. Thus, the FDA desired consistent scoring between a generic product and its RLD. There is also the problem of insurance comp – anies and doctors increasingly recommending that patients split high dosage tablets and take those halves or quarters to save money on their medicines bills. It is interesting that the FDA considers that tablet splitting is manufacturing under the Federal Food, Drug and Cosmetic Act and therefore establishments that do this must register with the FDA and comply with Current Good Manufacturing Practice (CGMP). However, this would not apply to a pharmacy dispensing a prescription for individually identified patients.

Isothermal calorimetry in the pharmaceutical sciences

Isothermal calorimetry in the pharmaceutical sciences

Issue 3 2013, Thermal Processing / 13 June 2013 / Anthony E. Beezer and Simon Gaisford, UCL School of Pharmacy

Fifty years ago, isothermal microcalorimetry (IMC) was a means to determine thermodynamic data (principally values for enthalpies of formation or reaction to assist in the calculation of Gibb’s Free Energy functions and entropies). These data were used in the compilation of tables of thermodynamic values, for use in evaluating, inter alia, reaction feasibilities, reaction extents (effectively equilibrium constants) and, indeed, reaction enthalpies. For these measurements, an experimental timescale of 30 minutes was considered long. The applications of IMC have developed and expanded considerably over the years, to the point where it can be considered a real-time process monitor with application to virtually all areas of pharmaceutical development. Accompanying this evolution has been a significant growth in the availability of commercial instruments (in contrast to the previous practice of individual, laboratory designed and built instruments).

Mass Spectrometry Supplement 2013

Mass Spectrometry: In-depth focus 2013

Chromatography, Issue 2 2013, Supplements / 17 April 2013 / Uwe Christians, Jelena Klawitter, Jost Klawitter, George McLeod, Min Yang

Corticosteroids and mass spectrometry; latest applications using LC/MS3.
Multi-analyte LC-MS/MS assays for the quantification of endogenous compounds during the development of drugs and companion diagnostics…

In-Depth Focus: Mass Spectrometry

In-depth focus – Mass Spectrometry

Chromatography, Issue 2 2012, Supplements / 25 April 2012 / Ana Rita Angelino, Min Yang, Tasso Miliotis, Constanze Hilgendorf, Anthony Bristow, George McLeod, Detlev Hochmuth, Alessandro Baldi, Gary Harland

Mass spectrometry in drug discovery – Proteomics, small molecules and metablomics.
Quantification of membrane drug transporters and application in drug discovery and development.
Mass spectrometry leaders roundtable.


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