Tony Moffat - 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.

Figure 1 Baseline treated Raman spectra of Zirtek 10 milligram tablet (blue) and titanium dioxide (red) measured using the Ahura Truscan instrument

Authentication of medicines using Raman spectroscopy

Issue 1 2011, Raman Spectroscopy / 16 February 2011 / Sulaf Assi, University of Hertfordshire, and Robert Watt & Tony Moffat, The School of Pharmacy, University of London

Raman spectroscopy offers a rapid and non-destructive technique for the identification of counterfeit medicines. Handheld Raman instruments offer the advantages of carrying the laboratory to the sample and giving a rapid pass or fail answer for the medicine inspected. It can identify a medicine regardless of its physical form as a tablet, powder, ointment, cream or liquid. However, the technique is limited as not all species of a medicine have a Raman scattering. Thus, the Raman spectrum obtained upon measuring a medicine might be due to the active pharmaceutical ingredient or any other excipient in the bulk or the coating of the formulation.


The deadline for submissions to the EPR Awards is 9 June 2017! Entry is FREE, so don't delay...