Current Edition

Clinical Gamma Scintigraphy for the Evaluation of Inhaled Medicine

IPI Speaks with Dr. Simon Warren, Research Director at Cardiff Scintigraphics on the benefits of
scintigraphic evaluation in respiratory drug delivery.

Q: Cardiff Scintigraphics Limited (CSL) is an Established Provider of Clinical Gamma Scintigraphy Services for the Evaluation of Pharmaceutical Formulations & Devices. Can you tell our readers a brief history of the company, how you started and your growth so far?

A: Cardiff Scintigraphics Limited (CSL, https://www.scintigraphics.co.uk) was formed in 1992, by three distinguished research academics from Cardiff University who had pioneered the application of gamma scintigraphy to the evaluation of pharmaceutical products. One of those founding directors, Prof Glyn Taylor, remains closely involved with the company.

CSL was established as an independent company to provide scintigraphy services to the pharma industry with a particular emphasis on respiratory drug delivery. CSL has for over 25 years performed clinical scintigraphy studies in collaboration with a local full-service contract research organisation (CRO), Simbec Research Limited. Together, in the early 2000’s, we established a purpose-built scintigraphy suite and GMP formulation laboratory at Simbec’s site and we continue to offer this unique combination of scientific, clinical, analytical, regulatory and project management expertise.

To promote the full range of research and development expertise available from CSL we started trading as i2c Pharmaceutical Services (https://www.i2cpharm.co.uk) to advance research and testing capabilities in pharmaceutical formulation and device development in addition to clinical scintigraphy services.

i2c’s laboratory key offerings include small scale manufacture (100’s–1000’s) of pressurised metered dose inhalers (pMDI’s) and dry powder inhalers (DPI’s), accelerated stability testing, particle size analysis by inertial impaction, chemical analysis by HPLC, and moisture analysis (Karl Fischer). i2c also performs analysis of oral dosage forms including tablet disintegration and dissolution and has a small-scale single-punch tablet machine. Accelerated stability assessments of all types of dosage forms are performed using four environmental cabinets at standard ICH and custom conditions.

In addition to the bespoke service offerings, CSL has developed a novel pMDI formulation & production approach and licensing opportunities are available for this Respitab™ platform technology (www. Respitab.co.uk) which offers affordable & accelerated development for NCE and generic products.

The experienced team of scientists at CSL / i2c provides independent services to global pharma, medical technology companies and emerging clients for the development of pharmaceutical formulations and inhaler devices and has performed studies for more than 30 different pharma companies, including half of the ‘Global Top 10’.

Q: You serve as the Research Director at Cardiff Scintigraphics. What does your day-to-day role look like and what are your daily goals and objectives?

A: As Research Director in a thriving R&D company, every day is different and that is what makes my role both challenging and exciting. For scintigraphy studies my day-to-day role involves close liaison with Simbec Research, in particular with the IMP management services group i.e. Research Pharmacist & QP, functions essential in the successful production of small-scale batches of radiolabelled products formulated to GMP quality standards.