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The complexity of contemporary pharmaceutical formulations demands innovative analytical approaches: are we ready?

The complexity of contemporary pharmaceutical formulations demands innovative analytical approaches: are we ready?

Antonijevic, Milan, Owusu-Ware, Samuel K. and Reading, Mike (2015) The complexity of contemporary pharmaceutical formulations demands innovative analytical approaches: are we ready? In: CEEC TAC3, 25-28 August 2015, Ljubljana, Slovenia.

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Abstract

Solid and semi-solid dosage forms still dominate the pharmaceutical market; furthermore, the composition and complexity of formulations is becoming more diverse. The foregoing has led to an expansion of ever demanding experimental procedures to understand and improve the performance of the formulations/products developed and monitor the quality of end products.
One of the new initiatives [1] based on chemical mapping using microscopy, thermal analysis and separation sciences has been recently developed in order to provide answers to complex questions such as chemical 3D mapping (tomography) of solid and semi-solid formulations (and many other systems under investigation/interest), solubility assessment and dissolution profiling in the presence of different solvents or mixtures of solvents.
In the new approach, chemical analysis by dissolution assessment (CIDA), material is selectively removed from the surface of the analyte and then analysed (HPLC and IR). Microscopy is used to monitor physical changes at the surface as the material is removed and software (image analysis) enables the analytical data to be correlated with changes in the surface of the sample; this can be undertaken at the nanoscale. The whole system can be analysed isothermally, at different temperatures or via a combination of heating and cooling cycles using thermal analysis techniques. CIDA is an exciting new technique; but, more importantly, significant scientific benefits arise from obtaining many important analytical parameters in a short period of time.
The real power of the CIDA approach is that analysis can be reliably applied to a single sample, a wide variety of solvents can be used, physico-chemical changes in surface properties and detection of removed chemicals are simultaneously monitored at the micro/nano scale; the use of chemicals is minimized. Unique information about surface properties and changes therein is obtained and the methodology used can be easily automated.
Analytical challenges often led to creativity in problem solving and this approach will, no doubt, present new demands in different areas of research; the example(s) provided in pharmaceuticals will influence interdisciplinary scientific developments in other areas of formulation science.

Item Type: Conference or Conference Paper (Speech)
Additional Information: Oral Presentations 4: Bio(macro)molecules & Biocomposites, BioCalorimetry, Life science and Organic & Functional complex compounds
Uncontrolled Keywords: Pharmaceutical Formulations, as chemical 3D mapping, solubility assessment, dissolution profiling, chemical analysis by dissolution assessment (CIDA)
Subjects: Q Science > QD Chemistry
Faculty / Department / Research Group: Faculty of Engineering & Science > Department of Pharmaceutical, Chemical & Environmental Sciences
Related URLs:
Last Modified: 17 Oct 2016 09:13
Selected for GREAT 2016: None
Selected for GREAT 2017: None
Selected for GREAT 2018: None
URI: http://gala.gre.ac.uk/id/eprint/14015

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