Ooi, J;
Traini, D;
Boyd, BJ;
Gaisford, S;
Young, PM;
(2015)
Determination of physical and chemical stability in pressurised metered dose inhalers: potential new techniques.
Expert Opinion on Drug Delivery
, 12
(10)
pp. 1661-1675.
10.1517/17425247.2015.1046834.
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Abstract
INTRODUCTION: Pressurised metered dose inhalers (pMDIs) are subject to rigorous physical and chemical stability tests during formulation. Due to the time and cost associated with product development studies, there is a need for online techniques to fast screen new formulations in terms of physical and chemical (physico-chemical) stability. The problem with achieving this is that pMDIs are by their definition, pressurised, making the direct observation of physico-chemical properties in situ difficult. AREAS COVERED: This review highlights the characterisation tools that can enhance the product development process for pMDIs. Techniques investigated include: laser diffraction, Raman spectroscopy, isothermal ampoule calorimetry, titration calorimetry and gas perfusion calorimetry. The operational principles behind each technique are discussed and complemented with examples from the literature. EXPERT OPINION: Laser diffraction is well placed to analyse real-time physical stability as a function of particle size; however, its use is restricted to suspension pMDIs. Raman spectroscopy can be potentially used to attain both suspension and solution pMDI spectra in real time; however, the majority of experiments are ex-valve chemical composition mapping. Calorimetry is an effective technique in capturing both chemical and physical degradations of APIs in real time but requires redevelopment to withstand pressure for the purposes of pMDI screening.
| Type: | Article |
|---|---|
| Title: | Determination of physical and chemical stability in pressurised metered dose inhalers: potential new techniques |
| Location: | England |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1517/17425247.2015.1046834 |
| Publisher version: | http://dx.doi.org/10.1517/17425247.2015.1046834 |
| Language: | English |
| Additional information: | Copyright © 2015 Elsevier B.V. This manuscript is made available under a Creative Commons Attribution Non-commercial Non-derivative 4.0 International license (CC BY-NC-ND 4.0). This license allows you to share, copy, distribute and transmit the work for personal and non-commercial use providing author and publisher attribution is clearly stated. Further details about CC BY licenses are available at http://creativecommons.org/ licenses/by/4.0. Access may be initially restricted by the publisher. |
| Keywords: | Raman, drug stability, fast screening techniques, isothermal calorimetry, laser diffraction, pressurised metered dose inhalers |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy > Pharmaceutics |
| URI: | https://discovery.ucl.ac.uk/id/eprint/1471878 |
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