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Isothermal calorimetry: a predictive tool to model drug-propellant interactions in pressurized metered dose systems

Ooi, J; Gaisford, S; Boyd, BJ; Young, PM; Traini, D; (2013) Isothermal calorimetry: a predictive tool to model drug-propellant interactions in pressurized metered dose systems. International Journal of Pharmaceutics , 461 (1-2) 301 - 309. 10.1016/j.ijpharm.2013.11.055. Green open access

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Abstract

The purpose of this work was to evaluate gas perfusion isothermal calorimetry (ITC) as a method to characterize the physicochemical changes of active pharmaceutical ingredients (APIs) intended to be formulated in pressurized metered dose inhalers (pMDIs) after exposure to a model propellant. Spray dried samples of beclomethasone dipropionate (BDP) and salbutamol sulphate (SS) were exposed to controlled quantities of 2H,3H-decafluoropentane (HPFP) to determine whether ITC could be used as a suitable analytical method for gathering data on the behavioural properties of the powders in real time. The crystallization kinetics of BDP and the physiochemical properties of SS were successfully characterized using ITC and supported by a variety of other analytical techniques. Correlations between real and model propellant systems were also established using hydrofluoroalkane (HFA-227) propellant. In summary, ITC was found to be suitable for gathering data on the crystallization kinetics of BDP and SS. In a wider context, this work will have implications on the use of ITC for stability testing of APIs in HFA-based pMDIs.

Type: Article
Title: Isothermal calorimetry: a predictive tool to model drug-propellant interactions in pressurized metered dose systems
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.ijpharm.2013.11.055
Publisher version: http://dx.doi.org/10.1016/j.ijpharm.2013.11.055
Language: English
Additional information: This work is licensed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivativeWorks 3.0 license. You are free to share (copy, distribute and transmit the work), but you must attribute the author, you may not use this work for commercial purposes and you may not alter, transform, or build upon this work and distribute any derivative works you create under a similar license.
Keywords: Aerosol science, Beclomethasone dipropionate, Crystallization, Fluorinated interactions, Isothemal microcalorimetry, Propellant, Salbutamol sulphate, pMDI
UCL classification: UCL
UCL > Provost and Vice Provost Offices
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/1417318
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