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

Jesslynn Ooi, Simon Gaisford, Ben J. Boyd, Paul M. Young, Daniela Traini

Research output: Contribution to journalArticlepeer-review

10 Citations (Scopus)

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.
Original languageEnglish
Pages (from-to)301-309
Number of pages9
JournalInternational Journal of Pharmaceutics
Volume461
Issue number1-2
DOIs
Publication statusPublished - 30 Jan 2014
Externally publishedYes

Keywords

  • Isothemal microcalorimetry
  • Fluorinated interactions
  • Propellant
  • Crystallization
  • pMDI
  • Aerosol science
  • Salbutamol sulphate
  • Beclomethasone dipropionate

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