A novel apparatus for the determination of solubility in pressurized metered dose inhalers

Daniela Traini, Paul M. Young, Robert Price, Phillipe Rogueda

Research output: Contribution to journalArticlepeer-review

12 Citations (Scopus)

Abstract

The accurate solubility of salbutamol sulfate, budesonide, and formoterol fumarate dihydrate in hydrofluoroalkane propellant 134a at 25°C for 24 h, are reported. The authors describe a novel reusable in-line pressurized solubility apparatus containing an integral filter holder and a continuous decrimpable valve for the determination of drug/excipients solubility in pressurized metered dose inhalers. The solubility was determined by high-performance liquid chromatography. Solubility of salbutamol sulfate was determined as being below the detection limits while budesonide and formoterol fumarate dihydrate solubility were 23.136 ± 2.951 μg.g−1 and 0.776 ± 1.023 μg.g−1, respectively (n = 3). This novel solubility apparatus offers an improved ease of use and potential higher analytical throughput.
Original languageEnglish
Pages (from-to)1159-1163
Number of pages5
JournalDrug Development and Industrial Pharmacy
Volume32
Issue number10
DOIs
Publication statusPublished - 2006
Externally publishedYes

Keywords

  • pMDI
  • Solubility
  • HFA
  • Salbutamol sulfate
  • Budesonide
  • Formoterol fumarate dihydrate

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