Dry powder aerosols generated by standardized entrainment tubes from drug blends with lactose monohydrate: 2. Ipratropium bromide monohydrate and fluticasone propionate

Zhen Xu, Heidi M. Mansour, Tako Mulder, Richard Mclean, John Langridge, Anthony J. Hickey

Research output: Contribution to journalArticle

28 Scopus citations

Abstract

The objectives of this study were: systematic investigation of dry powder aerosol performance using standardized entrainment tubes (SETs) and lactose-based formulations with two model drugs; mechanistic evaluation of performance data by powder aerosol deaggregation equation (PADE). The drugs (IPB and FP) were prepared in sieved and milled lactose carriers (2% w/w). Aerosol studies were performed using SETs (shear stresses τs=0.624-13. 143N/m2) by twin-stage liquid impinger, operated at 60 L/min. PADE was applied for formulation screening. Excellent correlation was observed when PADE was adopted correlating FPF to τs. Higher τs corresponded to higher FPF values followed by a plateau representing invariance of FPF with increasing τs. The R2 values for PADE linear regression were 0.9905-0.9999. Performance described in terms of the maximum FPF (FPFmax: 15.0-37.6%) resulted in a rank order of ML-B/IPB>ML-A/IPB>SV-A/IPB>SV-B/IPB>ML-B/FP>ML-A/FP>SV-B/ FP>SV-A/FP. The performance of IPB was superior to FP in all formulations. The difference in lactose monohydrate carriers was less pronounced for the FPF in IPB than in FP formulations. The novel PADE offers a robust method for evaluating aerodynamic performance of dry powder formulations within a defined τs range.

Original languageEnglish (US)
Pages (from-to)3415-3429
Number of pages15
JournalJournal of pharmaceutical sciences
Volume99
Issue number8
DOIs
StatePublished - Aug 2010
Externally publishedYes

Keywords

  • Aerosolization performance
  • Aerosols
  • Dry powder inhaler
  • Emitted dose
  • Fine particle fraction
  • Physical characterization
  • Powder aerosol deaggregation equation
  • Pulmonary drug delivery
  • Shear stress
  • Standardized entrainment tubes

ASJC Scopus subject areas

  • Pharmaceutical Science

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