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A European Pharmaceutical Aerosol Group (EPAG)-led cross-industry assessment of inlet flow rate profiles of compendial DPI test systems: Part 1 – experimental data

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conference contribution
posted on 08.10.2018, 14:06 by J.P. Mitchell, C.G. Blatchford, Roland Greguletz, Daryl L. Roberts, Hendrik Versteeg
We report outcomes from an EPAG-led cross-industry study, characterizing flow rate/elapsed-time profiles of equipment used for testing dry powder inhalers (DPIs). A thermal mass flow sensor was used by nine organizations in a round-robin approach to record inlet flow rate-time profiles of individual participant compendial test systems (TS) including either sample collection tubes (SCT) or a cascade impactor (either the Andersen 8-stage non-viable impactor, ACI, or the Next Generation Impactor, NGI) equipped with USP/PhEur induction port and pre-separator. An inlet orifice generated a 4-kPa pressure drop at each of the target flow rates (30, 60 and 90 L/min), simulating a pressure drop typical for high-, medium- and low-resistance DPIs respectively. Rise times to 90% of these target flow rates (t90) were longest with largest internal dead volume and followed the order NGI>ACI >SCT>TS. When the surrogate DPI (4-kPa orifice) was absent, t90 values generally lengthened with increasing target flow rate. In contrast, the opposite behaviour was observed when the surrogate DPI was present. A flow acceleration parameter was also calculated, expressed as the slope between the 20% and 80% flow rates of each final steady flow value (slopet20/t80). Greater flow acceleration occurred at higher final flow rates, irrespective of apparatus, but the presence of the surrogate DPI was associated with slower flow acceleration. These flow rate-rise time profiles will be useful for those involved in evaluating equipment for characterizing both existing and new DPIs.

History

School

  • Mechanical, Electrical and Manufacturing Engineering

Published in

Drug Delivery to the Lungs 2018

Citation

MITCHELL, J.P. ... et al, 2018. A European Pharmaceutical Aerosol Group (EPAG)-led cross-industry assessment of inlet flow rate profiles of compendial DPI test systems: Part 1 – experimental data. Presented at the Drug Delivery to the Lungs conference 2018 (DDL2018), Edinburgh, UK, 12-14 December 2018.

Publisher

© The Aerosol Society

Version

AM (Accepted Manuscript)

Publisher statement

This work is made available according to the conditions of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) licence. Full details of this licence are available at: https://creativecommons.org/licenses/by-nc-nd/4.0/

Acceptance date

11/09/2018

Publication date

2018

Notes

This is a conference paper.

Language

en

Location

Edinburgh

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