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

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...

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Main Authors:	J.P. Mitchell, C.G. Blatchford, Roland Greguletz, Daryl L. Roberts, Hendrik Versteeg
Format:	Default Conference proceeding
Published:	2018
Subjects:	Mechanical engineering not elsewhere classified untagged Mechanical Engineering not elsewhere classified
Online Access:	https://hdl.handle.net/2134/35227
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id	rr-article-9559640
record_format	Figshare
spelling	rr-article-95596402018-01-01T00:00:00Z A European Pharmaceutical Aerosol Group (EPAG)-led cross-industry assessment of inlet flow rate profiles of compendial DPI test systems: Part 1 – experimental data J.P. Mitchell (7209359) C.G. Blatchford (7165325) Roland Greguletz (7209581) Daryl L. Roberts (3359453) Hendrik Versteeg (1248945) Mechanical engineering not elsewhere classified untagged Mechanical Engineering not elsewhere classified 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. 2018-01-01T00:00:00Z Text Conference contribution 2134/35227 https://figshare.com/articles/conference_contribution/A_European_Pharmaceutical_Aerosol_Group_EPAG_-led_cross-industry_assessment_of_inlet_flow_rate_profiles_of_compendial_DPI_test_systems_Part_1_experimental_data/9559640 CC BY-NC-ND 4.0
institution	Loughborough University
collection	Figshare
topic	Mechanical engineering not elsewhere classified untagged Mechanical Engineering not elsewhere classified
spellingShingle	Mechanical engineering not elsewhere classified untagged Mechanical Engineering not elsewhere classified J.P. Mitchell C.G. Blatchford Roland Greguletz Daryl L. Roberts Hendrik Versteeg A European Pharmaceutical Aerosol Group (EPAG)-led cross-industry assessment of inlet flow rate profiles of compendial DPI test systems: Part 1 – experimental data
description	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.
format	Default Conference proceeding
author	J.P. Mitchell C.G. Blatchford Roland Greguletz Daryl L. Roberts Hendrik Versteeg
author_facet	J.P. Mitchell C.G. Blatchford Roland Greguletz Daryl L. Roberts Hendrik Versteeg
author_sort	J.P. Mitchell (7209359)
title	A European Pharmaceutical Aerosol Group (EPAG)-led cross-industry assessment of inlet flow rate profiles of compendial DPI test systems: Part 1 – experimental data
title_short	A European Pharmaceutical Aerosol Group (EPAG)-led cross-industry assessment of inlet flow rate profiles of compendial DPI test systems: Part 1 – experimental data
title_full	A European Pharmaceutical Aerosol Group (EPAG)-led cross-industry assessment of inlet flow rate profiles of compendial DPI test systems: Part 1 – experimental data
title_fullStr	A European Pharmaceutical Aerosol Group (EPAG)-led cross-industry assessment of inlet flow rate profiles of compendial DPI test systems: Part 1 – experimental data
title_full_unstemmed	A European Pharmaceutical Aerosol Group (EPAG)-led cross-industry assessment of inlet flow rate profiles of compendial DPI test systems: Part 1 – experimental data
title_sort	european pharmaceutical aerosol group (epag)-led cross-industry assessment of inlet flow rate profiles of compendial dpi test systems: part 1 – experimental data
publishDate	2018
url	https://hdl.handle.net/2134/35227
_version_	1797189548393889792

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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