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Introduction of the Electrical Next Generation Impactor (eNGI) and Investigation of its Capabilities for the Study of Pressurized Metered Dose Inhalers

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Abstract

Purpose

To introduce the design of the electrical Next Generation Impactor (eNGI), and validate its proposed function as a method of electrostatic characterization for pressurized metered dose inhaler (pMDI) formulations.

Methods

Flixotide® (fluticasone propionate), Ventolin® (salbutamol sulphate), and QVAR® (beclomethasone dipropionate) were used as model pMDIs in this study. At an airflow rate of 30 l/min, five individual actuations of each pMDI were introduced into the electrical low-pressure impactor (ELPI), Next Generation Impactor (NGI), and the eNGI. Charge profiles for each actuation were measured by the ELPI and eNGI, while mass profiles were recorded by the all three impactors.

Results

The difference in estimated mass median aerodynamic diameters and geometric standard deviations for all pMDIs using the NGI and eNGI were not found to be statistically significant (p < 0.05). The mean charge profiles from the ELPI and eNGI overlap well between 0.54 and 6.61 μm (Flixotide® and Ventolin®), and between 0.615 and 11.72 μm (QVAR®), where the majority of the impacted doses were collected. Conclusion: For the analysis of pMDIs, the eNGI is comparable to the NGI in measuring particle size distribution, while still being comparable to the ELPI in measuring charge distribution.

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Acknowledgments

The authors would like to acknowledge Michael Paterson, Terry Pfeiffer and Herbert Chiou for their technical advice and expertise in assisting the construction of the eNGI, and Philip Kwok for his advice on the ELPI.

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Authors and Affiliations

  1. Advanced Drug Delivery Group, Faculty of Pharmacy (A15), University of Sydney, Sydney, New South Wales, 2006, Australia

    Susan Hoe, Paul M. Young, Hak-Kim Chan & Daniela Traini

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  1. Susan Hoe
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  2. Paul M. Young
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  3. Hak-Kim Chan
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  4. Daniela Traini
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Correspondence to Paul M. Young.

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Hoe, S., Young, P.M., Chan, HK. et al. Introduction of the Electrical Next Generation Impactor (eNGI) and Investigation of its Capabilities for the Study of Pressurized Metered Dose Inhalers. Pharm Res 26, 431–437 (2009). https://doi.org/10.1007/s11095-008-9761-6

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  • DOI: https://doi.org/10.1007/s11095-008-9761-6

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