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Pharmaceutical Research

, 36:15 | Cite as

Measuring The Bipolar Charge Distributions of Fine Particle Aerosol Clouds of Commercial PMDI Suspensions Using a Bipolar Next Generation Impactor (bp-NGI)

  • Martin RowlandEmail author
  • Alessandro Cavecchi
  • Frank Thielmann
  • Janusz Kulon
  • Jag Shur
  • Robert Price
Research Paper
  • 145 Downloads

Abstract

Purpose

To measure the charge to mass (Q/M) ratios of the impactor stage masses (ISM) from commercial Flixotide™ 250 μg Evohaler, containing fluticasone propionate (FP), Serevent™ 25 μg Evohaler, containing salmeterol xinafoate (SX), and a combination Seretide™ 250/25 μg (FP/SX) Evohaler metered dose inhalers (MDIs). Measurements were performed with a purpose built bipolar charge measurement apparatus (bp-NGI) based on an electrostatic precipitator, which was directly connected below Stage 2 of a Next Generation Impactor (NGI).

Methods

Five successive shots of the respective MDIs were actuated through the bp-NGI. The whole ISM doses were electrostatically precipitated to determine their negative, positive and net Q/m ratios.

Results

The ISM doses collected in the bp-NGI were shown to be equivalent to those collected in a standard NGI. FP particles, actuated from Flixotide™ and Seretide™ MDIs, exhibited greater quantities of negatively charged particles than positive. However, the Q/m ratios of the positively charged particles were greater in magnitude. SX particles from Serevent™ exhibited a greater quantity of positively charged particles whereas SX aerosol particles from Seretide™ exhibited a greater quantity of negatively charged particles. The Q/m ratio of the negatively charged SX particles in Serevent™ was greater in magnitude than the positively charged particles.

Conclusions

The bp-NGI was used to quantify the bipolar Q/m ratios of aerosol particles collected from the ISMs of commercial MDI products. The positive charge recorded for each of the three MDIs may have been enhanced by the presence of charged ice crystals formed from the propellant during the aerosolisation process.

KEY WORDS

Bipolar charge bipolar next generation impactor electrostatic charge pressurized metered dose inhaler 

Abbreviations

API

Active pharmaceutical ingredient

BNC

Bayonet Neill-Concelman

BOLAR

Bipolar charge analyser

bp-NGI

Bipolar next generation impactor

DC

Direct current

ED

Emitted dose

ELPI

Electrical low pressure impactor

ESPART

Electrical single particle aerodynamic relaxation time

FP

Fluticasone propionate

HFA

Hydrofluroalkane

HPLC

High performance liquid chromatography

ISM

Impactor stage mass

NGI

Next generation impactor

pMDI

Pressurized metered dose inhaler

RD

Recovered dose

SX

Salmeterol xinafoate

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Pharmaceutical Surface Science Research Group, Department of Pharmacy and PharmacologyUniversity of BathBathUK
  2. 2.Pfizer LtdKentUK
  3. 3.Novartis Pharma AG, Forum 1BaselSwitzerland
  4. 4.Chiesi Farmaceutici S.p.AParmaItaly
  5. 5.Faculty of Computing, Engineering and ScienceUniversity of South WalesPontypriddUK

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