Intertek co-author study on inhaled medicine test procedures

21 Jul 2014

Melbourn, United Kingdom – Intertek, a leading quality solutions provider to industries worldwide, has co-published a study that enhances the pharmaceutical industry’s understanding of current industry standard test methods for inhaled medicine products.

The study, which was published in May 2014 in the American Association of Pharmaceutical Scientist (AAPS) journal, PharmSciTech, focused on current industry standard test procedures, termed pharmacopeial tests, for dry powder inhaled (DPI) medicine products which help developers determine the effectiveness and performance of inhalation products. Intertek inhalation expert, Laboratory Director, Mark Hammond, contributed to this study as a member of the European Pharmaceutical Aerosol Group (EPAG) research team which was responsible for conducting this investigation.

Current pharmacopeial methods for determining aerodynamic particle size distribution (APSD) of dry powder inhalers (DPIs) require 4L volume sample to be drawn through an impactor at a steady flow rate. Many industry stakeholders have questioned whether a reduced sample volume would more realistically match the volumes that can be inhaled by patients and so provide a more realistic simulation of patient use or greater clinical realism in the laboratory testing of inhalers. The study, however, provides support for the current sample volume of 4 L to be retained in the pharmacopeial procedure for the determination of APSD for DPI products as reducing the volume could give rise to an unacceptable level of volume–related influence on the outcome for some types of inhaler device.

Mark shared “Our EPAG research team had a very clear goal to review current established testing methods and so help industry to be more confident in the relevancy of pharmacopeia testing approaches.”

Intertek’s integrated formulation and analytical teams carry out early stage pre-formulation support, solubility screening, drug-excipient compatibility, stability testing and device selection support and inhaled medicine product testing to aid clients working to develop more efficient devices and formulations to target specific regions of the respiratory tract including nasal and sub-lingual delivery for small molecule and biologics.

The paper was published online on 29th May 2014.
Investigation of Dry Powder Inhaler (DPI) Resistance and Aerosol Dispersion Timing on Emitted Aerosol Aerodynamic Particle Sizing by Multistage Cascade Impactor when Sampled Volume Is Reduced from Compendial Value of 4 L. Mohammed H1 Arp J, Chambers F, Copley M, Glaab V, Hammond M, Solomon D, Bradford K, Russell T, Sizer Y, Nichols SC, Roberts DL, Shelton C, Greguletz R, Mitchell JP. (1GSK plc, Park Road, Ware, Hertfordshire, SG12 0DP, UK.), AAPS PharmSciTech. 2014 May 29. [Epub ahead of print]

Contacts:

Dr Lorna Kettle, Marketing Manager,
Intertek Pharmaceutical Services
Tel.:+44 161 721 1476
Email: lorna.kettle@intertek.com

About Intertek
Intertek is a leading quality solutions provider to industries worldwide. From auditing and inspection, to testing, training, advisory, quality assurance and certification, Intertek adds value for its customers by helping improve the quality and safety of their products, assets and processes. With a network of more than 1,000 laboratories and offices and over 36,000 people in more than 100 countries, Intertek supports companies’ success in the global marketplace, by helping customers to meet end users’ expectations for safety, sustainability, performance, integrity and desirability in virtually any market worldwide. Visit www.intertek.com.