A new white paper from Copley Scientific provides expert guidance on how to use breathing simulators effectively when testing orally inhaled products (OIPs).

Breathing simulators are machines that mimic the inhalation and/or exhalation profile of a patient and are used increasingly in OIP testing. Copley Scientific’s white paper clearly explains where breathing simulators are specified by pharmacopoeial methods and also where their optional use is beneficial. This may be in improving understanding of product performance, for example, or to support a Quality by Design (QbD) approach. 

For OIPs such as nebulisers - and now pressurised metered dose inhalers (pMDIs) with add-on devices - pharmacopoeial monographs specify the use of breathing simulators to measure the dose of drug delivered to the patient. Here the active ingredient is inhaled from a continuous stream or reservoir of aerosolised droplets/particles and consequently the inhalation profile directly affects the success of drug delivery. The use of standardised breathing profiles allows the generation of representative drug delivery data for neonates, infants, children and adults. 

Breathing simulators are not specified in the pharmacopoeias for testing dry powder inhalers. However advances in breathing simulator technology and accessories, and the implementation of QbD are encouraging their use to gain a greater understanding of the performance of this important class of OIPs. Because DPI dose uniformity and particle size performance is directly influenced by the inhalation profile applied during product use, breathing simulators reproducing profiles obtained in clinic, can help characterize a product’s behaviour more completely, for the intended patient population. This can be valuable for innovative product development and/or contribute to the demonstration of bioequivalence for a generic product within an in vitro testing environment. 

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