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Pharmaceutical Manufacturing and Packing Sourcer

Putting Inhalers to the Test

PMPS: What new technologies are emerging to improve and evolve inhaler testing processes?

Anna Sipitanou: A key trend in inhaler testing is improving the clinical realism of in vitro studies. In vitro tests are simple and cost-efficient, so maximising their use is beneficial to the speed and cost of product development. When it comes to demonstrating bioequivalence (BE), better in vitro data substantially reduce reliance on clinical trials, in theory, under EMA guidelines, to the extent of eliminating them (1).

Examples of new technology associated with this trend range from equipment that enables predictive dissolution methods to accessories that more realistically simulate regional drug deposition. More anatomically realistic throat and nose models are an increasingly routine feature in modern test set-ups.

Despite the historic assumption that drug particles reaching the lung will dissolve rapidly, fluid levels in the lung are far from optimal for dissolution. Representative dissolution testing enables researchers to better investigate this critical aspect of drug delivery and can help to detect subtle but important differences between generic and reference products.

What are the current challenges in the testing of inhalation products?

Most challenges associated with the testing of inhalation products relate to their underlying complexity and the associated difficulties of refining testing to produce more consistent, better quality data.

Inhaled drug delivery is impacted by interactions between the patient, the device, and the formulation. This sets orally inhaled and nasal drug products (OINDPs) apart from other drug products. With oral solid dosage, injection, or infusion, the patient receives a known quantity of drug. In contrast, with an OINDP, the amount of drug received depends on multiple factors, including the technique and physiology of the patient, device design, and formulation properties.

This complexity directly impacts testing. Though there is commonality between the methods used for different types of OINDPs, test set-ups and conditions are essentially product specific, notably for DPIs because of the need to reflect device flow resistance and their passive nature. This specificity and the convoluted nature of core techniques, such as cascade impaction (for APSD measurement), make end-to-end automation difficult to achieve. Inhalation product testing remains largely manual and, as a result, subject to operator variability. Reducing variability while at the same time improving testing productivity is a major challenge, but semi-automation can help significantly; so too can better training. Interest in the broader exploitation of inhaled drug delivery also brings challenges. Inhalation products are used predominantly to deliver small molecule active drugs for localised action. However, there is potential for the delivery of systemic therapies – as evidenced by the success of nasal spray treatments for migraine – and for vaccines and biologics. Avoidance of the gastrointestinal tract is a major advantage, and OINDPs enjoy relatively high patient acceptance. Trends towards increasingly personalised medicine further intensify the need to progressively enhance test methods to generate more precise and relevant data, for increasingly specific patient physiologies, for different types of drugs, and to better understand in vivo drug delivery.

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Anna Sipitanou holds a BSc in Chemistry and an MSc in Drug Discovery & Pharmaceutical Sciences. Having joined Copley Scientific in 2017, Anna plays a key role in the company’s technical and sales support services, including the training of customers on a wide range of pharmaceutical testing equipment, with a particular focus on OINPD testing. Having worked closely with pharmaceutical companies on a wide range of OINDP projects, Anna has gained specialist knowledge of the regulatory requirements for both delivered dose uniformity and aerodynamic particle size distribution testing, as well as extensive experience in methods to improve in vitro-in vivo correlations and other specialist testing applications, including generic drug development, inhaled dissolution, and facemask testing.
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