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European Biopharmaceutical Review

Thinking Throats with Anatomical Throat Models

In recent years, anatomical throat models, for the purpose of generating aerodynamic particle size distribution (APSD) profiles for inhaled pharmaceutical products, have become increasingly utilised within the inhalation industry. This has been driven, at least in part, by the need to demonstrate the in vitro to in vivo relationship. The FDA has funded specific research in this area (1).

Historically, APSD data has been generated using the standard US Pharmacopeia (USP) throat (2). An appreciation of the differences between profiles generated using this and anatomically relevant throats is necessary to ensure that, when developing new inhalation products, consideration is given to showing in vitro equivalence. The use of an anatomical throat may also be a useful tool to facilitate in vivo therapeutic bioequivalence prediction.

This paper assesses the level of drug deposition in the throat, impactor sized mass (ISM), and <5μm fine particle mass (FPM<5μm) when assessing data generated using the Nanopharm anatomical throat and the Emmace medium throat model compared to the standard USP throat.

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Alex Slowey is an inhalation formulation specialist at 3M Drug Delivery Systems. He earned his credentials as a pharmacist in 1997, and he joined the team at 3M later that year. Since then, he has held various roles within the R&D function at 3M DDSD. He is specialized in early phase development activities related to the formulation of new and established molecules for nasal and pulmonary delivery.

Samantha Holmes is an R&D Group Leader at 3M Drug Delivery Systems. She joined 3M in 2007 as an Analytical Chemist, after graduating from York University. She has worked with metred-dose inhalers for both early feasibility projects and late phase development programmes. Samantha specialises in analytical chemistry and works alongside the key R&D groups, supporting the development team.
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