Non-destructive microstructural characterisation of inhalation blends in-situ within capsules

Parmesh Gajjar^1,2,3*, Abhishek Rajbanshi², Giorgia Vaccaro², Fabien Leonard⁴,

Alexander Rack⁴, Phil Withers³ & Darragh Murnane^{1, 2}

¹ InformiX Pharma Limited, Unit 6 Church Farm, Bury St Edmunds, IP29 5AX, UK

² University of Hertfordshire, College Lane, Hatfield, AL10 9AB, UK

³ University of Manchester, Oxford Road, Manchester, M13 9PL, UK

⁴ European Synchrotron Radiation Facility, 38000 Grenoble, France

* Correspondence: parmesh.gajjar@informixpharma.com

Summary

The interaction between the excipient lactose and drug within a dry-powder-inhaler formulation plays an important role in the generation of the aerosol to deliver medicine to a patient. A critical challenge, however, is characterising the pre-actuated formulation without disturbing the powder structure, i.e. in a non-destructive manner. In this work, we demonstrate how X-ray Computed Tomography (XCT) can be used to distinguish between drug and excipient in inhalation blends at different strengths, with powder contained within capsules. This work is a key step in developing microstructural metrics, which can be used to compare market formulations in a non-destructive manner.