Gresham, Joel, Bruin, Gerardus, Picci, Marie, Bechtold-Peters, Karoline, Dimke, Thomas, Blazejczyk, Kasia, Willekens, Wouter, Fehervary, Heleen, Vande Velde, Greetje and Davies, Evan (2024) Visualisation and Quantification of Subcutaneous Injections of Different Volumes, Viscosities and Injection Rates: An Ex-Vivo micro-CT Study. Journal of pharmaceutical sciences, - (-). ISSN -

Abstract

The effects of subcutaneous (SC) injection parameters such as drug formulation volume, viscosity and injection rate on therapeutic performance and tolerability have not been established for any drug product. In this study four groups of SC injections were performed on fresh ex vivo minipig abdominal tissue samples, varying volume (0.5-1 mL), viscosity (1-11 cP) and rate (0.02-0.1 mL/s). Micro-CT provided high resolution (50 micron) imaging of the SC tissues before and after injection, enabling a detailed 3D visualisation and analysis of how both injection parameters and tissue microstructure influence spatial distribution of injectables. We found that volume was the only significant factor for spatial distribution of injectate within our design space, and there were no significant factors for tissue backpressure. Variability between tests groups was typically greater than differences between group means. Accordingly, whilst the higher viscosity formulations consistently exhibited reduced spatial distribution, the sample size was not large enough to establish confidence in this result.

Item Type:	Article
Keywords:	Injectate dispersion, Imaging method, Permeability, Pharmacokinetics
Date Deposited:	03 Oct 2024 00:45
Last Modified:	03 Oct 2024 00:45
URI:	https://oak.novartis.com/id/eprint/53699