Journal of Biotechnology & Biomaterials
Open Access

Abstract

A novel flow through elution method mimicking embolization was developed to quantify drug elution from Drug-Eluting Beads (DEB). This study intends to overcome limitations of existing techniques and to provide more in vivo like drug elution profiles for DEB evaluation. DEB of various sizes loaded with doxorubicin at clinically relevant concentrations were tested. The developed method used a temperature controlled continuous open-loop flow through extraction cell, through which the elution medium was driven by a peristaltic pump and drug elution was monitored by a UV detector. Historically, elution rates have been generated largely on a closed loop system, which are highly dependent upon the method and conditions used, making comparisons very difficult. USP II and IV methods offer comparative or quality control data due to rapid drug extraction and automation, whereas the T-apparatus mimics the in vivo situation correlating to systemic exposure but has some practical limitations. Our method generates reproducible data, allowing more effective DEB elution over a practical time period. Elution remains faster the smaller the beads size but the difference in release rates is less pronounced than the other methods which are highly dependent on bead surface area exposure. This new method was used to characterize the elution of drug from a number of different DEB for comparison with published in vivo data and offered more clinically relevant conditions than existing methods. It allowed for evaluation of various parameters (drug, extraction flow rate, size, geometry, novel DEB materials etc.), ultimately aiding in the development of more sophisticated products for the clinician.

Biography

Tanya Sian Swaine is currently a PhD Researcher at the University of Huddersfield, executing a project in collaboration with Biocompatibles UK Ltd. Prior to the commencement of her PhD; she gained five years industrial experience working with medical devices, before pursuing her interests at doctorate level. Prior to the completion of her first year in research, she had already published a paper in the well reputed International Journal of Pharmaceutics.

Email: Tanya.Swaine@hud.ac.uk