A Fast and Non-destructive Terahertz Dissolution Assay for Immediate Release Tablets.
Goodwin, Daniel J
J Pharm Sci
MetadataShow full item record
Bawuah, P., Markl, D., Turner, A., Evans, M., Portieri, A., Farrell, D., Lucas, R., et al. (2021). A Fast and Non-destructive Terahertz Dissolution Assay for Immediate Release Tablets.. J Pharm Sci, 110 (5), 2083-2092. https://doi.org/10.1016/j.xphs.2020.11.041
There is a clear need for a robust process analytical technology tool that can be used for on-line/in-line prediction of dissolution and disintegration characteristics of pharmaceutical tablets during manufacture. Tablet porosity is a reliable and fundamental critical quality attribute which controls key mass transport mechanisms that govern disintegration and dissolution behavior. A measurement protocol was developed to measure the total porosity of a large number of tablets in transmission without the need for any sample preparation. By using this fast and non-destructive terahertz spectroscopy method it is possible to predict the disintegration and dissolution of drug from a tablet in less than a second per sample without the need of a chemometric model. The validity of the terahertz porosity method was established across a range of immediate release (IR) formulations of ibuprofen and indomethacin tablets of varying geometries as well as with and without debossing. Excellent correlation was observed between the measured terahertz porosity, dissolution characteristics (time to release 50% drug content) and disintegration time for all samples. These promising results and considering the robustness of the terahertz method pave the way for a fully automated at-line/on-line porosity sensor for real time release testing of IR tablets dissolution.
Tablets, Drug Compounding, Solubility, Porosity, Terahertz Spectroscopy
Is supplemented by: https://doi.org/10.17863/CAM.62356
Technology Strategy Board (104196)
Engineering and Physical Sciences Research Council (EP/P006965/1)
External DOI: https://doi.org/10.1016/j.xphs.2020.11.041
This record's URL: https://www.repository.cam.ac.uk/handle/1810/314845
Attribution-NonCommercial-NoDerivatives 4.0 International
Licence URL: https://creativecommons.org/licenses/by-nc-nd/4.0/