A Fast and Non-destructive Terahertz Dissolution Assay for Immediate Release Tablets.
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Authors
Markl, Daniel
Turner, Alice
Evans, Mike
Portieri, Alessia
Farrell, Daniel
Lucas, Ralph
Anderson, Andrew
Goodwin, Daniel J
Publication Date
2021-05Journal Title
J Pharm Sci
ISSN
0022-3549
Publisher
Elsevier BV
Volume
110
Issue
5
Pages
2083-2092
Language
eng
Type
Article
This Version
AM
Physical Medium
Print-Electronic
Metadata
Show full item recordCitation
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
Abstract
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.
Keywords
Tablets, Drug Compounding, Solubility, Porosity, Terahertz Spectroscopy
Relationships
Is supplemented by: https://doi.org/10.17863/CAM.62356
Sponsorship
Technology Strategy Board (104196)
Engineering and Physical Sciences Research Council (EP/P006965/1)
Identifiers
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
Rights
Attribution-NonCommercial-NoDerivatives 4.0 International
Licence URL: https://creativecommons.org/licenses/by-nc-nd/4.0/
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