Péter-Haraszti, Anna and Bakucz, Liliána Györgyi and Mészáros, Lilla Alexandra and Záhonyi, Petra and Szabó, Edina (2025) Drug content determination of amorphous solid dispersion containing tablets using a non-destructive and rapid UV imaging method. INTERNATIONAL JOURNAL OF PHARMACEUTICS, 678. No. 125726. ISSN 0378-5173
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Abstract
This study investigates UV imaging as a rapid and cost-effective process analytical technology (PAT) tool for quantifying drug content in tablets containing amorphous solid dispersion (ASD) fibers. ASD fibers produced via high-speed electrospinning were blended with excipients using batch and continuous methods, and then subsequently compressed into tablets. UV imaging enabled the non-destructive quantification of the active pharmaceutical ingredient (API) solely based on the captured images by taking advantage of the fluorescence phenomenon of the drug under UV illumination. The principal component analysis of the images pointed out that UV imaging can distinguish tablets compressed after batch and continuous blending, highlighting the method's potential significance in quality control (e.g. detection of faulty batches or filtration of counterfeits). To quantify the API content of tablets prepared after different blending processes, two separate calibration models were developed using a partial least squares regression method with data from the preprocessed images recorded from both sides of the tablets. External validation confirmed the reliability of the models, achieving API content determination with a root mean square error of prediction of 0.381 w/w% and a relative error of 4.59 %. These findings suggest that UV imaging provides high accuracy and efficiency in a cost-effective way, positioning the method as a potentially viable PAT tool for both batch and continuous pharmaceutical manufacturing of ASD-loaded tablets. © 2025 The Author(s)
| Item Type: | Article |
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| Additional Information: | Project no. RRF-2.3.1–21–2022–00015 has been implemented with the support provided by the European Union. This paper was supported by the János Bolyai Research Scholarship of the Hungarian Academy of Science. The scientific research publicized in this article was reached with the sponsorship of Gedeon Richter Talentum Foundation in framework of Gedeon Richter Excellence PhD Scholarship of Gedeon Richter. This project was supported by the EKÖP-24-3-BME-313 and the the EKÖP-24-4-I-BME-284 New National Excellence Program of the Ministry for Culture and Innovation from the source of the National Research, Development and Innovation Fund. The project supported by the Doctoral Excellence Fellowship Programme (DCEP) is founded by the National Research Development and Innovation Fund of the Ministry of Culture and Innovation and the Budapest University of Technology and Economics. |
| Uncontrolled Keywords: | Tablets; Machine vision; Amorphous solid dispersion; Process analytical technology; UV imaging; drug content; |
| Subjects: | Q Science / természettudomány > QD Chemistry / kémia |
| SWORD Depositor: | MTMT SWORD |
| Depositing User: | MTMT SWORD |
| Date Deposited: | 23 Sep 2025 14:24 |
| Last Modified: | 23 Sep 2025 14:24 |
| URI: | https://real.mtak.hu/id/eprint/224991 |
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