@article{MTMT:34771157, title = {Machine vision-based non-destructive dissolution prediction of meloxicam-containing tablets}, url = {https://m2.mtmt.hu/api/publication/34771157}, author = {Mészáros, Lilla Alexandra and Madarász, Lajos and Kádár, Szabina and Ficzere, Máté and Farkas, Attila and Nagy, Zsombor Kristóf}, doi = {10.1016/j.ijpharm.2024.124013}, journal-iso = {INT J PHARM}, journal = {INTERNATIONAL JOURNAL OF PHARMACEUTICS}, volume = {655}, unique-id = {34771157}, issn = {0378-5173}, abstract = {Machine vision systems have emerged for quality assessment of solid dosage forms in the pharmaceutical industry. These can offer a versatile tool for continuous manufacturing while supporting the framework of process analytical technology, quality-by-design, and real-time release testing. The aim of this work is to develop a digital UV/VIS imaging-based system for predicting the in vitro dissolution of meloxicam-containing tablets. The alteration of the dissolution profiles of the samples required different levels of the critical process parameters, including compression force, particle size and content of the API. These process parameters were predicted non-destructively by multivariate analysis of UV/VIS images taken from the tablets. The dissolution profile prediction was also executed using solely the image data and applying artificial neural networks. The prediction error (RMSE) of the dissolution profile points was less than 5%. The alteration of the API content directly affected the maximum concentrations observed at the end of the dissolution tests. This parameter was predicted with a relative error of less than 10% by PLS models that are based on the color components of UV and VIS images. In conclusion, this paper presents a modern, non-destructive PAT solution for real-time testing of the dissolution of tablets. © 2024 The Author(s)}, keywords = {meloxicam; Quality assessment; artificial neural network; Machine vision; Dissolution testing; Dissolution prediction}, year = {2024}, eissn = {1873-3476}, orcid-numbers = {Farkas, Attila/0000-0002-8877-2587} } @article{MTMT:34759143, title = {Effects of omitting titanium dioxide from the film coating of a pharmaceutical tablet – An industrial case study of attempting to comply with EU regulation 2022/63}, url = {https://m2.mtmt.hu/api/publication/34759143}, author = {Galata, Dorián László and Sinka Lázárné, Melinda and Kiss-Kovács, Dorottya and Fülöp, Gergő and Dávid, Barnabás and Bogáti, Botond and Ficzere, Máté and Péterfi, Orsolya and Nagy, Brigitta and Marosi, György and Nagy, Zsombor Kristóf}, doi = {10.1016/j.ejps.2024.106750}, journal-iso = {EUR J PHARM SCI}, journal = {EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES}, volume = {196}, unique-id = {34759143}, issn = {0928-0987}, year = {2024}, eissn = {1879-0720}, orcid-numbers = {Marosi, György/0000-0002-4774-2023} } @article{MTMT:34759117, title = {UV–VIS imaging-based investigation of API concentration fluctuation caused by the sticking behaviour of pharmaceutical powder blends}, url = {https://m2.mtmt.hu/api/publication/34759117}, author = {Péterfi, Orsolya and Mészáros, Lilla Alexandra and Szabó-Szőcs, Bence and Ficzere, Máté and Sipos, Emese and Farkas, Attila and Galata, Dorián László and Nagy, Zsombor Kristóf}, doi = {10.1016/j.ijpharm.2024.124010}, journal-iso = {INT J PHARM}, journal = {INTERNATIONAL JOURNAL OF PHARMACEUTICS}, volume = {655}, unique-id = {34759117}, issn = {0378-5173}, abstract = {Surface powder sticking in pharmaceutical mixing vessels poses a risk to the uniformity and quality of drug formulations. This study explores methods for evaluating the amount of pharmaceutical powder mixtures adhering to the metallic surfaces. Binary powder blends consisting of amlodipine and microcrystalline cellulose (MCC) were used to investigate the effect of the mixing order on the adherence to the vessel wall. Elevated API concentrations were measured on the wall and within the dislodged material from the surface, regardless of the mixing order of the components. UV imaging was used to determine the particle size and the distribution of the API on the metallic surface. The results were compared to chemical maps obtained by Raman chemical imaging. The combination of UV and VIS imaging enabled the rapid acquisition of chemical maps, covering a substantially large area representative of the analysed sample. UV imaging was also applied in tablet inspection to detect tablets that fail to meet the content uniformity criteria. The results present powder adherence as a possible source of poor content uniformity, highlighting the need for 100% inspection of pharmaceutical products to ensure product quality and safety.}, year = {2024}, eissn = {1873-3476}, orcid-numbers = {Péterfi, Orsolya/0000-0002-1921-1452; Farkas, Attila/0000-0002-8877-2587} } @article{MTMT:34544805, title = {Quantitative and qualitative analysis of cell culture media powders for mammalian cells by Raman microscopy}, url = {https://m2.mtmt.hu/api/publication/34544805}, author = {Hirsch, Edit and Bornemissza, Zsuzsanna and Nagy, Zsombor Kristóf and Marosi, György and Farkas, Attila}, doi = {10.1016/j.saa.2024.123906}, journal-iso = {SPECTROCHIM ACTA A}, journal = {SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY}, volume = {310}, unique-id = {34544805}, issn = {1386-1425}, year = {2024}, eissn = {1873-3557}, orcid-numbers = {Marosi, György/0000-0002-4774-2023; Farkas, Attila/0000-0002-8877-2587} } @inproceedings{MTMT:34476285, title = {Droplet Based Prediction of Viscosity of Water-PVP Solutions Using Convolutional Neural Networks}, url = {https://m2.mtmt.hu/api/publication/34476285}, author = {Mrad, Mohamed Azouz and Csorba, Kristóf and Galata, Dorián László and Nagy, Zsombor Kristóf and Nagy, Brigitta}, booktitle = {Proceedings of the Automation and Applied Computer Science Workshop 2023 (AACS'23)}, unique-id = {34476285}, abstract = {The viscosity of a liquid is the property that measures the liquid internal resistance to flow. Monitoring viscosity is a vital component of quality control in several industrial fields including chemical, pharmaceutical, food, and energy-related industries. The most commonly used instrument for measuring viscosity is capillary viscometers, but their cost and complexity pose challenges for industries where accurate and real-time viscosity information is vital. In this work, we prepared thirteen solutions with different water and PVP (Polyvinylpyrrolidone) ratios, measured their different viscosity values, and produced videos of their droplets. We extracted the images of the fully developed droplets from the videos and we used the images to train a Convolutional neural network model to estimate the viscosity values of the WaterPVP solutions. The proposed model was able to predict the viscosity values of the samples using images of their droplets with a high accuracy on the test dataset.}, year = {2023}, pages = {1-15}, orcid-numbers = {Mrad, Mohamed Azouz/0000-0001-5223-3680} } @article{MTMT:34420142, title = {Development of a PAT platform for the prediction of granule tableting properties}, url = {https://m2.mtmt.hu/api/publication/34420142}, author = {Casian, T. and Nagy, Brigitta and Lazurca, C. and Marcu, V. and Tőkés, E.O. and Kelemen, É.K. and Zöldi, K. and Oprean, R. and Nagy, Zsombor Kristóf and Tomuta, I. and Kovács, B.}, doi = {10.1016/j.ijpharm.2023.123610}, journal-iso = {INT J PHARM}, journal = {INTERNATIONAL JOURNAL OF PHARMACEUTICS}, volume = {648}, unique-id = {34420142}, issn = {0378-5173}, year = {2023}, eissn = {1873-3476} } @article{MTMT:34401080, title = {Szerves Kémia és Technológia Tanszék}, url = {https://m2.mtmt.hu/api/publication/34401080}, author = {Hegedűs, László and Hornyánszky, Gábor and Nagy, Zsombor Kristóf}, journal-iso = {MAGY KEM LAP}, journal = {MAGYAR KÉMIKUSOK LAPJA}, volume = {78}, unique-id = {34401080}, issn = {0025-0163}, year = {2023}, eissn = {1588-1199}, pages = {356-359}, orcid-numbers = {Hegedűs, László/0000-0002-7980-0443} } @article{MTMT:34352488, title = {Development and Comparison of Alternative Methods for the Purification of Adalimumab Directly from Harvested Cell Culture Fluid}, url = {https://m2.mtmt.hu/api/publication/34352488}, author = {Vaskó, Dorottya and Domján, Júlia and Szűcs, Bence and Bakk, László and Hajdinák, Péter and Marosi, György and Nagy, Zsombor Kristóf and Hirsch, Edit and Fehér, Csaba}, doi = {10.17113/ftb.61.03.23.8094}, journal-iso = {FOOD TECHNOL BIOTECH}, journal = {FOOD TECHNOLOGY AND BIOTECHNOLOGY}, volume = {61}, unique-id = {34352488}, issn = {1330-9862}, abstract = {Research background. Protein A affinity chromatography is a well-established methodcurrently used in the pharmaceutical industry. However, the high costs usually associated with chromatographic separation of protein A and the difficulties in continuous operation make the investigation of alternative purification methods very important.Experimental approach. In this study, extraction/back-extraction and precipitation/dissolution methods were developed and optimised. They were compared with protein A and cation exchange chromatography separations in terms of yield of monoclonal antibody (mAb) and amount of residual impurities, such as DNA and host cell proteins, and amount of mAb aggregates. For a comprehensive comparison of the different methods, experiments were carried out with the same cell-free fermentation broth containing adalimumab.Results and conclusions. Protein A and cation exchange chromatographic separationsresulted in high yield and purity of adalimumab. The precipitation-based process resulted in high yield but with lower purity. The extraction-based purification resulted in low yield and purity. Thus, the precipitation-based method proved to be more promising than the extraction-based method for direct purification of adalimumab from harvested cell culture fluid.Novelty and scientific contribution. Although alternative purification methods may offerthe advantages of simplicity and low-cost operation, further significant improvementsare required to compete with the performance of chromatographic separations of adalimumab from true fermentation broth.}, year = {2023}, eissn = {1334-2606}, pages = {339-349}, orcid-numbers = {Vaskó, Dorottya/0000-0002-2502-0644; Hajdinák, Péter/0000-0002-7705-2074; Marosi, György/0000-0002-4774-2023} } @article{MTMT:34342443, title = {Image-based simultaneous particle size distribution and concentration measurement of powder blend components with deep learning and machine vision}, url = {https://m2.mtmt.hu/api/publication/34342443}, author = {Ficzere, Máté and Péterfi, Orsolya and Farkas, Attila and Nagy, Zsombor Kristóf and Galata, Dorián László}, doi = {10.1016/j.ejps.2023.106611}, journal-iso = {EUR J PHARM SCI}, journal = {EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES}, volume = {191}, unique-id = {34342443}, issn = {0928-0987}, year = {2023}, eissn = {1879-0720}, orcid-numbers = {Farkas, Attila/0000-0002-8877-2587} } @article{MTMT:34131207, title = {Comparing the Performance of Raman and Near-Infrared Imaging in the Prediction of the In Vitro Dissolution Profile of Extended-Release Tablets Based on Artificial Neural Networks}, url = {https://m2.mtmt.hu/api/publication/34131207}, author = {Galata, Dorián László and Gergely, Szilveszter and Nagy, Rebeka and Slezsák, János and Ronkay, Ferenc György and Nagy, Zsombor Kristóf and Farkas, Attila}, doi = {10.3390/ph16091243}, journal-iso = {PHARMACEUTICALS-BASE}, journal = {PHARMACEUTICALS}, volume = {16}, unique-id = {34131207}, abstract = {In this work, the performance of two fast chemical imaging techniques, Raman and near-infrared (NIR) imaging is compared by utilizing these methods to predict the rate of drug release from sustained-release tablets. Sustained release is provided by adding hydroxypropyl methylcellulose (HPMC), as its concentration and particle size determine the dissolution rate of the drug. The chemical images were processed using classical least squares; afterwards, a convolutional neural network was applied to extract information regarding the particle size of HPMC. The chemical images were reduced to an average HPMC concentration and a predicted particle size value; these were used as inputs in an artificial neural network with a single hidden layer to predict the dissolution profile of the tablets. Both NIR and Raman imaging yielded accurate predictions. As the instrumentation of NIR imaging allows faster measurements than Raman imaging, this technique is a better candidate for implementing a real-time technique. The introduction of chemical imaging in the routine quality control of pharmaceutical products would profoundly change quality assurance in the pharmaceutical industry.}, year = {2023}, eissn = {1424-8247}, orcid-numbers = {Gergely, Szilveszter/0000-0003-1945-526X; Ronkay, Ferenc György/0000-0003-0525-1493; Farkas, Attila/0000-0002-8877-2587} }