Inline Determination of Residence Time Distribution in Hot-Melt-Extrusion
In the framework of Quality-by-Design (QbD), the inline determination of process parameters or quality attributes of a product using sufficient process analytical technology (PAT) is a center piece for the establishment of continuous processes as a standard pharmaceutical technology. In this context...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2018-04-01
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| Series: | Pharmaceutics |
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| Online Access: | http://www.mdpi.com/1999-4923/10/2/49 |
| _version_ | 1828275969962541056 |
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| author | Jens Wesholowski Andreas Berghaus Markus Thommes |
| author_facet | Jens Wesholowski Andreas Berghaus Markus Thommes |
| author_sort | Jens Wesholowski |
| collection | DOAJ |
| description | In the framework of Quality-by-Design (QbD), the inline determination of process parameters or quality attributes of a product using sufficient process analytical technology (PAT) is a center piece for the establishment of continuous processes as a standard pharmaceutical technology. In this context, Twin-Screw-Extrusion (TSE) processes, such as Hot-Melt-Extrusion (HME), are one key aspect of current research. The main benefit of this process technology is the combination of different unit operations. Several of these sub-processes are linked to the Residence Time Distribution (RTD) of the material within the apparatus. In this study a UV/Vis spectrophotometer from ColVisTec was tested regarding the suitability for the inline determination of the RTD of an HME process. Two different measuring positions within a co-rotating Twin-Screw-Extruder were compared to an offline HPLC–UV as reference method. The obtained results were overall in good agreement and therefore the inline UV/Vis spectrophotometer is suitable for the determination of the RTD in TSE. An influence of the measuring position on repeatability was found and has to be taken into consideration for the implementation of PATs. An effect of the required amount of marker on process rheology is not likely due to the low Limit-of-Quantification (LoQ). |
| first_indexed | 2024-04-13T06:52:20Z |
| format | Article |
| id | doaj.art-7a55a90460284184aac0c63e02b32175 |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-04-13T06:52:20Z |
| publishDate | 2018-04-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-7a55a90460284184aac0c63e02b321752022-12-22T02:57:22ZengMDPI AGPharmaceutics1999-49232018-04-011024910.3390/pharmaceutics10020049pharmaceutics10020049Inline Determination of Residence Time Distribution in Hot-Melt-ExtrusionJens Wesholowski0Andreas Berghaus1Markus Thommes2Institute of Solids Process Engineering, TU Dortmund University, Dortmund 44227, GermanyColVisTec AG, Berlin 12489, GermanyInstitute of Solids Process Engineering, TU Dortmund University, Dortmund 44227, GermanyIn the framework of Quality-by-Design (QbD), the inline determination of process parameters or quality attributes of a product using sufficient process analytical technology (PAT) is a center piece for the establishment of continuous processes as a standard pharmaceutical technology. In this context, Twin-Screw-Extrusion (TSE) processes, such as Hot-Melt-Extrusion (HME), are one key aspect of current research. The main benefit of this process technology is the combination of different unit operations. Several of these sub-processes are linked to the Residence Time Distribution (RTD) of the material within the apparatus. In this study a UV/Vis spectrophotometer from ColVisTec was tested regarding the suitability for the inline determination of the RTD of an HME process. Two different measuring positions within a co-rotating Twin-Screw-Extruder were compared to an offline HPLC–UV as reference method. The obtained results were overall in good agreement and therefore the inline UV/Vis spectrophotometer is suitable for the determination of the RTD in TSE. An influence of the measuring position on repeatability was found and has to be taken into consideration for the implementation of PATs. An effect of the required amount of marker on process rheology is not likely due to the low Limit-of-Quantification (LoQ).http://www.mdpi.com/1999-4923/10/2/49UV/Vis spectroscopyResidence Time Distributiontwin screw extrusionprocess analytical toolQuality-by-Design |
| spellingShingle | Jens Wesholowski Andreas Berghaus Markus Thommes Inline Determination of Residence Time Distribution in Hot-Melt-Extrusion Pharmaceutics UV/Vis spectroscopy Residence Time Distribution twin screw extrusion process analytical tool Quality-by-Design |
| title | Inline Determination of Residence Time Distribution in Hot-Melt-Extrusion |
| title_full | Inline Determination of Residence Time Distribution in Hot-Melt-Extrusion |
| title_fullStr | Inline Determination of Residence Time Distribution in Hot-Melt-Extrusion |
| title_full_unstemmed | Inline Determination of Residence Time Distribution in Hot-Melt-Extrusion |
| title_short | Inline Determination of Residence Time Distribution in Hot-Melt-Extrusion |
| title_sort | inline determination of residence time distribution in hot melt extrusion |
| topic | UV/Vis spectroscopy Residence Time Distribution twin screw extrusion process analytical tool Quality-by-Design |
| url | http://www.mdpi.com/1999-4923/10/2/49 |
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