Inline UV/Vis spectroscopy as PAT tool for hot-melt extrusion
| Autor: | Jens Wesholowski, Andreas Berghaus, Sebastian Prill, Markus Thommes |
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| Rok vydání: | 2018 |
| Předmět: |
Hot Temperature
Pyrrolidines Vinyl Compounds Materials science Drug Compounding Process analytical technology Pharmaceutical Science Context (language use) 02 engineering and technology 030226 pharmacology & pharmacy Dosage form Quality by Design Matrix (chemical analysis) 03 medical and health sciences 0302 clinical medicine Theophylline Critical to quality Technology Pharmaceutical Process engineering Active ingredient Spectroscopy Near-Infrared Calorimetry Differential Scanning business.industry 021001 nanoscience & nanotechnology Carbamazepine Feasibility Studies Extrusion 0210 nano-technology business |
| Zdroj: | Drug Delivery and Translational Research. 8:1595-1603 |
| ISSN: | 2190-3948 2190-393X |
| Popis: | Hot-melt extrusion on co-rotating twin screw extruders is a focused technology for the production of pharmaceuticals in the context of Quality by Design. Since it is a continuous process, the potential for minimizing product quality fluctuation is enhanced. A typical application of hot-melt extrusion is the production of solid dispersions, where an active pharmaceutical ingredient (API) is distributed within a polymer matrix carrier. For this dosage form, the product quality is related amongst others to the drug content. This can be monitored on- or inline as critical quality attribute by a process analytical technology (PAT) in order to meet the specific requirements of Quality by Design. In this study, an inline UV/Vis spectrometer from ColVisTec was implemented in an early development twin screw extruder and the performance tested in accordance to the ICH Q2 guideline. Therefore, two API (carbamazepine and theophylline) and one polymer matrix (copovidone) were considered with the main focus on the quantification of the drug load. The obtained results revealed the suitability of the implemented PAT tool to quantify the drug load in a typical range for pharmaceutical applications. The effort for data evaluation was minimal due to univariate data analysis, and in combination with a measurement frequency of 1 Hz, the system is sufficient for real-time data acquisition. |
| Databáze: | OpenAIRE |
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