UV imaging of multiple unit pellet system (MUPS) tablets: A case study of acetylsalicylic acid stability
| Autor: | Claudia S. Leopold, Anna Novikova, Thomas Rades, Jens Michael Carstensen |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Polymers
Surface Properties Ultraviolet Rays Pellets Pharmaceutical Science 02 engineering and technology engineering.material medicine.disease_cause 01 natural sciences High-performance liquid chromatography Excipients Drug Stability Coating Partial least squares regression Pellet medicine Technology Pharmaceutical Relative humidity Chromatography High Pressure Liquid Drug Implants Chromatography Aspirin Chemistry 010401 analytical chemistry Temperature Humidity General Medicine 021001 nanoscience & nanotechnology 0104 chemical sciences engineering Degradation (geology) 0210 nano-technology Ultraviolet Tablets Biotechnology |
| Zdroj: | European Journal of Pharmaceutics and Biopharmaceutics. 119:447-453 |
| ISSN: | 0939-6411 |
| Popis: | The applicability of multispectral ultraviolet (UV) imaging in combination with multivariate image analysis was investigated to monitor API degradation within multiple unit pellet system (MUPS) tablets during storage. For this purpose, acetylsalicylic acid (ASA) layered pellets were coated with Eudragit® RL PO and compressed to MUPS tablets. These tablets were stored under four different conditions with different levels of relative humidity (0 and 75%) and temperature (21 and 40°C) and analysed at seven storage time points (0, 15, 40, 140, 165, 265, and 330d). The UV imaging results for estimation of the salicylic acid (SA) concentration as degradation product of ASA in the tablets were compared to the SA concentration measured by high performance liquid chromatography with a partial least squares regression resulting in an RMSEP of 4.86% and an R2 of 0.9812. The estimation of the SA concentration based on mean UV reflectance spectra was possible even through the coating of the API pellets and at low concentration levels. In addition, the distribution of the SA concentration on the tablet surfaces for different storage time periods was visualized. UV imaging as fast and non-destructive method appears to offer significant potential for monitoring of API degradation during stability studies. |
| Databáze: | OpenAIRE |
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