TY - JOUR
T1 - UV imaging of Multiple Unit Pellet System (MUPS) tablets: A case study of acetylsalicylic acid stability
AU - Novikova, Anna
AU - Carstensen, Jens Michael
AU - Rades, Thomas
AU - Leopold, Claudia S.
PY - 2017
Y1 - 2017
N2 - 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 330 d). 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.
AB - 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 330 d). 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.
KW - API stability
KW - HPLC
KW - MUPS tablets
KW - PLS
KW - UV imaging
KW - Multivariate Data Analysis
U2 - 10.1016/j.ejpb.2017.08.002
DO - 10.1016/j.ejpb.2017.08.002
M3 - Journal article
C2 - 28780276
SN - 0939-6411
VL - 119
SP - 447
EP - 453
JO - European Journal of Pharmaceutics and Biopharmaceutics
JF - European Journal of Pharmaceutics and Biopharmaceutics
ER -