TY - JOUR

T1 - UV imaging of multiple unit pellet system (MUPS) tablets

T2 - A case study of acetylsalicylic acid stability

AU - Novikova, Anna

AU - Carstensen, Jens M

AU - Rades, Thomas

AU - Leopold, Claudia S

N1 - Copyright © 2017 Elsevier B.V. All rights reserved.

PY - 2017/10

Y1 - 2017/10

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 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 R(2) 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 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 R(2) 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 - Journal Article

U2 - 10.1016/j.ejpb.2017.08.002

DO - 10.1016/j.ejpb.2017.08.002

M3 - Journal article

C2 - 28780276

VL - 119

SP - 447

EP - 453

JO - European Journal of Pharmaceutics and Biopharmaceutics

JF - European Journal of Pharmaceutics and Biopharmaceutics

SN - 0939-6411

ER -