Multispectral UV imaging for surface analysis of MUPS tablets with special focus on the pellet distribution
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Multispectral UV imaging for surface analysis of MUPS tablets with special focus on the pellet distribution. / Novikova, Anna; Carstensen, Jens M; Rades, Thomas; Leopold, Prof Dr Claudia S.
In: International Journal of Pharmaceutics, Vol. 515, No. 1-2, 01.10.2016, p. 374-383.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Multispectral UV imaging for surface analysis of MUPS tablets with special focus on the pellet distribution
AU - Novikova, Anna
AU - Carstensen, Jens M
AU - Rades, Thomas
AU - Leopold, Prof Dr Claudia S
N1 - Copyright © 2016 Elsevier B.V. All rights reserved.
PY - 2016/10/1
Y1 - 2016/10/1
N2 - In the present study the applicability of multispectral UV imaging in combination with multivariate image analysis for surface evaluation of MUPS tablets was investigated with respect to the differentiation of the API pellets from the excipients matrix, estimation of the drug content as well as pellet distribution, and influence of the coating material and tablet thickness on the predictive model. Different formulations consisting of coated drug pellets with two coating polymers (Aquacoat(®) ECD and Eudragit(®) NE 30 D) at three coating levels each were compressed to MUPS tablets with various amounts of coated pellets and different tablet thicknesses. The coated drug pellets were clearly distinguishable from the excipients matrix using a partial least squares approach regardless of the coating layer thickness and coating material used. Furthermore, the number of the detected drug pellets on the tablet surface allowed an estimation of the true drug content in the respective MUPS tablet. In addition, the pellet distribution in the MUPS formulations could be estimated by UV image analysis of the tablet surface. In conclusion, this study revealed that UV imaging in combination with multivariate image analysis is a promising approach for the automatic quality control of MUPS tablets during the manufacturing process.
AB - In the present study the applicability of multispectral UV imaging in combination with multivariate image analysis for surface evaluation of MUPS tablets was investigated with respect to the differentiation of the API pellets from the excipients matrix, estimation of the drug content as well as pellet distribution, and influence of the coating material and tablet thickness on the predictive model. Different formulations consisting of coated drug pellets with two coating polymers (Aquacoat(®) ECD and Eudragit(®) NE 30 D) at three coating levels each were compressed to MUPS tablets with various amounts of coated pellets and different tablet thicknesses. The coated drug pellets were clearly distinguishable from the excipients matrix using a partial least squares approach regardless of the coating layer thickness and coating material used. Furthermore, the number of the detected drug pellets on the tablet surface allowed an estimation of the true drug content in the respective MUPS tablet. In addition, the pellet distribution in the MUPS formulations could be estimated by UV image analysis of the tablet surface. In conclusion, this study revealed that UV imaging in combination with multivariate image analysis is a promising approach for the automatic quality control of MUPS tablets during the manufacturing process.
U2 - 10.1016/j.ijpharm.2016.09.087
DO - 10.1016/j.ijpharm.2016.09.087
M3 - Journal article
C2 - 27702695
VL - 515
SP - 374
EP - 383
JO - International Journal of Pharmaceutics
JF - International Journal of Pharmaceutics
SN - 0378-5173
IS - 1-2
ER -
ID: 168931864