TY - JOUR
T1 - Real-time prediction of dissolution profiles of coated oral dosage forms
AU - Sacher, Stephan
AU - Fink, Elisabeth
AU - Alva, Carolina
AU - Alberto Afonso Urich, Jesús
AU - Doğan, Aygün
AU - Herndler, Vanessa
AU - Koutsamanis, Ioannis
AU - Kushwah, Varun
AU - Peter, Anna
AU - Salar-Behzadi, Sharareh
AU - Wilfling, Katrina
AU - Stranzinger, Sandra
AU - Zettl, Manuel
AU - Feng, Xin
AU - Korang-Yeboah, Maxwell
AU - Wu, Huiquan
AU - Khinast, Johannes G.
N1 - Publisher Copyright:
© 2024 Elsevier B.V.
PY - 2024/12/5
Y1 - 2024/12/5
N2 - Optical coherence tomography (OCT) has emerged as an in-line monitoring technique for pharmaceutical coating processes based on a representative number of samples. In this study, an approach was developed to correlate the coating thickness measured in-line via OCT with the resultant tablet dissolution profile. This strategy enables prediction of the dissolution profile of coated oral dosage forms for each individual state of the coating process in real-time. Correlation models were developed for a tablet pan coating process and for a pellet fluid-bed coating process. The feasibility of the correlation models was tested using different process parameters and types of coating formulations. This work demonstrated that using the OCT data to predict dissolution could possibly form a unique way of assuring drug product quality and establishing a control strategy within the real-time release testing (RTRT) concept.
AB - Optical coherence tomography (OCT) has emerged as an in-line monitoring technique for pharmaceutical coating processes based on a representative number of samples. In this study, an approach was developed to correlate the coating thickness measured in-line via OCT with the resultant tablet dissolution profile. This strategy enables prediction of the dissolution profile of coated oral dosage forms for each individual state of the coating process in real-time. Correlation models were developed for a tablet pan coating process and for a pellet fluid-bed coating process. The feasibility of the correlation models was tested using different process parameters and types of coating formulations. This work demonstrated that using the OCT data to predict dissolution could possibly form a unique way of assuring drug product quality and establishing a control strategy within the real-time release testing (RTRT) concept.
KW - Coating
KW - Dissolution prediction
KW - Dissolution profile
KW - In-line monitoring
KW - Optical coherence tomography
KW - Real-time release testing
UR - http://www.scopus.com/inward/record.url?scp=85196266740&partnerID=8YFLogxK
U2 - 10.1016/j.ijpharm.2024.124841
DO - 10.1016/j.ijpharm.2024.124841
M3 - Article
C2 - 39414187
AN - SCOPUS:85196266740
SN - 0378-5173
VL - 666
JO - International Journal of Pharmaceutics
JF - International Journal of Pharmaceutics
M1 - 124841
ER -