Abstract
This study demonstrates an in-line measurement of the coating performance of a continuous drum coater (DRIACONTI-T, Driam GmbH). Process monitoring is performed by an optical coherence tomography (OCT) sensor (OCT Pharma 1D, Phyllon GmbH) providing cross-sectional images of film-coatings in a non-destructive and contactless manner.
OCT measurement and subsequent automatic data analysis is a method to determine the coating thickness from OCT images without the need of chemometric calibration models, based on a known refractive index of the coating materials. OCT was used to obtain the temporal evolution of the quality parameters mean coating thickness, inter-tablet coating variability and intra-tablet coating variability during the coating process. Thereby the influence of spray rate, air temperature and spray pattern pressure on the quality parameters was studied based on a full-factorial DoE. Additionally, the variability of single drum segments of an extended period of time was studied.
Continuous coating, here in the form of small batches, is an important enabler for continuous manufacturing of solid dosage forms. In combination with an in-line OCT system the coating process can be monitored and actively controlled.
OCT measurement and subsequent automatic data analysis is a method to determine the coating thickness from OCT images without the need of chemometric calibration models, based on a known refractive index of the coating materials. OCT was used to obtain the temporal evolution of the quality parameters mean coating thickness, inter-tablet coating variability and intra-tablet coating variability during the coating process. Thereby the influence of spray rate, air temperature and spray pattern pressure on the quality parameters was studied based on a full-factorial DoE. Additionally, the variability of single drum segments of an extended period of time was studied.
Continuous coating, here in the form of small batches, is an important enabler for continuous manufacturing of solid dosage forms. In combination with an in-line OCT system the coating process can be monitored and actively controlled.
Titel in Übersetzung | Optische Kohärenz Tomographie (OCT) zur Echtzeit-Analyse der Coating-Variabilität eines kontinuierlichen Coating Prozesses |
---|---|
Originalsprache | englisch |
Publikationsstatus | Veröffentlicht - 17 Nov. 2016 |
Veranstaltung | AIChE Annual Meeting 2016 - Hilton, San Francisco, USA / Vereinigte Staaten Dauer: 14 Nov. 2016 → 19 Nov. 2016 |
Konferenz
Konferenz | AIChE Annual Meeting 2016 |
---|---|
Land/Gebiet | USA / Vereinigte Staaten |
Ort | San Francisco |
Zeitraum | 14/11/16 → 19/11/16 |