Characterization of NIR interfaces for the feeding and in-line monitoring of a continuous granulation process

Publication date: Available online 5 December 2019Source: International Journal of PharmaceuticsAuthor(s): Andrés D. Román-Ospino, Ashutosh Tamrakar, Benoît Igne, Elyse Towns Dimaso, Christian Airiau, Donald J. Clancy, Glinka Pereira, Fernando J. Muzzio, Ravendra Singh, Rohit RamachandranAbstractThis work describes the characterization of three NIR interfaces intended to monitor a continuous granulation process. Two interfaces (i.e. a barrel interface and a rotating paddle interface) were evaluated in order to monitor the API concentration at the entrance of the granulator, and a third interface (i.e. an outlet interface), was evaluated to monitor the quality of the resulting outlet granules. The barrel interface provided an assessment of the API concentration during the feeding process by scanning the material conveyed by the screws of the loss-in-weight feeder. The rotating paddle interface analyzed discrete amounts of powder upon exiting the feeder via the accumulation of material on the paddles. Partial Least Squares (PLS) calibration models were constructed using the same powder blends for the two inlet interfaces and using the outlet granules for the outlet interface. Five independent batches were used to evaluate the prediction performance of each inlet calibration model. The outlet interface produced the lowest error of prediction due to the homogeneity of the granules. The barrel interface produced lower errors of prediction than the rotating paddle interface. How...
Source: International Journal of Pharmaceutics - Category: Drugs & Pharmacology Source Type: research