(493j) Innovative Technologies for Measurement of Film Coating Bed Conditions During Investigation of Proposed Operating Ranges

The new QbD paradigm requires a range of tools and techniques to provide process understanding during product development. Two novel technologies that have been employed to acquire information about film coating conditions in the tablet bed are CorTemp^TM, a real-time temperature monitoring device, and Pyrobutton^TM, a portable temperature/humidity data logger. Since each of these sensors is approximately the size of a large tablet, they can be mixed into the tablet bed, capturing the actual conditions experienced by the tablets during the film coating process.

As part of the technical transfer of this NCE from the development site to its designated production site, the film coating unit operation was investigated by evaluating two process parameters, spray rate and inlet temperature, in a response surface design of experiments (DoE) with two centerpoints in a commercial-scale (36?) film coater. Data collected from these two novel technologies, combined with conventional data streams, provided insight into the effect of these process parameters on the finished film coated tablets and helped define the operating ranges for the process parameters during film coating for this product at the proposed scale. No impact on tablet dissolution was observed within the range of coating conditions that were examined, which supports the proposed operating ranges.

Given the variability in exhaust temperature and humidity sensor locations across different process scales and even different equipment of the same scale, capturing the tablet bed conditions with these monitoring technologies provides a critical linkage between validated equipment-based sensors and the actual conditions experienced within the tablet bed during film coating. Additionally, while no film coating process parameters were deemed critical for this product within the defined operating ranges, a product that is highly sensitive to temperature and humidity excursions may benefit greatly from the ability to monitor the bed conditions during the film coating process.