Monitoring microsphere coating processes using PAT tools in a bench scale fluid bed.

Monitoring microsphere coating processes using PAT tools in a bench scale fluid bed. Eur J Pharm Sci. 2019 May 05;: Authors: Silva BS, Colbert MJ, Santangelo M, Bartlett JA, Lapointe-Garant PP, Simard JS, Gosselin R Abstract Among the factors that influence adherence to medication within the pediatric population, taste/irritation has been identified as a critical barrier to patient compliance. With the goal of improving compliance, microspheres (matrix systems within which the drug is dispersed) can be coated with a reverse enteric polymer that will prevent the release of the drug in the oral cavity while maintaining an immediate release once the drug product reaches the stomach, thereby achieving a taste neutral profile. In this work, the in-line performance of three process analytical technology (PAT) tools is evaluated in order to monitor the microsphere coating process. These tools are Raman spectroscopy, near-infrared spectroscopy and focused beam reflectance measurements, together with process data and raw material attributes. The ability of these different sources of information to predict the coating's barrier performance is evaluated by using a combined-data-approach: multiblock partial least squares (MBPLS). Results show that Raman spectroscopy has a superior predictive performance and that it has the potential to monitor the coating process of the microspheres as well as to detect process discrepancies (such as spray rate ...
Source: European Journal of Pharmaceutical Sciences - Category: Drugs & Pharmacology Authors: Tags: Eur J Pharm Sci Source Type: research