Scale up of pan coating process is of high importance to the pharmaceutical and food industry. The number of process variables and their interdependence in a pan coating process can make it a rather complex scale-up problem. This review discusses breaking down the coating process variables into three main categories: pan-related, spray-related, and thermodynamic-related factors. A review on how to scale up each of these factors is presented via two distinct strategies--"macroscopic" and "microscopic" scale-up. In a Quality by Design paradigm, where an increased process understanding is required, there is increased emphasis on "microscopic" scale-up, which by definition ensures a more reproducible process and thereby robust scale-up. This article also reviews the various existing and new modeling and process analytical technology tools that can provide additional information to facilitate a more fundamental understanding of the coating process.
Keywords: coating; process analytical technology (PAT); processing; quality by design (QbD); solid dosage form; tablet; thermodynamics; unit operations.
© 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.