title: Scale Up of Pan Coating Process Using Quality by Design Principles.
abstract: 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.
authors.affiliation: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut 06877.
authors.forename: Anjali M
authors.initials: AM
authors.lastname: Agrawal
authors.affiliation: Bristol-Myers Squibb, Drug Product Science and Technology, New Brunswick, New Jersey 08901. Electronic address: preetanshu.pandey@bms.com.
authors.forename: Preetanshu
authors.initials: P
authors.lastname: Pandey
mesh_terms: D004339:Drug Compounding / Q000295:instrumentation / Q000379:methods*; D011786:Quality Control; D013608:Tablets, Enteric-Coated / Q000737:chemistry*; D013816:Thermodynamics
chemical_list: D013608:Tablets, Enteric-Coated
keywords: coating; process analytical technology (PAT); processing; quality by design (QbD); solid dosage form; tablet; thermodynamics; unit operations