13 - Continuous secondary process selection and the modeling of batch and continuous wet granulation

Abstract

Continuous manufacture of solid dosage forms has been receiving increasing attention from pharmaceutical companies over the past decade. Novartis, Pfizer, GSK, and universities such as MIT, Purdue, and Rutgers have been actively developing expertise in this area since approximately 2004. A review of most of the possible continuous manufacturing options being considered has been summarized by Pfizer in 2004. In 2007, Novartis funded a $65 million 10-year partnership with MIT to develop a continuous pharmaceutical manufacturing process from input chemicals to final dosage form. In 2012, the Novartis-MIT Center of Continuous Processing announced successful demonstration of a complete continuous process for manufacture of tablets, starting from API synthesis.