Chapter 7 - Current Practices in Wet Granulation-Based Generic Product Development

Abstract

Wet granulation is one of the most important unit operations in the production of pharmaceutical dosage forms. This chapter describes various wet granulation methodologies, with major focus on high-shear wet granulation (HSWG) and fluid bed granulation (FBG) processes. Current industrial practices, including application of quality by design (QbD) in wet granulation process development is presented along with few case studies. QbD represents a move away from the traditional approach in the industry of quality by testing (QbT). This systematic approach includes development studies using univariate experiments and multivariate statistical experimental designs, i.e., design of experiments (DoE). These will be discussed in the case studies. Techniques of end-point determination also are described. Scale-up principles are covered for both high-shear and fluid bed-based granulation. Finally, recommendations and practical tips are given, ones that should be useful to the reader for successful development of wet granulation-based products.