Chapter 11 - Role of Drug Substance Material Properties in the Processibility and Performance of Wet Granulated Products

Abstract

Various physical attributes of the excipients and drug substances govern the granulation process and therefore the final characteristics of the resultant drug product. Examples of physical properties of input materials (excipients and drug substance) that have been shown to have an effect on the granulation process include particle size and shape, surface area, solubility, porosity, and contact angle with the binder solution. This chapter discusses the relationship between input material properties and its behavior during high-shear wet granulation. The effect of the material properties on the processibility and performance in wet granulation was shown to be of paramount importance as they affect granule quality attributes such as granule size, porosity, compactibility, and flow properties. Understanding the dependency of granule critical quality attributes on input material properties is essential to ensure an adequate control strategy for the wet granulation process. Such critical input material attributes should be identified and controlled within a proven and acceptable range to ensure quality of the final product.