Wet Granulation End-Point Determination of a Drug Formulation

Abstract

Wet granulation is commonly used in oral solid dosage industry. The end-point is required to design a process that consistently meet products Critical Quality Attributes (CQAs) and the Critical Processing Parameters (CPPs). There are many methods available for end-point determination with their owns constraints of reproductivity and accuracy. Torque measurer was installed on the Low shear granulation and product “XA” was monitored. The results confirm that automated process provide better process control and reproducibility. Torque measurement demonstrate to be a reliable control method in relation to mass resistance. In order to determine wet granulation end-point the Project Management Institute (PMI®) methodology was used. PMI® comprise of five main steps in the process; initiating, planning, executing, monitoring and controlling, and closure. This research pursue to improve and determine the wet granulation end-point of a drug product. PMI® methodology brings a structure and the tool to identify and solve the problem. Key Terms ⎯ Automation, End-Point, Torque, Wet Granulation.