Scale up and technology transfer of pharmaceutical suspensions

Abstract

Scaling up of suspension dosage form is considered a challenge as pharmaceutical suspensions are thermodynamically unstable. During the scale-up process, the effect of operational variables on the dispersion process, and physical properties affecting overall attributes need systematic evaluation. Though the scale up process can be studied using dimensional analysis, mathematical modeling, and computer simulation, most of the work in the field of suspension manufacturing still depends on empirical studies and the principles of geometric similarities. Various aspects of the scale up process, technology transfer, and process analytical technology (PAT) applications in suspension manufacturing are discussed.