LAUSR

Abstract Polymeric microparticles are preferred over the non-polymeric one based on the market trends and diverse conventional methods have been used to fabricate the polymeric microparticles. However, poor encapsulation, unpredictable drug release, non-uniform particle size, difficulties of removing the residual solvent, and tedious scale-up procedures associated with the traditional techniques affected the overall quality attributes of the formulation. This might lead to the development of novel approaches (droplet-microfluidics/microchips, membrane emulsification, ultra-fine particle processing system, self-healing encapsulation) for microparticles preparation. These novel methods are capable of delivering desired quality products by eliminating the quality and manufacturing issues. This review systematically outlines various quality attributes of microparticles along with innovative methods to overcome the manufacturing-related limitations of the conventional preparations. Furthermore, this review discusses in vitro-in vivo correlation concerning the parenteral microparticles as an essential quality parameter in formulation development. Moreover, different simulation models like population balance model, computational fluid dynamics, finite element model, and fine element analysis are elaborated to define polymer erosion, degradation, burst release, injectability, and drug release profiles, which will affect overall quality of microparticles.