Challenges and opportunities in modelling wet granulation in pharmaceutical industry – A critical review

Wet granulation is a key step in the pharmaceutical manufacturing of solid-dosage forms. used production to enhance formulation qualities such as flowability, compressibility, etc. Different methods are for wet granulation, including fluidised bed, twin-screw extrusion, and high-shear method, leading different mechanisms granule properties. Modelling great importance industry, which aspiring shift from batch mode continuous one. Moreover, model-based understanding critical implementing Quality-by-Design (QbD) approach industry. The current review represents an overview approaches modelling granulation. Three major models, population balance model (PBM), discrete element method (DEM), data-driven evaluated, advantages each outlined. PBM primary properties tracked process. On other hand, DEM provides better at particle level. Recent studies have significantly advanced knowledge design scale-up capturing suitable wetting physics scaling thus mitigating traditionally known challenges application processes. However, further research required include level effects, like breakage, attrition, into through either built-in or hybrid approaches. Data-driven models fast accurate but do not investigate involved based on neural networks been indicated be adopted with accuracy compared approaches, can also implemented process control. A joint prospect first-principles anticipated, play important role future design, optimisation, control