ABSTRACT

Melt granulation involves the use of a meltable, thermoplastic binder for the agglomerate formation and offers numerous advantages. It allows the processing of moisture-sensitive drugs since no organic or aqueous solvents are used, processing of highly drug-loaded formulations, enhancement of the bioavailability, and modification of the drug release by using either hydrophilic or lipophilic binders. Depending on the selected binder or melt granulation process, granules with varying properties, that is, density, porosity, and sphericity, and drug loads can be produced. Batch-wise granulation techniques such as high-shear and fluid-bed melt granulation have been extensively studied since the 1990s, while continuous melt granulation techniques, such as spray congealing, prilling, and twin-screw melt granulation, are currently gaining more and more interest.