ABSTRACT

The melt processes require at least a meltable material in the manufacture of the solid dosage form. This article intends to address the influence of meltable materials on the processes of melt pelletization, melt granulation, and tumbling melt granulation. Approaches to meet the processing attributes of the meltable materials for these melt agglomeration processes, via spray congealing, are discussed. In design and development of a formulation by melt processes, multiple-unit solid dosage form is popular with manufacturers as it allows a high degree of flexibility in modifying the dosage regimen. It is usually not possible to clearly distinguish between granulation and pelletization. For the melt pelletization and melt granulation processes, it is desirable that meltable materials have a high viscosity to improve the mechanical strength of the agglomerates, but a reduced particle size to prevent uncontrollable agglomerate growth. The viscosity and particle size of a meltable material critically affect the formative process of the melt agglomerates.