Factors Affecting the Granulation Process and Granule Properties

FACTORS AFFECTING THE GRANULATION PROCESS AND GRANULE PROPERTIES 

Besides the API, excipients such as a filler or fillers, a disintegrant (not applicable to controlled release), and a binder are also included in the powder mixture of a tablet formulation. The fillers used in tablet formulations can be classified into two categories, based on their water solubility soluble fillers such as lactose, sucrose, mannitol, etc., and insoluble fillers such as MCC, starch, calcium carbonate, calcium phosphate, etc. The binders used in the wet granulation process are water-soluble 

The influenee of the primary particle size of lactose on the breakage of erythro-sine granules was investigated by van den Dries et al. (4). The results showed that a deerease in particle size of the starting material, lactose, led to a decrease in 

The size distribution of granules prepared from three different tablet excipients, lactose, glucose, and mannitol, in a high-shear granulator, were studied by both sieve analysis and laser light diffractometry (24). Both the shapes and the size distribution of the granules produced from the three excipients differed. 

The physical properties of the API also affect the wet granulation process and the properties of the resulting granules. For example, when the particle shape of the API was changed from spherical to plate like due to a change in the crystallization solvent, the compressibility of the resulting granules dramatically decreased (26). 

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