ABSTRACT
Granulation is a process selected by formulation scientists to prevent segregation of formulation components in a powder mix, improve blend flow, bulk volume of granulation, content uniformity, compressibility, and other properties. Granulation minimizes the technical risks associated from batch to batch variability in raw materials that could impact the manufacturing process and performance. Various granulation techniques such as high-and low-shear granulation, roller compaction, spray drying, fluid-bed granulation, extrusion speronization, and melt granulation are used in solid dosage form development. The choice of granulation technique depends on various factors such as chemical and physical stability of the final dosage form, intended biopharmaceutical performance, and is occasionally limited due to available equipment. Dosage form performance is assessed through a characterization program in which drug dissolution, bioavailability, chemical stability, or manufacturing ruggedness is taken into account. The scientist can rely on many different tools for granulation characterization. These tools can probe the physical and chemical attributes of the material. In this chapter many characterization techniques that are applied to granulation will be reviewed. Most of the techniques used for granulation characterization are conducted during the research and development stage of product development. A significant portion of this chapter was adapted from the previous edition of Handbook of Pharmaceutical Granulation Technology (1).
