DOI: 10.36347/sajp

Pages: 153-161

The objective of present study was to document the requirements for manufacturing of semisolid dosage forms. These guidelines also brief about some issues associated with tools, strategies, critical process parameters and strategies of the manufacturing and validation processes specific to semisolid dosage forms. Studies about the effect of manufacturing processes and formulation excipients on the rheology of semisolids have contributed significantly toward their characterization. The development of computer-assisted instruments also has contributed substantially to their characterization and thereby to improving their quality. Moreover, some of the guidelines established by regulatory agencies, especially by FDA, are major steps toward the standardization of these dosage forms. Variations in the manufacturing procedure that occur after either of these events are likely to be critical to the characteristics of the finished product. This is especially true of any process intended to increase the degree of dispersion through reducing droplet or particle size (e.g., homogenization)