ABSTRACT
Oral route, the most widely accepted route for drug applications, has some drawbacks such as difficulty in swallowing and the lack of utilization without water. Therefore, orally disintegrating tablets (ODT), or so-called fast disintegrating tablets (FDT), have been developed, by which the dispersion of the tablet in the oral cavity provides the release of drug and its pre-gastric absorption with no need for water and swallowing. The development of such a formulation is possible using different methods, most importantly using granulation. Wet granulation, dry granulation, and melt granulation are counted as the most important methods in this regard. In all of these methods, a disintegrant or superdisintegrant, a lubricant, in some cases a permeabilizing agent, a sweetener, and finally a flavoring agent are utilized to provide a fast disintegration process for accomplishing the patient compliances.
In this chapter, a brief explanation of the desired properties of ODTs and the needs for their development is followed by their production technologies with special emphasis on granulation. Furthermore, the challenges in preparation of ODTs such as taste masking and affording fast disintegration without producing highly fragile tablets are discussed in detail. The chapter is finalized with the characterization methods of ODTs.
