Use of Wet Granulation for Low-Dose Formulations

In the last few sections, the basic principles of wet granulations were summarized. The focus of this section will be on the use of wet granulation as a manufacturing process in the production of low-dose formulations. 

There are two main paths that can be followed to incorporate a low-dose active ingredient in a formulation via wet granulation  

Each of these two paths has advantages and disadvantages, and these will be discussed below. 

TABLE 5.3 Mixing Uniformity of a Low-Dose, Dry Formulation as a Function of Impeller and Chopper Speeds 

The uniformity of the active ingredient in the powder blend prior to granulation can be assessed directly by taking samples of the powder blend from the granulator. This may be insightful during formulation development so that the impact of each of the unit operations on the uniformity of the finished granulations and the finished product can be clearly understood. 

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