Effect of the granulation process on nitrofurantoin granule characteristics.

We studied four granulation methods on the same quantitative and qualitative formula: wet massing by forced agglomeration (Lödige) and free agglomeration (Glatt); and dry massing by slugging and roller compaction technique. Three different particle sizes of nitrofurantoin (bioinequivalent drug) were used. The nitrofurantoin particle size has a very low influence on the physical characteristics of the granules. The granulating process influenced the binding of the particles. Granules processed using the wet granulating method were harder than those made by dry process. Lödige granules were more bonded than Glatt granules. Granules prepared by dry massing presented broken particles. The surface area and the porosity of Glatt granules were the most important parameters. Dissolution studies must be effected to make a correlation between the physical results and the dissolution rates. It is necessary to effect a new validation and a comparison of the results when a new granulating apparatus is used.