2009 Volume 69 Issue 3 Pages 228-238
To investigate drug conformity in various granule size-fractions and their effects on compressed tablets, granules with various physicochemical properties of active ingredients, manufactured by agitation and fluidized-bed methods, were assayed. It was observed that the drug contents of different size-fractions in various granules were affected by the surface polarity (P0) of the component drug and excipients. Drugs possessing higher P0 had lower drug content in the fine granule fraction, while drugs possessing lower P0 had higher content. Regarding drug content in the large granule fraction, the relationship between P0 was the opposite. The granules prepared by agitation exhibited various drug contents in different size-fractions, compared to the granules prepared by the fluidized-bed method. However, the drug uniformity of the resultant compressed tablets manufactured from these blended granules using a rotary tableting machine was showed almost suitable conforming and it was concluded that the drug homogeneity of compressed tablets was not strongly affected by the drug content uniformity of granule size-fractions.
