Effect of process variables on physicomechanical properties of the agglomerates obtained by spherical crystallization technique

Abstract

This study deals with the spherical crystallization process by the spherical agglomeration mechanism to obtain agglomerates with improved physicomechanical properties. The effect of temperature and speed of agitation on the micromeritic, mechanical and dissolution behavior of the agglomerates were investigated in order to make the link between the variables and properties of the agglomerates. Primary properties of the agglomerates were also evaluated by powder X-ray diffraction (XRPD) and differential scanning calorimetry (DSC). The mean particle size, flowability, bulk density and drug release of the agglomerates were found to be affected by either of the two variables, but there is no significant influence found on the compactibility properties. Hence, both variables must be fixed to obtained dense and well-shaped agglomerates adequate for direct tableting. XRPD and DSC results showed that during the agglomeration process, carbamazepine Form III changed to Form I.