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Extrusion and spheronization (ES), direct rotor pelletizaton (DRP) and high-shear mixer pelletization (HSMP) are alternative techniques for matrix pellet production in process of wet agglomeration. The ES is the most widely used technique. In this study some of the physico-technological parameters of matrix pellets produced by DRP and HSMP were compared. Additionally the influence of model drug solubility on the suitability of microcrystalline cellulose (MCC) matrix pellets for immediate or sustained release systems were studied.
The physico-technological parameters of produced pellets are comparable. For the model drugs the size distribution is wide for both techniques, pellets produced by DRP are more friable but more spherical and with smother surface. No differences in dissolution profiles for the same model drug within the same pellet size were observed. If immediate release dosage form is required for freely soluble drug the MCC matrix pellets produced by wet agglomeration are good choice. For less soluble drugs, where the dissolution of the drug is limiting factor, the MMC matrix pellets (without any additional excipient which facilitates the disintegration of the pellet and dissolution rate of the drug) is not the appropriate dosage form for immediate release of the drug.