Hot Melt Granulation in a Twin Screw Extruder Effects of Processing on Formulations with Caffeine and Ibuprofen

Hot-melt granulation (HMG) by twin screw extrusion can be a good novel technology for the continuous processing of pharmaceuticals but self confidence must be gained regarding if the environment affects drug properties. In this preliminary analysis, granulation was studied for a unit product including double screw extruder lactose monohydrate and active ingredients of differing normal water solubility, ibuprofen versus caffeine namely. The formulations were granulated at 220 rpm and 100¡ãC with polyethylene glycol binders of differing molecular weights and at concentrations between 6.5% and 20%. When it comes to granule properties, the low melting point of ibuprofen experienced a dominant impact by producing larger, better granules, whereas the caffeine goods were more comparable to a blank containing no active ingredient. Drug degradation was analysis by differential scanning calorimetry, X-ray diffraction, and high-pressure liquid chromatography. The only real detected change was the dehydration of lactose monohydrate for the caffeine and blank products, whereas the lubricating impact of the ibuprofen guarded its granules. The short residence period (¡«60 s) was consider to come to be influential in minimizing destruction of the drug regardless of the temperature and shear attributed to HMG in the twin screw extruder.

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