Hot-melt granulation (HMG) by twin screw extrusion is undoubtedly a good novel technology for the continuous processing of pharmaceuticals but assurance must still be gained regarding whether the environment affects medicine real estate. In this preliminary study, granulation was studied for a version product including lactose monohydrate and active ingredients of differing drinking water solubility, namely ibuprofen versus caffeine. The formulations had been granulated at 220 rpm and 100C with polyethylene glycol binders of differing molecular weights and at concentrations between 6.5% and 20%. In terms of granule extruder barrel properties, the reduced melting point of ibuprofen acquired a dominant impact by producing larger, better granules, whereas the caffeine items were more much like a blank made up of no active component. Drug degradation was study by differential scanning calorimetry, X-ray diffraction, and high-pressure liquid chromatography. The only real detected switch was the dehydration of lactose monohydrate for the caffeine and blank goods, whereas the lubricating affect of the ibuprofen secured its granules. The short residence period (60 s) was consider to get influential in minimizing destruction of the drug despite the temperature and shear related to HMG in the twin screw extruder.
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December 2015
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