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 is going to be a good novel technology for the continuous processing of pharmaceuticals but self-confidence must still be gained regarding if the environment affects medicine real estate. In this preliminary research, granulation was studied plastic compounding machines for a style product made up of lactose monohydrate and substances of differing normal water solubility, namely ibuprofen versus caffeine. The formulations were granulated at 220 rpm and 100 C with polyethylene glycol binders of differing molecular weights and at concentrations between 6.5% and 20%. With regards to granule properties, the low melting point of ibuprofen possessed a dominant affect by producing larger, more robust granules, whereas the caffeine products were more comparable to a blank containing no active ingredient. Drug degradation was study by differential scanning calorimetry, X-ray diffraction, and high-pressure liquid chromatography. The only detected change was the dehydration of lactose monohydrate for the caffeine and blank products, whereas the lubricating affect of the ibuprofen protected its granules. The short residence period ( 60 s) was consider to come to be influential in minimizing harm of the drug despite the high temperature and shear attributed to HMG in the twin screw extruder.
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