PubMed · 11862723
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Jeffrey M Ewig. 2002. Croup.. https://doi.org/10.3928/0090-4481-20020201-10
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Controlled-release theophylline containing spherical pellets were successfully produced by a hot-melt extrusion (HME) and spheronization process. A powder blend of anhydrous theophylline, Eudragit Preparation 4135 F, microcrystalline cellulose and polyethylene glycol 8000 powder was sieved, blended and then melt-extruded in a Randcastle Microtruder. The hot-melt extruded pellets were prepared by first cutting a thin, extruded composite rod into symmetrical pellets. The pellets were then spheronized in a traditional spheronizer at an elevated temperature. Thermal properties of the pellet formulation components and the hot-melt extrudate were studied to determine suitability of the formulation for HME. Pellets were examined using scanning electron microscopy to determine the effect of spheronization time on surface morphology. The rate of release of theophylline from the hot-melt extruded spherical pellets was characterized using USP 24 Apparatus 2 dissolution testing after initial pellet production and after 1 year storage in sealed HDPE containers at 25 degrees C/60% RH.
Extrusion-spheronization is frequent method for pellet production and especially extrusion stage has been studied for its influence on pellet properties. However, the formation of pellet structure is not finished before drying stage. The possible influence of different drying methods and used temperatures on some properties of pellets, containing theophylline as active ingredient and Avicel CL-611 as spheronizing agent, is the object of this paper.
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