Investigations on the influence of the type of extruder for pelletization by extrusion-spheronization. II. Sphere characteristics.
Three different extruders, the Alexanderwerk gravity-feed roll extruder, the Gabler axial, single-screw extruder, and the NICA radial-screw extruder, were compared for their suitability for different placebo formulations and for fenoldopam pellets. A fourth extruder, the experimental ram extruder, was also included in some of the comparisons. The successful spheronization of extrudates from each of these extruders requires the correct water content. This water content, however, is different for each of the formulations and for each extruder. Generally, the Gabler unit required the highest amounts of water for a successful spheronization, yielding > or = 90% between 710 and 1250 microns. The NICA unit needed much less water for the same formulation, and the Alexanderwerk unit required even less water than the NICA unit. Pellet sphericity was also strongly dependent on the correct water content of formulations, but was generally better for pellets produced with the Alexanderwerk or NICA units. A two-way ANOVA test for the individual formulations showed a significant difference in the mean particle size of batches produced with the NICA or the Alexanderwerk and the Gabler extruder. No significant differences could be found between any of the Alexanderwerk or NICA batches. Both extruders showed a linear dependence of the mean particle size on the water content of formulations, but the Gabler extruder showed an almost unchanged particle size over a wide range of water contents, provided that the formulation could be extruded successfully. Batches that were extruded on the NICA unit showed a significantly lower bulk density than comparable Alexanderwerk or Gabler batches. Comparing the true density of pellets, we found that significant differences could only be stated for Avicel PH 101 + water batches and only for the NICA/Gabler interaction. True density increased for all three extruders with increasing amounts of soluble components and with increasing water content. The NICA batches also exhibited a significant difference of the Hausner factor from the other two extruders, but no differences could be found in the friability of pellets.
Thoma
K
K
Department of Pharmaceutical Technology, Ludwig-Maximilians University Munich, Germany. Prof.Thoma@lrz.uni-muenchen.de
Ziegler
I
I
D002626:Chemistry, Pharmaceutical; D004339:Drug Compounding / Q000295:instrumentation* / Q000379:methods*; D005069:Evaluation Studies as Topic; D018818:Fenoldopam / Q000008:administration & dosage / Q000302:isolation & purification; D006801:Humans; D010316:Particle Size; D014677:Pharmaceutical Vehicles; D010919:Placebos; D012995:Solubility; D013499:Surface Properties; D014867:Water
D014677:Pharmaceutical Vehicles; D010919:Placebos; D014867:Water; D018818:Fenoldopam