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Optimization of a Spheronization Process for Manufacturing Lipase Pellets using a Factorial Design

Stefan Scheler und Eberhard Nürnberg Lehrstuhl für Pharmazeutische Technologie der Friedrich-Alexander-Universität Erlangen-Nürnberg Herrn Professor Dr. Bernhard C. Lippold zum 60. Geburtstag gewidmet

Optimization of a Spheronization Process for Manufacturing Lipase Pellets using a Factorial Design The manufacturing of a plastified drug/excipient mixture into spherical pellets by the methods of extrusion and spheronization is carried out using a two-step process. The respective processing conditions are decisive to the resulting parameters, i.e. particle shape and size distribution. Because of the interdependence between various process variables it is difficult to optimize the process using the classic way of experimental procedure. In contrast to this, a factorial design allows to assess separately all the factors of influence as well as potential interactions. In the course of formulating a preparation for treatment of exocrine pancreatic insufficiency -based on enzymes of fungal origin -the parameters of the spheronization process are optimized applying a 2 3 -factorial design. Spheronization of extrudates -made from a wet powder mass with 89 % drug content using ethanol as granulation fluid -provides best results when a grooved rotating plate is applied. In order to ensure a self-cleaning procedure and to minimize loss of product, despite of the grooved surface, a speed of 1250 rpm is shown to be necessary. Since liquid escapes from the rotating pellets and leads to an increased cohesivity and agglomeration, an exactly timed drying period is imperative to obtain a well-shaped product.

Key words Extrusionspellets · Faktorielle Versuchsplanung · Lipase · Sphäronisation