The aim of this study was to develop monodimensional, spherical particles of 400 microm by extrusion-spheronization. An Alexanderwerk GA65 cylinder extruder with two counter-rotating rollers associated with a Caleva model 15 spheronizer were used. The study was made with an auxiliary substance of fatty consistency and with amphiphilic properties: Gelucire 50/02. The plasticity of the mass can be deduced using a piston extruder. Pellet quality can be determined by particle-size analysis and shape estimation by microscopy. Modifications to the cylinders and the extruder itself are required for feasibility studies of extruded materials of 400 microm. The horizontal plate of the spheronizer had to be adapted to take into account the small size of the extruded materials. For the chosen auxiliary substance, Gelucire 50/02, the formulation of the wet mass to be extruded and the conditions required to obtain this mass were defined. The results show the feasibility of 400 microm pellets with Gelucire 50/02. At least 90% of the pellets have a particle size of between 250 microm and 500 microm and particle shape is acceptable. In this form the dose can be adapted to individual patients. After proving the feasibility of 400 microm spheroids of Gelucire 50/02, the association of a drug with it was considered.

The aim of this work was to obtain 400 μm spheroids that can be sprinkled on food to improve patient compliance particularly in the case of children and old people. A methodology to select wet masses for extrusion-spheronization through a 400 μm orifice was developed. The first step was to define the parameters that make it possible to assess the qualities required by the wet mass and the extrudates and evaluation norms: plasticity, cohesiveness, brittleness of the mass and the extrudates, and appearance of extrudates. A feasibility assay was then performed on the cylinder extruder, showing that extrusion of the lactose/Avicel PH 101/water (50/50/60) mass is not feasible through the 400 μm orifice. Precirol ato 5 and Gelucire 50/02 wetted with a sodium lauryl sulfate solution at 0.5% show plastic flow through the 400 μm diameter orifice. The presence of Avicel PH 101 does not improve plasticity for this orifice. Micropellets of 400 μm have been proved feasible as long as excipients with suitable pharmaceutical technological properties are used. After proving the feasibility of 400 μm spheroids of Gelucire 50/02, we considered the association of a drug with it.