Development of 400 µm Pellets by Extrusion‐Spheronization Application with Gelucire 50/02 to Produce a “Sprinkle” Form

Abstract

The aim of this study was to develop monodimensional, spherical particles of 400 µm 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 µm. 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 µm pellets with Gelucire 50/02. At least 90% of the pellets have a particle size of between 250 µm and 500 µm and particle shape is acceptable. In this form the dose can be adapted to individual patients. After proving the feasibility of 400 µm spheroids of Gelucire 50/02, the association of a drug with it was considered.

Key Words:

• Extrusion‐spheronization
• Gelucire
• 400 µm pellets
• Active drug