PARAMETRIC STUDY OF FLUIDIZED-BED GRANULATION OF A LOW-DENSITY MICRONIZED POWDER

A pharmaceutical active principle, Amphotericin B, requires, before capsule-filling, a granulation in order to improve its handling, theological and density properties. In a changing-process situation, a parametric study is undertaken about a fluidized-bed granulation. For yield and densification improvment, it is suggested to premix the raw materials and to add the binder, that is PVP, in external phase. When it is added in internal phase, growths tends to take place in layers, resulting in granules which are more spherical, larger and less friable. In the same time desintegration time is reduced. This study also points out the influence of some process parameters for such a microfine active principle and underlines how to enhance the quality of the granulated material inside the specific limits of equipment and formula.