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

A pharmaceutical active principle, Amphotericin B, requires, before ca psule-filling, a granulation in order to improve its handling, theolog ical and density properties. In a changing-process situation, a parame tric study is undertaken about a fluidized-bed granulation. For yield and densification improvment, it is suggested to premix the raw materi als 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, result ing in granules which are more spherical, larger and less friable. In the same time desintegration time is reduced. This study also points o ut the influence of some process parameters for such a microfine activ e principle and underlines how to enhance the quality of the granulate d material inside the specific limits of equipment and formula.