Lise Vandevivere

Lise Vandevivere

Laboratory of Pharmaceutical TechnologyLIse Vandevivere
Ottergemsesteenweg 460
B-9000 Gent(Belgium)
Tel. : +32-9-264.80.82
E-mail :
Education : Master of Pharmaceutical Care









The development of formulations of highly dosed and poorly wettable API’s through twin screw granulation

Nowadays continuous manufacturing is quickly gaining momentum in the pharmaceutical sector. Twin screw granulation is a continuous process that can be implemented into a fully continuous from-powder-to-tablet line. This implies important economic advantages and improved product quality. While most of previous studies focused on the influence of process parameters on granule and tablet quality, only a limited number of studies concentrates on formulation development. The aim of the current study is to develop formulations including highly dosed and poorly wettable APIs through twin screw granulation. This topic is considered as challenging because of the short residence time via twin screw granulation (typically 5 – 20s), which implies limited interaction between powder bed and the granulation liquid. Furthermore, to granulate such APIs high amounts of aqueous granulation liquids are required which in turn results in excessively long drying times to be applied to dry the granules. This can limit the suitability of the six-segmented fluid bed dryer of the ConsiGmaTM system as the maximal applicable drying time is approximately six times the filling time of one cel of the fluid bed dryer. Therefore different binders and surfactants (in different concentrations) will be evaluated on the quality of granules and tablets with a high drug load of poorly wettable APIs produced via twin screw granulation. Also, it is favorable to make predictions without doing multiple tests on ConsiGmaTM system concerning the wettability of the different APIs by the binder and surfactant solutions and it will be investigated if there is a correlation between these wettability measurements and the granule quality. This would make it possible to define recommendations on the use of different binder and surfactant solutions to be used during twin screw granulation followed by fluid bed drying of highly dosed and poorly wettable APIs.