Ke. Fielden et al., THE INFLUENCE OF MOISTURE-CONTENT ON SPHERONIZATION OF EXTRUDATE PROCESSED BY A RAM EXTRUDER, International journal of pharmaceutics, 97(1-3), 1993, pp. 79-92
The presence of water is an essential feature of formulations containi
ng mirocrystalline cellulose (MCC) for the preparation of spherical gr
anules by the process of extrusion/spheronisation. The current work pr
ovides further proof of this observation. Formulations consisting of M
CC and either a coarse (118.0 mum) or a fine grade (18.0 mum) of lacto
se mixed with two levels of water have been examined as they spheronis
e and after collection and drying. The shape changes on the plate, plu
s the size and shape changes, as a function of spheronisation time, sh
ow that the mixtures containing fine particle size will form good sphe
res at either 33 or 37% water content, but the mixtures containing the
coarse particle size will only form controlled size spheres at 33% mo
isture content. The results were found to be equivalent for both 1.0 a
nd 1.5 mm extrudates. The effect can be related to the mobility of the
water in the different packing structures produced by the different p
article sizes of lactose.