B. Evrard et al., Influence of melting and rheological properties of fatty binders on the melt granulation process in a high-shear mixer, DRUG DEV IN, 25(11), 1999, pp. 1177-1184
The preparation of granules by melt granulation was investigated using a la
boratory-scale high-shear mixer (Pellmix PL 1/8) and binary mixtures contai
ning lactose and different lipidic binders, namely, Compritol (R) 888, Cuti
na (R) HR, or Precirol (R) AT05. During the process, the product temperatur
e and the impeller motor power consumption were monitored. On the other han
d, the melting behavior (thermal analysis) and the rheological properties (
controlled stress capillary rheometer) of the different lipophilic binders
were also determined. The granule formulation was shown to be quite effecti
ve at product temperatures even below the melting point of the lipidic bind
er, that is, when the binder is sufficiently softened to be deformed by the
very high shearing forces developed in the high-shear mixer. On the other
hand the performance of lipidic binders during the melt granulation process
was shown to be closely dependent on their melting and rheological propert
ies. The granule growth rate was shown to be higher wizen the binder meltin
g range is narrow and the influence of temperature on the viscosity of the
unmelted product is high.