US EPA

5303768 

Journal Article 

Melt pelletization in high shear mixer using a hydrophobic melt binder: influence of some apparatus and process variables 

Voinovich, D; Moneghini, M; Perissutti, B; Franceschinis, E 

2001 

1 

European Journal of Pharmaceutics and Biopharmaceutics
ISSN: 0939-6411
EISSN: 1873-3441 

52 

3 

305-313 

English 

11677073 

10.1016/S0939-6411(01)00196-5 

WOS:000172338300006 

The effects of process conditions and the apparatus variables on the granulometric characteristics of a formulation containing a hydrophobic binder (stearic acid), lactose and paracetamol prepared by melt pelletization process were investigated in a 10-litre high shear mixer. The factors under investigation were: impeller speed, massing time, type of impeller blades and presence of the deflector and their reciprocal interactions. Two granule characteristics were analysed: the percentage of aggregates larger than 3000 microm (Y(1)) and the yield of the 2000-microm pellet size fraction (Y(2)). In order to estimate simultaneously the above-mentioned factors, a particular experimental design was adopted, that allowed the reduction of the number of trials from 378 to 35 and took into consideration other uncontrolled factors with the aid of a block variable. Using the postulated model, we found the optimal operating conditions to minimize Y(1) and increase Y(2) by selecting the type of impeller, and by using an impeller speed lower than 300 rpm, a massing time of 8-9 min and by not using the deflector. Finally, the validity of the adopted strategy has been proved with an additional check point. 

melt pelletization; 10 liter high shear mixer; paracetamol; stearic acid; D-optimal design