B. Campisi et al., Melt granulation in a high shear mixer: optimization of mixture and process variables using a combined experimental design, CHEM INTELL, 48(1), 1999, pp. 59-70
Melt granulation of a formulation of theophylline, containing lactose, micr
ocrystalline cellulose and hydroxypropylmethylcellulose as excipients, was
investigated in a 10 l high shear mixer as an alternative method to the wet
granulation process, using polyethylene glycol 6000 as melting binder. The
experimentation was planned by combining mixture and factorial designs in
order to study the effect of two process variables, namely impeller speed a
nd massing time, and of excipient mixture composition on two characteristic
s of the granules. By the response surface methodology, it was possible to
find the mixture composition and the processing conditions leading to granu
lates with optimal granule characteristics. (C) 1999 Elsevier Science B.V.
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