Influence of melting and rheological properties of fatty binders on the melt granulation process in a high-shear mixer

Citation
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
Citations number
23
Categorie Soggetti
Pharmacology & Toxicology
Journal title
DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY
ISSN journal
03639045 → ACNP
Volume
25
Issue
11
Year of publication
1999
Pages
1177 - 1184
Database
ISI
SICI code
0363-9045(1999)25:11<1177:IOMARP>2.0.ZU;2-A
Abstract
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.