title: Formulation design for optimal high-shear wet granulation using on-line torque measurements.
abstract: An alternative procedure for achieving formulation design in a high-shear wet granulation process has been developed. Particularly, a new formulation map has been proposed which describes the onset of a significant granule growth as a function of the formulation variables (diluent, dry and liquid binder). Granule growth has been monitored using on-line impeller torque and evaluated as changes in granule particle size distribution with respect to the dry formulation. It is shown how the onset of granule growth is denoted by an abrupt increase in the torque value requires the amount of binder liquid added to be greater than a certain threshold that is identified here as 'minimum liquid volume'. This minimum liquid volume is determined as a function of dry binder type, amount, hygroscopicity and particle size distribution of diluent. It is also demonstrated how this formulation map can be constructed from independent measurements of binder glass transition temperatures using a static humidity conditioning system.
authors.affiliation: Dipartimento di Principi e Impianti di Ingegneria Chimica I. Sorgato, Università di Padova, via Marzolo 9, 35131 Padova, Italy. mauro.cavinato@unipd.it
authors.forename: Mauro
authors.initials: M
authors.lastname: Cavinato
authors.forename: Massimo
authors.initials: M
authors.lastname: Bresciani
authors.forename: Marianna
authors.initials: M
authors.lastname: Machin
authors.forename: Guido
authors.initials: G
authors.lastname: Bellazzi
authors.forename: Paolo
authors.initials: P
authors.lastname: Canu
authors.forename: Andrea C
authors.initials: AC
authors.lastname: Santomaso
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods; D005079:Excipients / Q000737:chemistry*; D006813:Humidity; D010316:Particle Size; D013678:Technology, Pharmaceutical / Q000379:methods*; D019415:Torque; D044366:Transition Temperature; D017155:Wettability
chemical_list: D005079:Excipients