Surface responses and desirability functions to determine optimal granulation domains.
BACKGROUND
Single pot mixer-granulator-dryer (high-shear granulator with in situ double jacket vacuum drying) and multiphase equipment (high-shear granulator associated with fluid bed dryer) are classically used for wet granulation. At present time, industrial production imperatives may require to switch one formulation from one equipment to another.


METHODS
To compare the two processes and to define, for each of them, the optimal formulation domain, experiments were organized according to Doehlert experimental designs. Response surfaces were used to identify the levels of each factor (binder and filler ratios) inducing the more satisfying responses. The contribution of binder and filler ratios to granule properties was highlighted according to the process. Then the desirability function was used to determine and compare the optimal formulation domain for each process.


CONCLUSIONS
In the studied formulation domain and for the considered equipment, the transposition from a single pot to a multiphase high-shear granulation process did not seem to raise difficulties; the same formulations were out of specification for both processes and other trials, the technological properties were maintained or improved in the Fielder/Niro equipment.
Giry
K
K
Université de Limoges, Faculté de Pharmacie, Laboratoire de Pharmacie Galénique, Limoges Cedex, France. karine.giry@unilim.fr
Viana
M
M
Genty
M
M
Wüthrich
P
P
Chulia
D
D
D003890:Desiccation; D004304:Dosage Forms; D004339:Drug Compounding / Q000295:instrumentation / Q000379:methods; D005079:Excipients; D010316:Particle Size; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D016062:Porosity; D012995:Solubility; D013499:Surface Properties; D013607:Tablets; D013678:Technology, Pharmaceutical
D004304:Dosage Forms; D005079:Excipients; D004364:Pharmaceutical Preparations; D013607:Tablets