Surface responses and desirability functions to determine optimal granulation domains
1Université de Limoges, Faculté de Pharmacie, Laboratoire de Pharmacie Galénique, Limoges Cedex, France. karine.giry@unilim.fr
Drug Development and Industrial Pharmacy
|September 8, 2010
Summary
Switching between single pot and multiphase high-shear granulation processes is feasible. Formulation optimization for wet granulation showed that technological properties were maintained or improved when transposing to the multiphase equipment.
Area of Science:
- Pharmaceutical Technology
- Chemical Engineering
- Materials Science
Background:
- Traditional wet granulation utilizes single pot mixer-granulator-dryers or multiphase equipment (high-shear granulator with fluid bed dryer).
- Industrial demands may necessitate transferring formulations between these distinct granulation systems.
Purpose of the Study:
- To compare single pot and multiphase high-shear granulation processes.
- To define optimal formulation domains for each granulation equipment.
- To assess the feasibility of transposing formulations between granulation processes.
Main Methods:
- Doehlert experimental designs were employed to compare the two granulation processes.
- Response surface methodology identified optimal binder and filler ratios.
- Desirability functions determined and compared optimal formulation domains for each process.
Main Results:
- The contribution of binder and filler ratios to granule properties varied depending on the granulation process.
- Formulations that were out-of-specification for one process were also out-of-specification for the other.
- Technological properties were either maintained or enhanced when using the multiphase (Fielder/Niro) equipment.
Conclusions:
- Transposing formulations from single pot to multiphase high-shear granulation processes presents no significant difficulties within the studied domain.
- The multiphase equipment demonstrated capability in maintaining or improving granule properties.
- Optimal formulation domains were comparable across both granulation systems.
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