“Design Space” Determination of a Paracetamol Fluid Bed Granulation Using Design of Experiments

Rubrik: Originale

(Treffer aus pharmind, Nr. 04, Seite 644 (2012))

Hartung A | Johansson E | Knoell M | Valthorsson H | Langguth P

“Design Space” Determination of a Paracetamol Fluid Bed Granulation Using Design of Experiments / Hartung et al. • Design Space Determination · Hartung A, Johansson E, Knoell M, Valthorsson H, Langguth P · ¹ Department of Pharmaceutical Technology and Biopharmaceutics, Johannes Gutenberg-University, Mainz, Germany und ² Hüttlin GmbH, Schopfheim, Germany und ³ Umetrics AB, Umeå, Sweden und ⁴ Novartis Pharma Stein AG, Stein, Switzerland
Design of experiments Design space Fluid bed granulation Paracetamol Quality by design “Quality by design” means designing and developing formulations and manufacturing processes to ensure predefined quality by understanding how formulation and manufacturing process variables influence the quality of a drug product [ 1 , 2 ]. There is a need for developing deeper scientific understanding of critical process and product attributes. As a result the “design space” should be established, i. e., a range of process parameter settings that have been demonstrated to provide predefined end product quality. Mathematically, it is a multidimensional combination and interaction of input variables and ...