Industrial application of heat- and mass balance model for fluid-bed granulation for technology transfer and design space exploration

Graphical abstract

[1]  Alexander M. Niziolek,et al.  Multi-dimensional mechanistic modeling of fluid bed granulation processes: An integrated approach , 2013 .

[2]  T. De Beer,et al.  Mechanistic modelling of fluidized bed drying processes of wet porous granules: a review. , 2011, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[3]  David R. Ochsenbein,et al.  Agglomeration of Needle-like Crystals in Suspension: I. Measurements , 2015 .

[4]  R. Gupta.  Fluid bed granulation and drying , 2017 .

[5]  Éric Poulin,et al.  Nonlinear model predictive control of a batch fluidized bed dryer for pharmaceutical particles , 2017 .

[6]  Manfred Morari,et al.  Agglomeration of Needle-like Crystals in Suspension. II. Modeling , 2015 .

[7]  Rohit Ramachandran,et al.  Model Development and Validation of Fluid Bed Wet Granulation with Dry Binder Addition Using a Population Balance Model Methodology , 2018, Processes.

[8]  Dana Barrasso,et al.  A Multi-Scale Hybrid CFD-DEM-PBM Description of a Fluid-Bed Granulation Process , 2014 .

[9]  Victoria Pauli,et al.  Orthogonal Redundant Monitoring of a New Continuous Fluid-Bed Dryer for Pharmaceutical Processing by Means of Mass and Energy Balance Calculations and Spectroscopic Techniques. , 2019, Journal of pharmaceutical sciences.

[10]  Stefan Heinrich,et al.  Fluidized bed spray granulation: analysis of heat and mass transfers and dynamic particle populations , 2005 .

[11]  David R. Ochsenbein,et al.  Effect of needle‐like crystal shape on measured particle size distributions , 2016 .

[12]  Salvador García-Muñoz,et al.  A flowsheet model for the development of a continuous process for pharmaceutical tablets: An industrial perspective , 2018 .

[13]  Christopher L. Burcham,et al.  Designing Robust Crystallization Processes in the Presence of Parameter Uncertainty Using Attainable Regions , 2015 .

[14]  Zorica Djuric,et al.  Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment. , 2017, International journal of pharmaceutics.

[15]  Jeroen Geens,et al.  Applications of Modeling in Oral Solid Dosage Form Development and Manufacturing , 2016 .

[16]  Salvador García Muñoz,et al.  Handling uncertainty in the establishment of a design space for the manufacture of a pharmaceutical product , 2010, Comput. Chem. Eng..

[17]  Ich Harmonised,et al.  INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE , 2006 .

[18]  Evdokia Korakianiti,et al.  Statistical Thinking and Knowledge Management for Quality-Driven Design and Manufacturing in Pharmaceuticals , 2011, Pharmaceutical Research.

[19]  Krist V. Gernaey,et al.  Quantitative risk assessment via uncertainty analysis in combination with error propagation for the determination of the dynamic Design Space of the primary drying step during freeze‐drying , 2017, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[20]  D L Massart,et al.  Using experimental design to optimize the process parameters in fluidized bed granulation on a semi-full scale. , 2001, International journal of pharmaceutics.

[21]  Sharmista Chatterjee,et al.  An Overview of the Role of Mathematical Models in Implementation of Quality by Design Paradigm for Drug Development and Manufacture , 2017 .

[22]  Rohit Ramachandran,et al.  Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture , 2016 .

[23]  Denita Winstead,et al.  Understanding and predicting bed humidity in fluidized bed granulation. , 2008, Journal of pharmaceutical sciences.