Applications of Modeling in Oral Solid Dosage Form Development and Manufacturing

[1]  P. V. Danckwerts Continuous flow systems , 1953 .

[2]  O. Levenspiel Chemical Reaction Engineering , 1972 .

[3]  Dominic F. Sherony A model of surface renewal with application to fluid bed coating of particles , 1981 .

[4]  E. L. Parrott,et al.  Comparison of granule strength and tablet tensile strength. , 1983, Journal of pharmaceutical sciences.

[5]  U. Mann Analysis of spouted-bed coating and granulation. 1. Batch operation , 1983 .

[6]  C. Buurman,et al.  Scaling-up rules for solids suspension in stirred vessels , 1986 .

[7]  M. Hounslow,et al.  A discretized population balance for nucleation, growth, and aggregation , 1988 .

[8]  Fredrik Setterwall,et al.  The coating of particles in a fluidized bed (residence time distribution in a system of two coupled perfect mixers) , 1989 .

[9]  Christopher T. Rhodes,et al.  The spray drying of pharmaceuticals , 1992 .

[10]  Kei Miyanami,et al.  Application of fuzzy logic to bed height control in agitation-fluidized bed granulation , 1994 .

[11]  M. Hounslow,et al.  Adjustable discretized population balance for growth and aggregation , 1995 .

[12]  P. V. Danckwerts Continuous flow systems. Distribution of residence times , 1995 .

[13]  Yoshinobu Sato,et al.  Application of Fuzzy Logic to Moisture Control in Fluidized Bed Granulation , 1995 .

[14]  G. L. Fourman,et al.  Assessing the uniformity of aqueous film coatings applied to compressed tablets , 1995 .

[15]  Ragnar Ek,et al.  Compression behaviour and compactability of microcrystalline cellulose pellets in relationship to their pore structure and mechanical properties , 1995 .

[16]  G. Alefeld,et al.  Experimental investigation of heat transfer in a horizontal tube falling film absorber with aqueous solutions of LiBr with and without surfactants , 1996 .

[17]  Kei Miyanami,et al.  Control of moisture content in fluidized bed granulation by neural network. , 1997 .

[18]  Peter York,et al.  The use of solubility parameters in pharmaceutical dosage form design , 1997 .

[19]  D. Parikh,et al.  Application of Powder-Layering Technology and Film Coating for Manufacture of Sustained-Release Pellets Using a Rotary Fluid Bed Processor , 1997 .

[20]  Roland Bodmeier,et al.  Tableting of coated pellets , 1997 .

[21]  Masayuki Horio,et al.  Numerical simulation of cohesive powder behavior in a fluidized bed , 1998 .

[22]  Eiichi Abe,et al.  Coating mass distributions of seed particles in a tumbling fluidized bed coater Part II. A Monte Carlo simulation of particle coating , 1998 .

[23]  P York,et al.  Solubility parameters as predictors of miscibility in solid dispersions. , 1999, Journal of pharmaceutical sciences.

[24]  J Dressman,et al.  Improving drug solubility for oral delivery using solid dispersions. , 2000, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[25]  T. Abberger,et al.  The effect of powder type, free moisture and deformation behaviour of granules on the kinetics of fluid-bed granulation. , 2001, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[26]  S. Hoag,et al.  Influence of various drugs on the glass transition temperature of poly(vinylpyrrolidone): a thermodynamic and spectroscopic investigation. , 2001, International journal of pharmaceutics.

[27]  T. Rades,et al.  Characterization of glass solutions of poorly water‐soluble drugs produced by melt extrusion with hydrophilic amorphous polymers , 2001, The Journal of pharmacy and pharmacology.

[28]  T. Rades,et al.  Selection of excipients for melt extrusion with two poorly water-soluble drugs by solubility parameter calculation and thermal analysis. , 2001, International journal of pharmaceutics.

[29]  R C Rowe,et al.  Process control and scale-up of pharmaceutical wet granulation processes: a review. , 2001, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[30]  J. Kuipers,et al.  Discrete element modelling of fluidised bed spray granulation , 2003 .

[31]  Bhagwant D Rege,et al.  Identification of critical process variables for coating actives onto tablets via statistically designed experiments. , 2002, International journal of pharmaceutics.

[32]  Peter Kleinebudde,et al.  Coating uniformity and coating efficiency in a Bohle Lab-Coater using oval tablets. , 2003, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[33]  Peter Kleinebudde,et al.  Coating Uniformity: Influence of Atomizing Air Pressure , 2003, Pharmaceutical development and technology.

[34]  Kenji Yamane,et al.  Computer Simulation of Tablet Motion in Coating Drum , 1995, Pharmaceutical Research.

[35]  Chau-Chyun Chen,et al.  Solubility Modeling with a Nonrandom Two-Liquid Segment Activity Coefficient Model , 2004 .

[36]  J. Rantanen,et al.  The characterization of fluidization behavior using a novel multichamber microscale fluid bed. , 2004, Journal of pharmaceutical sciences.

[37]  C. Liew,et al.  Wet Spheronization by Rotary Processing—A Multistage Single‐Pot Process for Producing Spheroids , 2004, Drug development and industrial pharmacy.

[38]  Peter A. Crafts,et al.  Correlation and Prediction of Drug Molecule Solubility in Mixed Solvent Systems with the Nonrandom Two-Liquid Segment Activity Coefficient (NRTL−SAC) Model , 2006 .

[39]  Da-Wen Sun,et al.  Computational fluid dynamics (CFD) ¿ an effective and efficient design and analysis tool for the food industry: A review , 2006 .

[40]  Patrick J. Marsac,et al.  Theoretical and Practical Approaches for Prediction of Drug–Polymer Miscibility and Solubility , 2006, Pharmaceutical Research.

[41]  Stefan Heinrich,et al.  Improved accuracy and convergence of discretized population balance for aggregation: The cell average technique , 2006 .

[42]  Nitin Joshi,et al.  Mathematical Model to Predict Coat Weight Variability in a Pan Coating Process , 2007, Pharmaceutical development and technology.

[43]  J. Cunningham,et al.  A qualitative method for monitoring of nucleation and granule growth in fluid bed wet granulation by reflectance near-infrared spectroscopy. , 2007, Journal of pharmaceutical sciences.

[44]  B. Sarmento,et al.  Solid dispersions as strategy to improve oral bioavailability of poor water soluble drugs. , 2007, Drug discovery today.

[45]  J. Lasheras,et al.  Atomization of viscous and Non-Newtonean liquids by a co-axial high-speed gas jet: Experiments and droplet size modelling , 2008 .

[46]  Manfred Morari,et al.  OPTIMIZING CONTROL OF VARIABLE CYCLE TIME SIMULATED MOVING BEDS , 2007 .

[47]  Patrick J. Marsac,et al.  Estimation of Drug–Polymer Miscibility and Solubility in Amorphous Solid Dispersions Using Experimentally Determined Interaction Parameters , 2008, Pharmaceutical Research.

[48]  Cristian Grossmann,et al.  ‘Cycle to cycle’ optimizing control of simulated moving beds , 2008 .

[49]  O. Antikainen,et al.  Controlling granule size by granulation liquid feed pulsing. , 2008, International journal of pharmaceutics.

[50]  Richard Turton,et al.  Modeling weight variability in a pan coating process using Monte Carlo simulations , 2006, AAPS PharmSciTech.

[51]  Chau‐Chyun Chen,et al.  Modeling Drug Molecule Solubility to Identify Optimal Solvent Systems for Crystallization , 2008 .

[52]  O. Antikainen,et al.  Particle Size, Moisture, and Fluidization Variations Described by Indirect In-line Physical Measurements of Fluid Bed Granulation , 2008, AAPS PharmSciTech.

[53]  Peter Kleinebudde,et al.  Mathematical modeling of an aqueous film coating process in a Bohle Lab-Coater: Part 2: Application of the model , 2008, AAPS PharmSciTech.

[54]  Peter Kleinebudde,et al.  Mathematical modeling of an aqueous film coating process in a Bohle Lab-Coater, Part 1: Development of the model , 2008, AAPS PharmSciTech.

[55]  H. Tung,et al.  Prediction of pharmaceutical solubility Via NRTL-SAC and COSMO-SAC. , 2008, Journal of pharmaceutical sciences.

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

[57]  Lian Yu,et al.  Solubility of Small-Molecule Crystals in Polymers: d-Mannitol in PVP, Indomethacin in PVP/VA, and Nifedipine in PVP/VA , 2009, Pharmaceutical Research.

[58]  K. Wagner,et al.  Molecular dynamics simulations for drug dosage form development: thermal and solubility characteristics for hot-melt extrusion , 2008 .

[59]  Gabriele Sadowski,et al.  Modeling the solubility of pharmaceuticals in pure solvents and solvent mixtures for drug process design. , 2009, Journal of pharmaceutical sciences.

[60]  Simon Bates,et al.  Evaluation of Drug-Polymer Miscibility in Amorphous Solid Dispersion Systems , 2009, Pharmaceutical Research.

[61]  Jouko Yliruusi,et al.  Granule size control and targeting in pulsed spray fluid bed granulation. , 2009, International journal of pharmaceutics.

[62]  Alexander J. Marchut,et al.  Experimental and model-based approaches to studying mixing in coating pans , 2009, Pharmaceutical development and technology.

[63]  Lian Yu,et al.  Solubilities of crystalline drugs in polymers: an improved analytical method and comparison of solubilities of indomethacin and nifedipine in PVP, PVP/VA, and PVAc. , 2010, Journal of pharmaceutical sciences.

[64]  Andrew Prpich,et al.  Drug product modeling predictions for scale-up of tablet film coating - A quality by design approach , 2010, Comput. Chem. Eng..

[65]  Peter W Wypych,et al.  Experimental validation of particle flow through conveyor transfer hoods via continuum and discrete element methods , 2010 .

[66]  Wei Chen,et al.  Modeling of pan coating processes: Prediction of tablet content uniformity and determination of critical process parameters. , 2010, Journal of pharmaceutical sciences.

[67]  Saurabh Srivastava,et al.  FLUID BED TECHNOLOGY: OVERVIEW AND PARAMETERS FOR PROCESS SELECTION , 2010 .

[68]  Peter Langguth,et al.  Role of continuous moisture profile monitoring by inline NIR spectroscopy during fluid bed granulation of an Enalapril formulation , 2011, Drug development and industrial pharmacy.

[69]  Andrey Bogomolov,et al.  Multivariate process trajectories: capture, resolution and analysis , 2011 .

[70]  Peter W Wypych,et al.  Investigation into calibration of discrete element model parameters for scale-up and validation of particle–structure interactions under impact conditions , 2011 .

[71]  Lipika Chablani,et al.  Inline Real-Time Near-Infrared Granule Moisture Measurements of a Continuous Granulation–Drying–Milling Process , 2011, AAPS PharmSciTech.

[72]  Jasmine Gupta,et al.  Prediction of solubility parameters and miscibility of pharmaceutical compounds by molecular dynamics simulations. , 2011, The journal of physical chemistry. B.

[73]  Gintaras V. Reklaitis,et al.  Process systems engineering: From Solvay to modern bio- and nanotechnology.: A history of development, successes and prospects for the future , 2011 .

[74]  I. Economou,et al.  Thermodynamics of pharmaceuticals: Prediction of solubility in pure and mixed solvents with PC-SAFT , 2011 .

[75]  T. De Beer,et al.  Batch statistical process control of a fluid bed granulation process using in-line spatial filter velocimetry and product temperature measurements. , 2011, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[76]  Jean Paul Remon,et al.  Development of a fluid bed granulation process control strategy based on real-time process and product measurements. , 2012, Talanta.

[77]  J.M. Laínez,et al.  Challenges and opportunities in enterprise-wide optimization in the pharmaceutical industry , 2012, Comput. Chem. Eng..

[78]  James DiNunzio,et al.  Dry powder coating of pharmaceuticals: a review. , 2013, International journal of pharmaceutics.

[79]  Ali R. Rajabi-Siahboomi,et al.  Process Optimization of a Novel Immediate Release Film Coating System using QbD Principles , 2013, AAPS PharmSciTech.

[80]  David S. Jones,et al.  Construction of drug-polymer thermodynamic phase diagrams using Flory-Huggins interaction theory: identifying the relevance of temperature and drug weight fraction to phase separation within solid dispersions. , 2013, Molecular pharmaceutics.

[81]  T. De Beer,et al.  Process analytical tools for monitoring, understanding, and control of pharmaceutical fluidized bed granulation: A review. , 2013, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[82]  Soon Huat Tan,et al.  Cytocompatibility and Mechanical Properties of Hydroxyapatite Composite Reinforced with Multi-Walled Carbon Nanotubes and Bovine Serum Albumin , 2013 .

[83]  S. Thakral,et al.  Prediction of drug-polymer miscibility through the use of solubility parameter based Flory-Huggins interaction parameter and the experimental validation: PEG as model polymer. , 2013, Journal of pharmaceutical sciences.

[84]  Gregory M. Troup,et al.  Process systems engineering tools in the pharmaceutical industry , 2013, Comput. Chem. Eng..

[85]  J. Breitkreutz,et al.  Improved group contribution parameter set for the application of solubility parameters to melt extrusion. , 2013, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[86]  G. Sadowski,et al.  Influence of copolymer composition on the phase behavior of solid dispersions. , 2014, Molecular pharmaceutics.

[87]  Marianthi G. Ierapetritou,et al.  A systematic framework for onsite design and implementation of a control system in a continuous tablet manufacturing process , 2014, Comput. Chem. Eng..

[88]  Yuanhui Ji,et al.  Thermodynamic phase behavior of API/polymer solid dispersions. , 2014, Molecular pharmaceutics.

[89]  M. Pudlas,et al.  A fast and reliable empirical approach for estimating solubility of crystalline drugs in polymers for hot melt extrusion formulations. , 2014, Journal of pharmaceutical sciences.

[90]  Hongyuan Liu,et al.  Hybrid finite–discrete element modeling of geomaterials fracture and fragment muck-piling , 2015 .