Scale-Up and Endpoint Issues of Pharmaceutical Wet Granulation in a V-Type Low Shear Granulator

REFERENCES

• Handbook of Pharmaceutical Granulation Technology, D.M. Parikh. Marcel Dekker, New York 1997
   Google Scholar
• Lacey P.M.C. The Mixing of Solid Particles. Trans. Inst. Chem. Eng. 1943; 21: 53–59
   Google Scholar
• Kristensen H.G. Agglomeration of Powders. Acta Pharm. Suec. 1988; 25: 187–204
   Google Scholar
• Carstensen J.T., Lai T., Flickner D.W., Huber H.E., Zoglio M.A. Physical Aspects of Wet Granulation I: Distribution Kinetics of Water. J. Pharm. Sci. 1976; 65(7)992–997
   PubMed Web of Science ®Google Scholar
• Kristensen H.G., Schaefer T. Granulation—A Review on Pharmaceutical Wet Granulation. Drug Dev. Ind. Pharm. 1987; 13(4&5)803–872
   Web of Science ®Google Scholar
• Stamm A., Paris L. Influence of Technological Factors on the Optimal Granulation Liquid Requirement Measured by Power Consumption. Drug Dev. Ind. Pharm. 1985; 11(2&3)333–360
   Web of Science ®Google Scholar
• Pilpel N. Granulation of Pharmaceuticals. Chem. Proc. Eng. 1969, July
   Web of Science ®Google Scholar
• Parker M.D., York P., Rowe R.C. Binder–Substrate Interaction in Wet Granulation. 1. The Effect of Binder Characteristics. Int. J. Pharm. 1990; 64: 207–216
   Web of Science ®Google Scholar
• Rowe R.C. Binder–Substrate Interactions in Granulation: A Theoretical Approach Based on Surface Free Energy Polarity. Int. J. Pharm. 1989; 52: 149–154
   Web of Science ®Google Scholar
• Schaefer T. Equipment for Wet Granulation. Acta Pharm. Suec. 1988; 25: 205–228
   Google Scholar
• Titley P.C. Agglomeration and Granulation of Powders, Processing and Manufacturing Practice. Acta Pharm. Suec. 1988; 25: 267–280
   Google Scholar
• Zoglio M.A., Huber H.E., Koehne G., Chan P.L., Carstensen J.T. Physical Aspects of Wet Granulation II: Factors Involved in Prolonged and Excessive Mixing. J. Pharm. Sci. 1976; 65(8)1205–1208
   PubMed Web of Science ®Google Scholar
• Zoglio M.A., Carstensen J.T. Physical Aspects of Wet Granulation III: Effect of Wet Granulation on Granule Porosity. Drug Dev. Ind. Pharm. 1983; 9(8)1417–1434
   Web of Science ®Google Scholar
• Ghanta S.R., Srinivas R., Rhodes C.T. Use of Mixer-Torque Measurements as an Aid to Optimizing Wet Granulation Process. Drug Dev. Ind. Pharm. 1984; 10(2)305–311
   Web of Science ®Google Scholar
• Alleva D.S., Schwartz J.B. Granulation Rheology I: Equipment Design and Preliminary Testing. Drug Dev. Ind. Pharm. 1986; 12(4)471–487
   Web of Science ®Google Scholar
• Remon J.P., Schwartz J.B. Effect of Raw Materials and Processing on the Quality of Granules Prepared from Microcrystalline Cellulose–Lactose Mixtures. Drug Dev. Ind. Pharm. 1987; 13(1)1–14
   Web of Science ®Google Scholar
• Parker M.D., York P., Rowe R.C. Binder–Substrate Interactions in Wet Granulation. 2. The Effect of Binder Molecular Weight. Int. J. Pharm. 1991; 72: 243–249
   Web of Science ®Google Scholar
• Vojnovic D., Selenati P., Rubessa F., Moneghini M. Wet Granulation in a Small Scale High Shear Mixer. Drug Dev. Ind. Pharm. 1992; 18(9)961–972
   Web of Science ®Google Scholar
• Corvari V., Fry W.C., Seibert W.L., Augsberger L. Instrumentation of a High Shear Mixer: Evaluation and Comparison of a New Capacitive Sensor, a Watt Meter and a Strain-Gage Torque Sensor for Wet Granulation Monitoring. Pharm. Res. 1992; 9(12)1525–1533
   PubMed Web of Science ®Google Scholar
• Kopcha M., Roland E., Bubb G., Vadino W.A. Instrumentation of a Vertical High Shear/Mixer Granulator to Monitor the Granulation Operation. Drug Dev. Ind. Pharm. 1992; 18(18)1945–1968
   Web of Science ®Google Scholar
• Vojnovic D., Moneghini M., Rubessa F. Simultaneous Optimization of Several Response Variables in a Granulation Process. Drug Dev. Ind. Pharm. 1993; 19(12)1479–1496
   Web of Science ®Google Scholar
• Wehrle P., Nobelis Ph., Cuine A., Stamm A. Response Surface Methodology: An Interesting Statistical Tool for Process Optimization and Validation: Example of Wet Granulation in a High Shear Mixer. Drug Dev. Ind. Pharm. 1993; 19(13)1637–1653
   Web of Science ®Google Scholar
• Vojnovic D., Moneghini M., Rubessa F. Optimiza-tion of Granulation in a High Shear Mixer by Mixture Design. Drug Dev. Ind. Pharm. 1994; 20(6)1035–1047
   Web of Science ®Google Scholar
• Sheskey P.J., Williams D.M. Comparison of Low-Shear and High-Shear Wet Granulation Techniques and the Influence of Percent Water Addition in the Preparation of a Controlled-Release Matrix Tablet Containing HPMC and a High-Dose, Highly Water-Soluble. Drug. Pharm. Technol., 20(3)80–91
   Google Scholar
• Nouh A.T.I. The Effect of Variations in Concentration and Type of Binder on the Physical Characteristics of Sulfadiazine Tablets and Granulation Prepared by Wet and Fluidized-Bed Granulation Method. Pharm. Ind. 1986; 48(6)
   Web of Science ®Google Scholar
• Chirkot T.S. Characterization of a Pharmaceutical Wet Granulation Process in a V-Type Granulator. Pharm. Eng. 1999; 19(4)50–61
   Google Scholar
• Newitt D., Conway-Jones J. Trans. Instr. Chem. Engrs. 1958; 36: 422
   Google Scholar
• Hancock B.C., York P., Rowe R.C., Parker M.D. Characterization of Wet Masses Using a Mixer-Torque Rheometer: 1. Effect of Instrument Geometry. Int. J. Pharm. 1991; 76: 239–245
   Web of Science ®Google Scholar
• Lipps D.M., Sakr A.M. Characterization of Wet Granulation Process Parameters Using Response Surface Methodology. 1. Top Spray Fluidized Bed. J. Pharm. Sci. 1994; 83(7)937–947
   PubMed Web of Science ®Google Scholar
• Lindberg N.O., Jonsson C. The Granulation of Lactose and Starch in a Recording High-Shear Mixer, Diosna P25. Drug Dev. Ind. Pharm. 1985; 11(2&3)387–403
   Web of Science ®Google Scholar
• Paris L., Stamm A. Optimal Massing Liquid Volume Determination by Energy Consumption Measurements: Study of the Influence of Some Physical Properties of Solvents and Products Used. Drug Dev. Ind. Pharm. 1985; 11(2&3)361–386
   Web of Science ®Google Scholar
• Wang R.H., Fan L.T. Methods for Scaling-Up Tumble Blenders. Chem. Eng. 1974, May; 88–94
   Web of Science ®Google Scholar
• Patterson-Kelley Proprietary Documents. Patterson-Kelley Co., East Stroudsburg, PA
   Google Scholar
• Kay D., Record P.C. Automatic Wet Granulation End-Point Control System. Manuf. Chem. Aerosol News 1978, Sept; 45–46
   Google Scholar
• Fry W.C., Stagner W.C., Wichman K.C. Computer-Interfaced Capacitive Sensor for Monitoring the Gran-ulation Process. J. Pharm. Sci. 1984; 73(3)420–421
   PubMed Web of Science ®Google Scholar
• Werani J. Production Experience with End Point Control. Acta Pharm. Suec. 1988; 25: 247–266
   Google Scholar
• Cliff M.J. Granulation Endpoint and Automated Process Control of Mixer-Granulators: Part I. Pharm. Technol. 1990, April; 112–132
   Google Scholar
• Cliff M.J. Granulation Endpoint and AutomatedProcess Control of Mixer-Granulators: Part II. Pharm. Technol. Int. 1990, Feb; 18–22
   Google Scholar
• Watano S., Terashita K., Miyanami K. Determina-tion of an End-Point with a Complex Granulation Applying Infrared Moisture Sensor. Chem. Pharm. Bull. 1991; 39(4)1013–1017
   Web of Science ®Google Scholar
• Leuenberger H., Bier H.-P., Sucker H.B. Theory of Granulating Liquid Requirement in the Conventional Granulating Process. Pharm. Technol. 1987, June; 76–80
   Google Scholar