Focused beam reflectance method as an innovative (PAT) tool to monitor in-line granulation process in fluidized bed

References

• Betz G, Junker-Bürgin P, Leuenberger H. Batch and continuous processing in the production of pharmaceutical granules. Pharm Dev Technol 2003;8:289–297.
   PubMed Web of Science ®Google Scholar
• Leuenberger H, Puchkov M, Krausbauer E, Betz G. Manufacturing pharmaceutical granules: Is the granulation end-point a myth? Powder Technology 2009;189:141–148.
   Web of Science ®Google Scholar
• Holm P, Jungersen O, Schaefer T, Kristensen HG. Granulation in high speed mixers:I. Effects of process variables during kneading. Pharm Ind 1983;45:806–811.
   Web of Science ®Google Scholar
• Holm P, Jungersen O, Schaefer T, Kristensen HG. Granulation in high speed mixers: 2. Effects of process variables during kneading. Pharm Ind 1984;46:97–101.
   Web of Science ®Google Scholar
• Knight PC, Johansen A, Kristensen HG, Schaefer T, Seville JPK. An invsetigation of the effects on agglomeration of changing the speed of the mechanical mixer. Powder Tech 1999;110:204–209.
   Web of Science ®Google Scholar
• Liu LX, Litster JD, Iveson SM, Ennis BJ. Coalescence of deformable granules in wet granulation processes, AlChE J 2000;46:529–539.
   Google Scholar
• Iveson SM, Litster JD, Hapgood K, Ennis BJ. Nucleation, growth and breakage phenomena in agitated wet granulation processes: a review. Powder tech 2001;117:3–39.
   Web of Science ®Google Scholar
• Litster JD. Scale-up of wet granulation processes: science not art. Powder Tech 2003;130:35–40.
   Web of Science ®Google Scholar
• Wikberg M, Alderborn G. Compression characteristics of granulated materials. The effect of granule porosity on the fragmentation propensity and the compatibility of some granulations. Intl J Pharm 1990;69:239–253.
   Google Scholar
• Shah NH, Phuapradit W, Niphadkar M, Igbal K, Infeld MH, Malick AW. Effect of particle size on deformation and compaction characteristics of Ascorbic acid and Potassium chloride: Neat and granulated drug, Drug Dev Ind Pharm 1994;20:1761–1776.
   Google Scholar
• Watano S, Yamamoto A, Miyanami K. Effects of operational variables on the properties of granules prepared by moisture control method in tumbling fluidized bed granulation. Chem and pharm bulletin 1994;42:133–137.
   Web of Science ®Google Scholar
• Tardos IT, Irfan Khan M, Mort PR. Critical parameters and limiting conditions in binder granulation of fine powders. Powder Tech 1997;94:245–258.
   Web of Science ®Google Scholar
• Arnaud P, Brossard D, Chaumeil JC. Effect of the granulation process on nitrofurantoin granule characteristics. Drug Dev Ind Pharm 1998;24:57–66.
   PubMed Web of Science ®Google Scholar
• Rambali B, Baert L, Massart DL. Using experimental design to optimize the process parameters in fluidized bed granulation on a semi-full scale. Int J Pharm 2001;220:149–160.
   PubMed Web of Science ®Google Scholar
• Giry K, Genty M, Viana M, Wuthrich P, Chulia D. Multiphase versus single pot granulation process: influence of process and granulation parameters on granules properties. Drug Dev Ind Pharm 2006;32:509–530.
   PubMed Web of Science ®Google Scholar
• Giry K, Viana M, Genty M, Louvet F, Wüthrich P, Chulia D. Comparison of single pot and multiphase granulation. Part 2: Effect of the drying process on granules manufactured in a single pot granulator and dried either in situ or in a fluid bed dryer. Pharm Dev Technol 2009;14:149–158.
   PubMed Web of Science ®Google Scholar
• Jiménez T, Turchiuli C, Dumoulin E. Particles agglomeration in a conical fluidized bed in relation with air temperature profiles. Chem Eng Sci 2006;61:5954–5961.
   Web of Science ®Google Scholar
• Mukherjee T, Plakogiannis FM. Effects of process parameters on solid self-microemulsifying particles in a laboratory scale fluid bed. Pharm Dev Technol 2011. DOI:10.3109/10837450.2010.550625.
   Web of Science ®Google Scholar
• Katdare AV, Bavitz JF. A study of the compactibilty characteristics of a direct compression and a wet granulated formulation of Norfloxacin. Drug Dev Ind Pharm 1987;13:1047–1061.
   Web of Science ®Google Scholar
• Schwartz JB. Granulation. Drug Dev Ind Pharm 1988;14:2071–2090.
   Web of Science ®Google Scholar
• Frake P, Greenhalgh D, Grierson SM, Hempenstall JM, Rudd DR. Process control and end-point determination of a fluid bed granulation by application of near infra-red spectroscopy. Intl J pharm 1997;151:75–80.
   Web of Science ®Google Scholar
• Das S, Jarowski CI. Effect of granulating method on content uniformity and other physical properties of granules and their corresponding tablets. Drug Dev Ind Pharm 1979;5:489–500.
   Web of Science ®Google Scholar
• Kristensen J, Hansen VW. Wet granulation in rotary processor and fluid bed: comparison of granule and tablet properties. AAPS PharmSciTech 2006;7:E22.
   PubMed Web of Science ®Google Scholar
• Faure A, York P, Rowe RC. Process control and scale-up of pharmaceutical wet granulation processes: a review. Eur J Pharm Biopharm 2001;52:269–277.
   PubMed Web of Science ®Google Scholar
• Bouffard J, Kaster M, Dumont H. Influence of process variable and physicochemical properties on the granulation mechanism of mannitol in a fluid bed top spray granulator. Drug Dev Ind Pharm 2005;31:923–933.
   PubMed Web of Science ®Google Scholar
• Hu X, Cunningham JC, Winstead D. Study growth kinetics in fluidized bed granulation with at-line FBRM. Int J Pharm 2008;347:54–61.
   PubMed Web of Science ®Google Scholar
• Ehlers H, Räikkönen H, Antikainen O, Heinämäki J, Yliruusi J. Improving flow properties of ibuprofen by fluidized bed particle thin-coating. Int J Pharm 2009;368:165–170.
   PubMed Web of Science ®Google Scholar
• Kesavan JG, Peck GE. Pharmaceutical granulation and tablet formulation using neural networks. Pharm Dev Technol 1996;1:391–404.
   PubMedGoogle Scholar
• Schinzinger O, Schmidt PC. Comparison of the granulation behavior of three different excipients in a laboratory fluidized bed granulator using statistical methods. Pharm Dev Technol 2005;10:175–188.
   PubMed Web of Science ®Google Scholar
• Hemati M, Cherif R, Saleh K, Pont V. Fluidized bed coating and granulation: influence of process-related variables and physicochemical properties on the growth kinetics. Powder Tech 2003;130:18–34.
   Web of Science ®Google Scholar
• Merkku P, Yliruusi J. Use of 33 factorial design and multi-linear stepwise regression analysis in studying the fluidized bed granulation process, Part I Eur J Pharm Biopharm 1993;39:75–81.
   Google Scholar
• Merkku P, Antikainen O, Yliruusi J. Use of 33 factorial design and multi-linear stepwise regression analysis in studying the fluidized bed granulation process, Part II Eur J Pharm Biopharm 1993;39:112–116.
   Google Scholar
• Kawaguchi T, Sunada H, Yonezawa Y, Danjo K, Hasegawa M, Makino T et al. Granulation of acetaminophen by a rotating fluidized-bed granulator. Pharm Dev Technol 2000;5:141–151.
   PubMed Web of Science ®Google Scholar
• Tan HS, Salman AD, Hounslow MJ. Kinetics of fluidized bed melt granulation I: The effect of process variables. Chem Eng Sci 2006;61:1585–1601.
   Web of Science ®Google Scholar
• Hlinak AJ, Saleki-Gerhardt A. An evaluation of fluid bed drying of aqueous granulations. Pharm Dev Technol 2000;5:11–17.
   PubMed Web of Science ®Google Scholar
• Goeble SG, Steffens KJ. Online-measurement of moisture and particle size in the fluidized-bed processing with the near-infrared spectroscopy. Pharm Ind 1998;60:889–895.
   Web of Science ®Google Scholar
• Findlay WP, Peck GR, Morris KR. Determination of fluidized bed granulation end point using near-infrared spectroscopy and phenomenological analysis. J Pharm Sci 2005;94:604–612.
   PubMed Web of Science ®Google Scholar
• Luukkonen P, Fransson M, Björn IN, Hautala J, Lagerholm B, Folestad S. Real-Time assessment of granule and tablet properties using in-line data from a high-shear granulation process. J Pharm Sci 2008;97:950–959.
   PubMed Web of Science ®Google Scholar
• Tok AT, Goh X, Ng WK, Tan RB. Monitoring granulation rate processes using three PAT tools in a pilot-scale fluidized bed. AAPS PharmSciTech 2008;9:1083–1091.
   PubMed Web of Science ®Google Scholar
• Kaddour AA, Cuq B. In-line monitoring of wet agglomeration of wheat flour using near infrared spectroscopy. Powder Tech 2009;190:10–18.
   Web of Science ®Google Scholar
• Rantanen J, Antikainen O, Mannermaa JP, Yliruusi J. Use of the near-infrared reflectance method for measurement of moisture content during granulation. Pharm Dev Technol 2000;5:209–217.
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration, Process Analytical Technology Initiative, Guidance for Industry PAT − A framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance, http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm088828.htm.
   Google Scholar
• Richmond WR, Jones RL, Fawell PD. The relationship between particle aggregation and rheology in mixed silica-titania suspensions. Chem Eng J 1998;71:67–75.
   Web of Science ®Google Scholar
• Barrett P, Glennon B. In-line FBRM monitoring of particle size in dilute agitated suspensions. Part Part Syst Charact 1999;16:207–211.
   Web of Science ®Google Scholar
• Kougoulos E, Jones AG, Jennings KH, Wood-Kaczmar MW. Use of focused beam reflectance measurement (FBRM) and process video imaging (PVI) in a modified mixed suspension mixed product removal (MSMPR) cooling crystallizer. J Cryst Growth 2005;273:529–534.
   Web of Science ®Google Scholar
• Barrett P, Ward JA. Case study: Tracking, a polymorphic transition using FBRM, PVN, Raman, FTIR and calorimetry. Abstracts for papers of the American Chemical Society 2003;225:U960–U960.
   Web of Science ®Google Scholar
• Jeffers P, Raposo S, Lima-Costa ME, Connolly P, Glennon B, Kieran PM. Focussed beam reflectance measurement (FBRM) monitoring of particle size and morphology in suspension cultures of Morinda citrifolia and Centaurea calcitrapa. Biotechnol Lett 2003;25:2023–2028.
   PubMed Web of Science ®Google Scholar
• Worlitschek J, Mazzotti M. Choice of focal point position using Lasentec FBRM. Part Part Syst Charact 2003;20:12–17.
   Web of Science ®Google Scholar
• Alfano JC, Carter PW, Dunham AJ, Nowak MJ, Tubergen KR. Polyelectrolyte-Induced Aggregation of Microcrystalline Cellulose: Reversibility and Shear Effects. J Colloid Interface Sci 2000;223:244–254.
   PubMed Web of Science ®Google Scholar
• Heath AR, Fawell PD, Bahri PA, Swift JD. Estimating average particle size by focused beam reflectance measurement (FBRM). Part Part Syst Charact 2002;19:84–95.
   Web of Science ®Google Scholar
• McDonald KA, Jackman AP, Hurst S. Characterization of plant suspension cultures using the focused beam reflectance technique. Biotech Lett 2001;23:317–324.
   Web of Science ®Google Scholar
• Chew JW, Chow PS, Tan RBH. Automated in-line technique using FBRM to achieve consistent product quality in cooling crystallization. Cryst Growth Design 2007;7:1416–1422.
   Web of Science ®Google Scholar
• Schaafsma SH, Kossen NWF, Mos MT, Blauw L, Hoffmann AC. Effects and control of humidity and particle mixing in fluid-bed granulation. AIChE J 1999;45:1202–1210.
   Web of Science ®Google Scholar
• Rajniak P, Mancinelli C, Chern RT, Stepanek F, Farber L, Hill BT. Experimental study of wet granulation in fluidized bed: impact of the binder properties on the granule morphology. Int J Pharm 2007;334:92–102.
   PubMed Web of Science ®Google Scholar
• Schaefer T, Worts O. Control of fluidized bed granulation: III. Effect of inlet temperature and liquid flow rate on granule size distribution. Control of moisture content of granules in the drying phase. Arch Pharm Chemi Sci Ed 1978a;6:1–13.
   Web of Science ®Google Scholar
• Niskanen T, Yliruusi J, Niskanen M, Kontro O. Granularion of potassium chloride in instrumented fluidized bed granulator: 1. Effect of flow rate. Acta Pharm Fenn 1990;99:13–22.
   Google Scholar
• Walker GM, Holland CR, Ahmad MMN, Craig DQM. Influence of process parameters on fluidized hot-melt granulation and tablet pressing of pharmaceutical powders. Chem Eng Sci 2005;60:3867–3877.
   Web of Science ®Google Scholar
• Alkan MH, Yuksel A. Granulation in a fluidized bed II, effect of binder amount on the final granules. Drug Dev Ind Pharm 1986;12:1529–1543.
   Web of Science ®Google Scholar
• Schaefer T, Worts O. Control of fluidized bed granulation: IV. Effects of binder solution and atomization on granule size distribution. Arch Pharm Chemi Sci Ed 1978b;6:14–25.
   Google Scholar
• Schaefer T, Worts O. Control of fluidized bed granulation: V. Factors affecting granule growth. Arch Pharm Chemi Sci Ed 1978c;6:69–82.
   Google Scholar
• Wan LSC, Heng WSP, Liew CV. The influence of liquid spray rate and atomizing pressure on the size of spray droplets and spheroids. Intl J Pharm 1994;118:213–219.
   Google Scholar
• Juslin L, Antikainen O, Merkku P, Yliruusi J. Droplet size measurement: II. Effect of three independent variables on parameters describing the droplet size distribution from a pneumatic nozzle studied by multilinear stepwise regression analysis. Intl J Pharm 1995;123:257–264.
   Web of Science ®Google Scholar
• Van der Scheur FT, Goedendorp PL, Goot AJ van der Olieman JJ. Fluidised bed agglomeration with polyethylene glycol melt binder: effects of bed temperature and droplet size. Proceedings of World Congress of Part Tech 1998;3:103.
   Google Scholar
• Tan HS, Salman AD, Hounslow MJ. Kinetics of fluidized bed melt granulation II: Modeling the net rate of growth. Chem Eng Sci 2006;61:3930–3941.
   Web of Science ®Google Scholar
• Seo A, Holm P, Schaefer T. Effects of droplet size and type of binder on the agglomerate growth mechanisms by melt agglomeration in a fluidised bed. Eur J Pharm Sci 2002;16:95–105.
   PubMed Web of Science ®Google Scholar