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Volumn 100, Issue 5, 2011, Pages 1969-1986

Quality-by-design: An integrated process analytical technology approach to determine the nucleation and growth mechanisms during a dynamic pharmaceutical coprecipitation process

Author keywords

Coprecipitation; Heterogeneous nucleation; Homogeneous nucleation; Induction; Kinetics; Mathematical modeling; Process analytical technology; Quality by Design; Regulatory science; Thermodynamics

Indexed keywords

EUDRAGIT; NAPROXEN;

EID: 79952260305     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22430     Document Type: Article
Times cited : (27)

References (47)
  • 1
    • 0028006355 scopus 로고
    • Optimization of process variables for the preparation of ibuprofen coprecipitates with Eudragit S100
    • Khan MA, Bolton S, Kislalioglu MS. 1994. Optimization of process variables for the preparation of ibuprofen coprecipitates with Eudragit S100. Int J Pharm 102:185-192.
    • (1994) Int J Pharm , vol.102 , pp. 185-192
    • Khan, M.1    Bolton, S.2    Kislalioglu, M.3
  • 2
    • 0035045372 scopus 로고    scopus 로고
    • Naproxen-Eudragit microspheres: Screening of process and formulation variables for the preparation of extended release tablets
    • Zaghloul AA, Faltinek J, Vaithiyalingam SR, Reddy IK, Khan MA. 2001. Naproxen-Eudragit microspheres: Screening of process and formulation variables for the preparation of extended release tablets Pharmazie 56:321-324.
    • (2001) Pharmazie , vol.56 , pp. 321-324
    • Zaghloul, A.1    Faltinek, J.2    Vaithiyalingam, S.3    Reddy, I.4    Khan, M.5
  • 3
    • 0035217531 scopus 로고    scopus 로고
    • Response surface methodology to obtain naproxen controlled release tablets from its microspheres with Eudragit L100-55
    • Zaghloul AA, Vaithiyalingam SR, Faltinek J, Reddy IK, Khan MA. 2001. Response surface methodology to obtain naproxen controlled release tablets from its microspheres with Eudragit L100-55. J Microencapsul 18:651-662.
    • (2001) J Microencapsul , vol.18 , pp. 651-662
    • Zaghloul, A.1    Vaithiyalingam, S.2    Faltinek, J.3    Reddy, I.4    Khan, M.5
  • 4
    • 67549111174 scopus 로고    scopus 로고
    • Physicomechanical properties of naproxen-loaded microparticles prepared from Eudragit L100
    • Maghsoodi M. 2009. Physicomechanical properties of naproxen-loaded microparticles prepared from Eudragit L100. AAPS PharmSciTech 10:120-128.
    • (2009) AAPS PharmSciTech , vol.10 , pp. 120-128
    • Maghsoodi, M.1
  • 5
    • 79952261018 scopus 로고    scopus 로고
    • FDA. Guidance for industry. PAT-A framework for innovative pharmaceutical development, manufacturing, and quality assurance. Accessed August 10, 2010, at.
    • FDA2004. Guidance for industry. PAT-A framework for innovative pharmaceutical development, manufacturing, and quality assurance. Accessed August 10, 2010, at.
    • (2004)
  • 6
    • 1042264120 scopus 로고    scopus 로고
    • Applications of process analytical technology to crystallization processes
    • Yu L, Lionberger RA, Raw AS, D'Costa R, Wu H, Hussain AS. 2004. Applications of process analytical technology to crystallization processes. Adv Drug Deliv Rev 56:349-369.
    • (2004) Adv Drug Deliv Rev , vol.56 , pp. 349-369
    • Yu, L.1    Lionberger, R.2    Raw, A.3    D'Costa, R.4    Wu, H.5    Hussain, A.6
  • 7
    • 76649117080 scopus 로고    scopus 로고
    • Quality-by-Design (QbD): An integrated process analytical technology (PAT) approach for real-time monitoring and mapping the state of a pharmaceutical co-precipitation process
    • Wu H, Khan MA. 2010. Quality-by-Design (QbD): An integrated process analytical technology (PAT) approach for real-time monitoring and mapping the state of a pharmaceutical co-precipitation process. J Pharm Sci 99:1516-1534.
    • (2010) J Pharm Sci , vol.99 , pp. 1516-1534
    • Wu, H.1    Khan, M.2
  • 8
    • 85031251028 scopus 로고    scopus 로고
    • FDA. Guidance for industry. Process validation: General principles and practices. draft guidance. Accessed August 10, 2010, at.
    • FDA2008. Guidance for industry. Process validation: General principles and practices. draft guidance. Accessed August 10, 2010, at.
    • (2008)
  • 9
    • 85031269707 scopus 로고    scopus 로고
    • FDA/ICH. Guidance for industry. Q8 pharmaceutical development. Accessed August 10, 2010, at.
    • FDA/ICH2006. Guidance for industry. Q8 pharmaceutical development. Accessed August 10, 2010, at.
    • (2006)
  • 10
    • 85031276136 scopus 로고    scopus 로고
    • FDA/ICH. Q8(R2) pharmaceutical development revision 2. Accessed August 10, 2010, at.
    • FDA/ICH2009. Q8(R2) pharmaceutical development revision 2. Accessed August 10, 2010, at.
    • (2009)
  • 11
    • 77956361367 scopus 로고    scopus 로고
    • Prediction of onset of crystallization in amorphous pharmaceutical systems: Phenobarbital, nifedipine/PVP, and phenobarbital/PVP
    • Varon V, Bhugra C, Pikal MJ. 2010. Prediction of onset of crystallization in amorphous pharmaceutical systems: Phenobarbital, nifedipine/PVP, and phenobarbital/PVP. J Pharm Sci 99(9):3887-900.
    • (2010) J Pharm Sci , vol.99 , Issue.9 , pp. 3887-3900
    • Varon, V.1    Bhugra, C.2    Pikal, M.3
  • 12
    • 77955234073 scopus 로고    scopus 로고
    • Crystallization tendency of active pharmaceutical ingredients following rapid solvent evaporation - classification and comparison with crystallization tendency from undercooled melts
    • Eerdenbrugh BV, Baird JA, Taylor LS. 2010. Crystallization tendency of active pharmaceutical ingredients following rapid solvent evaporation - classification and comparison with crystallization tendency from undercooled melts. J Pharm Sci 99(9):3826-3838.
    • (2010) J Pharm Sci , vol.99 , Issue.9 , pp. 3826-3838
    • Eerdenbrugh, B.1    Baird, J.2    Taylor, L.3
  • 13
    • 0024015052 scopus 로고
    • Interpretation of crystallization induction periods
    • Söhnel O, Mullin JW. 1988. Interpretation of crystallization induction periods. J Colloid Interface Sci 123:43-50.
    • (1988) J Colloid Interface Sci , vol.123 , pp. 43-50
    • Söhnel, O.1    Mullin, J.2
  • 14
    • 77951666723 scopus 로고    scopus 로고
    • Prediction of the induction period of crystallization of naproxen in solid dispersion using differential scanning calorimetry
    • Yosjihashi Y, Yonemochi E, Maeda Y, Terada K. 2010. Prediction of the induction period of crystallization of naproxen in solid dispersion using differential scanning calorimetry. J Therm Anal Calorim 99:15-19.
    • (2010) J Therm Anal Calorim , vol.99 , pp. 15-19
    • Yosjihashi, Y.1    Yonemochi, E.2    Maeda, Y.3    Terada, K.4
  • 15
    • 0001375432 scopus 로고
    • A method for the determination of precipitation induction periods
    • Söhnel O, Mullin JW. 1978. A method for the determination of precipitation induction periods. J Cryst Growth 44:377-382.
    • (1978) J Cryst Growth , vol.44 , pp. 377-382
    • Söhnel, O.1    Mullin, J.2
  • 16
    • 0000525207 scopus 로고
    • Precipitation of barium sulfate: Induction time and the effect of an additive on nucleation and growth
    • Van Der Leeden MC, Kashchiev D, Van Rosmalen GM. 1992. Precipitation of barium sulfate: Induction time and the effect of an additive on nucleation and growth. J Colloid Interface Sci 152:338-350.
    • (1992) J Colloid Interface Sci , vol.152 , pp. 338-350
    • Van Der, L.M.1    Kashchiev, D.2    Van Rosmalen, G.3
  • 17
    • 33645213838 scopus 로고    scopus 로고
    • 4 homogeneous nucleation by a cluster coagulation model
    • 4 homogeneous nucleation by a cluster coagulation model. J Colloid Interface Sci 297:190-198.
    • (2006) J Colloid Interface Sci , vol.297 , pp. 190-198
    • Guo, Z.1    Jones, A.2    Li, N.3
  • 18
    • 33847285901 scopus 로고    scopus 로고
    • Determination the growth mechanism of tolazamide by induction time measurement
    • Kuldipkumar A, Kwon GS, Zhang GZ. 2007. Determination the growth mechanism of tolazamide by induction time measurement. Cryst Growth Des 7:234-242.
    • (2007) Cryst Growth Des , vol.7 , pp. 234-242
    • Kuldipkumar, A.1    Kwon, G.2    Zhang, G.3
  • 19
    • 0006188880 scopus 로고
    • Analysis of precipitation processes of bis(dimethylglyoximato)Ni(II) and related complexes
    • Wakita MIH, Masuda I. 1983. Analysis of precipitation processes of bis(dimethylglyoximato)Ni(II) and related complexes. J Cryst Growth 61:377-382.
    • (1983) J Cryst Growth , vol.61 , pp. 377-382
    • Wakita, M.1    Masuda, I.2
  • 20
    • 0036815826 scopus 로고    scopus 로고
    • Characterizing the metastable zone width and solubility curve using Lasentec FBRM and PVM
    • Barrett P, Glennon B. 2002. Characterizing the metastable zone width and solubility curve using Lasentec FBRM and PVM. Trans IChemE 80(Part A)799-805.
    • (2002) Trans IChemE , vol.80 , Issue.PART A , pp. 799-805
    • Barrett, P.1    Glennon, B.2
  • 21
    • 36749056217 scopus 로고    scopus 로고
    • Modeling of metastable zone width behavior with dynamic equation
    • Yang DR, Lee KS, Lee JS, Kim SG, Kim DH, Bang YK. 2007. Modeling of metastable zone width behavior with dynamic equation. Ind Eng Chem Res 46:8158-8165.
    • (2007) Ind Eng Chem Res , vol.46 , pp. 8158-8165
    • Yang, D.1    Lee, K.2    Lee, J.3    Kim, S.4    Kim, D.5    Bang, Y.6
  • 22
    • 77953165732 scopus 로고    scopus 로고
    • A stochastic model for nulceation kinetics determination in droplet-based microfluidic systems
    • Goh L, Chen K, Bhamidi V, He G, Kee NCS, Kenis PJA, Zukoski III CF, Braatz RD. 2010. A stochastic model for nulceation kinetics determination in droplet-based microfluidic systems. Cryst Growth Des 10:2515-2521.
    • (2010) Cryst Growth Des , vol.10 , pp. 2515-2521
    • Goh, L.1    Chen, K.2    Bhamidi, V.3    He, G.4    Kee, N.5    Kenis, P.6    Zukoski, I.C.7    Braatz, R.8
  • 23
    • 32544460072 scopus 로고    scopus 로고
    • Precipitation of L-glutamic acid: Determination of nucleation kinetics
    • Schöll J, Vicum L, Müller M, Mazzotti M. 2006. Precipitation of L-glutamic acid: Determination of nucleation kinetics. Chem Eng Technol 29:257-264.
    • (2006) Chem Eng Technol , vol.29 , pp. 257-264
    • Schöll, J.1    Vicum, L.2    Müller, M.3    Mazzotti, M.4
  • 24
    • 0003440119 scopus 로고
    • Theory of particulate processes: Analysis and techniques of continuous crystallization
    • New York: Academic Press, Inc. Harcourt Brace Jovanovich, Publishers.
    • Randolph AD, Larson MA. 1988. Theory of particulate processes: Analysis and techniques of continuous crystallization. New York: Academic Press, Inc. Harcourt Brace Jovanovich, Publishers. pp 51-79.
    • (1988) , pp. 51-79
    • Randolph, A.1    Larson, M.2
  • 25
    • 0038388739 scopus 로고    scopus 로고
    • Nucleation of crystalline phases of water in homogeneous and inhomogeneous environments
    • Radhakrishnan R, Trout BL. 2003. Nucleation of crystalline phases of water in homogeneous and inhomogeneous environments. Phys Rev Lett 90(15): 158301-158304.
    • (2003) Phys Rev Lett , vol.90 , Issue.15 , pp. 158301-158304
    • Radhakrishnan, R.1    Trout, B.2
  • 27
    • 48149111993 scopus 로고    scopus 로고
    • Evidence for a size dependent nucleation mechanism in solid state polymorph transformations
    • Beckham GT, Peters B, Trout BL. 2008. Evidence for a size dependent nucleation mechanism in solid state polymorph transformations. J Phys Chem B 112:7460-7466.
    • (2008) J Phys Chem B , vol.112 , pp. 7460-7466
    • Beckham, G.1    Peters, B.2    Trout, B.3
  • 28
    • 0001708068 scopus 로고
    • Kinetics of nucleation in solutions
    • Nývlt J. 1968. Kinetics of nucleation in solutions. J Cryst Growth 3, 4:377-383.
    • (1968) J Cryst Growth , vol.3-4 , pp. 377-383
    • Nývlt, J.1
  • 29
    • 0004294969 scopus 로고
    • Crystallization
    • 2nd edLondon: Butterworth-Heinemann.
    • Mullin JW. 1972. Crystallization. 2nd edLondon: Butterworth-Heinemann, pp 573-573.
    • (1972) , pp. 573-573
    • Mullin, J.1
  • 30
    • 0026412835 scopus 로고
    • Induction time and metastability limit in new phase formation
    • Kashchiev D, Verdoes D, van Rosmalen GM. 1991. Induction time and metastability limit in new phase formation. J Cryst Growth 110:373-380.
    • (1991) J Cryst Growth , vol.110 , pp. 373-380
    • Kashchiev, D.1    Verdoes, D.2    van Rosmalen, G.3
  • 31
    • 0037188055 scopus 로고    scopus 로고
    • Effect of ultrasound on the induction time and the metastable zone widths of potassium sulphate
    • Lyczko N, Espitalier F, Louisnard O, Schwartzentruber J. 2002. Effect of ultrasound on the induction time and the metastable zone widths of potassium sulphate. Chem Eng J 86:233-241.
    • (2002) Chem Eng J , vol.86 , pp. 233-241
    • Lyczko, N.1    Espitalier, F.2    Louisnard, O.3    Schwartzentruber, J.4
  • 32
    • 0030105732 scopus 로고    scopus 로고
    • Salting-out precipitation of potassium dihydrogen phosphate (KDP). I. Precipitation mechanism
    • Barata PA, Serrano ML. 1996. Salting-out precipitation of potassium dihydrogen phosphate (KDP). I. Precipitation mechanism. J Cryst Growth 160:361-369.
    • (1996) J Cryst Growth , vol.160 , pp. 361-369
    • Barata, P.1    Serrano, M.2
  • 33
    • 10644222846 scopus 로고    scopus 로고
    • Real-time product morphology monitoring in crystallization using imaging technique
    • Anda JCD, Wang XZ, Lai X, Roberts KJ. 2005. Real-time product morphology monitoring in crystallization using imaging technique. AIChE J 51:1406-1413.
    • (2005) AIChE J , vol.51 , pp. 1406-1413
    • Anda, J.1    Wang, X.2    Lai, X.3    Roberts, K.4
  • 34
    • 36549008702 scopus 로고    scopus 로고
    • Study growth kinetics in fluidized bed granulation with at-line FBRM
    • Hu X, Cunningham JC, Winstead D. 2008. Study growth kinetics in fluidized bed granulation with at-line FBRM. Int J Pharm 347:54-61.
    • (2008) Int J Pharm , vol.347 , pp. 54-61
    • Hu, X.1    Cunningham, J.2    Winstead, D.3
  • 35
    • 10644282943 scopus 로고    scopus 로고
    • Use of focused beam reflectance measurement (FBRM) and process video imaging (PVI) in a modified mixed suspension mixed product removal (MSMPR) cooling crystallizer
    • Kougoulos E, Jones AG, Jennings KH, Wood-Kaczmar MW. 2005. 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 273:529-534.
    • (2005) J Cryst Growth , vol.273 , pp. 529-534
    • Kougoulos, E.1    Jones, A.2    Jennings, K.3    Wood-Kaczmar, M.4
  • 36
    • 68049118671 scopus 로고    scopus 로고
    • FBRM and PVM investigations of the double feed semi-batch crystallization of 6-aminopenicillanic acid
    • Su M, Wang L, Sun H, Wang J. 2009. FBRM and PVM investigations of the double feed semi-batch crystallization of 6-aminopenicillanic acid. Frontiers of Chemical Engineering in China 3(3):282-288.
    • (2009) Frontiers of Chemical Engineering in China , vol.3 , Issue.3 , pp. 282-288
    • Su, M.1    Wang, L.2    Sun, H.3    Wang, J.4
  • 37
    • 54149085115 scopus 로고    scopus 로고
    • Measuring the particle size of a known distribution using the focused beam reflectance measurement technique
    • Greaves D, Boxall J, Mulligan J, Montesi A, Creek J, Sloan ED, Koh CA. 2008. Measuring the particle size of a known distribution using the focused beam reflectance measurement technique. Chem Eng Sci 63:5410-5419.
    • (2008) Chem Eng Sci , vol.63 , pp. 5410-5419
    • Greaves, D.1    Boxall, J.2    Mulligan, J.3    Montesi, A.4    Creek, J.5    Sloan, E.6    Koh, C.7
  • 38
    • 58749105286 scopus 로고    scopus 로고
    • Estimation of particle size distributions from focused beam reflectance measurements based on an optical model
    • Kail N, Marquardt W, Briesen H. 2009. Estimation of particle size distributions from focused beam reflectance measurements based on an optical model. Chem Eng Sci 64:984-1000.
    • (2009) Chem Eng Sci , vol.64 , pp. 984-1000
    • Kail, N.1    Marquardt, W.2    Briesen, H.3
  • 39
    • 77955976395 scopus 로고    scopus 로고
    • Online monitoring of PLGA microparticles formation using lasentec focused beam reflectance (FBRM) and particle video microscope (PVM)
    • Zidan AS, Rahman Z, Habib MJ, Khan MA. 2010. Online monitoring of PLGA microparticles formation using lasentec focused beam reflectance (FBRM) and particle video microscope (PVM). AAPS J 12(3):254-262.
    • (2010) AAPS J , vol.12 , Issue.3 , pp. 254-262
    • Zidan, A.1    Rahman, Z.2    Habib, M.3    Khan, M.4
  • 40
    • 0347875950 scopus 로고    scopus 로고
    • A new model of periodic precipitation incorporating nucleation, growth and ripening
    • Chacron M, L'Heureux I. 1999. A new model of periodic precipitation incorporating nucleation, growth and ripening. Phys Lett A 263:70-77.
    • (1999) Phys Lett A , vol.263 , pp. 70-77
    • Chacron, M.1    L'Heureux, I.2
  • 42
    • 1042298067 scopus 로고    scopus 로고
    • Phase transformation considerations during process development and manufacture of solid oral dosage forms
    • Zhang GGZ, Law D, Schmitt EA, Qiu Y. 2004. Phase transformation considerations during process development and manufacture of solid oral dosage forms. Adv Drug Deliv Rev 56:371-390.
    • (2004) Adv Drug Deliv Rev , vol.56 , pp. 371-390
    • Zhang, G.1    Law, D.2    Schmitt, E.3    Qiu, Y.4
  • 43
    • 44749093943 scopus 로고    scopus 로고
    • The aggregation of naproxen in acetonitrile and tetrahydrofuran studied by the ultrasonic, volumetic and viscometric methods
    • Marczak W, Sajewicz M, Bucek M, Piotrowski D, Szewczyk K, Kowalska T. 2008. The aggregation of naproxen in acetonitrile and tetrahydrofuran studied by the ultrasonic, volumetic and viscometric methods. J Mol Liq 141:8-16.
    • (2008) J Mol Liq , vol.141 , pp. 8-16
    • Marczak, W.1    Sajewicz, M.2    Bucek, M.3    Piotrowski, D.4    Szewczyk, K.5    Kowalska, T.6
  • 44
    • 79952257209 scopus 로고    scopus 로고
    • Application of principal component analysis in assessing pharmaceutical formulation design: Exploring the casual links between the tablet processing conditions and drug dissolution rate. In: Proceedings of symposium on innovations in pharmaceutical and biotechnology development and manufacturing,2003 AIChE Annual Meeting [TE001], San Francisco, CA, Nov. 17-21, 2003.
    • Wu H, Lyon RC, Hussain AS, Drenene JD, Das-Gupta D, Voytilla RJ, Bejic L. 2003. Application of principal component analysis in assessing pharmaceutical formulation design: Exploring the casual links between the tablet processing conditions and drug dissolution rate. In: Proceedings of symposium on innovations in pharmaceutical and biotechnology development and manufacturing, 2003 AIChE Annual Meeting [TE001], San Francisco, CA, Nov. 17-21, 2003, pp 635-642.
    • (2003) , pp. 635-642
    • Wu, H.1    Lyon, R.2    Hussain, A.3    Drenene, J.4    Das-Gupta, D.5    Voytilla, R.6    Bejic, L.7
  • 45
    • 0003701151 scopus 로고    scopus 로고
    • Handbook of near-infrared analysis
    • 2nd ed New York: Marcel Dekker.
    • Burns DA, Ciurczak EW. 2001. Handbook of near-infrared analysis. 2nd ed New York: Marcel Dekker, pp 95-95.
    • (2001) , pp. 95-95
    • Burns, D.1    Ciurczak, E.2
  • 46
    • 39749133046 scopus 로고    scopus 로고
    • Process analytical technology (PAT): Quantification approaches in terahertz spectroscopy for pharmaceutical application
    • Wu H, Heilweil EJ, Hussain AS, Khan MA. 2008. Process analytical technology (PAT): Quantification approaches in terahertz spectroscopy for pharmaceutical application. J Pharm Sci 97:970-984.
    • (2008) J Pharm Sci , vol.97 , pp. 970-984
    • Wu, H.1    Heilweil, E.2    Hussain, A.3    Khan, M.4
  • 47
    • 68249125315 scopus 로고    scopus 로고
    • Quality-by-Design (QbD): An integrated approach for evaluation of powder blending process kinetics and determination of powder blending end-point
    • Wu H, Khan MA. 2009. Quality-by-Design (QbD): An integrated approach for evaluation of powder blending process kinetics and determination of powder blending end-point. J Pharm Sci 98:2784-2798.
    • (2009) J Pharm Sci , vol.98 , pp. 2784-2798
    • Wu, H.1    Khan, M.2


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