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Volumn 100, Issue 8, 2011, Pages 3453-3470

Controlled nucleation in freeze-drying: Effects on pore size in the dried product layer, mass transfer resistance, and primary drying rate

Author keywords

Algorithm; Controlled nucleation; Freeze drying; Heat transfer; Lyophilization; Mass transfer resistance; Mathematical modeling; Pore diffusion; Pore radius

Indexed keywords

MANNITOL; SUCROSE;

EID: 79958824043     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22561     Document Type: Article
Times cited : (130)

References (31)
  • 3
    • 0036741133 scopus 로고    scopus 로고
    • The impact of the freezing stage in lyophilization: Effects of the ice nucleation temperature on process design and product quality
    • Pikal MJ, Rambhatla S, Ramot R. 2002. The impact of the freezing stage in lyophilization: Effects of the ice nucleation temperature on process design and product quality. Amer Pharm Rev 5:48-52.
    • (2002) Amer Pharm Rev , vol.5 , pp. 48-52
    • Pikal, M.J.1    Rambhatla, S.2    Ramot, R.3
  • 4
    • 33544454991 scopus 로고    scopus 로고
    • rimary drying rate heterogeneity during pharmaceutical lyophilization
    • Searles JA, Carpenter JF, Randolph TW. 2000. Primary drying rate heterogeneity during pharmaceutical lyophilization. Amer Pharm Rev 3:6-24.
    • (2000) Amer Pharm Rev , vol.3 , pp. 6-24
    • Searles, J.A.1    Carpenter, J.F.2    Randolph, T.W.3
  • 6
    • 77953368242 scopus 로고    scopus 로고
    • A practical method for resolving the nucleation problem in lyophilization
    • Bursac R, Sever R, Hunek B. 2009. A practical method for resolving the nucleation problem in lyophilization. Bio Process Int 7:66-72.
    • (2009) Bio Process Int , vol.7 , pp. 66-72
    • Bursac, R.1    Sever, R.2    Hunek, B.3
  • 7
    • 23144460878 scopus 로고    scopus 로고
    • Heat and mass transfer scale-up issues during freeze drying: II. Control and characterization of the degree of supercooling. AAPS Pharm
    • Rambhatla S, Ramot R, Bhugra C, Pikal MJ. 2004. Heat and mass transfer scale-up issues during freeze drying: II. Control and characterization of the degree of supercooling. AAPS Pharm Sci Tech 5(4):e58.
    • (2004) Sci Tech , vol.5 , Issue.4
    • Rambhatla, S.1    Ramot, R.2    Bhugra, C.3    Pikal, M.J.4
  • 8
    • 75549083533 scopus 로고    scopus 로고
    • Reduced pressure ice fog technique for controlled ice nucleation during freeze-drying
    • Patel SM, Bhugra C, Pikal MJ. 2009. Reduced pressure ice fog technique for controlled ice nucleation during freeze-drying. AAPS Pharm Sci Tech 10(4):1406-1411.
    • (2009) AAPS Pharm Sci Tech , vol.10 , Issue.4 , pp. 1406-1411
    • Patel, S.M.1    Bhugra, C.2    Pikal, M.J.3
  • 9
    • 44249121743 scopus 로고    scopus 로고
    • Effect of ultrasound-controlled nucleation on structural and morphological properties of freeze-dried mannitol solutions
    • Hottot A, Nakagawa K, Andrieu J. 2008. Effect of ultrasound-controlled nucleation on structural and morphological properties of freeze-dried mannitol solutions. Chem Eng Res Des 86:193-200.
    • (2008) Chem Eng Res Des , vol.86 , pp. 193-200
    • Hottot, A.1    Nakagawa, K.2    Andrieu, J.3
  • 10
    • 77950690142 scopus 로고    scopus 로고
    • Effect of ultrasonically induced nucleation on ice crystals' size and shape during freezing in vials
    • Saclier M, Peczalski R, Andrieu J. 2010. Effect of ultrasonically induced nucleation on ice crystals' size and shape during freezing in vials. Chem Eng Sci 65:3064-3071.
    • (2010) Chem Eng Sci , vol.65 , pp. 3064-3071
    • Saclier, M.1    Peczalski, R.2    Andrieu, J.3
  • 11
    • 70349932496 scopus 로고    scopus 로고
    • Effect of controlled ice nucleation on primary drying stage and protein recovery in vials cooled in a modified freeze-dryer
    • Passot S, Trelea IC, Marin M, Galan M, Morris GJ, Fonseca F. 2009. Effect of controlled ice nucleation on primary drying stage and protein recovery in vials cooled in a modified freeze-dryer. J Biomech Eng 131:1-5.
    • (2009) J Biomech Eng , vol.131 , pp. 1-5
    • Passot, S.1    Trelea, I.C.2    Marin, M.3    Galan, M.4    Morris, G.J.5    Fonseca, F.6
  • 12
    • 0036169760 scopus 로고    scopus 로고
    • Freeze-drying using vacuum-induced surface freezing
    • Kramer M, Sennhenn B, Lee G. 2002. Freeze-drying using vacuum-induced surface freezing. J Pharm Sci 91(2):433-443.
    • (2002) J Pharm Sci , vol.91 , Issue.2 , pp. 433-443
    • Kramer, M.1    Sennhenn, B.2    Lee, G.3
  • 13
    • 18744408458 scopus 로고    scopus 로고
    • A study of the impact of freezing on the lyophilization of a concentrated formulation with a high fill depth
    • Liu J, Viverette T, Virgin M, Anderson M, Dalal P. 2005. A study of the impact of freezing on the lyophilization of a concentrated formulation with a high fill depth. Pharm Dev Technol 10: 261-272.
    • (2005) Pharm Dev Technol , vol.10 , pp. 261-272
    • Liu, J.1    Viverette, T.2    Virgin, M.3    Anderson, M.4    Dalal, P.5
  • 15
    • 79958802781 scopus 로고    scopus 로고
    • Product mass transfer resistance directly determined during freeze-drying using tunable diode laser absorption spectroscopy (TDLAS) and pore diffusion model
    • DOI: 10.3109/10837451003739263.
    • Kuu WY, O'Bryan KR, Hardwick LM, Paul TW. 2010. Product mass transfer resistance directly determined during freeze-drying using tunable diode laser absorption spectroscopy (TDLAS) and pore diffusion model. Pharm Dev Technol: 1-11.DOI: 10.3109/10837451003739263.
    • (2010) Pharm Dev Technol: , pp. 1-11
    • Kuu, W.Y.1    O'Bryan, K.R.2    Hardwick, L.M.3    Paul, T.W.4
  • 16
    • 0036285548 scopus 로고    scopus 로고
    • Mannitol-sucrose mixtures-Versatile formulations for protein lyophilization
    • Johnson RE, Kirchhoff CF, Gaud HT. 2002. Mannitol-sucrose mixtures-Versatile formulations for protein lyophilization. J Pharm Sci 91(4):914-922.
    • (2002) J Pharm Sci , vol.91 , Issue.4 , pp. 914-922
    • Johnson, R.E.1    Kirchhoff, C.F.2    Gaud, H.T.3
  • 17
    • 77950918345 scopus 로고    scopus 로고
    • Determination of end point of primary drying in freeze-drying process control
    • Patel SM, Doen T, Pikal MJ. 2010. Determination of end point of primary drying in freeze-drying process control. AAPS Pharm Sci Tech 11(1):73-84.
    • (2010) AAPS Pharm Sci Tech , vol.11 , Issue.1 , pp. 73-84
    • Patel, S.M.1    Doen, T.2    Pikal, M.J.3
  • 18
    • 0030846563 scopus 로고    scopus 로고
    • Evaluation of manometric temperature measurement as a method of monitoring product temperature during lyophilization
    • Milton N, Pikal MJ, Roy ML, Nail SL. 1997. Evaluation of manometric temperature measurement as a method of monitoring product temperature during lyophilization. PDA J Pharm Sci Technol 51:7-16.
    • (1997) PDA J Pharm Sci Technol , vol.51 , pp. 7-16
    • Milton, N.1    Pikal, M.J.2    Roy, M.L.3    Nail, S.L.4
  • 19
    • 0020596449 scopus 로고
    • Physical chemistry of freeze drying: Measurement of sublimation rates for frozen aqueous solutions by a microbalance technique
    • Pikal MJ, Shah S, Senior D, Lang JE. 1983. Physical chemistry of freeze drying: Measurement of sublimation rates for frozen aqueous solutions by a microbalance technique. J Pharm Sci 72:635-650.
    • (1983) J Pharm Sci , vol.72 , pp. 635-650
    • Pikal, M.J.1    Shah, S.2    Senior, D.3    Lang, J.E.4
  • 20
    • 18044391843 scopus 로고    scopus 로고
    • Freeze-drying process design by manometric temperature measurement: Design of a smart freeze-dryer
    • Tang X, Nail SL, Pikal MJ. 2005. Freeze-drying process design by manometric temperature measurement: Design of a smart freeze-dryer. Pharm Res 22(4):685-700.
    • (2005) Pharm Res , vol.22 , Issue.4 , pp. 685-700
    • Tang, X.1    Nail, S.L.2    Pikal, M.J.3
  • 21
    • 34547212342 scopus 로고    scopus 로고
    • Evaluation of tunable diode laser absorption spectroscopy for in-process water vapor mass flux measurements during freeze drying
    • Gieseler H, Kessler W, Finson M, Davis S, Mulhall P, Bons V, Debo D, Pikal MJ. 2007. Evaluation of tunable diode laser absorption spectroscopy for in-process water vapor mass flux measurements during freeze drying. J Pharm Sci 96(7):1776-1793.
    • (2007) J Pharm Sci , vol.96 , Issue.7 , pp. 1776-1793
    • Gieseler, H.1    Kessler, W.2    Finson, M.3    Davis, S.4    Mulhall, P.5    Bons, V.6    Debo, D.7    Pikal, M.J.8
  • 22
    • 35648934050 scopus 로고    scopus 로고
    • Determination of shelf heat transfer coefficients along the shelf flow path of a freeze dryer using the shelf fluid temperature perturbation approach
    • Kuu WY, Nail SL, Hardwick LM. 2007. Determination of shelf heat transfer coefficients along the shelf flow path of a freeze dryer using the shelf fluid temperature perturbation approach. Pharm Dev Technol 12:485-494.
    • (2007) Pharm Dev Technol , vol.12 , pp. 485-494
    • Kuu, W.Y.1    Nail, S.L.2    Hardwick, L.M.3
  • 23
    • 0021198926 scopus 로고
    • Mass and heat transfer in vial freeze-drying of pharmaceuticals: Role of the vial
    • Pikal MJ, Roy ML, Shah S. 1984. Mass and heat transfer in vial freeze-drying of pharmaceuticals: Role of the vial. J Pharm Sci 73:1224-1237.
    • (1984) J Pharm Sci , vol.73 , pp. 1224-1237
    • Pikal, M.J.1    Roy, M.L.2    Shah, S.3
  • 24
    • 62849094484 scopus 로고    scopus 로고
    • Rapid determination of vial heat transfer parameters using tunable diode laser absorption spectroscopy (TDLAS) in response to step-changes in pressure set-point during freeze-drying
    • Kuu WY, Nail SL, Sacha GA. 2009. Rapid determination of vial heat transfer parameters using tunable diode laser absorption spectroscopy (TDLAS) in response to step-changes in pressure set-point during freeze-drying. J Pharm Sci 98(3):1136-1154.
    • (2009) J Pharm Sci , vol.98 , Issue.3 , pp. 1136-1154
    • Kuu, W.Y.1    Nail, S.L.2    Sacha, G.A.3
  • 25
    • 0021836493 scopus 로고
    • Use of laboratory data in freeze drying process design: Heat and mass transfer coefficients and the computer simulation of freeze drying
    • Pikal MJ. 1985. Use of laboratory data in freeze drying process design: Heat and mass transfer coefficients and the computer simulation of freeze drying. J Parent Sci Tech 39(3):115-138.
    • (1985) J Parent Sci Tech , vol.39 , Issue.3 , pp. 115-138
    • Pikal, M.J.1
  • 26
    • 33645325915 scopus 로고    scopus 로고
    • Rapid determination of dry layer mass transfer resistance for various pharmaceutical formulations during primary drying using product temperature profiles
    • Kuu WY, Hardwick LM, Akers MJ. 2006. Rapid determination of dry layer mass transfer resistance for various pharmaceutical formulations during primary drying using product temperature profiles. Int J Pharm 313:99-113.
    • (2006) Int J Pharm , vol.313 , pp. 99-113
    • Kuu, W.Y.1    Hardwick, L.M.2    Akers, M.J.3
  • 27
    • 68949114041 scopus 로고    scopus 로고
    • Rapid freeze-drying cycle optimization using computer programs developed based on heat and mass transfer models and facilitated by tunable diode laser absorption spectroscopy (TDLAS)
    • Kuu WY, Nail SL. 2009. Rapid freeze-drying cycle optimization using computer programs developed based on heat and mass transfer models and facilitated by tunable diode laser absorption spectroscopy (TDLAS). J Pharm Sci 98(9):3469-3482.
    • (2009) J Pharm Sci , vol.98 , Issue.9 , pp. 3469-3482
    • Kuu, W.Y.1    Nail, S.L.2
  • 28
    • 0034933284 scopus 로고    scopus 로고
    • The ice nucleation temperature determines the primary drying rate of lyophilization for samples frozen on a temperature-controlled shelf
    • Searles JA, Carpenter JF, Randolph TW, 2001. The ice nucleation temperature determines the primary drying rate of lyophilization for samples frozen on a temperature-controlled shelf. J Pharm Sci 90(7):860-871.
    • (2001) J Pharm Sci , vol.90 , Issue.7 , pp. 860-871
    • Searles, J.A.1    Carpenter, J.F.2    Randolph, T.W.3
  • 29
    • 0024602083 scopus 로고
    • Process control in freeze drying: Determination of the end point of sublimation drying by an electronic moisture sensor
    • Roy ML, Pikal MJ. 1989. Process control in freeze drying: Determination of the end point of sublimation drying by an electronic moisture sensor. J Parent Sci Technol 43(2):60-66.
    • (1989) J Parent Sci Technol , vol.43 , Issue.2 , pp. 60-66
    • Roy, M.L.1    Pikal, M.J.2
  • 30
    • 14644437110 scopus 로고    scopus 로고
    • The nonsteady state modeling of freeze drying: In-process product temperature and moisture content mapping and pharmaceutical product quality applications
    • Pikal MJ, Cardon S, Bhugra C, Jameel F, Rambhatla S. 2005. The nonsteady state modeling of freeze drying: In-process product temperature and moisture content mapping and pharmaceutical product quality applications. Pharm Dev Technol 1:17-32
    • (2005) Pharm Dev Technol , vol.1 , pp. 17-32
    • Pikal, M.J.1    Cardon, S.2    Bhugra, C.3    Jameel, F.4    Rambhatla, S.5
  • 31
    • 0025359216 scopus 로고
    • The secondary drying stage of freeze drying: Drying kinetics as a function of temperature and chamber pressure
    • Pikal MJ, Shah S, Roy ML, Putman R. 1990.The secondary drying stage of freeze drying: Drying kinetics as a function of temperature and chamber pressure. Int J Pharm 60:203-217.
    • (1990) Int J Pharm , vol.60 , pp. 203-217
    • Pikal, M.J.1    Shah, S.2    Roy, M.L.3    Putman, R.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.