메뉴 건너뛰기




Volumn 10, Issue 2, 2005, Pages 261-272

A study of the impact of freezing on the lyophilization of a concentrated formulation with a high fill depth

Author keywords

Cycle optimization; Freeze drying; Freezing process; Lyophilization; Product quality

Indexed keywords

CYCLODEXTRIN DERIVATIVE; IODINE DERIVATIVE; SIVER IODIDE; TERT BUTYL ALCOHOL; UNCLASSIFIED DRUG;

EID: 18744408458     PISSN: 10837450     EISSN: None     Source Type: Journal    
DOI: 10.1081/PDT-200054452     Document Type: Article
Times cited : (89)

References (30)
  • 1
    • 0024602083 scopus 로고
    • Process control in freeze-drying: Determination of the end point of sublimation drying by an electronic moisture sensor
    • Roy, M.L.; Pikal, M.J. Process control in freeze-drying: determination of the end point of sublimation drying by an electronic moisture sensor. J. Parenter. Sci. Technol. 1989, 43, 60-66.
    • (1989) J. Parenter. Sci. Technol. , vol.43 , pp. 60-66
    • Roy, M.L.1    Pikal, M.J.2
  • 2
    • 0010576015 scopus 로고    scopus 로고
    • Supercooling
    • web journal
    • Jennings, T.A. Supercooling. Insight 2002, 5 (5), (web journal), http://www.phase-technologies.com/html.vol._5_no._5.html.
    • (2002) Insight , vol.5 , Issue.5
    • Jennings, T.A.1
  • 3
    • 0026221296 scopus 로고
    • The influence of the freezing process on vapor transport during sublimation in vacuum-freezing-drying
    • Kochs, M.; Korber, C.; Nunner, B.; Heschel, I. The influence of the freezing process on vapor transport during sublimation in vacuum-freezing- drying. Int. J. Heat Mass Transfer 1991, 34, 2395-2408.
    • (1991) Int. J. Heat Mass Transfer , vol.34 , pp. 2395-2408
    • Kochs, M.1    Korber, C.2    Nunner, B.3    Heschel, I.4
  • 4
    • 0036169760 scopus 로고    scopus 로고
    • Freeze-drying using vacuum-induced surface freezing
    • Kramer, M.; Sennhenn, B.; Lee, G. Freeze-drying using vacuum-induced surface freezing. J. Pharm. Sci. 2002, 91, 433-443.
    • (2002) J. Pharm. Sci. , vol.91 , pp. 433-443
    • Kramer, M.1    Sennhenn, B.2    Lee, G.3
  • 5
    • 0036129507 scopus 로고    scopus 로고
    • The importance of freezing on lyophilization cycle development
    • Patapoff, T.W.; Overcashier, D.E. The importance of freezing on lyophilization cycle development. Biopharm 2002, 3, 16-21.
    • (2002) Biopharm , vol.3 , pp. 16-21
    • Patapoff, T.W.1    Overcashier, D.E.2
  • 6
    • 33847115952 scopus 로고    scopus 로고
    • Freeze-drying
    • Swarbrick, K., Boylan, J.C., Eds.; Marcel Dekker: New York
    • Pikal, M.J. Freeze-drying. In Encyclopedia of Pharmaceutical Technology; Swarbrick, K., Boylan, J.C., Eds.; Marcel Dekker: New York, 2002; 1299-1326.
    • (2002) Encyclopedia of Pharmaceutical Technology , pp. 1299-1326
    • Pikal, M.J.1
  • 7
    • 0036919798 scopus 로고    scopus 로고
    • Freezing and annealing phenomena in lyophilization: Effects upon primary drying rate, morphology and heterogeneity
    • Randolph, T.W.; Searles, J.A. Freezing and annealing phenomena in lyophilization: effects upon primary drying rate, morphology and heterogeneity. Am. Pharm. Rev. 2002, 5 (4), 40-46.
    • (2002) Am. Pharm. Rev. , vol.5 , Issue.4 , pp. 40-46
    • Randolph, T.W.1    Searles, J.A.2
  • 8
    • 0025905723 scopus 로고
    • Use of 2-hydroxypropyl-beta-cyclodextrin as a solubilizing and stabilizing excipient for protein drugs
    • Brewster, M.E.; Hora, M.S.; Simpkins, J.W.; Bodor, N. Use of 2-hydroxypropyl-beta-cyclodextrin as a solubilizing and stabilizing excipient for protein drugs. Pharm. Res. 1991, 8, 792-795.
    • (1991) Pharm. Res. , vol.8 , pp. 792-795
    • Brewster, M.E.1    Hora, M.S.2    Simpkins, J.W.3    Bodor, N.4
  • 10
    • 0031042310 scopus 로고    scopus 로고
    • Cyclodextrins - Enabling excipients: Their present and future use in pharmaceuticals
    • Thompson, D.O. Cyclodextrins - enabling excipients: their present and future use in pharmaceuticals. Crit. Rev. Ther. Drug Carrier Syst. 1997, 14, 1-104.
    • (1997) Crit. Rev. Ther. Drug Carrier Syst. , vol.14 , pp. 1-104
    • Thompson, D.O.1
  • 11
    • 0032868056 scopus 로고    scopus 로고
    • New injectable melphalan formulations utilizing (SBE)(7m)-beta-CD or HP-beta-CD
    • Ma, D.Q.; Rajewski, R.A.; Stella, V.J. New injectable melphalan formulations utilizing (SBE)(7m)-beta-CD or HP-beta-CD. Int. J. Pharm. 1999, 189, 227-234.
    • (1999) Int. J. Pharm. , vol.189 , pp. 227-234
    • Ma, D.Q.1    Rajewski, R.A.2    Stella, V.J.3
  • 12
    • 0242334093 scopus 로고    scopus 로고
    • Physico-chemical investigation of the effects of water-soluble polymers on vinpocetine complexation with beta-cyclodextrin and its sulfobutyl ether derivative in solution and solid state
    • Ribeiro, L.S.; Ferreira, D.C.; Veiga, F.J. Physico-chemical investigation of the effects of water-soluble polymers on vinpocetine complexation with beta-cyclodextrin and its sulfobutyl ether derivative in solution and solid state. Eur. J. Pharm. Sci. 2003, 20, 253-266.
    • (2003) Eur. J. Pharm. Sci. , vol.20 , pp. 253-266
    • Ribeiro, L.S.1    Ferreira, D.C.2    Veiga, F.J.3
  • 13
    • 2342627492 scopus 로고    scopus 로고
    • Formulation development of protein dosage forms
    • Nail, S.L., Akers, M.J., Eds.; Kluwer Academic/Plenum Publishers: New York
    • Akers, M.; Vasudevan, V.; Stickelmeyer, M. Formulation development of protein dosage forms. In Development and Manufacturing of Protein Pharmaceuticals; Nail, S.L., Akers, M.J., Eds.; Kluwer Academic/Plenum Publishers: New York, 2002; 47-127.
    • (2002) Development and Manufacturing of Protein Pharmaceuticals , pp. 47-127
    • Akers, M.1    Vasudevan, V.2    Stickelmeyer, M.3
  • 14
    • 0031863157 scopus 로고    scopus 로고
    • The influence of tertiary butyl alcohol and volatile salts on the sublimation of ice from frozen sucrose solutions: Implications for freeze drying
    • Oesterle, J.; Franks, F.; Auffret, T. The influence of tertiary butyl alcohol and volatile salts on the sublimation of ice from frozen sucrose solutions: implications for freeze drying. Pharm. Dev. Technol. 1998, 3, 175-183.
    • (1998) Pharm. Dev. Technol. , vol.3 , pp. 175-183
    • Oesterle, J.1    Franks, F.2    Auffret, T.3
  • 15
    • 1442334238 scopus 로고    scopus 로고
    • Incorporation of lipophilic drugs in sugar glasses by lyophilization using a mixture of water and tertiary butyl alcohol as solvent
    • Van Drooge, D.J.; Hindrichs, W.L.J.; Frijlink, H.W. Incorporation of lipophilic drugs in sugar glasses by lyophilization using a mixture of water and tertiary butyl alcohol as solvent. J. Pharm. Sci. 2004, 93, 713-725.
    • (2004) J. Pharm. Sci. , vol.93 , pp. 713-725
    • Van Drooge, D.J.1    Hindrichs, W.L.J.2    Frijlink, H.W.3
  • 16
    • 0028911823 scopus 로고
    • The effect of tertiary butyl alcohol on the resistance of the dry product layer during primary drying
    • Kasraian, K.; DeLuca, P.P. The effect of tertiary butyl alcohol on the resistance of the dry product layer during primary drying. Pharm. Res. 1995, 12, 491-495.
    • (1995) Pharm. Res. , vol.12 , pp. 491-495
    • Kasraian, K.1    DeLuca, P.P.2
  • 17
    • 18744372539 scopus 로고    scopus 로고
    • Role of product temperature in the lyophilization process
    • Jennings, T.A. Role of product temperature in the lyophilization process. Am. Pharm. Rev. 2001, 4 (1), 14-22.
    • (2001) Am. Pharm. Rev. , vol.4 , Issue.1 , pp. 14-22
    • Jennings, T.A.1
  • 19
    • 18744416359 scopus 로고    scopus 로고
    • Miscibility of components in frozen solutions and amorphous freeze-dried protein formulations
    • Levine, H., Ed.; The Royal Society of Chemistry: Cambridge
    • Izutsu, K.; Kojima, S. Miscibility of components in frozen solutions and amorphous freeze-dried protein formulations. In Amorphous Food and Pharmaceutical Systems; Levine, H., Ed.; The Royal Society of Chemistry: Cambridge, 2002; 257-274.
    • (2002) Amorphous Food and Pharmaceutical Systems , pp. 257-274
    • Izutsu, K.1    Kojima, S.2
  • 20
    • 0030812233 scopus 로고    scopus 로고
    • Intravial distribution of moisture during the secondary drying stage of freeze drying
    • Pikal, M.J.; Shah, S. Intravial distribution of moisture during the secondary drying stage of freeze drying. PDA J. Pharm. Sci. Technol. 1997, 51, 17-24.
    • (1997) PDA J. Pharm. Sci. Technol. , vol.51 , pp. 17-24
    • Pikal, M.J.1    Shah, S.2
  • 21
    • 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, M.J.; Rambhatla, S.; Ramot, R. The impact of the freezing stage in lyophilization: effects of the ice nucleation temperature on process design and product quality. Am. Pharm. Rev. 2002, 5 (3), 48-52.
    • (2002) Am. Pharm. Rev. , vol.5 , Issue.3 , pp. 48-52
    • Pikal, M.J.1    Rambhatla, S.2    Ramot, R.3
  • 22
    • 0021198926 scopus 로고
    • Mass and heat transfer in vial freeze-drying of pharmaceuticals: Role of the vial
    • Pikal, M.J.; Roy, M.L.; Shah, S. Mass and heat transfer in vial freeze-drying of pharmaceuticals: role of the vial. J. Pharm. Sci. 1994, 73, 1224-1237.
    • (1994) J. Pharm. Sci. , vol.73 , pp. 1224-1237
    • Pikal, M.J.1    Roy, M.L.2    Shah, S.3
  • 23
    • 6044273800 scopus 로고
    • The vapor pressure of ice between 0.01 and -100°C
    • Janso, G.; Pupezin, J.; van Hook, W.A. The vapor pressure of ice between 0.01 and -100°C. J. Phys. Chem. 1970, 74, 2984-2989.
    • (1970) J. Phys. Chem. , vol.74 , pp. 2984-2989
    • Janso, G.1    Pupezin, J.2    Van Hook, W.A.3
  • 24
    • 18744408575 scopus 로고    scopus 로고
    • Freeze drying, scale-up consideration
    • Swarbrick, J., Boylan, J.C.. Eds.; Marcel Dekker: New York
    • Trappler, E.H. Freeze drying, scale-up consideration. In Encyclopedia of Pharmaceutical Technology; Swarbrick, J., Boylan, J.C.. Eds.; Marcel Dekker: New York, 2004; 1-18.
    • (2004) Encyclopedia of Pharmaceutical Technology , pp. 1-18
    • Trappler, E.H.1
  • 25
    • 0022087191 scopus 로고
    • Structure of products prepared by freeze-drying solutions containing organic solvents
    • Seager, H.; Taskis, C.B.; Lee, T.J. Structure of products prepared by freeze-drying solutions containing organic solvents. J. Parenter. Sci. Technol. 1985, 39, 161-179.
    • (1985) J. Parenter. Sci. Technol. , vol.39 , pp. 161-179
    • Seager, H.1    Taskis, C.B.2    Lee, T.J.3
  • 26
    • 0036279479 scopus 로고    scopus 로고
    • Freeze-drying of tert-butanol/water cosolvent systems: A case report on formation of a friable freeze-dried powder of tobramycin sulfate
    • Wittaya-Areekul, S.; Needham, G.F.; Milton, N.; Roy, M.L.; Nail, S.L. Freeze-drying of tert-butanol/water cosolvent systems: a case report on formation of a friable freeze-dried powder of tobramycin sulfate. J. Pharm. Sci. 2002, 91, 1147-1155.
    • (2002) J. Pharm. Sci. , vol.91 , pp. 1147-1155
    • Wittaya-Areekul, S.1    Needham, G.F.2    Milton, N.3    Roy, M.L.4    Nail, S.L.5
  • 28
    • 0036181889 scopus 로고    scopus 로고
    • Practical aspects of lyophilization using non-aqueous co-solvent systems
    • Teagarden, D.L.; Baker, D.S. Practical aspects of lyophilization using non-aqueous co-solvent systems. Eur. J. Pharm. Sci. 2002, 15, 115-133.
    • (2002) Eur. J. Pharm. Sci. , vol.15 , pp. 115-133
    • Teagarden, D.L.1    Baker, D.S.2
  • 29
    • 0034938921 scopus 로고    scopus 로고
    • Annealing to optimize the primary drying rate, reduce freezing-induced drying rate heterogeneity, and determination Tg′ in pharmaceutical lyophilization
    • Searles, J.A.; Carenter, J.F.; Randolph, T.W. Annealing to optimize the primary drying rate, reduce freezing-induced drying rate heterogeneity, and determination Tg′ in pharmaceutical lyophilization. J. Pharm. Sci. 2001, 90, 872-887.
    • (2001) J. Pharm. Sci. , vol.90 , pp. 872-887
    • Searles, J.A.1    Carenter, J.F.2    Randolph, T.W.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.