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Volumn 100, Issue 12, 2011, Pages 5244-5253

Impact of heat treatment on the physical properties of noncrystalline multisolute systems concentrated in frozen aqueous solutions

Author keywords

Calorimetry (DSC); Excipients; Formulation; Freeze drying; Freezing; Miscibility; Phase separation; Stabilization; Thermal analysis

Indexed keywords

DEXTRAN; GLUCOSE; POVIDONE; SUCROSE; TREHALOSE;

EID: 80054943738     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22706     Document Type: Article
Times cited : (7)

References (41)
  • 2
    • 0034255393 scopus 로고    scopus 로고
    • Lyophilization and development of solid protein pharmaceuticals
    • Wang W. 2000. Lyophilization and development of solid protein pharmaceuticals. Int J Pharm 203(1-2):1-60.
    • (2000) Int J Pharm , vol.203 , Issue.1-2 , pp. 1-60
    • Wang, W.1
  • 3
    • 77349099478 scopus 로고    scopus 로고
    • An overview of liposome lyophilization and its future potential
    • Chen C, Han D, Cai C, Tang X. 2010. An overview of liposome lyophilization and its future potential. J Control Release 142:299-311.
    • (2010) J Control Release , vol.142 , pp. 299-311
    • Chen, C.1    Han, D.2    Cai, C.3    Tang, X.4
  • 4
    • 35748979712 scopus 로고    scopus 로고
    • Protein stability during freezing: Separation of stresses and mechanisms of protein stabilization
    • Bhatnagar BS, Bogner RH, Pikal MJ. 2007. Protein stability during freezing: Separation of stresses and mechanisms of protein stabilization. Pharm Dev Technol 12(5):505-523.
    • (2007) Pharm Dev Technol , vol.12 , Issue.5 , pp. 505-523
    • Bhatnagar, B.S.1    Bogner, R.H.2    Pikal, M.J.3
  • 6
    • 33750586203 scopus 로고    scopus 로고
    • Near-infrared imaging for studying homogeneity of protein-sugar mixtures
    • Jovanović N, Gerich A, Bouchard A, Jiskoot W. 2006. Near-infrared imaging for studying homogeneity of protein-sugar mixtures. Pharm Res 23(9):2002-2013.
    • (2006) Pharm Res , vol.23 , Issue.9 , pp. 2002-2013
    • Jovanović, N.1    Gerich, A.2    Bouchard, A.3    Jiskoot, W.4
  • 7
    • 68949122435 scopus 로고    scopus 로고
    • Mixing properties of lyophilized protein systems: A spectroscopic and calorimetric study
    • Katayama DS, Carpenter JF, Menard KP, Manning MC, Randolph TW. 2009. Mixing properties of lyophilized protein systems: A spectroscopic and calorimetric study. J Pharm Sci 98(9):2954-2969.
    • (2009) J Pharm Sci , vol.98 , Issue.9 , pp. 2954-2969
    • Katayama, D.S.1    Carpenter, J.F.2    Menard, K.P.3    Manning, M.C.4    Randolph, T.W.5
  • 8
    • 79951907894 scopus 로고    scopus 로고
    • The study of phase separation in amorphous freeze-dried systems, part 2: Investigation of Raman mapping as a tool for studying amorphous phase separation in freeze-dried protein formulations
    • Padilla AM, Pikal MJ. 2011. The study of phase separation in amorphous freeze-dried systems, part 2: Investigation of Raman mapping as a tool for studying amorphous phase separation in freeze-dried protein formulations. J Pharm Sci 100.
    • (2011) J Pharm Sci , vol.100
    • Padilla, A.M.1    Pikal, M.J.2
  • 9
    • 0031807819 scopus 로고    scopus 로고
    • Mixing behavior of colyophilized binary systems
    • Shamblin SL, Taylor LS, Zografi G. 1998. Mixing behavior of colyophilized binary systems. J Pharm Sci 87:694-701.
    • (1998) J Pharm Sci , vol.87 , pp. 694-701
    • Shamblin, S.L.1    Taylor, L.S.2    Zografi, G.3
  • 10
    • 0031797174 scopus 로고    scopus 로고
    • Sugar-polymer hydrogen bond interactions in lyophilized amorphous mixtures
    • Taylor LS, Zografi G. 1998. Sugar-polymer hydrogen bond interactions in lyophilized amorphous mixtures. J Pharm Sci 87(12):1615-1621.
    • (1998) J Pharm Sci , vol.87 , Issue.12 , pp. 1615-1621
    • Taylor, L.S.1    Zografi, G.2
  • 11
    • 55749088198 scopus 로고    scopus 로고
    • Characterization of amorphous API: Polymer mixtures using X-ray powder diffraction
    • Newman A, Engers D, Bates S, Ivanisevic I, Kelly RC, Zografi G. 2008. Characterization of amorphous API: Polymer mixtures using X-ray powder diffraction. J Pharm Sci 97:4840-4856.
    • (2008) J Pharm Sci , vol.97 , pp. 4840-4856
    • Newman, A.1    Engers, D.2    Bates, S.3    Ivanisevic, I.4    Kelly, R.C.5    Zografi, G.6
  • 12
    • 0017591703 scopus 로고
    • The physico-chemical basis for the freeze-drying process
    • MacKenzie AP. 1977. The physico-chemical basis for the freeze-drying process. Develop Biol Stand 36:51-67.
    • (1977) Develop Biol Stand , vol.36 , pp. 51-67
    • MacKenzie, A.P.1
  • 14
    • 0030443488 scopus 로고    scopus 로고
    • Effects of phase separating systems on lyophilized hemoglobin
    • Heller MC, Carpenter JF, Randolph TW. 1996. Effects of phase separating systems on lyophilized hemoglobin. J Pharm Sci 85(12):1358-1362.
    • (1996) J Pharm Sci , vol.85 , Issue.12 , pp. 1358-1362
    • Heller, M.C.1    Carpenter, J.F.2    Randolph, T.W.3
  • 15
    • 0033558793 scopus 로고    scopus 로고
    • Application of a thermodynamic model to the prediction of phase separations in freeze-concentrated formulations for protein lyophilization
    • Heller MC, Carpenter JF, Randolph TW. 1999. Application of a thermodynamic model to the prediction of phase separations in freeze-concentrated formulations for protein lyophilization. Arch Biochem Biophys 363:191-201.
    • (1999) Arch Biochem Biophys , vol.363 , pp. 191-201
    • Heller, M.C.1    Carpenter, J.F.2    Randolph, T.W.3
  • 16
    • 17844407208 scopus 로고    scopus 로고
    • Effect of polymer size and cosolutes on phase separation of poly(vinylpyrrolidone) (PVP) and dextran in frozen solutions
    • Izutsu K, Aoyagi N, Kojima S. 2005. Effect of polymer size and cosolutes on phase separation of poly(vinylpyrrolidone) (PVP) and dextran in frozen solutions. J Pharm Sci 94(4):709-717.
    • (2005) J Pharm Sci , vol.94 , Issue.4 , pp. 709-717
    • Izutsu, K.1    Aoyagi, N.2    Kojima, S.3
  • 17
    • 0030712895 scopus 로고    scopus 로고
    • Phase separation of excipients during lyophilization: Effects on protein stability
    • Randolph TW. 1997. Phase separation of excipients during lyophilization: Effects on protein stability. J Pharm Sci 86(11):1198-1203.
    • (1997) J Pharm Sci , vol.86 , Issue.11 , pp. 1198-1203
    • Randolph, T.W.1
  • 18
    • 0029040644 scopus 로고
    • Electrolyte-induced changes in glass transition temperatures of freeze-concentrated solutes
    • Her LM, Deras M, Nail SL. 1995. Electrolyte-induced changes in glass transition temperatures of freeze-concentrated solutes. Pharm Res 12(5):768-772.
    • (1995) Pharm Res , vol.12 , Issue.5 , pp. 768-772
    • Her, L.M.1    Deras, M.2    Nail, S.L.3
  • 20
    • 33748730527 scopus 로고    scopus 로고
    • Effect of salts and sugars on phase separation of polyvinylpyrrolidone-dextran solutions induced by freeze-concentration
    • Izutsu K, Heller M, Randolph TW, Carpenter JF. 1998. Effect of salts and sugars on phase separation of polyvinylpyrrolidone-dextran solutions induced by freeze-concentration. J Chem Soc Faraday Trans 94:411-418.
    • (1998) J Chem Soc Faraday Trans , vol.94 , pp. 411-418
    • Izutsu, K.1    Heller, M.2    Randolph, T.W.3    Carpenter, J.F.4
  • 21
    • 78650064598 scopus 로고    scopus 로고
    • The study of phase separation in amorphous freeze-dried systems. Part I: Raman mapping and computational analysis of XRPD data in model polymer systems
    • Padilla AM, Ivanisevic I, Yang Y, Engers D, Bogner RH, Pikal MJ. 2011. The study of phase separation in amorphous freeze-dried systems. Part I: Raman mapping and computational analysis of XRPD data in model polymer systems. J Pharm Sci 100:206-222.
    • (2011) J Pharm Sci , vol.100 , pp. 206-222
    • Padilla, A.M.1    Ivanisevic, I.2    Yang, Y.3    Engers, D.4    Bogner, R.H.5    Pikal, M.J.6
  • 22
    • 0029855850 scopus 로고    scopus 로고
    • Effects of sugars and polymers on crystallization of poly(ethylene glycol) in frozen solutions: Phase separation between incompatible polymers
    • Izutsu K, Yoshioka S, Kojima S, Randolph TW, Carpenter JF. 1996. Effects of sugars and polymers on crystallization of poly(ethylene glycol) in frozen solutions: Phase separation between incompatible polymers. Pharm Res 13:1393-1400.
    • (1996) Pharm Res , vol.13 , pp. 1393-1400
    • Izutsu, K.1    Yoshioka, S.2    Kojima, S.3    Randolph, T.W.4    Carpenter, J.F.5
  • 24
    • 0037331216 scopus 로고    scopus 로고
    • The effect of additives on the crystallization of cefazolin sodium during freeze-drying
    • Pyne A, Suryanarayanan R. 2003. The effect of additives on the crystallization of cefazolin sodium during freeze-drying. Pharm Res 20:283-291.
    • (2003) Pharm Res , vol.20 , pp. 283-291
    • Pyne, A.1    Suryanarayanan, R.2
  • 25
    • 0034938921 scopus 로고    scopus 로고
    • Annealing to optimize the primary drying rate, reduce freezing-induced drying rate heterogeneity, and determine T'(g) in pharmaceutical lyophilization
    • Searles JA, Carpenter JF, Randolph TW. 2001. Annealing to optimize the primary drying rate, reduce freezing-induced drying rate heterogeneity, and determine T'(g) in pharmaceutical lyophilization. J Pharm Sci 90(7):872-887.
    • (2001) J Pharm Sci , vol.90 , Issue.7 , pp. 872-887
    • Searles, J.A.1    Carpenter, J.F.2    Randolph, T.W.3
  • 26
    • 0024316909 scopus 로고
    • Salt precipitation during the freeze-concentration of phosphate buffer solutions
    • Murase N, Franks F. 1989. Salt precipitation during the freeze-concentration of phosphate buffer solutions. Biophys Chem 34:293-300.
    • (1989) Biophys Chem , vol.34 , pp. 293-300
    • Murase, N.1    Franks, F.2
  • 27
  • 28
    • 17644414570 scopus 로고    scopus 로고
    • Phase behavior of amorphous molecular dispersions I: Determination of the degree and mechanism of solid solubility
    • Vasanthavada M, Tong WQ, Joshi Y, Kislalioglu MS. 2004. Phase behavior of amorphous molecular dispersions I: Determination of the degree and mechanism of solid solubility. Pharm Res 21:1598-1606.
    • (2004) Pharm Res , vol.21 , pp. 1598-1606
    • Vasanthavada, M.1    Tong, W.Q.2    Joshi, Y.3    Kislalioglu, M.S.4
  • 29
    • 0242494046 scopus 로고    scopus 로고
    • Effects of annealing on freeze-dried Lactobacillus acidophilus
    • Ekdawi-Sever N, Goentoro LA, De Pablo JJ. 2006. Effects of annealing on freeze-dried Lactobacillus acidophilus. J Food Sci 68:2504-2511.
    • (2006) J Food Sci , vol.68 , pp. 2504-2511
    • Ekdawi-Sever, N.1    Goentoro, L.A.2    De, P.J.3
  • 30
    • 53549127558 scopus 로고    scopus 로고
    • Investigation of the impact of annealing on global molecular mobility in glasses: Optimization for stabilization of amorphous pharmaceuticals
    • Luthra SA, Hodge IM, Pikal MJ. 2008. Investigation of the impact of annealing on global molecular mobility in glasses: Optimization for stabilization of amorphous pharmaceuticals. J Pharm Sci 97:3865-3882.
    • (2008) J Pharm Sci , vol.97 , pp. 3865-3882
    • Luthra, S.A.1    Hodge, I.M.2    Pikal, M.J.3
  • 31
    • 68949101699 scopus 로고    scopus 로고
    • Thermal analysis of frozen solutions: Multiple glass transitions in amorphous systems
    • Sacha GA, Nail SL. 2009. Thermal analysis of frozen solutions: Multiple glass transitions in amorphous systems. J Pharm Sci 98(9):3397-3405.
    • (2009) J Pharm Sci , vol.98 , Issue.9 , pp. 3397-3405
    • Sacha, G.A.1    Nail, S.L.2
  • 32
    • 43049104495 scopus 로고    scopus 로고
    • Application of calorimetry, sub-ambient atomic force microscopy and dynamic mechanical analysis to the study of frozen aqueous trehalose solutions
    • Wu J, Reading M, Craig DQ. 2008. Application of calorimetry, sub-ambient atomic force microscopy and dynamic mechanical analysis to the study of frozen aqueous trehalose solutions. Pharm Res 25:1396-1404.
    • (2008) Pharm Res , vol.25 , pp. 1396-1404
    • Wu, J.1    Reading, M.2    Craig, D.Q.3
  • 33
    • 37049068040 scopus 로고
    • Thermomechanical properties of small-carbohydrate-water glasses and 'rubbers'
    • Levine H, Slade L. 1988. Thermomechanical properties of small-carbohydrate-water glasses and 'rubbers'. J Chem Soc Faraday Trans 1 84:2619-2633.
    • (1988) J Chem Soc Faraday Trans 1 , vol.84 , pp. 2619-2633
    • Levine, H.1    Slade, L.2
  • 34
    • 0025713990 scopus 로고
    • Aspects of the glass transition behaviour of mixtures of carbohydrates of low molecular weight
    • Orford PD, Parker R, Ring SG. 1990. Aspects of the glass transition behaviour of mixtures of carbohydrates of low molecular weight Carbohydr Res 196:11-18.
    • (1990) Carbohydr Res , vol.196 , pp. 11-18
    • Orford, P.D.1    Parker, R.2    Ring, S.G.3
  • 35
    • 78549292420 scopus 로고    scopus 로고
    • Crystallization of trehalose in frozen solutions and its phase behavior during drying
    • Sundaramurthi P, Patapoff TW, Suryanarayanan R. 2010. Crystallization of trehalose in frozen solutions and its phase behavior during drying. Pharm Res 27(11):2374-2383.
    • (2010) Pharm Res , vol.27 , Issue.11 , pp. 2374-2383
    • Sundaramurthi, P.1    Patapoff, T.W.2    Suryanarayanan, R.3
  • 36
    • 3042601972 scopus 로고    scopus 로고
    • Solid-state solubility influences encapsulation and release of hydrophobic drugs from PLGA/PLA nanoparticles
    • Panyam J, Williams D, Dash A, Leslie-Pelecky D, Labhasetwar V. 2004. Solid-state solubility influences encapsulation and release of hydrophobic drugs from PLGA/PLA nanoparticles. J Pharm Sci 93:1804-1814.
    • (2004) J Pharm Sci , vol.93 , pp. 1804-1814
    • Panyam, J.1    Williams, D.2    Dash, A.3    Leslie-Pelecky, D.4    Labhasetwar, V.5
  • 37
    • 17644395269 scopus 로고    scopus 로고
    • Phase behavior of amorphous molecular dispersions II: Role of hydrogen bonding in solid solubility and phase separation kinetics
    • Vasanthavada M, Tong WQ, Joshi Y, Kislalioglu MS. 2005. Phase behavior of amorphous molecular dispersions II: Role of hydrogen bonding in solid solubility and phase separation kinetics. Pharm Res 22:440-448.
    • (2005) Pharm Res , vol.22 , pp. 440-448
    • Vasanthavada, M.1    Tong, W.Q.2    Joshi, Y.3    Kislalioglu, M.S.4
  • 38
    • 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 PharmSciTech 10(4):1406-1411.
    • (2009) AAPS PharmSciTech , vol.10 , Issue.4 , pp. 1406-1411
    • Patel, S.M.1    Bhugra, C.2    Pikal, M.J.3
  • 39
  • 40
    • 75749087999 scopus 로고    scopus 로고
    • Specific volume-hole volume correlations in amorphous carbohydrates: Effect of temperature, molecular weight, and water content
    • Townrow S, Roussenova M, Giardiello M-I, Alam A, Ubbink J. 2010. Specific volume-hole volume correlations in amorphous carbohydrates: Effect of temperature, molecular weight, and water content. J Phys Chem B 114:1568-1578.
    • (2010) J Phys Chem B , vol.114 , pp. 1568-1578
    • Townrow, S.1    Roussenova, M.2    Giardiello, M.-I.3    Alam, A.4    Ubbink, J.5
  • 41
    • 42949166804 scopus 로고    scopus 로고
    • Characteristics of hydrogen bond formation between sugar and polymer in freeze-dried mixtures under different rehumidification conditions and its impact on the glass transition temperature
    • Imamura K, Asano Y, Maruyama Y, Yokoyama T, Nomura M, Ogawa S, Nakanishi K. 2008. Characteristics of hydrogen bond formation between sugar and polymer in freeze-dried mixtures under different rehumidification conditions and its impact on the glass transition temperature. J Pharm Sci 97(3):1301-1312.
    • (2008) J Pharm Sci , vol.97 , Issue.3 , pp. 1301-1312
    • Imamura, K.1    Asano, Y.2    Maruyama, Y.3    Yokoyama, T.4    Nomura, M.5    Ogawa, S.6    Nakanishi, K.7


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