1,303
Views
88
CrossRef citations to date
0
Altmetric
Research Article

Freeze‐Drying of Mannitol–Trehalose–Sodium Chloride‐Based Formulations: The Impact of Annealing on Dry Layer Resistance to Mass Transfer and Cake Structure

&
Pages 85-95 | Received 02 Jan 2003, Accepted 14 Jun 2003, Published online: 02 Apr 2004

References

  • Pikal M. J., Shah S., Senior D., Lang J. E. Physical chemistry of freeze‐drying: measurement of sublimation rates for frozen aqueous solutions by a microbalance technique. J. Pharm. Sci. 1983; 72(6)635–650
  • Searles J. A., Carpenter J. F., Randolph T. W. Annealing to optimize primary drying rate, reduce freezing‐induced drying rate heterogeneity, and determine Tg′ in pharmaceutical lyophilization. J. Pharm. Sci. 2001; 90(7)872–887
  • Pikal M. J. J. Swarbrick, J. C. BoylanLyophilization. Encyclopedia of Pharmaceutical Technology, . Marcel Dekker, Inc., New York 2001; Vol. 6
  • Pikal M. J. Freeze‐drying of protein, part I: process design. Biopharm 1990; 3: 18–27
  • Cameron P. R. CameronThe freeze‐drying process. Good Pharmaceutical Freeze‐Drying Practice, . Interpharm Press Inc. 1997, 34 pp.
  • Mellor J. D. Fundamentals of Freeze‐Drying. Academic Press, New York 1978
  • Overcashier D. E., Patapoff T. W., Hsu C. C. Lyophilization of protein formulations in vials: investigation of the relationship between resistance to vapor flow during primary drying and small‐scale product collapse. J. Pharm. Sci. 1999; 88(7)688–695
  • Korey D. J., Schwartz J. B. Effects of excipients on the crystallization of pharmaceutical compounds during lyophilization. J. Parenter. Sci Technol. 1989; 43(2)80
  • Carpenter J. F., Pikal M. J., Chang B. S., Randoph T. W. Rational design of stable lyophilized protein formulations: some practical advance. Pharm. Res. 1997; 14(8)969–975
  • Milton N., Nail S. L. The crystallization kinetics of glycine hydrochloride from frozen solution. Cryo‐Lett. 1997; 18: 335–342
  • Izutsu K., Yoshioka S., Terao T. The effect of mannitol crystallization on the stabilization of enzymes during freeze‐drying. Chem. Pharm. Bull. 1994; 42(1)5–8
  • Kim A. I., Akers M. J., Nail S. L. The physical state of mannitol after freeze‐drying: effects of mannitol concentration, freezing rate, and a noncrystallizing cosolute. J. Pharm. Sci. 1998; 87(8)931–935
  • Martini A., Kume S., Crivellente M., Artico R. Use of subambient differential scanning calorimetry to monitor the frozen‐state behavior of blends of excipients for freeze‐drying. PDA J. Pharm. Sci. Technol. 1997; 51(2)62–67
  • Izutsu K., Yoshioka S., Terao T. Decreased protein stabilizing effects of cryoprotectants due to crystallization. Pharm. Res. 1993; 10: 1232–1237
  • Herman B. D., Sinclair B. D., Milton N., Nail S. L. The effect of bulking agent on the solid‐state stability of freeze‐dried methyprednisolone sodium succinate. Pharm. Res. 1994; 11: 1467–1473
  • Besman M., Bjornson E., Jameel F., Kashi R., Pikal M. J., Tchessalov S., Carpenter J. Novel albumin‐free factor VIII formulations. PCT Int. Appl. 2000, 43 pp.
  • Mackenzie A. P. S. A. Goldblith, L. Rev, W. W. RothmayrCollapse during freeze‐drying: qualitative and quantitative aspects. Freeze Drying and Advanced Food Technology, . Academic Press, London 1975; 277–307
  • Milton N., Pikal M. J., Roy M. L., Nail S. L. Evaluation of manometric temperature measurement as a method of monitoring product temperature during lyophilization. PDA J. Pharm. Sci. Technol. 1997; 5(1)7–16
  • DIFFRACPlus Software, Version 3.0. International Centre for Diffraction Data, Newtown Square, PA, pattern number 22‐1793, 22‐1794, 22‐1797
  • Izutsu K., Yoshioka S., Kojima S. Effect of cryoprotectants on the eutectic crystallization of NaCl in frozen solutions studied by differential scanning calorimetry (DSC) and broad‐line pulsed NMR. Chem. Pharm. Bull. 1995; 43(10)1804–1806
  • Tang X. Critical engineering and chemical problems in freeze drying process design. Ph.D. thesis. University of Connecticut. 2002
  • Yoshioka M., Hancock B. C., Zografi G. Crystallization of indomethacin from the amorphous state below and above its glass transition temperature. J. Pharm. Sci. 1994; 83(12)1700–1705
  • Cavatur R. K., Suryanarayanan R. Characterization of phase transitions during freeze‐drying by in situ X‐ray powder diffractometry. Pharm. Dev. Technol. 1998; 3(4)579–586
  • Williams N. A., Dean T. Vial breakage by frozen mannitol solutions: correlation with thermal characteristics and effect of steroisomerism, additive and vial configuration. J. Parenter. Sci. Technol. 1991; 45: 94–100
  • Haikala R., Eerola R., Tanninen V. P., Yliruusi J. Polymorphic change of mannitol during freeze‐drying: effect of surface‐active agents. PDA J. Pharm. Sci. Technol. 1997; 51(2)96–101

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.