Insights from a Thermodynamic Study and Its Implications on the Freeze-Drying of Pharmaceutical Solutions Containing Water and tert-Butyl Alcohol as a Cosolvent

References

1. 1.↵
   1. Teagarden D. L.,
   2. Baker D. S.

   Practical aspects of lyophilization using non aqueous co-solvent systems. Eur. J. Pharm. Sci. 2002, 15(2), 115–133.

   OpenUrlPubMedGoogle Scholar
2. 2.↵
   1. Rathore N.,
   2. Rajan R. S.

   Current perspectives on stability of protein drug products during formulation, fill and finish operations. Biotechnol. Prog. 2008, 24 (3), 504–514.

   OpenUrlPubMedGoogle Scholar
3. 3.↵
   1. Vessot S.,
   2. Andrieu J.

   A review on freeze drying of drugs with tert-butanol (TBA) + water systems: characteristics, advantages, drawbacks. Drying Technol. 2012, 30 (4), 377–385.

   OpenUrlGoogle Scholar
4. 4.↵
   1. Wang J.-C.,
   2. Bruttini R.,
   3. Liapis A. I.

   Dehydration and rehydration of polymeric porous media studied by molecular dynamics modeling and simulations. Ind. Eng. Chem. Res. 2015, 54 (44), 11065–11074.

   OpenUrlGoogle Scholar
5. 5.↵
   1. Wang J.-C.,
   2. Bruttini R.,
   3. Liapis A. I.

   Molecular dynamics modeling and simulation studies of the effects of additive solutes on the dehydration and rehydration of polymeric porous media. Ind. Eng. Chem. Res. 2016, 55 (23), 6649–6660.

   OpenUrlGoogle Scholar
6. 6.↵
   1. Rey M.,
   2. May J. C.

   Freeze Drying/Lyophilization of Pharmaceutical and Biological Products, Marcel Dekker: New York, 2004.

   Google Scholar
7. 7.↵
   1. Kunz C.,
   2. Schuldt-Lieb S.,
   3. Gieseler H.

   Freeze-drying from organic cosolvent systems, part 1: thermal analysis of cosolvent-based placebo formulations in the frozen State. J. Pharm. Sci. 2018, 107 (3), 887–896.

   OpenUrlGoogle Scholar
8. 8.↵
   1. Kasraian K.,
   2. DeLuca P. P.

   Thermal analysis of the tertiary butyl alcohol–water system and its implications on freeze drying. Pharmacol. Res. 1995, 12 (4), 484–490.

   OpenUrlGoogle Scholar
9. 9.↵
   1. Mallard W. G.,
   2. Linstrom P. J.

   , Eds. NIST Chemistry WebBook, NIST Standard Reference Database Number 69; National Institute of Standards and Technology: Gaithersburg, MD, 200.

   Google Scholar
10. 10.↵
    1. Maczynski A.,
    2. Shaw D. G.,
    3. Goral M.,
    4. Wisniewska-Goclowska B.

    IUPAC-NIST Solubility Data Series. 82. Alcohols with Water—Revised and Updated: Part 1. C4 Alcohols with Water. J. Phys. Chem. Ref. Data 2007, 36 (1), 59–132.

    OpenUrlGoogle Scholar
11. 11.↵
    1. Nakagawa M.,
    2. Inubushi H.,
    3. Moriyoshi T.

    Compressions of water + t-butanol mixtures at 298.15 K and pressures up to 142 MPa. J. Chem. Thermodyn. 1981, 13 (2), 171–178.

    OpenUrlGoogle Scholar
12. 12.↵
    1. Sadikoglu H.,
    2. Liapis A. I.

    Mathematical modelling of the primary and secondary drying stages of bulk solution freeze drying in trays: Parameter estimation and model discrimination by comparison of theoretical results with experimental data. Drying Technol. 1997, 15 (3–4), 791–810.

    OpenUrlGoogle Scholar
13. 13.↵
    1. Millman M. J.,
    2. Liapis A. I.,
    3. Marchello J. M.

    An analysis of the lyophilization process using a sorption – sublimation model and various operational policies. AIChE J. 1985, 31 (10), 1594–1604.

    OpenUrlGoogle Scholar
14. 14.↵
    1. Liapis A. I.,
    2. Bruttini R.

    Exergy analysis of the freeze drying of pharmaceuticals in vials and trays. Int. J. Heat Mass Transfer 2008, 51 (15), 3854–3868.

    OpenUrlGoogle Scholar
15. 15.↵
    1. Liapis A. I.,
    2. Bruttini R.

    A mathematical model for the spray freeze drying process: The drying of frozen particles in trays and in vials on trays. Int. J. Heat Mass Transfer 2009, 52 (1–2), 100–111.

    OpenUrlGoogle Scholar
16. 16.↵
    1. Bruttini R,
    2. Liapis A. I.

    The drying rates of spray freeze drying systems increase through the use of stratified packed bed structures. Int. J. Heat Mass Transfer 2015, 90, 515–522.

    OpenUrlGoogle Scholar
17. 17.↵
    1. Gmehling J.,
    2. Li J.,
    3. Schiller M.

    A modified UNIFAC model. 2. Present parameter matrix and results for different thermodynamic properties. Ind. Eng. Chem. Res. 1993, 32 (1), 178–193.

    OpenUrlGoogle Scholar
18. 18.↵
    1. Smith J. M.,
    2. Van Ness H. C.,
    3. Abbott M. M.

    Chemical Engineering Thermodynamics, 7th ed.; McGraw-Hill Education: New York, 2004.

    Google Scholar
19. 19.↵
    1. Angell C. A.,
    2. Oguni M.,
    3. Sichina W. J.

    Heat capacity of water at extremes of supercooling and superheating. J. Phys. Chem. 1982, 86 (6), 998–1002.

    OpenUrlCrossRefWeb of ScienceGoogle Scholar
20. 20.↵
    1. Murphy D. M.,
    2. Koop T.

    Review of the vapour pressures of ice and supercooled water for atmospheric applications. Q. J. R. Meteorol. Soc. 2005, 131 (608), 1539–1565.

    OpenUrlCrossRefWeb of ScienceGoogle Scholar
21. 21.↵
    1. Fukusako S.

    Thermophysical properties of ice, snow, and sea ice. Int. J. Thermophys. 1990, 11 (2), 353–372.

    OpenUrlCrossRefGoogle Scholar
22. 22.↵
    1. Oetting F. L.

    The heat capacity and entropy of 2-methyl-2-propanol from 15 to 330 K. J. Phys. Chem. 1963, 67 (12), 2757–2761.

    OpenUrlGoogle Scholar
23. 23.↵
    1. Bogdani E.,
    2. Daoussi R.,
    3. Vessot S.,
    4. Jose J.,
    5. Andrieu J.

    Implementation and validation of the thermogravimetric method for the determination of equilibrium vapour pressure values and sublimation enthalpies of frozen organic formulations used in drug freeze–drying processes. Chem. Eng. Res. Des. 2011, 89 (12), 2606–2612.

    OpenUrlGoogle Scholar
24. 24.↵
    1. Renon H.,
    2. Prausnitz J. M.

    Local compositions in thermodynamic excess functions for liquid mixtures. AIChE J. 1968, 14 (1), 135–144.

    OpenUrlGoogle Scholar
25. 25.↵
    1. Geankoplis C. H.

    Transport Processes and Separation Process Principles; Prentice Hall: Upper Saddle River, NJ, 2003.

    Google Scholar
26. 26.↵
    1. Hirschfelder J. O.,
    2. Curtiss C. F.,
    3. Bird R. B.

    Molecular Theory of Gases and Liquids; Wiley: New York, 1954.

    Google Scholar