Acknowledgments
The authors acknowledge Hiltrud Lindenblatt, PhD and senior scientist of life-cycle management CMC management at Merck KGaA,
for providing the gentamicin sulphate.
Henning Gieseler* is an assistant professor and group leader in the Freeze-Drying Focus Group, Division of Pharmaceutics, University of Erlangen
(Germany) and managing director of Gilyos GmbH, 15 Friedrich-Bergius-Ring, Wuerzburg, Germany, 97076, tel. +49 931 907 05678,
info@gilyos.com . Susanne Hibler is a graduate student in the Freeze-Drying Focus Group, Division of Pharmaceutics, University of Erlangen.
*To whom all correspondence should be addressed.
Submitted: 22 Mar. 2012; Accepted 23 Mar. 2012.
CITATION: When referring to this article, please cite it as "Henning Gieseler And Susanne Hibler, "Freeze-Drying Process Optimization
for a Small Molecule," Pharmaceutical Technology,
36(6) (2012).
References
1. S. Rambhatla and M.J. Pikal, "Heat and Mass Transfer Issues in Freeze-drying Process Development," in Lyophilization of Biopharmaceuticals, H. R. Constantino and M.J. Pikal, Eds. (American Association of Pharmaceutical Scientists, Arlington, 1st ed., 2004), pp
75–109.
2. X. Tang and M.J. Pikal, Pharm. Res.
21 (2), 191–200 (2004).
3. M.J. Pikal and S. Shah, Int. J. Pharm. 62 (2-3), 165–186 (1990).
4. J.F. Carpenter et al., Pharm. Res. 14 (8), 969–975 (1997).
5. R.E. Johnson et al., J. Pharm. Sci. 99 (6), 2863–2873 (2010).
6. D.E. Overcashier, T.W. Patapoff, and C.C. Hsu, J. Pharm. Sci.
88 (7), 688–695 (1999).
7. J.D. Colandene et al. J. Pharm. Sci.
96 (6), 1598–1608 (2007).
8. E. Meister and H. Gieseler, J. Pharm. Sci. 98 (9), 3072–3087 (2009).
9. L.M. Her and S.L. Nail, Pharm. Res. 11 (1), 54–59 (1994).
10. J. Liu, Pharm. Dev. Technol. 11 (1), 3–28 (2006).
11. E. Meister, Methodology, Data Interpretation and Practical Transfer of Freeze-Dry Microscopy, PhD. Thesis, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen (2009).
12. F. Fonseca et al., Biotechnol. Prog.
20 (1), 229–238 (2004).
13. M.J. Pikal, J. Parenter. Sci. Technol.
39 (3), 115–139 (1985).
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