Freeze-Drying Process Optimisation for a Small Molecule - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Freeze-Drying Process Optimisation for a Small Molecule


Pharmaceutical Technology Europe
Volume 24, Issue 6

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,
. 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).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
38%
Breakthrough designations
13%
Protecting the supply chain
38%
Expedited reviews of drug submissions
13%
More stakeholder involvement
0%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
USP Faces New Challenges
Source: Pharmaceutical Technology Europe,
Click here