Controlling Ice Nucleation During the Freezing Step of Lyophilization - Pharmaceutical Technology

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PharmTech Europe

Controlling Ice Nucleation During the Freezing Step of Lyophilization
Lyophilization technologies for controlled nucleation.


Pharmaceutical Technology
Volume 37, Issue 5, pp. 36-40

References

1. ABB website, "Freeze Drying in the Pharmaceutical Industry," http://www.abb.com/, accessed Apr. 9, 2013.

2. R. Bursac, R. Sever, and B. Hunek, BioProcess Int. 7 (9) 66-72 (2009).

3. K Scoffin and L Ciccolini, BioPharm Int. 26 (3) 46-51 (2013).

4. A. Hottot, S. Vessot, and J. Andrieu, Drying Technology 22 (8) 2009-2021 (2004).

5. M.L. Roy and M.J. Pikal, J Parenter. Sci. Technol. 43, 60–66 (1989).

6. J.A. Searles, J. F. Carpenter, and T.W. Randolph, J Pharm. Sci. 90, 860–871 (2001).

7. A.K. Konstantinidis et al, J Pharm. Sci. 100 (8) 3453-70 (2011).

8. P. Startzel, M. Gieseler, and H. Gieseler, "Rational Freeze-Drying Cycle Optimization Using Two Innovative Technologies: SMART Freeze-Dryer and ControLyo Nucleation On-Demand," presentation at the Controlled Release Society Germany Local Chapter Meeting (Wuerzburg, Mar., 2012).

9. G.A. Sacha and R. Sever, "Controlled Nucleation in Lyophilization: The Effects on Lyophilization Time and Physical Appearance of Lyophilized Pharmaceutical Excipients," presentation at the CPPR Freeze Drying of Pharmaceuticals & Biologicals Conference (Breckenridge, CO, Aug., 2012).

10. G.B. Strambini and E. Gabellieri, Biophys. J 70 (2) 971-976. (1996).

11. A. Millqvist-Fureby, M. Malmsten, and B. Bergenstahl, Int. J Pharm. 191 (2) 103-114 (1999).

12. B.S. Chang, B.S. Kendrick, and J.F. Carpenter, J Pharm. Sci. 85 (12) 1325–1330 (1996).

13. S. Jiang and S.L. Nail, Eur. J Pharm. Biopharm. 45 (3) 249-257 (1998).

14. M. Pikal, "Advances in Controlled Ice Nucleation," presentation at the PEP Talk Conference (Palm Springs, CA, Jan., 2013).

15. P. Chakravarty et al, BioPharm Int. 25 (1) 33-38 (2012).

16. P. Thomas, PharmaManufacturing website, "Controlled Ice Nucleation Moves into Manufacturing," http://www.pharmamanufacturing.com/, accessed Apr. 9, 2013.

17. J. Brower, "Ice Fog Induced Nucleation: A Case Study," presentation at the First Annual Lyo Summit: Lyophilization Conference (Garmisch-Partenkirchen, Germany, Oct., 2012).

18. R. Sever et al, "ControLyo Nucleation On-Demand Technology: New Case Studies and Manufacturing Scale Implementation," presentation at the PEP Talk Conference (SanDiego, Jan., 2012).

19. M. Shon and B. Uchil, "Scale-Up of Controlled Nucleation to a Production Environment," presentation at the PEP Talk Conference (Palm Springs, CA, Jan., 2013).


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