Crystallization of cephalothin sodium during lyophilization from tert-butyl alcohol-water cosolvent system

Pharmaceutical Research

Volumn 22, Issue 1, 2005, Pages 153-160

  Telang, Chitra ^a,b   Suryanarayanan, Raj ^a  

^a UNIVERSITY OF MINNESOTA   (United States)

^b BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

Author keywords

Cephalothin; Crystallinity; Freeze drying; tert butyl alcohol; X ray diffractometry

Indexed keywords

2 PROPANOL; ALCOHOL; CEFALOTIN; SOLVENT; TERT BUTYL ALCOHOL; WATER;

ACCELERATION; AQUEOUS SOLUTION; ARTICLE; CONCENTRATION RESPONSE; CRYSTAL STRUCTURE; CRYSTALLIZATION; DRUG FORMULATION; ENERGY YIELD; FREEZE DRYING; GAS CHROMATOGRAPHY; OXYGEN SATURATION; PRIORITY JOURNAL; SOLUTE; X RAY DIFFRACTION;

CEPHALOTHIN; CRYSTALLIZATION; FREEZE DRYING; SOLVENTS; TERT-BUTYL ALCOHOL; WATER;

EID: 17644415380     PISSN: 07248741     EISSN: None     Source Type: Journal    
DOI: 10.1007/s11095-004-9021-3     Document Type: Article

References (31)

1. M. J. Pikal, A. L. Lukes, J. E. Lang, and K. Gaines. Quantitative crystallinity determinations for beta-lactam antibiotics by solution calorimetry: correlations with stability. J. Pharm. Sci. 67:767-773 (1978).
2. K. Kasraian and P. P. DeLuca. The effect of tertiary butyl alcohol on the resistance of the dry product layer during primary drying. Pharm. Res. 12:491-495 (1995).
3. H. Willemer. Low temperature freeze drying of aqueous and non-aqueous solutions using liquid nitrogen. In S. A. Goldblith, L. Rey, and W. W. Rothmayr (eds.), Freeze Drying and Advanced Food Technology, Academic Press, New York, 1975, pp. 461-477.
4. H. Seager, C. B. Taskis. M. Syrop, and T. J. Lee. Structure of products prepared by freeze-drying solutions containing organic solvents. J. Parenter. Sci. Technol. 39:161-179 (1985).
5. D. L. Teagarden and D. S. Baker. Practical aspects of lyophilization using non-aqueous co-solvent systems. Eur. J. Pharm. Sci. 15:115-133 (2002).
6. M. S. Tesconi, K. Sepassi, and S. H. Yalkowsky. Freeze-drying above room temperature. J. Pharm. Sci. 88:501-506 (1999).
7. J. Oesterle, F. Franks, and T. Auffret. The influence of tertiary butyl alcohol and volatile salts on the sublimation of ice from frozen sucrose solutions: implications for freeze-drying. Pharm. Dev. Technol. 3:175-183 (1998).
8. D. W. Flamberg, D. L. Francis, S. L. Morgan, and G. F. Wickes. Low temperature vacuum drying of sterile parenterals from ethanol. Bull. Parenter. Drug Assoc. 24:209-217 (1970).
9. N. Ni, M. Tesconi, S. E. Tabibi, S. Gupta, and S. H. Yalkowsky. Use of pure t-butanol as a solvent for freeze-drying: a case study. Int. J. Pharm. 226:39-46 (2001).
10. M. S. Kamat. Factors Which Influence the Mass-Transfer Phenomenon During Freeze-Drying. Ph.D. dissertation, University of Kentucky: Lexington, Kentucky, 1989.
11. S. Wittaya-Areekul, G. F. Needham, N. Milton, M. L. Roy, and S. L. Nail. Freeze-drying of tert-butanol/water cosolvent systems: a case report on formation of a friable freeze-dried powder of tobramycin sulfate. J. Pharm. Sci. 91:1147-1155 (2002).
12. Y. Koyama, M. Kamat, R. J. De Angelis, R. Srinivasan. and P. P. DeLuca. Effect of solvent addition and thermal treatment on freeze drying of cefazolin sodium. J. Parenter. Sci. Technol. 42:47-52 (1988).
13. J. B. Ott, J. R. Goates, and B. A. Waite. (Solid + liquid) phase equilibriums and solid-hydrate formation in water + methyl, + ethyl, + isopropyl, and + tertiary butyl alcohols. J. Chem. Therm. 11:739-746 (1979).
14. K. Kasraian and P. P. DeLuca. Thermal analysis of the tertiary butyl alcohol-water system and its implications on freeze-drying. Pharm. Res. 12:484-490 (1995).
15. M. Inoue, K. Shima, and K. Inazu. Crystal growth of cephalothin sodium in frozen solution. II. Effects of amount of seed, concentration, and temperature. Yakugaku Zasshi 104:1268-1274 (1984).
16. T. Takeda, Y. Suzuki, K. Inazu, T. Sakamoto, and H. Maekawa. Crystallization and subsequent freeze-drying of cephalothin sodium by seeding method. Yakugaku Zasshi 109:395-401 (1989).
17. M. D. Cise. Stable sterile crystalline cephalosporins for parenteral administration. Canadian Patent No. 1068680. 1979.
18. A. Pyne and R. Suryanarayanan. The effect of additives on the crystallization of cefazolin sodium during freeze-drying. Pharm. Res. 20:283-291 (2003).
19. M. D. Cise and M. L. Roy. Rapidly dissolving powder of crystalline cephalothin sodium for parenteral administration. U.S. Patent No. 4132848, 1979.
20. M. Inoue, H. Tanaka, K. Shima, and K. Inazu. Crystal growth of cephalothin sodium in frozen solution. III. Effect of organic solvent on growth rate. Yakugaku Zasshi 105:289-295 (1985).
21. S. Wittaya-areekul and S. L. Nail. Freeze-drying of tert-butyl alcohol/water cosolvent systems: effects of formulation and process variables on residual solvents. J. Pharm. Sci. 87:491-495 (1998).
22. Powder Diffraction File. (PDF-2. Card #00-016-1134). International Center for Diffraction Data, Newtown Square, PA, 1996.
23. L. Gatlin and P. P. Deluca. A study of the phase transitions in frozen antibiotic solutions by differential scanning calorimetry. J. Parenter. Drug Assoc. 34:398-408 (1980).
24. A. V. Lesikar. Glass transition in organic halide-alcohol mixtures. J. Chem. Phys. 63:2297-2302 (1975).
25. D. L. Teagarden. W. J. Petre, and P. M. Gold. Stabilized prostaglandin E1. U.S. Patent No. 5741523, 1998.
26. R. K. Cavatur and R. Suryanarayanan. Characterization of phase transitions during freeze-drying by in situ X-ray powder diffractometry. Pharm. Dev. Tech. 3:579-586 (1998).
27. J. R. Marsh and P. J. Weiss. Solubility of antibiotics in twenty-six solvents. III. J. Assoc. Off. Anal. Chem. 50:457-462 (1967).
28. D. J. Korey and J. B. Schwartz. Effects of excipients on the crystallization of pharmaceutical compounds during lyophilization. J. Parenter. Sci. Technol. 43:80-83 (1989).
29. Y. Suzuki, T. Takeda, K. Inazu, and T. Sakamoto. Freeze-drying of cephalothin sodium: granularly agglomerated crystallization during freezing. I. Biol. Pharm. Bull. 16:402-406 (1993).
30. J. Flink and M. Karel. Retention of organic volatiles in freeze-dried solutions of carbohydrates. J. Agric. Food Chem. 18:295-297 (1970).
31. W. K. Hubbard. International Conference on Harmonization; guidance on impurities: residual solvents. Fed. Reg. 62:67377-67388 (1997).