Polymorphic changes of mannitol during freeze-drying: Effect of surface- active agents

PDA Journal of Pharmaceutical Science and Technology

Volumn 51, Issue 2, 1997, Pages 96-101

  Haikala, Ritva ^a   Eerola, Riikka ^a   Tanninen, Veli Pekka ^a   Yliruusi, Jouko ^b  

^a ORION CORPORATION   (Finland)

^b UNIVERSITY OF HELSINKI   (Finland)

Author keywords

[No Author keywords available]

Indexed keywords

MANNITOL; POLYSORBATE 80; SURFACTANT;

ARTICLE; DRUG MANUFACTURE; DRUG SOLUBILITY; DRUG STABILITY; FREEZE DRYING; SCANNING ELECTRON MICROSCOPY; X RAY DIFFRACTION;

CRYSTALLIZATION; DRUG STABILITY; FREEZE DRYING; MANNITOL; MICROSCOPY, ELECTRON, SCANNING; POLYSORBATES; SOLUTIONS; SURFACE PROPERTIES; SURFACE-ACTIVE AGENTS; X-RAY DIFFRACTION;

EID: 0030947164     PISSN: 1076397X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (19)

1. F. Franks, "Improved freeze-drying: An analysis of the basic scientific principles," Process Biochem., 24, iii-vii (1989).
2. L. R. Rey, "Thermal analysis of eutectics in freezing solutions," Ann. N.Y. Acad. Sci., 85, 510 (1960).
3. M. J. Pikal, "Freeze-drying of proteins, Part I: Process design," Biopharm, 3, 18-27 (1990).
4. L. R. Rey, "Fundamental aspects of lyophilization," in Aspects Theoriques et Industriels de la Lyophilisation, Hermann, Paris, 1964, pp. 23-43.
5. M. J. Pikal, A. L. Lukes, and J. E. Lang, "Thermal decomposition of amorphous β-lactam antibiotics," J. Pharm. Sci., 66, 1312-1316 (1977).
6. M. J. Pikal, A. L. Lukes, J. E. Lang, and K. Gaines, "Quantitative crystallinity determination for β-lactam antibiotics by solution calorimetry: Correlations with stability," J. Pharm. Sci., 67, 767-773 (1978).
7. A. P. Mackenzie "The physico-chemical basis for freeze-drying process," International Symposium on Freeze-Drying of Biological Products, Washington, D.C., 1976, Dev. Biol. Stand., 36, 51-67 (1977).
8. 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).
9. J. L. Ford and P. Timmins, Pharmaceutical Thermal Analysis and Applications, 1st ed., Ellis Horwood Limited, Chichester, 1989, p. 138.
10. A. P. Mackenzie, "Collapse during freeze-drying: Qualitative and quantitative aspects," in Freeze Drying and Advanced Food Technology, S. A. Goldblith, L. Rev, and W. W. Rothmayr, eds, Academic Press, London, 1975, pp. 277-307.
11. R. H. M. Hatley, "The effective use of differential scanning calorimetry in the optimisation of freeze-drying processes and formulations," Dev. Biol. Stand., 74, 105-122 (1991).
12. I. Pitkänen, P. Perkkalainen, and H. Rautiainen, "Thermal studies on phases of D-mannitol," Thermochim. Acta, 214, 157-162 (1993).
13. N. A. Williams and T. Dean, "Vial breakage by frozen mannitol solutions: Correlation with thermal characteristics and effect of steroisomerism, additives and vial configuration," J. Parenter. Sci. Technol., 45, 94-100 (1991).
14. S. Nema and K. E. Avis, "Freeze-thaw studies of a model protein, lactate dehydrogenase, in the presence of cryoprotectants," J. Parenter. Sci. Technol., 47, 76 (1993).
15. M. J. Pikal, "Freeze-drying of proteins, Pan II: Formulation selection," Biopharm. 3, 26-30 (1990).
16. F. Franks and R. H. M. Hatley, "Stable enzymes by water removal," In Proceedings of Stability and Stabilization of Enzymes, International Symposium, held Nov. 22-25, 1992, in Maastricht, The Netherlands, W. J. J. van den Tweel, A. Harder and R. M. Buitelaar, eds, pp. 45-54.
17. I. S. Gibbs, A. Heald, H. Jacobson, D. Wadke, and I. Weliky, "Physical characterization and activity in vivo of polymorphic forms of 7-chloro-5,11-dihydrodibenz[b,e][1,4] oxazepine-5-carboxamide, a potential tricyclic antidepressant," J. Pharm. Sci., 65, 1380-1385 (1976).
18. P. J. Dawson and D. J. Hockley, "Scanning electron microscopy of freeze-dried preparations: Relationship of morphology to freeze-drying parameters," Dev. Biol. Stand. 74, 185-192 (1991).
19. C. Körber, "Solute redistribution and ice front morphology," In Freeze-drying, Principles and Practice, Seminar organized by BioUpDate Foundation, held Oct. 28-29, 1993, in Amersfoort, Netherlands.