Peer-Reviewed Technical Note: Influence of Common Excipients on the Crystalline Modification of Freeze-Dried Mannitol - Pharmaceutical Technology

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Peer-Reviewed Technical Note: Influence of Common Excipients on the Crystalline Modification of Freeze-Dried Mannitol

Pharmaceutical Technology
Volume 3, Issue 32


1. M. J. Pikal, "Freeze Drying," Encyclopedia of Pharmaceutical Technology (Marcel Dekker, New York, 2002), pp. 1299–1326.

2. R.K. Cavatur et al., "Crystallization Behavior of Mannitol in Frozen Aqueous Solutions," Pharm. Res. 19 (6), 894–900 (2002).

3. X. Liao et al., "Influence of Processing Conditions on the Physical State of Mannitol—Implications in Freeze-Drying," Pharm. Res. 24 (2), 370–376 (2007).

4. A.I. Kim et al., "The Physical State of Mannitol after Freeze-Drying: Effects of Mannitol Concentration, Freezing Rate, and a NonCrystallizing Cosolute," J. Pharm. Sci., 87 (8), 931–935 (1998).

5. A. Burger et al., "Energy/Temperature Diagram and Compression Behavior of the Polymorphs of D-Mannitol," J. Pharm. Sci. 89 (4), 457–468 (2000).

6. C. Telang et al., "Crystallization of D-Mannitol in Binary Mixtures with NaCl: Phase Diagram and Polymorphism," Pharm. Res. 20 (12), 1939–1945 (2003).

7. J. Liu, "Physical Characterization of Pharmaceutical Formulations in Frozen and Freeze-Dried Solid States: Techniques and Applications in Freeze-Drying Development," Pharm. Dev. Technol. 11 (1), 3–38 (2006).

8. K. Chatterjee et al., "Partially Crystalline Systems in Lyophilization: II. Withstanding Collapse at High Primary Drying Temperatures and Impact on Protein Activity Recovery," J. Pharm. Sci. 94 (4), 809–820 (2005).

9. T. Yoshinari et al., "Moisture Induced Polymorphic Transition of Mannitol and its Morphological Transformation," Int. J. Pharm. 247 (1–2), 69–77 (2002).

10. L. Yu et al., "Existence of a Mannitol Hydrate During Freeze-Drying and Practical Implications," J. Pharm. Sci. 88 (2), 196-198(1999).

11. A. Hawe and W. Friess, "Impact of Freezing Procedure and Annealing on the Physico-Chemical Properties and the Formation of Mannitol Hydrate in Mannitol-Sucrose-NaCl Formulations," Eur J Pharm Biopharm 64 (3), 316–325 (2006).

12. L. Yu et al., "Determination of the Glass Properties of D-Mannitol Using Sorbitol as an Impurity," J. Pharm. Sci. 87 (6), 774–777 (1998).


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