The exploration and use of thermal analytical technologies during formulation and process development of freeze-dried products

American Pharmaceutical Review

Volumn 6, Issue 4, 2003, Pages 46-51

  Milton, Nathaniel ^a   Pyne, Abira ^a   Mishra, Dinesh ^a   Yu, Lian ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EXCIPIENT; MANNITOL;

DIFFERENTIAL SCANNING CALORIMETRY; DRUG FORMULATION; DRUG INDUSTRY; FREEZE DRYING; POWDER; PROCESS DEVELOPMENT; REVIEW; SOLID STATE; THERMAL ANALYSIS;

EID: 0346339549     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (13)

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9. Williams, NA. Dean, T. Vial breakage by frozen mannitol solutions: correlation with thermal characteristics and effect of stereoisomerism, additives, and vial configuration. Journal of Parenteral Science & Technology. 45(Mar-Apr): p 94-100. 1991.
10. Williams, N.A. Guglielmo, J. Thermal mechanical analysis of frozen solutions of mannitol and some related stereoisomers: evidence of expansion during warming and correlation with vial breakage during lyophilization. Journal of Pharmaceutical Science & Technology. 47(May-Jun): p 119-123. 1993.
11. Herman, BD. Sinclair, BD. Milton, N. Nail, SL. Effect of bulking agent on the solid-state stability of freeze-dried methylprednisolone sodium succinate. Pharmaceutical Research. 11(Oct): p 1467-1473. 1994.
12. Yu, L. Milton, N. Groleau, EG. Mishra, DS. Vansickle, RE. Existence of a mannitol hydrate during freeze-drying and practical implications. Journal of Pharmaceutical Sciences. 88(Feb): p 196-198. 1999.
13. Johnson, RE. Kirchhoff, CF. Gaud, HT. Mannitol-sucrose mixtures - Versatile formulations for protein lyophilization. Journal of Pharmaceutical Sciences. 91 (4): p 914-922. 2002.