Characterization of the "hygroscopic" properties of active pharmaceutical ingredients

Journal of Pharmaceutical Sciences

Volumn 97, Issue 3, 2008, Pages 1047-1059

  Newman, Ann W ^a   Reutzel Edens, Susan M ^b   Zografi, George ^c  

^a SSCI Incorporated   (United States)

^b ELI LILLY AND COMPANY   (United States)

^c UNIVERSITY OF WISCONSIN MADISON   (United States)

Author keywords

Amorphous; Hygroscopicity; Moisture sorption; Physical characterization; Preformulation; Solid state; Water in solids

Indexed keywords

DRUG; WATER;

ADSORPTION; CLASSIFICATION; DESICCATION; DRUG STABILITY; HUMIDITY; ISOTHERM; LIQUEFACTION; MATERIALS MANAGEMENT; MEASUREMENT; MOISTURE; PREFORMULATION; SHORT SURVEY; SOLID; THERMOGRAVIMETRY; TIME; TITRIMETRY; WATER CONTENT; WATER VAPOR; WETTABILITY; CHEMISTRY; REVIEW;

PHARMACEUTICAL PREPARATIONS; WATER;

EID: 42949121619     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21033     Document Type: Short Survey

References (23)

1. Callahan JC, Cleary GW, Elefant M, Kaplan G, Kensler T, Nash RA. 1982. Equilibrium moisture content of pharmaceutical excipients. Drug Dev Ind Pharm 8:355-369.
2. Umprayn K, Mendes RW. 1987. Hygroscopicity and moisture adsorption kinetics of pharmaceutical solids: A review. Drug Dev Ind Pharm 13:653-693.
3. Zografi G. 1988. States of water associated with solids. Drug Dev Ind Pharm 14:1905-1926.
4. Ahlneck C, Zografi G. 1990. The molecular basis for moisture effects on the physical and chemical stability of drugs in the solid state. Int J Pharm 62:87-95.
5. Kontny MJ, Zografi G. 1995. Sorption of water by solids. In: Brittain HG, editor. Physical characterization of pharmaceutical solids. New York: Marcel Dekker. pp 386-418.
6. Visalakshi NA, Mariappan TT, Bhutani H, Singh S. 2005. Behavior of moisture gain and equilibrium moisture contents (EMC) of various drug substances and correlation with compendial information on hygroscopicity and loss on drying. Pharm Dev Tech 10:489-497.
7. Reutzel-Edens SM, Newman AW. 2006. The physical characterization of hygroscopicity in pharmaceutical solids. In: Hilfiker R, editor. Polymorphism in the pharmaceutical industry. Chapter 9. Wein-heim: Wiley-VCH. pp 235-258.
8. European Pharmacopeia Technical Guide, December 1999.
9. 2O on NaCl: From single molecule to clusters, to monolayer, to thin film, to deliquesce. Intermol Forces Clusters II Struct Bonding 116:1-25.
10. Van Campen L, Amidon GL, Zografi G. 1983. Moisture sorption kinetics by water-soluble substances. II: Experimental aspects of a heat transfer model. J Pharm Sci 72:1388-1398.
11. Yoshioka S, Shibazaki T, Ejima A. 1982. Stability of solid dosage forms. I. Hydrolysis of meclofenoxate hydrochloride in the solid state. Chem Pharm Bull 30:3734-3741.
12. Salameh AK, Taylor LS. 2006. Role of deliquescence lowering in enhancing chemical reactivity in physical mixtures. J Phys Chem B 110:10190-10196.
13. Adamson AW, Gast AP. 1997. Physical chemistry of surfaces, 6th edition. New York: Wiley-Inter-science. pp 53-55.
14. Cleaver JAS, Karatzas G, Louis S, Hayatti I. 2004. Moisture-induced caking of boric acid powder. Powder Tech 146:93-101.
15. Byrn SR, Pfeiffer RR, Stowell JG. 1999. Solid-state chemistry of drugs, 2nd edition. West Lafayette, IN: SSCI, Inc. pp 233-258.
16. Authelin JR. 2005. Thermodynamics of non-stoi-chiometric pharmaceutical hydrates. Int J Pharm 303:37-53.
17. Saleki-Gerhardt A, Ahlneck C, Zografi G. 1994. Assessment of disorder in crystalline solids. Int J Pharm 101:237-247.
18. Nyqvist H. 1983. Saturated salt solutions for maintaining specified relative humidities. Int J Pharm Tech Prod Mfr 4:47-48.
19. Roberts A. 1999. The design of an automatic system for the gravimetric measurement of water sorption. J Therm Anal Calorim 55:389-396.
20. Stubberud L, Arwidsson HG, Graffner C. 1995. Water-solid interactions. I. A technique for studying moisture sorption/desorption. Int J Pharm 114: 55-64.
21. Zhang J, Zografi G. 2000. The relationship between "BET" and the free volume-derived models for water vapor sorption by amorphous solids. J Pharm Sci 89:1063-1072.
22. Crowley K, Zografi G. 2001. The use of thermal analysis for predicting glass-former fragility. Ther-mochim Acta 380:79-83.
23. Morris KR. 1999. Structural aspect of hydrates and solvates. In: Brittain HG, editor. Polymorphism in pharmaceutical solids. New York: Marcel Dekker. pp 125-226.