Classification of lyophilised mixtures using multivariate analysis of NIR spectra

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 74, Issue 2, 2010, Pages 406-412

  Grohganz, Holger ^a   Fonteyne, Margot ^a   Skibsted, Erik ^b   Falck, Thomas ^b   Palmqvist, Bent ^b   Rantanen, Jukka ^a  

^a UNIVERSITY OF COPENHAGEN   (Denmark)

^b NOVO NORDISK A S   (Denmark)

Author keywords

Excipients; Freeze drying; Multivariate analysis; NIR; Solid state

Indexed keywords

BETA MANNITOL; CALCIUM CHLORIDE; DELTA MANNITOL; EXCIPIENT; HISTIDINE; MANNITOL; SODIUM CHLORIDE; SUCROSE; UNCLASSIFIED DRUG;

ANALYTIC METHOD; ARTICLE; CHEMICAL COMPOSITION; CHEMICAL REACTION KINETICS; CLUSTER ANALYSIS; CONTROLLED STUDY; CRYSTALLIZATION; FEASIBILITY STUDY; FREEZE DRYING; HUMIDITY; MULTIVARIATE ANALYSIS; NEAR INFRARED SPECTROSCOPY; PRINCIPAL COMPONENT ANALYSIS; QUALITY CONTROL; REACTION ANALYSIS; REACTION OPTIMIZATION; SOLID STATE; STORAGE TEMPERATURE; WATER CONTENT;

CALCIUM CHLORIDE; CHEMISTRY, PHARMACEUTICAL; DRUG COMPOUNDING; DRUG STABILITY; DRUG STORAGE; EXCIPIENTS; FREEZE DRYING; HISTIDINE; HUMIDITY; MANNITOL; MULTIVARIATE ANALYSIS; PRINCIPAL COMPONENT ANALYSIS; SPECTROSCOPY, NEAR-INFRARED; SUCROSE; WATER;

EID: 75749132791     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2009.06.016     Document Type: Article

References (21)

1. Nunes C., Suryanarayanan R., Botez C.E., and Stephens P.W. Characterization and crystal structure of d-mannitol hemihydrate. J. Pharm. Sci. 93 (2004) 2800-2809
2. Yu L., Milton N., Groleau E.G., Mishra D.S., and Vansickle R.E. Existence of a mannitol hydrate during freeze-drying and practical implications. J. Pharm. Sci. 88 (1999) 196-198
3. Beattie J.R., Barrett L.J., Malone J.F., McGarvey J.J., Nieuwenhuyzen M., and Kett V.L. Investigation into the subambient behavior of aqueous mannitol solutions using temperature-controlled Raman microscopy. Eur. J. Pharm. Biopharm. 67 (2007) 569-578
4. Liao X., Krishnamurthy R., and Suryanarayanan R. Influence of processing conditions on the physical state of mannitol-implications in freeze-drying. Pharm. Res. 24 (2007) 370-376
5. Derksen M.W.J., Van De Oetelaar P.J.M., and Maris F.A. The use of near-infrared spectroscopy in the efficient prediction of a specification for the residual moisture content of a freeze-dried product. J. Pharm. Biomed. Anal. 17 (1998) 473-480
6. Kamat M.S., Lodder R.A., and DeLuca P.P. Near-infrared spectroscopic determination of residual moisture in lyophilized sucrose through intact glass vials. Pharm. Res. 6 (1989) 961-965
7. Buckton G., Yonemochi E., Hammond J., and Moffat A. The use of near infra-red spectroscopy to detect changes in the form of amorphous and crystalline lactose. Int. J. Pharm. 168 (1998) 231-241
8. Dziki W., Bauer J.F., Szpylman J.J., Quick J.E., and Nichols B.C. The use of near-infrared spectroscopy to monitor the mobility of water within the sarafloxacin crystal lattice. J. Pharm. Biomed. Anal. 22 (2000) 829-848
9. Cao W., Mao C., Chen W., Lin H., Krishnan S., and Cauchon N. Differentiation and quantitative determination of surface and hydrate water in lyophilized mannitol using NIR spectroscopy. J. Pharm. Sci. 95 (2006) 2077-2086
10. Luukkonen P., Rantanen J., Makela K., Rasanen E., Tenhunen J., and Yliruusi J. Characterization of wet massing behavior of silicified microcrystalline cellulose and alpha-lactose monohydrate using near-infrared spectroscopy. Pharm. Dev. Technol. 6 (2001) 1-9
11. Zhou G.X., Ge Z., Dorwart J., Izzo B., Kukura J., Bicker G., and Wyvratt J. Determination and differentiation of surface and bound water in drug substances by near infrared spectroscopy. J. Pharm. Sci. 92 (2003) 1058-1065
12. Xie Y., Cao W., Krishnan S., Lin H., and Cauchon N. Characterization of mannitol polymorphic forms in lyophilized protein formulations using a multivariate curve resolution (MCR)-based Raman spectroscopic method. Pharm. Res. 25 (2008) 2292-2301
13. De Beer T.R.M., Alleso M., Goethals F., Coppens A., Heyden Y.V., De Diego H.L., Rantanen J., Verpoort F., Vervaet C., Remon J.P., and Baeyens W.R.G. Implementation of a process analytical technology system in a freeze-drying process using Raman spectroscopy for in-line process monitoring. Anal. Chem. 79 (2007) 7992-8003
14. Romero-Torres S., Wikstrom H., Grant E.R., and Taylor L.S. Monitoring of mannitol phase behavior during freeze-drying using non-invasive Raman spectroscopy. PDA J. Pharm. Sci. Technol. 61 (2007) 131-145
15. Bruells M., Folestad S., Sparen A., and Rasmuson A. In-situ near-infrared spectroscopy monitoring of the lyophilization process. Pharm. Res. 20 (2003) 494-499
16. Kim A.I., Akers M.J., and Nail S.L. The physical state of mannitol after freeze-drying: effects of mannitol concentration, freezing rate, and a noncrystallizing cosolute. J. Pharm. Sci. 87 (1998) 931-935
17. Haikala R., Eerola R., Tanninen V.P., and Yliruusi J. Polymorphic changes of mannitol during freeze-drying: effect of surface-active agents. PDA J. Pharm. Sci. Technol. 51 (1997) 96-101
18. Pyne A., Chatterjee K., and Suryanarayanan R. Solute crystallization in mannitol-glycine systems-implications on protein stabilization in freeze-dried formulations. J. Pharm. Sci. 92 (2003) 2272-2283
19. Telang C., Yu L., and Suryanarayanan R. Effective inhibition of mannitol crystallization in frozen solutions by sodium chloride. Pharm. Res. 20 (2003) 660-667
20. Yoshinari T., Forbes R.T., York P., and Kawashima Y. Crystallization of amorphous mannitol is retarded using boric acid. Int. J. Pharm. 258 (2003) 109-120
21. Barnes R.J., Dhanoa M.S., and Lister S.J. Standard normal variate transformation and de-trending of near-infrared diffuse reflectance spectra. Appl. Spectrosc. 43 (1989) 772-777