In situ moisture determination of a cytotoxic compound during process optimization

Journal of Pharmaceutical Sciences

Volumn 92, Issue 3, 2003, Pages 529-535

  Hicks, Michael B ^a   Zhou, George X ^a   Lieberman, David R ^b   Antonucci, Vincent ^a   Ge, Zhihong ^a   Shi, Yao Jun ^a   Cameron, Mark ^a   Lynch, Joseph E ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b Merck Sharp & Dohme Limited   (United Kingdom)

Author keywords

Cytotoxic compound; Karl Fischer titration; Near infrared spectroscopy; Process optimization

Indexed keywords

DOXORUBICIN;

ABSORPTION; ARTICLE; CALIBRATION; CYTOTOXICITY; DRUG FORMULATION; MEASUREMENT; MOISTURE; NEAR INFRARED SPECTROSCOPY; REPRODUCIBILITY; SIGNAL TRANSDUCTION; SOLID STATE; TITRIMETRY; VOLUMETRY;

EID: 0037370185     PISSN: 00223549     EISSN: None     Source Type: Journal    
DOI: 10.1002/jps.10318     Document Type: Article

References (26)

1. Martin KA. 1992. Recent advances in NIRS. Appl Spectrosc Rev 27:325-382.
2. Kirsh JD, Drennen J. 1995. NIRS applications in the analysis of tablets and solid pharmaceutical dosage forms. Appl Spectrosc Rev 30(3):139-174.
3. Morisseau KM, Rhodes CT. 1995. Pharmaceutical user of NIRS. Drug Dev Ind Pharm 21(9):1071-1090.
4. Norris T, Aldridge PK. 1996. End-point determination on-line and reaction co-ordinate modeling of homogeneous and heterogeneous reactions in principal component space using periodic near-infrared monitoring. Analyst 121:1003-1008.
5. Macaloney G, Hall JW, Rollins MJ, Draper I, Anderson KB, Preston J, Thompson BG, McNeil B. 1997. The utility and performance of near-infrared spectroscopy in simultaneous monitoring of multiple components in a high cell density recombinant Escherichia coli production process. Bioprocess Eng 17:157-167.
6. Rhiel M, Riley MR, Arnold MA, Murhammer DW. 1997. Evaluation of near-infrared spectroscopy for bioreactor monitoring. Am Chem Soc 213 meeting abstract BIOT171.
7. Ge Z, Buchanan B, Timmermans J, DeTora D, Ellison D, Wyvratt J. 1999. On-line monitoring of the distillates of a solvent switch process by near-infrared spectroscopy. Proc Control Quality 11(4):277-287.
8. Threlfall TL. 1995. Analysis of organic polymorphs: A review - Infrared spectroscopy. Analyst 120:2440-2444.
9. Norris T, Aldridge PK, Sekulic SS. 1997. Determination of end-points for polymorph conversions of crystalline organic compounds using online near-infrared spectroscopy. Analyst 122:549-552.
10. Dunuwila D, Berglund K. 1997. Identification of infrared spectral features related to solution structure for utilization in solubility and supersaturation measurements. Org Process Res Dev 1:350-364.
11. Skrdla PJ, Antonucci V, Crocker LS, Wenslow RM, Wright L, Zhou G. 2001. A simple quantitative FT-IR approach for the study of a polymorphic transformation under crystallization slurry conditions. J Pharm Biomed 25:731-739.
12. Beebe KH, Kowalski BR. 1987. An introduction to multivariate calibration and analysis. Anal Chem 59:1007A-1017A.
13. Cuesta Sanchez F, Toft J, van den Bogaert B, Massart DL. 1996. Orthogonal projection approach applied to peak purity assessment. Anal Chem 35:2771-2778.
14. Zhou X, Hines P, Borer MW. 1998. Moisture determination in hygroscopic drug substances by near infrared spectroscopy. J Pharm Biomed 17:219-225.
15. Zhou X, Hines PA, White KC, Borer MW. 1998. Gas chromatography as a reference method for moisture determination by near-infrared spectroscopy. Anal Chem 70:390-394.
16. Rantanen J. 2000. In-line moisture measurement during granulation with a four-wavelength near infrared sensor: An evaluation of particle size and binder effects. Eur J Pharm Biopharm 50:271-276.
17. Chen Z, Yang T, Wu W, Agarwal P. 1999. Continuous drying and dehydration of sodium monohydrate in a fluidized bed. Powder Technol 103:274-285.
18. Rantanen J, Lehtola S, Ramet P, Mannermaa JP, Yliruusi J. 1998. On-line monitoring of moisture content in an instrumented fluidized bed granulator with a multi-channel NIR moisture sensor. Powder Technol 99:163-170.
19. Suehara K-I, Ohta Y, Nakano Y, Yano T. 1999. Rapid measurement and control of the moisture content of compost using near-infrared spectroscopy. J Biosci Bioeng 87(6):769-774.
20. Gangwer MK. 2002. In-process coulometric Karl Fischer assay of moisture in a potent and hygroscopic active pharmaceutical ingredient. Am Pharm Rev 5(2):55-61.
21. DeFeo-Jones D, Garsky VM, Wong BK, Feng DM, Bolyar T, Haskell K, Kiefer DM, Leander K, McAvoy E, Lumma P, Wai J, Senderak ET, Motzel SL, Keenan K, Van Zwieten M, Lin JH, Freidinger R, Huff J, Oliff A, Jones RE. 2000. A peptide-doxorubicin 'prodrug' activated by prostate-specific antigen selectively kills prostate tumor cells positive for prostate-specific antigen in vivo. Nat Med 6:1248-1252.
22. Wong BK, DeFeo-Jones D, Jones RE, Garsky VM, Feng DF, Oliff A, Chiba M, Ellis JD, Lin JH. 2000. PSA-specific and non-PSA-specific conversion of a PSA-targeted peptide conjugate of doxorubicin to its active metabolites. Drug Metab Dispos 29:313-318.
23. Naumann BD, Sargent EV, Starkman BS, Fraser WJ, Becker GT, Kirk GD. 1996. Performance-based exposure control limits for pharmaceutical active ingredients. Am Ind Hyg Assoc J 37:33-42.
24. Scholz E. 1985. Karl Fischer titrations of aldehydes and ketones. Anal Chem 57(14):2965-2971.
25. PLSplus/IQ user guide, appendix B. 1991. Salem, New Hampshire: Galactic Industries Corporation.
26. Geladi P, Kowalski BR. 1986. Partial least-squares regression: A tutorial. Anal Chim Acta 185:1-17.