Quantitative determination of amorphous cyclosporine in crystalline cyclosporine samples by fourier transform infrared spectroscopy

Journal of Pharmaceutical Sciences

Volumn 95, Issue 1, 2006, Pages 159-166

  Bertacche, Vittorio ^a   Pini, Elena ^a   Stradi, Riccardo ^a   Stratta, Fabio ^a  

^a UNIVERSITY OF MILAN   (Italy)

Author keywords

Amorphous; Chemometrics; Crystallinity; Cyclosporine; Infrared spectroscopy; Peptides; Solid state

Indexed keywords

CYCLOSPORIN; POTASSIUM BROMIDE;

ARTICLE; CHEMOMETRICS; CRYSTAL STRUCTURE; DRUG DETERMINATION; DRUG FORMULATION; INFRARED SPECTROSCOPY; MEASUREMENT ERROR; QUANTITATIVE ANALYSIS; REGRESSION ANALYSIS; SOLID STATE; SPECTRAL SENSITIVITY; VALIDITY; CHEMISTRY; CRYSTALLIZATION; DRUG STABILITY; METHODOLOGY;

CHEMISTRY, PHARMACEUTICAL; CRYSTALLIZATION; CYCLOSPORINE; DRUG STABILITY; LEAST-SQUARES ANALYSIS; SPECTROSCOPY, FOURIER TRANSFORM INFRARED;

EID: 33645224835     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.20523     Document Type: Article

References (19)

1. Hancock BC, Zografi G. 1997. Characteristic and significance of the amorphous state in pharmaceutical systems. J Pharm Sci 86:1-12.
2. Lai MC, Topp EM. 1999. Solid-state chemical stability of proteins and peptides. J Pharm Sci 88:489-500.
3. Professor R. Stradi personal communication.
4. Kahan BD. 1999. Cyclosporine: A revolution in transplantation. Transplant Proc 31:14S-15S.
5. Bach JF. 1999. The contribution of cyclosporine A to the understanding and treatment of autoimmune diseases. Transplant Proc 31:16S-18S.
6. Vachon MG, Grant DJW. 1987. Enthalpy-entropy compensation in pharmaceutical solids. Int J Pharm 40:1-14.
7. Kimura K, Hirayama F, Uekama K. 1999. Characterization of tolbutamide polymorphe (Burger's forms and IV) and polymorphyc transition behavior. J Pharm Sci 88:385-391.
8. Guinot S, Laveiller F. 1999. The use of MTDSC to assess the amorphous phase content of a micronised drug substance. Int J Pharm Sci 192:63-75.
9. Katon JE. 1994. Applications of vibrational microspectroscopy to chemistry. Vibrational Spectroscopy 7:201-229.
10. Miller CE. 2000. Chemometrics for on-line spectroscopy applications - Theory and practice. J Chemometrics 14:513-528.
11. Wold S. 1995. Chemometrics; what do we mean with it, and what do we want from it? Chemometrics and Intelligent Laboratory System 30:109-115.
12. Trygg J. 2004. Prediction and spectral profile estimation in multivariate calibration. J Chemometrics 18:166-172.
13. Wold S, Sjöström M, Eriksson L. 2001. PLS-regression: A basic tool of chemometrics. Chemometrics and Intelligent laboratory Systems 58:109-130.
14. Wold H. 1966. Nonlinear estimation by iterative least squares procedures. In: David F, editor. Research papers in statistics. New York: Wiley. pp 411-444.
15. Katz MH. 1999. Multivariate analysis: A practice guide for clinicians. New York: Cambridge University Press, pp 158-162.
16. Efron B, Gong G. 1983. A leisurely look at the bootstrap, the jack-knife, and cross-validation. Am Stat 37:36-48.
17. Brereton RG. 2003. Chemometrics: Data analysis for the laboratory and chemical plant. Chichester, UK: Wiley. 138p.
18. Honigs DE. 1985. Near infrared analysis. Anal Instrum 14:1-62.
19. Bai SJ, Rani M, Suryanarayanan R, Carpenter JF, Nayar R, Manning MC. 2004. Quantification of glycine crystallinity by near-infrared (NIR) spectroscopy. J Pharm Sci 93:2439-2446.