Characterization of drug-cyclodextrin formulations using Raman mapping and multivariate curve resolution

Journal of Pharmaceutical and Biomedical Analysis

Volumn 56, Issue 1, 2011, Pages 38-44

  Vajna, Balázs ^a   Farkas, István ^a   Farkas, Attila ^a   Pataki, Hajnalka ^a   Nagy, Zsombor ^a   Madarász, János ^a   Marosi, György ^a  

^a BUDAPEST UNIVERSITY OF TECHNOLOGY AND ECONOMICS   (Hungary)

Author keywords

Chemometrics; Crystallinity; Cyclodextrin; Hyperspectral imaging; Micro Raman; Pharmaceutical

Indexed keywords

2 HYDROXYPROPYL BETA CYCLODEXTRIN; ALPHA CYCLODEXTRIN; BETA CYCLODEXTRIN; CYCLODEXTRIN; GAMMA CYCLODEXTRIN; HYDROXYPROPYL GAMMA CYCLODEXTRIN; RANDOMLY METHYLATED BETA CYCLODEXTRIN; UNCLASSIFIED DRUG;

ARTICLE; COMPLEX FORMATION; CRYSTALLIZATION; DRUG FORMULATION; DRUG SOLUBILITY; PRIORITY JOURNAL; RAMAN SPECTROMETRY; ROENTGEN SPECTROSCOPY; SCANNING ELECTRON MICROSCOPY; X RAY DIFFRACTION;

CHEMISTRY, PHARMACEUTICAL; CRYSTALLIZATION; CYCLODEXTRINS; EXCIPIENTS; LINEAR MODELS; MICROSCOPY, ELECTRON, SCANNING; MULTIVARIATE ANALYSIS; PHARMACEUTICAL PREPARATIONS; REPRODUCIBILITY OF RESULTS; SPECTROMETRY, X-RAY EMISSION; SPECTRUM ANALYSIS, RAMAN; X-RAY DIFFRACTION;

EID: 79958039805     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2011.05.005     Document Type: Article

References (31)

1. Yu L. Amorphous pharmaceutical solids: preparation, characterization and stabilization. Adv. Drug Deliv. Rev. 2001, 48:27-42.
2. Hancock B.C., Zografi G.J. Characteristics and significance of the amorphous state in pharmaceutical systems. J. Pharm. Sci. 1997, 86:1-12.
3. Zhang G.G.Z., Law D., Schmitt E.A., Qiu Y. Phase transformation considerations during process development and manufacture of solid oral dosage forms. Adv. Drug Deliv. Rev. 2004, 56:371-390.
4. Breitenbach J., Schrof W., Neumann J. Confocal Raman-spectroscopy: analytical approach to solid dispersions and mapping of drugs. Pharm. Res. 1999, 16:1109-1113.
5. Karavas E., Georgarakis M., Docoslis A., Bikiaris D. Combining SEM, TEM, and micro-Raman techniques to differentiate between the amorphous molecular level dispersions and nanodispersions of a poorly water-soluble drug within a polymer matrix. Int. J. Pharm. 2007, 340:76-83.
6. Nagy Zs.K., Nyúl K., Wágner I., Molnár K., Marosi Gy. Electrospun water soluble polymer mat for ultrafast release of Donepezil HCl. Express Polym. Lett. 2010, 4:763-772.
7. Uekama K., Hirayama F., Irie T. Cyclodextrin drug carrier systems. Chem. Rev. 1998, 98:2045-2076.
8. Patyi G., Bódis A., Antal I., Vajna B., Nagy Zs., Marosi G. Thermal and spectroscopic analysis of inclusion complex of spironolactone prepared by evaporation and hot melt methods. J. Therm. Anal. Calorim. 2010, 102:349-355.
9. Willart J.F., Descamps M. Solid state amorphization of pharmaceuticals. Mol. Pharm. 2008, 5:905-920.
10. Docoslis A., Huszarik K.L., Papageorgiou G.Z., Bikiaris D., Stergiou A., Georgarakis E. Characterization of the distribution, polymorphism, and stability of nimodipine in its solid dispersions in polyethylene glycol by micro-Raman spectroscopy and powder X-ray diffraction. AAPS J. 2007, 9:E361-E370.
11. Furuyama N, Hasegawa S., Hamaura T., Yada S., Nakagami H., Yonemochi E., Terada K. Evaluation of solid dispersions on a molecular level by the Raman mapping technique. Int. J. Pharm. 2008, 361:12-18.
12. Šašić S. A comparison of Raman chemical images produced by univariate and multivariate data processing - a simulation with an example from pharmaceutical practice. Analyst 2004, 129:1001-1007.
13. Zhang F., Aaltonen J., Tian F., Saville D.J., Rades T. Influence of particle size and preparation methods on the physical and chemical stability of amorphous simvastatin. Eur. J. Pharm. Biopharm. 2009, 71:64-70.
14. Stephenson G.A., Forbes R.A., Reutzel-Edens S.M. Characterization of the solid state: quantitative issues. Adv. Drug Deliv. Rev. 2001, 48:67-90.
15. Gowen A.A., O'Donnell C.P., Cullen P.J., Bell S.E.J. Recent applications of chemical imaging to pharmaceutical process monitoring and quality control. Eur. J. Pharm. Biopharm. 2008, 69:10-22.
16. Gendrin C., Roggo Y., Collet C. Pharmaceutical applications of vibrational chemical imaging and chemometrics: a review. J. Pharm. Biomed. Anal. 2008, 48:533-553.
17. Amigo J.M. Practical issues of hyperspectral imaging analysis of solid dosage forms. Anal. Bioanal. Chem. 2010, 398:93-109.
18. K.C. Gordon, C.M. McGoverin, Raman mapping of pharmaceuticals, Int. J. Pharm. doi:10.1016/j.ijpharm.2010.12.030.
19. Šašić S. An in-depth analysis of Raman and near-infrared chemical images of common pharmaceutical tablets. Appl. Spectrosc. 2007, 61:239-250.
20. Vajna B., Farkas I., Szabó A., Zsolt Z., Marosi G. Raman microscopic evaluation of technology dependent structural differences in tablets containing imipramine model drug. J. Pharm. Biomed. Anal. 2010, 51:30-38.
21. Heinz A., Savolainen M., Rades T., Strachan C.J. Quantifying ternary mixtures of different solid-state forms of indomethacin by Raman and near-infrared spectroscopy. Eur. J. Pharm. Sci. 2007, 32:182-192.
22. Rantanen J., Wikstroem H., Rhea F.E., Taylor L.S. Improved understanding of factors contributing to quantification of anhydrate/hydrate powder mixtures. Appl. Spectrosc. 2005, 59:942-951.
23. Widjaja E., Kanaujia P., Lau G., Ng W.K., Garland M., Saal C., Hanefeld A., Fischbach M., Maio M., Tan R.B.H. Detection of trace crystallinity in an amorphous system using Raman microscopy and chemometric analysis. Eur. J. Pharm. Sci. 2010, 42:45-54.
24. Duponchel L., Elmi-Rayaleh W., Ruckebusch C., Huvenne J.P. Multivariate curve resolution methods in imaging spectroscopy: influence of extraction methods and instrumental perturbations. J. Chem. Inf. Model. 2003, 43:2057-2067.
25. Gendrin C., Roggo Y., Collet C. Self-modelling curve resolution of near infrared imaging data. J. Near Infrared Spectrosc. 2008, 16:151-157.
26. B. Vajna, G. Patyi, Z. Nagy, A. Bódis, A. Farkas, G. Marosi, Comparison of chemometric methods in the analysis of pharmaceuticals with hyperspectral Raman imaging, J. Raman Spectrosc. (2011), doi:10.1002/jrs.2943.
27. Tauler R. Multivariate curve resolution applied to second order data. Chemom. Intell. Lab. Syst. 1995, 30:133-146.
28. Pitha J., Hoshino T. Effects of ethanol on formation of inclusion complexes of hydroxypropyl cyclodextrins with testosterone or with methyl orange. Int. J. Pharm. 1992, 80:243-251.
29. Pitha J., Hoshino T., Torres-Labandeira J., Irie T. Preparation of drug-hydroxypropyl cyclodextrin complexes by a method using ethanol or aqueous ammonium hydroxide as co-solubilizers Int. J. Pharm. 1992, 80:253-258.
30. Tauler R. Calculation of maximum and minimum band boundaries of feasible solutions for species profiles obtained by multivariate curve resolution. J. Chemometr. 2001, 15:627-646.
31. Rajkó R. Computation of the range (band boundaries) of feasible solutions and measure of the rotational ambiguity in self-modeling/multivariate curve resolution. Anal. Chim. Acta 2009, 645:18-24.