Content uniformity in granules for aceclofenac controlled release (CR) tablets determined using near-infrared spectroscopy and wide area illumination (WAI) raman spectroscopy

Archives of Pharmacal Research

Volumn 35, Issue 2, 2012, Pages 351-358

  Woo, Young Ah ^a  

^a Korea United Pharm Inc   (South Korea)

Author keywords

Aceclofenac CR tablet; Near infrared spectroscopy; PLS; Wide area illumination (WAI) Raman spectroscopy

Indexed keywords

ACECLOFENAC; DICLOFENAC; DRUG DERIVATIVE;

ARTICLE; CHEMOMETRICS; CONTROLLED RELEASE FORMULATION; DRUG GRANULE; DRUG MANUFACTURE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; ILLUMINATION; NEAR INFRARED SPECTROSCOPY; QUANTITATIVE ANALYSIS; RAMAN SPECTROMETRY; TABLET; WIDE AREA NETWORK; CHEMISTRY; DELAYED RELEASE FORMULATION; EVALUATION; INSTRUMENTATION; METHODOLOGY; QUALITY CONTROL;

DELAYED-ACTION PREPARATIONS; DICLOFENAC; QUALITY CONTROL; SPECTROSCOPY, NEAR-INFRARED; SPECTRUM ANALYSIS, RAMAN; TABLETS;

EID: 84862705772     PISSN: 02536269     EISSN: 19763786     Source Type: Journal    
DOI: 10.1007/s12272-012-0216-6     Document Type: Article

References (19)

1. Beebe, K. R. and Kowalski, B. R., An introduction to multivariate calibration and analysis. Anal. Chem., 59, 1007A-1015A (1987).
2. Beebe, K. R., Pell, P. J., and Seasholtz, M. B., Chemometrics: A Practical Guide. John Wiley and Sons, New York, (1998).
3. Burns, D. A. and Ciuczak, E. W., Handbook of Near-Infrared Analysis, 3rd Ed. CRC Press, New York, (2008).
4. De Beer, T. R. M., Baeyens, W. R. G., Ouyang, J., Vervaet, C., and Remon, J. P., Raman spectroscopy as a process analytical technology tool for the understanding and the quantitative in-line monitoring of the homogenization process of a pharmaceutical suspension. Analyst, 131, 1137-1144 (2006).
5. De Beer, T. R. M., Alleso, M., Goethals, F., Coppens, A., Vander Heyden, Y., 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 inline process monitoring. Anal. Chem., 79, 7992-8003 (2007).
6. Donoso, M. and Ghaly, E. S., Use of near-infrared for quantitative measurement of viscosity and concentration of active ingredient in pharmaceutical gel. Pharm. Dev. Technol., 11, 389-397 (2006).
7. El-Hagrasy, A. S., D'Amico, F., and Drennen, J. K., A process analytical technology approach to near-infrared pocess control of pharmaceutical powder blending, Part I: Doptimal design for characterization of powder mixing and preliminary spectral data evaluation. J. Pharm. Sci., 95, 392-406 (2006a).
8. El-Hagrasy, A. S., Delgado-Lopez, M., and Drennen, J. K., A process analytical technology approach to near-infrared process control of pharmaceutical powder blending, Part II: Qualitative near-infrared models for prediction of blend homogeneity. J. Pharm. Sci., 95, 407-421 (2006b).
9. El-Hagrasy, A. S. and Drennen, K., A process analytical technology approach to near-infrared process control of pharmaceutical powder blending, Part III: Quantitative near-infrared calibration for prediction of blend homogeneity and characterization of powder mixing kinetics. J. Pharm. Sci., 95, 422-434 (2006).
10. Kim, J., Noh, J., Chung, H., Woo, Y.-A., Kemper, M. S., and Lee, Y., Direct, non-destructive quantitative measurement of an active pharmaceutical ingredient in an intact capsule formulation using Raman spectroscopy. Anal. Chim. Acta, 598, 280-285 (2007).
11. Kim, M.-J, Chung, H., Woo, Y.-A., and Kemper, M. S., New reliable Raman collection system using the wide area illumination (WAI) scheme combined with the synchronous intensity correction standard for the analysis of pharmaceutical tablets. Anal. Chim. Acta, 579, 209-216 (2006).
12. Kim, M.-J, Chung, H., Woo, Y.-A., and Kemper, M. S., A new non-invasive, quantitative Raman technique for the determination of an active ingredient in pharmaceutical liquids by direct measurement through a plastic bottle. Anal. Chim. Acta, 587, 200-207 (2007).
13. Martens, H. and Naes, T. M., Multivariate Calibration. Wiley and Sons, New York, (1989).
14. McGoverin, C. M., Rades, T., and Gordon, K. C., Recent pharmaceutical applications of Raman and teraherz spectroscopies. J. Pharm. Sci., 97, 4598-4621 (2008).
15. Park, S. C., Kim, M., Noh, J., Chung, H., Woo, Y., Lee, J., and Kemper, M. S., Reliable and fast quantitative analysis of active ingredient in pharmaceutical suspension using Raman spectroscopy. Anal. Chim. Acta, 593, 46-53 (2007).
16. PAT Guidance for Industry: PAT-A framework for innovative pharmaceutical development, manufacturing and quality assurance. http://www.fda.gov (2004).
17. Process Analytical Technology (PAT) Initiative, Office of Pharmaceutical Science (OPS), http://www.fda.gov
18. Sasic, S., Pharmaceutical Applications of Raman Spectroscopy. John Wiley & Sons, New Jersey, (2007).
19. Walker, G. M., Bell, S. E. J., Greene, K., Jones, D. S., and Andrews, G. P., Characterization of fludized bed granulation processes using in-situ Raman spectroscopy. Chem. Eng. Sci., 64, 91-98 (2009).