Drug product characterization by macropixel analysis of chemical images

Journal of Pharmaceutical Sciences

Volumn 96, Issue 12, 2007, Pages 3390-3401

  Hamad, Mazen L ^a   Ellison, Christopher D ^a   Khan, Mansoor A ^a   Lyon, Robbe C ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Algorithms; Chemical imaging; Heterogeneity; Heterogeneous systems; Image analysis; Imaging methods; Macropixels; Multivariate analysis; Near infrared spectroscopy; NIR imaging

Indexed keywords

ALGORITHM; ARTICLE; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG RESEARCH; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; SPECTROSCOPY;

EID: 38149109809     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.20971     Document Type: Article

References (27)

1. Roggo Y, Edmond A, Chalus P, Ulmschneider M. 2005. Infrared hyperspectral imaging for qualitative analysis of pharmaceutical solid forms. Anal Chim Acta 535:79-87.
2. Clarke FC, Jamieson MJ, Clark DA, Hammond SV, Jee RD, Moffat AC. 2001. Chemical image fusion. The synergy of FT-NIR and Raman mapping microscopy to enable a more complete visualization of pharmaceutical formulations. Anal Chem 73:2213-2220.
3. Chan KL, Hammond SV, Kazarian SG. 2003. Applications of attenuated total reflection infrared spectroscopic imaging to pharmaceutical formulations. Anal Chem 75:2140-2146.
4. Woodward AM, Kaderbhai N, Kaderbhai M, Shaw A, Rowland J, Kell DB. 2001. Histometrics: Improvement of the dynamic range of fluorescently stained proteins resolved in electrophoretic gels using hyperspectral imaging. Proteomics 1:1351-1358.
5. Chalmers JM, Everall NJ, Schaeberle MD, Levin IW, Lewis EN, Kidder LH, Wilson J, Crocombe R. 2002. FT-IR imaging of polymers: An industrial appraisal. Vib Spectrosc 30:43-52.
6. Mehl PM, Chen YR, Kim MS, Chan DE. 2004. Development of hyperspectral imaging technique for the detection of apple surface defects and contaminations. J Food Eng 61:67-81.
7. Mumby PJ, Chisholm JRM, Clark CD, Hedley JD, Jaubert J. 2001. Spectrographic imaging: A bird's-eye view of the health of coral reefs. Nature 413:36.
8. Cassis LA, Lodder RA. 1993. Near-IR imaging of atheromas in living arterial tissue. Anal Chem 65: 1247-1256.
9. Potter K, Kidder LH, Levin IW, Lewis EN, Spencer RGS. 2001. Imaging of collagen and proteoglycan in cartilage sections using Fourier transform infrared spectral imaging. Arthritis Rheum 44:846-855.
10. Candolfi A, De Maesschalck R, Massart DL, Hailey PA, Harrington ACE. 1999. Identification of pharmaceutical excipients using NIR spectroscopy and SIMCA. J Pharm Biomed Anal 19:923-935.
11. Kemper MS, Magnuson EJ, Lowry SR, McCarthy WJ, Aksornkoae N, Watts DC, Johnson JR, Shukla AJ. 2001. Use of FT-NIR transmission spectroscopy for the quantitative analysis of an active ingredient in a translucent pharmaceutical topical gel formulation. AAPS PharmSci 3.
12. Koehler FW IV, Lee E, Kidder LH, Lewis EN. 2002. Near infrared spectroscopy: The practical chemical imaging solution. Spectrosc Eur 14.
13. U.S. Food and Drug Administration. September, 2004. Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance.
14. Lyon RC, Jefferson EH, Ellison CD, Buhse LF, Spencer JA, Nasr MM, Hussain AS. 2003. Exploring pharmaceutical applications of near-infrared technology. Am Pharm Rev 6:62-70.
15. El-Hagrasy AS, Morris HR, D'Amico F, Lodder RA, Drennen JK III. 2001. Near-infrared spectroscopy and imaging for the monitoring of powder blend homogeneity. J Pharm Sci 90:1298-1307.
16. Reich G. 2005. Near-infrared spectroscopy and imaging: Basic principles and pharmaceutical applications. Adv Drug Deliv Rev 57:1109-1143.
17. Roggo Y, Jent N, Edmond A, Chalus P, Ulmschneider M. 2005. Characterizing process effects on pharmaceutical solid forms using near-infrared spectroscopy and infrared imaging. Eur J Pharm Biopharm 61:100-110.
18. Lyon RC, Lester DS, Lewis EN, Lee E, Yu LX, Jefferson EH, Hussain AS. 2002. Near-infrared spectral imaging for quality assurance of pharmaceutical products: Analysis of tablets to assess powder blend homogeneity. AAPS PharmSciTech 3:E17.
19. Lee E, Huang WX, Chen P, Lewis EN, Vivilecchia RV. 2006. High-throughput analysis of pharmaceutical tablet content uniformity by near-infrared chemical imaging. Spectroscopy 21:24-32.
20. Westenberger BJ, Ellison CD, Fussner AS, Jenney S, Kolinski RE, Lipe TG, Lyon RC, Moore TW, Revelle LK, Smith AP. 2005. Quality assessment of internet pharmaceutical products using traditional and non-traditional analytical techniques. Int J Pharm 306:56-70.
21. Gianinetto M, Lechi G. 2004. The development of superspectral approaches for the improvement of land cover classification. IEEE Trans Geosci Remote Sens 42:2670-2679.
22. Vogt F. 2006. Trends in remote spectroscopic sensing and imaging - Experimental techniques and chemometric concepts. Curr Anal Chem 2:107-127.
23. Cassis LA, Urbas A, Lodder RA. 2005. Hyperspectral integrated computational imaging. Anal Bioanal Chem 382:868-872.
24. Savitzky A, Golay MJE. 1964. Smoothing and differentiation of data by simplified least squares procedures. Anal Chem 36:1627-1639.
25. Aksu O, Bozdogan A, Kunt G. 2006. Simultaneous determination of mepyramine maleate, lidocaine hydrochloride, and dexpanthenol in pharmaceutical preparations by partial least-squares multivariate calibration. Anal Lett 39: 751-761.
26. U.S. Food and Drug Administration. October 2003. Guidance for Industry: Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment.
27. Wikstrom H, Lewis IR, Taylor LS. 2005. Comparison of sampling techniques for in-line monitoring using Raman spectroscopy. Appl Spectrosc 59:934-941.