Comparison of near infrared and microwave resonance sensors for at-line moisture determination in powders and tablets

Analytica Chimica Acta

Volumn 696, Issue 1-2, 2011, Pages 84-93

  Corredor, Claudia C ^a   Bu, Dongsheng ^a   Both, Douglas ^a  

^a BRISTOL MYERS SQUIBB   (United States)

Author keywords

At line water determination; Microwave resonance technology (MRT); Near infrared (NIR); Powders; Process analytical technology (PAT); Tablets

Indexed keywords

MICROWAVE RESONANCE; NEAR INFRARED (NIR); PROCESS ANALYTICAL TECHNOLOGY (PAT); TABLETS; WATER DETERMINATION;

CALIBRATION; DRUG PRODUCTS; FORECASTING; INFRARED DEVICES; MATHEMATICAL MODELS; MICROWAVE SENSORS; MOISTURE DETERMINATION; POWDERS; PROCESS CONTROL; RESONANCE;

WATER CONTENT;

ACCURACY; ANALYTIC METHOD; ARTICLE; CALIBRATION; CONTROLLED STUDY; FEASIBILITY STUDY; KARL FISCHER INSTRUMENT; MATHEMATICAL PARAMETERS; MICROWAVE RESONANCE SENSOR; MOISTURE; NEAR INFRARED SPECTROSCOPY; POWDER; PRIORITY JOURNAL; QUALITY CONTROL; REFERENCE VALUE; TABLET; WATER CONTENT;

EQUIPMENT DESIGN; HUMIDITY; MICROWAVES; POWDERS; SENSITIVITY AND SPECIFICITY; SPECTROSCOPY, NEAR-INFRARED; TABLETS; WATER;

EID: 79957486220     PISSN: 00032670     EISSN: 18734324     Source Type: Journal    
DOI: 10.1016/j.aca.2011.03.048     Document Type: Article

References (42)

1. Airaksinen S., Karjalainen M., Shevchenko A., Westermarck S., Leppanen E., Rantanen J., Yliruusi J. Role of water in the physical stability of solid dosage formulations. J. Pharm. Sci. 2005, 94:2147-2165.
2. Adeyeye M.C. Drug-excipient interaction occurrences during solid dosage form development. Drugs Pharm. Sci. 2008, 178:357-436.
3. Ahlneck C., Zografi G. The molecular basis of moisture effects on the physical and chemical stability of drugs in the solid state. Int. J. Pharm. 1990, 62:87-95.
4. United States Pharmacopoeia USP 32-NF 27 on-line. General chapter <921> Water determination.
5. Bravo O.I., Ferrero R.C., Leon W.M.J., Jimenez-Castellanos B.M.R. Solid-water interaction. I. Study of water-pharmaceuticals interactions. Ciencia y Tecnologia Pharmaceutica 2004, 14:3-12.
6. Dalton C.R., Hancock B.C. Processing and storage effects on water vapor sorption by some model pharmaceutical solid dosage formulations. Int. J. Pharm. 1997, 156:143-151.
7. Emery E., Oliver J., Pugsley T., Sharma J., Zhou J. Flowability of moist pharmaceutical powders. Powder Technol. 2009, 189:409-415.
8. Grunke S. Main and side reactions in the Karl Fischer solution. Food Control 2001, 12:419-426.
9. Lam P., Nariman M. A robust, automated Karl Fischer titration system. Pharm. Technol. 2009, 33:52-60.
10. Portala F., Burkhard M., Geil N., Steinbach A. On-site water determination: at line system for Karl Fischer titration, CPP. Chemical Plants+Processing 2009, 2:76-78.
11. US food and drug administration September 2004 " Guidance for industry PAT-A framework for innovative pharmaceutical development, manufacturing, and quality assurance" .
12. International Conference on Harmonisation (ICH) Q8: Pharmaceutical Development (May 2006).
13. International Conference on Harmonisation (ICH) Q9: Quality Risk Management (November 2005).
14. International Conference on Harmonisation (ICH) Q10: Pharmaceutical Quality System (June 2008).
15. Maurer L., Leuenberger H. Applications of near infrared spectroscopy in the full-scale manufacturing of pharmaceutical solid dosage forms. Pharmazeutische Industrie 2009, 71:672-674. (676-678).
16. Luypaert J., Massart D.L., Vander Heyden Y. Near-infrared spectroscopy applications in pharmaceutical analysis. Talanta 2007, 72:865-883.
17. De Beer T.R.M., Vercruysse P., Burggraeve A., Quinten T., Ouyang J., Zhang X., Vervaet C., Remon J.P., Baeyens W.R.G. In-line and real-time process monitoring of a freeze drying process using Raman and NIR spectroscopy as complementary process analytical technology (PAT) tools. J. Pharm. Sci. 2009, 98:3430-3446.
18. Grohganz H., Fonteyne M., Skibsted E., Falck T., Palmqvist B., Rantanen J. Role of excipients in the quantification of water in lyophilized mixtures using NIR spectroscopy. J. Pharm. Biomed. Anal. 2009, 49:901-907.
19. Mantanus J., Ziemons E., Lebrun P., Rozet E., Klinkenberg R., Streel B., Evrard B., Hubert Ph. Moisture content determination of pharmaceutical pellets by near infrared spectroscopy: method development and validation. Anal. Chim. Acta 2009, 642:186-192.
20. Grohganz H., Gildemyn D., Skibsted E., Flink J.M., Rantanen J. Towards a robust water content determination of freeze-dried samples by near-infrared spectroscopy. Anal. Chim. Acta 2010, 676:34-40.
21. Roggo Y., Chalus P., Maurer L., Lema-Martinez C., Edmond A., Jent N. A review of near infrared spectroscopy and chemometrics in pharmaceutical technologies. J. Pharm. Biomed. Anal. 2007, 44:683-700.
22. Reich G. Near-infrared spectroscopy and imaging: basic principles and pharmaceutical applications. Adv. Drug Deliv. Rev. 2005, 57:1109-1143.
23. Nieuwmeyer F.J.S., Damen M., Gerich A., Rusmini F., Voort Maarschalk K., Vromans H. Granule characterization during fluid bed drying by development of a near infrared method to determine water content and median granule size. Pharm. Res. 2007, 24:1854-1861.
24. Buschmüller C., Wiedey W., Döscher C., Dressler J., Breitkreutz J. In-line monitoring of granule moisture in fluidized-bed dryers using microwave resonance technology. Eur. J. Pharm. Biopharm. 2008, 69:380-387.
25. Near-infrared spectrometry, Chapter 2.2.40, European Pharmacopoeia, 6th ed., 2010, pp. 60.
26. Near-infrared spectrophotometry, Chapter 1119, United States Pharmacopoeia USP26NF21, 2003, pp. 2388-2391.
27. Buschmueller C., Wiedey W., Doescher C., Plitzko M., Breitkreutz J. In-line monitoring of granule moisture and temperature throughout the entire fluidized-bed granulation process using microwave resonance technology: part I. Pharmazeutische Industrie 2009, 71:1403-1408.
28. Buschmueller C., Wiedey W., Doescher C., Plitzko M., Breitkreutz J. In-line monitoring of granule moisture and temperature throughout the entire fluidized-bed granulation process using microwave resonance technology: part II. Pharmazeutische Industrie 2009, 71:1614-1620.
29. Knoechel R., Taute W., Doescher C. Stray field ring resonators and a novel trough guide resonator for precise microwave moisture and density measurements. Meas. Sci. Technol. 2007, 18:1061-1068.
30. Trabelsi S., Kraszewski A.W., Nelson S.O. A microwave method for on-line determination of bulk density and moisture content of particulate materials. IEEE Trans. Instr. Meas. 1998, 47:127-132.
31. Trabelsi S., Nelson S.O. Free-space measurement of dielectric properties of cereal grain and oilseed at microwave frequencies. Meas. Sci. Technol. 2003, 14:589-600.
32. Trabelsi S., Nelson S.O., Lewis M. Microwave moisture sensor for grain and seed. Biol. Eng. 2008, 1:195-202.
33. C. Buschmueller, In-line monitoring of granule moisture in fluidized bed granulators using microwave resonance technology as novel PAT tool. Germany (2010), Ger. Dissertation 2010 (D0610-1).
34. Shi Z., Anderson C.A. Application of Monte Carlo simulation-based photon migration for enhanced understanding of near-infrared (NIR) diffuse reflectance. Part I: depth of penetration in pharmaceutical materials. J. Pharm. Sci. 2010, 2399-2412.
35. Saeed M., Probst L., Betz G. Assessment of diffuse transmission and reflection modes in near-infrared quantification. Part 2: diffuse reflection information depth. J. Pharm. Sci. 2011, 1130-1141.
36. Dreassi E., Ceramelli G., Corti P., Perruccio P.L., Lonardi S. Application of near-infrared reflectance spectrometry to the analytical control of pharmaceuticals: ranitidine hydrochloride tablet production. Analyst 1996, 121:219-222.
37. Compression Test Guide: basic information about AB compression tests of microwave moisture measurement systems, Sartorius Mechatronics, Arvada, CO, USA.
38. Olivieri A.C., Faber N.M., Ferré J., Boqué R., Kalivas J.H., Mark H. Uncertainty estimation and figures of merit for multivariate calibration. Pure Appl. Chem. 2006, 78:633-661.
39. Valderrama P., Braga J.W.B., Poppi R.J. Variable selection, outlier detection, and figures of merit estimation in a partial least-squares regression multivariate calibration model. A case study for the determination of quality parameters in the alcohol industry by near-infrared spectroscopy. J. Agric. Food Chem. 2007, 55:8331-8338.
40. Short S.M., Cogdill R.P., Anderson C.A. Determination of figures of merit for near-infrared and Raman spectrometry by net analyte signal analysis for a 4-component solid dosage system. AAPS PharmSci. Tech. 2007, 8:E96.
41. Zhou X., Hines P., Borer M.W. Moisture determination in hygroscopic drug substances by near infrared spectroscopy. J. Pharm. Biomed. Anal. 1998, 17:219-225.
42. Brülls M., Folestad S., Sparén A., Rasmuson A., Salomonsson J. Applying spectral peak area analysis in near-infrared spectroscopy moisture assays. J. Pharm. Biomed. Anal. 2007, 44:127-136.