Acoustic-resonance spectrometry as a process analytical technology for rapid and accurate tablet identification

AAPS PharmSciTech

Volumn 7, Issue 1, 2006, Pages

  Medendorp, Joseph ^a   Lodder, Robert A ^a  

^a Division of Pharmacy Practice and Science   (United States)

Author keywords

Chemometrics; Integrated sensing and processing (ISP); Pharmaceuticals; Process analytical technology (PAT); Sound

Indexed keywords

ACETYLSALICYLIC ACID; ASCORBIC ACID; CYANOCOBALAMIN; DRUG; IBUPROFEN; PARACETAMOL;

ACCURACY; ACOUSTIC RESONANCE SPECTROMETRY; ARTICLE; CALCULATION; CLASSIFICATION; CONTROLLED STUDY; COST CONTROL; DENSITY; DRUG DETERMINATION; DRUG IDENTIFICATION; DRUG LABELING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HIGH THROUGHPUT SCREENING; INFORMATION PROCESSING; MASS; NONPARAMETRIC TEST; ONLINE ANALYSIS; PROCESS TECHNOLOGY; SENSOR; SHIPPING; SPECTROMETRY; SYSTEMATIC ERROR; TABLET; THICKNESS; TIME; UNITED STATES; VALIDATION PROCESS; PHARMACEUTICS; SOUND; SPECTROSCOPY;

DRUG LABELING; SOUND; SPECTRUM ANALYSIS; TABLETS; TECHNOLOGY, PHARMACEUTICAL;

EID: 33645474351     PISSN: 15309932     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/pt070101     Document Type: Article

References (40)

1. US Food and Drug Administration. Magno-Humphries, Inc. voluntarily recalls one lot of Dixon's®, Acetaminophen 325 mg Analgesic, 100 Tablet bottles. Available at: http://www.fda.gov/oc/po/firmrecalls/ magno12_03.html. Accessed: April 1, 2005.
2. US Food and Drug Administration. Process Analytical Technology (PAT) Initiative. Available at: http://www.fda.gov/cder/OPS/PAT.htm. Accessed: April 1, 2005.
3. Lu Z, Hickey C, Sabatier J. Effects of compaction on the acoustic velocity in soils. Soil Sci Am J 2004;68:7-16.
4. Buice R, Pinkston P, Lodder R. Optimization of acoustic-resonance spectrometry for analysis of intact tablets and prediction of dissolution rate. Appl Spectrosc. 1994;48:517-524.
5. Medendorp J, Lodder RA. Integrated Sensing and Processing and a Novel Acoustic-Resonance Spectrometer. Baltimore, MD: American Association of Pharmaceutical Sciences; 2004.
6. Medendorp J, Lodder RA. Acoustic Resonance Spectrometry and Analysis of Powder Drying. Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy; March 7-12, 2004; Chicago, IL.
7. Medendorp J, Lodder RA. Applications of Integrated Sensing and Processing (ISP) in Acoustic and Optical Sceptroscopy. Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy; February 27-March 4, 2005; Orlando, FL.
8. Serris E, Camby-Perier L, Thomas G, Desfontaines M, Fantozzi G. Acoustic emission of pharmaceutical powders during compaction. Powder Technol. 2002;128:296-299.
9. Reynaud P, Dubois J, Rouby D, Fantozzi G. Acoustic emission monitoring of uniaxial pressing of ceramic powders. Ceramics Int. 1992;18:391-397.
10. Martin L, Poret J, Danon A, Rosen M. Effect of adsorbed water on the ultrasonic velocity in alumina powder compacts. Mater Sci Eng. 1998;252:27-35.
11. Kaatze U, Wehrmann B, Pottel R. Acoustical absorption spectroscopy of liquids between 0.15 and 3000 MHz, I: high resolution ultrasonic resonator method. J Phys E Sci Instrum. 1987;20:1025-1030.
12. Bolotnikov M, Neruchev Y. Speed of sound of hexane + 1-chlorohexane, hexane + 1-iodohexane, and 1-chlorohexane + 1-iodohexane at saturation condition. J Chem Eng Data. 2003;48:411-415.
13. Shah V, Tsong Y, Sathe P, Liu J. In vitro dissolution profile comparison-statistics and analysis of the similarity factor f2. Pharm Res. 1998;15:889-896.
14. Shah V, Williams R. Roles of dissolution testing: Regulatory, industry, and academic perspectives. Available at: http://www.dissolutiontech.com/ DTresour/899Art/Roles_Ptl.htm/. Accessed: March 15, 2005.
15. Drennen J, Lodder RA. Nondestructive near-infrared analysis of intact tablets for determination of degradation products. J Pharm Sci. 1990;79:622-627.
16. Zannikos P, Li W, Drennen J, Lodder R. Spectrophotometric prediction of the dissolution rate of carbamazepine tablets. Pharm Res. 1991;8:974-978.
17. Dousseau F, Pezolet M. On the spectral subtraction of water from the FTIR spectra of aqueous solutions of proteins. Appl Spectrosc. 1989;43:538-543.
18. Dousseau F, Pezolet M. Determination of the secondary structure content of proteins in aqueous solutions from their amide I and amide II infrared bands. Biochemistry. 1990;29:8771-8779.
19. Maddams W, Southon M. The measurement of derivative IR spectra, III: The effect of band width and band shape on resolution enhancement by derivative spectroscopy. Spectrochim Acta [A]. 1982;38:459-466.
20. Fleissner G, Hage W, Hallbrucker A, Mayer E. Improved curve resolution of highly overlapping bands by comparison of fourth-derivative curves. Appl Spectrosc. 1996;50:1235-1245.
21. Cassis LA, Dai B, Urbas A, Lodder RA. In vivo applications of a molecular computing-based high-throughput NIR spectrometer. Proc SPIE Int Soc Opt Eng. 2004;239:5329-5344.
22. Kirmse D, Westerberg A. Resolution enhancement of chromatograph peaks. Anal Chem. 1971;43:1035-1039.
23. Maldacker T, Davis J, Rogers L. Applications of Fourier transform techniques to steric-exclusion chromatography. Anal Chem. 1974;46: 637-642.
24. Buice RG, Jr, Lodder RA. Determination of cholesterol using a novel magnetohydrodynamic acoustic-resonance near-IR spectrometer. Appl Spectrosc. 1993;47:887-890.
25. Ultrasonic Scientific. High Resolution Ultrasonic Spectroscopy for Material Characterization. Available at: http://www.ultrasonic-scientific.com. Accessed: April 1, 2005.
26. Halliday D, Resnick R, Walker J. Fundamentals of Physics. New York, NY. Wiley; 2001.
27. Mills T, Jones A, Lodder R. Identification of wood species by acoustic-resonance spectrometry using multivariate subpopulation analysis. Appl Spectrosc. 1993;47:1880-1886.
28. Ono Y, Jen CK, Cheng CC, Kobayashi M. Real time monitoring of injection molding for microfluidic devices using ultrasound. Poly Eng Sci. 2005;45:606-612.
29. Kowalska B. Ultrasonic measurements in polymeric processing. Polimery. 2005;50:646-650.
30. Moisan JF, Jen CK, Liaw JW, et al. Ultrasonic sensor and technique for in-line monitoring of die casting process. Meas Sci Tech. 2001;12:1956-1963.
31. Kilian & Co Inc. Product showcase for pharmaceutical manufacturing, pharmaceutical process technology engineering. Available at: http://www.pharmaceuticalonline.com/Content/ProductShowcase/Product.asp? DocID={E21A91E3-9BB6-11D4-8C69-009027DE0829}&VNETCOOKIE=NO/. Accessed: November 25, 2005.
32. Lodder R. CD/MP3 acoustic resonance spectrometer. Available at: http://www.pharm.uky.edu/. Accessed: April 1, 2005.
33. Jolliffe IT. Principal Component Analysis. New York, NY: Springer; 2002.
34. Alves M, Oliveira M. Interpolative biplots applied to principal component analysis and canonical correlation analysis. J Chemometr. 2003;17:594-602.
35. Hamilton S, Lodder R. Hyperspectral imaging technology for pharmaceutical analysis. Proc Soc Photo-Optic Instrum Eng. 2002;4626:136-147.
36. Lowell A, Ho K-S, Lodder RA. Remote hyperspectral imaging of endolithic biofilms using a robotic probe. Contact Context. 2002;1:1-10.
37. Buice R, Lodder RA. Determination of Cholesterol Using a Novel Magnetohydrodynamic Acostic-Resonance Near-IR (MARNIR) Spectrometer. Appl Spectrosc. 1993;47:887-890.
38. Lai E, Chan B, Chen S. Ultrasonic resonance spectroscopic analysis of microliters of liquids. Appl Spectrosc. 1988;42:526-529.
39. Ritter T. Random noise sources. Available at: http://www.ciphersbyritter.com/NOISE/NOISRC.HTM/. Accessed: April 1, 2005.
40. Western Red Cedar Physical Properties. Available at: http://www.bearcreeklumber.com/generalinfo/onlineliterature/ technicalinfohtml/wrcphysicalproperties.html/.