Foreign matter identification from solid dosage forms

Journal of Pharmaceutical and Biomedical Analysis

Volumn 80, Issue , 2013, Pages 116-125

  Pajander, Jari ^a   Haugshøj, Kenneth Brian ^b   Bjørneboe, Kathrine ^b   Wahlberg, Pia ^b   Rantanen, Jukka ^a  

^a UNIVERSITY OF COPENHAGEN   (Denmark)

^b DANISH TECHNOLOGICAL INSTITUTE   (Denmark)

Author keywords

Foreign matter; FTIR; Identification; SEM EDX; Solid dosage form; ToF SIMS

Indexed keywords

ARTICLE; CHEMICAL STRUCTURE; CONFORMATION; ENERGY DISPERSIVE X RAY MICROANALYSIS; FOREIGN BODY; MICROSCOPY; PRIORITY JOURNAL; SCANNING ELECTRON MICROSCOPY; SOLID; X RAY MICROANALYSIS;

EID: 84875820226     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2013.02.036     Document Type: Article

References (32)

1. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Pharmaceutical Development Q8(R2), Step 4, 2009, from (accessed 12.12.12). http://www.ich.org/.
2. Akseli I., Mani G.N., Cetinkaya C. Non-destructive acoustic defect detection in drug tablets. Int. J. Pharm. 2008, 360:65-76.
3. Varghese I., Cetinkaya C. Noncontact photo-acoustic defect detection in drug tablets. J. Pharm. Sci. 2007, 96:2125-2133.
4. Edge S., Belu A.M., Potter U.J., Steele D.F., Young P.M., Price R., Staniforth J.N. Chemical characterisation of sodium starch glycolate particles. Int. J. Pharm. 2002, 240:67-78.
5. Jain R.A., Brito L., Straub J.A., Tessier T., Bernstein H. Effect of powder processing on performance of fenofibrate formulation. Eur. J. Pharm. Biopharm. 2008, 69:727-734.
6. Tran H.T.T., Park J.B., Hong K.-H., Choi G.-G., Han H.-K., Lee J., Oh K.T., Lee B.-J. Preparation and characterization of pH-independent sustained release tablet containing solid dispersion granules of a poorly water-soluble drug. Int. J. Pharm. 2011, 415:83-88.
7. Ensslin S., Moll K.P., Paulus K., Mäder K. New insight into modified release pellets - internal structure and drug release mechanism. J. Controll. Rel. 2008, 128:149-156.
8. Liu F., Lizio R., Schneider U.J., Petereit H.-U., Blakey P., Basit A.W. SEM/EDX and confocal microscopy analysis of novel and conventional enteric-coated systems. Int. J. Pharm. 2009, 369:72-78.
9. ® formulation. Int. J. Pharm. 2009, 366:74-81.
10. Khan M.A., Sinha S., Vartak S., Bhartiya A., Kumar S. LC determination of glimepiride and its related impurities. J. Pharm. Biomed. Anal. 2005, 3:928-943.
11. Német Z., Demeter á., Pokol G. Quantifying low levels of polymorphic impurity in clopidogrel bisulphate by vibrational spectroscopy and chemometrics. J. Pharm. Biomed. Anal. 2009, 49:32-41.
12. Pasadakis N., Kardamakis A.A. Identifying constituents in commercial gasoline using Fourier transform-infrared spectroscopy and independent component analysis. Anal. Chim. Acta 2006, 578:250-255.
13. Himmelsbach D.S., Hellgeth J.W., McAlister D.D. Development and use of an attenuated total reflectance/Fourier transform infrared (ATR/FTIR) spectral database to identify foreign matter in cotton. J. Agric. Food. Chem. 2006, 54:7405-7412.
14. Cao X., Masatani P., Torraca G., Wen Z.Q. Identification of a mixed microparticle by combined microspectroscopic techniques: a real forensic case study in the biopharmaceutical industry. Appl. Spectrosc. 2010, 64:895-900.
15. Cao X., Wen Z.Q., Vance A., Torraca G. Raman microscopic applications in the biopharmaceutical industry: in situ identification of foreign particulates inside glass containers with aqueous formulated solution. Appl. Spectrosc. 2009, 63:830-834.
16. Sjövall P., Lausmaa J., Johansson B.-L., Andersson M. Surface chemical analysis of carbohydrate materials used for chromatography media by time-of-flight secondary ion mass spectrometry. Anal. Chem. 2004, 76:1857-1864.
17. Fisher G.L., Belu A.M., Mahoney C.M., Wormuth K., Sanada N. Three-dimensional time-of-flight secondary ion mass spectrometry imaging of a pharmaceutical in a coronary stent coating as a function of elution time. Anal. Chem. 2009, 81:9930-9940.
18. Zhou Q., Denman J.A., Gengenbach T., Das S., Qu L., Zhang H., Larson I., Stewart P.J., Morton D.A.V. Characterization of the surface properties of a model pharmaceutical fine powder modified with a pharmaceutical lubricant to improve flow via mechanical dry coating approach. J. Pharm. Sci. 2011, 100:3421-3430.
19. Richardin P., Mazer V., Walter P., Laprévote O., Brunelle A. Identification of different copper green pigments in renaissance paintings by cluster-TOF-SIMS imaging analysis. J. Am. Soc. Mass. Spectrom. 2011, 22:1729-1736.
20. Scoutaris N., Hook A.L., Gellert P.R., Roberts C.J., Alexander M.R., Scurr D.J. ToF-SIMS analysis of chemical heterogenities in inkjet micro-array printed drug/polymer formulations. J. Mater. Sci. Mater. Med. 2012, 23:385-391.
21. Belu A.M., Davies M.C., Newton J.M., Patel N. TOF-SIMS characterization and imaging of controlled-release drug delivery systems. Anal. Chem. 2000, 72:5625-5638.
22. Mains J., Wilson C., Urquhart A. ToF-SIMS analysis of ocular tissues reveals biochemical differentiation and drug distribution. Eur. J. Pharm. Biopharm. 2011, 79:328-333.
23. Meeus J., Chen X., Scurr D.J., Ciarnelli V., Amssoms K., Roberts C.J., Davies M.C., van den Mooter G. Nanoscale surface characterization and miscibility study of a spray-dried injectable polymeric matrix consisting of poly(lactic-co-glycolic acid) and polyvinylpyrrolidone. J. Pharm. Sci. 2012, 101:3473-3485.
24. Kulp K.S., Berman E.S.F., Knize M.G., Shattuck D.L., Nelson E.J., Wu L., Montgomery J.L., Felton J.S., Wu K.J. Chemical and biological differentiation of three human breast cancer cell types using time-of-flight secondary ion mass spectrometry. Anal. Chem. 2006, 78:3651-3658.
25. Socrates G. Infrared and Raman Characteristic Group Frequencies: Tables and Charts 2001, John Wiley & Sons Inc., Hoboken. 3rd ed.
26. Sylla C. Experimental investigation of human and machine-vision arrangements in inspection task. Control. Eng. Pract. 2002, 10:347-361.
27. Derganc J., Likar B., Bernard R., Tomaževič D., Pernuš F. Real-time automated visual inspection of color tablets in pharmaceutical blisters. Real-Time Imaging 2003, 9:113-124.
28. Lakio S., Hatara J., Tervakangas H., Sandler N. Determination of segregation tendency of granules using surface imaging. J. Pharm. Sci. 2012, 101:2229-2238.
29. Ketterhagen W.R. Modeling the motion and orientation of various pharmaceutical tablet shapes in a film coating pan using DEM. Int. J. Pharm. 2011, 409:137-149.
30. Carćia-Muñoz S., Carmody A. Multivariate wavelet texture analysis for pharmaceutical solid product characterization. Int. J. Pharm. 2010, 398:97-106.
31. Leskinen J.T.T., Simonaho S.-P., Hakulinen M., Ketolainen J. In-line ultrasound measurement system for detecting tablet integrity. Int. J. Pharm. 2010, 400:104-113.
32. May R.K., Evans M.J., Zhong S., Warr I., Gladden L.F., Shen Y., Zeitler J.A. Terahertz in-line sensor for direct coating thickness measurement of individual tablets during film coating in real-time. J. Pharm. Sci. 2010, 100:1535-1544.