Pellet coating thickness determination by near-infrared reflectance spectroscopy: Comparison of two reference methods

Current Pharmaceutical Analysis

Volumn 6, Issue 4, 2010, Pages 225-233

  Muselík, Jan ^a   Dvořáčková, Kateřina ^a   Krejčová, Kateřina ^b   Rabišková, Miloslava ^a   Pazourek, Jiří ^a   Marton, Sylvia ^a   Dračková, Michaela ^a   Vorlová, Lenka ^a  

^a UNIVERSITY OF VETERINARY AND PHARMACEUTICAL SCIENCES   (Czech Republic)

^b Ricesteele Manufacturing Ltd   (Ireland)

Author keywords

Coating thickness; Near infrared spectroscopy; Pellet coating; Pharmaceutical applications

Indexed keywords

DILTIAZEM; ETHYL CELLULOSE; EUDRAGIT; POLYMER; POVIDONE;

ARTICLE; CALIBRATION; CONTROLLED STUDY; DISSOLUTION; DRUG COATING; DRUG INDUSTRY; ERROR; FEASIBILITY STUDY; FILM; INFRARED SPECTROSCOPY; MICROANALYSIS; NEAR INFRARED REFLECTANCE SPECTROSCOPY; PARTIAL LEAST SQUARES REGRESSION; PELLET EXTRUSION; PRIORITY JOURNAL; QUALITY CONTROL; QUANTITATIVE ANALYSIS; WEIGHT GAIN;

EID: 79952743372     PISSN: 15734129     EISSN: None     Source Type: Journal    
DOI: 10.2174/157341210793292419     Document Type: Article

References (65)

1. Debunne, A.; Vervaet, Ch.; Mangelings, D.; Remona, J.-P. Com paction of enteric-coated pellets: influence of formulation and process parameters on tablet properties and in vivo evaluation. Eur. J. Pharm. Sci., 2004, 22(4), 305-314.
2. Luo, Y.; Zhu, J.; Ma, Y.; Zhang, H. Dry coating, a novel coating technology for solid pharmaceutical dosage forms. Int. J. Pharm., 2008, 358(1-2), 16-22.
3. Maurer, L.; Leuenberger, H. Terahertz pulsed imaging and near infrared imaging to monitor the coating process of pharmaceutical tablets. Int. J. Pharm., 2009, 370(1-2), 8-16.
4. Ho, L.; Cuppok, Y.; Muschert, S.; Gordon, K.C.; Pepper, M.; Shen, Y.; Siepmann, F.; Siepmann, J.; Taday, P.F.; Rades, T. Effects of film coating thickness and drug layer uniformity on in vitro drug release from sustained-release coated pellets: A case study using terahertz pulsed imaging. Int. J. Pharm., 2009, 382(1-2), 151-159.
5. Haddish-Berhane, N.; Jeong, S.H.; Haghighi, K.; Park K. Modeling film-coat non-uniformity in polymer coated pellets: A stochastic approach. Int. J. Pharm., 2006, 323(1-2), 64-71.
6. Lee, M.J.; Park, C.R.; Kim, A.Y.; Kwon, B.S.; Bang, K.H.; Cho, Y.S.; Jeong, M.Y.; Choi, G.J. Dynamic calibration for the in-line NIR monitoring of film thickness of pharmaceutical tablets processed in a fluid-bed coater. J. Pharm. Sci., 2010, 99(1), 325-335.
7. Hellen, L.; Yliruusi, J.; Kristoffersson, E. Process variables of instant granulator and spheroniser. Part 2. Size and size distributions of pellets. Int. J. Pharm., 1993, 96(1-3), 205-216.
8. Lindner, H.; Kleinebudde, P. Characterization of pellets by means of automatic image analysis. Pharm. Ind., 1993, 55(7), 694-701.
9. Podczeck, F.; Rahman, S.R.; Newton, J.M. Evaluation of a stan- dardized procedure to assess the shape of pellets using image analysis. Int. J. Pharm., 1999, 192(2), 123-138.
10. Larsen, C.C.; Sonnergaardb, J.M.; Bertelsen, P.; Holm, P. Validation of an image analysis method for estimating coating thickness on pellets. Eur. J. Pharm. Sci., 2003, 18(2), 191-196.
11. Pérez-Ramos, J.; Findlay, W.P.; Peck, G.; Morris, K.R. Quantitati ve analysis of film coating in a pan coater based on in-line sensor measurements. AAPS Pharm. Sci. Tech., 2005, 6(1), E:20.
12. Sovány, T.; Nikowitz, K.; Regdon, G.; Kása, P.; Pintye-Hódi, K. Raman Spectroscopic investigation of film thickness. Polym. Test., 2009, 28(7), 770-772.
13. Muraoka, M.; Hu, Z.; Shimokawa, T.; Sekino, S.; Kurogoshi, R.; Kuboi, Z.; Yoshikawa, Z., Takada, K. Evaluation of intestinal pressure-controlled colon delivery capsule containing caffeine as a model drug in human volunteers. J. Control. Release, 1998, 52(1-2), 119-129.
14. Akseli, I.; Cetinkaya, C. Drug tablet thickness estimations using air-coupled acoustics. Int. J. Pharm., 2008, 351(1-2), 165-173.
15. Mauritz, J.M.A.; Morrisby, R.S.; Hutton, R.S.; Legge, C.H.; Ka-minski, C.F. Imaging pharmaceutical tablets with optical coherence tomography. Int. J. Pharm., 2010, 99(1), 385-391.
16. Mowery, M.D.; Sing, R.; Kirsch, J.; Razaghi, A.; Bechard, S.; Reed, R.A. Rapid at-line analysis of coating thickness and uniformity on tablets using laser induced breakdown spectroscopy. J. Pharm. Biomed. Anal., 2002, 28(5), 935-943.
17. Ho, L.; Cuppok, Y.; Muschert, S.; Gordon, K.C.; Pepper, M.; Shen, Y.C.; Siepmann, F.; Siepmann, J.; Taday, P.F.; Rades, T. Effects of film coating thickness and drug layer uniformity on in vitro drug release from ustained-release coated pellets: A case study using terahertz pulsed paging. Int. J. Pharm., 2009, 382(1-2), 151-159.
18. Yamada, H.; Terada, K.; Suryanarayanan, R. Non-destructive determination of the coating film thickness by X-ray powder diffrac-tometry and correlation with the dissolution behavior of film-coated tablets. J. Pharm. Biomed. Anal., 2010, 51(4), 952-957.
19. Luypaert, J.; Massart, D.L.; Heyden Y.V. Near-infrared spectros-copy applications in pharmaceutical analysis. Talanta, 2007, 72(3), 865-883.
20. Azzouz, T.; Tauler, R. Application of multivariate curve resolution alternating least squares (MCR-ALS) to the quantitative analysis of pharmaceutical and agricultural samples. Talanta, 2008, 74(5), 1201-1210.
21. Ali, H.R.H.; Edwards, H.G.M.; Scowen, I.J. Noninvasive in situ identification and band assignments of some pharmaceutical ex-cipients inside USP vials with FT-near-infrared spectroscopy. Spectrochim. Acta Pt. A-Mol. Bio., 2009, 72(4), 890-896.
22. Li, Y.Z.; Min, S.G.; Xia, L. Study on the methods and applications of near-infrared spectroscopy chemical pattern recognition. Spectrosc. Spect. Anal., 2007, 27(7), 1299-1303.
23. Zalewska, M.; Dlugosz, M.; Olszanowski, A. Identification and quantification of L-ascorbic acid in intact tablets of pharmaceutical preparation by near-infrared (NIR) spectroscopy. Chem. Anal., 2006,51(3), 419-426.
24. Cui, X.J.; Zhang, Z.Y.; Ren, W.L.; Liu, S.D.; Harrington, P.D. Quality control of the powder pharmaceutical samples of sulfagua-nidine by using NIR reflectance spectrometry and temperature-constrained cascade correlation networks. Talanta, 2004, 64(4), 943-948.
25. Blanco, M.; Romero, M.A. Near-infrared libraries in the pharmaceutical industry: a solution for identity confirmation. Analyst, 2001, 126(12), 2212-2217.
26. Lopes, M.B.; Wolff, J.C. Investigation into classification/sourcing of suspect counterfeit Heptodin (TM) tablets by near infrared chemical imaging. Anal. Chim. Acta, 2009, 633(1), 149-155.
27. Moffat, A.C.; Assi, S.; Watt, R.A. Identifying counterfeit medicines using near infrared spectroscopy. J. Near Infrared Spectrosc., 2010, 18(1), 1-15.
28. Dowell, F.E.; Maghirang, E.B.; Fernandez, F.M.; Newton, P.N.; Green, M.D. Detecting counterfeit antimalarial tablets by near-infrared spectroscopy. J. Pharm. Biomed. Anal., 2008, 48(3), 1011-1014.
29. Zhang, H.; Jiang, Z.D.; Pi, J.Y.; Xu, H.K.; Du, R. On-line monitoring of pharmaceutical production processes using hidden markov model. J. Pharm. Sci., 2009, 98(4), 1487-1498.
30. Ma, H.; Anderson, C.A. Characterization of pharmaceutical powder blends by NIR chemical imaging. J. Pharm. Sci., 2009, 97(8), 3305-3320.
31. Shi, Z.Q.; Cogdill, R.P.; Short, S.M.; Anderson, C.A.; Process characterization of powder blending by near-infrared spectroscopy: Blend end-points and beyond. J. Pharmaceut. Biomed. Anal., 2008, 47(4-5), 738-745.
32. Alcala, M.; Blanco, M.; Bautista, M.; Gonzalez, J.M. On-line monitoring of a granulation process by NIR spectroscopy. J. Pharm. Sci., 2010, 99(1), 336-345.
33. Mantanus, J.; Ziemons, E.; Lebrun, P.; Rozet, E.; Klinkenberg, R.; Streel, B.; Evrard, B.; Hubert, P. Moisture content determination of pharmaceutical pellets by near infrared spectroscopy: Method development and validation. Anal. Chim. Acta, 2009, 642(1-2), 186-192.
34. Li, W.Y.; Bagnol, L.; Berman, M.; Chiarella, R.A.; Gerber, M. Applications of NIR in early stage formulation development. Part II. Content uniformity evaluation of low dose tablets by principal component analysis. Int. J. Pharm., 2009, 380(1-2), 49-54.
35. Xiang, D.; Konigsberger, M.; Wabuyele, B.; Hornung, K.; Cheney, J. Development of robust quantitative methods by near-infrared spectroscopy for rapid pharmaceutical determination of content uniformity in complex tablet matrix. Analyst, 2009, 134(7), 1405-1415.
36. Blanco, M.; Alcala, M.; Gonzalez, J.M.; Torras E. Near infrared spectroscopy in the study of polymorphic transformations. Anal. Chim. Acta, 2006, 567(2), 262-268.
37. McGoverin, C.M.; Ho, L.C.H.; Zeitler, J.A.; Strachan, C.J.; Gordon, K.C.; Rades, T. Quantification of binary polymorphic mixtures of ranitidine hydrochloride using NIR spectroscopy. Vib. Spectrosc., 2006, 41(2), 225-231.
38. Shah, R.B.; Tawakkul, M.A.; Khan, M.A. Process analytical technology: Chemometric analysis of Raman and near infra-red spec-troscopic data for predicting physical properties of extended release matrix tablets. J. Pharm. Sci., 2007, 96(5), 1356-1365.
39. Otsuka, M.; Tanabe, H.; Osaki, K.; Otsuka, K.; Ozaki, Y. Chemoinformetrical evaluation of dissolution property of indo-methacin tablets by near-infrared spectroscopy. J. Pharm. Sci., 2007,96(4), 788-801.
40. Blanco, M.; Alcala, M.; Gonzalez, J.M.; Torrasz, E. A process analytical technology approach based on near infrared spectros-copy: Tablet hardness, content uniformity, and dissolution test measurements of intact tablets. J. Pharm. Sci., 2006, 95(10), 2137-2144.
41. Li, W.Y.; Woldu, A.; Kelly, R.; Mcool, J.; Bruce, R.; Rasmussen, H.; Cunningham, J.; Winstead, D. Measurement of drug agglomerates in powder blending simulation samples by near infrared chemical imaging. Int. J. Pharm., 2008, 350(1-2), 369-373.
42. Read, E.K.; Shah, R.B.; Riley, B.S.; Park, J.T.; Brorson, K.A.; Rathore, A.S. Process analytical technology (PAT) for biopharma-ceutical products: Part II. Concepts and applications. Biotechnol. Bioeng., 2010, 105(2), 285-295.
43. Blanco, M.; Cueva-Mestanza, R.; Peguero, A. Controlling individual steps in the production process of paracetamol tablets by use of NIR spectroscopy. J. Pharm. Biomed. Anal, 2010, 51(4), 797-804.
44. Richmond, E.W.; Buchanan, B.R.; Baxter, M.A.; Duff, A.; Tully, O.M.; Thornton, S.A. Method and system for determining the homogeneity of tablets. U.S. Patent 5,504,332, April 02, 1996.
45. Qiao, Y.M. Method for degree of homogeneity for different matter. C.N. Patent 1,967,213, May 23, 2007.
46. Gehrlein, L.; Ciurczak, E.; Ritchie, G.; Bynum, K.C. Method and apparatus for determining the homogeneity of a granulation during tableting. W.O. Patent 03,087,740, October 23, 2003.
47. Polli, J.E.; Hoag, S.W. Drug authentication. W.O. Patent 2005,031,302, April 07, 2005.
48. Kirsch, J.D.; Drennen, J.K. Near-infrared spectroscopic monitoring of the film coating process. Pharm. Res., 1996, 13(2), 234-237.
49. Soon, M.H.; Faulkner, P.G. Determination of SE 216469-S during tablet production using near-infrared reflectance spectroscopy. J. Pharm. Biomed. Anal, 1996, 14(12), 1681-1689.
50. Andersson, M.; Josefson, M.; Langkilde, F.W.; Wahlund, K.G. Monitoring of a film coating process for tablets using near infrared reflectance spectrometry. J. Pharm. Biomed. Anal, 1999, 20(1-2), 27-37.
51. Muselík, J.; Krejcová, K.; Rabisková, M.; Bartosíková, A.; Dracková,M.; Vorlová, L. Determination of the thickness of tablet coating by near-infrared spectroscopy. Chem. Li sty, 2010, 104(1), 41-45.
52. Tabasi, S.H.; Fahmy, R.; Bensley, D.; O'Brien, C; Hoag, S.W. Quality by design, part II: Application of NIR spectroscopy to monitor the coating process for a pharmaceutical sustained release product. J. Pharm. Sci., 2008, 97(9), 4052-4066.
53. Kirsch, J.D.; Drennen, J.K. Determination of film-coated tablet parameters by near-infrared spectroscopy. J. Pharm. Biomed. Anal, 1995, 13(10), 1273-1281.
54. Moes, J.J.; Ruijken, M.M.; Gout, E.; Frijlink, H.W.; Ugwoke, M.I. Application of process analytical technology in tablet process development using NIR spectroscopy: Blend uniformity, content uni-formity and coating thickness measurement. Int. J. Pharm., 2008, 357(1-2), 108-118.
55. Römer, M.; Heinämäki, J.; Strachan, C; Sandler, N.; Yliruusi, J. Prediction of tablet film-coating thickness using a rotating plate coating system and NIR spectroscopy. AAPS Pharm. Sci. Tech., 2008, 9(4), 1047-1053.
56. Maurer, F. Drum coater having an NIR measuring unit. W.O. Patent 2009,150,166, December 17, 2009.
57. Muselík, J.; Dvofácková, K.; Rabisková, M.; Bartosíková, A.; Rosendorfová, M.; Dracková, M.; Vorlová, L. Determination of the coating thickness of HPMC hard capsules by near-infrared reflectance spectroscopy. Ces. Slov. Farm., 2009, 58(4), 155-159.
58. Andersson, J.; Folestad, S.; Gottfries, J.; Johansson, M.O.; Josefson, M.; Wahlund, K.G. Quantitative analysis of film coating in a fluidized bed process by in line NIR spectrometry and multivariate batch calibration. Anal Chem., 2000, 72(9), 2099-2108.
59. Blanco, M.; Coello, J.; Iturriaga, H.; Maspoch, S.; Pagès, J. Calibration in non-linear near infrared reflectance spectroscopy: a comparison of several methods. Anal Chim. Acta, 1999, 384(2), 207-214.
60. Reich, G. Near-infrared spectroscopy and imaging: Basic principles and pharmaceutical applications. Adv. Drug Deliv. Rev., 2005, 57(8), 1109-1143.
61. Smith, B.C. Quantitative Spectroscopy: Theory and Practice, Elsevier Science: Amsterdam, 2002.
62. Mark, H.; Ritchie, G.E.; Roller, R.W.; Ciurczak, E.W.; Tso, C; MacDonald, S.A. Validation of a near-infrared transmission spectroscopic procedure, part A: Validation protocols. J. Pharm. Biomed. Anal, 2002, 28(2), 251-260.
63. Vetchy, D.; Rabiskova, M. Some variables influencing rotoag-glomeration in the multiprocessor MP-1. Int. J. Pharm., 2002, 242(1-2), 353-356.
64. Krejcova, K.; Rabiskova, M.; Vetchy, D.; Polasek, E.; Tomasek, V.; Prokopova, A. The influence of drug solubility and particle size on the pellet formulation in a rotoprocessor. Drug Dev. Ind. Pharm., 2006, 32(5), 585-593.
65. Laasonen, M.; Harmia-Pulkkinen, T.; Simard, C; Räsänen, M.; Vuorela, H. Determination of the thickness of plastic sheets used in blister packaging by near infrared spectroscopy: development and validation of the method. Eur. J. Pharm. Sci., 2004, 21(4), 493-500.