Near InfraRed Spectroscopy homogeneity evaluation of complex powder blends in a small-scale pharmaceutical preformulation process, a real-life application

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 72, Issue 1, 2009, Pages 189-198

  Storme Paris, I ^a,b   Clarot, I ^c   Esposito, S ^d   Chaumeil, J C ^d   Nicolas, A ^c   Brion, F ^b,e   Rieutord, A ^b   Chaminade, P ^a  

^a IPSIT   (France)

^b HÔPITAL ROBERT DEBRÉ   (France)

^c UNIVERSITÉ DE LORRAINE   (France)

^d Microsurgery Laboratory   (France)

^e UNIVERSITÉ PARIS DESCARTES   (France)

Author keywords

Chemometrics; Colimycin; Near InfraRed Spectroscopy; Paediatrics; Powder blend homogeneity; Tobramycin

Indexed keywords

CITRIC ACID; FLAVORING AGENT; INRESA; MAGNESIUM STEARATE; NEOMYCIN; SILICON DIOXIDE; SUCROSE; TOBRAMYCIN; UNCLASSIFIED DRUG; UNIPEX;

ARTICLE; CHEMOMETRIC ANALYSIS; GRAVIMETRY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LIGHT SCATTERING; NEAR INFRARED SPECTROSCOPY; POWDER; PREFORMULATION; QUALITATIVE ANALYSIS; QUANTITATIVE ANALYSIS;

CALIBRATION; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; COLISTIN; DRUG COMPOUNDING; EQUIPMENT DESIGN; LIGHT; PARTICLE SIZE; PHARMACEUTICAL PREPARATIONS; POWDERS; SCATTERING, RADIATION; SOFTWARE; SPECTROSCOPY, NEAR-INFRARED; TECHNOLOGY, PHARMACEUTICAL; TOBRAMYCIN;

EID: 63149152085     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2008.11.002     Document Type: Article

References (30)

1. Paris I., Janoly-Dumenil A., Paci A., Mercier L., Bourget P., Brion F., Chaminade P., and Rieutord A. Near infrared spectroscopy and process analytical technology to master the process of busulfan paediatric capsules in a university hospital. J. Pharm. Biomed. Anal. 41 (2006) 1171-1178
2. Sekulic S.S., Wakeman J., Doherty P., and Hailey P.A. Automated system for the on-line monitoring of powder blending processes using near-infrared spectroscopy. Part II. Qualitative approaches to blend evaluation. J. Pharm. Biomed. Anal. 17 (1998) 1285-1309
3. Hailey P.A., Doherty P., Tapsell P., Oliver T., and Aldridge P.K. Automated system for the on-line monitoring of powder blending processes using near-infrared spectroscopy. Part I. System development and control. J. Pharm. Biomed. Anal. 14 (1996) 551-559
4. Lyon R., Lester D., Lewis E., Lee E., Yu L., Jefferson E., and Hussain A. Near-infrared spectral imaging for quality assurance of pharmaceutical products: analysis of tablets to assess powder blend homogeneity. AAPS Pharm. Sci. Tech. 3 (2002) 1-15
5. Popo M., Romero-Torres S., Conde C., and Romañach R.J. Blend uniformity analysis using stream sampling and near infrared spectroscopy. AAPS Pharm. Sci. Tech. 3 (2002) 1-11
6. El-Hagrasy A.S., Delgado-Lopez M., and Drennen J.K. A process analytical technology approach to near-infrared process control of pharmaceutical powder blending. Part II: Qualitative near-infrared models for prediction of blend homogeneity. J. Pharm. Sci. 95 (2006) 407-421
7. Wargo D.J., and Drennen J.K. Near-infrared spectroscopic characterization of pharmaceutical powder blends. J. Pharm. Biomed. Anal. 14 (1996) 1415-1423
8. El-Hagrasy A.S., D'Amico F., and Drennen J.K. A process analytical technology approach to near-infrared process control of pharmaceutical powder blending. Part: ID-optimal design for characterization of powder mixing and preliminary spectral data evaluation. J. Pharm. Sci. 95 (2006) 392-406
9. Berntsson O., Danielsson L.G., Lagerholm B., and Folestad S. Quantitative in-line monitoring of powder blending by near infrared reflection spectroscopy. Powder Technol. 123 (2002) 185-193
10. Berntsson O., Danielsson L.G., Johansson M.O., and Folestad S. Quantitative determination of content in binary powder mixtures using diffuse reflectance near infrared spectrometry and multivariate analysis. Anal. Chim. Acta 419 (2000) 45-54
11. Bodson C., Dewe W., Hubert P., and Delattre L. Comparison of FT-NIR transmission and UV-vis spectrophotometry to follow the mixing kinetics and to assay low-dose tablets containing riboflavin. J. Pharm. Biomed. Anal. 41 (2006) 783-790
12. El-Hagrasy A.S., Morris H.R., D'Amico F., Lodder R.A., and Drennen J.K. Near-infrared spectroscopy and imaging for the monitoring of powder blend homogeneity. J. Pharm. Sci. 90 (2001) 1298-1307
13. El-Hagrasy A.S., and Drennen III J.K. A process analytical technology approach to near-infrared process control of pharmaceutical powder blending. Part III: Quantitative near-infrared calibration for prediction of blend homogeneity and characterization of powder mixing kinetics. J. Pharm. Sci. 95 (2006) 422-434
14. Li W., Johnson M.C., Bruce R., Rasmussen H., and Worosila G.D. The effect of beam size on real-time determination of powder blend homogeneity by an online near infrared sensor. J. Pharm. Biomed. Anal. 43 (2007) 711-717
15. Li W., Johnson M.C., Bruce R., Ulrich S., Rasmussen H., and Worosila G.D. Mass-balanced blend uniformity analysis of pharmaceutical powders by at-line near-infrared spectroscopy with a fiber-optic probe. Int. J. Pharm. 326 (2006) 182-185
16. Muzzio F.J., Robinson P., Wightman C., and Brone D. Sampling practices in powder blending. Int. J. Pharm. 155 (1997) 153-178
17. Candolfi A., De Maesschalck R., Jouan-Rimbaud D., Hailey P.A., and Massart D.L. The influence of data pre-processing in the pattern recognition of excipients near-infrared spectra. J. Pharm. Biomed. Anal. 21 (1999) 115-132
18. Duong N.H., Arratia P., Muzzio F., Lange A., Timmermans J., and Reynolds S. A homogeneity study using NIR spectroscopy: tracking magnesium stearate in Bohle bin-blender. Drug. Dev. Ind. Pharm. 29 (2003) 679-687
19. Westerhuis J.A., De Jong S., and Smilde A.K. Direct orthogonal signal correction. Chemometr. Intell. Lab. 56 (2001) 13-25
20. Chalus P., Walter S., and Ulmschneider M. Combined wavelet transform-artificial neural network use in tablet active content determination by near-infrared spectroscopy. Anal. Chim. Acta 591 (2007) 219-224
21. Trygg J., and Wold S. PLS regression on wavelet compressed NIR spectra. Chemometr. Intell. Lab. 42 (1998) 209-220
22. Cozzolino D., Kwiatkowski M.J., Parker M., Cynkar W.U., Dambergs R.G., Gishen M., and Herderich M.J. Prediction of phenolic compounds in red wine fermentations by visible and near infrared spectroscopy. Anal. Chim. Acta 513 (2004) 73-80
23. Chalus P., Roggo Y., Walter S., and Ulmschneider M. Near-infrared determination of active substance content in intact low-dosage tablets. Talanta 66 (2005) 1294-1302
24. I. Clarot, I. Storme-Paris, P. Chaminade, O. Estevenon, A. Nicolas, A. Rieutord, Simultaneous quantitation of tobramycin and colistin sulphate by HPLC with evaporative light scattering detection, J. Pharm. Biomed. Anal., submitted for publication (JPBA-D-08-01587).
25. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Validation of Analytical Procedures: Text and Methodology Q2R1 (Step 4), 2005. .
26. Sekulic S.S., Ward H.W., Brannegan D.R., Stanley E.D., Evans C.L., Sciavolino S.T., Hailey P.A., and Aldridge P.K. On-line monitoring of powder blend homogeneity by Near-Infrared Spectroscopy. Anal. Chem. 68 (1996) 509-513
27. Li W., and Worosila G.D. Quantitation of active pharmaceutical ingredients and excipients in powder blends using designed multivariate calibration models by near-infrared spectroscopy. Int. J. Pharm. 295 (2005) 213-219
28. Wikström C., Albano C., Eriksson L., Fridén H., Johansson E., Nordahl A., Rännar S., Sandberg M., Kettaneh-Wold N., and Wold S. Multivariate process and quality monitoring applied to an electrolysis process. Part II. Multivariate time-series analysis of lagged latent variables. Chemometr. Intell. Lab. 42 (1998) 233-240
29. Food and Drug Administration, Guidance for Industry Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment, 2003. .
30. European Medicines Agency, Note for guidance on manufacture of the finished dosage form, CPMP/QWP/486/95, London, 1996. .