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Volumn 55, Issue 3, 2011, Pages 429-434

Blend uniformity end-point determination using near-infrared spectroscopy and multivariate calibration

Author keywords

Blend uniformity; Near infrared; Off line calibration; Partial least squares; Pharmaceutical

Indexed keywords

CROSPOVIDONE; LACTOSE; MICROCRYSTALLINE CELLULOSE;

EID: 79953253138     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2011.02.017     Document Type: Article
Times cited : (52)

References (22)
  • 1
    • 33747086889 scopus 로고    scopus 로고
    • Use of near-infrared for quantitative measurement of viscosity and concentration of active ingredient in pharmaceutical gel
    • Donoso M., Ghaly E.S. Use of near-infrared for quantitative measurement of viscosity and concentration of active ingredient in pharmaceutical gel. Pharm. Dev. Technol. 2006, 11:389-397.
    • (2006) Pharm. Dev. Technol. , vol.11 , pp. 389-397
    • Donoso, M.1    Ghaly, E.S.2
  • 2
    • 32644440958 scopus 로고    scopus 로고
    • A process analytical technology approach to near-infrared process control of pharmaceutical powder blending Part I: D-optimal design for characterization of powder mixing and preliminary spectral data evaluation
    • El-Hagrasy A.S., DAmico F., Drennen J.K. A process analytical technology approach to near-infrared process control of pharmaceutical powder blending Part I: D-optimal design for characterization of powder mixing and preliminary spectral data evaluation. J. Pharm. Sci. 2006, 95:392-406.
    • (2006) J. Pharm. Sci. , vol.95 , pp. 392-406
    • El-Hagrasy, A.S.1    DAmico, F.2    Drennen, J.K.3
  • 3
    • 32644437395 scopus 로고    scopus 로고
    • 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
    • El-Hagrasy A.S., Delgado-Lopez M., 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. 2006, 95:407-421.
    • (2006) J. Pharm. Sci. , vol.95 , pp. 407-421
    • El-Hagrasy, A.S.1    Delgado-Lopez, M.2    Drennen, J.K.3
  • 4
    • 32644436263 scopus 로고    scopus 로고
    • 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
    • El-Hagrasy A.S., Drennen 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. 2006, 95:422-434.
    • (2006) J. Pharm. Sci. , vol.95 , pp. 422-434
    • El-Hagrasy, A.S.1    Drennen, J.K.2
  • 5
    • 39649120798 scopus 로고    scopus 로고
    • Near-infrared multivariate calibration updating using placebo: a content uniformity determination of pharmaceutical tablets
    • Sulub Y., LoBrutto R., Vivilecchia R., Wabuyele B. Near-infrared multivariate calibration updating using placebo: a content uniformity determination of pharmaceutical tablets. Vibrat. Spectrosc. 2008, 46:128-134.
    • (2008) Vibrat. Spectrosc. , vol.46 , pp. 128-134
    • Sulub, Y.1    LoBrutto, R.2    Vivilecchia, R.3    Wabuyele, B.4
  • 6
    • 39949083193 scopus 로고    scopus 로고
    • Content uniformity determination of pharmaceutical tablets using five near-infrared reflectance spectrometers: a process analytical technology (PAT) approach using robust multivariate calibration transfer algorithms
    • Sulub Y., LoBrutto R., Vivilecchia R., Wabuyele B.W. Content uniformity determination of pharmaceutical tablets using five near-infrared reflectance spectrometers: a process analytical technology (PAT) approach using robust multivariate calibration transfer algorithms. Anal. Chim. Acta 2008, 611:143-150.
    • (2008) Anal. Chim. Acta , vol.611 , pp. 143-150
    • Sulub, Y.1    LoBrutto, R.2    Vivilecchia, R.3    Wabuyele, B.W.4
  • 7
    • 0030217890 scopus 로고    scopus 로고
    • Near-infrared spectroscopic characterization of pharmaceutical powder blends
    • Wargo D., Drennen J.K. Near-infrared spectroscopic characterization of pharmaceutical powder blends. J. Pharm. Biomed. Anal. 1996, 14:1415-1423.
    • (1996) J. Pharm. Biomed. Anal. , vol.14 , pp. 1415-1423
    • Wargo, D.1    Drennen, J.K.2
  • 8
    • 79953246371 scopus 로고    scopus 로고
    • US Food and Drugs Administration, Guidance for Industry Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment. Draft Guidance.
    • US Food and Drugs Administration, Guidance for Industry Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment. Draft Guidance, 2003. http://www.fda.gov/.
    • (2003)
  • 10
    • 0006234729 scopus 로고    scopus 로고
    • A solid dosage and blend content uniformity troubleshooting diagram
    • Prescott J.K., Garcia T.P. A solid dosage and blend content uniformity troubleshooting diagram. Pharm. Technol. 2001, 25:68-88.
    • (2001) Pharm. Technol. , vol.25 , pp. 68-88
    • Prescott, J.K.1    Garcia, T.P.2
  • 11
    • 79953242591 scopus 로고    scopus 로고
    • PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, in: Center for Drug Development and Research U.S. Food and Drug Administration, Rockville, MD.
    • PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, in: Center for Drug Development and Research U.S. Food and Drug Administration, Rockville, MD, 2004.
    • (2004)
  • 12
    • 33845659187 scopus 로고    scopus 로고
    • The effect of beam size on real-time determination of powder blend homogeneity by an online near infrared sensor
    • Li W., Johnson M.C., Bruce R., Rasmussen H., 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. 2007, 43:711-717.
    • (2007) J. Pharm. Biomed. Anal. , vol.43 , pp. 711-717
    • Li, W.1    Johnson, M.C.2    Bruce, R.3    Rasmussen, H.4    Worosila, G.D.5
  • 13
    • 1542724954 scopus 로고    scopus 로고
    • Measurement of low-dose active pharmaceutical ingredient in a pharmaceutical blend using frequency-domain photon migration
    • Pan T., Barber D., Coffin-Beach D., Sun Z., Sevick-Murara E.M. Measurement of low-dose active pharmaceutical ingredient in a pharmaceutical blend using frequency-domain photon migration. J. Pharm. Sci. 2003, 93:635-645.
    • (2003) J. Pharm. Sci. , vol.93 , pp. 635-645
    • Pan, T.1    Barber, D.2    Coffin-Beach, D.3    Sun, Z.4    Sevick-Murara, E.M.5
  • 14
    • 0032582289 scopus 로고    scopus 로고
    • Automated system for the on-line monitoring of powder blending process using near-infrared spectroscopy
    • Sekulic S.S., Wakeman J., Doherty P., Hailey P.A. Automated system for the on-line monitoring of powder blending process using near-infrared spectroscopy. J. Pharm. Biomed. Anal. 1998, 17:1285-1309.
    • (1998) J. Pharm. Biomed. Anal. , vol.17 , pp. 1285-1309
    • Sekulic, S.S.1    Wakeman, J.2    Doherty, P.3    Hailey, P.A.4
  • 15
    • 0037061158 scopus 로고    scopus 로고
    • Quantitative in-line monitoring of powder blending by near infrared reflection spectroscopy
    • Berntsson O., Danielsson L.G., Lagerholm B., Folestad S. Quantitative in-line monitoring of powder blending by near infrared reflection spectroscopy. Powder Technol. 2002, 123:185-193.
    • (2002) Powder Technol. , vol.123 , pp. 185-193
    • Berntsson, O.1    Danielsson, L.G.2    Lagerholm, B.3    Folestad, S.4
  • 16
    • 33645055644 scopus 로고    scopus 로고
    • Simple assessment of homogeneity in pharmaceutical mixing processes using a near-infrared reflectance probe and control charts
    • Skibsted E.T.S., Boelens H.F.M., Westerhuis J.A., Witte D.T., Smilde A.K. Simple assessment of homogeneity in pharmaceutical mixing processes using a near-infrared reflectance probe and control charts. J. Pharm. Biomed. Anal. 2006, 41:26-35.
    • (2006) J. Pharm. Biomed. Anal. , vol.41 , pp. 26-35
    • Skibsted, E.T.S.1    Boelens, H.F.M.2    Westerhuis, J.A.3    Witte, D.T.4    Smilde, A.K.5
  • 18
    • 33750469307 scopus 로고    scopus 로고
    • Mass-balanced blend uniformity analysis of pharmaceutical powders by at-line near-infrared spectroscopy with a fiber-optic probe
    • Li W., Johnson M.C., Bruce R., Ulrich S., Rasmussen H., 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. 2006, 326:182-185.
    • (2006) Int. J. Pharm. , vol.326 , pp. 182-185
    • Li, W.1    Johnson, M.C.2    Bruce, R.3    Ulrich, S.4    Rasmussen, H.5    Worosila, G.D.6
  • 19
    • 44749088589 scopus 로고    scopus 로고
    • Process characterization of powder blending by near-infrared spectroscopy: blend end-points and beyond
    • 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. Pharm. Biomed. Anal. 2008, 47:738-745.
    • (2008) J. Pharm. Biomed. Anal. , vol.47 , pp. 738-745
    • Shi, Z.Q.1    Cogdill, R.P.2    Short, S.M.3    Anderson, C.A.4
  • 21
    • 79953250418 scopus 로고    scopus 로고
    • ICH Guidelines, Q2B, Validation of analytical procedures: methodology, the Federal Registrar, 27463-27467, No. 96.
    • ICH Guidelines, Q2B, Validation of analytical procedures: methodology, the Federal Registrar, vol. 62: 27463-27467, No. 96, 1997.
    • (1997) , vol.62


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.