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Volumn 101, Issue 7, 2012, Pages 2502-2511

A novel sample selection strategy by near-infrared spectroscopy-based high throughput tablet tester for content uniformity in early-phase pharmaceutical product development

Author keywords

Chemometrics; Content uniformity; Near infrared spectroscopy; Sample selection strategy; Solid dosage form; Tablet

Indexed keywords

ACTIVE PHARMACEUTICAL INGREDIENT; BIOLOGICAL PRODUCT; UNCLASSIFIED DRUG;

EID: 84866304487     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23153     Document Type: Article
Times cited : (10)

References (16)
  • 1
    • 85030497665 scopus 로고    scopus 로고
    • USP905. 34 ed. Uniformity of dosage units.
    • USP905. 34 ed. 2011. Uniformity of dosage units.
    • (2011)
  • 2
    • 85030490750 scopus 로고    scopus 로고
    • EP2.9.40. 7.0 ed. Uniformity of dosage units.
    • EP2.9.40. 7.0 ed. Uniformity of dosage units.
  • 4
    • 20444399524 scopus 로고    scopus 로고
    • Near-infrared spectroscopy and imaging: Basic principles and pharmaceutical applications
    • Reich G. 2005. Near-infrared spectroscopy and imaging: Basic principles and pharmaceutical applications. Adv Drug Deliv Rev 57(8):1109-1143.
    • (2005) Adv Drug Deliv Rev , vol.57 , Issue.8 , pp. 1109-1143
    • Reich, G.1
  • 5
    • 67649868327 scopus 로고    scopus 로고
    • Development of robust quantitative methods by near-infrared spectroscopy for rapid pharmaceutical determination of content uniformity in complex tablet matrix
    • Xiang D, Konigsberger M, Wabuyele B, Hornung K, Cheney J. 2009. Development of robust quantitative methods by near-infrared spectroscopy for rapid pharmaceutical determination of content uniformity in complex tablet matrix. Analyst 134(7):1405-1415.
    • (2009) Analyst , vol.134 , Issue.7 , pp. 1405-1415
    • Xiang, D.1    Konigsberger, M.2    Wabuyele, B.3    Hornung, K.4    Cheney, J.5
  • 6
    • 62849125292 scopus 로고    scopus 로고
    • Robust calibration design in the pharmaceutical quantitative measurements with near-infrared (NIR) spectroscopy: Avoiding the chemometric pitfalls
    • Xiang D, Berry J, Buntz S, Gargiulo P, Cheney J, Joshi Y, Wabuyele B, Wu H, Hamed M, Hussain AS, Khan MA. 2009. Robust calibration design in the pharmaceutical quantitative measurements with near-infrared (NIR) spectroscopy: Avoiding the chemometric pitfalls. J Pharm Sci 98(3):1155-1166.
    • (2009) J Pharm Sci , vol.98 , Issue.3 , pp. 1155-1166
    • Xiang, D.1    Berry, J.2    Buntz, S.3    Gargiulo, P.4    Cheney, J.5    Joshi, Y.6    Wabuyele, B.7    Wu, H.8    Hamed, M.9    Hussain, A.S.10    Khan, M.A.11
  • 7
    • 69549084553 scopus 로고    scopus 로고
    • Applications of NIR in early stage formulation development. Part II. Content uniformity evaluation of low dose tablets by principal component analysis
    • Li W, Bagnol L, Berman M, Chiarella RA, Gerber M. 2009. Applications of NIR in early stage formulation development. Part II. Content uniformity evaluation of low dose tablets by principal component analysis. Int J Pharm 380(1-2):49-54.
    • (2009) Int J Pharm , vol.380 , Issue.1-2 , pp. 49-54
    • Li, W.1    Bagnol, L.2    Berman, M.3    Chiarella, R.A.4    Gerber, M.5
  • 8
    • 42749083254 scopus 로고    scopus 로고
    • Application of process analytical technology in tablet process development using NIR spectroscopy: Blend uniformity, content uniformity and coating thickness measurements
    • Moes JJ, Ruijken MM, Gout E, Frijlink HW, Ugwoke MI. 2008. Application of process analytical technology in tablet process development using NIR spectroscopy: Blend uniformity, content uniformity and coating thickness measurements. Int J Pharm 357(1-2):108-118.
    • (2008) Int J Pharm , vol.357 , Issue.1-2 , pp. 108-118
    • Moes, J.J.1    Ruijken, M.M.2    Gout, E.3    Frijlink, H.W.4    Ugwoke, M.I.5
  • 9
    • 34447260516 scopus 로고    scopus 로고
    • Applications of NIR in early stage formulation development. Part I. Semi-quantitative blend uniformity and content uniformity analyses by reflectance NIR without calibration models
    • Li W, Bashai-Woldu A, Ballard J, Johnson M, Agresta M, Rasmussen H, Hu S, Cunningham J, Winstead D. 2007. Applications of NIR in early stage formulation development. Part I. Semi-quantitative blend uniformity and content uniformity analyses by reflectance NIR without calibration models. Int J Pharm 340(1-2):97-103.
    • (2007) Int J Pharm , vol.340 , Issue.1-2 , pp. 97-103
    • Li, W.1    Bashai-Woldu, A.2    Ballard, J.3    Johnson, M.4    Agresta, M.5    Rasmussen, H.6    Hu, S.7    Cunningham, J.8    Winstead, D.9
  • 11
    • 77952591420 scopus 로고    scopus 로고
    • Optical coefficient-based multivariate calibration on near-infrared spectroscopy
    • Shi Z, Cogdill RP, Martens H, Anderson CA. 2009. Optical coefficient-based multivariate calibration on near-infrared spectroscopy. J Chemometrics 24(5):288-299.
    • (2009) J Chemometrics , vol.24 , Issue.5 , pp. 288-299
    • Shi, Z.1    Cogdill, R.P.2    Martens, H.3    Anderson, C.A.4
  • 12
    • 27644448665 scopus 로고    scopus 로고
    • Efficient spectroscopic calibration using net analyte signal and pure component projection methods
    • Cogdill RP, Anderson CA. 2005. Efficient spectroscopic calibration using net analyte signal and pure component projection methods. J Near Infrared Spectrosc 13(3):119-131.
    • (2005) J Near Infrared Spectrosc , vol.13 , Issue.3 , pp. 119-131
    • Cogdill, R.P.1    Anderson, C.A.2
  • 13
    • 36849024572 scopus 로고    scopus 로고
    • Determination of figures of merit for near-infrared and Raman spectrometry by net analyte signal analysis for a 4-component solid dosage system
    • Short SM, Cogdill RP, Anderson CA. 2007. Determination of figures of merit for near-infrared and Raman spectrometry by net analyte signal analysis for a 4-component solid dosage system. AAPS Pharm Sci Tech 8(4):109-119.
    • (2007) AAPS Pharm Sci Tech , vol.8 , Issue.4 , pp. 109-119
    • Short, S.M.1    Cogdill, R.P.2    Anderson, C.A.3
  • 14
    • 0035972910 scopus 로고    scopus 로고
    • A comparison of orthogonal signal correction and net analyte preprocessing methods. Theoretical and experimental study
    • Goicoechea HC, Olivieri AC. 2001. A comparison of orthogonal signal correction and net analyte preprocessing methods. Theoretical and experimental study. Chemom Intell Lab Syst 56(2):73-81.
    • (2001) Chemom Intell Lab Syst , vol.56 , Issue.2 , pp. 73-81
    • Goicoechea, H.C.1    Olivieri, A.C.2
  • 15
    • 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-Muraca EM. 2004. Measurement of low-dose active pharmaceutical ingredient in a pharmaceutical blend using frequency-domain photon migration. J Pharm Sci 93(3):635-645.
    • (2004) J Pharm Sci , vol.93 , Issue.3 , pp. 635-645
    • Pan, T.1    Barber, D.2    Coffin-Beach, D.3    Sun, Z.4    Sevick-Muraca, E.M.5
  • 16
    • 85030498837 scopus 로고    scopus 로고
    • PQRI The use of stratified sampling of blend and dosage units to demonstrate adequacy of mix for powder blends. Accessed, at:
    • PQRI 2002. The use of stratified sampling of blend and dosage units to demonstrate adequacy of mix for powder blends. Accessed, at: http://wwwpqriorg/pdfs/DTC/Articles/Final_BUWG_Stratfied_Samplingpdf.
    • (2002)


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