메뉴 건너뛰기




Volumn 362, Issue 1-2, 2008, Pages 29-36

Quantitative determination of solid-state forms of a pharmaceutical development compound in drug substance and tablets

Author keywords

Form stability; Quantitation; Raman spectroscopy; Solid state forms; Tablet

Indexed keywords

EXCIPIENT;

EID: 50249169281     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2008.05.038     Document Type: Article
Times cited : (32)

References (30)
  • 1
    • 0034528902 scopus 로고    scopus 로고
    • Polymorphic analysis of a pharmaceutical preparation by NIR spectroscopy
    • Blanco M., and Villar A. Polymorphic analysis of a pharmaceutical preparation by NIR spectroscopy. Analyst (Cambridge, United Kingdom) 125 (2000) 2311-2314
    • (2000) Analyst (Cambridge, United Kingdom) , vol.125 , pp. 2311-2314
    • Blanco, M.1    Villar, A.2
  • 2
    • 3843092896 scopus 로고    scopus 로고
    • Figures of merit for the determination of the polymorphic purity of carbamazepine by infrared spectroscopy and multivariate calibration
    • Braga J.W.B., and Poppi R.J. Figures of merit for the determination of the polymorphic purity of carbamazepine by infrared spectroscopy and multivariate calibration. J. Pharm. Sci. 93 (2004) 2124-2134
    • (2004) J. Pharm. Sci. , vol.93 , pp. 2124-2134
    • Braga, J.W.B.1    Poppi, R.J.2
  • 4
    • 50249128344 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Q6A, 2000. Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances.
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Q6A, 2000. Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances.
  • 5
    • 23944455134 scopus 로고    scopus 로고
    • Characterization of different laser irradiation methods for quantitative Raman tablet assessment
    • Johansson J., Pettersson S., and Folestad S. Characterization of different laser irradiation methods for quantitative Raman tablet assessment. J. Pharm. Biomed. 39 (2005) 510-516
    • (2005) J. Pharm. Biomed. , vol.39 , pp. 510-516
    • Johansson, J.1    Pettersson, S.2    Folestad, S.3
  • 6
    • 33845656998 scopus 로고    scopus 로고
    • Quantitative analysis of paracetamol polymorphs in powder mixtures by FT-Raman spectroscopy and PLS regression
    • Kachrimanis K., Braun D.E., and Griesser U.J. Quantitative analysis of paracetamol polymorphs in powder mixtures by FT-Raman spectroscopy and PLS regression. J. Pharm. Biomed. 43 (2007) 407-412
    • (2007) J. Pharm. Biomed. , vol.43 , pp. 407-412
    • Kachrimanis, K.1    Braun, D.E.2    Griesser, U.J.3
  • 7
    • 33750908727 scopus 로고    scopus 로고
    • Simultaneous quantification of carbamazepine crystal forms in ternary mixtures (I, III, and IV) by diffuse reflectance FTIR spectroscopy (DRIFTS) and multivariate calibration
    • Kipouros K., Kachrimanis K., Nikolakakis I., Tserki V., and Malamataris S. Simultaneous quantification of carbamazepine crystal forms in ternary mixtures (I, III, and IV) by diffuse reflectance FTIR spectroscopy (DRIFTS) and multivariate calibration. J. Pharm. Sci. 95 (2006) 2419-2431
    • (2006) J. Pharm. Sci. , vol.95 , pp. 2419-2431
    • Kipouros, K.1    Kachrimanis, K.2    Nikolakakis, I.3    Tserki, V.4    Malamataris, S.5
  • 8
    • 34547182895 scopus 로고    scopus 로고
    • Qualitative in situ analysis of multiple solid-state forms using spectroscopy and partial least squares discriminant modeling
    • Kogermann K., Aaltonen J., Strachan C.J., Pollanen K., Veski P., Heinamaki J., Yliruusi J., and Rantanen J. Qualitative in situ analysis of multiple solid-state forms using spectroscopy and partial least squares discriminant modeling. J. Pharm. Sci. 96 (2007) 1802-1820
    • (2007) J. Pharm. Sci. , vol.96 , pp. 1802-1820
    • Kogermann, K.1    Aaltonen, J.2    Strachan, C.J.3    Pollanen, K.4    Veski, P.5    Heinamaki, J.6    Yliruusi, J.7    Rantanen, J.8
  • 9
    • 33947093072 scopus 로고
    • Comments on Savitzky-Golay convolution method for least-squares fit smoothing and differentiation of digital data
    • Madden H.H. Comments on Savitzky-Golay convolution method for least-squares fit smoothing and differentiation of digital data. Anal. Chem. 50 (1978) 1383-1386
    • (1978) Anal. Chem. , vol.50 , pp. 1383-1386
    • Madden, H.H.1
  • 10
    • 32644464469 scopus 로고    scopus 로고
    • Quantitative determination of captopril and prednisolone in tablets by FT-Raman spectroscopy
    • Mazurek S., and Szostak R. Quantitative determination of captopril and prednisolone in tablets by FT-Raman spectroscopy. J. Pharm. Biomed. 40 (2006) 1225-1230
    • (2006) J. Pharm. Biomed. , vol.40 , pp. 1225-1230
    • Mazurek, S.1    Szostak, R.2
  • 12
    • 50249087137 scopus 로고    scopus 로고
    • Nielsen, O.F., 2001. Low-frequency raman spectroscopy and biomolecular dynamics: a comparison between different low-frequency experimental techniques. Collectivity of vibrational modes, Handbook of Raman Spectroscopy. From the Research Laboratory to the Process Line, vol. 28. pp. 593-616.
    • Nielsen, O.F., 2001. Low-frequency raman spectroscopy and biomolecular dynamics: a comparison between different low-frequency experimental techniques. Collectivity of vibrational modes, Handbook of Raman Spectroscopy. From the Research Laboratory to the Process Line, vol. 28. pp. 593-616.
  • 13
    • 34548595345 scopus 로고    scopus 로고
    • Granule characterization during fluid bed drying by development of a near infrared method to determine water content and median granule size
    • Nieuwmeyer F.J.S., Damen M., Gerich A., Rusmini F., Voort Maarschalk K., and Vromans H. Granule characterization during fluid bed drying by development of a near infrared method to determine water content and median granule size. Pharm. Res. 24 (2007) 1854-1861
    • (2007) Pharm. Res. , vol.24 , pp. 1854-1861
    • Nieuwmeyer, F.J.S.1    Damen, M.2    Gerich, A.3    Rusmini, F.4    Voort Maarschalk, K.5    Vromans, H.6
  • 14
    • 0027375709 scopus 로고
    • Effects of environmental temperature and compression energy on polymorphic transformation during tabletting
    • Otsuka M., and Matsuda Y. Effects of environmental temperature and compression energy on polymorphic transformation during tabletting. Drug Dev. Ind. Pharm. 19 (1993) 2241-2269
    • (1993) Drug Dev. Ind. Pharm. , vol.19 , pp. 2241-2269
    • Otsuka, M.1    Matsuda, Y.2
  • 15
    • 19644362083 scopus 로고    scopus 로고
    • IR spectroscopy together with multivariate data analysis as a process analytical tool for in-line monitoring of crystallization process and solid-state analysis of crystalline product
    • Poellaenen K., Haekkinen A., Reinikainen S.-P., Rantanen J., Karjalainen M., Louhi-Kultanen M., and Nystroem L. IR spectroscopy together with multivariate data analysis as a process analytical tool for in-line monitoring of crystallization process and solid-state analysis of crystalline product. J. Pharm. Biomed. 38 (2005) 275-284
    • (2005) J. Pharm. Biomed. , vol.38 , pp. 275-284
    • Poellaenen, K.1    Haekkinen, A.2    Reinikainen, S.-P.3    Rantanen, J.4    Karjalainen, M.5    Louhi-Kultanen, M.6    Nystroem, L.7
  • 16
    • 0035093341 scopus 로고    scopus 로고
    • Novel identification of pseudopolymorphic changes of theophylline during wet granulation using near infrared spectroscopy
    • Rasanen E., Rantanen J., Jorgensen A., Karjalainen M., Paakkari T., and Yliruusi J. Novel identification of pseudopolymorphic changes of theophylline during wet granulation using near infrared spectroscopy. J. Pharm. Sci. 90 (2001) 389-396
    • (2001) J. Pharm. Sci. , vol.90 , pp. 389-396
    • Rasanen, E.1    Rantanen, J.2    Jorgensen, A.3    Karjalainen, M.4    Paakkari, T.5    Yliruusi, J.6
  • 17
  • 19
    • 0042553279 scopus 로고
    • Smoothing + differentiation of data by simplified least squares procedures
    • Savitzky A., and Golay M.J.E. Smoothing + differentiation of data by simplified least squares procedures. Anal. Chem. 36 (1964) 1627-1639
    • (1964) Anal. Chem. , vol.36 , pp. 1627-1639
    • Savitzky, A.1    Golay, M.J.E.2
  • 20
    • 33747177115 scopus 로고    scopus 로고
    • Analytical techniques for quantification of amorphous/crystalline phases in pharmaceutical solids
    • Shah B., Kakumanu V.K., and Bansal A.K. Analytical techniques for quantification of amorphous/crystalline phases in pharmaceutical solids. J. Pharm. Sci. 95 (2006) 1641-1665
    • (2006) J. Pharm. Sci. , vol.95 , pp. 1641-1665
    • Shah, B.1    Kakumanu, V.K.2    Bansal, A.K.3
  • 21
    • 50249177289 scopus 로고    scopus 로고
    • Smith, C.D., Carabatos-Nedelec, C., 2001. Raman spectroscopy applied to crystals: phenomena and principles, concepts and conventions. Handbook of Raman Spectroscopy.
    • Smith, C.D., Carabatos-Nedelec, C., 2001. Raman spectroscopy applied to crystals: phenomena and principles, concepts and conventions. Handbook of Raman Spectroscopy.
  • 23
    • 33846794632 scopus 로고    scopus 로고
    • Raman spectroscopy for quantitative analysis of pharmaceutical solids
    • Strachan C.J., Rades T., Gordon K.C., and Rantanen J. Raman spectroscopy for quantitative analysis of pharmaceutical solids. J. Pharm. Pharmacol. 59 (2007) 179-192
    • (2007) J. Pharm. Pharmacol. , vol.59 , pp. 179-192
    • Strachan, C.J.1    Rades, T.2    Gordon, K.C.3    Rantanen, J.4
  • 24
    • 33646386480 scopus 로고
    • The dissolution rates of crystalline drugs
    • Tawashi R. The dissolution rates of crystalline drugs. J. Mond. Pharm. 4 (1968) 371-379
    • (1968) J. Mond. Pharm. , vol.4 , pp. 371-379
    • Tawashi, R.1
  • 25
    • 0031750863 scopus 로고    scopus 로고
    • The quantitative analysis of crystallinity using FT-Raman spectroscopy
    • Taylor L.S., and Zografi G. The quantitative analysis of crystallinity using FT-Raman spectroscopy. Pharm. Res. 15 (1998) 755-761
    • (1998) Pharm. Res. , vol.15 , pp. 755-761
    • Taylor, L.S.1    Zografi, G.2
  • 26
    • 50249153182 scopus 로고    scopus 로고
    • The United States Food and Drug Administration (FDA), 2007. Guidance for industry. ANDAs: Pharmaceutical Solid Polymorphism.
    • The United States Food and Drug Administration (FDA), 2007. Guidance for industry. ANDAs: Pharmaceutical Solid Polymorphism.
  • 27
    • 20444371510 scopus 로고    scopus 로고
    • Pharmaceutical applications of mid-IR and Raman spectroscopy
    • Wartewig S., and Neubert R.H.H. Pharmaceutical applications of mid-IR and Raman spectroscopy. Adv. Drug Delivery Rev. 57 (2005) 1144-1170
    • (2005) Adv. Drug Delivery Rev. , vol.57 , pp. 1144-1170
    • Wartewig, S.1    Neubert, R.H.H.2
  • 28
    • 23444457946 scopus 로고    scopus 로고
    • Quantitative determination of polymorphic composition in intact compacts by parallel-beam X-ray powder diffractometry II. Data correction for analysis of phase transformations as a function of pressure
    • Wildfong P.L.D., Morley N.A., Moore M.D., and Morris K.R. Quantitative determination of polymorphic composition in intact compacts by parallel-beam X-ray powder diffractometry II. Data correction for analysis of phase transformations as a function of pressure. J. Pharm. Biomed. 39 (2005) 1-7
    • (2005) J. Pharm. Biomed. , vol.39 , pp. 1-7
    • Wildfong, P.L.D.1    Morley, N.A.2    Moore, M.D.3    Morris, K.R.4
  • 29
    • 51649109341 scopus 로고    scopus 로고
    • Xie, Y., Cao, W., Krishnan, S., Lin, H., Cauchon, N., 2008. Characterization of mannitol polymorphic forms in lyophilized protein formulations using a multivariate curve resolution (MCR)-based Raman spectroscopic method. Pharm. Res., in press.
    • Xie, Y., Cao, W., Krishnan, S., Lin, H., Cauchon, N., 2008. Characterization of mannitol polymorphic forms in lyophilized protein formulations using a multivariate curve resolution (MCR)-based Raman spectroscopic method. Pharm. Res., in press.
  • 30
    • 0034269610 scopus 로고    scopus 로고
    • Enhanced chemical classification of Raman images in the presence of strong fluorescence interference
    • Zhang D.M., and Ben-Amotz D. Enhanced chemical classification of Raman images in the presence of strong fluorescence interference. Appl. Spectrosc. 54 (2000) 1379-1383
    • (2000) Appl. Spectrosc. , vol.54 , pp. 1379-1383
    • Zhang, D.M.1    Ben-Amotz, D.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.