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Volumn 103, Issue 8, 2014, Pages 2376-2385

Near-infrared and fourier transform infrared chemometric methods for the quantification of crystalline tacrolimus from sustained-release amorphous solid Dispersion

Author keywords

amorphous; chemometrics; crystallinity; infrared spectroscopy; near infrared spectroscopy; partial least squares; principal component analysis; solid dispersion

Indexed keywords

DRUG CARRIER; ETHYL CELLULOSE; HYDROXYPROPYLMETHYLCELLULOSE; LACTOSE; TACROLIMUS; DELAYED RELEASE FORMULATION; IMMUNOSUPPRESSIVE AGENT;

EID: 84905121677     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.24055     Document Type: Article
Times cited : (23)

References (32)
  • 1
    • 84885843865 scopus 로고    scopus 로고
    • Chemometric evaluation of near infrared, fourier transform infrared, and Raman spectroscopic models for the prediction of nimodipine polymorphs
    • Siddiqui A, Rahman Z, Sayeed VA, Khan MA,. 2013. Chemometric evaluation of near infrared, fourier transform infrared, and Raman spectroscopic models for the prediction of nimodipine polymorphs. J Pharm Sci 102: 4024-4035.
    • (2013) J Pharm Sci , vol.102 , pp. 4024-4035
    • Siddiqui, A.1    Rahman, Z.2    Sayeed, V.A.3    Khan, M.A.4
  • 2
    • 33645224835 scopus 로고    scopus 로고
    • Quantitative determination of amorphous cyclosporine in crystalline cyclosporine samples by Fourier transform infrared spectroscopy
    • Bertacche V, Pini E, Stradi R, Stratta F,. 2006. Quantitative determination of amorphous cyclosporine in crystalline cyclosporine samples by Fourier transform infrared spectroscopy. J Pharm Sci 95: 159-166.
    • (2006) J Pharm Sci , vol.95 , pp. 159-166
    • Bertacche, V.1    Pini, E.2    Stradi, R.3    Stratta, F.4
  • 3
    • 0034528902 scopus 로고    scopus 로고
    • Polymorphic analysis of a pharmaceutical preparation by NIR spectroscopy
    • Blanco M, Villar A,. 2000. Polymorphic analysis of a pharmaceutical preparation by NIR spectroscopy. Analyst 125: 2311-2314.
    • (2000) Analyst , vol.125 , pp. 2311-2314
    • Blanco, M.1    Villar, A.2
  • 4
    • 34548361885 scopus 로고    scopus 로고
    • Determination of crystallinity of an aliphatic polyester by FTIR spectroscopy
    • Partini M, Patani R,. 2007. Determination of crystallinity of an aliphatic polyester by FTIR spectroscopy. Polym Bull 59: 403-412.
    • (2007) Polym Bull , vol.59 , pp. 403-412
    • Partini, M.1    Patani, R.2
  • 5
    • 71249149458 scopus 로고    scopus 로고
    • Review of the most common pre-processing techniques for near-infrared spectra
    • Rinnan A, Berg FVD, Engelsen SB,. 2009. Review of the most common pre-processing techniques for near-infrared spectra. Trends Anal Chem 28: 1201-1222.
    • (2009) Trends Anal Chem , vol.28 , pp. 1201-1222
    • Rinnan, A.1    Berg, F.V.D.2    Engelsen, S.B.3
  • 6
    • 68949089977 scopus 로고    scopus 로고
    • Novel method for the assessment of miscibility in amorphous dispersions
    • Ivanisevic I, Bates S, Chen P,. 2009. Novel method for the assessment of miscibility in amorphous dispersions. J Pharm Sci 98: 3373-3386.
    • (2009) J Pharm Sci , vol.98 , pp. 3373-3386
    • Ivanisevic, I.1    Bates, S.2    Chen, P.3
  • 7
    • 68949119479 scopus 로고    scopus 로고
    • Amorphous drug-PVP dispersions: Application of theoretical, thermal and spectroscopic analytical techniques to the study of a molecule with intermolecular bonds in both the crystalline and pure amorphous state
    • Tobyn M, Brown J, Dennis AB, Fakes M, Gao Q, Gamble J, Khimyak YZ, McGeorge G, Patel C, Sinclair W, Timmins P, Yin S,. 2009. Amorphous drug-PVP dispersions: Application of theoretical, thermal and spectroscopic analytical techniques to the study of a molecule with intermolecular bonds in both the crystalline and pure amorphous state. J Pharm Sci 98: 3456-3468.
    • (2009) J Pharm Sci , vol.98 , pp. 3456-3468
    • Tobyn, M.1    Brown, J.2    Dennis, A.B.3    Fakes, M.4    Gao, Q.5    Gamble, J.6    Khimyak, Y.Z.7    McGeorge, G.8    Patel, C.9    Sinclair, W.10    Timmins, P.11    Yin, S.12
  • 8
    • 84886723948 scopus 로고    scopus 로고
    • Hunter screening design to understand the product variability of solid dispersion formulation of a peptide antibiotic
    • Rahman Z, Khan MA,. 2013. Hunter screening design to understand the product variability of solid dispersion formulation of a peptide antibiotic. Int J Pharm 456: 572-582.
    • (2013) Int J Pharm , vol.456 , pp. 572-582
    • Rahman, Z.1    Khan, M.A.2
  • 9
    • 84888206040 scopus 로고    scopus 로고
    • Characterization of a nonribosomal peptide antibiotic solid dispersion formulation by process analytical technologies sensors
    • Rahman Z, Siddiqui A, Khan MA,. 2013. Characterization of a nonribosomal peptide antibiotic solid dispersion formulation by process analytical technologies sensors. J Pharm Sci 102: 4337-4346.
    • (2013) J Pharm Sci , vol.102 , pp. 4337-4346
    • Rahman, Z.1    Siddiqui, A.2    Khan, M.A.3
  • 12
    • 0027793514 scopus 로고
    • Physicochemical characterization of acetaminophen-ethylcellulose solid dispersion
    • Ghaly ES, Hernández JI, Malavé A, Marti A,. 1993. Physicochemical characterization of acetaminophen-ethylcellulose solid dispersion. P R Health Sci J 12: 273-276.
    • (1993) P R Health Sci J , vol.12 , pp. 273-276
    • Ghaly, E.S.1    Hernández, J.I.2    Malavé, A.3    Marti, A.4
  • 13
    • 57149143582 scopus 로고    scopus 로고
    • Hydroxypropyl methylcellulose acetate succinate: Potential drug-excipient incompatibility
    • Dong Z, Choi DS,. 2008. Hydroxypropyl methylcellulose acetate succinate: Potential drug-excipient incompatibility. AAPS Pharm Sci Tech 9: 991-997.
    • (2008) AAPS Pharm Sci Tech , vol.9 , pp. 991-997
    • Dong, Z.1    Choi, D.S.2
  • 14
    • 0029015405 scopus 로고
    • Molecular mobilityof amorphous pharmaceutical solids below their glass transition temperatures
    • Hancock BC, Shamblin SL, Zografi G,. 1995. Molecular mobilityof amorphous pharmaceutical solids below their glass transition temperatures. Pharm Res 12: 799-806.
    • (1995) Pharm Res , vol.12 , pp. 799-806
    • Hancock, B.C.1    Shamblin, S.L.2    Zografi, G.3
  • 15
    • 33749447574 scopus 로고    scopus 로고
    • A comparison of the physical stability of amorphous felodipine and nifedipine systems
    • Marsac PJ, Konno H, Taylor LS,. 2006. A comparison of the physical stability of amorphous felodipine and nifedipine systems. Pharm Res 23: 2306-2316.
    • (2006) Pharm Res , vol.23 , pp. 2306-2316
    • Marsac, P.J.1    Konno, H.2    Taylor, L.S.3
  • 16
    • 0141678823 scopus 로고    scopus 로고
    • The effect of low concentrations of molecularly dispersed poly(vinylpyrrolidone) on indomethacin crystallization from the amorphous state
    • Crowley KJ, Zografi G,. 2003. The effect of low concentrations of molecularly dispersed poly(vinylpyrrolidone) on indomethacin crystallization from the amorphous state. Pharm Res 20: 1417-1422.
    • (2003) Pharm Res , vol.20 , pp. 1417-1422
    • Crowley, K.J.1    Zografi, G.2
  • 17
    • 33749442356 scopus 로고    scopus 로고
    • Theoretical and practical approaches for prediction of drug-polymer miscibility and solubility
    • Marsac PJ, Shamblin SL, Taylor LS,. 2006. Theoretical and practical approaches for prediction of drug-polymer miscibility and solubility. Pharm Res 23: 2417-2426.
    • (2006) Pharm Res , vol.23 , pp. 2417-2426
    • Marsac, P.J.1    Shamblin, S.L.2    Taylor, L.S.3
  • 18
    • 0036278164 scopus 로고    scopus 로고
    • Tacrolimus is a class II low-solubility high-permeability drug: The effect of P-glycopropetein efflux on regional permeability of tacrolimus in rats
    • Tamura S, Ohike A, Ibuki R, Amidon GL, Yamashita S,. 2002. Tacrolimus is a class II low-solubility high-permeability drug: The effect of P-glycopropetein efflux on regional permeability of tacrolimus in rats. J Pharm Sci 91: 719-729.
    • (2002) J Pharm Sci , vol.91 , pp. 719-729
    • Tamura, S.1    Ohike, A.2    Ibuki, R.3    Amidon, G.L.4    Yamashita, S.5
  • 19
    • 75749094421 scopus 로고    scopus 로고
    • Review: Physical chemistry of solid dispersions
    • Janssens S, Van den Mooter G,. 2009. Review: Physical chemistry of solid dispersions. J Pharm Pharmacol 61: 1571-1586.
    • (2009) J Pharm Pharmacol , vol.61 , pp. 1571-1586
    • Janssens, S.1    Den Mooter, G.V.2
  • 20
    • 85030403935 scopus 로고    scopus 로고
    • Accessed on June 9
    • FDA Prograf® Capsule label. Accessed on June 9, 2014 at: http://www.accessdata.fda.gov/drugsatfda-docs/label/2013/050708s043, 050709s036lbl.pdf.
    • (2014) FDA Prograf® Capsule Label
  • 21
    • 84906311413 scopus 로고    scopus 로고
    • Chemometric methods for the quantification of crystalline tacrolimus in solid dispersion by powder X-ray diffractrometry
    • [Epub ahead of print.]
    • Siddiqui A, Rahman Z, Bykadi S, Khan MA,. 2014. Chemometric methods for the quantification of crystalline tacrolimus in solid dispersion by powder X-ray diffractrometry. J Pharm Sci.[Epub ahead of print.]
    • (2014) J Pharm Sci
    • Siddiqui, A.1    Rahman, Z.2    Bykadi, S.3    Khan, M.A.4
  • 22
    • 84856537046 scopus 로고    scopus 로고
    • Crystallinity evaluation of tacrolimus solid dispersions by chemometric analysis
    • Zidan AS, Rahman Z, Sayeed V, Raw A, Yu L, Khan MA,. 2012. Crystallinity evaluation of tacrolimus solid dispersions by chemometric analysis. Int J Pharm 423: 341-450.
    • (2012) Int J Pharm , vol.423 , pp. 341-450
    • Zidan, A.S.1    Rahman, Z.2    Sayeed, V.3    Raw, A.4    Yu, L.5    Khan, M.A.6
  • 23
    • 1442348833 scopus 로고    scopus 로고
    • Solid dispersion of carbamazepine in PVP K30 by conventional solvent evaporation and supercritical methods
    • Sethia S, Squillante E,. 2004. Solid dispersion of carbamazepine in PVP K30 by conventional solvent evaporation and supercritical methods. Int J Pharm 272: 1-10.
    • (2004) Int J Pharm , vol.272 , pp. 1-10
    • Sethia, S.1    Squillante, E.2
  • 24
    • 0009470340 scopus 로고
    • Physico-chemical properties of (-)-1R,9S,12S,13R,14S,17R,18E,21S,23S,24R, 25S,27R)-17-allyl-1,14-dihydroxy-12-[(E)-2-[(1R,3R,4R)-4-hydroxy-3- methoxycyclohexyl]-1-methylvinyl]-23,25-dimethoxy-13,19,21,27-tetrametyl-11, 28-dioxa-4-azatricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone hydrate (FK-506)
    • Hane K, Fujioka M, Namiki Y, Kitagawa T, Kihara N, Shimatani K, Yasuda T,. 1992. Physico-chemical properties of (-)-1R,9S,12S,13R,14S,17R,18E,21S,23S, 24R,25S,27R)-17-allyl-1,14-dihydroxy-12-[(E)-2-[(1R,3R,4R)-4-hydroxy-3- methoxycyclohexyl]-1-methylvinyl]-23,25-dimethoxy-13,19,21,27-tetrametyl-11, 28-dioxa-4-azatricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone hydrate (FK-506). Iyakuhin Kenkyu 23: 33-43.
    • (1992) Iyakuhin Kenkyu , vol.23 , pp. 33-43
    • Hane, K.1    Fujioka, M.2    Namiki, Y.3    Kitagawa, T.4    Kihara, N.5    Shimatani, K.6    Yasuda, T.7
  • 27
    • 33947175110 scopus 로고    scopus 로고
    • Lactose: A definitive guide to polymorph determination
    • Kirk JH, Danna SE, Blatchford CG,. 2007. Lactose: A definitive guide to polymorph determination. Int J Pharm 334: 103-114.
    • (2007) Int J Pharm , vol.334 , pp. 103-114
    • Kirk, J.H.1    Danna, S.E.2    Blatchford, C.G.3
  • 28
    • 77950668247 scopus 로고    scopus 로고
    • Near-infrared investigations of novel anti-HIV tenofovir liposomes
    • Zidan AS, Spinks C, Fortunak J, Habib M, Khan MA,. 2010. Near-infrared investigations of novel anti-HIV tenofovir liposomes. AAPS J 12: 202-214.
    • (2010) AAPS J , vol.12 , pp. 202-214
    • Zidan, A.S.1    Spinks, C.2    Fortunak, J.3    Habib, M.4    Khan, M.A.5
  • 29
    • 76649099150 scopus 로고    scopus 로고
    • Spectral and spatial characterization of protein loaded PLGA nanoparticles
    • Zidan AS, Rahman Z, Habib MJ, Khan MA,. 2010. Spectral and spatial characterization of protein loaded PLGA nanoparticles. J Pharm Sci 99: 1180-1192.
    • (2010) J Pharm Sci , vol.99 , pp. 1180-1192
    • Zidan, A.S.1    Rahman, Z.2    Habib, M.J.3    Khan, M.A.4
  • 30
    • 77955659891 scopus 로고    scopus 로고
    • Non-destructive methods of characterization of risperidone solid lipid nanoparticles
    • Rahman Z, Zidan AS, Khan MA,. 2010. Non-destructive methods of characterization of risperidone solid lipid nanoparticles. Eur J Pharm Biopharm 76: 127-137.
    • (2010) Eur J Pharm Biopharm , vol.76 , pp. 127-137
    • Rahman, Z.1    Zidan, A.S.2    Khan, M.A.3
  • 31
    • 84889080791 scopus 로고    scopus 로고
    • Orally disintegrating tablet of novel salt of antiepileptic drug: Formulation strategy and evaluation
    • Rahman Z, Siddiqui A, Khan MA,. 2013. Orally disintegrating tablet of novel salt of antiepileptic drug: Formulation strategy and evaluation. Eur J Pharm Biopharm 85: 1300-1309.
    • (2013) Eur J Pharm Biopharm , vol.85 , pp. 1300-1309
    • Rahman, Z.1    Siddiqui, A.2    Khan, M.A.3
  • 32
    • 0003597018 scopus 로고
    • Principles, theory, and practice of internal reflection spectroscopy, internal reflection spectroscopy-theory and applications
    • Mirabella F.M. Jr, Ed. New York: Marcel Dekker, Inc
    • Maribeli FM,. 1993. Principles, theory, and practice of internal reflection spectroscopy, internal reflection spectroscopy-theory and applications. In Internal reflection spectroscopy: Theory and application;, Mirabella FM Jr, Ed. New York: Marcel Dekker, Inc., pp 17-52.
    • (1993) Internal Reflection Spectroscopy: Theory and Application , pp. 17-52
    • Maribeli, F.M.1


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