메뉴 건너뛰기




Volumn 427, Issue 2, 2012, Pages 260-269

Developability assessment of clinical drug products with maximum absorbable doses

Author keywords

Developability assessment; Drug absorption; GastroPlus ; Maximum absorbable dose; Simulation

Indexed keywords

ATENOLOL; CARBAMAZEPINE; CIMETIDINE; DESIPRAMINE; ENALAPRILAT; FLUINDOSTATIN; FOSINOPRIL; FUROSEMIDE; HYDROCHLOROTHIAZIDE; KETOPROFEN; METOPROLOL; NAPROXEN; PHENAZONE; PROPRANOLOL; RANITIDINE; TERBUTALINE; VERAPAMIL;

EID: 84859104300     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2012.02.003     Document Type: Article
Times cited : (29)

References (39)
  • 2
    • 36549043514 scopus 로고    scopus 로고
    • A critical evaluation of fasted state simulating gastric fluid (FaSSGF) that contains sodium lauryl sulfate and proposal of a modified recipe
    • A. Aburub, D.S. Risley, and D. Mishra A critical evaluation of fasted state simulating gastric fluid (FaSSGF) that contains sodium lauryl sulfate and proposal of a modified recipe Int. J. Pharm. 347 2008 16 22
    • (2008) Int. J. Pharm. , vol.347 , pp. 16-22
    • Aburub, A.1    Risley, D.S.2    Mishra, D.3
  • 3
    • 0025804183 scopus 로고
    • Correlation between oral drug absorption in humans and apparent drug permeability coefficients in human intestinal epithelial (Caco-2) cells
    • P. Artursson, and J. Karlsson Correlation between oral drug absorption in humans and apparent drug permeability coefficients in human intestinal epithelial (Caco-2) cells Biochem. Biophys. Res. Commun. 175 1991 880 885
    • (1991) Biochem. Biophys. Res. Commun. , vol.175 , pp. 880-885
    • Artursson, P.1    Karlsson, J.2
  • 4
    • 0025102678 scopus 로고
    • The use of cultured epithelial and endothelia cells for drug transport and metabolism studies
    • K.L. Audus, R.L. Bartel, I.J. Hidalgo, and R.T. Borchardt The use of cultured epithelial and endothelia cells for drug transport and metabolism studies Pharm. Res. 7 1990 435 451
    • (1990) Pharm. Res. , vol.7 , pp. 435-451
    • Audus, K.L.1    Bartel, R.L.2    Hidalgo, I.J.3    Borchardt, R.T.4
  • 5
    • 0034821939 scopus 로고    scopus 로고
    • Role of transport proteins in drug absorption, distribution and excretion
    • A. Ayrton, and P. Morgan Role of transport proteins in drug absorption, distribution and excretion Xenobiotica 31 2001 469 497
    • (2001) Xenobiotica , vol.31 , pp. 469-497
    • Ayrton, A.1    Morgan, P.2
  • 6
    • 0025930844 scopus 로고
    • Solubilization and wetting effects of bile salts on the dissolution of steroids
    • V. Bakatselou, R.C. Oppenheim, and J.B. Dressman Solubilization and wetting effects of bile salts on the dissolution of steroids Pharm. Res. 8 1991 1461 1499
    • (1991) Pharm. Res. , vol.8 , pp. 1461-1499
    • Bakatselou, V.1    Oppenheim, R.C.2    Dressman, J.B.3
  • 7
    • 0141611171 scopus 로고    scopus 로고
    • Predicting passive transport in silico: History, hype, hope
    • D.E. Clark, and P.D.J. Grootenhuis Predicting passive transport in silico: history, hype, hope Curr. Top. Med. Chem. 3 2003 1193 1203
    • (2003) Curr. Top. Med. Chem. , vol.3 , pp. 1193-1203
    • Clark, D.E.1    Grootenhuis, P.D.J.2
  • 8
    • 0031913402 scopus 로고    scopus 로고
    • Dissolution testing as a prognostic tool for oral drug absorption: Immediate-release dosage forms
    • J.B. Dressman, G.L. Amidon, C. Reppas, and V.P. Shah Dissolution testing as a prognostic tool for oral drug absorption: immediate-release dosage forms Pharm. Res. 15 1998 11 22
    • (1998) Pharm. Res. , vol.15 , pp. 11-22
    • Dressman, J.B.1    Amidon, G.L.2    Reppas, C.3    Shah, V.P.4
  • 10
    • 0037204547 scopus 로고    scopus 로고
    • Prediction of intestinal permeability
    • W.J. Egan, and G. Lauri Prediction of intestinal permeability Adv. Drug Deliv. Rev. 54 2002 273 289
    • (2002) Adv. Drug Deliv. Rev. , vol.54 , pp. 273-289
    • Egan, W.J.1    Lauri, G.2
  • 11
    • 0026095587 scopus 로고
    • Drug absorption in gastrointestinal disease and surgery. Clinical pharmacokinetic and therapeutic implications
    • P.O. Gubbins, and K.E. Bertch Drug absorption in gastrointestinal disease and surgery. Clinical pharmacokinetic and therapeutic implications Clin. Pharmacokinet. 21 1991 431 447
    • (1991) Clin. Pharmacokinet. , vol.21 , pp. 431-447
    • Gubbins, P.O.1    Bertch, K.E.2
  • 13
    • 84882910186 scopus 로고    scopus 로고
    • Integration of physical, chemical, mechanical, and biopharmaceutical properties in solid oral dosage form development
    • Y. Qiu, Y. Chen, G.Z. Zhang, Elsevier Inc. Oxford, UK
    • X. He Integration of physical, chemical, mechanical, and biopharmaceutical properties in solid oral dosage form development Y. Qiu, Y. Chen, G.Z. Zhang, Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice 2009 Elsevier Inc. Oxford, UK 407 441
    • (2009) Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice , pp. 407-441
    • He, X.1
  • 14
    • 0024596954 scopus 로고
    • The effect of particle size distribution on the dissolution rate and oral absorption
    • R.J. Hintz, and K.C. Johnson The effect of particle size distribution on the dissolution rate and oral absorption Int. J. Pharm. 51 1989 9 17
    • (1989) Int. J. Pharm. , vol.51 , pp. 9-17
    • Hintz, R.J.1    Johnson, K.C.2
  • 15
    • 1042264121 scopus 로고    scopus 로고
    • Impact of solid state properties in developability assessment of drug candidate
    • L.F. Huang, and W.Q. Tong Impact of solid state properties in developability assessment of drug candidate Adv. Drug Deliv. Rev. 56 2004 321 334
    • (2004) Adv. Drug Deliv. Rev. , vol.56 , pp. 321-334
    • Huang, L.F.1    Tong, W.Q.2
  • 16
    • 0030444550 scopus 로고    scopus 로고
    • Guidance in the setting of drug particle size specifications to minimize variability in absorption
    • K.C. Johnson, and A.C. Swindell Guidance in the setting of drug particle size specifications to minimize variability in absorption Pharm. Res. 13 1996 1795 1798
    • (1996) Pharm. Res. , vol.13 , pp. 1795-1798
    • Johnson, K.C.1    Swindell, A.C.2
  • 17
    • 0141680647 scopus 로고    scopus 로고
    • Dissolution and absorption modeling: Model expansion to simulate the effects of precipitation, water absorption, longitudinally changing intestinal permeability, and controlled release on drug absorption
    • K.C. Johnson Dissolution and absorption modeling: model expansion to simulate the effects of precipitation, water absorption, longitudinally changing intestinal permeability, and controlled release on drug absorption Drug Dev. Ind. Pharm. 29 2003 833 842
    • (2003) Drug Dev. Ind. Pharm. , vol.29 , pp. 833-842
    • Johnson, K.C.1
  • 19
    • 0024218061 scopus 로고
    • Endogenous and exogenous opioids in the control of gastrointestinal motility and secretion
    • W. Kromer Endogenous and exogenous opioids in the control of gastrointestinal motility and secretion Pharmacol. Rev. 40 1988 121 162
    • (1988) Pharmacol. Rev. , vol.40 , pp. 121-162
    • Kromer, W.1
  • 20
    • 0026795241 scopus 로고
    • Regional jejunal perfusion, a new in vivo approach to study oral drug absorption in man
    • H. Lennernäs, Ö. Ahrenstedt, R. Hällgren, L. Knutson, M. Ryde, and L. Paalzow Regional jejunal perfusion, a new in vivo approach to study oral drug absorption in man Pharm. Res. 9 1992 1243 1251
    • (1992) Pharm. Res. , vol.9 , pp. 1243-1251
    • Lennernäs, H.1    Ahrenstedt, Ö.2    Hällgren, R.3    Knutson, L.4    Ryde, M.5    Paalzow, L.6
  • 21
    • 0030023536 scopus 로고    scopus 로고
    • Comparison between active and passive drug transport in human intestinal epithelial (Caco-2) cells in vitro and human jejunum in vivo
    • H. Lennernäs, K. Palm, U. Fagerholm, and P. Artursson Comparison between active and passive drug transport in human intestinal epithelial (Caco-2) cells in vitro and human jejunum in vivo Int. J. Pharm. 127 1996 103 107
    • (1996) Int. J. Pharm. , vol.127 , pp. 103-107
    • Lennernäs, H.1    Palm, K.2    Fagerholm, U.3    Artursson, P.4
  • 22
    • 0031925268 scopus 로고    scopus 로고
    • Human intestinal permeability
    • H. Lennernäs Human intestinal permeability J. Pharm. Sci. 87 1998 403 410
    • (1998) J. Pharm. Sci. , vol.87 , pp. 403-410
    • Lennernäs, H.1
  • 24
    • 0043127396 scopus 로고    scopus 로고
    • PH-dependent bidirectional transport of weakly basic drugs across Caco-2 monolayers: Implications for drug-drug interactions
    • S. Neuhoff, A.-L. Ungell, I. Zamora, and P. Artusson pH-dependent bidirectional transport of weakly basic drugs across Caco-2 monolayers: implications for drug-drug interactions Pharm. Res. 20 2003 1141 1148
    • (2003) Pharm. Res. , vol.20 , pp. 1141-1148
    • Neuhoff, S.1    Ungell, A.-L.2    Zamora, I.3    Artusson, P.4
  • 25
    • 19444382806 scopus 로고    scopus 로고
    • PH-dependent passive and active transport of acidic drugs across Caco-2 cell monolayers
    • S. Neuhoff, A.-L. Ungell, I. Zamora, and P. Artusson pH-dependent passive and active transport of acidic drugs across Caco-2 cell monolayers Eur. J. Pharm. Sci. 25 2005 211 220
    • (2005) Eur. J. Pharm. Sci. , vol.25 , pp. 211-220
    • Neuhoff, S.1    Ungell, A.-L.2    Zamora, I.3    Artusson, P.4
  • 26
    • 0027473738 scopus 로고
    • Estimating the fraction dose absorbed from suspensions of poorly soluble compounds in humans
    • D-M. Oh, R.L. Curl, and G.L. Amidon Estimating the fraction dose absorbed from suspensions of poorly soluble compounds in humans Pharm. Res. 10 1993 264 270
    • (1993) Pharm. Res. , vol.10 , pp. 264-270
    • Oh, D.-M.1    Curl, R.L.2    Amidon, G.L.3
  • 27
    • 33847394968 scopus 로고    scopus 로고
    • Lipids and lipid-based formulations: Optimizing the oral delivery of lipophilic drugs
    • C.J.H. Porter, N.L. Trevaskis, and W.N. Charman Lipids and lipid-based formulations: optimizing the oral delivery of lipophilic drugs Nat. Rev. Drug Discov. 2007 6231 6248
    • (2007) Nat. Rev. Drug Discov. , pp. 6231-6248
    • Porter, C.J.H.1    Trevaskis, N.L.2    Charman, W.N.3
  • 28
    • 67049169036 scopus 로고    scopus 로고
    • Developability assessment in pharmaceutical industry: An integrated group approach for selecting developable candidates
    • V. Saxena, R. Panicucci, Y. Joshi, and S. Garad Developability assessment in pharmaceutical industry: an integrated group approach for selecting developable candidates J. Pharm. Sci. 98 2009 1962 1979
    • (2009) J. Pharm. Sci. , vol.98 , pp. 1962-1979
    • Saxena, V.1    Panicucci, R.2    Joshi, Y.3    Garad, S.4
  • 29
    • 0032885450 scopus 로고    scopus 로고
    • Solid dispersion of poorly water-soluble drugs: Early promises, subsequent problems, and recent breakthroughs
    • A.T. Serajuddin Solid dispersion of poorly water-soluble drugs: early promises, subsequent problems, and recent breakthroughs J. Pharm. Sci. 88 1999 1058 1066
    • (1999) J. Pharm. Sci. , vol.88 , pp. 1058-1066
    • Serajuddin, A.T.1
  • 30
    • 2942717194 scopus 로고    scopus 로고
    • Development and use of hydrophobic surface area (HAS) descriptors for computer-assisted quantitative structure-activity and structure-property relationship studies
    • D.T. Stanton, B.E. Mattioni, J.J. Knittel, and P.C. Jurs Development and use of hydrophobic surface area (HAS) descriptors for computer-assisted quantitative structure-activity and structure-property relationship studies J. Chem. Inf. Comput. Sci. 44 2004 1010 1023
    • (2004) J. Chem. Inf. Comput. Sci. , vol.44 , pp. 1010-1023
    • Stanton, D.T.1    Mattioni, B.E.2    Knittel, J.J.3    Jurs, P.C.4
  • 31
    • 2942585051 scopus 로고    scopus 로고
    • In vitro testing of drug absorption for drug 'developability' assessment: Forming an interface between in vitro preclinical data and clinical outcome
    • D. Sun, L.X. Yu, M.A. Hussain, D.A. Wall, R.L. Smith, and G.L. Amidon In vitro testing of drug absorption for drug 'developability' assessment: forming an interface between in vitro preclinical data and clinical outcome Curr. Opin. Drug Discov. Devel. 7 2004 75 85
    • (2004) Curr. Opin. Drug Discov. Devel. , vol.7 , pp. 75-85
    • Sun, D.1    Yu, L.X.2    Hussain, M.A.3    Wall, D.A.4    Smith, R.L.5    Amidon, G.L.6
  • 32
    • 68249133855 scopus 로고    scopus 로고
    • Role of physiological intestinal water in oral absorption
    • S.C. Sutton Role of physiological intestinal water in oral absorption AAPS J. 11 2009 277 285
    • (2009) AAPS J. , vol.11 , pp. 277-285
    • Sutton, S.C.1
  • 34
    • 39749114622 scopus 로고    scopus 로고
    • Variability in Caco-2 and MDCK cell-based intestinal permeability assay
    • D.A. Volpe Variability in Caco-2 and MDCK cell-based intestinal permeability assay J. Pharm. Sci. 97 2008 712 725
    • (2008) J. Pharm. Sci. , vol.97 , pp. 712-725
    • Volpe, D.A.1
  • 35
    • 0035991618 scopus 로고    scopus 로고
    • Examination of the solubilization of drugs by bile salt micelles
    • T.S. Wiedmann, and L. Kamel Examination of the solubilization of drugs by bile salt micelles J. Pharm. Sci. 91 2002 1743 1764
    • (2002) J. Pharm. Sci. , vol.91 , pp. 1743-1764
    • Wiedmann, T.S.1    Kamel, L.2
  • 36
    • 0032480901 scopus 로고    scopus 로고
    • Correlation of human jejunal permeability (in vivo) of drugs with experimentally and theoretically derived parameters. A multivariate data analysis approach
    • S. Winiwarter, N.M. Bonham, F. Ax, A. Hallberg, H. Lennernäs, and A. Karlén Correlation of human jejunal permeability (in vivo) of drugs with experimentally and theoretically derived parameters. A multivariate data analysis approach J. Med. Chem. 41 1998 4939 4949
    • (1998) J. Med. Chem. , vol.41 , pp. 4939-4949
    • Winiwarter, S.1    Bonham, N.M.2    Ax, F.3    Hallberg, A.4    Lennernäs, H.5    Karlén, A.6
  • 37
    • 4243572731 scopus 로고
    • A strategic approach for predicting oral drug absorption
    • L.X. Yu, J.R. Crison, and G.L. Amidon A strategic approach for predicting oral drug absorption Pharm. Res. 12 1995 S8
    • (1995) Pharm. Res. , vol.12 , pp. 8
    • Yu, L.X.1    Crison, J.R.2    Amidon, G.L.3
  • 38
    • 0032531309 scopus 로고    scopus 로고
    • Characterization of small intestinal transit time distribution in humans
    • L. Yu, and G.L. Amidon Characterization of small intestinal transit time distribution in humans Int. J. Pharm. 171 1998 157 163
    • (1998) Int. J. Pharm. , vol.171 , pp. 157-163
    • Yu, L.1    Amidon, G.L.2
  • 39
    • 0033427120 scopus 로고    scopus 로고
    • An integrated model for determining causes of poor oral drug absorption
    • L.X. Yu An integrated model for determining causes of poor oral drug absorption Pharm. Res. 16 1999 1883 1887
    • (1999) Pharm. Res. , vol.16 , pp. 1883-1887
    • Yu, L.X.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.