메뉴 건너뛰기




Volumn 69, Issue 2, 2008, Pages 648-657

Using biorelevant dissolution to obtain IVIVC of solid dosage forms containing a poorly-soluble model compound

Author keywords

Biorelevant media; Dissolution; In vivo in vitro correlation (IVIVC); Poorly soluble; Solubility

Indexed keywords

ANTIDIABETIC AGENT; BILE SALT; CATIONIC SURFACTANT; CETRIMIDE; GLYCEROL OLEATE; HEMIBENZATHINE; MALEIC ACID DERIVATIVE; NNC 25 0926; OLEIC ACID; PHOSPHATIDYLCHOLINE; SODIUM AZIDE; SODIUM CHLORIDE; TRISMA MALEATE;

EID: 43249127225     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2007.12.013     Document Type: Article
Times cited : (58)

References (33)
  • 1
    • 0028948839 scopus 로고
    • A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability
    • Amidon G.L., Lennernas H., Shah V.P., and Crison J.R. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm. Res. 12 3 (1995) 413-420
    • (1995) Pharm. Res. , vol.12 , Issue.3 , pp. 413-420
    • Amidon, G.L.1    Lennernas, H.2    Shah, V.P.3    Crison, J.R.4
  • 2
    • 0033805179 scopus 로고    scopus 로고
    • In vitro-in vivo correlations for lipophilic, poorly water-soluble drugs
    • Dressman J.B., and Reppas C. In vitro-in vivo correlations for lipophilic, poorly water-soluble drugs. Eur. J. Pharm. Sci. 11 Suppl. 2 (2000) S73-S80
    • (2000) Eur. J. Pharm. Sci. , vol.11 , Issue.SUPPL. 2
    • Dressman, J.B.1    Reppas, C.2
  • 3
    • 0031913402 scopus 로고    scopus 로고
    • Dissolution testing as a prognostic tool for oral drug absorption: immediate release dosage forms
    • Dressman J.B., Amidon G.L., Reppas C., and Shah V.P. Dissolution testing as a prognostic tool for oral drug absorption: immediate release dosage forms. Pharm. Res. 15 1 (1998) 11-22
    • (1998) Pharm. Res. , vol.15 , Issue.1 , pp. 11-22
    • Dressman, J.B.1    Amidon, G.L.2    Reppas, C.3    Shah, V.P.4
  • 4
    • 0034948871 scopus 로고    scopus 로고
    • Biorelevant dissolution testing to predict the plasma profile of lipophilic drugs after oral administration
    • Nicolaides E., Symillides M., Dressman J.B., and Reppas C. Biorelevant dissolution testing to predict the plasma profile of lipophilic drugs after oral administration. Pharm. Res. 18 3 (2001) 380-388
    • (2001) Pharm. Res. , vol.18 , Issue.3 , pp. 380-388
    • Nicolaides, E.1    Symillides, M.2    Dressman, J.B.3    Reppas, C.4
  • 5
    • 25444464372 scopus 로고    scopus 로고
    • Bioavailability of seocalcitol I: relating solubility in biorelevant media with oral bioavailability on rats - effect of medium and long chain triglycerides
    • Grove M., Pedersen G.P., Nielsen J.L., and Mullertz A. Bioavailability of seocalcitol I: relating solubility in biorelevant media with oral bioavailability on rats - effect of medium and long chain triglycerides. J. Pharm. Sci. 94 8 (2005) 1830-1838
    • (2005) J. Pharm. Sci. , vol.94 , Issue.8 , pp. 1830-1838
    • Grove, M.1    Pedersen, G.P.2    Nielsen, J.L.3    Mullertz, A.4
  • 6
    • 0031750861 scopus 로고    scopus 로고
    • Evaluation of various dissolution media for predicting in vivo performance of class I and II drugs
    • Galia E., Nicolaides E., Horter D., Lobenberg R., Reppas C., and Dressman J.B. Evaluation of various dissolution media for predicting in vivo performance of class I and II drugs. Pharm. Res. 15 5 (1998) 698-705
    • (1998) Pharm. Res. , vol.15 , Issue.5 , pp. 698-705
    • Galia, E.1    Nicolaides, E.2    Horter, D.3    Lobenberg, R.4    Reppas, C.5    Dressman, J.B.6
  • 7
    • 0033452575 scopus 로고    scopus 로고
    • Forcasting the in vivo performance of four low solubility drugs from their in vitro dissolution data
    • Nicolaides E., Galia E., Efthymiopoulos C., Dressman J.B., and Reppas C. Forcasting the in vivo performance of four low solubility drugs from their in vitro dissolution data. Pharm. Res. 16 12 (1999) 1876-1882
    • (1999) Pharm. Res. , vol.16 , Issue.12 , pp. 1876-1882
    • Nicolaides, E.1    Galia, E.2    Efthymiopoulos, C.3    Dressman, J.B.4    Reppas, C.5
  • 8
    • 24644431507 scopus 로고    scopus 로고
    • Canine versus in vitro data for predicting input profiles of I-sulpiride after oral administration
    • Fotaki N., Symillides M., and Reppas C. Canine versus in vitro data for predicting input profiles of I-sulpiride after oral administration. Eur. J. Pharm. Sci. 26 3-4 (2005) 324-333
    • (2005) Eur. J. Pharm. Sci. , vol.26 , Issue.3-4 , pp. 324-333
    • Fotaki, N.1    Symillides, M.2    Reppas, C.3
  • 9
    • 1942498896 scopus 로고    scopus 로고
    • Use of in vitro lipid digestion data to explain the in vivo performance of triglyceride-based oral lipid formulations of poorly water-soluble drugs: studies with halofantrine
    • Porter C.J.H., Kaukonen A.M., Taillardat-Bertschinger A., Boyd B.J., O'Connor J.M., Edwards G.A., and Charman W.N. Use of in vitro lipid digestion data to explain the in vivo performance of triglyceride-based oral lipid formulations of poorly water-soluble drugs: studies with halofantrine. J. Pharm. Sci. 93 5 (2004) 1110-1121
    • (2004) J. Pharm. Sci. , vol.93 , Issue.5 , pp. 1110-1121
    • Porter, C.J.H.1    Kaukonen, A.M.2    Taillardat-Bertschinger, A.3    Boyd, B.J.4    O'Connor, J.M.5    Edwards, G.A.6    Charman, W.N.7
  • 10
    • 0031900490 scopus 로고    scopus 로고
    • Development and internal validation of an in vitro-in vivo correlation for a hydrophilic metoprolol tartrate extended release tablet formulation
    • Eddington N.D., Marroum P., Uppoor V., Hussain A., and Augsburger L. Development and internal validation of an in vitro-in vivo correlation for a hydrophilic metoprolol tartrate extended release tablet formulation. Pharm. Res. 15 3 (1998) 466-473
    • (1998) Pharm. Res. , vol.15 , Issue.3 , pp. 466-473
    • Eddington, N.D.1    Marroum, P.2    Uppoor, V.3    Hussain, A.4    Augsburger, L.5
  • 11
    • 43249128719 scopus 로고    scopus 로고
    • IVIVC: an important tool in the development of drug delivery
    • Sunkara G., and Chilukuri D.M. IVIVC: an important tool in the development of drug delivery. Drug Deliv. Tech. 3 4 (2003)
    • (2003) Drug Deliv. Tech. , vol.3 , Issue.4
    • Sunkara, G.1    Chilukuri, D.M.2
  • 12
    • 32244434196 scopus 로고    scopus 로고
    • Characterization of the human upper gastrointestinal contents under conditions simulating bioavailability/bioequivalence studies
    • Kalantzi L., Goumas K., Kalioras V., Abrahamsson B., Dressman J.B., and Reppas C. Characterization of the human upper gastrointestinal contents under conditions simulating bioavailability/bioequivalence studies. Pharm. Res. 23 1 (2006) 165-176
    • (2006) Pharm. Res. , vol.23 , Issue.1 , pp. 165-176
    • Kalantzi, L.1    Goumas, K.2    Kalioras, V.3    Abrahamsson, B.4    Dressman, J.B.5    Reppas, C.6
  • 13
    • 0030927353 scopus 로고    scopus 로고
    • Characterization of fluids from the stomach and proximal jejunum in men and women
    • Lindahl A., Ungell A.L., Knutson L., and Lennernas H. Characterization of fluids from the stomach and proximal jejunum in men and women. Pharm. Res. 14 4 (1997) 497-502
    • (1997) Pharm. Res. , vol.14 , Issue.4 , pp. 497-502
    • Lindahl, A.1    Ungell, A.L.2    Knutson, L.3    Lennernas, H.4
  • 14
    • 0035095380 scopus 로고    scopus 로고
    • Wetting behaviour of bile salt-lipid dispersions and dissolution media patterned after intestinal fluids
    • Luner P.E., and Vander Kamp K.D. Wetting behaviour of bile salt-lipid dispersions and dissolution media patterned after intestinal fluids. J. Pharm. Sci. 90 3 (2001) 348-359
    • (2001) J. Pharm. Sci. , vol.90 , Issue.3 , pp. 348-359
    • Luner, P.E.1    Vander Kamp, K.D.2
  • 15
    • 0035478436 scopus 로고    scopus 로고
    • In vitro assessment of oral lipid based formulations
    • Porter C.J.H., and Charman W.N. In vitro assessment of oral lipid based formulations. Adv. Drug Deliv. Rev. 50 (2001) S127-S147
    • (2001) Adv. Drug Deliv. Rev. , vol.50
    • Porter, C.J.H.1    Charman, W.N.2
  • 18
    • 0030606871 scopus 로고    scopus 로고
    • Dissolution testing for sustained or controlled release oral dosage forms and correlation with in vivo data: challenges and opportunities
    • Khan M.Z.I. Dissolution testing for sustained or controlled release oral dosage forms and correlation with in vivo data: challenges and opportunities. Int. J. Pharm. 140 2 (1996) 131-143
    • (1996) Int. J. Pharm. , vol.140 , Issue.2 , pp. 131-143
    • Khan, M.Z.I.1
  • 19
    • 43249105161 scopus 로고    scopus 로고
    • [Anon], FIP Guidelines for dissolution testing of solid oral products - 1997, Dissol. Tech. (1997) 5-14.
    • [Anon], FIP Guidelines for dissolution testing of solid oral products - 1997, Dissol. Tech. (1997) 5-14.
  • 20
    • 43249102534 scopus 로고    scopus 로고
    • [Anon], The dissolution procedure: development and validation (1092) In process revision, Pharmacopeial Forum 31 (5) (2005) 1463-1475.
    • [Anon], The dissolution procedure: development and validation (1092) In process revision, Pharmacopeial Forum 31 (5) (2005) 1463-1475.
  • 21
    • 0035660775 scopus 로고    scopus 로고
    • Evaluation and selection of biorelevant dissolution media for a poorly water-soluble new chemical entity
    • Tang L., Khan S.U., and Muhammad N.A. Evaluation and selection of biorelevant dissolution media for a poorly water-soluble new chemical entity. Pharm. Dev. Tech. 6 4 (2001) 531-540
    • (2001) Pharm. Dev. Tech. , vol.6 , Issue.4 , pp. 531-540
    • Tang, L.1    Khan, S.U.2    Muhammad, N.A.3
  • 22
    • 0034601240 scopus 로고    scopus 로고
    • Improving drug solubility for oral delivery using solid dispersions
    • Leuner C., and Dressman J.B. Improving drug solubility for oral delivery using solid dispersions. Eur. J. Pharm. Biopharm. 50 1 (2000) 47-60
    • (2000) Eur. J. Pharm. Biopharm. , vol.50 , Issue.1 , pp. 47-60
    • Leuner, C.1    Dressman, J.B.2
  • 23
    • 0035292910 scopus 로고    scopus 로고
    • Influence of physicochemical properties on dissolution of drugs in the gastrointestinal tract
    • Hörter D., and Dressman J.B. Influence of physicochemical properties on dissolution of drugs in the gastrointestinal tract. Adv. Drug Deliv. Rev. 46 1-3 (2001) 75-87
    • (2001) Adv. Drug Deliv. Rev. , vol.46 , Issue.1-3 , pp. 75-87
    • Hörter, D.1    Dressman, J.B.2
  • 24
    • 21544447265 scopus 로고    scopus 로고
    • Simulation of fasting gastric conditions and its importance for the in vivo dissolution of lipophilic compounds
    • Vertzoni M., Dressman J.B., Butler J., Hempenstall J., and Reppas C. Simulation of fasting gastric conditions and its importance for the in vivo dissolution of lipophilic compounds. Eur. J. Pharm. Biopharm. 60 3 (2005) 413-417
    • (2005) Eur. J. Pharm. Biopharm. , vol.60 , Issue.3 , pp. 413-417
    • Vertzoni, M.1    Dressman, J.B.2    Butler, J.3    Hempenstall, J.4    Reppas, C.5
  • 25
    • 0035808325 scopus 로고    scopus 로고
    • Wetting characteristics of media emulating gastric fluids
    • Luner P.E., and Vander Kamp K.D. Wetting characteristics of media emulating gastric fluids. Int. J. Pharm. 212 1 (2001) 81-91
    • (2001) Int. J. Pharm. , vol.212 , Issue.1 , pp. 81-91
    • Luner, P.E.1    Vander Kamp, K.D.2
  • 27
    • 15744390959 scopus 로고    scopus 로고
    • Diclofenac sodium multisource prolonged release tablets - a comparative study on the dissolution profiles
    • Bertocchi P., Antoniella E., Valvo L., Alimonti S., and Memoli A. Diclofenac sodium multisource prolonged release tablets - a comparative study on the dissolution profiles. J. Pharm. Biomed. Anal. 37 4 (2005) 679-685
    • (2005) J. Pharm. Biomed. Anal. , vol.37 , Issue.4 , pp. 679-685
    • Bertocchi, P.1    Antoniella, E.2    Valvo, L.3    Alimonti, S.4    Memoli, A.5
  • 28
    • 12344280118 scopus 로고    scopus 로고
    • An investigation of the disintegration of tablets in biorelevant media
    • Anwar S., Fell J.T., and Dickinson P.A. An investigation of the disintegration of tablets in biorelevant media. Int. J. Pharm. 290 1-2 (2005) 121-127
    • (2005) Int. J. Pharm. , vol.290 , Issue.1-2 , pp. 121-127
    • Anwar, S.1    Fell, J.T.2    Dickinson, P.A.3
  • 29
    • 14144250013 scopus 로고    scopus 로고
    • In vivo-in vitro correlations for a poorly soluble drug, danazol, using the flow-through dissolution method with biorelevant dissolution media
    • Sunesen V.H., Pedersen B.L., Kristensen H.G., and Müllertz A. In vivo-in vitro correlations for a poorly soluble drug, danazol, using the flow-through dissolution method with biorelevant dissolution media. Eur. J. Pharm. Sci. 24 4 (2005) 305-313
    • (2005) Eur. J. Pharm. Sci. , vol.24 , Issue.4 , pp. 305-313
    • Sunesen, V.H.1    Pedersen, B.L.2    Kristensen, H.G.3    Müllertz, A.4
  • 30
    • 28444435904 scopus 로고    scopus 로고
    • A level A in vitro/in vivo correlation in fasted and fed states using different methods: applied to solid immediate release oral dosage forms
    • Souliman S., Blanquet S., Beyssac E., and Cardot J.M. A level A in vitro/in vivo correlation in fasted and fed states using different methods: applied to solid immediate release oral dosage forms. Eur. J. Pharm. Sci. 27 1 (2006) 72-79
    • (2006) Eur. J. Pharm. Sci. , vol.27 , Issue.1 , pp. 72-79
    • Souliman, S.1    Blanquet, S.2    Beyssac, E.3    Cardot, J.M.4
  • 31
    • 33745377516 scopus 로고    scopus 로고
    • Canine intestinal contents vs. simulated media for the assessment of solubility of two weak bases in the human small intestinal contents
    • Kalantzi L., Persson E., Polentarutti B., Abrahamsson B., Goumas K., Dressman J.B., and Reppas C. Canine intestinal contents vs. simulated media for the assessment of solubility of two weak bases in the human small intestinal contents. Pharm. Res. 23 6 (2006) 1373-1381
    • (2006) Pharm. Res. , vol.23 , Issue.6 , pp. 1373-1381
    • Kalantzi, L.1    Persson, E.2    Polentarutti, B.3    Abrahamsson, B.4    Goumas, K.5    Dressman, J.B.6    Reppas, C.7
  • 32
    • 0022966980 scopus 로고
    • Comparison of canine and human gastrointestinal physiology
    • Dressman J.B. Comparison of canine and human gastrointestinal physiology. Pharm. Res. 3 3 (1986) 123-131
    • (1986) Pharm. Res. , vol.3 , Issue.3 , pp. 123-131
    • Dressman, J.B.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.