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Volumn 18, Issue 3, 2011, Pages 6-13

Intrinsic dissolution as a tool for evaluating drug solubility in accordance with the biopharmaceutics classification system

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOPHARMACEUTICS CLASSIFICATION SYSTEM; DRUG ABSORPTION; DRUG CLASSIFICATION; DRUG PENETRATION; DRUG RESEARCH; DRUG SCREENING; DRUG SOLUBILITY; INTRINSIC DISSOLUTION TEST; PH;

EID: 80052709171     PISSN: 1521298X     EISSN: None     Source Type: Journal    
DOI: 10.14227/DT180311P6     Document Type: Article
Times cited : (77)

References (45)
  • 1
    • 80052777391 scopus 로고    scopus 로고
    • Bioavailability and bioequivalence
    • Qiu, Y., Chen, Y., Zhang, G. G. Z., Liu, L., Porter, W. R., Eds.; Academic Press: Burlington, MA
    • Zhu, H.; Zhou, H.; Seitz, K. Bioavailability and Bioequivalence. In Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice; Qiu, Y., Chen, Y., Zhang, G. G. Z., Liu, L., Porter, W. R., Eds.; Academic Press: Burlington, MA, 2009; pp 341-364.
    • (2009) Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice , pp. 341-364
    • Zhu, H.1    Zhou, H.2    Seitz, K.3
  • 2
    • 33747373878 scopus 로고    scopus 로고
    • Century of dissolution research: From Noyes and Whitney to the biopharmaceutics classification system
    • Dokoumetzidis, A.; Macheras, P. A century of dissolution research: From Noyes and Whitney to the biopharmaceutics classification system. Int. J. Pharm.2006, 321, 1-11.
    • (2006) Int. J. Pharm. , vol.321 , pp. 1-11
    • Dokoumetzidis, A.1    Macheras, P.A.2
  • 3
    • 0034713284 scopus 로고    scopus 로고
    • Biopharmaceutics and pharmacokinetics in drug research
    • Panchagnula, R.; Thomas, N. S. Biopharmaceutics and pharmacokinetics in drug research. Int. J. Pharm. 2000, 201, 131-150.
    • (2000) Int. J. Pharm. , vol.201 , pp. 131-150
    • Panchagnula, R.1    Thomas, N.S.2
  • 4
    • 0035524043 scopus 로고    scopus 로고
    • In vitro prediction of gastrointestinal absorption and bioavailability: An experts' meeting report
    • Pelkonen, O.; Boobis, A. R.; Gundert-Remy, U. In vitro prediction of gastrointestinal absorption and bioavailability: an experts' meeting report. Eur. J. Clin. Pharmacol. 2001, 57 (9), 621-629.
    • (2001) Eur. J. Clin. Pharmacol. , vol.57 , Issue.9 , pp. 621-629
    • Pelkonen, O.1    Boobis, A.R.2    Gundert-Remy, U.3
  • 5
    • 3843097202 scopus 로고    scopus 로고
    • Classification of orally administered drugs on the World Health Organization model list of essential medicines according to the biopharmaceutics classification system
    • Lindenberg, M.; Kopp, S.; Dressman, J. B. Classification of orally administered drugs on the World Health Organization model list of essential medicines according to the biopharmaceutics classification system. Eur. J. Pharm. Biopharm. 2004, 58, 265-278.
    • (2004) Eur. J. Pharm. Biopharm. , vol.58 , pp. 265-278
    • Lindenberg, M.1    Kopp, S.2    Dressman, J.B.3
  • 7
    • 0028948839 scopus 로고
    • A theoretical basis for a biopharmaceutic drugclassification: The correlation of in vitro drug product dissolution and in vivo bioavailability
    • Amidon, G. L.; Lennernäs, H.; Shah, V. P.; Crison, J. R. A theoretical basis for a biopharmaceutic drugclassification: The correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm. Res.1995, 12 (3), 413-420.
    • (1995) Pharm. Res. , vol.12 , Issue.3 , pp. 413-420
    • Amidon, G.L.1    Lennernäs, H.2    Shah, V.P.3    Crison, J.R.4
  • 8
    • 14744272833 scopus 로고    scopus 로고
    • The use of biopharmaceutic classification of drugs in drug discovery and development: Current status and future extension
    • Lennernäs, H.; Abrahamsson, B. The use of biopharmaceutic classification of drugs in drug discovery and development: current status and future extension. J. Pharm. Pharmacol. 2005, 57, 273-285.
    • (2005) J. Pharm. Pharmacol. , vol.57 , pp. 273-285
    • Lennernäs, H.1    Abrahamsson, B.2
  • 9
    • 0032844618 scopus 로고    scopus 로고
    • Setting bioequivalence requirements for drug development based on preclinical data: Optimizing oral drug delivery systems
    • Lipka, E.; Amidon, G. L. Setting bioequivalence requirements for drug development based on preclinical data: optimizing oral drug delivery systems. J. Controlled Release 1999, 62, 41-49.
    • (1999) J. Controlled Release , vol.62 , pp. 41-49
    • Lipka, E.1    Amidon, G.L.2
  • 10
    • 0343527392 scopus 로고    scopus 로고
    • Modern biovailability, bioequivalence and biopharmaceutics classification system. New scientific approaches to international regulatory standards
    • Löbenberg, R.; Amidon, G. L. Modern biovailability, bioequivalence and biopharmaceutics classification system. New scientific approaches to international regulatory standards. Eur. J. Pharm. Biopharm. 2000, 50, 3-12.
    • (2000) Eur. J. Pharm. Biopharm. , vol.50 , pp. 3-12
    • Löbenberg, R.1    Amidon, G.L.2
  • 12
    • 84882895605 scopus 로고    scopus 로고
    • Solubility of Pharmaceutical Solids
    • Academic Press: Burlington, MA, Qiu, Y., Chen, Y., Zhang, G. G. Z., Liu, L., Porter, W. R., Eds
    • Rao, V. M.; Sanghvi, R.; Zhu, H. Solubility of Pharmaceutical Solids. In Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice; Qiu, Y., Chen, Y., Zhang, G. G. Z., Liu, L., Porter, W. R., Eds.; Academic Press: Burlington, MA, 2009; pp 3-23.
    • (2009) Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice , pp. 3-23
    • Rao, V.M.1    Sanghvi, R.2    Zhu, H.3
  • 14
    • 37849048981 scopus 로고    scopus 로고
    • Study of equilibrium solubility measurement by saturation shake-flask method using hydrochlorothiazide as model compound
    • Baka, E.; Comer, J. E.; Takács-Novák, K. Study of equilibrium solubility measurement by saturation shake-flask method using hydrochlorothiazide as model compound. J. Pharm. Biomed. Anal. 2008, 46 (2), 335-341.
    • (2008) J. Pharm. Biomed. Anal. , vol.46 , Issue.2 , pp. 335-341
    • Baka, E.1    Comer, J.E.2    Takács-Novák, K.3
  • 15
    • 0347021207 scopus 로고    scopus 로고
    • Feasibility studies of utilizing disk intrinsic dissolution rate to classify drugs
    • Yu, L. X.; Carlin, A. S.; Amidon, G. L.; Hussain A. S. Feasibility studies of utilizing disk intrinsic dissolution rate to classify drugs. Int. J. Pharm. 2004, 270 (1-2), 221-227.
    • (2004) Int. J. Pharm. , vol.270 , Issue.1-2 , pp. 221-227
    • Yu, L.X.1    Carlin, A.S.2    Amidon, G.L.3    Hussain, A.S.4
  • 16
    • 74249085196 scopus 로고    scopus 로고
    • Investigation of intrinsic dissolution behavior of different carbamazepine samples
    • Sehic, S.; Betz, G.; Hadzidedic, S.; El-Arini, S. K.; Leuenberger, H. Investigation of intrinsic dissolution behavior of different carbamazepine samples. Int. J. Pharm. 2010, 386 (1-2), 77-90.
    • (2010) Int. J. Pharm. , vol.386 , Issue.1-2 , pp. 77-90
    • Sehic, S.1    Betz, G.2    Hadzidedic, S.3    El-Arini, S.K.4    Leuenberger, H.5
  • 19
    • 68349157679 scopus 로고    scopus 로고
    • Biopharmaceutical classification of drugs using intrinsic dissolution rate (IDR) and rat intestinal permeability
    • Zakeri-Milani, P.; Barzegar-Jalali, M.; Azimi, M.; Valizadeh, H. Biopharmaceutical classification of drugs using intrinsic dissolution rate (IDR) and rat intestinal permeability. Eur. J. Pharm. Biopharm. 2009, 73 (1), 102-106.
    • (2009) Eur. J. Pharm. Biopharm. , vol.73 , Issue.1 , pp. 102-106
    • Zakeri-Milani, P.1    Barzegar-Jalali, M.2    Azimi, M.3    Valizadeh, H.4
  • 20
    • 51249095402 scopus 로고    scopus 로고
    • Use of the Biopharmaceutical Classification System in Early Drug Development
    • Ku, M. S. Use of the Biopharmaceutical Classification System in Early Drug Development. AAPS J. 2008, 10 (1), 208-212.
    • (2008) AAPS J , vol.10 , Issue.1 , pp. 208-212
    • Ku, M.S.1
  • 21
    • 46749104406 scopus 로고    scopus 로고
    • Bioavailability and Bioequivalence: Focus on Physiological Factors and Variability
    • Karalis, V.; Macheras, P.; Van Peer, A.; Shah, V. P. Bioavailability and Bioequivalence: Focus on Physiological Factors and Variability. Pharm. Res. 2008, 25 (8), 1956-1962.
    • (2008) Pharm. Res. , vol.25 , Issue.8 , pp. 1956-1962
    • Karalis, V.1    Macheras, P.2    van Peer, A.3    Shah, V.P.4
  • 22
    • 0036000312 scopus 로고    scopus 로고
    • Mechanistic approach to understanding the factors affecting drug absorption: A review of fundamentals
    • Martinez, M. N.; Amidon, G. L. A Mechanistic approach to understanding the factors affecting drug absorption: A review of fundamentals. J. Clin. Pharmacol. 2002, 42 (6), 620-643.
    • (2002) J. Clin. Pharmacol. , vol.42 , Issue.6 , pp. 620-643
    • Martinez, M.N.1    Amidon, G.L.A.2
  • 23
    • 84892037285 scopus 로고    scopus 로고
    • Assessment of Biopharmaceutical Properties
    • Pharmaceutics: The Science of Dosage Form Design; Aulton, M. E., Ed, London
    • Ashford, M. Assessment of Biopharmaceutical Properties. In Pharmaceutics: The Science of Dosage Form Design; Aulton, M. E., Ed.; Churchill Livingstone: London, 2002; pp 253-274.
    • (2002) Churchill Livingstone , pp. 253-274
    • Ashford, M.1
  • 24
    • 33646478910 scopus 로고    scopus 로고
    • Prediction of the permeability of drugs through study on quantitative structure- permeability relationship
    • Jung, S. J.; Choi, S. O.; Um, S. Y.; Kim, J. I.; Choo, H. Y. P.; Choi, S. Y.; Chung, S. Y. Prediction of the permeability of drugs through study on quantitative structure- permeability relationship. J. Pharm. Biomed. Anal.2006, 41 (2), 469-475.
    • (2006) J. Pharm. Biomed. Anal. , vol.41 , Issue.2 , pp. 469-475
    • Jung, S.J.1    Choi, S.O.2    Um, S.Y.3    Kim, J.I.4    Choo, H.Y.P.5    Choi, S.Y.6    Chung, S.Y.7
  • 25
    • 85038484838 scopus 로고    scopus 로고
    • Proposal to waive in vivo bioequivalence requirements for WHO model list of essential medicines immediaterelease, solid oral dosage forms. WHO technical Report series No. 937; World Health Organization: Geneva
    • Proposal to waive in vivo bioequivalence requirements for WHO model list of essential medicines immediaterelease, solid oral dosage forms. WHO technical Report series No. 937; World Health Organization: Geneva, 2006; pp 391-415.
    • (2006) , pp. 391-415
  • 26
    • 35648949409 scopus 로고    scopus 로고
    • Modelling and simulation in drug absorption processes
    • Dokoumetzidis, A.; Valsami, G.; Macheras, P. Modelling and simulation in drug absorption processes. Xenobiotica 2007, 37 (10-11), 1052-1065.
    • (2007) Xenobiotica , vol.37 , Issue.10-11 , pp. 1052-1065
    • Dokoumetzidis, A.1    Valsami, G.2    Macheras, P.3
  • 27
    • 1242337282 scopus 로고    scopus 로고
    • The"high solubility" definition of the current FDA Guidance on Biopharmaceutical Classification System may be too strict for acidic drugs
    • Yazdanian, M.; Briggs, K.; Jankovsky, C.; Hawi, A. The"high solubility" definition of the current FDA Guidance on Biopharmaceutical Classification System may be too strict for acidic drugs. Pharm. Res. 2004, 21 (2), 293-299.
    • (2004) Pharm. Res. , vol.21 , Issue.2 , pp. 293-299
    • Yazdanian, M.1    Briggs, K.2    Jankovsky, C.3    Hawi, A.4
  • 29
    • 47949129181 scopus 로고    scopus 로고
    • Biopharmaceutics classification systems for new molecular entities (BCS-NMEs) and marketed drugs (BCD-MD): Theoretical basis and practical examples
    • Papadopoulou, V.; Valsami, G.; Dokoumetzidis, A.; Macheras, P. Biopharmaceutics classification systems for new molecular entities (BCS-NMEs) and marketed drugs (BCD-MD): Theoretical basis and practical examples. Int. J. Pharm. 2008, 361 (1-2), 70-77.
    • (2008) Int. J. Pharm. , vol.361 , Issue.1-2 , pp. 70-77
    • Papadopoulou, V.1    Valsami, G.2    Dokoumetzidis, A.3    Macheras, P.4
  • 30
    • 0026621209 scopus 로고
    • Intrinsic dissolution rate and solubility studies on josamycin, a macrolide antibiotic
    • Skinner, M.; Kanfer, I. Intrinsic dissolution rate and solubility studies on josamycin, a macrolide antibiotic. Int. J. Pharm. 1992, 88 (1-3), 151-158.
    • (1992) Int. J. Pharm. , vol.88 , Issue.1-3 , pp. 151-158
    • Skinner, M.1    Kanfer, I.2
  • 31
    • 55549119280 scopus 로고    scopus 로고
    • Intrinsic dissolution rate determinations in early development and relevance to in vivo performance
    • Ayres, C.; Burke, W.; Dickinson, P; Kirk, G.; Pugh R.; Sharma- Singh, G.; Kittlety, R. Intrinsic dissolution rate determinations in early development and relevance to in vivo performance. Am. Pharm. Rev. 2007, 10 (1), 74-78.
    • (2007) Am. Pharm. Rev. , vol.10 , Issue.1 , pp. 74-78
    • Ayres, C.1    Burke, W.2    Dickinson, P.3    Kirk, G.4    Pugh, R.5    Sharma-Singh, G.6    Kittlety, R.7
  • 32
    • 0043283915 scopus 로고    scopus 로고
    • Measurement of Intrinsic Drug Dissolution Rates Using Two Types of Apparatus
    • Viegas, T. X.; Curatella, R. U.; Winkle, L. L. V.; Brinker, G., Measurement of Intrinsic Drug Dissolution Rates Using Two Types of Apparatus. Pharm. Technol. 2001, 25 (6), 44-53.
    • (2001) Pharm. Technol. , vol.25 , Issue.6 , pp. 44-53
    • Viegas, T.X.1    Curatella, R.U.2    Winkle, L.L.V.3    Brinker, G.4
  • 33
    • 51649089515 scopus 로고    scopus 로고
    • Simultaneousmeasurement of liquid-phase and solid-phase transformation kinetics in rotating disc and channel flow cell dissolution devices
    • Lehto, P.; Aaltonen, J.; Niemelä, P.; Rantanen, J.; Hirvonen, J.; Tanninen, V. P.; Peltonen, L. Simultaneousmeasurement of liquid-phase and solid-phase transformation kinetics in rotating disc and channel flow cell dissolution devices. Int. J. Pharm. 2008, 363 (1-2), 66-72.
    • (2008) Int. J. Pharm. , vol.363 , Issue.1-2 , pp. 66-72
    • Lehto, P.1    Aaltonen, J.2    Niemelä, P.3    Rantanen, J.4    Hirvonen, J.5    Tanninen, V.P.6    Peltonen, L.7
  • 34
    • 34547651036 scopus 로고    scopus 로고
    • Current perspectives in dissolution testing of conventional and novel dosage forms
    • Azarmi, S.; Roa, W.; Löbenberg, R. Current perspectives in dissolution testing of conventional and novel dosage forms. Int. J. Pharm. 2007, 328 (1), 12-21.
    • (2007) Int. J. Pharm. , vol.328 , Issue.1 , pp. 12-21
    • Azarmi, S.1    Roa, W.2    Löbenberg, R.3
  • 35
    • 80052702803 scopus 로고    scopus 로고
    • European Pharmacopoeia, 6th ed.; European Directorate for the Quality of Medicines, Council of Europe: Strasbourg, France
    • European Pharmacopoeia, 6th ed.; European Directorate for the Quality of Medicines, Council of Europe: Strasbourg, France, 2008.
    • (2008)
  • 36
    • 0043092347 scopus 로고    scopus 로고
    • Dissolution testing of acetylsalicylic acid by a channel flow method-correlation to USP basket and intrinsic dissolution methods
    • Peltonen, L.; Liljeroth, P.; Heikkilä, T.; Kontturi, K.; Hirvonen, J. Dissolution testing of acetylsalicylic acid by a channel flow method-correlation to USP basket and intrinsic dissolution methods. Eur. J. Pharm. Sci.2003, 19, 395-401.
    • (2003) Eur. J. Pharm. Sci. , vol.19 , pp. 395-401
    • Peltonen, L.1    Liljeroth, P.2    Heikkilä, T.3    Kontturi, K.4    Hirvonen, J.5
  • 37
    • 32644490018 scopus 로고    scopus 로고
    • Physico-chemical characterisation and intrinsic dissolution studies of a new hydrate form of diclofenac sodium: Comparison with anhydrous form
    • Bartolomei, M.; Bertocchi, P.; Antoniella, E; Rodomonte, A. Physico-chemical characterisation and intrinsic dissolution studies of a new hydrate form of diclofenac sodium: comparison with anhydrous form. J. Pharm. Biomed. Anal. 2006, 40 (5), 1105-1113.
    • (2006) J. Pharm. Biomed. Anal. , vol.40 , Issue.5 , pp. 1105-1113
    • Bartolomei, M.1    Bertocchi, P.2    Antoniella, E.3    Rodomonte, A.4
  • 38
    • 43249110027 scopus 로고    scopus 로고
    • Preparation, characterization and in vivo evaluation of amorphous atorvastatin calcium nanoparticles using supercritical antisolvent (SAS) process
    • Kim, M.; Jin, S.; Kim, J.; Park, H. J.; Song, H.; Neubert, R. H. H., Hwang, S. Preparation, characterization and in vivo evaluation of amorphous atorvastatin calcium nanoparticles using supercritical antisolvent (SAS) process. Eur. J. Pharm. Biopharm. 2008, 69 (2), 454-465.
    • (2008) Eur. J. Pharm. Biopharm. , vol.69 , Issue.2 , pp. 454-465
    • Kim, M.1    Jin, S.2    Kim, J.3    Park, H.J.4    Song, H.5    Neubert, R.H.H.6    Hwang, S.7
  • 39
    • 2142728539 scopus 로고    scopus 로고
    • Solid-state characterization of rifampicin samples and its biopharmaceutic relevance
    • Agrawal, S.; Ashokraj, Y.; Bharatam, P.; Pillai, O.; Panchagnula, R. Solid-state characterization of rifampicin samples and its biopharmaceutic relevance. Eur. J. Pharm. Sci. 2004, 22 (2-3), 127-144.
    • (2004) Eur. J. Pharm. Sci. , vol.22 , Issue.2-3 , pp. 127-144
    • Agrawal, S.1    Ashokraj, Y.2    Bharatam, P.3    Pillai, O.4    Panchagnula, R.5
  • 40
    • 80052737072 scopus 로고    scopus 로고
    • Fundamentals of dissolution
    • Yihong, Q., Chen, Y., Zhang, G. Z. Z., Liu, L., Porter, W., Eds.; Academic Press: Burlington, MA
    • Wang, J.; Flanagan, D. R. Fundamentals of Dissolution. In Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice; Yihong, Q., Chen, Y., Zhang, G. Z. Z., Liu, L., Porter, W., Eds.; Academic Press: Burlington, MA, 2009; pp 309-316.
    • (2009) Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice , pp. 309-316
    • Wang, J.1    Flanagan, D.R.2
  • 41
    • 84862248212 scopus 로고    scopus 로고
    • The Stationary Office: London
    • The British Pharmacopoeia, The Stationary Office: London, 2009; pp A310-A311.
    • (2009) The British Pharmacopoeia
  • 42
    • 84962045147 scopus 로고    scopus 로고
    • Miniaturized Intrinsic Dissolution Rate (Mini-IDRTM) Measurement of Griseofulvin and Carbamazepine
    • Berge, C. M.; Tsinman, O.; Voloboy, D.; Lipp, D.; Stones, S.; Avdeef, A. Miniaturized Intrinsic Dissolution Rate (Mini-IDRTM) Measurement of Griseofulvin and Carbamazepine. Dissolution Technol. 2007, 14 (4), 39-41.
    • (2007) Dissolution Technol , vol.14 , Issue.4 , pp. 39-41
    • Berge, C.M.1    Tsinman, O.2    Voloboy, D.3    Lipp, D.4    Stones, S.5    Avdeef, A.6
  • 43
    • 68149179817 scopus 로고    scopus 로고
    • Powder Dissolution Method for Estimating Rotating Disk Intrinsic Dissolution Rates of Low Solubility Drugs
    • Tsinman, K.; Avdeef, A.; Tsinman, O.; Voloboy, D. Powder Dissolution Method for Estimating Rotating Disk Intrinsic Dissolution Rates of Low Solubility Drugs. Pharm. Res. 2009, 26 (9), 2093-2100.
    • (2009) Pharm. Res. , vol.26 , Issue.9 , pp. 2093-2100
    • Tsinman, K.1    Avdeef, A.2    Tsinman, O.3    Voloboy, D.4


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