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Volumn 33, Issue 7, 2012, Pages 366-377

In silico prediction of drug dissolution and absorption with variation in intestinal pH for BCS class II weak acid drugs: Ibuprofen and ketoprofen

Author keywords

dissolution media; GastroPlus; ibuprofen; in vitro dissolution; ketoprofen; pH; simulation; weak acid

Indexed keywords

BUFFER; IBUPROFEN; KETOPROFEN; PHOSPHATE BUFFERED SALINE;

EID: 84867101149     PISSN: 01422782     EISSN: 1099081X     Source Type: Journal    
DOI: 10.1002/bdd.1800     Document Type: Article
Times cited : (95)

References (50)
  • 3
    • 0028948839 scopus 로고
    • A theoretical basis for a biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability
    • Amidon GL, Lennernas H, Shah VP, et al,. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 1995; 12: 413-420.
    • (1995) Pharm Res , vol.12 , pp. 413-420
    • Amidon, G.L.1    Lennernas, H.2    Shah, V.P.3
  • 4
    • 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, et al,. The 'high solubility' definition of the current FDA Guidance on Biopharmaceutical Classification System may be too strict for acidic drugs. Pharm Res 2004; 21: 293-299.
    • (2004) Pharm Res , vol.21 , pp. 293-299
    • Yazdanian, M.1    Briggs, K.2    Jankovsky, C.3
  • 5
    • 33750161035 scopus 로고    scopus 로고
    • Review of global regulations concerning biowaivers for immediate release solid oral dosage forms
    • Gupta E, Barends DM, Yamashita E, et al,. Review of global regulations concerning biowaivers for immediate release solid oral dosage forms. Eur J Pharm Sci 2006; 29: 315-324.
    • (2006) Eur J Pharm Sci , vol.29 , pp. 315-324
    • Gupta, E.1    Barends, D.M.2    Yamashita, E.3
  • 6
    • 53849133765 scopus 로고    scopus 로고
    • Summary workshop report: Bioequivalence, biopharmaceutics classification system, and beyond
    • Polli JE, Abrahamsson BS, Yu LX, et al,. Summary workshop report: bioequivalence, biopharmaceutics classification system, and beyond. AAPS J 2008; 10: 373-379.
    • (2008) AAPS J , vol.10 , pp. 373-379
    • Polli, J.E.1    Abrahamsson, B.S.2    Yu, L.X.3
  • 7
    • 28044443143 scopus 로고    scopus 로고
    • Implication of biopharmaceutics and pharmacokinetics of rifampicin in variable bioavailability from solid oral dosage forms
    • Agrawal S, Panchagnula R,. Implication of biopharmaceutics and pharmacokinetics of rifampicin in variable bioavailability from solid oral dosage forms. Biopharm Drug Dispos 2005; 26: 321-334.
    • (2005) Biopharm Drug Dispos , vol.26 , pp. 321-334
    • Agrawal, S.1    Panchagnula, R.2
  • 8
    • 0028984776 scopus 로고
    • Clinical pharmacokinetics of flurbiprofen and its enantiomers
    • Davies NM,. Clinical pharmacokinetics of flurbiprofen and its enantiomers. Clin Pharmacokinet 1995; 28: 100-114.
    • (1995) Clin Pharmacokinet , vol.28 , pp. 100-114
    • Davies, N.M.1
  • 9
    • 10944259270 scopus 로고    scopus 로고
    • Biowaivers for oral immediate-release products: Implications of linear pharmacokinetics
    • Faassen F, Vromans H,. Biowaivers for oral immediate-release products: implications of linear pharmacokinetics. Clin Pharmacokinet 2004; 43: 1117-1126.
    • (2004) Clin Pharmacokinet , vol.43 , pp. 1117-1126
    • Faassen, F.1    Vromans, H.2
  • 10
    • 62649134312 scopus 로고    scopus 로고
    • Justification of biowaiver for carbamazepine, a low soluble high permeable compound, in solid dosage forms based on IVIVC and gastrointestinal simulation
    • Kovacevic I, Parojcic J, Homsek I, et al,. Justification of biowaiver for carbamazepine, a low soluble high permeable compound, in solid dosage forms based on IVIVC and gastrointestinal simulation. Mol Pharm 2008; 6: 40-47.
    • (2008) Mol Pharm , vol.6 , pp. 40-47
    • Kovacevic, I.1    Parojcic, J.2    Homsek, I.3
  • 11
    • 51249098751 scopus 로고    scopus 로고
    • Application of gastrointestinal simulation for extensions for biowaivers of highly permeable compounds
    • Tubic-Grozdanis M, Bolger MB, Langguth P,. Application of gastrointestinal simulation for extensions for biowaivers of highly permeable compounds. AAPS J 2008; 10: 213-226.
    • (2008) AAPS J , vol.10 , pp. 213-226
    • Tubic-Grozdanis, M.1    Bolger, M.B.2    Langguth, P.3
  • 12
    • 27944492442 scopus 로고    scopus 로고
    • Biowaiver monographs for immediate release solid oral dosage forms: Ibuprofen
    • Potthast H, Dressman JB, Junginger HE, et al,. Biowaiver monographs for immediate release solid oral dosage forms: ibuprofen. J Pharm Sci 2005; 94: 2121-2131.
    • (2005) J Pharm Sci , vol.94 , pp. 2121-2131
    • Potthast, H.1    Dressman, J.B.2    Junginger, H.E.3
  • 13
    • 79954554225 scopus 로고    scopus 로고
    • Investigation on the possibility of biowaivers for ibuprofen
    • Alvarez C, Nunez I, Torrado JJ, et al,. Investigation on the possibility of biowaivers for ibuprofen. J Pharm Sci 2011; 100: 2343-2349.
    • (2011) J Pharm Sci , vol.100 , pp. 2343-2349
    • Alvarez, C.1    Nunez, I.2    Torrado, J.J.3
  • 14
    • 0019350675 scopus 로고
    • Dissolution kinetics of carboxylic acids II: Effect of buffers
    • Mooney KG, Mintun MA, Himmelstein KJ, et al,. Dissolution kinetics of carboxylic acids II: effect of buffers. J Pharm Sci 1981; 70: 22-32.
    • (1981) J Pharm Sci , vol.70 , pp. 22-32
    • Mooney, K.G.1    Mintun, M.A.2    Himmelstein, K.J.3
  • 15
    • 0032999413 scopus 로고    scopus 로고
    • Intraluminal pH of the human gastrointestinal tract
    • Fallingborg J,. Intraluminal pH of the human gastrointestinal tract. Dan Med Bull 1999; 46: 183-196.
    • (1999) Dan Med Bull , vol.46 , pp. 183-196
    • Fallingborg, J.1
  • 16
    • 1842576537 scopus 로고    scopus 로고
    • Dissolution media simulating the intralumenal composition of the small intestine: Physiological issues and practical aspects
    • Vertzoni M, Fotaki N, Kostewicz E, et al,. Dissolution media simulating the intralumenal composition of the small intestine: physiological issues and practical aspects. J Pharm Pharmacol 2004; 56: 453-462.
    • (2004) J Pharm Pharmacol , vol.56 , pp. 453-462
    • Vertzoni, M.1    Fotaki, N.2    Kostewicz, E.3
  • 17
    • 0003948263 scopus 로고    scopus 로고
    • USP 24 The National Formulary NF19
    • The United States Pharmacopeia. USP 24 The National Formulary NF19, 2000.
    • (2000) The United States Pharmacopeia
  • 18
    • 62649112150 scopus 로고    scopus 로고
    • Toward an in vivo dissolution methodology: A comparison of phosphate and bicarbonate buffers
    • Sheng JJ, McNamara DP, Amidon GL,. Toward an in vivo dissolution methodology: a comparison of phosphate and bicarbonate buffers. Mol Pharm 2009; 6: 29-39.
    • (2009) Mol Pharm , vol.6 , pp. 29-39
    • Sheng, J.J.1    McNamara, D.P.2    Amidon, G.L.3
  • 19
    • 0022213731 scopus 로고
    • Ibuprofen disposition in obese individuals
    • Abernethy DR, Greenblatt DJ,. Ibuprofen disposition in obese individuals. Arthritis Rheum 1985; 28: 1117-1121.
    • (1985) Arthritis Rheum , vol.28 , pp. 1117-1121
    • Abernethy, D.R.1    Greenblatt, D.J.2
  • 20
    • 0032585804 scopus 로고    scopus 로고
    • PH-metric log P 11. pKa determination of water-insoluble drugs in organic solvent-water mixtures
    • Avdeef A, Box KJ, Comer JE, et al,. pH-metric log P 11. pKa determination of water-insoluble drugs in organic solvent-water mixtures. J Pharm Biomed Anal 1999; 20: 631-641.
    • (1999) J Pharm Biomed Anal , vol.20 , pp. 631-641
    • Avdeef, A.1    Box, K.J.2    Comer, J.E.3
  • 21
    • 0031942688 scopus 로고    scopus 로고
    • PH-metric logP 10. Determination of liposomal membrane-water partition coefficients of ionizable drugs
    • Avdeef A, Box KJ, Comer JE, et al,. pH-metric logP 10. Determination of liposomal membrane-water partition coefficients of ionizable drugs. Pharm Res 1998; 15: 209-215.
    • (1998) Pharm Res , vol.15 , pp. 209-215
    • Avdeef, A.1    Box, K.J.2    Comer, J.E.3
  • 22
    • 0029067669 scopus 로고
    • Pharmacokinetics of ketoprofen enantiomers after different doses of the racemate
    • Geisslinger G, Menzel S, Wissel K, et al,. Pharmacokinetics of ketoprofen enantiomers after different doses of the racemate. Br J Clin Pharmacol 1995; 40: 73-75.
    • (1995) Br J Clin Pharmacol , vol.40 , pp. 73-75
    • Geisslinger, G.1    Menzel, S.2    Wissel, K.3
  • 23
    • 0020616875 scopus 로고
    • Dissociation constants, solubilities and dissolution rates of some selected nonsteroidal antiinflammatories
    • Herzfeldt CD, Kummel R,. Dissociation constants, solubilities and dissolution rates of some selected nonsteroidal antiinflammatories. Drug Dev Ind Pharm 1983; 9: 767-793.
    • (1983) Drug Dev Ind Pharm , vol.9 , pp. 767-793
    • Herzfeldt, C.D.1    Kummel, R.2
  • 24
    • 3242728351 scopus 로고    scopus 로고
    • Molecular properties of WHO essential drugs and provisional biopharmaceutical classification
    • Kasim NA, Whitehouse M, Ramachandran C, et al,. Molecular properties of WHO essential drugs and provisional biopharmaceutical classification. Mol Pharm 2004; 1: 85-96.
    • (2004) Mol Pharm , vol.1 , pp. 85-96
    • Kasim, N.A.1    Whitehouse, M.2    Ramachandran, C.3
  • 26
    • 0027275798 scopus 로고
    • Dissolution modeling: Factors affecting the dissolution rates of polydisperse powders
    • Lu AT, Frisella ME, Johnson KC,. Dissolution modeling: factors affecting the dissolution rates of polydisperse powders. Pharm Res 1993; 10: 1308-1314.
    • (1993) Pharm Res , vol.10 , pp. 1308-1314
    • Lu, A.T.1    Frisella, M.E.2    Johnson, K.C.3
  • 27
    • 38349100118 scopus 로고    scopus 로고
    • Enhancement of dissolution rate and bioavailability of aceclofenac: A chitosan-based solvent change approach
    • Mutalik S, Anju P, Manoj K, et al,. Enhancement of dissolution rate and bioavailability of aceclofenac: a chitosan-based solvent change approach. Int J Pharm 2008; 350: 279-290.
    • (2008) Int J Pharm , vol.350 , pp. 279-290
    • Mutalik, S.1    Anju, P.2    Manoj, K.3
  • 28
    • 0003455059 scopus 로고    scopus 로고
    • US FDA Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a Biopharmaceutics Classification System
    • US FDA Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a Biopharmaceutics Classification System. FDA Guidance for Industry, 2002.
    • (2002) FDA Guidance for Industry
  • 30
    • 0035997323 scopus 로고    scopus 로고
    • Biopharmaceutics classification system: The scientific basis for biowaiver extensions
    • Yu LX, Amidon GL, Polli JE, et al,. Biopharmaceutics classification system: the scientific basis for biowaiver extensions. Pharm Res 2002; 19: 921-925.
    • (2002) Pharm Res , vol.19 , pp. 921-925
    • Yu, L.X.1    Amidon, G.L.2    Polli, J.E.3
  • 31
    • 0031886547 scopus 로고    scopus 로고
    • Clinical pharmacokinetics of ibuprofen. The first 30 years
    • Davies NM,. Clinical pharmacokinetics of ibuprofen. The first 30 years. Clin Pharmacokinet 1998; 34: 101-154.
    • (1998) Clin Pharmacokinet , vol.34 , pp. 101-154
    • Davies, N.M.1
  • 33
    • 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
    • Aburub A, Risley DS, Mishra D,. A critical evaluation of fasted state simulating gastric fluid (FaSSGF) that contains sodium lauryl sulfate and proposal of a modified recipe. Int J Pharm 2008; 347: 16-22.
    • (2008) Int J Pharm , vol.347 , pp. 16-22
    • Aburub, A.1    Risley, D.S.2    Mishra, D.3
  • 34
    • 0031777573 scopus 로고    scopus 로고
    • Product development studies on the tablet formulation of ibuprofen to improve bioavailability
    • Ghosh LK, Ghosh NC, Chatterjee M, et al,. Product development studies on the tablet formulation of ibuprofen to improve bioavailability. Drug Dev Ind Pharm 1998; 24: 473-477.
    • (1998) Drug Dev Ind Pharm , vol.24 , pp. 473-477
    • Ghosh, L.K.1    Ghosh, N.C.2    Chatterjee, M.3
  • 35
    • 0021182956 scopus 로고
    • Effect of stress on the gastric emptying of capsules
    • Kaus LC, Fell JT,. Effect of stress on the gastric emptying of capsules. J Clin Hosp Pharm 1984; 9: 249-251.
    • (1984) J Clin Hosp Pharm , vol.9 , pp. 249-251
    • Kaus, L.C.1    Fell, J.T.2
  • 36
    • 74049120114 scopus 로고    scopus 로고
    • Very rapid dissolution is not needed to guarantee bioequivalence for biopharmaceutics classification system (BCS) i drugs
    • Kortejarvi H, Shawahna R, Koski A, et al,. Very rapid dissolution is not needed to guarantee bioequivalence for biopharmaceutics classification system (BCS) I drugs. J Pharm Sci 2010; 99: 621-625.
    • (2010) J Pharm Sci , vol.99 , pp. 621-625
    • Kortejarvi, H.1    Shawahna, R.2    Koski, A.3
  • 37
    • 0025009075 scopus 로고
    • The influence of the interdigestive migrating myoelectric complex on the gastric emptying of liquids
    • Oberle RL, Chen TS, Lloyd C, et al,. The influence of the interdigestive migrating myoelectric complex on the gastric emptying of liquids. Gastroenterology 1990; 99: 1275-1282.
    • (1990) Gastroenterology , vol.99 , pp. 1275-1282
    • Oberle, R.L.1    Chen, T.S.2    Lloyd, C.3
  • 38
    • 46749083350 scopus 로고    scopus 로고
    • Interplay between intestinal pH, transit time and feed status on the in vivo performance of pH responsive ileo-colonic release systems
    • Ibekwe VC, Fadda HM, McConnell EL, et al,. Interplay between intestinal pH, transit time and feed status on the in vivo performance of pH responsive ileo-colonic release systems. Pharm Res 2008; 25: 1828-1835.
    • (2008) Pharm Res , vol.25 , pp. 1828-1835
    • Ibekwe, V.C.1    Fadda, H.M.2    McConnell, E.L.3
  • 39
    • 0024328216 scopus 로고
    • Gastrointestinal scintiscanning: Dosimetry
    • Madsen JL, Krogsgaard OW,. Gastrointestinal scintiscanning: dosimetry. Eur J Nucl Med 1989; 15: 260-261.
    • (1989) Eur J Nucl Med , vol.15 , pp. 260-261
    • Madsen, J.L.1    Krogsgaard, O.W.2
  • 40
    • 1542327008 scopus 로고    scopus 로고
    • Influence of duodenal acidification on the sensorimotor function of the proximal stomach in humans
    • Lee KJ, Vos R, Janssens J, et al,. Influence of duodenal acidification on the sensorimotor function of the proximal stomach in humans. Am J Physiol Gastrointest Liver Physiol 2004; 286: G278-G284.
    • (2004) Am J Physiol Gastrointest Liver Physiol , vol.286
    • Lee, K.J.1    Vos, R.2    Janssens, J.3
  • 41
    • 33747049558 scopus 로고    scopus 로고
    • Characterization of fasted-state human intestinal fluids collected from duodenum and jejunum
    • Perez de la Cruz Moreno M, Oth M, Deferme S, et al,. Characterization of fasted-state human intestinal fluids collected from duodenum and jejunum. J Pharm Pharmacol 2006; 58: 1079-1089.
    • (2006) J Pharm Pharmacol , vol.58 , pp. 1079-1089
    • Perez De La Cruz Moreno, M.1    Oth, M.2    Deferme, S.3
  • 42
    • 32244434196 scopus 로고    scopus 로고
    • Characterization of the human upper gastrointestinal contents under conditions simulating bioavailability/bioequivalence studies
    • Kalantzi L, Goumas K, Kalioras V, et al,. Characterization of the human upper gastrointestinal contents under conditions simulating bioavailability/ bioequivalence studies. Pharm Res 2006; 23: 165-176.
    • (2006) Pharm Res , vol.23 , pp. 165-176
    • Kalantzi, L.1    Goumas, K.2    Kalioras, V.3
  • 43
    • 29244445764 scopus 로고    scopus 로고
    • The effects of food on the dissolution of poorly soluble drugs in human and in model small intestinal fluids
    • Persson EM, Gustafsson AS, Carlsson AS, et al,. The effects of food on the dissolution of poorly soluble drugs in human and in model small intestinal fluids. Pharm Res 2005; 22: 2141-2151.
    • (2005) Pharm Res , vol.22 , pp. 2141-2151
    • Persson, E.M.1    Gustafsson, A.S.2    Carlsson, A.S.3
  • 44
    • 0037467162 scopus 로고    scopus 로고
    • Influence of dissolution medium buffer composition on ketoprofen release from ER products and in vitro-in vivo correlation
    • Corrigan OI, Devlin Y, Butler J,. Influence of dissolution medium buffer composition on ketoprofen release from ER products and in vitro-in vivo correlation. Int J Pharm 2003; 254: 147-154.
    • (2003) Int J Pharm , vol.254 , pp. 147-154
    • Corrigan, O.I.1    Devlin, Y.2    Butler, J.3
  • 45
    • 0037422394 scopus 로고    scopus 로고
    • Effect of buffer media composition on the solubility and effective permeability coefficient of ibuprofen
    • Levis KA, Lane ME, Corrigan OI,. Effect of buffer media composition on the solubility and effective permeability coefficient of ibuprofen. Int J Pharm 2003; 253: 49-59.
    • (2003) Int J Pharm , vol.253 , pp. 49-59
    • Levis, K.A.1    Lane, M.E.2    Corrigan, O.I.3
  • 46
    • 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, et al,. Evaluation of various dissolution media for predicting in vivo performance of class I and II drugs. Pharm Res 1998; 15: 698-705.
    • (1998) Pharm Res , vol.15 , pp. 698-705
    • Galia, E.1    Nicolaides, E.2    Horter, D.3
  • 47
    • 44749087279 scopus 로고    scopus 로고
    • Dissolution media simulating conditions in the proximal human gastrointestinal tract: An update
    • Jantratid E, Janssen N, Reppas C, et al,. Dissolution media simulating conditions in the proximal human gastrointestinal tract: an update. Pharm Res 2008; 25: 1663-1676.
    • (2008) Pharm Res , vol.25 , pp. 1663-1676
    • Jantratid, E.1    Janssen, N.2    Reppas, C.3
  • 48
    • 9844221302 scopus 로고
    • Intubation studies of the human small intestine. IV. Chemical characteristics of the intestinal contents in the fasting state and as influenced by the administration of acids, of alkalies and of water
    • Karr WG, Abbott WO, Sample AB,. Intubation studies of the human small intestine. IV. Chemical characteristics of the intestinal contents in the fasting state and as influenced by the administration of acids, of alkalies and of water. J Clin Invest 1935; 14: 893-900.
    • (1935) J Clin Invest , vol.14 , pp. 893-900
    • Karr, W.G.1    Abbott, W.O.2    Sample, A.B.3
  • 49
    • 80052592985 scopus 로고    scopus 로고
    • Dissolution testing for generic drugs: An FDA perspective
    • Anand O, Yu LX, Conner DP, et al,. Dissolution testing for generic drugs: an FDA perspective. AAPS J 2011; 13: 328-335.
    • (2011) AAPS J , vol.13 , pp. 328-335
    • Anand, O.1    Yu, L.X.2    Conner, D.P.3
  • 50
    • 0141800053 scopus 로고    scopus 로고
    • FIP/AAPS guidelines to dissolution/in vitro release testing of novel/special dosage forms
    • Siewert M, Dressman J, Brown CK, et al,. FIP/AAPS guidelines to dissolution/in vitro release testing of novel/special dosage forms. AAPS PharmSciTech 2003; 4: E7.
    • (2003) AAPS PharmSciTech , vol.4
    • Siewert, M.1    Dressman, J.2    Brown, C.K.3


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