Study on dissolution and absorption of four dosage forms of isosorbide mononitrate: Level A in vitro-in vivo correlation

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 79, Issue 2, 2011, Pages 364-371

  Li, Zi Qiang ^a   He, Xin ^a   Gao, Xiumei ^a   Xu, Yan Yan ^a   Wang, Yue Fei ^a   Gu, Hui ^a   Ji, Rui Feng ^a   Sun, Shu Jun ^a  

^a TIANJIN UNIVERSITY OF TRADITIONAL CHINESE MEDICINE   (China)

Author keywords

[No Author keywords available]

Indexed keywords

ISOSORBIDE 5 NITRATE; SHANSU; UNCLASSIFIED DRUG; XINKANG;

ACCURACY; ANIMAL EXPERIMENT; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; COMPARATIVE STUDY; CONTROLLED STUDY; CORRELATION COEFFICIENT; DOG; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DOSAGE FORM; DRUG DOSAGE FORM COMPARISON; DRUG SOLUBILITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; IN VITRO STUDY; IN VIVO STUDY; MALE; NONHUMAN; RAT; SUSTAINED DRUG RELEASE;

EID: 80055025434     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2011.04.015     Document Type: Article

References (45)

1. Food and Drug Administration: Guidance for Industry: Nonsterile Semisolid Dosage Forms, Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In vitro Release Testing and In vivo Bioequivalence Documentation, US Department of Health and Human Services/Food and Drug Administration/Center for Drug Evaluation and Research, 1997.
2. G.L. Amidon, H. Lennernas, V.P. Shah, J.R. Crison, A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability, Pharm. Res. 12 (1995) 413-420.
3. J.E. Polli, G.S. Re, L.L. Augsburger, V.P. Shah, Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets, J. Pharm. Sci. 86 (1995) 690-700. (Pubitemid 27248819)
4. J.E. Polli, J.R. Amidon, G.L. Amidon, Novel approaches to the analysis of in vitro-in vivo relationships, J. Pharm. Sci. 85 (1996) 753-760. (Pubitemid 26234682)
5. G.S. Rekhi, N.D. Eddington, M.J. Fossler, P. Schwartz, L.J. Lesko, L.L. Augsburger, Evaluation of in vitro release rate and in vivo absorption characteristics of four metoprolol tartrate immediate-release tablet formulations, Pharm. Dev. Technol. 2 (1997) 11-24. (Pubitemid 28257328)
6. A. Pagliara, M. Geinoz, S. Geinoz, P.A. Carrupt, B. Testa, Evaluation and prediction of drug permeation, J. Pharm. Pharmacol. 51 (1999) 1339-1357. (Pubitemid 30064063)
7. M.J. Ginski, J.E. Polli, Prediction of dissolution-absorption relationships from a dissolution/Caco-2system, Int. J. Pharm. 177 (1999) 117-125.
8. M. Kobayashi, N. Sada, M. Sugawara, K. Iseki, K. Miyazaki, Development of a new system for prediction of drug absorption that takes into account drug dissolution and pH change in the gastro-intestinal tract, Int. J. Pharm. 221 (2001) 87-94. (Pubitemid 32524038)
9. X. He, M. Sugawara, M. Kobayashi, Y. Takekuma, K. Miyazaki, An in vitro system for prediction of oral absorption of relatively water-soluble drugs and ester prodrugs, Int. J. Pharm. 263 (2003) 35-44. (Pubitemid 37087930)
10. X. He, S. Kadomura, Y. Takekuma, M. Sugawara, K. Miyazaki, A new system for the prediction of drug absorption using a pH-controlled Caco-2 model: evaluation of pH-dependent soluble drug absorption and pH-related changes in absorption, J. Pharm. Sci. 93 (2004) 71-77. (Pubitemid 38081815)
11. X. He, M. Sugawara, Y. Takekuma, K. Miyazaki, Absorption of ester prodrugs in Caco-2 and Rat intestine models, Antimicrob. Agents Chemother. 48 (2004) 2604-2609. (Pubitemid 38823432)
12. X. He, M. Sugawara, X.B. Zhu, S. Kadomura, Y. Takekuma, C.X. Liu, Application of an in vitro dissolution and absorption system to evaluate oral absorption of ketoprofen and two preparations of ketoprofen, AJPP 9 (2009) 203-210.
13. M. Kataoka, Y. Masaoka, Y. Yamazaki, T. Sakane, H. Sezaki, S. Yamashita, In vitro system to evaluate oral absorption of poorly water-soluble drugs: simultaneous analysis on dissolution and permeation of drugs, Pharm. Res. 20 (10) (2003) 1674-1680. (Pubitemid 37268286)
14. M. Kataoka, Y. Masaoka, S. Sakuma, S. Yamashita, Effect of food intake on the oral absorption of poorly water-soluble drugs: in vitro assessment of drug dissolution and permeation assay system, J. Pharm. Sci. 95 (9) (2006) 2051-2061. (Pubitemid 44433034)
15. S.A. Motz, J. Klimundova, U.F. Schaefer, S. Balbach, T. Eichinger, P. Solich, C.M. Lehr, Automated measurement of permeation and dissolution of propranolol HCl tablets using sequential injection analysis, Anal. Chim. Acta 581 (2007) 174-180. (Pubitemid 44781431)
16. S.A. Motz, U.F. Schaefer, S. Balbach, T. Eichinger, C.M. Lehr, Permeability assessment for solid oral drug formulations based on Caco-2 monolayer in combination with a flow through dissolution cell, Eur. J. Pharm. Biopharm. 66 (2007) 286-295. (Pubitemid 46654772)
17. X. He, A Simulating Apparatus used for Evaluating Drug Complete Solid Dosage Forms, C.N. Patent, 201488990 U, 2009.
18. Z.Q. Li, Z.D. Liu, C.C. Zhu, R. Liu, H. Juma, X. He, Evaluation on the release discipline of salvianolic acid B sustained-release tablets using a drug dissolution and absorption simulating system, Drug Eval. Res. 33 (5) (2010) 367-373.
19. T. Taylor, L.F. Chasseaud, R. Major, E. Doyle, Isosorbide 5-mononitrate pharmacokinetics in humans, Biopharm. Drug Dispos. 2 (1981) 255-263. (Pubitemid 12225209)
20. United States Pharmacopeial Convention, Dissolution, US Pharmacopeia 32-National Formulary 27, Rockville, MD, 1, 2009, pp. 711-720.
21. R.W. Korsmeyer, R. Gurny, E. Doelker, P. Buri, N.A. Peppas, Mechanisms of solute release from porous hydrophilic polymers, Int. J. Pharm. 15 (1983) 25-35. (Pubitemid 13092121)
22. P.L. Ritger, N.A. Peppas, A simple equation for description of solute release II. Fickian and anomalous release from swellable devices, J. Control. Release 5 (1987) 37-42. (Pubitemid 17106644)
23. United States Pharmacopeial Convention, In vitro and In vivo Evaluation of Dosage Forms, US Pharmacopeia 32-National Formulary 27, Rockville, MD, 1, 2009, pp. 1088-1089.
24. National Pharmacopoeial Committee, Guidance for Sustained-release, Controlled Release and Delayed release Formulations, Pharmacopoeia of the People's Republic of China (Appendix XIX D), Beijing, 2, 2010, pp. 201-204.
25. Y.B. Wang, J. Nedelman, Bias in the Wagner-Nelson estimate of the fraction of drug absorbed, Pharm. Res. 19 (4) (2002) 470-476. (Pubitemid 34408947)
26. H. Akaike, Likelihood of a model and information criteria, J. Econom. 16 (1981) 3-14.
27. Food and Drug Administration: Guidance for Industry: Statistical Approaches to Establishing Bioequivalence, US Department of Health and Human Services/Food and Drug Administration/Center for Drug Evaluation and Research, 2001.
28. P. Artursson, J. Karlsson, Correlation between oral drug absorption in humans and apparent drug permeability coefficients in human intestinal epithelial cells, Biochem. Biophys. Res. Commun. 175 (3) (1991) 880-885.
29. R. Löbenberg, G.L. Amidon, Modern bioavailability, bioequivalence and biopharmaceutics classification system. New scientific approaches to international regulatory standards, Eur. J. Pharm. Biopharm. 50 (2000) 3-12. (Pubitemid 30326685)
30. G. Corti, F. Maestrelli, M. Cirri, N. Zerrouk, P. Mura, Development and evaluation of an in vitro method for prediction of human drug absorption II, demonstration of the method suitability, Eur. J. Pharm. Sci. 27 (2006) 354-362. (Pubitemid 43143261)
31. U. Abshagen, G. Betzien, R. Endele, B. Kaufmann, Pharmacokinetics of intravenous and oral isosorbide-5-mononitrate, Eur. J. Clin. Pharmacol. 20 (1981) 269-275. (Pubitemid 11052667)
32. W.G. Kramer, Absorption of isosobide-5-mononitrate at specific sites in the gastrointestinal tract, J. Clin. Pharmacol. 34 (1994) 1218-1221.
33. C.Y. Wu, L.Z. Benet, Predicting drug disposition via application of BCS: transport/absorption/elimination interplay and development of a biopharmaceutics drug disposition classification system, Pharm. Res. 22 (2005) 11-23. (Pubitemid 40558141)
34. A. Dahan, J.M. Miller, G.L. Amidon, Prediction of solubility and permeability class membership: provisional BCS classification of the world's top oral drugs, AAPS J. 11 (4) (2009) 740-746.
35. Food and Drug Administration: Guidance for Industry: Waiver of In vivo Bioavailability and Bioequivalence Studies for Immediate-release Solid Oral Dosage Forms based on a Biopharmaceutics Classification System, US Department of Health and Human Services/Food and Drug Administration/Center for Drug Evaluation and Research (CDER), 2000.
36. O.A. Lake, M. Olling, D.M. Barends, In vitro/in vivo correlations of dissolution data of carbamazepine immediate release tablets with pharmacokinetics data obtained in healthy volunteers, Eur. J. Pharm. Biopharm. 48 (1999) 13-19. (Pubitemid 29308920)
37. S. Li, H. He, L.J. Parthiban, H. Yin, T.M. Serajuddin, IV-IVC considerations in the development of immediate-release oral dosage form, J. Pharm. Sci. 94 (7) (2005) 1396-1417. (Pubitemid 41168672)
38. P. Buch, P. Langguth, M. Kataoka, S. Yamashita, IVIVC in oral absorption for fenofibrate immediate release tablets using a dissolution/permeation system, J. Pharm. Sci. 98 (6) (2009) 2001-2009.
39. A. Tangerman, A. Van Schaik, E.W. Van der Hoek, Analysis of conjugated and unconjugated bile acids in serum and jejunal fluid of normal subjects, Clin. Chim. Acta 159 (1986) 123-132. (Pubitemid 16033046)
40. T.L. Peeters, G. Vantrappen, J. Janssens, Bile acid output and the interdigestive migrating motor complex in normals and in cholecystectomy patients, Gastroenterology 79 (1980) 678-681. (Pubitemid 10009557)
41. J.B. Dressman, G.L. Amidon, C. Reppas, V.P. Shah, Dissolution testing as a prognostic tool for oral drug absorption: immediate release dosage forms, Pharm. Res. 15 (1) (1998) 11-22. (Pubitemid 28080861)
42. E. Galia, E. Nicolaides, D. Hörter, R. Löbenberg, C. Reppas, J.B. Dressman, Evaluation of various dissolution media for predicting in vivo performance of class I and II drugs, Pharm. Res. 15 (5) (1998) 68-75.
43. S. Souliman, S. Blanquet, E. Beyssac, J.M. Cardot, A level A in vitro/in vivo correlation in fasted and fed states using different methods: applied to solid immediate release oral dosage form, Eur. J. Pharm. Sci. 27 (2006) 72-79. (Pubitemid 41728257)
44. J.H. Hochman, M. Chiba, J. Nishime, M. Yamazaki, J.H. Lin, Influence of Pglycoprotein on the transport and metabolism of indinavir in Caco-2 cells expressing cytochrome P-450 3A4, J. Pharm. Exp. Ther. 292 (1) (2000) 310-318. (Pubitemid 30026387)
45. C.L. Cummins, L.M. Mangravite, L.Z. Benet, Characterizing the expression of CYP3A4 and efflux transporters (P-gp, MRT1, and MRP2) in CYP3A4-transfected Caco-2 cells after induction with sodium butyrate and the phorbol ester 12-O-tetradecanoylphorbol-13-acetate, Pharm. Res. 18 (8) (2001) 1102-1109. (Pubitemid 32900394)