Studies on dissolution testing of the nifedipine gastrointestinal therapeutic system. II. Improved in vitro-in vivo correlation using a two- phase dissolution test

Journal of Controlled Release

Volumn 48, Issue 1, 1997, Pages 9-17

  Grundy, John S ^a   Anderson, Keith E ^b   Rogers, James A ^b   Foster, Robert T ^b  

^a ELANCO ANIMAL HEALTH   (United States)

^b UNIVERSITY OF ALBERTA   (Canada)

Author keywords

Deconvolution; Dissolution testing; Gastrointestinal therapeutic system; In vitro in vivo correlation; Nifedipine; Wagner Nelson method; Zero order release

Indexed keywords

NIFEDIPINE;

ARTICLE; BIOEQUIVALENCE; DATA ANALYSIS; DRUG ABSORPTION; DRUG SOLUBILITY; GASTROINTESTINAL SYMPTOM; HUMAN; PRIORITY JOURNAL;

EID: 0030874214     PISSN: 01683659     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0168-3659(97)01638-6     Document Type: Article

References (36)

1. M. Gibaldi, D. Perrier, Pharmacokinetics, Second Edition, Marcel Dekker Inc., New York, 1982.
2. USP Subcommittee on Biopharmaceutics, In-vitro/in-vivo correlation for extended-release oral dosage forms, Pharm. Forum July-Aug. (1988) 4160-4161.
3. J.P. Skelley, G.L. Amidon, W.H. Barr, L.Z. Benet, J.E. Carter, J.R. Robinson, V.P. Shah, A. Yacobi, Report of the workshop on in vitro and in vivo testing and correlation for oral controlled/modified-release dosage forms, J. Pharm. Sci. 79 (1990) 849-854.
4. S.S. Hwang, W. Bayne, F. Theeuwes, In vivo evaluation of controlled-release products, J. Pharm. Sci. 82 (1993) 1145-1150.
5. A.C. Mehta, S. Hart-Davies, E.A. Kay, In vitro dissolution studies on nifedipine capsules, J. Clin. Pharm. Ther. 20 (1995) 243-245.
6. D.R. Swanson, B.L. Barclay, P.S. Wong, F. Theeuwes, Nifedipine gastrointestinal therapeutic system, Am. J. Med. 83(Suppl. 6B) (1987) 3-9.
7. J.S. Grundy, R.T. Foster, The nifedipine gastrointestinal therapeutic system (GITS): evaluation of pharmaceutical, pharmacokinetic and pharmacological properties, Clin. Pharmacokinet. 30 (1996) 28-51.
8. M. Takahashi, M. Mochizuki, T. Itoh, M. Ohta, Studies on dissolution tests for soft gelatin capsules. IV. Dissolution test of nifedipine soft gelatin capsule containing water soluble vehicles by the rotating dialysis cell method, Chem. Pharm. Bull. 42 (1994) 333-336.
9. J.G. Kelly, K. O'Malley, Clinical pharmacokinetics of calcium antagonists. An update. (Review), Clin. Pharmacokinet. 22 (1992) 416-433.
10. E.M. Sorkin, S.P. Clissold, R.N. Brogden, Nifedipine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy, in ischaemic heart disease, hypertension and related cardiovascular disorders. (Review), Drugs 30 (1985) 182-274.
11. C.H. Kleinbloesem, P. van Brummelen, D.D. Breimer, Nifedipine. Relationship between pharmacokinetics and pharmacodynamics. (Review), Clin. Pharmacokinet. 12 (1987) 12-29.
12. C.H. Kleinbloesem, J. van Harten, L.G.J. de Leede, P. van Brummelen, D.D. Breimer, Nifedipine kinetics and dynamics during rectal infusion to steady state with an osmotic system, Clin. Pharmacol. Ther. 36 (1984) 396-401.
13. S.L. Ali, Nifedipine, in: K. Florey (Ed.) Analytical Profiles of Drug Substances, Vol. 18, Academic Press, New York, 1989, pp. 221-288.
14. N. Kohri, K. Miyazaki, T. Arita, H. Shimono, A. Nomura, H. Yasuda, Release characteristics of nifedipine sustained-release granules in vitro and in healthy subjects, Chem. Pharm. Bull. 35 (1987) 2504-2509.
15. S.A. Qureshi, G. Caillé, R. Brien, G. Piccirilli, V. Yu, I.J. McGilveray, Application of flow-through dissolution method for the evaluation of oral formulations of nifedipine, Drug Dev. Ind. Pharm. 20 (1994) 1869-1882.
16. M. Chung, D.P. Reitberg, M. Gaffney, W. Singleton, Clinical pharmacokinetics of nifedipine gastrointestinal therapeutic system. A controlled-release formulation of nifedipine, Am. J. Med. 83(Suppl. 6B) (1987) 10-14.
17. L. Shargel, A.B.C. Yu, Applied Biopharmaceutics and Pharmacokinetics, Third Edition, Appleton and Lange, Norwalk, CT, 1993.
18. J.S. Grundy, R.Z. Lewanczuk, D. Grace, R.T. Foster, Observation of time-dependent and variable subject kinetics in a nifedipine gastrointestinal therapeutic system bioequivalency study, J. Control. Release 44 (1997) 247-254.
19. J.S. Grundy, R. Kherani, R.T. Foster, Sensitive high-performance liquid chromatographic assay for nifedipine in human plasma utilizing ultraviolet detection, J. Chromatogr. B Biomed. Appl. 654 (1994) 146-151.
20. J.G. Wagner, E. Nelson, Kinetic analysis of blood levels and urinary excretion in the absorptive phase after single doses of drug, J. Pharm. Sci. 53 (1964) 1392-1403.
21. Z. Yu, S.S. Hwang, S.K. Gupta, DeMonS - A new deconvolution method for estimating drug absorbed at different time intervals and/or drug disposition model parameters using monotone cubic spline. Biopharm. Drug Dispos. (in press).
22. C.H. Kleinbloesem, P. van Brummelen, J.A. van de Linde, P.J. Voogd, D.D. Breimer, Nifedipine: kinetics and dynamics in healthy subjects, Clin. Pharmacol. Ther. 35 (1984) 742-749.
23. T.S. Foster, S.R. Hamann, V.R. Richards, P.J. Bryant, D.A. Graves, R.G. McAllister, Nifedipine kinetics and bioavailability after single intravenous and oral doses in normal subjects, J. Clin. Pharmacol. 23 (1983) 161-170.
24. P. Crome, P.O. Müller, P. Wijayawardhana, G. Groenewoud, H.K.L. Hundt, G. Leighton, H.G. Luus, R. Schall, M. van Dyk, Single dose and steady-state pharmacokinetic profiles of nifedipine GITS tablets in healthy elderly and young volunteers, Drug Invest. 5 (1993) 193-199.
25. A.T. Melia, T.E. Mulligan, J. Zhi, Lack of effect of orlistat on the bioavailability of a single dose of nifedipine extended-release tablets (Procardia XL) in healthy volunteers, J. Clin. Pharmacol. 36 (1996) 352-355.
26. R. Schneider, D. Stolero, L. Griffel, R. Kobelt, E. Brendel, A. Iaina, Pharmacokinetic profile of nifedipine GITS in hypertensive patients with chronic renal impairment, Drugs 48(Suppl. 1) (1994) 16-22.
27. J.S. Grundy, K.E. Anderson, J.A. Rogers, R.Z. Lewanczuk, R.T. Foster, Comparison of the in-vivo pharmacokinetic (PK) and in-vitro delivery rate profiles of the nifedipine (NIF) gastrointestinal therapeutic system (GITS), Pharm. Res. 12 (1995) S-421 (Abstract).
28. S.S. Hwang, J. Gorsline, J. Louie, D. Dye, D. Guinta, L. Hamel, In vitro and in vivo evaluation of a once-daily controlled-release pseudoephedrine product, J. Clin. Pharmacol. 35 (1995) 259-267.
29. D.E. Hilleman, U.V. Banakar, Issues in contemporary drug delivery. Part VI: Advanced cardiac drug formulations. (Review), J Pharm. Technol. 8 (1992) 203-211.
30. S.S. Davis, J.G. Hardy, M.J. Taylor, A. Stockwell, D.R. Whalley, C.G. Wilson, The in-vivo evaluation of an osmotic device (Osmet) using gamma scintigraphy, J. Pharm. Pharmacol. 36 (1984) 740-742.
31. S.T. Chao, D. Prather, D. Pinson, P. Coen, B. Pruitt, M. Knowles, V. Place, Effect of food on bioavailability of pseudoephedrine and brompheniramine administered from a gastrointestinal therapeutic system, J. Pharm. Sci. 80 (1991) 432-435.
32. G. van den Berg, F. van Steveninck, J.M. Gubbens-Stibbe, H.C. Schoemaker, A.G. deBoer, A.F. Cohen, Influence of food on the bioavailability of metoprolol from an OROS system; a study in healthy volunteers, Eur. J. Clin. Pharmacol. 39 (1990) 315-316.
33. V. Challenor, D.G. Waller, B.S. Gruchy, A.G. Renwick, C.F. George, E.T. McMurdo, J. McEwen, The effects of food and posture on the pharmacokinetics of a biphasic release preparation of nifedipine, Br. J. Clin. Pharmacol. 22 (1986) 565-570.
34. K. Ueno, S. Kawashima, K. Uemoto, T. Ikada, K. Miyai, K. Wada, K. Yamazaki, K. Matsumoto, I. Nakata, Effect of food on nifedipine sustained-release preparation, DICP 23 (1989) 662-665.
35. P.S. Banerjee, J.R. Robinson, Novel drug delivery systems. An overview of their impact on clinical pharmacokinetic studies. (Review), Clin. Pharmacokinet. 20 (1991) 1-14.
36. J.P. Skelly, G.F. Shiu, In vitro/in vivo correlations in biopharmaceutics: scientific and regulatory implications. (Review), Eur. J. Drug Metab. Pharmacokinet. 18 (1993) 121-129.