Differences in bioavailability between 60 mg of nifedipine osmotic push-pull systems after fasted and fed administration

International Journal of Clinical Pharmacology and Therapeutics

Volumn 48, Issue 2, 2010, Pages 158-170

  Anschutz M ^a   Wonnemann, M ^b   Schug, B ^a   Toal, C ^c   Donath, F ^a   Pontius, A ^e   Pauli, K ^e   Brendel, E ^d   Blume, H ^a  

^a SocraTec R and D GmbH   (Germany)

^b SocraMetrics GmbH   (Germany)

^c Bayer Inc   (Canada)

^d BAYER CORPORATION   (United States)

^e BAYER PHARMA AG   (Germany)

Author keywords

Bioavailability; Food effect; Modified release; Nifedipine; Once daily

Indexed keywords

GEN NIFEDIPINE; NIFEDIPINE; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; CARBOHYDRATE DIET; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG ADSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG DOSAGE FORM COMPARISON; DRUG FORMULATION; DRUG RELEASE; DRUG SAFETY; EXTENDED DRUG RELEASE; HUMAN; HUMAN EXPERIMENT; LIPID DIET; MAXIMUM PLASMA CONCENTRATION; OSMOSIS; SINGLE DRUG DOSE; UNSPECIFIED SIDE EFFECT;

EID: 76749121819     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CPP48158     Document Type: Article

References (25)

1. Abrahamsson B, Alpsten M, Bake B. Drug absorption from nifedipine hydrophilic matrix-extended release (ER) tablet - comparison with an osmotic pump tablet and effect of food. J Control Rel. 1998; 52: 301-310.
2. Banzet O, Colin JN, Thibonnier M, Singlas E, Alexandre JM, Crovol P. Acute antihypertensive effect and pharmacokinetics of a table preparation of nifedipine. Eur J Clin Pharmacol. 1983; 24: 145-150.
3. Brown MJ, Toal CB. Formulation of long acting nifedipine tablets influences the heart rate and sympathetic nervous system response in hypertensive patients. Br J Clin Pharmacol. 2007; 65: 646-652.
4. Brown MJ, Palmer CR, Castaigne A, de Leeuw PW, Mancia G, Rosenthal, T, Ruilope LM. Morbidity and mortality in patients randomised to double-blind treatment with a long acting calcium channel blocker or diuretic in the International Nifedipine GITS study: Intervention as a goal in hypertension treatment (INSIGHT). Lancet. 2000; 356: 366-372.
5. Chung M, Reitberg DP, Gaffney M, Singleton W. Clinical pharmacokinetics of nifedipine gastrointestinal therapeutic system.AmJMed. 1987; 83: 10-14
6. Donnelly R, Elliott HL, Meredith PA, Kelman AW, Reid JL. Nifedipine: Individual responses and concentration-effect relationships. Hypertension. 1988; 12: 443-449.
7. Frishman WH, Sherman D, Feinfeld DA. Innovative drug delivery systems in cardiovascular medicine: Nifedipine-GITS and Clonidine-TTS. Cardiol Clin. 1987; 5: 703-716.
8. Foster TS, Hamann SR, Richards VR, Bryant PJ, Graves DA, McAllister RG. Nifedipine kinetics and bioavailability after single intravenous and oral doses in normal subjects. J Clin Pharmacol. 1983; 23: 161-170.
9. Guidance for Industry, Bioavailability and bioequivalence. studies for orally administered drug products - general considerations, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Revision 1, March 2003.
10. Karim A, Burns T, Wearly L, Streicher J, Palmer M. Food-induced changes in theophylline absorption from controlled-release formulations. Part I. Substantial increased and decreased absorption with Uniphyl tablets and Theo-Dur Sprinkle. Clin Pharmacol Ther. 1985; 38: 77-83.
11. Karim A, Burns T, Janky D, Hurwitz A. Food-induced changes in theophylline absorption from controlled-release formulations. Part II. Importance of meal composition and dosing time relative to meal intake in assessing changes in absorption. Clin Pharmacol Ther. 1985; 38: 642-647.
12. Kleinbloesem CH, van Brummelen P, van de Linde JA, Voogd PJ, Breimer DD. Nifedipine: kinetics and dynamics in healthy subjects. Clin Pharmacol Ther. 1984; 35: 742-749.
13. Liu L, Xu X. Preparation of bilayer-core osmotic pump tablet by coating the indented core tablet. Int J Pharm. 2008; 352: 225-230.
14. Meier J, Nüebsch E, Schmidt R. Pharmacokinetic criteria for the evaluation of retard formulations. Eur J Clin Pharmacol. 1974; 7: 429-432.
15. Poole-Wilson PA, Lubsen J, Kirwan BA, vanDalen FJ, Wagener G, Danchin N, Just H,Fox KAA,Pocock S, Clayton TC, Motro M, Parker JD, Bourassa MG, Dart AM,Hildebrandt P, Hjalmarson A, Kragten JA, Molhoek GP, Otterstad JE, Seabra-Gomes R, Soler-Soler J, Weber S. Effect of long acting nifedipine on mortality and cardiovascular morbidity in patients with stable angina requiring treatment (ACTION trial): randomized controlled trial. Lancet. 2004; 364: 849-857.
16. Whelton PK, He J, Appel LJ, Cutler JA, Havas S, Kotchen TA, Roccella EJ, Stout R, Vallbona C, Winston MC, Karimbakas J. Primary prevention of hypertension: clinical and public health advisory from The National High Blood Pressure Education Program. JAMA. 2002; 288: 1882-1888.
17. [17) Waters D. Related Articles, Links Calcium channel blockers: an evidence-based review. Can J Cardiol. 1997; 13: 757-766.
18. Schug BS, Brendel E, Wolf D, Wonnemann M, Wargenau M, Blume HH. Formulation-dependent food effects demonstrated for nifedipine modified-release preparations marketed in the European Union. Eur J Pharm Sci. 2002; 15: 279-285.
19. Schug BS, Brendel E, Chantraine E, Wolf D, Martin W, Schall R, Blume HH. The effect of food on the pharmacokinetics of nifedipine in two slow release formulations: pronounced lag-time after a high fat breakfast. Br J Clin Pharmacol. 2002; 53: 582-588.
20. Schug BS, Brendel E, Wonnemann M, Wolf D, Wargenau M, Dingler A, Blume HH. Dosage form-related food interaction observed in a marketed once-daily nifedipine formulation after a high-fat American breakfast. Eur J Clin Pharmacol. 2002; 58: 119-125.
21. Summary of Product Characteristics Bundesverband der Pharmazeutischen Industrie (e.v.). Fachinformation (SmPC) zu Adalat 5/10 mg, Weichkapseln, Aulendorf: Editio Cantor Verlag, Fachinfo-Service, 01/2009.
22. Swanson DR, Barclay BL, Wong PSL, Theeuwes F. Nifedipine gastrointestinal therapeutic system. Am J Med. 1987; 83 (Suppl): 3-9.
23. Toal CB, Laplante L. Is there a difference in hypertensive patient compliance between a once a day or twice a day Nifedipine. Amer J Hyper. 1995; 8: 71A.
24. Wonnemann M, Schug B, Schmuecker K, Brendel E, van Zwieten PA, Blume H. Significant food interactions observed with a nifedipine modifiedrelease formulation marketed in the European Union. Int J Clin Pharmacol Ther. 2006; 44: 38-48.
25. Wonnemann M, Schug B, Anschuetz M, Brendel E, de NucciG, Blume H. Comparison of two marketed Nifedipine modified-release formulations: An exploratory clinical food interaction study. Clin Ther. 2008; 30: 48-58.