Comparative pharmacokinetic study of a floating multiple-unit capsule, a high-density multiple-unit capsule and an immediate-release tablet containing 25 mg atenolol

Pharmaceutica Acta Helvetiae

Volumn 73, Issue 2, 1998, Pages 81-87

  Rouge, Nathalie ^a   Allémann, Eric ^a   Gex Fabry, Marianne ^a   Balant, Luc ^a   Cole, Ewart T ^b   Buri, Pierre ^a   Doelker, Eric ^a  

^a UNIVERSITY OF GENEVA   (Switzerland)

^b CAPSUGEL   (France)

Author keywords

Atenolol; Capsules; Floating dosage forms; High density dosage forms; Minitablets; Multiple unit dosage forms; Pharmacokinetics

Indexed keywords

ATENOLOL; BARIUM SULFATE; BICARBONATE; ETHYL CELLULOSE; GELATIN; HYDROXYPROPYLCELLULOSE; MAGNESIUM STEARATE; METHYLCELLULOSE;

ARTICLE; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG DOSAGE FORM; DRUG MANUFACTURE; HUMAN; HUMAN EXPERIMENT; HUMAN TISSUE; MALE; NORMAL HUMAN; ORAL DRUG ADMINISTRATION; SPECTROPHOTOMETRY; SUSTAINED RELEASE PREPARATION; TABLET;

ADRENERGIC BETA-ANTAGONISTS; ADULT; ATENOLOL; CAPSULES; GASTRIC JUICE; HUMANS; MALE; TABLETS;

EID: 0344541908     PISSN: 00316865     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0031-6865(97)00050-2     Document Type: Article

References (31)

1. Amidon G.L., Lennernäs H., Shah V.P., Crison J.R. 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.
2. Babu V.B.M., Khar K. In vitro and in vivo studies of sustained-release floating dosage forms containing salbutamol sulfate. Pharmazie. 45:1990;268-270.
3. Clarke G.M., Newton J.M., Short M.D. Gastrointestinal transit of pellets of different size and density. Int. J. Pharm. 100:1993;81-92.
4. Clarke G.M., Newton J.M., Short M.B. Comparative gastrointestinal transit of pellet systems of varying density. Int. J. Pharm. 114:1995;1-11.
5. Davis S.S., Stockwell A.F., Taylor M.J., Hardy J.G., Walley D.R., Wilson C.G., Bechgaard H., Christensen F.N. The effect of density on gastric emptying of single- and multiple-unit dosage forms. Pharmacol. Res. 3:1986;208-213.
6. Devereux J.E., Newton J.M., Short M.B. The influence of density on the gastrointestinal transit of pellets. J. Pharm. Pharmacol. 42:1990;500-501.
7. Evrard, B., 1995. Développement d'une forme galénique orale à libération prolongée en médecine vétérinaire: mise au point d'un bolus à rétention dans le réticulo-rumen chez l'ovin. PhD Thesis.
8. Follonier N., Doelker E. Biopharmaceutical comparison of oral multiple-unit and single-unit sustained-release dosage forms. STP Pharma. 2:1992;141-158.
9. Ichikawa M., Kato T., Kawahara M., Watanabe S., Kayano M. A new multiple-unit oral floating dosage system: II. In vivo evaluation of floating and sustained-release characteristics with p-aminobenzoic acid and isosorbide dinitrate as model drugs. J. Pharm. Sci. 80:1991;1153-1156.
10. Ingani H.M., Timmermans J., Moës A.J. Conception and in vivo investigation of peroral sustained release floating dosage forms with enhanced gastrointestinal transit. Int. J. Pharm. 35:1987;157-164.
11. Kaniwa N., Aoyagi N., Ogata H., Ejima A., Motoyama H., Yasumi H. Gastric emptying rates of drug preparations: II. Effects of size and density of enteric-coated drug preparations and food on gastric emptying rates in humans. J. Pharmacobio-Dyn. 11:1988;571-575.
12. Kaus L.C. The effect of density on the gastric emptying and intestinal transit of solid dosage forms: comments on the article by Davis et al. Pharm. Res. 4:1987;78.
13. Kawashima Y., Niwa T., Takeuchi H., Hino T., Itoh Y. Preparation of multiple unit hollow microspheres (microballoons) with acrylic resin containing tranilast and their drug release characteristics (in vitro) and floating behavior (in vivo). J. Control. Release. 16:1991;279-290.
14. Kirch W., Görg K.G. Clinical pharmacokinetics of atenolol - a review. Eur. J. Clin. Pharmacol. 7:1982;81-91.
15. Lipold B.C., Günther J. In-vivo-Prüfung einer multipartikulären Retard-Schwimmarzneiform. Eur. J. Pharm. Biopharm. 37:1991;254-261.
16. Mazer N., Abisch E., Gfeller J.C., Laplanche R., Bauerfeind P., Cucala M., Lukachich M., Blum A. Intragastric behavior and absorption kinetics of a normal and 'floating' modified-release capsule of isradipine under fasted and fed conditions. J. Pharm. Sci. 77:1988;647-657.
17. Melander A., Stenberg P., Liedholm H., Scherstén B., Wahlin-Boll E. Food-induced reduction in bioavailability of atenolol. Eur. J. Clin. Pharmacol. 16:1979;327-330.
18. Miller R.B. A validated high-performance liquid chromatographic method for the determination of atenolol in whole blood. J. Pharm. Biomed. Anal. 9:1991;849-853.
19. Rauws, A.G., Bilthoven, M.O., 1990. Regulatory recommendations in Europe on investigation and evaluation of oral controlled release products. In: Gundert-Remy, U., Möller, H. (Eds.), Oral Controlled Release Products - Therapeutic and Biopharmaceutic Assessment. Wissenschaftliche Verlagsgesellschaft, Stuttgart, pp. 195-207.
20. Regardh C.G., Lundborg P., Persson B.A. The effect of antacid, metoclopramide, and propantheline on the bioavailability of metoprolol and atenolol. Biopharm. Drug Dispos. 2:1981;79-87.
21. Riley S.A., Sutcliffe F.A., Kim M., Kapas M., Rowland M., Turnberg L.A. The influence of gastrointestinal transit on drug absorption in healthy volunteers. Br. J. Clin. Pharmacol. 34:1992;32-39.
22. Rouge N., Cole E.T., Doelker E., Buri P. Screening of the potentially excipients for floating minitablets. STP Pharma. 7:1997;386-388.
23. Rouge, N., Cole, E.T., Doelker, E., Buri, P., 1998. Buoyancy and drug release patterns of floating minitablets containing piretanide and atenolol as model drugs. Pharm. Dev. Technol. (in press).
24. Ruhnke, A., 1989. Einfluss der Dichte von Pellets auf die Verweildauer im Magen und die Absorption eines Modell-Arzneistoffes. PhD Thesis, University of Hamburg.
25. Sangekar S., Vadino W.A., Chaudry I., Parr A., Beihn R., Digenis G. Evaluation of the effect of food and specific gravity of tablets on gastric retention time. Int. J. Pharm. 35:1987;187-191.
26. Schuirmann D.J. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J. Pharmacokinet. Biopharm. 15:1987;657-680.
27. Stockwell A.F., Davis S.S., Walker S.E. In vitro evaluation of alginate gel systems as sustained release drug delivery systems. J. Control. Release. 3:1986;167-175.
28. Sutcliffe, F.A., Riley, S.A., Lynch, J., Taylor, D.C., Turnberg, L.A., Rowland, M., 1988. Comparative absorption of drugs from jejunum and ileum of rat and human. Third Conference on Drug Absorption, Conference Edimburg, p. 37.
29. Timmermans, J., 1991. Floating hydrophilic matrix dosage forms for oral use: factors controlling their buoyancy and gastric residence capabilities. PhD Thesis, University of Brussels.
30. Timmermans J., Moës A.J. Factors controlling the buoyancy and gastric retention capabilities of floating matrix capsules: new data for reconsidering the controversy. J. Pharm. Sci. 83:1994;18-24.
31. Wijnand H.P., Timmer C.J. Mini-computer programs for bioequivalence testing of pharmaceutical drug formulations in two-way cross-over studies. Comput. Methods Programs Biomed. 17:1983;73-88.