Summary
Various brands of digoxin tablets, and even different batches of one brand, may differ greatly in bioavailability. Digoxin-Sandoz® tablets have been compared with Lanoxin® manufactured between 1969 and 1972 and after May 1972. Comparisons were also made between and within batches of Digoxin-Sandoz tablets. Three separate cross-over studies were conducted involving a total of 20 volunteers. Digoxin-Sandoz tablets were shown to have a constant bioavailability and to produce plasma concentrations very similar to “new” Lanoxin. Storage for 2 years of one batch of Digoxin-Sandoz did not alter the bioavailability. Particle size was shown to influence bioavailability. Care should be exercised when plasma data alone are interpreted as an index of bioavailability. Measures of bioavailability based on plasma data obtained up to 6 h after administration differed from those based on cumulative urinary excretion data (in this study by a factor of about 2), which can lead to the belief that a difference in bioavailability is much greater than is actually the case. Data from cumulative urinary excretion, collected over a sufficiently long period of time, are likely to be the most reliable method for determining the bioavailability of a substance such as digoxin.
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References
Editorial. The bioavailability of digoxin. Lancet1972 II 311–312
Beveridge, T., Schmidt, R., Kalberer, F., Nüesch, E.: Bioavailability of digoxin. Lancet1973 II 499
Manninen, V., Melin, J., Härtel, G.: Serum digoxin concentrations during treatment with different preparations. Lancet1971 II 934–935
Lindenbaum, J., Mellow, M.H., Blackstone, M.O., Butler, V.P.: Variation in biologic availability of digoxin from four preparations. New. Engl. J. Med.285 1344–1347 (1971)
Shaw, T.R.D., Howard, M.R., Hamer, J.: Variation in the biological availability of digoxin. Lancet1972 II 303–307
Shaw, T.R.D., Carless, J.E., Howard, M.R., Raymond, K.: Particle size and absorption of digoxin. Lancet1973 II 209–210
Falch, D., Teien, A., Bjerkelund, C.J.: Comparative study of the absorption, plasma levels, and urinary excretion of the “new” and the “old” Lanoxin. Brit. med. J.1973 I 695–697
Johnson, B.F., Fowle, A.S.E., Lader, S., Fox, J., Munro-Faure, A.D.: Biological availability of digoxin from Lanoxin produced in the United Kingdom. Brit. med. J.1973 IV 323–326
Shaw, T.R.D.: The digoxin affair. Postgrad. med. J.50 98–102 (1974)
Manninen, V., Korhonen, A.: Inequal digoxin tablets. Lancet1973 II 1268
Huffmann, D.H., Azarnoff, D.L.: Absorption of orally given digoxin preparations. J. Amer. med. Ass.222 957–960 1972
Sanchez, N., Sheiner, L.B., Halkin, H., Melmon, K.L.: Pharmacokinetics of digoxin: Interpreting bioavailability. Brit. med. J.1973 IV 132–134
Sorby, D.L., Tozer, T.N.: On the evaluation of biologic availability of digoxin from tablets. Drug Intell. clin. Pharm.7 78–83 (1973)
Wagner, J.G., Christensen, M., Sakmar, E., Blair, D., Yates, J.D., Willis, P.W., Sedman, A.J., Stoll, R.G.: Equivalence lack in digoxin plasma levels. J. Amer. med. Ass.224 199–204 (1973)
Greenblatt, D.J., Duhme, D.W., Koch-Weser, J., Smith, T.W.: Evaluation of digoxin bioavailability in single — dose studies. New.Engl. J. Med.289 651–654 (1973)
Doherty, J.E.: The clinical pharmacology of digitalis glycosides: a review. Amer. J. med. Sci.255 382–414 (1968)
Azarnoff, D.L.: Pharmacokinetics and bioavailability. In: Clinical pharmacological evaluation in drug control. Report on a Symposium, Heidelberg 27–30 Nov., 1972, pp 41–42. Regional Office for Europe, WHO, Copenhagen
Nimmerfall, F., Rosenthaler, J.: Vergleichende Bioavailability-Studie mit je zwei verschiedenen oralen Arzenizubereitungen von Lanoxin und Sandoz Digoxin am Rhesusaffen. Unpublished Sandoz Report 1974
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Beveridge, T., Kalberer, F., Nüesch, E. et al. Bioavailability studies with Digoxin-Sandoz® and Lanoxin® . Eur J Clin Pharmacol 8, 371–376 (1975). https://doi.org/10.1007/BF00562665
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DOI: https://doi.org/10.1007/BF00562665