Bioavailability of Digoxin

Biological Availability of Digoxin from Lanoxin Produced in the United Kingdom

“…Differences in peak plasma digoxin concentrations occurred in some subjects after treatment with different batches, but areas measured under plasma concentration/time curves over many hours showed less variation. Differences in bioavailability between batches of certain branded products may be explained by low content uniformity of the tablets (Vitti et al, 1971;van Oudtshoorn, 1972), but this could not explain the differences between brands conforming to high standards of content uniformity. Our own experience is that major change in bioavailability can occur without dramatic reduction in content uniformity, and that enforcement of existing regulations in regard to content uniformity would not ensure uniformity of digoxir.…”

Influence of Dispersion Method on Dissolution Rate and Bioavailability of Digoxin from Triturations and Compressed Tablets II

“…Such variations were also found in different lots of the formulated product made by the same manufacturer (1,6,7). Several poorly absorbed preparations were reported (1)(2)(3)(4) to be therapeutically ineffective or associated with digoxin levels below the therapeutic range.…”

Influence of Dispersion Method on Dissolution Rate of Digoxin–Lactose and Hydrocortisone–Lactose Triturations I

“…Recent publications pointed out the wide variation in digoxin absorption from tablets produced by various manufacturers (1)(2)(3). Furthermore, significant variations in blood levels were noted between batches made by the same manufacturer (1).…”