Absorption of digoxin from a new microencapsulated formulation.

The absorption of digoxin from two capsule preparations containing a large number of small, enteric-coated granules of the glycoside (0.38 mg) was compared with that of the same amount from ultrarapidly dissolving commercial tablets. Eight volunteers were studied during steady state conditions. Digoxin concentrations in plasma and urine were measured by radioimmunoassay. Peak plasma concentrations of digoxin were significantly (p < 0.01) delayed after taking the capsules (2.6 +/- 1 h and 2.6 +/- 0.9 h, mean +/- SD) as compared to the tablets (1.3 +/- 0.7 h). The peak concentrations produced by the capsules were 3.1 +/- 1.0 and 2.6 +/- 1.1 nmol/l; only the latter was significantly (p less than 0.05) lower than after the tablets (3.4 +/- 1.0 nmol/l). Areas under the plasma concentration-time curves during a 24 h dosage interval were similar for the three preparations, and so was the 24 h urinary excretion of digoxin, which averaged 60-63% of the daily dose. Thus, this particular enteric coating of digoxin delayed absorption without reducing the amount absorbed.

RCT Entities:   Population Interventions Outcomes