Abstract
Twelve lots of digoxin tablets from eight American companies were studied in vivo and in vitro. Biological availability was tested in normal human subjects after single 0·5 mg. doses and in the steady state after 8-10 days of drug administration. Excellent correlations were observed between dissolution-rate in 0·6% hydrochloric acid and bioavailability. Variation in digoxin bioavailability appears to result from differences in the rate at which the tablets go into solution in the gastrointestinal tract. It is recommended that a lower limit of acceptability for dissolution-rate be established for digoxin tablets to be used in patients.
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