44837
document
Comparison of the in vitro and in vivo release of digoxin from four different soft gelatin capsule formulations . A blinded , four-treatment crossover study in 16 normal adult male volunteers compared plasma concentrations and urinary excretion of digoxin , measured by radioimmunoassay , after oral administration of soft gelatin capsule formulations of digoxin . Four 0.4-mg formulations with different in vitro " burst times " and dissolution rates were administered , with 2-week intervals between treatments . The two capsules with lowest in vitro burst times ( 2.9 and 16 min ) gave comparable in vivo results . The other two capsules , with in vitro burst times of 62 and 229 min , produced significant delays in digoxin absorption . In vitro-in vivo correlations were obtained by comparing the logarithm of the in vitro burst time with time to peak plasma level and the time to the first measurable plasma level ( > or = 0 . 05 ng/ml ) . Also , the mean time to peak plasma level correlated with the logarithm of the time required to release either 50 % or 85 % of the digoxin in vitro . No significant changes were found in the amount of digoxin absorbed from each capsule as determined by urinary excretion or AUC0-infinity .
44838
Intervention_Pharmacological
digoxin
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Intervention_Pharmacological
capsule formulations
44840
Intervention_Pharmacological
digoxin
44841
Intervention_Pharmacological
soft gelatin capsule formulations of digoxin
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Intervention_Other
formulations with different in vitro " burst times "
44843
Intervention_Other
dissolution rates
44844
Intervention_Pharmacological
digoxin
44845
Outcome_Physical
in vitro and in vivo release of digoxin
44846
Outcome_Physical
urinary excretion of digoxin
44847
Outcome_Other
peak plasma level
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Outcome_Other
plasma level
44849
Outcome_Physical
peak plasma level
44850
Participant_Sample-size
16
44851
Participant_Condition
normal
44852
Participant_Age
adult
44853
Participant_Sex
male