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Disposition of tablet and capsule formulations of digoxin in the elderly
J Hui1, Y M Wang, A Chandrasekaran
1College of Pharmacy, Ohio State University, Columbus 43210.
Study Objective:
To compare digoxin tablets and liquid-filled capsules with respect to excretion of the drug and its metabolites in urine and feces at steady state.
Design:
A randomized, crossover trial, each period lasting 3 weeks, with no washout period.
Setting:
A university hospital.
Patients:
Six patients, five of whom were elderly, with histories of gastrointestinal disorders, such as hypochlorhydria, intestinal bacterial overgrowth, and inflammatory bowel disease.
Interventions:
The patients received digoxin once/day in either tablet or capsule form for 3 weeks, and then were switched to the other formulation. Total urinary and fecal excretion from the last 3 days of each regimen were analyzed for the drug and metabolites.
Measurements And Main Results:
No statistically significant differences were found between tablets and capsules in recovery of digoxin or its metabolites in urine or feces (p = 0.05). One subject had a 4-fold increase in urinary drug excretion and 50% decrease in fecal excretion after taking the capsules compared with tablets. Intersubject variability in extent and type of metabolite excretion was greater than intrasubject variability.
Conclusions:
Fecal analyses may be an accurate way to classify patients as formers of digoxin reduction products.