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Disposition of Tablet and Capsule Formulations of Digoxin in the Elderly
Authors:Dr. James Hui Ph.D.  Dr. Yow-Ming C. Wang Ph.D.  Dr. Appavu Chandrasekaran Ph.D.  Dr. Douglas R. Geraets Pharm.D.  Dr. James H. Caldwell M.D.  Dr. Larry W. Robertson Ph.D.  Dr. Richard H. Reuning Ph.D.
Affiliation:1. Colleges of Pharmacy and Medicine Ohio State University, Columbus, Ohio.;2. Medicine Ohio State University, Columbus, Ohio.
Abstract:
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.
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