Graduate Thesis Or Dissertation
 

The effect of food and tablet age on the relative bioavailability and pharmacodynamics of two tolbutamide products

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  • The relative bioavailability and pharmacodynamics of tolbutamide from two different commercially available tablet products has been evaluated in healthy subjects in a single dose cross over study. Products were aged by exposing tablets to 98% relative humidity for 3 days at ambient temperature which was found to differentially affect both rate and extent of absorption for the two products. Differences were reflected by log AUC, peak concentration, mean absorption time, and mean residence time. The aged inovator's product produced statistically significantly higher serum tolbutamide concentrations for the first 8 hours post dosing and a greater glucose depression than the aged generic product. Administration of unaged tablets with food produced differences in the rate of absorption manifested in time to peak, peak concentration, and mean absorption time which resulted in statistically significantly higher serum tolbutamide concentrations for the first 3 hours post dosing. Administration with food produced a 14% greater reduction in glucose concentration for the inovator's product than for the generic product at 40 minutes post dose. Statistical moment theory, bivariate distribution plots, across study comparisons, non-parametric trend analysis techniques and linear regression were utilized in data analysis. Results of this study demonstrate that the two commercially available products do not respond equally under the conditions investigated.
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