James T. Doluisio

Single-dose fasting bioequivalence assessment of erythromycin stearate tablets in man

The bioequivalence of film-coated erythromycin stearate tablets produced by five different manufacturers was evaluated in a balanced incomplete block design involving the five formulations given to 30 fasted subjects over a 3-week study period. Serum levels of erythromycin activity were determined microbiologically. Statistical analysis of variance was performed on the observed bioavailability parameters: maximum serum concentration Cmax, time to maximum serum concentration (tmax), and area under the serum concentrationtime curve (AUC). There was no statistical difference between formulations for the tmax parameter. Formulation differences were found, however, based on the analysis of variance of the Cmax and AUC parameters. Two products, although not significantly different from one another, showed significantly greater Cmax and AUC values than the other three products.

Report of the Workshop on Controlled Release Dosage Forms: Issues and Controversies: Academy of Pharmaceutical Sciences American Society for Clinical Pharmacology 3 Therapeutics Drug Information Association and Food and Drug Administration

AbstractControlled release pharmaceutical dosage forms may offer one or several advantages over conventional dosage forms of the same drug, including reduced dosing frequency, decreased incidence and/or intensity of adverse effects, greater selectivity of pharmacologic activity and a more constant therapeutic effect. In other instances, controlled release products may have no significant advantages or they may actually be less effective and/or more hazardous than conventional dosage forms of the same drug. In some cases, controlled release products may be therapeutically advantageous primarily for certain subpopulations of patients.