Biopharmaceutical properties of solid dosage form

A completely automatic continuous flow dissolution procedure was developed and tested. Pertinent dissolution conditions were investigated and chosen to study the dissolution characteristics of seven brands of phenylbutazone tablets. A pumping system enabled the simulated digestive fluid to flow from the dissolution vessel into the flow cell of a recording spectrophotometer for a continuous recording of the drug concentration in the dissolution medium, which was gradually changed from an acidic medium to a basic one. From the "in vitrott” data obtained by this test procedure, a T₅₀% value of 120 minutes was chosen as a limit of acceptance for the test products. The "in vivo" characteristics of six of the brands were compared with those observed for a pharmaceutically acceptable product. Of the seven test products, only four were acceptable on the basis of both the "in vitro" and the "in vivo" data. Correlation of the "in vitro" and the "in vivo" data resulted in "least squares" lines with negative slopes.Pharmaceutical Sciences, Faculty ofGraduat