Correlation of in vivo bioavailability of erythromycin stearate tablets with in vitro tests

Correlations between the bioavailability parameters for erythromycin stearate tablets from five manufacturers and in vitro tests of these tablets were examined using forward (stepwise), multiple linear regression analysis. Bioavailability parameters were determined in clinical studies employing a balanced, incomplete block design. In vitro tests used disintegration, dissolution, and dissolution/dialysis as the independent variables in regression equations. Significant correlations were found between linear combinations of these parameters and the time of peak and the peak serum levels. The inclusion of an in vitro disintegration test to describe peak serum levels of erythromycin is noteworthy since it has been suggested that disintegration tests are of less value than dissolution techniques employed in the present investigation may be useful for selection of appropriate physicochemical tests for continued monitoring of the bioavailability of erythromycin stearate tablets.