Effect of Dissolving pH of Enteric Coating Agent on Bioavailability of Enteric Coated Tablets of Erythromycin in Man

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Abstract
Since of bioavailability of enteric-coated commercial erythormycin tablets seemed to depend on dissolving pH of the enteric coating agents, examinations were made on specially prepared tablets coated with enteric-coating agents having different dissolving pH ranging from 5.0 to 7.0. After confirming disintegration and dissolution characteristics of the tablets, the preparations were administered to more than 10 healthy volunteers, and serum levels of the drug and area under the serum level vs time curve (AUC) were determined. Significant differences were found in the results obtained from tablets coated with the agents having dissolving pH of 5.0 or 5.5 and those of pH 6.5 or 7.0. These results supported the previous findings and might present important information to formulators in selecting enteric coating agents to formulate more effective preparations with high bioavailability. During the couse of the study, relation of the bioavailability to coefficients of variation in the maximum serum level of the drug and in the AUC were also investigated in detail, and it was found that the coefficients of variation were small when the tablets having high bioavailability were adminstered.

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