RESUMO
Eprosartan mesylate is the latest angiotensin II receptor antagonist approved by FDA. It is used for the treatment of hypertension. It has a low oral bioavailabilty not more than 13%. This study aims to enhance eprosartan mesylate release from immediate release oral tablet by adding solubility enhancers to the formula of the marketed tablet, then comparing dissolution profiles. The formula of the studied tablet was determined by preparing a formula similar to that of the marketed tablet in its physical properties and dissolution profiles. Eprosartan mesylate release from the prepared tablet and the marketed tabled was studied in different dissolution media: HCI acidic medium pH 1.2, phosphate buffer pH 6.8, and phosphate buffer pH 7.5. Results were compared. Spectrophotometer was used to titrate the amount of active ingredient release in the dissolution medium. Titration method by spectrophotometry was validated. Effect of addition of solubility enhancers in various percentages to the formula on eprosartan mesylate release was studied. Tween 80, gypsophila saponin, L-arginin, citric acid, and sodium bicarbonate were used. Statistical study was performed using T-Test and one-way ANOVA Test to compare means of samples at a confidence level of 5%. Consequent Dunnett's Test was used to compare with control sample. The highest release of eprosartan mesylate from the prepared tablet was noted successively in the phosphate buffer pH 7.5, HCI acidic medium pH 1.2, and phosphate buffer pH 6.8. One-way ANOVA Test did not show any statistically significant difference [p>0.05]. Using 6% of Tween 80, 6% of gypsophila saponinin, or L-arginin in a molar ratio 1:3 resulted in minor improvement in dissolution rate 0.05]. Addition of studied solubility enhancers to eprosartan mesylate tablet did not result in statistically significant imrovement of drug release