Development and Evaluation of Combined Gliclazide and Enalapril Maleate Immediate Release Tablet

Chronic diseases such as diabetes mellitus and systemic hypertension have high prevalence all over the world. In majority of cases, patients having diabetes mellitus are also suffering from systemic hypertension and vice versa. Aims: The purpose of the study is to prepare a combination dosage form which can be used to treat both the diseases concomitantly, reducing pill burden and increasing patient compliance. Methods: Based on positive results of a feasibility study, including doctors’ opinion and prescription survey, Gliclazide and Enalapril maleate were selected as the active ingredients for developing a FDC (Fixed Dose Combination) preparation. Immediate release combination tablet (Gliclazide and Enalapril maleate Tablet, GET), containing 80 mg of Gliclazide and 5 mg of Enalapril maleate, were prepared by direct compression method having diameter of 8.7 mm and thickness of 3.45 mm. Their physical properties were determined. The tablets were subjected to dissolution testing in a six-station USP paddle apparatus rotated at 100 rpm. The dissolution medium was pH 7.4 phosphate buffer maintained at 37C. The prepared tablets were again subjected to stability testing at conditions of 25°C/60%RH and 40°C/75%RH for 6 months. Shelf-lives of the drugs were determined following ICH guidelines as well as by kinetic calculations. Results: The prepared tablets showed hardness of 6.13 kg.cm and friability value of 0.1676%. The dissolution of Gliclazide and Enalapril maleate was 98% and 85% respectively at 45 minutes. During stability testing, slight discoloration of the tablets was observed at higher temperature although the assay results were found to be satisfactory. Conclusion: The prepared tablets met the pharmacopeial standards.