Effect of Crospovidone, Croscaramellose Sodium in Combination on the Drug Release of Anti diabetic Medication in Tablet Form

Abstract

Objective: The current study’s objective is to check the impact of superdisintegrants on the drug release of Vildagliptin by developing oral disintegrating tablets (ODT). Vildagliptin, new class of oral hypoglycemic agent. It acts by inhibiting dipeptidyl peptidase-4. Conventional Vildagliptin tablets are (due to its first pass effect) unsuitable where quicker onset of action is required Hence, it is necessary to develop oral disintegrating tablet, in order to obtain improved patient compliance. Methods: Using Oral disintegrating tablets of Vildagliptin were prepared using various quantities of Crospovidone & Croscaramellose sodium as Superdisintegrants by direct compression method. Nine trials were developed by varying the quantities of Crospovidone, Croscaramellose sodium such as 6 ± 1.5 mg i.e. 4.5, 6, 7.5 mg respectively. Prepared formulations were assessed for Pharmaceutical Product Performance as per official methods such as hardness, friability, weight variation, drug content, wetting time, disintegration time, and drug release studies. Results: Findings indicate that all formulations meet the acceptance criteria such as good mechanical strength (>4.3 kg/cm2), less friable (<0.65%), uniform drug content (>98%) and kinetic modeling was applied to the in-vitro dissolution profiles. Conclusion: The best formulation (F1), which is likewise identical to the marketed product (Galvus-50) (f2= 89.01, f1= 1.85), contained 7.5 mg of Crospovidone and 7.5 mg of Croscaramellose sodium. Formulation (F1) follow first order, whereas release mechanism found to be Fickian type (n= 0.323).