DEVELOPMENT AND CHARACTERIZATION OF ORAL DISINTEGRATING TABLETS OF SITAGLIPTIN
Abstract
Objective: The current study's objective is to develop and evaluate oral disintegrating tablets (ODT) for Sitagliptin. Sitagliptin, a selective DPP-4 Inhibitor. Once DPP-4 mediated incretins are inactivated effects the glucose regulation in body. It is necessary to develop oral disintegrating tablet addressing specific need for convenience and enhanced drug delivery, helpful for diabetic patients with fast-paced life style.
Methods: Using various quantities of Croscaramellose sodium & Sodium starch glycolate as Superdisintegrants, ODT formulations of Sitagliptin were prepared utilizing the Direct Compression technique. Nine trials were developed and assessed for Pharmaceutical Product Performance.
Results: Findings indicate that all formulations meet the acceptance criteria, and kinetic modelling was applied to the In-Vitro dissolution profiles.
Conclusion: The formulation F8, which is considered as best formulation, contained 5 mg of Croscaramellose sodium and 7.5 mg of Sodium starch glycolate. Formulation (F8) follow first order (r=0.999), whereas release mechanism found to be non-fickian type (n= 0.540).
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