Formulation development and evaluation of Sitagliptin Phosphate Monohydrate sustained release tablet by using natural polymers

In 2007, sitagliptin, the first drug in a new family of oral glucose-lowering drugs, was introduced to the UK market. When hyperglycemia is present, it suppresses the secretion of glucagon and increases the secretion of insulin. The goal of the current study is to use lactose as a diluent in a direct compression approach to create a novel drug delivery system: sustained release tablets of the antidiabetic medication sitagliptin phosphate monohydrate. FTIR investigations were used to rule out the drug-excipient interaction. Using xanthan gum (X1) and microcrystalline cellulose (MCC) (X2), nine formulations of sitagliptin phosphate tablets were created based on factors like hardness and dissolving profile. Organoleptic characteristics, hardness, friability, weight fluctuation, and in vitro drug release were assessed for the manufactured batches. Each formulation exhibited a sluggish rate of disintegration and minimal weight fluctuation. The formulation made with 27.5% xanthan gum ended up being the best overall out of nine potential formulations. This optimized formulation (F5) showed good dissolution profile with 99.61% drug release within 10 hours. It was concluded that sustained release tablets of Sitagliptin Phosphate Monohydrate can be successfully formulated by using Xanthan gum natural polymer.