Saxagliptin HCl is a potent, selective, reversible dipeptidyl peptidase 4 (DPP4) inhibitor. Glipizide is second generation\nsulphonylurea drug. The combination of therapy of two drugs with different mechanism of action minimizes unwanted side\neffects and lowers the dose of antihyperglycemic agent. A multilayer tablet with one layer of immediate release and another\nlayer of sustained release will have wide spread acceptability. Co-administration of two drugs was achieved by formulating\nsaxagliptin HCl and glipizide into two separated layers of bilayer tablet. A simultaneous analytical method was developed for\nboth the drugs using UV Vis spectrophotometric technique and validated as per ICH (Q2, R1) guidelines. An immediate release\nlayer of saxagliptin HCl was prepared and then another layer of glipizide sustained release was compressed on it. P4 of\nimmediate release formulation and F6 of sustained release formulation give release as per IP specification. It was concluded that\nthe bilayer tablets prepared provide an effective combination therapy for T2DM.
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