EP3811930A1 — Oral gliptin compositions and method for preparation thereof

USPTO Abstract

Described is an aqueous oral gliptin solution comprising a gliptin, a sweetening agent, an antioxidant and a thickening agent. Also described is a method the consecutive steps of heating 80 - 95 v/v% of the water to 40 - 65°C, admixing the antioxidant, and, if present, the chelating agent and buffering agent, optionally, cooling down to 25 - 35°C, admixing sweetener, and, if present, preservative agent, and optionally pH adjusting agent or a portion of the pH adjusting agent, admixing the gliptin, if necessary, adjust the pH to the envisaged value by addition of a pH adjusting agent, admix a solution, prepared by dissolving the thickening agent in the co-solvent, homogenising the obtained mixture, admixing, if present, the wetting agent, if necessary, adjust the final volume by adding from the rest of the water, optionally filter through a 10 µm sieve, and filling in an appropriate container.