The bilayer film-coated tablets containing sustained release metformin hydrochloride 500 mg and immediate release sitagliptin 50 mg met the in-house specification and equivalent dissolution levels in vitro with the Janumet XR 50/500 mg tablet at pH 1.2 (f2 = 67.5 for metformin hydrochloride; f2 = 63.3 for sitagliptin); at pH 4.5 (f2 = 71.95 for metformin hydrochloride; f2 = 64.05 for sitagliptin); and at pH 6.8 (f2 = 83.19 for metformin hydrochloride; f2 = 60.26 for sitagliptin).