Glyburide Impurities

Glibenclamide, also known as glyburide, is an antidiabetic medication used to treat type 2 diabetes. It is recommended that it be taken together with diet and exercise. It may be used with other antidiabetic medication. It is not recommended for use by patients with type 1 diabetes or diabetic ketoacidosis, and use in pregnancy is generally avoided when insulin is preferred; caution is required in severe renal or hepatic impairment. Glyburide is a second generation sulfonylurea that acts as an insulin secretagogue by binding the SUR1 subunit of the pancreatic beta cell ATP-sensitive potassium channel, causing membrane depolarization, voltage-gated calcium channel opening, and insulin exocytosis. Typical oral dosing varies by product and patient response, commonly from 1.25 mg up to 20 mg per day depending on formulation; pharmacokinetic characteristics include high plasma protein binding (about 99 percent), hepatic metabolism primarily via CYP2C9 to less active metabolites, onset of effect within 1 to 2 hours, peak concentrations at roughly 2 to 4 hours, and a clinically relevant duration of action that can extend to about 24 hours, with elimination of parent drug and metabolites by both biliary and renal routes.