An Expert Report on Tromethamine (DB03754): Properties, Clinical Applications as an Alkalizing Agent, and Role as a Pharmaceutical Salt

Executive Summary

Tromethamine, also known by the synonyms Tris and THAM, is a small organic molecule with a multifaceted and distinct dual identity in the fields of medicine and pharmacology. This report provides a comprehensive analysis of Tromethamine (DrugBank ID: DB03754), meticulously differentiating its two primary roles to prevent the critical misattribution of pharmacological properties.

First, Tromethamine functions as an active pharmaceutical ingredient (API) in the form of an intravenous solution, commercially known as THAM. In this capacity, it is a potent, physiologically optimized alkalizing agent indicated for the prevention and correction of severe metabolic acidosis in specific, acute clinical settings such as cardiac bypass surgery and cardiac arrest.[1] Its mechanism as a proton acceptor that does not generate carbon dioxide offers a significant therapeutic advantage over sodium bicarbonate in patients with compromised respiratory function.[4] However, its use is confined to critical care environments due to a high-risk profile that includes potential respiratory depression, hypoglycemia, and severe tissue necrosis upon extravasation.[5]

Second, and more ubiquitously in modern pharmaceuticals, Tromethamine serves as a chemically vital but pharmacologically inert excipient. It is widely used to form a salt with an acidic active drug, a common strategy to enhance the drug's solubility, stability, and bioavailability.[7] The most prominent example is Ketorolac Tromethamine, a potent nonsteroidal anti-inflammatory drug (NSAID).[10] A significant portion of publicly available data and safety warnings associated with the term "Tromethamine" pertains to the severe, life-threatening adverse effects of the Ketorolac moiety, including gastrointestinal bleeding, cardiovascular events, and renal failure.