US12564592 — Injectable leucovorin formulations and methods of preparing same

USPTO Abstract

Described herein are clear, stable aqueous formulations comprising—in relevant part—leucovorin calcium; substituted cyclodextrins, specifically betadex suclfobutyl ether cyclodextrin (SBE-β-CD) or hydroxypropyl beta cyclodextrin (HP-β-CD), designed for parenteral administration. The formulations are designed to effectively prevent drug crystallization and particulate matter formation, addressing major stability challenges associated with existing products. These advancements not only improve the safety and efficacy of leucovorin calcium for intravenous administration but also facilitate compliance with regulatory standards, providing a reliable therapeutic option for patients. Methods of making and using these formulations are also described herein.