Stable Solutions of Ursodiol

About

The Problem For many drugs that are prescribed to infants no paediatric formulations are available. With standard solid dosage forms being generally unsuitable in paediatrics, hospital staff rely heavily on the use of extemporaneous preparations, which are made in situ at the hospital from available drugs that were formulated for adults. Ursodiol (UDAC) is FDA approved in adults and commonly used in children for treatment of chronic cholestatic liver disease, hepatobiliary disease, hereditary cholestasis syndromes, biliary atresia, and parenteral nutrition-associated cholestasis. It is one of the top 10 most commonly prescribed liquid formulations prepared extemporaneously from crushed tablets and used off-label in 21 US children’s hospitals. Insufficient stability information and improper manufacturing standardization of this water-insoluble drug are common practice for these preparations. Therefore, it is desirable to develop a liquid dosage form of Ursodiol that can be prescribed for paediatric patients. The Technology Solution Researchers at the University of Tennessee have developed novel standardized methods for the preparation of Ursodiol solutions. The formulations are based on a combination of FDA approved lipophilic solvents, aqueous cosolvents and surfactants. Unlike the in-situ formulations that are the current standard and that form heterogeneous suspensions, our Ursodiol formulations provide clear solutions that remain homogeneous even when stored in a refrigerator for several days. Benefits Provides a homogeneous and stable solution of Ursodiol that can be stored in a refrigerator and used as needed. Saves staff work time. The median time for clinical staff to prepare the Ursodiol suspension is 20 min. All materials are FDA approved.