Physicochemical and Microbiological Stability of Ursodiol Oral Compounded Suspensions.

Objective: In the United States, ursodiol is commercially available as solid dosage forms, which represents a problem for children who cannot swallow capsules or tablets. There is a lack of an age-appropriate formulation for ursodiol, and the extemporaneous preparation of an oral suspension with an extended beyond-use-date (BUD) may represent a good therapeutic alternative for the pediatric population. However, all pharmacists need validated stability studies to prepare oral liquids with high quality and safety.

Methods: Oral compounded suspensions for ursodiol 20 to 60 mg/mL were prepared by adding the contents of ursodiol 300-mg commercial capsules (Actavis, KVK Tech, and Mylan) to a proprietary oral suspending vehicle. The BUD of the oral compounded suspensions was determined by using a valid, stability-indicating analytical method. The physical characterization consisted of observing all samples for appearance and color, and testing for pH. Microbiological stability testing followed the United States Pharmacopeia (USP) Chapter 51: Antimicrobial Effectiveness Testing.

Results: The ursodiol oral compounded suspensions exhibited a homogeneous white color and the pH did not change significantly. The potency of the oral suspensions remained within ±10% of the specifications. Considering the microbiological characterization, there was no growth of challenge microorganisms throughout the study for all samples.

Conclusion: This study demonstrates that ursodiol (Actavis, KVK Tech, and Mylan) is physically, chemically, and microbiologically stable in the oral suspending vehicle at room temperature for up to 6 months.