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Abstract:  Ursodiol is used in the treatment and prevention of certain types of gallstones and for patients with primary biliary cirrhosis. Ursodiol is marketed for this purpose by Watson Pharma, Inc. as ACTIGALL, by Axcan Scandipharm Inc. as URSO 250 and URSO Forte, and by a number of generic manufacturers. Ursodiol is available as capsules of varying strengths. The need for other dose-form options for those patients who cannot take capsules has led compounding pharmacies to seek other alternatives, namely oral solutions and suspensions. Additionally, some patients are unable to tolerate suspending agents containing alcohol or sorbitol. The objective of this study was to determine the stability of ursodiol in SyrSpend SF Cherry Flavored which does not contain sorbitol or alcohol. The studied sample was compounded into a 30-mcg/mL suspension and stored in a low-actinic plastic bottle at temperatures between 2°C and 8°C. Six samples were assayed at each time point out to 66 days by a stability-indicating high-performance liquid chromatography method. The method was validated for its specificity through forced degradation studies. The sample remained within 90% to 110% of the initial concentration throughout the course of the study. The beyond-use date of this product is at least 66 days, based on data collected when refrigerated and protected from light.

Related Keywords: ursodiol, bile acid, gallstones, cholelithiasis, oral suspension, stability

Related Categories: EXCIPIENTS, GASTROENTEROLOGY, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, DOSAGE FORMS/DRUG CARRIERS, STORAGE

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