Stability of Oral Suspensions of Ursodiol Made From Tablets

Cary E. Johnson and Darcie D. Streetman


Am J Health Syst Pharm. 2002;59(4) 

In This Article

Results and Discussion

At least 98% of the initial concentration of ursodiol remained throughout the 90-day study period in all suspensions (Table 1). There were no significant differences in the percentage remaining at day 90 among samples that contained strawberry syrup compared with those that contained Ora-Sweet SF (p = 0.82). No difference was found in the percentage of initial concentration remaining between refrigerated and room temperature samples (p = 0.31). There was no detectable change in color, odor, or taste and no visible microbial growth in any sample. There was no appreciable change from the initial mean ± S.D. pH (4.51 ± 0.02) in any of the samples containing strawberry syrup or samples prepared with Ora- Sweet SF (4.53 ± 0.01). Both preparations were found to be sweet with a slightly bitter aftertaste; however, the sugar-free preparation was slightly sweeter for a longer period of time than the preparation made with strawberry syrup.

The absorption of ursodiol has been reported to be 90% following an oral dose.[2] The absorption of the ursodiol formulation used in the current study has not been evaluated. However, the absorption and therapeutic effectiveness of a drug in a suspension compounded from crushed tablets are unlikely to differ appreciably from those of the original dosage form.


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