Stability of mycophenolate mofetil in an extemporaneously compounded oral liquid

Abstract

The stability of mycophenolate mofetil in an extemporaneously prepared 100-mg/mL oral liquid was studied. The contents of 80 250-mg capsules of mycophenolate mofetil were combined with sterile water for irrigation and cherry-flavored syrup to produce 200 mL of suspension. Six 1-mL samples were analyzed immediately, and the rest of the suspension was poured into 12 2-oz amber polyethylene tetraphthalate glycol (PETG) bottles; six bottles were stored at 23-25 °C and six at 2-8 °C. Samples were removed on days 14, 21, 28, 35, 49, 63, 92, and 121 for analysis by high-performance liquid chromatography; pH was measured initially and at each sampling time. The pH of the suspension was initially 6.1 and remained unchanged throughout the study. The suspension retained more than 90% of its initial drug concentration for 121 days at 23-25 and 2-8 °C. There was no detectable change in color or odor and no visible microbial growth in any sample. Mycophenolate mofetil in a 100-mg/mL oral liquid prepared with cherry- flavored vehicle and stored in amber PETG bottles was stable for 121 days at 23-25 and 2-8 °C.