Stability of mycophenolate mofetil in an extemporaneously compounded oral liquid.
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 terephthalate [corrected] G(PETG) bottles; six bottles were stored at 23-25 degrees C and six at 2-8 degrees 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 degrees 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 degrees C.
Anaizi
N H
NH
Department of Pharmacy, University of Rochester, NY 14642, USA.
Swenson
C F
CF
Dentinger
P J
PJ
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000737:chemistry*; D004339:Drug Compounding; D004355:Drug Stability; D007166:Immunosuppressive Agents / Q000737:chemistry*; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000737:chemistry; D011355:Prodrugs / Q000737:chemistry*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007166:Immunosuppressive Agents; D011355:Prodrugs; D009173:Mycophenolic Acid