Stability of gabapentin in extemporaneously compounded oral suspensions

作者：Friciu Mihaela; Roullin V Gaelle; Leclair Gregoire^*

来源：PLos One, 2017, 12(4): e0175208.

DOI：10.1371/journal.pone.0175208

This study reports the stability of extemporaneously prepared gabapentin oral suspensions prepared at 100 mg/mL from bulk drug and capsules in either Oral Mix or Oral Mix SF suspending vehicles. Suspensions were packaged in amber plastic bottles and amber plastic syringes at 25 degrees C / 60% RH for up to 90 days. Throughout the study period, the following tests were performed to evaluate the stability of the preparations: organoleptic inspection to detect homogeneity, color or odor changes; pH measurements; and gabapentin assay using a stability-indicating HPLC-UV method. As crystallization was observed at 5 degrees C, storage at this temperature condition is not recommended. All preparations stored at 25 degrees C / 60% RH remained stable for the whole study duration of 90 days.

• 出版日期2017-4-17