Stability of sumatriptan succinate in extemporaneously prepared oral liquids.
The stability of sumatriptan succinate in extemporaneously prepared oral liquids was studied. Suspensions of sumatriptan (as the succinate salt) in Ora-Sweet, Ora-Sweet SF, and Syrpalta syrups (Paddock Laboratories and Humco Laboratory) were extemporaneously compounded to produce a sumatriptan concentration of 5 mg/mL. Each suspension was prepared in triplicate. The suspensions were stored at 4 degrees C in amber glass bottles for 60 days. Two 1-mL samples were removed from each bottle initially and on days 2, 7, 14, 21, 28, 35, and 60. Sumatriptan concentrations were determined by high-performance liquid chromatography. The samples also underwent visual inspection and microbial testing. The mean concentration of sumatriptan in all suspensions remained above 90% of the initial concentration for up to 21 days. By day 28, the sumatriptan concentration of all suspensions had decreased to less than 90% of the initial concentration. None of the suspensions had microbial growth up to day 28, and there were no visible changes in the suspensions throughout the study period. Sumatriptan 5 mg/mL (as the succinate salt) in three oral suspensions was stable for up to 21 days when stored without light at 4 degrees C.
Fish
D N
DN
Department of Pharmacy Practice, University of Colorado Health Sciences Center, Denver 80262, USA. doug.fish@uchsc.edu
Beall
H D
HD
Goodwin
S D
SD
Fox
J L
JL
D000284:Administration, Oral; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D004356:Drug Storage; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008881:Migraine Disorders / Q000188:drug therapy; D009994:Osmolar Concentration; D010316:Particle Size; D012044:Regression Analysis; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage / Q000737:chemistry*; D018170:Sumatriptan / Q000008:administration & dosage / Q000737:chemistry*; D013535:Suspensions
D017366:Serotonin Receptor Agonists; D013535:Suspensions; D018170:Sumatriptan