Stability of sumatriptan succinate in extemporaneously prepared oral liquids

Am J Health Syst Pharm. 1997 Jul 15;54(14):1619-22. doi: 10.1093/ajhp/54.14.1619.

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Chromatography, High Pressure Liquid
  • Drug Stability
  • Drug Storage
  • Humans
  • Hydrogen-Ion Concentration
  • Migraine Disorders / drug therapy
  • Osmolar Concentration
  • Particle Size
  • Regression Analysis
  • Serotonin Receptor Agonists / administration & dosage
  • Serotonin Receptor Agonists / chemistry*
  • Sumatriptan / administration & dosage
  • Sumatriptan / chemistry*
  • Suspensions

Substances

  • Serotonin Receptor Agonists
  • Suspensions
  • Sumatriptan