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Stability of rifampin in SyrSpend SF

Bridget Sorenson1, Paul Whaley

  • 1Dynalabs, LLC, St. Louis, Missouri 63103, USA. bsorenson@dynalabs.us

International Journal of Pharmaceutical Compounding
|May 23, 2013
PubMed

Insights

This study found that rifampin (a key antibiotic) suspensions are stable for at least 60 days. The drug maintained its concentration when stored at room temperature or refrigerated, protected from light.

Area of Science:

  • Pharmaceutical Sciences
  • Microbiology

Background:

  • Rifampin is a crucial bactericidal antibiotic from the rifamycin group, derived from Streptomyces mediterranei.
  • It is available in various dosage forms, including capsules, tablets, and syrups, often containing alcohol or sorbitol.

Purpose of the Study:

  • To evaluate the stability of rifampin compounded into a 25-mg/mL oral suspension using SyrSpend SF.
  • To establish a beyond-use date for this specific rifampin preparation.

Main Methods:

  • Rifampin suspensions were prepared at 25 mg/mL and stored in low-actinic bottles under room temperature and refrigerated conditions.
  • Stability was assessed over 60 days using a validated, stability-indicating high-performance liquid chromatography (HPLC) method, including forced-degradation studies.

Main Results:

  • Rifampin concentration remained within 90% to 110% of the initial value throughout the 60-day study period.
  • The drug demonstrated stability under both room temperature and refrigerated storage conditions when protected from light.

Conclusions:

  • The compounded rifampin suspension in SyrSpend SF is stable for at least 60 days.
  • A beyond-use date of 60 days is recommended for refrigerated or room temperature storage, provided the preparation is protected from light.

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