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Insufficient Stability of Clavulanic Acid in Widely Used Child-Appropriate Formulations

Ines Mack1, Mike Sharland2, Janneke M Brussee3,4

  • 1Paediatric Infectious Diseases, University Children's Hospital Basel, 4056 Basel, Switzerland.

Antibiotics (Basel, Switzerland)
|March 6, 2021
PubMed

Insights

Amoxicillin-clavulanic acid (AMC) suspensions degrade significantly at higher temperatures, impacting effectiveness. Durable, child-appropriate formulations are needed, and proper storage awareness is crucial.

Area of Science:

  • Pharmaceutical Sciences
  • Microbiology
  • Global Health

Background:

  • Amoxicillin-clavulanic acid (AMC) is vital for pediatric essential medicines.
  • Refrigerated storage is required for reconstituted AMC suspensions to maintain antimicrobial effectiveness.
  • Low- and middle-income countries often lack consistent access to refrigeration for medications.

Purpose of the Study:

  • To assess the stability of amoxicillin (AMX) and clavulanic acid (CLA) in liquid suspensions and dispersible tablets.
  • To correlate ingredient stability with data on access to appropriate storage in various countries.
  • To inform recommendations for the WHO Essential Medicines List for children.

Main Methods:

  • Degradation of AMX and CLA was measured in commercial Swiss formulations at controlled ambient temperatures (8°C vs. 28°C for 7 days; 23°C vs. 28°C for 24 hours).
  • Stability was assessed in both reconstituted suspensions and dispersible tablets.
  • Data on global access to refrigeration and electricity were obtained from the USAID Demographic and Health Survey program.

Main Results:

  • In suspensions, clavulanic acid (CLA) degraded up to 72.3% at 28°C over 7 days, compared to 12.9% at 8°C.
  • Dispersible tablets showed CLA degradation of 21.7% at 28°C and 15.4% at 23°C over 24 hours.
  • Significant CLA degradation occurs in suspensions within a 7-day treatment course, especially at higher temperatures.

Conclusions:

  • Current amoxicillin-clavulanic acid suspensions face stability challenges due to temperature-dependent degradation of clavulanic acid.
  • Development of durable, child-appropriate formulations is essential to overcome these stability issues.
  • Enhanced awareness among prescribers and pharmacists regarding proper storage conditions is critical for maintaining antibiotic efficacy.

Keywords:
amoxicillin-clavulanic acidchild-appropriate formulationclavulanatedegradation

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