Abstract
Amoxicillin-clavulanic acid (AMC) belongs to the WHO Essential Medicines List for children, but for optimal antimicrobial effectiveness, reconstituted dry powder suspensions need to be stored in a refrigerated environment. Many patients in low- and middle-income countries who are sold AMC suspensions would be expected not to keep to the specified storage conditions. We aimed to assess the stability of both ingredients in liquid formulations and dispersible tablets, combined with nationally representative data on access to appropriate storage. Degradation of amoxicillin (AMX) and clavulanic-acid (CLA) was measured in suspensions and dispersible tablets commercially available in Switzerland at different ambient temperatures (8 °C vs. 28 °C over 7 days, and 23 °C vs. 28 °C over 24 h, respectively). Data on access to refrigeration and electricity were assessed from the USAID-funded Demographic and Health Survey program. In suspensions, CLA degraded to a maximum of 12.9% (95% CI −55.7%, +29.9%) at 8°C and 72.3% (95% CI −82.8%, −61.8%) at a 28 °C ambient temperature during an observation period of 7 days. Dispersible tablets were observed during 24 h and CLA degraded to 15.4% (95% CI −51.9%, +21.2%) at 23 °C and 21.7% (−28.2%, −15.1%) at a 28 °C ambient temperature. There is relevant degradation of CLA in suspensions during a 7-day course. To overcome the stability challenges for all active components, durable child-appropriate formulations are needed. Until then, prescribers of AMC suspensions or pharmacists who sell the drug need to create awareness for the importance of proper storage conditions regarding effectiveness of both antibiotics and this recommendation should be reflected in the WHO Essential Medicines List for children.
Highlights
Degradation is normalized for the median value at time point 0 (0% degradation)
This study comprehensively describes the degradation of AMX and CLA as ingredients of co-formulated and non-co-formulated child-appropriate formulations
AMC in high-income countries (HICs) have remained largely unchanged, CAF sales increased in low- and middle-income countries (LMICs) by 6.8%
Summary
Understanding and tracking patterns of antibiotic consumption over time and across countries is essential to ensure appropriate access. Antibiotic sales increasing by 8.6% per year mainly driven by LMICs were observed, with amoxicillin (AMX) with and without clavulanic-acid (AMC) being among the antibiotics with the highest sales volume globally [1]. Both AMX and AMC are listed as Access antibiotics on the 2019 revision of the WHO Essential Medicines List for children, this group representing the core set of antibiotics, which should be consistently available at an appropriate quality, formulation and price [2,3]
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