Stability of Expired Artemether-Lumefantrine in Tropical Conditions
Author Information
Author(s): Bate Roger, Tren Richard, Hess Kimberly, Attaran Amir
Primary Institution: Africa Fighting Malaria
Hypothesis
Can the shelf-life of fixed dose combination artemether-lumefantrine (FDC-ALU) be extended based on its stability in uncontrolled tropical conditions?
Conclusion
FDC-ALU is chemically and physically stable well beyond its stated shelf-life in uncontrolled tropical conditions.
Supporting Evidence
- 97% of samples passed testing for active ingredients and tablet integrity.
- Samples were tested between one and 58 months past expiry.
- A weak linear association was found between sample age and degradation.
Takeaway
The study found that most expired malaria medicine was still good to use, even after the expiration date.
Methodology
Seventy expired samples of FDC-ALU were tested using thin-layer chromatography, disintegration testing, and Raman spectrometry.
Potential Biases
Potential bias due to the limited range of products tested and the specific conditions under which they were stored.
Limitations
Findings are primarily valid for Coartem/Riamet and may not apply to other manufacturers' products.
Participant Demographics
Samples were collected from private pharmacies and malaria researchers in seven African countries.
Statistical Information
P-Value
0.004
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
Want to read the original?
Access the complete publication on the publisher's website