One of the most promising strategies against antimicrobial resistance is to strengthen the monitoring of the quality of medicines in middle and low-income countries. In Peru, several drug alerts related to quality defects of one of the most commonly used antibiotics, amoxicillin powder for oral suspension, have been reported. This study compared the quality and stability of three amoxicillin powders for oral suspension manufactured by national laboratories and stored for 1 and 3 months in drugstores of populated cities located in the coast, jungle and the Andes. Aesthetic appeal evaluation, delivered volume and pH and drug content determination were conducted with non-reconstituted and reconstituted samples. In-use stability was also tested after one week of refrigeration. All the results were within the specifications of the United States Pharmacopeia for the duration of the study but after 3 months of storage in Tarapoto, clusters formation, smell and taste changes and a statistically significant reduction in pH and drug content, were observed. Based on this and taking also into account the factors affecting the stability of this dosage form of amoxicillin, we can assume these variations are associated with high temperatures and relative humidities during longer periods of storage in drugstores.
Key words: Powder for oral suspension, reconstitution, amoxicillin, stability, storage conditions
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