Detection of quality deviations in compounded formulation: acetic acid solution, ketoconazole syrup and T4 thyroid hormone capsules
DOI:
https://doi.org/10.22239/2317-269X.01134Keywords:
Compounding Formulations, Health Surveillance, Pharmaceutical Assistance, Public HealthAbstract
Introduction: Incorrect doses of the active ingredient in compounding formulations make up common errors in the manipulation, which can cause harm to the patient’s health, reflecting the possible absence of Good Handling Practices (GHP). Objective: To report quality deviations in the medicines acetic acid solution, ketoconazole syrup and T4 capsules. Method: Identification by chemical reactions and by HPLC, content by titration and HPLC, pH by potentiometry. Results: Positive identification for acetic acid with 98.20% content compatible with glacial acetic acid, in disagreement with the prescription of 5% solution. The ketoconazole content of 16.20 mg/mL found in the syrup corresponds to 81.00% of the declared, the minimum specification is 90.00%; pH 8.0; positive identification for anionic surfactant component in the syrup. The results found were: 25 μg T4 capsules were 177.70 μg and for the 200 μg capsules it was 174.44 μg, corresponding to 710.96% and 87.22% of the declared content, respectively, in disagreement with specification 90.00% and 110.00%. Conclusions: The study illustrated the detection of quality deviations in manipulated drugs from different pharmacies, due to pharmacotechnical misconceptions, lack of quality control and lack of GHP implementation. Frequent inspection prevents health risks to the population.
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