Step Toward Flexible Dosing: Chemical Stability of Clopidogrel in Various Aqueous Media, A

Steiner, Jennifer
Clopidogrel is approved by the United States Food and Drug Administration (FDA) for the treatment of conditions such as coronary syndromes, stroke, arterial disease and coronary stent treatment. The objective of this study was to evaluate the decomposition of three compounded oral clopidogrel mixtures, prepared by combining crushed clopidogrel tablets with apple juice, sugar free (SF) syrup, and sterile water, USP, using High Performance Liquid chromatography (HPLC). All drug mixtures were stored at refrigerator and room temperature and were tested after storage time-periods of 0, 7, 14, 21, and 28 days. At the end of the study (day 28) clopidogrel concentration in all mixtures, except the refrigerated clopidogrel-apple juice sample, continued within ±10% of their respective average initial concentrations. During our research we observed that while pipetting 0.1 ml samples of freshly vortexed clopidogrel-water and clopidogrel-apple juice mixtures, the undissolved powder settled too rapidly, causing inconsistent results for clopidogrel concentration. As a practical conclusion to this study, we would suggest to health care providers to compound clopidogrel as an oral liquid using only viscous solvents such as SF syrup or another pharmaceutical-grade suspending medium to ensure consistent dispersion of the powder and measurement of reliable doses.
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