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Abstract:  The purpose of this study was to evaluate clopidogrel stability in three extemporaneously compounded oral liquid preparations (water, apple juice, water/sugar-free syrup) after storage of up to 28 days at room temperature and in the refrigerator. Three sets of clopidogrel tablets (75-mg/tablets, 4 tablets/set) were triturated individually in a mortar to a fine powder. The finished powder was mixed with water, apple juice, and sugar-free syrup, respectively, to a final volume of 50 mL for each set. The clopidogrel concentration of the three mixtures was 6 mg/mL. The content of each mixture was transferred to four separate 100-mL prescription bottles. Two bottles of each mixture were kept at room temperature (approximately 23°C to 25°C). The other two bottles of each mixture were stored in the refrigerator at a temperature of 4°C to 8°C. After storage periods of 7, 14, 21, and 28 days, samples from all 12 bottles (four bottles from each mixture) were analyzed in duplicate for clopidogrel concentrations by using stability-indicating high-performance liquid chromatography. Over the time period of up to 28 days at room temperature and in the refrigerator, there was no significant reduction of clopidogrel concentration in all three mixtures, except for some test samples of clopidogrel mixed in apple juice that had been stored in the refrigerator. The concentration of clopidogrel was found to be within ±10% of the initial concentration in all test samples of the mixtures of clopidogrel in water, and in sugar-free syrup. The average coefficient variation for the intra-day quality-control samples was 1.05%, whereas the average coefficient variation for the inter-day study was 0.67%. This study found no significant loss of clopidogrel concentration or potency in the extemporaneously compounded liquid preparations with water or sugar-free syrup after storage at room temperature and in the refrigerator for up to 28 days. However, to prevent any microbial growth, storing the finished preparation in the refrigerator is recommended.

Related Keywords: clopidogrel, antiplatelet agent, acute coronary syndromes, thrombotic disorders, thrombosis prevention, blood clots, blood clotting, stability, oral liquid preparations, potency, storage conditions, microbial contamination

Related Categories: EXCIPIENTS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, HEMOSTASIS, BLEEDING, ANTICOAGULATION, STORAGE

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