Key result
Clopidogrel suspension remains stable for 1 month under refrigeration but degrades faster at room temperature.
Why the study?
There is no commercially available liquid clopidogrel preparation for infants and existing formulations have not been evaluated for chiral stability.
Clopidogrel 1 mg/mL suspension made with Ora-Plus:Ora-Sweet is stable for 1 month under refrigeration and 2 weeks at room temperature, providing a viable compounded formulation for infants.
May support short-term use of compounded clopidogrel suspension in infants; leaves open need for human stability and clinical validation studies.
Background Clopidogrel is used in at‐risk infants to prevent thrombotic complications. There is no commercially available liquid preparation and existing formulations have not been evaluated for the chiral stability of clopidogrel. Aim To determine the stability of clopidogrel 1 mg/mL liquid formulations using chiral chromatography. Method Clopidogrel 1 mg/mL suspension was formulated using Plavix (clopidogrel) tablets and Ora‐Plus:Ora‐Sweet 1:1, and stored at room temperature and under refrigeration. Samples were also prepared using a variety of co‐solvents and stored at room temperature. Samples were taken for up to 49 days and assayed for S‐clopidogrel, R‐clopidogrel and S‐acid using high‐performance chiral liquid chromatography. Percentage of S‐clopidogrel remaining (at least 90% of nominal content) and percentage of degradation product formation were used to estimate shelf‐life. Results Only the refrigerated Ora‐Plus:Ora‐Sweet mixture did not have degradation products that exceeded USP limits for clopidogrel impurities for at least 30 days. The estimated shelf‐lives of the Ora‐Plus:Ora‐Sweet mixtures at room temperature (25 °C) and under refrigeration (4 °C) were 19 and 37.5 days, respectively. There was no improvement in stability when mixtures were prepared using a variety of co‐solvents. Conclusion Clopidogrel 1 mg/mL suspension made with Ora‐Plus:Ora‐Sweet and stored in amber glass bottles was stable for 1 month under refrigeration and 2 weeks at room temperature.
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Mihăilă et al. (2012) studied Thrombotic complications in at-risk infants (contextual). Clopidogrel liquid formulation (Ora-Plus:Ora-Sweet 1:1) vs. Room temperature vs refrigeration, and various co-solvents was evaluated on Percentage of S-clopidogrel remaining and degradation product formation (estimated shelf-life). Clopidogrel 1 mg/mL suspension made with Ora-Plus:Ora-Sweet was stable for 1 month under refrigeration and 2 weeks at room temperature.
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