Stability comparison of prasugrel tablets unit‐dose packaged versus maintained in the manufacturer container over 90 days

Abstract Background Unit‐dosing medications can improve time to drug administration and patient safety in inpatient settings. No available information supports the practice of unit‐dosing for prasugrel. Aim The stability of unit‐dosed prasugrel tablets was evaluated against tablets maintained in the manufacturer container. Method Three lots of 10 mg prasugrel tablets were packaged as individual unit‐doses and stored at room temperature. Tablets were analysed for prasugrel concentration over a 90‐day period and compared against control tablets retained in the manufacturer's container. Prasugrel was quantified using a previously validated stability‐indicating high‐performance liquid chromatography method with ultraviolet detection. Experimental lots were monitored for >10% loss of potency. A non‐linear one‐phase decay curve was used to describe drug potency changes in experimental versus control tablets. Ethics approval was not required for this research article as it was a stability study and did not involve human subjects. Results Average potency in all groups remained above 90% for the duration of the study; however, some individual experimental samples dropped below 90% at 7 days. Control tablets did not show a statistically significant potency change until 90 days. Modelling data indicated the ending average potencies in the experimental versus control tablets were 9.083 mg and 9.736 mg, respectively. Conclusion Unit‐dosing 10 mg prasugrel tablets has a negative effect on potency, which was most pronounced by day 7. The average potency remained above 9.00 mg over the 90‐day period. Conservative interpretation of these data may allow institutions to unit‐dose prasugrel tablets and discard after 72 h, when individual data points showed <90% potency. The decision to unit‐dose prasugrel must consider several factors surrounding patient care and individual institutional standards.