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.