Improving adherence by investigating the stability of dabigatran outside of the manufacturer's original packaging: a New Zealand perspective

Background: Dose administration aids (DAA) are widely used to improve adherence. In New Zealand (NZ) more pharmacies are utilizing automated filling robots to meet DAA demand. Pradaxa™ capsules containing dabigatran etexilate (DE) is problematic. It is moisture-sensitive, and Medsafe (NZ regulator), recommends keeping the capsule in its original packaging until administration. This prevents DE from repacking into DAA, reducing the effectiveness of the DAA. Overseas studies demonstrated stability of DE in DAA. However, the findings cannot be extrapolated to NZ environments.

Research design and methods: Pradaxa™ 110 mg capsules repackaged in DAA were stored in conditions mimicking real-life settings (room temperature, bedroom and fridge) for 16 weeks. At predetermined timepoints, the capsules were evaluated for drug content and dissolution profile.

Results: DE samples stored in NZ conditions for 16 weeks met the drug content requirement of 85-115% except for unit-dose sachet samples stored in fridge condition (79.7% ± 6.82). Samples demonstrated similarity in dissolution profile until 8 weeks with release rate decreased at 16 weeks under all storage conditions.

Conclusion: DE capsules repackaged in DAA demonstrated stability for up to 8 weeks in all NZ storage conditions, confirming the safety of repackaging DE into a DAA.