Stability of dabigatran etexilate in manufacturer's blister pack, unit-dose packaging, and community pharmacy blister pack

Abstract

Background: Dabigatran, a direct thrombin inhibitor, is indicated for the prevention and treatment of venous thromboembolism and for stroke prophylaxis in atrial fibrillation. The manufacturer recommends that dabigatran etexilate be retained in the original packaging until administration. Currently, no information exists about the stability of dabigatran etexilate outside its original packaging. Objective: To evaluate the stability of dabigatran etexilate capsules over 120 days, with storage in the manufacturer's original packaging, in unitdose packaging, and in community pharmacy blister packaging. Methods: Commercially available dabigatran etexilate capsules (110 mg) were stored at room temperature (25°C) in the manufacturer's original blister pack, in unit-dose packaging, or in community pharmacy blister packs. Samples were collected from each container daily for the first 3 days, weekly up to 28 days, every other week until day 98, and at day 120. Suspensions were prepared, pH was evaluated, and samples were stored at 85°C until analysis. Each sample was analyzed in duplicate by a validated, stability-indicating high-performance liquid chromatography ultraviolet detection method. The capsules were considered stable if they maintained at least 90% of the initial concentration. Results:Dabigatran etexilate capsules maintained 100.4% of the original concentration with 120 days of storage in the manufacturer's original blister pack, 98.7% with storage in unit-dose packaging, and 98.0% with storage in community pharmacy blister packs. There were no notable changes in appearance, ease of suspension of the capsule content, or pH over the 120-day period. Conclusion: Dabigatran etexilate 110-mg capsules were stable for 120 days with storage at room temperature in 3 types of packaging widely used in hospital and community settings.