title: 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 unit-dose 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: BScPharm, PharmD, ACPR, BCPS, is a Clinical Pharmacy Specialist in the Pharmacy Department, St Paul's Hospital, Vancouver, British Columbia.
authors.forename: Erica H Z
authors.initials: EH
authors.lastname: Wang
authors.affiliation: BScPharm, ACPR, PharmD, is Residency and Education Coordinator in the Pharmacy Department, Regina Qu'Appelle Health Region, Regina, Saskatchewan.
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Bolt
authors.affiliation: BSc, is a Research Consultant in the Department of Pharmacy, Children's and Women's Health Centre of British Columbia, Vancouver, British Columbia.
authors.forename: Diane
authors.initials: D
authors.lastname: Décarie
authors.affiliation: MSc, PharmD, FCSHP, is Manager of Pharmacy Practice, Regina Qu'Appelle Health Region, Regina, Saskatchewan.
authors.forename: William
authors.initials: W
authors.lastname: Semchuk
authors.affiliation: BS(Pharm), PharmD, FASHP, FCCP, FCSHP, FCAHS, is a Professor in the Faculty of Pharmaceutical Sciences and Distinguished University Scholar, The University of British Columbia, and a Clinical Pharmacy Specialist, Children's and Women's Health Centre of British Columbia, Vancouver, British Columbia. She is also the Editor of the CJHP .
authors.forename: Mary H H
authors.initials: MH
authors.lastname: Ensom
keywords: dabigatran; dabigatran etexilate; drug packaging; drug stability; liquid chromatography