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Dabigatran (brand name Pradaxa) Special Storage and Stability Issues - Use the Blister Packs?

February, 2011
Henry I. Bussey, Pharm.D.

Dabigatran was recently approved for stroke prevention in atrial fibrillation in the U.S. The product is available in bottles of 60 capsules (a 30 day supply) or in blister packs which seal each capsule separately. The problem, apparently, is that the product deteriorates rather quickly when exposed to humidity. Capsules packaged in bottles are stable for only 30 days after the bottle is open and capsules should NOT be placed in any other container (such as weekly dosing containers as are often used to enhance adherence). I am told that the bottles contain a dessicant in the lid so that the product should remain stable for 30 days after initially opening the container as long as the lid is replaced tightly following each dose.

One solution to the stability problem, reportedly, is to use the blister pack packaging in which each dose is sealed separately. But care should be taken not to break the seal on a capsule before being ready to administer that dose. Whether blister packs pose an issue of "child resistant" packaging also should be considered.

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Sunday, July 14, 2024