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Drug re-packaging in Compliance Aid Devices (CAD): Damp permeation in self-adhesive devices

Abstract:

The present study is the third of a series devoted to permeation study in compliance aid devices (CAD). The Standardized Working Protocol (SWP) for cool sealing and the testing for damp permeation has been included in this study following the method described in the United Sates Pharmacopoeia XXIV(USP XXIV) for the multi-compartmental compliance aid devices Venalink®. The aim is to determine damp permeation in CAD Venalink® in their room-temperature sealing presentation type. Method II described in the USP XXIV in Containers-Permeation to blisters Class B has been applied. Applying the hermeticity SWP and the proposal for room-temperature sealing SWP, the results show that CAD Venalink®, object of the present study, can be classified as Class B blisters following the USP XXIV specifications for those drugs that do not require special conditions.