ANALYTICAL DEVICES FOR DETECTION OF LOW-QUALITY PHARMACEUTICALS

摘要

A multilayer Paper Analytical Device (PAD) and method for detection of a low quality pharmaceutical or dietary supplement product. The multilayer PAD includes one or more assay regions,one or more reagent vessels in registry with the assay region(s), and a non-chemically interfering binder agent disposed between the assay regions and vessels, so that rupture of the vessels enables the reagents to wet the assaying regions and contact a sample of a suspected low quality pharmaceutical product or dietary supplement for testing thereof. A kit is also provided for detection of a low quality pharmaceutical or dietary supplement product, the kit including a multilayer PAD and instructions for using the kit.

主权项

1. A multilayer paper analytical device for detection of a low quality pharmaceutical product or dietary supplement, comprising:
one or more assay regions; one or more vessels each having a wall that houses one or more reagents in registry with at least one assay region for which testing for a chemical component is desired; and a non-chemically interfering binder agent disposed between the assay regions and vessels; wherein the vessels are arranged to be adjacent to the assaying regions with the binding agent providing a fluid path such that rupture of a vessel wall establishes fluid communication between the one or more reagents released by the ruptured vessel wall and the corresponding assay region along the fluid path; a hydrophobic material in the form of a sheet that is adjacent each vessel and that has openings that forms part of the fluid path for each vessel; wherein each assay region is configured to receive a sample of a suspected a low quality pharmaceutical product or dietary supplement such that, after activation of the device by rupturing of a vessel wall in registry with the assay region, the reagent wets the assaying region for reaction with the sample.