Methods of marking and testing pharmaceutical products

Details Methods of marking and testing pharmaceutical products Methods of marking and testing pharmaceutical products

2005-09-21

2010-10-05

Warden, Jill (Department: 1797)

Chemistry: analytical and immunological testing

Tracers or tags

C436S063000, C436S172000, C435S007100, C424S009100, C424S457000

Reexamination Certificate

active

07807468

ABSTRACT:
Methods of marking pharmaceutical products for use in clinical trials and for determining the origin or authenticity of the marked products are provided that use a variety of natural materials as markers. The natural materials have unique genetically controlled micromorphological structures that can be identified using enhanced visualization techniques. For example, cellulosic plant materials, sporopollenin and diatoms can be used as the natural materials. The natural materials are added to pharmaceutical products at sufficiently low levels so as not to have any significant effect on the products other than serving as markers. Dyes and reactants can be added to the natural materials to provide secondary markers. The markers can be identified in stool samples collected during clinical trials to prove that a particular pharmaceutical product has been ingested by a test subject.

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Mullin, Rick, “Recalibrating the Clinic,” C&EN, Feb. 28, 2005, pp. 29-39.
Dyer, Nicole, “Stealth Tags That Foil Counterfeiters,” Popular Science, Jul. 2005, p. 34.
See Also, references cited in Applicant's copending U.S. Appl. No. 10/897,781, filed Jul. 21, 2004.

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