Owing to the high cost of pharmaceuticals, there has become an ever increasing incidence of drug counterfeiting which has entered the market place. These counterfeit products represent significant danger to the public as it denies them safe access to needed medications. Current technologies to thwart counterfeiters include special packaging labels, ensuring lot and source of drug. However, these packages do not prevent refilling of empty bottles with counterfeit dosage forms. As an increased measure to prevent counterfeiting, the proposed effort will demonstrate the scalable manufacturability of a "per tablet" 3-D serial number labeling process. In Phase I we demonstrated UV writing to onto commercially available edible ink deposited on edible paper through an integral edible lens array. In addition, we demonstrated the ability of the spatial light modulator to project simple dot-matrix patterns, relay an image, or if required, to produce a detailed holographic projection. This flexibility, along with the added capability of the lens arrays, provides a matrix of choices for the level of complexity of encoded information which itself relates to the degree of difficulty in manufacturing and of course the associated cost of protecting the pharmaceutical. This will provide the industry with a sliding scale of capabilities in terms of information encoding. Everything from simple patterns to enable traceability of common over the shelf and well-established drugs to more complex encoded information to protect high end pharmaceuticals that are more likely to be the target of counterfeiting attempts would be available. During Phase II we will study the trade-offs in manufacturability and cost to develop a variable "custom" manufacturing process that would including everything from simple marking to 3-D imaging using lens arrays or even constructing full holograms.

Public Health Relevance

Counterfeit drugs are widely recognized threat to both public health and the bottom line of pharmaceutical manufacturing companies. This proposal addresses a means to improve safety, reduce fraud and provide traceability. In Phase I of this research we demonstrated the feasibility of writing information to edible surfaces coated with edible lens array material using UV illumination and also the ability to project complex information using a short wavelength spatial light modulator. For Phase II we propose to demonstrate the manufacturability of encoded pharmaceutical tablets with edible integral lens array imagery as an anti-counterfeit device where individual tablets can each be uniquely coded with a hologram-like marker with a matching, non-edible, hologram-like marker placed on the outside of the bottle or as a security seal around the cap. The successful development of manufacturing processes under the effort proposed here will provide a means to fight pharmaceutical counterfeiting and thereby safeguard public health.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44FD003890-02
Application #
8521837
Study Section
Special Emphasis Panel (ZRG1-IMST-S (12))
Project Start
2013-09-01
Project End
2015-08-31
Budget Start
2013-09-01
Budget End
2014-08-31
Support Year
2
Fiscal Year
2013
Total Cost
Indirect Cost
Name
Boulder Nonlinear Systems, Inc.
Department
Type
DUNS #
602673188
City
Lafayette
State
CO
Country
United States
Zip Code
80026