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Anti-counterfeit edible integral lens array for pharmaceuticals

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
Program Year/Program:
2013 / SBIR
Agency Tracking Number:
R44FD003890
Solicitation Year:
2013
Solicitation Topic Code:
FDA
Solicitation Number:
PA12-088
Small Business Information
Boulder Nonlinear Systems, Inc.
450 Courtney Way, Unit 107 Lafayette, CO 80026-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2013
Title: Anti-counterfeit edible integral lens array for pharmaceuticals
Agency: HHS
Contract: 2R44FD003890-02
Award Amount: $521,669.00
 

Abstract:

Project Summary/Abstract 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 deniesthem 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 anincreased 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 depositedon 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 thepharmaceutical. 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 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.

Principal Investigator:

.. E. .
303-604-0077
jstockley@bnonlinear.com

Business Contact:

Jay Stockley
303-604-0077
jstockley@bnonlinear.com
Small Business Information at Submission:

BOULDER NONLINEAR SYSTEMS, INC.
BOULDER NONLINEAR SYSTEMS, INC. 450 COURTNEY WAY, UNIT 107 LAFAYETTE, CO 80026-

EIN/Tax ID: 184111806
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No