PR Newswire - Pennsylvania
|
Information from the links below is distributed by companies featured through PR Newswire. Neither PR Newswire nor Philly.com can confirm the accuracy of the content. |
News of Pennsylvania |
|||||||
ARmark Authentication Technologies, LLC and Colorcon, Inc. Announce Alliance
Launch of Micro-Tag Technology for Authenticating Solid Oral Dose
Pharmaceuticals
GLEN ROCK, Pa., Nov. 9 /PRNewswire/ -- ARmark Authentication
Technologies, LLC, and Colorcon, Inc. announced today an alliance in the
development and introduction of ®mark® On-Dose ID(TM), an authentication
technology that incorporates microscopic covert micro-tags into the
immediate-release film coatings of solid oral dosage forms (SODFs) to
prevent counterfeiting. The alliance provides Colorcon exclusive rights to
market ARmark's micro-tags for tablet film coatings and to market this
technology to pharmaceutical manufacturers globally.
(Photo: http://www.newscom.com/cgi-bin/prnh/20091109/PH06061 )
By leveraging the tablet coating expertise of Colorcon, a world leader
in the manufacture and development of specialized film coatings, and
ARmark's customized micro-tag authentication technology, the two companies
collaborated to develop ®mark® On-Dose ID. The micro-tags are seamlessly
integrated into existing tablet film coating processes without additional
manufacturing steps or capital investments. By incorporating the micro-tags
directly into a tablet's film coating, drug manufacturers achieve reliable
placement on each and every tablet.
The customized micro-tags can hold significant amounts of brand-owner
specific, encrypted information such as lot and batch ID numbers, logos and
other text, patterns, shapes and symbols, in a particle the size of 75-110
microns, a space smaller than the diameter of a human hair. Nearly
impossible to replicate or reverse engineer, the markers are compatible
with other covert or overt identification technologies and can also be
incorporated as part of labels, bottles, paper and blister packaging.
"The availability of this authentication technology is significant to
drug manufacturers because adding ®mark® micro-tags to an existing
immediate release film coated tablet can now be considered to be a SUPAC
Level 1 annual reportable change," states Jeff Robertson, Director and
General Manager at ARmark Authentication Technologies, LLC. "That means
drug manufacturers can quickly begin using the On-Dose ID technology to
protect their product without prior approval from the FDA."
®mark® covert marker technology has been available for more than two
years in other markets, but the recent draft guidance issued by the Food
and Drug Administration (FDA) regarding the use of physical chemical
identifiers (PCIDs) defines how the commercial utilization of micro-tag
technology can be used for on-dose authentication in the pharmaceutical
industry. In accordance to the FDA's guidance document, ARmark manufactures
the micro-tags from approved excipient materials generally regarded as safe
(GRAS) or from the FDA's Inactive Ingredient Guide (IIG), under cGMP
conditions.
According to Dr. Kamlesh Oza, Colorcon's General Manager of Film
Coatings, "Colorcon's studies have shown there is no impact on dissolution
or stability when the ®mark® On-Dose ID micro-tags are incorporated into an
existing film-coated dosage form. This approach is in compliance to the
FDA's guidance, enabling pharmaceutical companies to provide patients with
safe security augmentation. As companies adopt this anticounterfeiting
technology to quickly secure their brands, our studies will help them note
the addition of micro-tags in their annual reports as required by the FDA."
The ®mark® On-Dose ID micro-tags are invisible to the naked eye once
they are incorporated into a tablet film coating, but are easily identified
with ®vision® optical viewing systems. These portable tools authenticate
products by magnifying the micro-tags at any stage following the tablet
coating process. The ®vision® system enables accurate, in-field detection
within a matter of seconds without destroying the SODF sample.
Colorcon, Inc. is a world leader in the development, supply and
technical support of fully formulated products for the pharmaceutical and
dietary supplement industry. Its core businesses include film coatings,
modified release technologies, functional excipients, and tablet branding
services. Colorcon has 18 technical service laboratories globally and more
than 1200 employees exclusively dedicated to its customer base. For more
information on Colorcon capabilities and its products, call 215-699-7733 or
visit http://www.colorcon.com.
ARmark Authentication Technologies, LLC, based in Glen Rock, PA,
develops custom authentication systems for brand protection, product surety
and risk mitigation to fight global counterfeiting. Our technologies
protect our clients' products with brand-owner-specific information so that
the authenticity of these products becomes Indisputable. ARmark
Authentication Technologies, LLC services a variety of industries,
including but not limited to: pharmaceutical, medical devices, luxury
goods, electronics, secure documents, food and apparel. ARmark
Authentication Technologies, LLC is a wholly-owned subsidiary of Adhesives
Research, Inc. For more information on ARmark Authentication Technologies,
LLC and its products, call 1-717-227-5920 or visit http://www.rmark.org.
®mark® is a registered trademark and On-Dose ID(TM) is a trademark of
ARmark Authentication Technologies, LLC. ARmark® is a registered trademark
of Adhesives Research, Inc.
Available Topic Expert(s): For information on the listed expert(s),
click appropriate link.
Jeff Robertson
https://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=90114
|
|||||||
|
|
|||||||