August 2, 2007--DataLase has entered into a license agreement with Colorcon whereby the two companies will work together to develop DataLase Pharmamark, an on-tablet marking technique for the pharmaceutical and nutritional industries.
Colorcon's core business is the design and technical support of advanced coating systems for pharmaceutical and nutritional supplement dosage forms, and its technological capabilities include assistance in the development of solid dosage formulations.
DataLase Pharmamark is a patented, edible, on-tablet marking technique for recording information such as product identification numbers and markings (human-readable barcodes), unique product logos, patient details, dosage information, and 'use by' dates directly on a tablet. Tablets may be numerically serialized readily in one production campaign with no two tablets being identical. The technology will help to eliminate medication errors and counterfeiting, and increase the traceability of drugs. Colorcon has licensed DataLase patented additives for incorporation onto pharmaceutical or nutritional supplement tablets via its film coatings. The patented additive induces a color change in the film coating precisely at locations on the tablet surface exposed to a low-power, DataLase-approved CO2 laser.
Reportedly, the additives are excipients that meet all appropriate compendial and regulatory requirements for use in the U.S. and key Eurpoean countries and they have been used in approved pharmaceuticals for many years. A U.S. Drug Master File (DMF) will be submitted, which will contain all additive and laser technology details needed for review by FDA during drug registration. Additional supporting studies are currently being performed, which will be included in the DMF. Colorcon and DataLase plan to coordinate a meeting with the FDA in the near future to discuss this technology and answer and questions they may have.
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