DataLase and Colorcon sign licensing agreement
AUGUST 2, 2007--DataLase (Norcross, GA, USA; www.datalase.com), originator of the DataLase process, has entered into a license agreement with Colorcon (West Point, PA, USA) in a move that will see the two companies working together to develop DataLase PHARMAMARK, an on-tablet marking technique for the pharmaceutical and nutritional industries. Colorcon is a provider of pharmaceutical technologies and a manufacturer of specialty chemicals for related industries. Its 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 or barcodes), unique product logos, patient details, dosage information, and use-by dates directly on a tablet. Advantageously, tablets can 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 to 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.
The DataLase PHARMAMARK additives are excipients that meet all appropriate compendial and regulatory requirements for use in this country, and they have been used in approved pharmaceuticals for many years. A US Drug Master File (DMF) will be submitted that will contain all additive and laser technology details needed for review by the US FDA during drug registration. Additional supporting studies are currently being performed that 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 any questions.