DataLase and Colorcon Inc. Sign Licensing Agreement to Develop DataLase PHARMAMARK
NORCROSS, Ga.—DataLase, originator of the DataLase process, has entered into a license agreement with Colorcon Inc. in a move which will see the two companies working together to develop DataLase® PHARMAMARK™, an on-tablet marking technique for the pharmaceutical and nutritional industries.
Colorcon Inc, is a world leading 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 barc odes), unique product logos, patient details, dosage information and use by dates directly on a tablet. Advantageously, 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.
Jean Claude Deneuville, executive vice president, corporate development, at Colorcon Inc. commented, “We see this as a huge step forward for the industry, which will give peace of mind not only to patients, but to pharmacists and medical staff alike. I’m pleased that Colorcon’s and DataLase’s combined experience will be able to solve a problem and satisfy the demand for this technology in the pharmaceutical and nutritional industries.”
Steve Kelly, CEO of DataLase, added,“We are delighted to be able to develop this innovative new technology, and are committed to working in partnership with industry experts at Colorcon to bring DataLase PHARMAMARK to these markets over the coming year. Patents for the technology have already been granted in the US and key European countries.”
The DataLase PHARMAMARK additives are excipients that meet all appropriate compendial and regulatory requirements for use in these 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 any questions they may have.
- Companies:
- Colorcon Inc., No-Tox Products Div.