UK-based DataLase has entered into a license agreement with Colorcon, of the US, to develop DataLase PHARMAMARK, an on-tablet marking technique for the pharmaceutical and nutritional industries.
DataLase PHARMAMARK is a patented, edible, on-tablet marking technique for recording information such as product identification numbers and markings (human readable or bar codes), unique product logos, patient details, dosage information, use-by dates and unique serial numbers directly on a tablet. The technology will help to eliminate medication errors and counterfeiting, and increase the traceability of drugs.
Colorcon is a leading provider of pharmaceutical technologies and a manufacturer of speciality 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.
The company has licensed from DataLase patented additives for incorporation onto pharmaceutical or nutritional supplement tablets via its film coatings. The patented additive induces a colour 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 these countries and have been used in approved pharmaceuticals for many years. A US Drug Master File will be submitted that will contain all additive and laser technology details needed for review by FDA during drug registration. Additional supporting studies are currently being performed that will be included in the DMF. Colorcon and DataLase plan to co-ordinate a meeting with the FDA in the near future to discuss this technology and answer any questions.
"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," said Jean Claude Deneuville. executive VP corporate development at Colorcon. "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."
