Metrics Scientist Awarded Patent for Zero-Order Release Technology

An expert scientist in pharmaceutical formulation development at Metrics Contract Services has been awarded a patent for intellectual property about controlled-release technology.

The US Patent and Trademark Office awarded Dr. Thomas B. “Brad” Gold a patent (No. 8,858,993) for his application, Coated Tablets With Zero-Order or Near Zero-Order Release Kinetics.

Gold’s intellectual property centers on formulation development technology that allows for the steady, continuous release of active pharmaceutical ingredient (API) during a particular duration of time, so that a patient won’t experience variations or spikes of the medication’s therapeutic benefit.

“For a drug with a 12-hour release profile, for example, the tablet would release 100% of the API steadily throughout that time period without any drop offs or spikes, which sometimes occur with other modified-release technologies,” Gold explained. “This is very advantageous for maintenance drugs and chronic therapies, such as heart medications, that need to reach a steady state in the patient’s bloodstream as soon as possible and remain there.”

Gold’s patent application builds upon osmotic techniques used to deliver soluble and insoluble large- or small-molecule drugs. Heretofore, true osmotic delivery relied on a matrix tablet with complex manufacturing needs – such as, for example, the application of a solvent for the coating, the need to drill an orifice into the coating, and specialized equipment.

“The manufacturing of osmotic tablets is difficult, not very practical, and expensive, and for that reason, not many companies do it,” Gold explained.

By contrast, Gold’s innovation provides osmotic-like delivery benefits without the accompanying manufacturing challenges. Gold’s patented zero-order release technology uses direct compression, three to five excipients plus the API, and a much simpler coating – so that the tablet behaves similarly to an osmotic-release tablet.

“Our technology offers the advantage of ease of manufacturing using standard industry processes and equipment,” he said.

John S. Ross, Executive Vice President of Metrics, said the patent reflects the kind of thoughtful scientific leadership that Gold and his colleagues apply to their work each day. The formulation development scientists at Metrics offer a depth of relevant experience that enables them to identify solutions to clients’ most challenging pharmaceutical projects, he said.

“For 20 years, pharma companies have consistently turned to Metrics for help in effectively delivering the full therapeutic benefit of their latest drug discoveries,” Ross said. “The reason they come back to us time and again is because we deliver sound and practical science. I congratulate Brad on this most impressive accomplishment.”

Metrics Contract Services is a full-service pharmaceutical development and manufacturing organization serving clients worldwide. The company delivers proven scientific and operational excellence for solid oral dosage forms. Its areas of expertise include quality formulation development; first-time-in-man formulations; Phase I-III clinical trial materials manufacturing; and analytical method development and validation services leading to commercial scale manufacturing. Technical capabilities include highly potent, cytotoxic, and unstable compounds; DEA Schedule II-V controlled substances; and products with poor bioequivalence, for which they offer an impressive propriety portfolio of advanced delivery methods. For more information, visit www.metricsinc.com.