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Greenville, NC, United States, 2014/10/28 - Dr. Brad Gold, vice president of pharmaceutical development, has received a U.S. patent for his intellectual property about controlled release technology [ASX: MYX] - MetricsInc.com.
An expert scientist in pharmaceutical formulation development at Metrics Contract Services has been awarded a patent for intellectual property about controlled release technology.
The U.S. 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 percent 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 active pharmaceutical ingredient (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.”
About Metrics Contract Services
Metrics Contract Services (metricsinc.com) is a full-service pharmaceutical development and manufacturing organization serving clients worldwide. We deliver proven scientific and operational excellence for solid oral dosage forms.
Our 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. Our technical capabilities include highly potent, cytotoxic and unstable compounds; DEA Schedule II-V controlled substances; and products with poor bioequivalence, for which we offer an impressive propriety portfolio of advanced delivery methods.
Located in Greenville, N.C., Metrics Contract Services is a proud member of the Mayne Pharma family. Learn more online.
About Mayne Pharma
Mayne Pharma is a publicly traded specialty pharmaceutical company listed on the Australian Securities Exchange. The company develops and manufactures branded and generic product globally either directly or through distribution partners while applying its drug-delivery expertise for contract development and manufacturing services.
Mayne Pharma has a 30-year track record of innovation and success in developing new oral drug delivery systems, and these technologies have been successfully commercialized in numerous products that have been marketed around the world. Mayne Pharma has drug development and manufacturing facilities in Salisbury, Australia, with expertise in formulating complex oral dose forms, including controlled substances, modified release products and inherently unstable compounds.