Metrics Inc. now offers proprietary pellet technologies enabling controlled release of active pharmaceutical ingredients (API).
The company’s advanced drug delivery technology supports the therapeutic effectiveness of API by tailoring drug release to the specific application and desired end point.
For a patient, the potential benefits of this technology are fewer doses and fewer side effects, notably gastrointestinal symptoms such as nausea – thereby increasing patient compliance. Metrics’ ability to offer these technologies results from the company’s recent acquisition by Mayne Pharma Group Limited.
Mayne Pharma has successfully applied pellet technology to a number of proprietary pharmaceuticals with modified release profiles, including Eryc™ (delayed release erythromycin), Doryx™ (delayed release doxycycline), Kadian™ (extended release morphine), Astrix™ (delayed release low-dose aspirin) and pulsed release diltiazem. The combined sales of these proprietary drugs exceed $500 million annually.
“At the end of the day, pharmaceutical science is all about making drugs as effective and tolerable as possible so that patients can experience both better health and a better quality of life when taking necessary medications,” said Dr. Brad Gold, vice president of pharmaceutical development at Metrics. “It’s exciting to offer pellet formulation to our clients – and to the patients they seek to help.”
Advanced pellet formulations can be developed for:
• Sustained release, delivering steady levels of API 12 to 24 hours after administration.
• Pulsed release, delivering pulses of API 12 to 24 hours after administration.
• Modified release, delivering API in any modification from immediate release, and
• Delayed release, allowing API to pass through the stomach undigested so that it can be absorbed in the small intestine.
Metrics and Mayne offer two technologies for formulations:
• The first, called extrusion granulation, granulates API with excipients, which is extruded to form a core then coated by polymers. This process allows potencies up to 90 percent.
• The second, called spheronization, applies drug particles to a “seed” core – typically sugar – with the aid of a binder. The core is coated with a polymer. This process provides a very tight size distribution of pellets. Potencies up to 60 percent are possible.
Metrics Inc. is a full-service global pharmaceutical development and manufacturing organization serving clients worldwide. We deliver proven scientific and operational excellence for solid oral dosage forms.
The company’s areas of expertise include quality pharmaceutical formulation development; first-time-inman (FTIM) formulations; clinical material manufacturing (CTM) for Phase I, II and III trials; and analytical method development and validation services leading to commercial scale manufacturing.
Metrics’ technical capabilities include highly potent, cytotoxic and unstable compounds; Schedule II-V controlled substances; and products with poor bioequivalence – for which we offer an impressive proprietary portfolio of advanced delivery methods.
Our work supports investigational new drug (IND), new drug (NDA) and abbreviated new drug (ANDA) submissions made to worldwide regulatory agencies on behalf of clients ranging from internationally renowned corporations to small virtual companies.