Originally Published MPMN January/February 2009

BREAKTHROUGHS

Bioresorbable Polymers Perform Localized Drug Delivery

Stephanie Steward

Not only can implants disappear within the body on schedule, they can now also deliver drugs at a predetermined rate, thanks to advances in combination products. Increased availability of biocompatible materials has played a significant role in the progress of these products. Taking these technologies to the next level is Foster Pharma, part of Foster Corp., a contract process development and manufacturing company, that offers custom Resorbable Delivery formulations.

Foster’s formulations are polymers blended with pharmaceuticals that are used to create implantable devices that feature drug-delivery capabilities. Using advanced melt extrusion technologies, the polymers are manufactured in a Class 7 pharmaceutical cleanroom. The melt extrusion processes ensure dispersion of the active pharmaceutical ingredient throughout the polymer matrix. As the materials resorb into the body, they release the drug.

“Combination products that simultaneously serve short-term mechanical functions as biocompatible implants and function as long-term drug-delivery devices is an expansion on the bioresorbable material technology that has gained traction in recent years,” Foster Pharma president Dan Lazas explains. “Bioresorbable materials are becoming more acceptable for device designs, and use of them is crossing over into more segments of the industry than ever before.”

In addition to producing the blended polymers in pellets suitable for injection molding implants, the company can produce resorbable drug-eluting fibers, rods, and films. And because they resorb, the need for implant removal surgery is eliminated. This is a great benefit to patients, Lazas says.

Benefits of creating these products can also be seen from both the pharmaceutical and manufacturing sides. “Localized drug delivery offered in the form of a drug-eluting implant can reduce potential adverse events associated with systemic treatments that can affect areas of the body that do not require treatment,” Lazas says. The controlled-release properties are part of the custom formulation process along with tailoring the implant degradation time, tensile strength, and other application-specific characteristics. And because the active pharmaceutical ingredient is blended within the polymer, no extra coating processes are required.

Foster Pharma, Putnam, CT
www.fostercorporation.com

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