Office of Technology Transfer – University of Michigan

Methods for Stabilizing Biologically Active Agents Encapsulated in Biodegradable Controlled-Release Polymers

Technology #2151-1

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Researchers
Steven P. Schwendeman
Managed By
Janani Ramaswamy
Licensing Specialist, Medical Deviceses 734-763-9081
Patent Protection
US Patent Pending

UM File # 2151.1

Background
Since the concept of protein or drug delivery from polymers was first introduced, research efforts have focused on developing polymer formulations that would be widely applicable for delivery of biologically active agents, such as proteins, oligonucleotides, and vaccine antigens. Efforts to this end have intensified recently since hundreds of recombinant proteins and other biotechnological drugs and vaccine antigens are in the pipeline for FDA approval, and the current method of protein delivery generally requires injections on a daily basis. Two injectable configurations of poly(lactide-co-glycolide) (PLGA) are currently used to deliver peptides and proteins. Although PLGA has been widely used owing to its safety and biodegradability, the microenvironment surrounding PLGA can become highly acidic, causing many of delivery agents to lose their biological activity. Accordingly, it is desirable to modify the preparation methods for polymer delivery systems to produce a polymeric implant that is capable of controlled release of the biologically active agent over a prolonged period of time, while maintaining the stability of the biologically active agent that is retained in the delivery system during nonenzymatic hydrolysis, or biodegradation.
Technology Description
Researchers at the University of Michigan have developed new methods for reducing or inhibiting the irreversible inactivation of water-soluble biologically active agents in biodegradable polymeric delivery systems, such as PLGA delivery systems. The present invention also relates to PLGA delivery systems prepared by this method. Such delivery systems have a low porosity (e.g. Applications • Enhanced controlled release of bio- and small molecules using PLGA with decreased loss of molecule stability and degradation.
Advantages • Stabilized agent encapsulation enhances efficacious delivery.