Impact of Active Pharmaceutical Ingredient (API) spatial orientation and matrix phase behavior on drug release from extruded and injection molded long-acting implants

Principal investigator: Anne Gohn, Alicyn Rhoades

University: The Pennsylvania State University, Behrend

Industry partners: Merck

Controlled drug delivery in long-acting implants is an innovative topic in pharmaceutical manufacturing. These implants are made from plastic that has been infused with drug molecules that transfer to the body after implantation. This method of drug delivery is advantageous, ensuring high patient compliance, thanks to decreased personal dosage management and reduced dosing schedule. Biologically, these systems can reduce drug misuse, optimize absorption rates, and administer at ideal locations within the body. While commercial examples exist, optimizing the manufacturing process is not complete. This proposal unites the pharmaceutical expertise of Merck of West Point, PA and the Plastics Engineering Technology program of Penn State Behrend in Erie, PA to develop an understanding of the interplay between manufacturing conditions and long-term drug release. Drug variables include particle shape, orientation, dispersion, and loading level. The plastic implantable itself has several variables including density, crystallinity, and morphology, all of which can change with manufacturing conditions. Formulation and manufacturing studies will be carried out in the plastics manufacturing lab at Penn State Behrend, including the comparison of the current industry-standard extrusion process to the potentially more-controlled and higher output process of injection molding. After pilot manufacturing, drug release studies will reveal the relationship between formulation, manufacturing, and drug release rates. Undergraduate students in the Plastics Engineering Technology Program can earn a medical plastics certificate, and this joint endeavor is an excellent use of resources to initiate a collaboration between Merck and Penn State that will lead to global recognition in pharmaceutical manufacturing, as well as the training of an engineering workforce ready to commercialize the technology in Pennsylvania.