This award is funded under the American Recovery and Reinvestment Act of 2009 (Public Law 111-5).
The research objective of this Grant Opportunity for Academic Liaison with Industry (GOALI) award is to develop a general and novel drug manufacturing technology based on Hot-Melt Extrusion (HME), a process that holds the potential of improving the bioavailabilty of poorly soluble drugs. HME will be treated as a multidisciplinary field, requiring fundamental knowledge and expertise from pharmaceutical and polymer science, and polymer processing. The research will address two fundamental, practically important, questions: 1) How to select or design appropriate polymeric excipients to mix with drugs that have poor water solubility so that the drugs can have accelerated release rate and/or improved solubility in water? 2) How do the Active Pharmaceutical Ingredients (API) and the polymeric excipients get mixed inside the extruder? A series of excipients, including polymer- nanoclay combinations, will be selected, and tested with model drugs to investigate their miscibilities and interactions. The extrusion process will be studied using on-line and off-line tools. The deliverables include a catalog of basic mixing mechanisms, analysis and modeling of stability/miscibility and processing results, and engineering student education at both academic and industry laboratories.
If successful, the results of this research will bring significant, potentially transformative, impact on the pharmaceutical industry. The results will help to commercialize numerous drugs that never went to the market place due to their solubility-caused poor bioavailability, and change the delivery route of some drugs from injection to oral. Both changes will assist the pharmaceutical industry by dramatically cutting costs and increasing the new drug pipeline. The fundamental understanding of the drug-excipient miscibility and the extrusion process will impact other industries as well, such as the medical device and food industries, since the same mixing and extrusion processes can also be applied. Graduate and undergraduate students will benefit from the hands-on research experience at NJIT/PPI and Wyeth laboratories, and also from the new pharmaceutical engineering courses to be developed.
