SBIR Phase I: Pre-filled Cartridges for Personalized Medicine

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This SBIR Phase I project aims to design, build, test, and refine a cartridge of medicine for use with an inkjet printer for printing medicine that was developed with past NSF ERC support for academic research and I-Corps support for market research. Similar to how a conventional inkjet printer deposits small quantities of liquid ink on blank paper, the printer deposits precisely measured quantities of medicine on blank carriers to make the final pharmaceutical product. Due to its smaller size and relatively quick production times, the printer enables and is currently aimed at personalized medicine applications, wherein dosages and other product factors are customized to individual named patients by their medical practitioner and drug products are made for the patient to suit based on such a patient-specific prescription. The detailed development of medicine cartridges has not been attempted before, and is specifically pursued in this SBIR Phase I project to demonstrate cleanliness, address potential counterfeiting concerns, provide ease of use, and provide tracking if required. Such cartridges are envisioned to enhance the impact of printed medicine for personalized medicine applications, thereby improving the level of healthcare for this nation?s ill and creating a high-value just-in-time pharmaceutical production market.It is technologically very challenging to adapt the cartridge concept to pharmaceutical applications. These challenges include: the need for the cartridge to maintain cleanliness and integrity during storage and in use; the need to ensure that final products match required composition and dissolution profiles; the need to ensure that the contents of a cartridge are shelf-stable over its life; the prevention of any accidental introduction of impurities or deliberate counterfeiting; and the need to preclude operator error in wrong-substance or wrong-dose dispensing. Further challenges include the need to select and optimize cartridge size and form factors. Preliminary designs for cartridges have been identified, and this SBIR Phase I support will enable such designs to be built, tested and improved. Such cartridges will be filled with both inert materials and with certain specific drug substances identified as being of commercial interest. The cartridge and printer are planned to recognize each other to prevent operator transcription error. Testing for composition and impurities is planned with standard analytical chemistry techniques used in the pharmaceutical sector, such as high pressure liquid chromatography (HPLC) or mass spectrometry. The end result is a robust and reliable cartridge, to transform personalized medicine for the better for everyone.