SBIR Phase I: Pre-filled Cartridges for Personalized Medicine

该SBIR第一阶段项目旨在设计，构建，测试和改进用于喷墨打印机的药物盒，用于打印药物，该药物盒是在过去NSF ERC支持学术研究和I-Corps支持市场研究的情况下开发的。与传统的喷墨打印机将少量液体墨水沉积在空白纸上的方式类似，打印机将精确测量的药物量沉积在空白载体上以制造最终的药物产品。由于其较小的尺寸和相对快速的生产时间，打印机能够实现并且目前旨在个性化的医学应用，其中剂量和其他产品因素由他们的医生针对个别指定的患者定制，并且基于这种患者特定的处方为患者制作药物产品以适合患者。以前从未尝试过药瓶的详细开发，在SBIR第I阶段项目中专门进行了详细开发，以证明清洁度，解决潜在的假冒问题，提供易用性，并在需要时提供跟踪。这样的墨盒被设想为提高个性化医疗应用的打印药物的影响，从而提高这个国家的医疗保健水平？这在技术上是非常具有挑战性的，以适应盒的概念，制药应用。这些挑战包括：需要药筒在储存和使用过程中保持清洁和完整性;需要确保最终产品与所需的组成和溶出曲线相匹配;需要确保药筒的内容物在其寿命期间是贮存稳定的;防止任何意外引入杂质或故意伪造;以及需要排除错误物质或错误剂量分配中的操作者错误。进一步的挑战包括需要选择和优化盒尺寸和形状因子。子弹的初步设计已经确定，SBIR第一阶段的支持将使这种设计能够被建造，测试和改进。这些笔芯将填充惰性材料和某些确定具有商业价值的特定原料药。墨盒和打印机计划相互识别，以防止操作员转录错误。计划采用制药行业使用的标准分析化学技术（如高压液相色谱法（HPLC）或质谱法）进行成分和杂质检测。最终的结果是一个强大而可靠的药筒，为每个人提供更好的个性化医疗。

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.