SBIR Phase I: Pre-filled Cartridges for Personalized Medicine

SBIR 第一阶段：用于个性化医疗的预填充药筒

• 批准号: 1721752
• 负责人: Arun Giridhar
• 金额: $ 22.5万
• 依托单位: PharmaPrinter LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-06-01 至 2018-11-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1721752&HistoricalAwards=false
• 关键词: SBIR; Phase; Pre; filled; Cartridges

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.

SBIR第一阶段项目旨在设计、制造、测试和改进一种药物墨盒，用于打印药物的喷墨打印机，该打印机是在过去的NSF ERC学术研究支持和I- corps市场研究支持下开发的。与传统的喷墨打印机将少量液体墨水沉积在空白纸上类似，打印机将精确测量的药物沉积在空白载体上，以制造最终的药物产品。由于其较小的尺寸和相对较快的生产时间，打印机支持并目前针对个性化医疗应用，其中剂量和其他产品因素是由他们的医生为个人命名的患者定制的，并且根据患者特定的处方为患者制造适合的药品。药物药盒的详细开发以前从未尝试过，并且在SBIR第一阶段项目中专门进行，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增强打印医学对个性化医疗应用的影响，从而提高这个国家的医疗保健水平。创造一个高价值的准时制药品生产市场。从技术上讲，将墨盒概念应用于制药应用是非常具有挑战性的。这些挑战包括：需要墨盒在存储和使用过程中保持清洁和完整性；需要确保最终产品符合要求的成分和溶出度；需要确保药筒的内容物在其使用寿命期间保持货架稳定；防止任何意外引入杂质或故意假冒；并且需要排除操作人员在错误的物质或错误的剂量分配中的错误。进一步的挑战包括需要选择和优化墨盒尺寸和形状因素。弹药筒的初步设计已经确定，SBIR第一阶段的支持将使这些设计能够被建造、测试和改进。这些药筒将装满惰性物质和某些确定为具有商业利益的特定药物物质。墨盒和打印机计划相互识别，以防止操作员转录错误。成分和杂质的检测计划采用制药部门使用的标准分析化学技术，如高压液相色谱（HPLC）或质谱法。最终的结果是一个强大而可靠的药筒，为每个人带来更好的个性化医疗。