Robust & Efficient Method for Pharmaceutical Freeze Drying in Pre-Filled Syringes

描述(由申请人提供)：建议的SBIR计划的目标是开发冻干机制造硬件和加工程序，使药品配方能够在预装好的注射器中高效冷冻干燥。预灌装注射器的使用1)减少了给药和用药错误，2)减少了微生物污染的风险，3)提高了给药的准确性，4)通过消除瓶子过度灌装的需要减少了浪费，5)增加了便利性，减少了紧急使用所需的时间，6)提高了医疗保健专业人员和患者的管理简易性。不幸的是，由于在单室或双室注射器中生产高质量的冻干药物产品所面临的挑战，在预装注射器中提供的冻干药物很少。在预灌装的注射器中冷冻干燥的困难主要是由于容器系统的奇怪形状导致温控干燥器货架和注射器之间的热量传递不佳。在这项拟议的研发计划中，物理科学公司将与康涅狄格大学药学院和北卡罗来纳州IMA生命学院合作开发新的冷冻干燥机硬件和加工程序，使具有代表性的药物配方(包括生物药物配方)能够在注射器中高效冷冻干燥。该项目支持美国国立卫生研究院开发制药规模和制造技术的目标，并支持旨在提高美国在关键经济部门(如制药业)的制造业竞争力的13329号行政命令。

DESCRIPTION (provided by applicant): The goal of the proposed SBIR program is to develop lyophilizer manufacturing hardware and processing procedures that enable the efficient freeze drying of pharmaceutical product formulations in prefilled syringes. The use of prefilled syringes 1) reduces dosing and medication errors, 2) reduces the risk of microbial contamination, 3) improves dosing accuracy, 4) reduces waste by eliminating the need for vial overfill, 5) increases convenience and reduces the time required for emergency use and 6) improves the ease of administration for the healthcare profession and patient. Unfortunately, very few lyophilized drugs are provided in prefilled syringes due, in part, to the challenges associated with producing high quality freeze dried drug product in single or dual chamber syringes. The difficulty of freeze drying in prefilled syringes is primarily due to the poor heat transfer betwee the temperature controlled dryer shelves and the syringes due to the odd shape of the container system. During this proposed R&D program Physical Sciences Inc. will collaborate with the University of Connecticut, School of Pharmacy and IMA Life, NA to develop new freeze dryer hardware and processing procedures that enable efficient lyophilization of representative pharmaceutical formulations, including biological drug formulations, in syringes. This project supports the NIH goal of developing scale-up and manufacturing technology for pharmaceuticals and also supports Executive Order 13329 targeted at improving U.S. manufacturing competitiveness in critical economic sectors, such as the pharmaceutical industry.