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

描述（由申请方提供）：拟定SBIR项目的目标是开发冻干机生产硬件和工艺程序，以实现预充式注射器中制剂的高效冷冻干燥。使用预充式注射器1）减少了给药和用药错误，2）减少了微生物污染的风险，3）提高了给药准确性，4）通过消除小瓶过量填充的需要减少了浪费，5）增加了便利性并减少了紧急使用所需的时间，以及6）提高了医疗保健专业人员和患者的给药便利性。不幸的是，在预填充注射器中提供的冻干药物很少，部分原因是与在单室或双室注射器中生产高质量冻干药物产品相关的挑战。预充式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架和注射器之间的热传递不良。在这个拟议的研发计划物理科学公司。将与康涅狄格大学药学院和IMA Life合作，开发新的冻干机硬件和处理程序，使注射器中的代表性药物制剂（包括生物药物制剂）能够有效冻干。该项目支持美国国立卫生研究院的目标，即开发扩大规模和制药技术，并支持行政命令13329，旨在提高美国在关键经济部门（如制药行业）的制造业竞争力。

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.