Formulation Core

制剂核心（核心B）将提供预配制、制剂开发和制剂 直接支持项目1、2、3和4的评估工作。在本计划范围内，核心B将 开发一种新的输送系统，利用奥瑞特制药公司开发的颗粒技术。这 将开发用于融合抑制剂RC-101和非核苷逆转录酶的技术 抑制剂CSIC单独和组合。这些候选药物中的每一种都有需要克服的障碍 将其开发成药品。RC-101是亲水性肽药物候选物，而CSIC是 本质上是疏水的。颗粒技术的使用允许这两种非常不同的药物的共同递送。 单一产品中的候选药物。为了输送到阴道，将丸粒插入阴道环中 设备.该药物递送系统将提供两种候选药物的持续释放，从而提供一种更好的性交效果。 独立的药物产品。我们预计最初会开发出一种能够持续交付的药物产品 一个月内服用一种药物。在核心中，每种候选药物的处方前数据将 首先要发展。这些数据将用于成功配制候选药物。将沉淀 Auritec制药公司将进行配方研究，帕特里克博士将开发阴道环 犹他州大学的凯泽说。Kiser博士还拥有所需的技术， 制造适当尺寸的阴道环，用于猕猴研究，这将是必要的， 顺利完成本计划中的研究。制剂前评估以及 药品评估将由匹兹堡大学的丽莎罗汉博士进行。 她还将协调三个小组在药物输送系统设计和开发方面的努力。 此外，在她的小组内，将开发第二种药物递送平台（快速溶解膜）， 这些代理人。核心将在整个药物开发过程中与项目1、2和3反复互动 产品开发阶段，最终将提供用于猕猴安全性和有效性的制剂 项目4正在进行研究。

The Formulations Core (Core B) will provide preformulation, formulation development, and formulation assessment efforts in direct support of Projects 1, 2, 3, & 4. Within the scope of this program Core B will develop a novel delivery system utilizing a pellet technology developed by Auritec Pharmaceuticals. This technology will be developed for the fusion inhibitor RC-101 and the non nucleoside reverse transcriptase inhibitor CSIC both individually and in combination. Each of these drug candidates has hurdles to overcome to develop them into drug products. RC-101 is a hydrophilic peptide drug candidate while CSIC is hydrophobic in nature. The use of the pellet technology allows for co-delivery of these two very dissimilar drug candidates in a single product. For delivery to the vagina the pellets are inserted into a vaginal ring device. This drug delivery system will provide sustained release of both drug candidates offering a coitally independent drug product. We anticipate initially developing a drug product which will consistently deliver drug over a period of one month. Within the core, preformulation data on each of the drug candidates will initially be developed. This data will be used to successfully formulate the drug candidates. The pellet formulation effort will occur at Auritec Pharmaceuticals and the vaginal rings will be developed by Dr. Patrick Kiser at the University of Utah. Dr. Kiser additionally has the needed technology available to him to manufacture vaginal rings of appropriate size for use in macaque studies which will be necessary for successful completion of studies planned within this program. Preformulation assessments as well as pharmaceutical product assessments will be conducted by Dr. Lisa Rohan at the University of Pittsburgh. She will also coordinate the efforts of the three groups toward drug delivery system design and development. In addition within her group a secondary drug delivery platform (quick dissolve film) will be developed for these agents. The core will interact with Projects 1, 2, and 3 on an iterative basis throughout the drug product development stages and will ultimately provide drug product for use in macaque safety and efficacy studies being conducted in Project 4.