Formulation Core

配方核心(核心B)将提供配方前、配方开发和配方 直接支持项目1、2、3和4的评估工作。在本计划的范围内，核心B将 利用Auritec制药公司开发的颗粒技术开发一种新的递送系统。这 将开发融合抑制物RC-101和非核苷逆转录酶的技术 抑制剂CSIC单独或联合使用。每一种候选药物都有需要克服的障碍。 把它们开发成药品。RC-101是亲水性多肽候选药物，而CSIC是 在自然界中是疏水性的。颗粒技术的使用允许这两个非常不同的共同输送 单一产品中的候选药物。为了将药丸送入阴道，药丸被插入阴道环中。 设备。这种给药系统将提供两种候选药物的持续释放，提供了一种友好的 独立药品。我们预计最初将开发一种药物产品，它将持续提供 在一个月内吸毒。在核心内，每个候选药物的配方前数据将 最初将被开发。这些数据将被用来成功地制定候选药物。小药丸 Auritec制药公司将进行配方工作，帕特里克博士将开发阴道环 犹他大学的Kiser说。此外，Kiser博士还拥有所需的技术 制造适当大小的阴道环，用于猕猴研究，这将是必要的 顺利完成本计划内计划的学习。制定前评估以及 匹兹堡大学的丽莎·罗翰博士将进行药品评估。 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，在她的团队内，将开发一个二次给药平台(快速溶解胶片)，用于 这些特工。核心将在整个药物的迭代基础上与项目1、2和3进行交互 产品开发阶段，并最终将提供用于猕猴安全性和有效性的药物产品 项目4中正在进行的研究。

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.