Vaginal Bioprotection by Controlled Acidification

通过控制酸化进行阴道生物保护

• 批准号: 6931475
• 负责人: ES S NUWAYSER
• 金额: $ 57.28万
• 依托单位: BIOTEK, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-07-01 至 2007-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6931475
• 关键词: Lactobacillus; Mycoplasma; Neisseria gonorrhoeae; Trichomonas vaginalis; acidity /alkalinity; antiinfective agents; clinical research; communicable disease control; communicable disease transmission; drug adverse effect; drug design /synthesis /production; drug screening /evaluation; female; gel; human immunodeficiency virus 1; human subject; human therapy evaluation; human tissue; iodine; laboratory rabbit; nonhuman therapy evaluation; sexually transmitted diseases; spermicide; topical drug application; vagina; women' s health

DESCRIPTION (provided by applicant): A single unobtrusive product capable of protecting women against both disease and pregnancy should gain widespread acceptance. BIOTEK is investigating a new vaginal gel, which deactivates pathogens by low pH buffering. Phase I developed and studied vaginal gels containing 2 mg/ml of nonoxynol-9 along with a soluble buffer salt capable of holding the pH between 2 and 3. Studies included in vitro measurements of viscosity, viscous stability, equilibrium pH, buffer capacity, spermicidal activity, in vivo investigation of vaginal pH in sheep, vaginal irritation in rabbits, and microbiological tests on both harmless and pathogenic organisms. The gel appears to inactivate sperm, bacteria and HIV-1 virus. Phase I concluded with a successful effort to reduce rabbit vaginal irritation by replacing the thickening agent. Phase II will revise the Phase I formulation to eliminate nonoxynol-9, confirm the performance of the final formulation, prepare and fully characterize GMP gel, conduct an in vivo study in rabbits and prepare an IND for submission to the FDA shortly before a first human clinical study of this new vaginal product.

描述（由申请人提供）：能够保护女性免受疾病和怀孕侵害的单一不引人注目的产品应该获得广泛的接受。 BIOTEK 正在研究一种新的阴道凝胶，它可以通过低 pH 值缓冲来灭活病原体。第一阶段开发并研究了含有 2 mg/ml nonoxynol-9 以及能够将 pH 值保持在 2 至 3 之间的可溶性缓冲盐的阴道凝胶。研究包括粘度、粘性稳定性、平衡 pH 值、缓冲能力、杀精子活性的体外测量。活性、绵羊阴道 pH 值的体内研究、兔子的阴道刺激以及无害和致病微生物的微生物测试。该凝胶似乎可以灭活精子、细菌和 HIV-1 病毒。第一阶段成功地通过更换增稠剂来减少兔子阴道刺激而结束。 II 期将修改 I 期配方以消除 nonoxynol-9，确认最终配方的性能，制备并充分表征 GMP 凝胶，在兔子中进行体内研究，并准备 IND 以便在第一批人体试验前不久提交给 FDA这种新的阴道产品的临床研究。