Vaginal Bioprotection by Controlled Acidification

描述(由申请人提供)：一种能够同时保护妇女免受疾病和怀孕影响的不显眼的产品应该得到广泛的接受。Biotek正在研究一种新的阴道凝胶，这种凝胶可以通过低pH缓冲来灭活病原体。第一阶段开发和研究含有2毫克/毫升的壬醇-9的阴道凝胶，以及一种能将pH值保持在2至3之间的可溶性缓冲盐。研究包括体外粘度、粘性稳定性、平衡pH、缓冲容量、杀精活性、绵羊阴道pH值的体内调查、对兔的阴道刺激性以及对无害和致病微生物的微生物试验。这种凝胶似乎能灭活精子、细菌和HIV-1病毒。第一阶段结束时，成功地通过更换增稠剂来减少对兔阴道的刺激性。第二阶段将修订第一阶段配方，以消除非氧合酚-9，确认最终配方的性能，制备和充分表征GMP凝胶，在兔身上进行体内研究，并在这种新阴道产品进行第一次人类临床研究前不久准备提交给FDA的IND。

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.