Vaginal Bioprotection by Controlled Acidification

描述（由申请人提供）：一个单一的不引人注目的产品，能够保护妇女免受疾病和怀孕应该得到广泛的接受。BIOTEK正在研究一种新的阴道凝胶，它通过低pH缓冲来灭活病原体。阶段I开发并研究了含有2 mg/ml壬苯醇醚-9沿着的阴道凝胶，所述阴道凝胶具有能够将pH保持在2和3之间的可溶性缓冲盐。研究包括粘度、粘性稳定性、平衡pH、缓冲能力、杀精子活性的体外测量，绵羊阴道pH的体内研究，兔阴道刺激，以及无害和致病微生物的微生物试验。这种凝胶似乎可以抑制精子、细菌和HIV-1病毒。第一阶段结束时，通过更换增稠剂成功减少了家兔阴道刺激。II期将修改I期制剂以消除壬苯醇醚-9，确认最终制剂的性能，制备并充分表征GMP凝胶，在家兔中进行体内研究，并在该新阴道产品的首次人体临床研究前不久准备IND提交给FDA。

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.