Long‐lasting vaginal dosage forms could improve the therapeutic efficacy of vaginal microbicides, but achieving long‐term delivery to the vaginal canal has been a significant challenge. To advance understanding of vaginal dosage retention and biodistribution, we describe a method of noninvasive imaging with 89Zr‐labeled bioadhesive nanoparticles (BNPs) in non‐human primates. We additionally examined the safety of repeated BNP application. BNPs administered vaginally to cynomolgus monkeys were still detected after 24 h (1.7% retention) and 120 h (0.1% retention). BNPs did not translocate to the uterus or into systemic circulation. Analysis of inflammatory biomarkers in the vaginal fluid and plasma suggest that BNPs are safe and biocompatible, even after multiple doses. BNPs are a promising delivery vehicle for vaginally administered therapeutics. Further studies using the non‐human primate imaging materials and methods developed here could help advance clinical translation of BNPs and other long‐lasting vaginal dosage forms.

中文翻译：

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食蟹猴阴道给药生物粘附纳米颗粒的 PET 试点研究：动力学和安全性评价


长效阴道剂型可以提高阴道杀菌剂的治疗效果，但实现长期输送到阴道管一直是一个重大挑战。为了加深对阴道剂量保留和生物分布的理解，我们描述了一种在非人灵长类动物中使用 89Zr 标记的生物粘附纳米颗粒 （BNP） 的无创成像方法。我们还检查了重复 BNP 应用的安全性。在 24 小时 （1.7% 保留） 和 120 小时 （0.1% 保留） 后，仍检测到经阴道施用食蟹猴的 BNP。BNP 没有转移到子宫或体循环中。对阴道液和血浆中炎症生物标志物的分析表明，BNP 即使在多次给药后也是安全和生物相容性的。BNP 是一种很有前途的阴道给药治疗的递送载体。使用此处开发的非人灵长类动物成像材料和方法的进一步研究可能有助于推进 BNP 和其他长效阴道剂型的临床转化。