Process-design-translation interplay in lipid nanocarriers for vaginal mucosa delivery: how far have we advanced?

Abstract

Nowadays, translational research all across the globe has increasingly been valued for focusing on mucosa delivery across the vaginal avenue, attributed to its anatomy and physiology; however, rapid mucus turnover, poor permeability, and retention popped out as the biggest constraints in this topic. Despite sidestepping these pitiable challenges, lipid nanocarriers (LNCs) are still underexplored and demand upcoming clinical demonstration to bridge the gaps between lab–human vaginal trials. Therefore, this paper delves into a process–design–translation perspective, linking vaginal barriers and lipid/excipient ratio with fabrication strategies and nanocarrier architecture. The first portion critically analyzes the key design/fabrication factors that interplay with LNCs’ architecture. In the second portion, various characterization evaluation models of LNCs, viz., quality by design (QbD), lipid/excipient ratio, drug release, vaginal mucoadhesion/penetration (>10-fold higher retention), and cytotoxicity profile, have been discussed with industrial considerations and in vitro–in vivo correlation (IVIVC). Looking ahead into 5–15 years, the author suggests that hybrid LNCs, which may outperform conventional LNCs, and the integration of in-silico models could desirably enhance efficacy. Although considerable, the preclinical model doesn’t outline strong enough evidence regarding optimized LNCs–vaginal mucosa delivery. A critical literature analysis was conducted through ScienceDirect, Taylor & Francis, Nature, and PubMed engines till March 2026.

The authors' abstract, as published at the source. Therapeutic Delivery, 2026 · DOI ↗