Polyprenol-Based Nanoformulations: Dual-Platform Innovation for Parenteral and Diagnostic Applications

Abstract

Polyprenols, long-chain isoprenoid alcohols of plant origin, possess notable hepatoprotective, antioxidant, antiviral, and immunomodulatory properties
and function as metabolic precursors to dolichols, keyessential in for glycoprotein synthesis. Despite growing pharmaceutical interest, their hydrophobic nature hampers bioavailability in aqueous systems. We address this challenge via patented liposomal and nanoemulsion technologies, enhancing solubility, stability, and controlled parenteral release. To bridge research and regulatory application, we propose three novel indices-IMMPREN, TRANSPREN, and STERILPREN—designed to quantify immunomodulatory potential, translational readiness, and sterilization resilience, respectively. IMMPREN evaluates immune traceability through macrophage polarization and Receiver Operating Characteristic (ROC)-based justification; TRANSPREN structures regulatory narratives for GRAS (Generally Recognized As Safe) and Novel Food dossiers; STERILPREN quantifies colloidal and structural integrity post- moist-heat sterilization, aligning with SAL Sterility Assurance level (SAL) standards. Each index enables formulation traceability, clarity in health claims, and stratification by cytokine/cell marker response, supporting injectable and diagnostic deployment. Collectively, our platform offers a modular, regulatory-explainable framework for polyprenol-based therapeutics—positioning these nanofor emulations as dual-use innovations in clinical translation and safety compliance.