NANO-ENABLED THERAPEUTICS: EXPLORING BIOEQUIVALENCE AND BIOAVAILABILITY FRONTIERS

Document Type

Article

Publication Title

International Journal of Applied Pharmaceutics

Abstract

The advancement of nanotechnology has significantly transformed pharmaceutical sciences, especially in enhancing the bioavailability and bioequivalence (BE) of drugs with poor solubility and permeability. Nanoparticulate drug delivery systems including nanoparticles, nanocrystals, nanoemulsions, and liposomes exhibit unique physicochemical properties such as increased surface area, improved dissolution rates, and enhanced permeability. These characteristics collectively contribute to superior therapeutic efficacy. For example, a 25-fold increase in the bioavailability of poorly soluble drugs such as retinoic acid has been reported by the use of solid lipid nanoparticles (SLNs), which act as protective lipid matrices, augmenting drug stability and allowing sustained release. This comprehensive review explores the fundamental concepts of bioavailability and BE as they pertain to nanoformulations, focusing on key factors that influence the absorption, distribution, metabolism, and excretion of nanosized drugs. It emphasizes the mechanistic pathways by which nanocarriers overcome biological barriers, including the gastrointestinal (GI) tract and first-pass metabolism, thereby improving pharmacokinetic (PK) profiles. Furthermore, the review discusses analytical methodologies and regulatory considerations critical to evaluating the BE of nanoformulated drugs. It highlights challenges in establishing equivalency arising from altered pharmacokinetic and pharmacodynamic (PD) behaviors unique to these formulations. A comparative analysis of conventional versus nanoformulated drugs illustrates the clinical implications of nanotechnology in drug delivery, such as dose reduction, improved patient compliance, and minimized adverse effects. Additionally, recent advancements in formulation strategies and characterization techniques are synthesized, showcasing how surface modifications, size optimization, and targeting moieties enhance oral bioavailability. By evaluating preclinical and clinical studies, this article provides valuable insights into the translational potential of nanoformulations. It also identifies existing gaps and future directions in regulatory frameworks and standardized BE testing. In summary, this review offers a holistic understanding of nanotechnology’s role in improving drug bioavailability and BE, serving as an essential resource for pharmaceutical scientists, clinicians, and regulatory authorities aiming to leverage nanoformulations for enhanced therapeutic outcomes. Despite notable progress, significant challenges remain especially in achieving scalable manufacturing, ensuring reproducibility of formulations and navigating complex regulatory landscapes. These challenges stress on the urgent need for internationally harmonized standards and robust quality control systems to support clinical translation.

First Page

111

Last Page

119

DOI

10.22159/ijap.2025v17i6.55458

Publication Date

11-1-2025

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