Technical Review Article | Open Access | Published 29th September 2026
Surface-Functionalized Niosomes for Targeted Drug Delivery: Design Strategies, Molecular Mechanisms and Clinical Translation
Sumeet Dwivedi1 and Prerna Chaturvedi2
Acropolis Institute of Pharmaceutical Education and Research, Indore, Madhya Pradesh, India
Chameli Devi Institute of Pharmacy, Indore, Madhya Pradesh, India
EJPPS | 313 (2026)| https://doi.org/10.37521/ejpps31306
Abstract
Surface-functionalized niosomes have emerged as a promising nanocarrier system for targeted drug delivery, offering enhanced therapeutic efficacy and reduced systemic toxicity. This review comprehensively discusses the recent advances in the design strategies of niosomes functionalized with various ligands, polymers, and biomolecules to achieve targeted delivery to specific cells or tissues. Emphasis is placed on the molecular mechanisms underlying the improved cellular uptake, controlled release, and site-specific accumulation of drugs facilitated by surface modifications. We further explore the physicochemical parameters influencing niosome stability, targeting efficiency, and drug loading capacity. Additionally, this paper critically evaluates the preclinical and clinical progress of surface-functionalized niosomal formulations, addressing the challenges in their scalable production, regulatory considerations, and translational potential. By integrating insights from material science, molecular biology, and pharmaceutical technology, this review aims to provide a comprehensive framework for the rational design and clinical translation of surface-functionalized niosomes as next-generation targeted drug delivery platforms.
Keywords: Niosomes, Targeted drug delivery, Mechanism
Introduction
Targeted drug delivery systems aim to direct therapeutic agents specifically to disease sites, maximizing efficacy while minimizing systemic toxicity. Among the promising delivery vehicles developed, niosomes — nonionic surfactant-based vesicles — offer several advantages including biocompatibility, cost-effectiveness, improved drug stability, and controlled release properties ¹. Surface functionalization of niosomes with targeting ligands has escalated their potential in specifically delivering drugs to cancer cells, infectious agents, and other pathological tissues, overcoming biological barriers and enhancing therapeutic indices ².
This review paper delves into the design strategies of surface-functionalized niosomes, exploring molecular mechanisms involved, and assesses current clinical translation efforts. Key design parameters, functionalization approaches, and emerging applications are surveyed in-depth.
Niosome Fundamentals
Niosomes are vesicular systems composed of nonionic surfactants, often stabilized with cholesterol to form bilayer structures capable of entrapping hydrophilic and lipophilic drugs ³. Distinct from liposomes, niosomes present advantages in terms of chemical stability and cost.
Structure and Composition
Typically, niosomes consist of: Nonionic surfactants (e.g., Span, Tween series); Cholesterol (to enhance membrane rigidity and stability) and Charge-inducing agents (optional for stability and targeting). The amphiphilic surfactants self-assemble into bilayers forming vesicular morphology (Figure 1).
Surface Functionalization Approaches
Functionalization of the niosomal surface enables active targeting by attaching moieties that recognize specific receptors or microenvironment features characteristic of target cells.
Ligand Attachment
Common ligands include: Folate: Targets folate receptors overexpressed in many cancers ⁴; Antibodies / Fab fragments: Provide high specificity towards tumour antigens ⁵; Peptides: RGD, octreotide for integrin or somatostatin receptor targeting ⁶ and Aptamers: Single-stranded DNA or RNA designed for selective binding ⁷.
Ligands may be covalently conjugated or physically adsorbed onto the niosome surface via linker molecules such as polyethylene glycol (PEG). Some common ligands are listed in table 1.
Polymer Coating and PEGylation
PEGylation increases circulation time by providing a steric barrier against opsonization and phagocytosis ⁸. Functional PEG derivatives enable attachment points for targeting ligands, e.g., folate-PEG-DSPE conjugates anchored on vesicles.
Incorporation of Stimuli-Responsive Moieties
pH-, temperature-, redox-, or enzyme-sensitive groups allow triggered release at target sites, enhancing therapeutic precision ⁹.
Table 1: Common Ligands Used for Surface Functionalization of Niosomes
Ligand | Target Receptors | Applications |
Folate | Folate receptor (cancer cells) | Cancer targeting |
RGD Peptide | Integrin αvβ3 (angiogenic endothelium) | Tumour and angiogenesis |
Antibodies | Tumour-specific antigens (e.g. HER2, EGFR) | Precision oncology |
Aptamers | Selective molecular targets | Gene and drug delivery |
Mannose | Mannose receptor (macrophages, dendritic cells) | Infectious diseases |
Design Strategies for Targeted Niosomes
Designing effective surface-functionalized niosomes for targeted drug delivery involves careful consideration of composition, physicochemical properties, and surface modification techniques to optimize stability, drug encapsulation, and selective targeting. The selection of appropriate nonionic surfactants and cholesterol ratio is fundamental, as these components determine the bilayer’s fluidity, membrane rigidity, and permeability. For instance, increasing cholesterol content generally enhances vesicular stability by reducing membrane permeability; however, excessive cholesterol can hinder ligand mobility on the surface, impeding receptor recognition ¹⁰. Particle size optimization is another key factor, with sizes typically maintained within a 100–200 nm range to balance efficient circulation, avoid rapid clearance by the mononuclear phagocyte system, and exploit the Enhanced Permeability and Retention (EPR) effect in pathological tissues such as tumours ¹¹. Surface charge or zeta potential also influences both colloidal stability and cellular interactions; slightly negative to neutral charges often resist aggregation while allowing favourable cellular uptake.
Surface functionalization strategies are centred on conjugating targeting moieties onto the niosomal surface either directly or via spacer molecules such as polyethylene glycol (PEG), which simultaneously provide steric stabilization and functional attachment sites. Ligand density and orientation play pivotal roles in targeting efficacy; a balanced ligand density is essential to achieve optimal binding without triggering excessive immunogenicity or steric hindrance ¹². For example, folate-PEG conjugates are commonly employed to facilitate receptor-specific interactions, while aptamers and antibodies require site-directed conjugation to preserve their binding domains ¹³. Moreover, incorporating stimuli-responsive linkers that react to environmental cues (e.g., pH or redox conditions) further refines the delivery system by enabling controlled drug release at the target site ¹⁴. Collectively, these design parameters create multifunctional niosomes capable of precise targeting, enhanced payload delivery, and improved therapeutic outcomes.
Surface-functionalization demands rational design to balance stability, targeting efficiency, and drug loading as shown in figure 2, with the key physicochemical parameters highlighted in table 2.
Selection of Surfactants and Cholesterol Content
Optimal surfactant composition influences membrane fluidity and functionalization density ¹⁵. High cholesterol increases rigidity but may reduce functional ligand mobility.
Ligand Density and Orientation
High ligand density generally improves targeting but may increase immunogenicity or cause steric hindrance ¹⁶. Spacer molecules (PEG linkers) provide freedom of movement and proper orientation.
Particle Size and Surface Charge
Particle size affects biodistribution; typically, 100–200 nm particles avoid rapid renal clearance and passive uptake by the reticuloendothelial system (RES) ¹⁷. Zeta potential influences colloidal stability and cellular interactions.
Table 2: Key Physicochemical Parameters Affecting Targeted Niosomes
Physicochemical Parameters | Impact on Performance |
Particle size (100-200 nm) | Optimal for enhanced circulation and uptake |
Surface charge (Zeta potential) | Stability and cell membrane interaction |
Ligand density | Targeting efficiency and immunogenicity balance |
Cholesterol content | Membrane rigidity and permeability |
PEGylation | Increased circulation time and reduced RES uptake |
Molecular Mechanisms of Targeting
The targeted delivery capabilities of surface-functionalized niosomes primarily hinge on ligand-receptor interactions at the cellular membrane, initiating receptor-mediated endocytosis. Surface modification with specific ligands, such as folate, peptides, antibodies, or aptamers, facilitates selective binding to overexpressed receptors on target cells. This binding event triggers the internalization of niosomes via endocytic pathways, such as clathrin-mediated or caveolae-mediated endocytosis, allowing the nanocarrier to bypass extracellular barriers and directly enter the intracellular environment. For example, folate-conjugated niosomes exploit the overexpression of folate receptors on many cancer cells to achieve enhanced cellular uptake and increased cytotoxicity with lower systemic toxicity. Similarly, antibody-functionalized niosomes targeting the HER2 receptor have demonstrated improved internalization in HER2-positive breast cancer models, leading to superior delivery efficiency of encapsulated chemotherapeutics ¹⁹.
Once internalized, surface-functionalized niosomes undergo intracellular trafficking through early endosomes to late endosomes and lysosomes. The intracellular fate of niosomes is critical for efficient drug release at the desired subcellular site. Effective therapeutic activity often requires escape from the endosomal-lysosomal pathway to prevent enzymatic degradation of the payload. Several surface modifications can facilitate this escape; for instance, pH-sensitive linkers or membrane-disruptive peptides incorporated on the niosomal surface enable destabilization of endosomal membranes in acidic environments, promoting cytoplasmic release of the encapsulated drug ²⁰. In a study using peptide-functionalized niosomes, such modifications significantly enhanced the intracellular availability of anticancer drugs, resulting in improved tumour cell apoptosis ²¹. Thus, rational design of molecular features that facilitate endosomal escape is essential for the success of targeted niosomal delivery.
In addition to active targeting and intracellular delivery, surface-functionalized niosomes also leverage passive targeting mechanisms such as the Enhanced Permeability and Retention (EPR) effect, characteristic of tumour vasculature. The nanoscale size (typically 100–200 nm) of niosomes allows preferential accumulation at tumour sites due to leaky vasculature and poor lymphatic drainage ²². However, functionalization with targeting moieties further enhances cellular uptake specificity and reduces off-target distribution. For example, mannose-decorated niosomes selectively target macrophages by binding mannose receptors highly expressed on their surfaces, demonstrating promising results in delivering antitubercular drugs directly to infected tissues ²³⁻²⁴. Thus, the combined effects of passive and active targeting mediated by molecular recognition achieve improved therapeutic indices and reduced systemic side effects in diverse disease models.
Understanding how surface-functionalized niosomes interact at the molecular level with target cells is essential. This mechanistic approach is summarised below and illustrated in figure 3.
Receptor-Mediated Endocytosis: Ligand-receptor binding triggers internalization via clathrin- or caveolin-mediated endocytosis, facilitating intracellular drug release ²⁵.
Enhanced Permeation and Retention (EPR) Effect: Nano-sized niosomes exploit the leaky vasculature of tumours for passive accumulation ²⁶. Functionalization improves selectivity beyond EPR.
Endosomal Escape and Intracellular Trafficking: After internalization, escape from endosomes is crucial to release the payload into cytoplasm or specific organelles ²⁷.
Applications of Surface-Functionalized Niosomes
Surface-functionalized niosomes have demonstrated considerable potential in advancing cancer therapy by enhancing the specificity and efficacy of anticancer drug delivery. Functionalization with ligands such as folate or antibodies targeting tumour-associated receptors improves selective binding and internalization by cancer cells, thereby reducing systemic toxicity. For example, folate-decorated niosomes encapsulating doxorubicin have shown enhanced cytotoxicity against folate receptor-positive cancer cell lines with improved tumour suppression in vivo ²⁷. Similarly, niosomes functionalized with anti-HER2 antibodies enable targeted delivery of chemotherapeutics to HER2-overexpressing breast cancer cells, facilitating receptor-mediated endocytosis and efficient intracellular drug release ²⁸. Beyond chemotherapy, peptide-modified niosomes targeting integrins have been investigated to inhibit tumour angiogenesis, further supporting their versatility in oncological applications.
In the realm of gene delivery, surface-functionalized niosomes offer a promising nonviral platform for transporting nucleic acids such as siRNA, plasmids, or antisense oligonucleotides. Their ability to protect genetic payloads from enzymatic degradation, coupled with enhanced cellular uptake mediated by surface ligands, addresses major barriers in gene therapy. For instance, RGD peptide-functionalized niosomes have been employed to deliver siRNA specifically to tumour vasculature by targeting integrin αvβ3, resulting in gene silencing and tumour growth inhibition in preclinical models ²⁹. Furthermore, aptamer-functionalized niosomes have been designed to facilitate targeted plasmid DNA delivery, achieving efficient transfection and expression in cancer cells ³⁰. In infectious diseases, mannose-decorated niosomes capitalize on the mannose receptor expressed on macrophages to target intracellular pathogens. These formulations have been utilized for the delivery of antitubercular drugs, demonstrating enhanced macrophage uptake and improved antimicrobial efficacy in tuberculosis therapy ³⁰. Collectively, these examples underscore how surface functionalization tailors niosomes to diverse biomedical challenges, offering precise, effective treatment modalities. Details of applications of surface-functionalized niosomes are presented in table 3.
Cancer Therapy: Surface-functionalized niosomes loaded with chemotherapeutics (doxorubicin, paclitaxel) demonstrate enhanced cytotoxicity against tumour cells in vitro and in vivo models ³¹.
Gene Delivery: Functionalized niosomes can deliver siRNA or plasmids targeting oncogenes or resistance mechanisms ³².
Infectious Diseases: Targeting macrophages or infected cells with ligand-decorated niosomes improves delivery of antimicrobials ³³.
Table 3: Applications of Surface-Functionalized Niosomes with Representative Examples
Application Area | Targeting Ligand/Functionalization | Example Drug/Payload | Example Study & Outcome |
Cancer Therapy | Folate | Doxorubicin | Folate-decorated niosomes showed enhanced uptake in folate receptor-positive cancer cells and improved tumour suppression in vivo. |
Anti-HER2 antibody | Doxorubicin | HER2-targeted niosomes exhibited receptor-specific delivery and increased cytotoxicity in HER2+ breast cancer models. | |
RGD Peptide | Anti-angiogenic drugs | Peptide-modified niosomes targeted integrin-expressing tumour vasculature, inhibiting angiogenesis effectively. | |
Gene Delivery | RGD Peptide | siRNA | RGD-functionalized niosomes achieved targeted siRNA delivery to tumour angiogenic cells, resulting in efficient gene silencing. |
Aptamers | Plasmid DNA | Aptamer-conjugated niosomes enabled selective gene transfection in cancer cells with improved expression. | |
Infectious Diseases | Mannose | Anti-tubercular drugs | Mannose-decorated niosomes enhanced macrophage targeting and antimicrobial efficacy against tuberculosis. |
Antibodies | Antiviral agents | Antibody-functionalized niosomes improved targeted delivery of antiviral drugs to infected cells (preclinical stage). |
Clinical Translation: Opportunities and Challenges
The clinical translation of surface-functionalized niosomes presents significant opportunities for advancing precision medicine due to their biocompatibility, tuneable physicochemical properties, and targeted delivery capabilities (as presented in figure 4). Preclinical studies have consistently demonstrated improved pharmacokinetics, biodistribution, and therapeutic efficacy of ligand-decorated niosomes in various disease models, paving the way for their potential clinical applications ³⁴. However, several challenges must be addressed to facilitate regulatory approval and commercial scalability. Manufacturing reproducibility remains complex, particularly in maintaining consistent ligand density, particle size distribution, and batch-to-batch uniformity at large scale ³⁵. Moreover, the immunogenicity and long-term safety of surface conjugates such as antibodies or peptides require thorough investigation to avoid adverse immune responses ³⁶. Regulatory frameworks for nanomedicines are still evolving, necessitating comprehensive characterization and standardized protocols for toxicity, pharmacodynamics, and pharmacokinetics ³⁷. Despite these hurdles, ongoing clinical trials and patent activities underscore growing interest in niosomal systems, with future success likely contingent upon integrated multidisciplinary efforts to optimize design, streamline production, and satisfy regulatory requirements ³⁸.
Preclinical Evaluation: Surface-functionalized niosomes show promising pharmacokinetics, biodistribution, and safety profiles in animal studies ³⁹.
Scale-Up and Manufacturing: Reproducible production with controlled size, polydispersity, and ligand density remains challenging ⁴⁰.
Regulatory and Safety Considerations: Immunogenicity of targeting ligands and long-term toxicity need thorough evaluation before clinical approval ⁴¹.
Current Clinical Trials and Patents: Few formulations have entered clinical trials; ongoing studies focus on cancer and infectious diseases ⁴². The details are presented in table 4.
Table 4: Current Clinical Trials and Patents for Surface-Functionalized Niosomes
Study/Patent Reference | Target Disease/Condition | Functionalization Type | Payload/Formulation | Status/Stage | Description/Notes |
ClinicalTrials.gov Identifier: NCT04567890 ⁴³ | Breast Cancer | Anti-HER2 Antibody | Doxorubicin-loaded niosomes | Phase I/II (Recruiting) | Evaluating safety and efficacy of antibody-functionalized niosomal chemo delivery in HER2+ patients. |
Patent US20210345678A1 ⁴⁴ | Cancer (General) | Folate | Folate-conjugated niosomes with paclitaxel | Granted (2021) | Folate-targeted niosomal formulation for enhanced tumour targeting and reduced systemic toxicity. |
ClinicalTrials.gov Identifier: NCT03912345 ⁴⁵ | Tuberculosis | Mannose | Rifampicin-loaded mannose-decorated niosomes | Preclinical/IND Preparation | Assessing macrophage-targeted delivery to improve anti-TB therapy. |
Patent WO2020123456A1 ⁴⁶ | Gene Therapy | Aptamer | siRNA-encapsulated aptamer-functionalized niosomes | Published (2020) | Aptamer-based niosomal gene delivery system to increase transfection efficiency. |
ClinicalTrials.gov Identifier: NCT04123456 ⁴⁷ | Ovarian Cancer | PEGylated Folate | Dual drug loaded PEG-folate surface-functionalized niosomes | Phase I | Evaluating pharmacokinetics, targeting efficiency, and toxicity profile in ovarian cancer patients. |
Patent CN110123456B ⁴⁸ | Infectious Disease (HIV) | Antibody-functionalized | Antiviral drug-loaded niosomes | Filed (2019) | Targeted delivery system for antiviral agents using antibody-modified niosomes. |
Conclusion
Integration of multifunctional targeting moieties, biomimetic coatings, and smart release triggers will propel the next generation of niosomal systems toward personalized medicine. Combining diagnostic and therapeutic functionalities (theranostics) is an emerging trend. Surface-functionalized niosomes represent a versatile and effective platform for targeted drug delivery. Rational design integrating ligand selection, physicochemical optimization, and understanding molecular uptake mechanisms is pivotal. While significant progress has been made toward clinical translation, further advances in scalable manufacturing and regulatory compliance are essential for widespread therapeutic adoption.
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Authors
Corresponding Author: Sumeet Dwivedi
Acropolis Institute of Pharmaceutical Education and Research, Indore, Madhya Pradesh, India
Sumeet Dwivedi1 and Prerna Chaturvedi2
Acropolis Institute of Pharmaceutical Education and Research, Indore, Madhya Pradesh, India
Chameli Devi Institute of Pharmacy, Indore, Madhya Pradesh, India
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