Niosomes in Drug Delivery: Current Researches in Niosomes

 

Harsh Vardhan*, Ashish Jain, Akhlesh Kumar Singhai

School of Pharmacy, LNCT University, Kolar Road, Bhopal, 462042, Madhya Pradesh, India.

*Corresponding Author E-mail: hvardhan1020@gmail.com

 

ABSTRACT:

Niosomes, non-ionic surfactant-based vesicular systems, have garnered significant attention in recent years for their potential applications in drug delivery, gene therapy, and vaccine development. This review article provides a comprehensive overview of current research on niosomes, focusing on their formulation, characterization, and therapeutic applications. Various preparation methods, including thin-film hydration, reverse-phase evaporation, and microfluidic techniques, are critically evaluated for their efficiency in producing niosomes with controlled size, morphology, and encapsulation efficiency. Recent advancements in surface modification strategies, such as PEGylation and targeting ligands, have enhanced the biocompatibility and targeting capabilities of niosomes, facilitating the delivery of hydrophilic and lipophilic drugs. The stability of niosomes under physiological conditions and their behavior in biological environments are also discussed, highlighting the influence of formulation parameters on drug release kinetics. Additionally, the review examines the integration of niosomes in emerging fields such as nanomedicine and personalized therapy, showcasing their role in overcoming barriers related to drug solubility and bioavailability. Recent clinical studies and preclinical trials underscore the therapeutic potential of niosomes in various diseases, including cancer, diabetes, and infectious diseases. By synthesizing current findings, this article aims to provide insights into the future directions of niosome research, emphasizing their promise in revolutionizing drug delivery systems and improving therapeutic outcomes. The challenges and opportunities in scaling up production and regulatory considerations are also discussed, paving the way for the translation of niosome technology from laboratory settings to clinical applications.

 

KEYWORDS: Niosomes, Vesicle, Drug delivery, Efficacy, Surfactant, Encapsulated, Targeting.

 

 

 

INTRODUCTION:

Niosomes are a new generation of vesicular structures that have gained a prominent place in the fields of drugs delivery and pharmaceutical sciences. These vesicles originate from non-ionic surfactants with cholesterol and thus represent a unique alternative to traditional lipid-based vesicles, such as liposomes. This new generation reflects convergence among materials science, chemistry, and pharmacology toward improving efficacy and specificity of drug delivery systems.

 

 

Niosomes were for the first time proposed in 1975 out of a need to overcome the restrictions on liposomal drug delivery. Liposomes made of phospholipids have been found to hold great promise in encapsulation and delivery but are often bogged down with issues regarding cost, stability, and scalability. Hence, the niosomes came forth as a low-cost and flexible alternative. They are formed as a result of the self-assembly of non-ionic surfactants—such as Span, Tween, or their derivatives—together with cholesterol. This complex exhibits the feature of a bilayer structure like that of liposomes but consists of the substances in a manner that provides it with unique physicochemical properties. Among the first works concerning niosomes were those referred to as the nature of preparation, stability, and encapsulation efficiency. Scientists, as early as 1975, L'Oreal, and colleagues identified that non-ionic surfactants could spontaneously form vesicular structures in aqueous environments. This work ushered a new era for drug delivery as niosomes were capable of encapsulating a wide range of drugs, both hydrophilic and hydrophobic, unlike their phospholipid counterparts, which offered higher chemical stability and resistance to environmental factors, besides being an attractive alternative. As the science advanced, individuals would continue exploring in the area of optimizing niosome formulation to ensure greater performance.1,2 Improvements were found in the types of surfactants, applications of various additives for modification of the vesicle properties, and designing methods to control size and niosome charge. These advances made it possible to engineer niosomes bearing properties suited to the intended application, such as targeting drug delivery systems, controlled release, and enhanced bioavailability. Niosomes have been found to be very useful within pharmaceutical formulations, especially because they are multilamellar structures capable of entrapping either hydrophilic or hydrophobic drugs, thus offering a wide range of possibilities-from enhancing bioavailability through solubilization of poorly soluble drugs to sustained release profiles. Furthermore, niosomes can be engineered to target specific tissues or cells where drugs are desired to act. This gives them further advantages in the treatment of diseases that require localized drug action, such as cancer or chronic inflammatory conditions. In addition, the stability and economy of niosomes make them a good candidate for pharmaceutical mass production.3

 

Advantages of Niosomes:

Niosomes are non-ionic surfactant-based vesicular systems. These have a large number of advantages for drug delivery and other applications. Important advantages include the following:

1.     Enhanced Stability of Drugs: Niosomes enhance the stability of drugs that are unstable in aqueous solutions or under physiological conditions.

2.     Controlled Release: It offers controlled release of the encapsulated drug, thereby allowing sustained therapeutic effects and reducing the requirement to dose frequently.

3.     Improved Bioavailability: Niosomes can improve the bioavailability of poorly soluble drugs by increasing the solubility and stability of such drugs in biological fluids.

4.     Targeted Delivery: They can be developed for tissue or cell specific delivery that may limit the undesirable side effects of drugs with maximum therapeutic benefit.

5.     Reduction in Toxicity: They result in safer drug delivery since they encapsulate drugs in a way that reduces their toxicity to nontarget tissues.

6.     Versatile Formulation: Niosomes can be formulated with any of the various non-ionic surfactants, and hence it is possible to exercise flexibility in formulation to suit drug as well as therapeutic requirements.

7.     Low Cost: Non-ionic surfactants used in niosomes are in general less expensive than those used in other vesicular systems like liposomes, and therefore niosome-based formulation is less costly compared to liposome-based counterparts.

8.     Ease of Preparation: Niosomes could be formulated through very simple and scalable methods like hydration of surfactant films, rendering them suitable for mass-scale production.

9.     Minimized Enzyme Degradation: The niosomes may prevent enzymatic degradation of the drugs encapsulated into them, which enhances drug efficacy.

10. Enhanced Penetration of Active Ingredient across the Skin: If the niosomes are formulated for topical application, they may facilitate better penetration of active ingredients through the skin.

11. Increased Compliance with Patients: Niosomes offer controlled release drugs that can reduce the frequency of drug administrations and increase patient compliance to a drug regimen.

12. Flexibility of Administration Routes: Niosomes can be used for any route of administration - oral, intravenous, topical, or even nasal administration.4-8

 

These advantages make niosomes a valuable tool in drug delivery and other biomedical fields.

 

Disadvantages of Niosomes:

·       Physical Stability Issues: It involves a problem associated with stability; such as aggregation, fusion, or leakage of the drug being encapsulated over time. This instability results in poor efficacy, as well as uneven drug release profiles, making their storage and transportation challenging.

·       Highly Expensive and Potentially Hazardous Process of Manufacture: Though niosomes are generally more economical compared to liposomes, the process of preparing niosomes still requires technological sophisticated operations such as sonication or extrusion, which is expensive and time-consuming. The requirement of special equipment as well as reagents can raise the cost of production and restrict scalability in mass production.

·       Low Drug Loading Capacity: It contains a very small amount of drug since its structure and size are very small. This could restrain some applications for some drugs or treatments based on the requirement for higher dosages, as the carrier system may need repeated administration or higher amounts of the carrier system.

·       Stored and Shelf-Life Concerns: At times, niosomes have to be preserved under specific conditions, for instance, at low temperatures, so as not to leak or degrade. This makes logistics significantly cumbersome, particularly for drugs that are destined for regions with a weak cold chain infrastructure.

·       Toxicity Problems: The niosome preparation method uses surfactants, and in specific concentration, formulations, and routes of administration, they might not be harmless to cells in general.

·       Obviously, surfactant type and dosage demand care to minimize the cytotoxic effect, which can limit the niosomes' applicability in some therapeutic applications.9,10

 

Structure of Niosomes:

Niosomes are vesicles of micro size, made up of non-ionic surfactants, which self-assemble in an aqueous environment. This is structurally very similar to liposomes but differs in the surfactant involved. The basic structure of a niosome consists of Bilayer Structure: The niosome is a bilayer formed due to the self-assembly of non-ionic surfactants in an aqueous environment. The hydrophilic heads of surfactants orient themselves toward the outer aqueous environment, whereas the tails orient themselves inward to form a bilayer. The bilayer structure is similar to that of the phospholipid bilayer inside liposomes but is prepared from synthetic non-ionic surfactants. Surfactants are more stable and lower in cost than phospholipids. Within the niosome is an aqueous core where hydrophilic drugs can be encapsulated. Around the aqueous space of the niosome, a bilayer exists that shields the encapsulated drug from degradation while permitting controlled release. Hydrophobic Region: Due to surfactants' tails, the hydrophobic region of the bilayer provides appropriate circumstances for the encapsulation of lipophilic drugs. Lipophilic drugs are added directly to the bilayer. Cholesterol Component: Cholesterol is incorporated into the niosomal formulation for providing backbone rigidity, as well as stabilizing the bilayer. This component decreases the permeability of the vesicle-a condition that indirectly decreases leakage of the drug and increases stability for the structure.11,12

 

 

 

Fig. 1: It represents structure of niosomes along with the components by which niosomes are formed.13

 

 

 

Table 1: Below is a detailed table outlining the various types of niosomes:14-17

Type of Niosome

Description

Key Characteristics

Applications

Unilamellar Vesicles (ULVs)

Single lipid bilayer surrounding an aqueous core.

Single lipid bilayer; high drug encapsulation efficiency.

Drug delivery, gene therapy, diagnostics.

Multilamellar Vesicles (MLVs)

Multiple concentric bilayers surrounding an aqueous core.

Multiple lipid bilayers; higher stability and larger drug loading capacity.

Drug delivery, cosmetic formulations.

Large Unilamellar Vesicles (LUVs)

A subtype of unilamellar vesicles with a larger diameter, typically >100 nm.

Larger size; can encapsulate larger quantities of drugs.

Controlled release systems, targeted drug delivery.

Small Unilamellar Vesicles (SUVs)

Smaller unilamellar vesicles with diameters typically <100 nm.

Smaller size; faster release rates.

Rapid drug release, imaging studies.

Reverse-Phase Evaporation Niosomes (REV Niosomes)

Prepared using the reverse-phase evaporation technique.

High entrapment efficiency; good stability.

Drug delivery, vaccines.

Dehydration-Rehydration Vesicles (DRVs)

Formed by dehydrating niosome suspensions followed by rehydration.

Enhanced stability; ability to control size and encapsulation.

Long-term storage of drugs, vaccine delivery.

Span-Based Niosomes

Made using Span surfactants (e.g., Span 60, Span 80).

Generally used for forming MLVs; high stability.

Controlled release, cosmetic products.

Tween-Based Niosomes

Made using Tween surfactants (e.g., Tween 80).

Typically forms ULVs; high drug loading capacity.

Drug delivery, imaging.

Mixed Niosomes

Combination of different surfactants (e.g., Span and Tween).

Adjustable properties depending on surfactant mixture.

Tailored drug delivery systems, improved stability.

Thermosensitive Niosomes

Niosomes that respond to temperature changes, often incorporating thermosensitive surfactants.

Can release drugs in response to temperature changes.

Targeted delivery, smart drug delivery systems

pH-Sensitive Niosomes

Niosomes that release their contents in response to pH changes.

Useful for targeting specific areas with different pH levels.

Gastrointestinal drug delivery, targeted therapy.

 

 

 

 

Factors affecting Niosomes:

Niosomes characteristics and effectiveness are influenced by several factors. Below are the factors which affect niosomes in numerous ways:

 

1. Type of Surfactant and Concentration:

Type of Surfactant:

Non-Ionic Surfactants: Niosomes are commonly prepared with surfactants of sorbitan esters, Span series. Other polyoxyethylene derivatives of sorbitan esters that are in the Tween series are also commonly used. Span 60 and Span 80 and Tween 20 and Tween 80 are mainly used. The nature of stability, size, and efficacy of encapsulation of the vesicles will depend on which surfactant is selected. Vesicles are typically developed with surfactants such as Span, which show higher stability without much leakage. Vesicles formed with surfactants such as Tween are usually larger in size and present release profiles.

 

Properties of Surfactant:

HLB (hydrophilic-lipophilic balance) value of surfactants defines whether or not the vesicles can be formed. Surfactants with high HLB values make them to be more hydrophilic and may cause less stable vesicles if inappropriate concentrations are used.

 

Concentration of Surfactant:

The concentration of surfactant further influences the size and the number of niosomes prepared. Overall, higher concentrations of surfactants result in vesicles of smaller sizes having a higher level of encapsulation efficiency however; excessively high concentration often leads to either instability or aggregation of the vesicles. Optimal concentration varies with experimental studies carried out for every formulation.

 

2. Cholesterol Content:

Role of cholesterol:

Cholesterol is generally added to niosome formulations in order to stabilize the membrane. The cholesterol inserts itself intermolecularly amongst surfactants. It increases the fluidity of the bilayer and reduces permeability, which helps in enhancing the stability and durability of the niosomes.

 

Ratio of Cholesterol to Surfactant:

The cholesterol to surfactant ratio is an influence on physical properties of niosomes. Generally, the higher the proportion of cholesterol makes for firm vesicles with decreased leakage but at the same time, too much cholesterol may result in increased size of the vesicles or aggregation.

 

3. Method of Preparation:

Thin Film Hydration:

This method involves dissolving surfactants and cholesterol in an organic solvent, the solvent is then evaporated to give a thin film, and finally, the hydration of this film with an aqueous phase. The hydration conditions; temperature and time will influence the size and homogeneity of niosomes. The formation of the vesicles might be incomplete if hydration is insufficient.

 

Reverse Phase Evaporation:

Solubilization of surfactants in an organic phase using an aqueous phase, which is then evaporated. This technique may be able to produce niosomes with controlled size and encapsulation efficiency; however, the choice of solvents used and how to remove them is crucial for vesicle formation.

 

Microfluidic Techniques:

This involves the precise control of niosome sizes and uniformity via microchannel application. The technique is useful for reproducibility but requires specialized equipment.

 

4. Temperature:

Effect on Membrane Fluidity: Temperature influences the fluidity of surfactant molecules as well as cholesterol in the niosome membrane. Generally, increased temperature enhances membrane fluidity. This might, on its part, affect the stability as well as the efficiency of encapsulation by the vesicles. At extremely low temperatures, however, the membrane may be too stiff, thus eventually affecting the release of contents from the interior of the vesicles.

 

5. pH of the Aqueous Phase:

Impact on Surfactant Behavior: The pH of the aqueous phase influences the ionization state of surfactants and the capacity of these amphiphilic molecules to form vesicles. Some surfactants are pH sensitive, in such a way that the variations in pH may influence the hydrophilic-lipophilic balance of the surfactants thereby affecting the preparation and stability of niosomes.

 

6. The Encapsulated Substance:

Nature of the Encapsulated Drug:

The characteristics of the drug to be entrapment hydrophilic or hydrophobic decides its interaction with the surfactant matrix. Hydrophobic drugs are generally easier to incorporate with higher efficiency in niosomes whereas the hydrophilic drugs may require a special formulation strategy for getting better entrapment efficiency.

 

Impact on Release Profile:

Type of drug substance exerts a huge effect on the release profile from niosomes. Hydrophobic drugs are released slowly, whereas hydrophilic drugs may have a faster release according to the formulation and surfactant properties.

 

7. Additives and Stabilizers:

Role of Additives:

Antioxidants, oxidation inhibitors, and preservatives could be added to the formulation to inhibit oxidative degradation and extend shelf life. Additives (for example, polymer such as polyvinyl alcohol) could be added to enhance the stability of the formulation and control the drug-release rate.

 

Effect on Formulation:

The concentration and type of additives can significantly influence the size of niosomes and also its stability and release properties of the drug. For example, PEG enhances the stability of niosomes and prolongs their circulation time in blood.

 

8. Size and Size Distribution:

Size Effect on Properties:

The size of niosomes impacts the drug release profile, stability, and cellular uptake. General smaller niosomes showed better stability and tissue penetration. Larger niosomes may be used for controlled or sustained release applications.

 

Size Uniformity:

A narrow size distribution is often desirable for uniform performance. Techniques such as size exclusion chromatography or filtration can be used for size distributions.

 

9. Storage Conditions:

Temperature and Light: Niosomes are responsive to environmental conditions. High temperature and light might degrade the surfactants and cholesterol molecules thereby affecting the stability of the vesicles. Right storage conditions will be essential for the durability of niosomes over an extended period. Humidity, high humidity can cause sticking or fusing of niosomes. Controlled storage of niosomes in the environment with right levels of moisture will thus become crucial.

 

10. Characterization Technique:

Dynamic Light Scattering (DLS):

To be used in determining the size distribution and stability of niosomes suspended. Also determines average size and polydispersity. Transmission Electron Microscopy (TEM), Provides microscopic photographs of niosome morphology and size with details that allow visualization of the vesicle structure. Atomic Force Microscopy (AFM), Provides topographical images of niosome surfaces at high resolution, useful for understanding the shape of the vesicles as well as their surface characteristics.18-23

 

Formulation of Niosomes by different methods: Niosomes are vesicular systems formed by self-assembly of non-ionic surfactants in aqueous phases. The process of niosome formulation involves combining surfactants, cholesterol (or other lipids), and the drug to be encapsulated. Various methods are used to prepare niosomes, each with specific advantages depending on the desired niosome size, encapsulation efficiency, and drug release characteristics. Below is a detailed explanation of the most commonly used methods for niosome formulation.

 

Thin Film Hydration Method (Hand Shaking Method):

Process:

Step 1: Surfactants and cholesterol are dissolved in an organic solvent such as chloroform or methanol in a RBF.

Step 2: The solvent is evaporated under reduced pressure using a rotary evaporator, forming a thin film on the walls of the round-bottom flask.

Step 3: The thin film is then hydrated by adding an aqueous phase (containing the drug) under continuous shaking at a specific temperature.

Step 4: Upon hydration, the surfactant molecules self-assemble into niosomes.

 

Advantages:

·       Simple and widely used.

·       Suitable for hydrophobic and hydrophilic drugs.

 

Disadvantages:

·       May lead to heterogeneous vesicle size.

·       Low encapsulation efficiency for some drugs.

 

Applications: Commonly used for large-scale niosome production and for drugs requiring high encapsulation efficiency.24-26

 

Reverse Phase Evaporation Method (REV):

Process:

Step 1: Surfactants and cholesterol are dissolved in an organic solvent.

Step 2: An aqueous solution containing the drug is added to the organic phase, forming a water-in-oil (w/o) emulsion.

Step 3: The solvent is then evaporated under reduced pressure, causing the emulsion to collapse and form vesicles.

Step 4: Niosomes are formed by the self-assembly of the surfactant in the aqueous phase.

 

Advantages:

·       High encapsulation efficiency for hydrophilic drugs.

·       Produces unilamellar vesicles with a large aqueous core.

 

Disadvantages:

·       Time-consuming process.

·       Requires the removal of organic solvents, which can be toxic.

 

Applications: Used in the formulation of niosomes for water-soluble drugs and therapeutic proteins.27,28

 

Ether Injection Method:

Process:

Step 1: A solution of surfactants and cholesterol is dissolved in diethyl ether or a volatile organic solvent.

Step 2: This solution is slowly injected into an aqueous phase containing the drug through a fine needle at a controlled rate.

Step 3: The rapid evaporation of ether due to heat causes the surfactant to precipitate and form niosomes.

 

Advantages:

·       Simple and easily controlled method.

·       Produces small unilamellar vesicles (SUVs).

Disadvantages:

·       Use of organic solvents may require careful removal.

·       Lower encapsulation efficiency compared to other methods.

 

Applications: Commonly used for producing small niosomes and for drugs requiring low doses.29,30

 

Sonication Method:

Process:

Step 1: Surfactants and cholesterol are dissolved in an organic solvent and evaporated to form a thin film.

Step 2: The film is hydrated with an aqueous drug solution to form multilamellar vesicles (MLVs).

Step 3: The suspension is subjected to sonication using either a bath sonicator or a probe sonicator, which breaks the MLVs into smaller unilamellar vesicles (SUVs).

 

Advantages:

·       Produces small and homogeneous vesicles.

·       Simple and easy to perform.

 

Disadvantages:

·       Low encapsulation efficiency.

·       Sonication may lead to drug degradation due to heat generation.

 

Applications: Widely used for producing small unilamellar vesicles in drug delivery and cosmetic applications.31,32

 

Microfluidization:

Process:

Step 1: The surfactant and cholesterol solution is mixed with an aqueous phase containing the drug under high pressure.

Step 2: The mixture is forced through a microfluidizer, where high shear forces cause the surfactant molecules to form niosomes.

 

Advantages:

·       Produces homogeneous vesicles with narrow size distribution.

·       High encapsulation efficiency.

 

Disadvantages:

·       Requires specialized equipment.

·       More complex than other methods.

 

Applications:

Used for large-scale production of niosomes with uniform size distribution, especially in the pharmaceutical industry.33,34

 

Transmembrane pH Gradient (Remote Loading) Method:

Process:

Step 1: Empty niosomes are prepared by conventional methods (e.g., thin film hydration or reverse phase evaporation).

Step 2: A pH gradient is created across the niosome membrane by adjusting the pH of the aqueous phase inside and outside the vesicle.

Step 3: The drug is added to the external medium and is passively loaded into the niosomes due to the pH gradient, achieving higher encapsulation efficiency.

 

Advantages:

·       High encapsulation efficiency for hydrophilic drugs.

·       Ensures active loading of drugs into the vesicles.

 

Disadvantages:

Requires the establishment of a pH gradient, which may complicate the process.

 

Applications:

Frequently used for drugs that are weak bases or acids, ensuring controlled drug release over time.35

 

Microemulsion Method:

Process:

Step 1: A mixture of surfactant, cholesterol, and co-surfactant is prepared in an organic solvent.

Step 2: The organic phase is emulsified with an aqueous phase (containing the drug) to form a microemulsion.

Step 3: Upon gentle heating, the microemulsion is converted into niosomes as the solvent evaporates.

 

Advantages:

·       Produces small and uniform niosomes.

·       High encapsulation efficiency.

 

Disadvantages:

·       Requires high temperatures, which may degrade heat-sensitive drugs.

·       Requires careful control of the microemulsion composition.

 

Applications:

Often used for producing thermodynamically stable vesicles, especially for topical and transdermal drug delivery systems.36

 

Bubble Method:

Process:

Step 1: Surfactants and cholesterol are dissolved in an organic solvent and injected into an aqueous phase containing the drug at high temperature.

Step 2: Nitrogen gas is bubbled through the solution to form niosomes via agitation.

 

Advantages:

·       Does not require the use of harmful organic solvents.

·       Produces vesicles with large aqueous cores.

 

Disadvantages:

·       May produce vesicles of heterogeneous size.

·       Low encapsulation efficiency for certain drugs.

Applications:

Used for the delivery of proteins, peptides, and large hydrophilic molecules.7,30,37

 

Ideal Characteristics of Niosomes:

Size and Size Distribution:

Ideal Size:

The size of niosomes plays a crucial role in their effectiveness for drug delivery. For systemic delivery, an ideal size range is between 50nm and 200nm. Vesicles within this range can efficiently penetrate biological membranes and tissues, and they are also small enough to avoid rapid clearance by the reticuloendothelial system (RES). Smaller niosomes (sub-100 nm) can provide better cellular uptake and tissue penetration, while larger niosomes might be used for controlled release or targeting specific areas.

 

Uniform Size Distribution:

A narrow size distribution (low polydispersity index) ensures uniform behavior of niosomes, leading to consistent drug release profiles and predictable pharmacokinetics. Variability in size can lead to inconsistent drug delivery and efficacy. Uniformity in size helps in achieving consistent therapeutic effects and minimizes variability in the drug release rate, which is critical for precise dosing.

 

Stability:

Physical Stability:

Niosomes should resist aggregation, fusion, or sedimentation during storage and handling. Physical instability can lead to a loss of encapsulated content and reduced effectiveness. Ensuring physical stability helps maintain the niosome's integrity and effectiveness throughout its shelf life.

 

Chemical Stability:

The components of niosomes, including surfactants and cholesterol, should remain chemically stable. This involves resistance to oxidation, hydrolysis, or degradation over time. Chemical stability is crucial for maintaining the niosome’s structural integrity and functionality, especially in drug delivery where chemical degradation can affect therapeutic efficacy.

 

Encapsulation Efficiency:

High Encapsulation Efficiency:

Encapsulation efficiency refers to the percentage of the drug or active ingredient successfully enclosed within the niosome. High encapsulation efficiency minimizes the need for excessive amounts of the drug and reduces waste. High encapsulation efficiency ensures that the maximum amount of the drug is available for therapeutic action, improving the overall efficacy of the formulation.

 

Controlled Release:

Niosomes should be designed to release their contents in a controlled manner, which can be sustained or targeted depending on the application. This involves modulating the release rate to match the therapeutic needs. Controlled release can improve therapeutic outcomes by providing a steady release of the drug over time or by targeting specific sites within the body.

 

Release Profile:

Desired Release Kinetics:

The release kinetics of the encapsulated substance should be tailored to the therapeutic requirements. For example, sustained release formulations should deliver the drug over an extended period, while rapid release formulations should release the drug quickly for immediate effects. Tailoring the release profile to meet specific therapeutic goals helps in achieving desired pharmacokinetics and pharmacodynamics.

 

Targeted Release:

In certain applications, niosomes should be engineered to release their contents at specific locations within the body. This can be achieved by modifying surface properties or incorporating targeting ligands. Targeted release improves the efficacy of the drug by concentrating its action at the intended site, thereby minimizing side effects and enhancing therapeutic outcomes.

 

Surface Properties:

Surface Charge:

The surface charge of niosomes can influence their stability and interaction with biological membranes. Neutral or slightly negative charges generally reduce aggregation, while positive charges can enhance cellular uptake. Optimizing surface charge is important for achieving desired stability and interaction profiles, particularly for intravenous administration and targeted delivery.

 

Surface Modifications:

Surface modifications, such as coating with polyethylene glycol (PEG) or attaching specific targeting moieties, can enhance niosome stability and direct them to specific cells or tissues. Surface modifications can improve the niosome's ability to target specific sites or evade the immune system, thereby enhancing its effectiveness and safety.

Biocompatibility and Toxicity:

Biocompatibility:

Niosomes should be biocompatible, meaning they should not provoke adverse reactions when in contact with biological tissues. This includes minimizing cytotoxicity and immunogenicity. Biocompatibility is crucial for ensuring that the niosomes do not cause harmful effects when administered to patients, making them suitable for clinical use.

 

Low Toxicity:

The surfactants and other components used in niosomes should be non-toxic and safe for their intended use. This is particularly important for drugs and cosmetics that are applied or injected into the body. Ensuring low toxicity is essential for patient safety and for meeting regulatory requirements for pharmaceutical and cosmetic products.

 

Thermal and Environmental Stability:

Thermal Stability:

Niosomes should be stable across a range of temperatures to withstand variations during storage and transport. This includes maintaining their integrity and functionality under both high and low temperatures. Thermal stability ensures that the niosomes retain their effectiveness and safety throughout their shelf life, regardless of storage conditions.

 

Environmental Resistance:

Niosomes should be resistant to environmental factors such as light and humidity, which can cause degradation or affect their stability. Environmental resistance is important for maintaining the quality and performance of niosomes during storage and handling.

 

Manufacturing Scalability:

Reproducibility:

The manufacturing process should produce niosomes with consistent quality and characteristics across different batches. This involves controlling parameters to ensure reproducibility. Reproducibility is essential for ensuring that each batch of niosomes meets the required specifications and performs consistently.

 

Scalability:

The process should be scalable from laboratory to industrial scale without compromising the quality or performance of the niosomes. This includes adapting the process for larger volumes and ensuring cost-effectiveness. Scalability is crucial for transitioning from research and development to commercial production, ensuring that the niosomes can be produced efficiently and economically.

 

Ease of Preparation and Characterization:

Simple Preparation:

The preparation method for niosomes should be straightforward, cost-effective, and compatible with large-scale production. It should also allow for precise control over niosome characteristics. Ease of preparation contributes to the feasibility and cost-effectiveness of manufacturing niosomes, making them practical for widespread use.

 

Characterization:

Niosomes should be easily characterized using standard techniques such as Dynamic Light Scattering (DLS) for size and polydispersity, Transmission Electron Microscopy (TEM) for morphology, and other methods for assessing stability, encapsulation efficiency, and release profiles. Accurate characterization is essential for ensuring that niosomes meet the desired specifications and for optimizing their formulation and performance.

 

Cost-Effectiveness:

Affordable Production:

The production of niosomes should be cost-effective, taking into account the cost of materials, manufacturing processes, and quality control. The overall cost should be justified by the benefits provided by the niosomes. Cost-effectiveness ensures that niosomes are economically viable for commercial production and can be offered at a competitive price while maintaining high quality.22,23,38-45

 

Niosomes in the Treatment of Various Disease Conditions:

Niosomes, which are non-ionic surfactant-based vesicles, offer significant potential in the treatment of various disease conditions due to their unique properties. Their ability to encapsulate both hydrophilic and hydrophobic drugs, combined with their versatility in formulation, makes them an attractive option for targeted and controlled drug delivery. Below it is explained about how niosomes can be used in the treatment of different disease conditions.

 

Cancer:

Niosomes can be engineered to deliver chemotherapeutic agents specifically to cancer cells, thereby increasing drug accumulation in tumors and reducing systemic toxicity. This can be achieved by modifying the niosome surface with targeting ligands that bind to specific cancer cell receptors. Niosomes can provide sustained release of anticancer drugs, which helps in maintaining therapeutic drug levels over extended periods and reducing the frequency of dosing. Some drugs had shown really good effect in the form of niosomes like, Liga S et, al.,46 proved that encapsulation of doxorubicin, a common chemotherapeutic agent, in niosomes has been explored to enhance its delivery to tumor sites and reduce side effects such as cardiotoxicity. Niosomes can also be used to deliver paclitaxel, another anticancer drug, improving its solubility and bioavailability. Udupa N et, al.,47 studied that if methotrexate a potent anti-neoplastic drug when given in form of Niosomes then the plasama level of the drug increases and the clearance of the drug slows down.

 

Infectious Diseases:

Niosomes can encapsulate antibiotics to enhance their stability and delivery to infected sites. This is particularly useful for targeting bacterial infections and improving the efficacy of antibiotics. By modifying niosomes with specific ligands, it is possible to direct antibiotics to particular bacterial strains or infected cells, reducing collateral damage to healthy tissues. Niosomes have been explored for delivering drugs like isoniazid and rifampicin to improve treatment outcomes for tuberculosis. Encapsulation of antifungal agents like amphotericin B in niosomes can enhance their efficacy and reduce nephrotoxicity.48-50

 

Cardiovascular Diseases:

Niosomes can deliver anti-inflammatory drugs to the site of inflammation in cardiovascular diseases, such as in the case of atherosclerosis or myocardial infarction. Surface-modified niosomes can be directed towards endothelial cells or specific vascular targets to improve the delivery of cardiovascular therapeutics. Encapsulation of statins in niosomes can enhance their bioavailability and provide localized delivery to the cardiovascular system.

 

Neurological Disorders:

Niosomes can be engineered to cross the blood-brain barrier, allowing for the delivery of drugs to the central nervous system (CNS). This is achieved through surface modifications or by using specific formulations that enhance BBB permeability. Niosomes can provide controlled release of neurotherapeutics, reducing the frequency of dosing and improving patient compliance. Niosome-encapsulated antiepileptic drugs can offer improved delivery to the brain and better control of seizure activity. Research is exploring the use of niosomes to deliver drugs like donepezil for managing Alzheimer’s disease, aiming to enhance drug delivery to the brain.

Dermatological Conditions:

Niosomes are well-suited for topical drug delivery, as they can enhance the penetration of active ingredients through the skin. This is beneficial for treating skin conditions or for delivering cosmetic agents. Niosomes can provide sustained release of dermatological agents, improving their efficacy and reducing the need for frequent application. Niosomes can encapsulate anti-acne drugs like benzoyl peroxide or antibiotics, targeting the delivery to the skin and improving therapeutic outcomes. Encapsulation of anti-aging compounds in niosomes can enhance their penetration into the skin, leading to better results in skincare applications.51

 

Allergic Conditions:

Niosomes can be used to deliver antihistamines more effectively, targeting specific sites of allergic reactions and providing controlled release. Niosomes can also be used to deliver immunomodulatory agents to modulate the immune response in allergic conditions. Niosome-encapsulated antihistamines can be used for nasal delivery to treat allergic rhinitis more effectively. Niosomes can enhance the delivery of topical antihistamines for treating skin allergies.

 

Ocular Disorders:

Niosomes can be formulated as eye drops or ointments to improve the delivery of ocular drugs. They can enhance drug penetration through the corneal barrier and provide prolonged drug release. Niosomes can be designed to target specific structures within the eye, such as the retina or lens, for treating conditions like macular degeneration or cataracts. Niosome-encapsulated anti-glaucoma medications can provide sustained release and improve intraocular pressure management. Niosomes can deliver anti-inflammatory drugs to treat conditions like uveitis or conjunctivitis.22,52

 

 

 

Table 2: Researchers and their findings on Niosomes

S. No.

Researchers/year

Findings

Ref.

1.

Patil et al.,/2024

aimed to develop a thin-film hydration-based formulation of a niosome loaded with fluvastatin sodium (FVS) for the treatment of antihyperlipidemia. In vitro drug release, zeta potential, vesicle size, entrapment efficiency, transmission electron microscopy, and three levels of statistical optimization were assessed for the created formulations using a three-level factorial design.

53

2.

Maheshwari et al., /2024

They investigated the possibility of using non-ionic surfactant-based niosomal vesicles to treat rheumatic disorders by encapsulating the anti-rheumatic medication tenoxicam (TN). A controlled pressure mechanical dispersion approach was used to create several niosomal compositions. The impact of various ratios of sodium deoxycholate, lipid, and surfactant (span-60) on the physicochemical features of noisomes have been investigated. Moreover, it was shown that the in vitro inflammatory profile could be evaluated by inhibiting TNF-α in lipopolysaccharide-activated cultured Human leukemia monocytic (THP-1) cells.

54

3.

Tyagi et al.,/ 2023

They created plumbagin enclosed within niosomes using the quality by design (QbD) strategy for efficient penetration and increased bioavailability. The formulation and optimization of plumbagin-loaded niosomes (P-Ns-Opt) involved the use of a Box–Behnken Design.

55

4.

Afreen et al.,/ 2022

developed eight formulations of chlorpheniramine (CPM) niosomes based on a 23-factorial design; characterized using multiple evaluation tests, such as in vitro drug release, SEM, FTIR, TGA, and release kinetics; optimized the eight formulations based on in vitro drug release data; created a gel of optimized dispersion; and carried out an in vivo and histopathological study on rabbits using the gel of optimized dispersion.

56

5.

Umbarkar,/2021

created niosome with the aid of a non-ionic surfactant. Niosome particle sizes must fall within the range of 10 nm and 100 nm. Niosomes come in a variety of forms, and the preparation technique chosen will determine the kind and size of the niosome. In this post he described process of production of pro-niosome and niosome. Medication, its chemical and physical properties, the quantity and kind of surfactant, cholesterol content and its charge, resistance to osmatic stress, and membrane composition are only a few of the numerous variables that influence the creation of niosome.

57

6.

Monireh ER et al.,/2020

Curcumin-loaded niosomes represent a promising approach for enhancing the delivery and bioavailability of curcumin, a compound known for its anti-inflammatory and antioxidant properties but limited by its poor solubility and rapid metabolism.

58

7.

Robabehbeygom G et al.,/2019

Cephalexin-loaded niosomes are an innovative approach to enhance the delivery and efficacy of cephalexin, a commonly used antibiotic. Niosomes, being non-ionic surfactant-based vesicles, provide several advantages, such as improved solubility, stability, and controlled release of drugs. In this article they prepared this niosomes by using span 60 and tween 60 as a promising drug carrier system.

59

8.

Abou-Taleb HA et al.,/2018

They formulated an intranasal niosomes by encapsulating nefopam drug which is a non-opioid analgesic used for the management of pain, particularly in conditions where traditional analgesics may not be suitable so that the bioavailability of the drug could be increased.

60

9.

Jacob S et al.,/2017

Formulated a niosome gel containing acyclovir to enhanced dermal deposition which was a promising approach to improve the bioavailability and therapeutic efficacy of this antiviral drug, particularly for treating skin infections caused by the herpes virus.

61

10.

Rajendran V et al.,/2016

Highlited the use of niosomes in the transdermal delivery of sertraline hydrochloride, an antidepressant belonging to the selective serotonin reuptake inhibitor (SSRI) class, is a promising approach to enhance drug absorption and improve therapeutic outcomes. Sertraline is primarily used for treating depression, anxiety disorders, obsessive-compulsive disorder (OCD), and post-traumatic stress disorder (PTSD). Niosomes improved the permeability of sertraline through the skin by disrupting the stratum corneum lipid barrier.

62

11.

El-Ridy MS et al.,/2015

Ethambutol hydrochloride is an anti-tubercular agent primarily used in the treatment of tuberculosis. Despite its effectiveness, its use can be limited by side effects and variable bioavailability. Researchers found that niosomal encapsulation is a promising strategy to enhance the efficacy and safety of ethambutol as it improves the solubility and permeability of ethambutol, and enhance its absorption.

63

12.

Puras G et al.,/2014

In this article the researchers discussed that retinal therapy which are almost least possible by conventional treatment and gene delivery was not possible without any carrier but when given by encapsulating it into niosomes produces a promising effect in sever retinal diseases. Cationic niosomes are non-ionic surfactant-based vesicles that carry a positive charge. This positive charge facilitates electrostatic interactions with negatively charged nucleic acids (DNA or RNA), enhancing encapsulation and delivery. The positive surface charge promotes interaction with the negatively charged cell membrane, leading to increased cellular uptake of the encapsulated genetic material. Cationic niosomes can protect the nucleic acids from degradation in biological environments.

64

13.

Onochie I.T.O et al.,/2013

They formulated a niosomal drug delivery system of benzyl-penicillin which is a widely used antibiotic, and can benefit from niosomal encapsulation to improve its stability, bioavailability, and targeted delivery. The method used was thin film hydration and it was proved to be much more effective towards S. typhi, Ps. Aereuginosa and P. vulgaris than the uncoated drug.

65

14.

Shirsand S et al.,/2012

Ketoconazole is an antifungal agent used to treat a variety of fungal infections. However, its poor solubility and limited bioavailability can hinder its therapeutic efficacy, that is why the researchers thought to formulate a niosomal gel drug delivery system that can enhance the solubility, stability, and localized delivery of ketoconazole, making it more effective for topical and systemic applications. By using thin film hydration method and taking span and tween for niosomal formulation they prepared a niosomal gel drug delivery system so that they get the desired effect.

66

15.

Rungphanichkul N et al.,/2011

The researchers in this article mentioned about curcuminoids. Curcuminoids, the active compounds in turmeric, are known for their anti-inflammatory, antioxidant, and antimicrobial properties. However, their clinical application is often limited due to poor solubility and low skin permeability. Niosomes can serve as effective carriers to enhance the skin permeation of curcuminoids. In this they formulated Curcuminoid noisome drug delivery by thin film hydration method and using formulations containing curcumin, demethoxycurcumin, and bisdemethoxycurcumin, and Non-ionic surfactants such as Span 60 (sorbitan monostearate) and Tween 80 (polysorbate 80).

67

 

 

 

Conclusions and future aspects of Niosomes:

Niosomes are versatile vesicular drug delivery systems that have garnered significant attention in pharmaceutical and biomedical fields due to their unique properties. Composed of non-ionic surfactants, they offer a promising alternative to liposomes, particularly for encapsulating both hydrophilic and lipophilic drugs. hey enhance the solubility, stability, and bioavailability of various pharmaceuticals, including anti-inflammatory, antifungal, and anticancer agents. Niosomes are being explored for delivering nucleic acids, such as DNA and RNA, in gene therapy applications. Their ability to enhance skin permeation makes them suitable for topical formulations, improving the efficacy of drugs like curcumin and ketoconazole. Niosomes can act as adjuvants and delivery systems for vaccines, boosting immune responses. Being composed of non-toxic materials, niosomes are generally well-tolerated by biological systems. They provide better stability compared to free drugs, protecting the active ingredients from degradation. Niosomes can offer sustained release profiles, minimizing the need for frequent dosing and improving patient compliance. Studies are aimed at optimizing surfactant compositions and preparation methods to enhance encapsulation efficiency and stability. Researchers are exploring niosomes in novel fields, such as nanomedicine, where they are used for targeted cancer therapy and personalized medicine. There is increasing interest in using niosomes to co-deliver multiple therapeutic agents to enhance treatment outcomes for complex diseases. Niosomes represent a promising drug delivery system with broad applications across various fields of medicine. Their unique advantages, coupled with ongoing research efforts, suggest that they will play an increasingly significant role in advancing therapeutic strategies and improving patient outcomes. As technology progresses, the potential of niosomes will continue to be explored, leading to innovative solutions in drug delivery and therapy. Niosomes have shown great promise in drug delivery systems, and their future holds significant potential across various fields. Combining niosomes with other delivery systems (e.g., liposomes or nanoparticles) to enhance their properties, such as targeting capabilities and drug loading efficiency. Development of niosomes that respond to external stimuli (e.g., pH, temperature, or light) to release their payloads selectively in specific environments, such as tumor sites. While niosomal formulations are still emerging in the market, several products have been developed or are in clinical trials like, Niosomal gels for antifungal and anti-inflammatory agents, like ketoconazole and curcumin, are showing promise in the cosmetic and dermatological markets. Some anticancer drugs are being formulated in niosomal systems to enhance bioavailability and reduce systemic toxicity. Niosomes are being explored as adjuvants or carriers in vaccine formulations, particularly in developing countries where stability and ease of storage are critical. The global drug delivery market, which includes niosomes, is expected to witness substantial growth. Analysts project a compound annual growth rate (CAGR) of around 7-10% over the next few years, driven by increasing demand for innovative drug delivery systems. Niosomes can be produced at a relatively low cost compared to liposomes, making them an attractive option for pharmaceutical companies looking to optimize production costs while maintaining product efficacy.

 

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Received on 06.10.2024      Revised on 19.12.2024

Accepted on 03.02.2025      Published on 03.03.2025

Available online from March 07, 2025

Asian J. Res. Pharm. Sci. 2025; 15(1):44-56.

DOI: 10.52711/2231-5659.2025.00007

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