1. INTRODUCTION:

A novel and creative way to drug delivery is the Nano Drug Delivery System. In order to help specific targeted cells bind up and involve with drugs, biological functional nano-carriers have been established.¹ The body of an individual is a complicated system that deals with a number of chronic and serious health conditions. We investigated how these Nano dose versions of the NSVs (Non-ionic Surfactant Vesicle) are going to be effective therapeutic agents due to their new properties. We are able to transform medications into nanomaterials and incorporate them in vesicles. In a similar manner, several nano-vehicles are present and exert their effects at the desired location.²

Niosomes are basically multilamellar or unilamellar vesicles made of non-ionic surfactants that are entirely contained by a membrane made of the multilayer arrangement of surfactant molecules.³ Niosomes range in size from 10 to 1000nm.⁴ The medicine is directly administered to the area of the body wherever the therapeutic impact is needed using niosomes. They distribute drugs in a regulated way that not only increases bioavailability but also has a long-lasting therapeutic effect. Cholesterol and charged particles serve as additives, and non-ionic surfactants found in the vesicular layers are employed to create niosomes. Additionally, it can prevent the drug’s molecule From becoming inactive as a result of unintended pharmacological and immunology impacts.⁵The usage of niosomes is increasing because it helps prevent the quick breakdown of medicines, insolubility, and instabilities.⁶

Figure 1: Structure of Niosomes⁷.

1.1 The advantages of niosomes:

· They are stable and osmotically active.

· They strengthen the medicine's stability.⁸

· It is possible to improve a drug’s bioavailability when taken orally.

· Increase the skin's ability to absorb drugs.

· Compared to oil-based solutions, the vesicle suspension offers improved the patient's compliance since it's water-based.

· The ability of the vesicles to act as a depot enables the regulated and gradual release of the medication.

· Reduce drug elimination and confine effects to target cells to increase the therapeutic effectiveness of the medicine by protecting it from biological contaminants.

1.2 Disadvantages:

· The medication leaking from the vesicles reduces the lifespan of niosomes.

· Vesicle aggregating and fusing are possible processes.⁹

· There can be minor issues with chemical and physical instabilities.

· The drug’s durability in water-based solutions may be impacted by hydrolyzed.

· The process of making niosomes takes a long period.

2. Niosomes contain:

· Non-ionic surfactants

· Cholesterol

2.1 Non-ionic surfactants:

They are made up of a hydrophobic tail with a polar head. They form a double-layer with their hydrophilic heads facing water-based media and hydrophobic or on polar tails facing inward.¹⁰ They increase permeation, increase solubility, are effective wetting substances, and are employed as emulsifiers. Because they inhibit p-glycoprotein, they improve uptake and delivery. Temperatures at which aqueous transitions occur depend on the choice of non-ionic surfactants.

2.2 Cholesterol:

Niosomes also contain cholesterol, which is a crucial component. Niosomes can be made without cholesterol, however it allows the formulation some useful features. Cholesterol gives the formulation numerous characteristics, including increased stability, entrapment effectiveness and rehydration of dry Niosomes.¹¹ Cholesterol increases vesicle stability when combined with surfactants with low HLB values, and also aids in the production of bilayer vesicles when HLB value is larger than 6

3. Niosomes can be divided into the following categories:

Figure 2: Niosomes Types¹²

4. Drug Delivery via Niosomes:

Niosomes are incredibly promising delivery systems for a variety of pharmaceutical and diagnostic substances. Niosomes' distinctive structure makes it possible to create innovative drug delivery systems that can efficiently load both hydrophilic and lipophilic medicines.

4.1. Delivery of Cancer Treatment Drugs:

Many anticancer medications have low tumor tissue absorption and significant adverse effects on normal cells, which restrict their therapeutic efficiency. Numerous initiatives have been developed attempted to address these issues, such as the usage of niosomes as a novel medication delivery system.

4.2. Targeted Delivery:

Through the use of a ligand paired to the surface of the niosomes, that might be thoroughly taking up, for example, via endocytosis mediated by receptors, active targeting for tumor treatment may improve the effectiveness and, in specific, the particularity of cellular targeting of niosomal drug delivery systems. To allow cell-specific targeting, niosome surfaces can be coupled with tiny molecule.

4.3. Antibiotics:

A niosomal delivery method for the broad-spectrum antibiotic rifampicin was created by Begum. Niosome antibacterial properties and the release of drugs through double-layers were investigated.

4.4. Antiviral Drug:

The ability of niosomes to distribute different antiviral medications has also been established. Created by combining equal amounts of cholesterol, span, and tween. When dicetyl phosphates were present, the amount of zidovudine that was retained through niosomes into Tween 80 was increased.

5. Techniques for preparing niosomes:

5.1. Ether injection:

Through a 14-gauge needle operating at 0.25 ml/min while being kept at 60°C, the medication and lipid (Figure 3) are slowly introduced to the diethyl ether and the aqueous phase, respectively. The creation of salbutamol niosomes with a 67.7% entrapment effectiveness using the ether injection approach.

Figure 3: Illustration of the ether injection procedure used to manufacture niosomes.¹³

5.2. Method for hydrating thin films by hand shaking:

Thin-layer hydration is used to dissolve the niosomes while a volatile solvent, such as diethyl ether or methanol, has been used to disperse the surfactant and cholesterol. The natural solvent is then removed using a rotating evaporator at room temperature. The drug-containing aqueous phase may be used to hydrate the dry surfactant while gradually shaking.

Figure 4: Illustration showing how to make niosomes using the thin-film hydration.¹⁴

5.3. Multi membrane extraction technique:

In chloroform, a thin layer is created by evaporating a combination of surfactant, cholesterol, and diacetyl phosphate. A therapeutic water-based solutions is used for hydrating this substance (Figure 5). A maximum of 8 passageways can then receive the suspension once it has been extruded via polycarbonate membrane.

Figure 5: Niosome production using the multiple-membrane extraction technique is illustrated.¹⁵

5.4. Sonication technique:

The combination of cholesterol and surfactant is put in a 10ml glass vial along with an aqueous phase that contains the active ingredient in the buffer. The mixture is subjected to sonication for 3 minutes at 60 °C.

Figure 6: Illustration of the sonication procedure used to prepare niosomes.¹⁶

5.5 The lipid injection technique:

A heated aqueous phase is mixed with soluble drug molecules and the melted surfactant and cholesterol, leading to the creation of niosomes (Figure 7).

Figure 7: Illustration of how to make niosomes using the lipid injection approach.¹⁷

6. Niosomes are evaluated as following:

6.1. Size:

The laser light scattering method can be used to determine the average size of niosomal vesicles, whose shape is assumed to be rounded.¹⁸Niosomes' vesicle diameter is increased by freeze-thawing, which can be explained by the cycle's vesicle fusion.

6.2. Forming two layers:

By observing the creation of an X-cross using light polarized microscopes, bilayer vesicles made up of non-ionic surfactants are identified.

6.3. The amount of lamellae:

The amount of lamellae in niosomes is counted using NMR spectroscopy, low-angle X-ray scattering, and electron microscopes.

6.4. Capture effectiveness:

Following the preparation of the niosomal dispersion, the medication that is not captured is extracted, and the drug that is still captured in the niosomes is determined by completely interrupting the vesicle with 50% n-propanol or 0.1% Triton X-100, and then analyzing the resulting solution by the appropriate test technique to identify the drug.

6.5. Stability studies:

The medication may escape from the niosomes during storage due to aggregation and fusing.¹⁹ Studies of stability involve frequent evaluations of criteria such as capture efficiency, size, and shape. Similar studies have been conducted on the stability of niosomes made from green tea extract²⁰, lornoxicam²¹, cefdinir²², and ginkgo biloba²³. The impact of digestive enzymes on niosome stability was investigated by Bayindir and Yuskel²⁴.

7. LIMITATIONS:

Sterilization is the main barrier preventing niosomes from being used as a viable medication delivery mechanism. Because heat can cause extensive drug leakage from the vesicles due to the destruction of the bilayer membranes, heat sterilization methods like dry heat and steam sterilization are inappropriate and destructive for lipid or surfactant-based formulations with a gel liquid the temperature of transition lower than the temperature used in the process of sterilization.²⁵Cobalt 60 radiation is used in the gamma sterilization procedure to eliminate microorganisms. This method produces rapid results and is gentle enough to penetrate packaging and products because it produces very little heat. Gamma radiation sterilizes a large number of pharmaceutical goods that are sold, including eye ointments, drops, and injectable preparations.²⁶

8. OPPORTUNITIES IN THE FUTURE:

Niosomes are a novel medication delivery molecule. Utilize it as prospective drug delivery systems to enhance therapeutic targeting and bioavailability while lowering toxicology and adverse effects. The primary goal of present study is on drug delivery targeting. After the invention of the magical medical treatment, only certain targeted products were able to enter the marketplace for sale.

9. CONCLUSION:

The niosomes delivering medications system is a successful strategy in this field while we discuss innovative drug delivery systems. This assignment leads us to the conclusion that niosomes are an essential drug delivery instrument that can target or incorporate drugs for a variety of therapeutic purposes and offer a number of benefits beyond traditional drug delivery methods. The niosomes can be shown to be an excellent appreciate for the near future.

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Received on 07.02.2024 Modified on 11.03.2024

Res. J. Pharma. Dosage Forms and Tech.2024; 16(2):178-182.

DOI: 10.52711/0975-4377.2024.00028