Niosomal-based Drug Delivery System:
A Novel Target Strategy for the Treatment of Arthritis
Priyanka A. Mandal*, Nilakshi N. Dhoble, Nitin Padole, Pankaj Dhapke, Jagdish R. Baheti
Kamla Nehru College of Pharmacy, Butibori, Nagpur, Maharashtra, India – 441108.
*Corresponding Author E-mail: priyankamandal344@gmail.com, dhoblenn18@gmail.com
ABSTRACT:
Arthritis is one or more joints that are swollen and sore. Joint stiffness and pain are the primary symptoms of arthritis, and they usually get worse with age. The two most common types of arthritis are osteoarthritis and rheumatoid arthritis. The firm, slick substance called cartilage, which covers the ends of bones where they meet to create joints, deteriorates as a result of osteoarthritis. The illness known as rheumatoid arthritis occurs when the body's immune system targets the joints, starting with the joint lining. Niosomal drug delivery system is one of the best examples of great evolution in drug delivery technology. The main composition of niosomes is cholesterol and non-ionic surfactants which act as penetration enhancers. Cholesterol also stabilizes the niosomes membrane. The idea of incorporating drugs into niosomes reduces the toxicity and side effects of the drugs and directs them toward a specific site. Niosomes appear to be a well-preferred drug delivery system over other dosage forms as niosomes are mostly stable in nature and economic. This study describes a more effective and efficient strategy to deliver the drug via the transdermal route at the affected joint area for a prolonged period to treat effectively the inflammation and other associated symptoms or progression of cartilage degradation associated with arthritis.
KEYWORDS: Arthritis, Osteoarthritis, Rheumatoid Arthritis, Niosome.
INTRODUCTION:
ARTHRITIS:
The term “arthritis” is a combinatorial creation made by fusing Latin and Greek. Joint is denoted by “Arthron” in Greek, and inflammation is denoted by “Itis” in Latin. As a result, arthritis is typically thought either acute or chronic inflammation which causes pain in the affected joint along with structural damage. Joint pain could result from harm to the tendons, bursae, or ligaments around the joint. Ligaments may become injured; bones and cartilage make up the joint. Arthritis could harm the joint's cartilage, which could further cause instability. Loss of function of the affected joints, which impacts the patient's quality of life. Numerous conditions, including osteoarthritis (OA), rheumatoid arthritis (RA), joint injury, and others, can cause joint discomfort.1,2
OSTEOARTHRITIS:
It is thought that osteoarthritis (OA) is the most prevalent type of arthritis. It is a joint illness that worsens gradually and causes severe impairment, greatly lowering the quality of life (QOL). The skeletal and muscular components of the musculoskeletal system enable the body to sustain its weight, hold itself in place, and perform precise, regulated movements, all of which aid in movement. It includes bones, muscles, articular cartilage, tendons, and ligaments spine's intervertebral discs. The illnesses that make up the musculoskeletal disorders (MSDs) are quite diverse. can have an impact on the spine, joints, muscles, and bones. MSDs are caused by several elements, such as age, profession, eating habits, and lifestyle, which are impacted by conduct and nutrition.3
The review on osteoarthritis includes etiology, pathophysiology, causes, diagnosis, management, and treatment.
Fig No 1: Comparison of normal and osteoarthritis patients
Etiology:
One common classification for OA is primary or secondary origin. Although the exact cause of primary OA is not well understood, it is most likely a complex etiology involving the interaction of systemic and local components. The genesis of secondary OA degenerative changes that arise from known causes, such as acute or chronic joint trauma, obesity, repetitive motion injuries, muscle dysfunction, inflammatory arthropathies, calcium deposits in the joints, and gout.4
Pathophysiology:
A major factor in the pathophysiology of OA is inflammation, particularly systemic inflammation and active synovitis. A potential rationale is that the degradation of cartilage triggers a foreign body response in the synovial cells. Further degeneration of cartilage may result from the synthesis of metalloproteases, synovial angiogenesis, and inflammatory cytokines. According to some views, the innate immune system and activated synovial macrophages play a major part in the development of osteoarthritis.5
Causes of osteoarthritis:
Trauma, Mechanical Stress, Inflammation, Neurological Disorder, Skeletal Deformities, and Drugs 6
Diagnostic Assessment:
History and physical examination, Radiologic studies of involved joints (e.g., x-ray, CT scan, MRI, bone scan), Synovial fluid analysis 7
Management:
Rest and joint protection, use of assistive devices, Nutritional and weight management counseling, Therapeutic exercise, Complementary and alternative therapies, and Reconstructive joint surgery. 8
Treatment:
Drug Treatment:
Phytoactive treatment:
Hesperidin - Hesperidin, a flavanone glycoside is found in citrus
fruits and is known as vitamin P. It reduced nitric oxide, prostaglandin E2,
and cyclooxygenase-2 expression in interleukin-1β-
stimulated osteoarthritis chondrocytes. It inhibited the inflammatory responses
and activation of the nuclear factor κB signaling pathway and finally was
used as a potent drug for patients having osteoarthritis. 10
Berberine - Berberine is an isoquinoline alkaloid, showing therapeutic activity on many autoimmune diseases including rheumatoid arthritis. It was given through the oral route because its anti-arthritic effect was gut-dependent. 11
Chlorogenic acid - Chlorogenic acid, a phenolic compound, inhibits the inflammatory pathway by regulating the gene expression in arthritis. Chlorogenic acid decreased joint swelling via inhibiting proinflammatory cytokine production and decreasing the histological damage in bone joints of collagen-induced arthritic mice.12
Curcumin - A yellow hydrophobic polyphenol compound derived from the herb Curcuma longa is named Curcumin. It was used in many chronic diseases where it acts by metastasis, inhibition of cell proliferation, interleukin-1β, nuclear factor κB, and tumor necrosis factor α. 13
Bromelain - The active component of the crude extract of the pineapple, Ananus comosus, which is a member of the Bromeliaceae family, is bromelain. In addition to trypsin and rutin, bromelain was utilized to treat osteoarthritis. 14
RHEUMATOID ARTHRITIS:
Fig No 2: Comparison of normal and rheumatoid arthritis patients
A prevalent systemic inflammatory autoimmune illness, rheumatoid arthritis (RA) is characterized by painful, swollen joints that can significantly affect quality of life and physical function. In clinical practice, musculoskeletal pain, edema, and stiffness are common presenting symptoms; therefore, it is important to be knowledgeable about identifying and treating RA. Compared to the general population, RA patients are more susceptible to severe infections, respiratory conditions, osteoporosis, cardiovascular disease, cancer, and death. Recent advances in disease-modifying antirheumatic medication therapy, including early diagnosis, intensive treatment, and larger therapeutic alternatives, have significantly improved the long-term prognosis and management of RA. 15
Signs and symptoms of rheumatoid arthritis may include:
Tender, warm, swollen joints, Joint stiffness that is usually worse in the mornings and after inactivity, Fatigue, fever, and loss of appetite 16
Diagnostic Assessment: History and physical examination, Complete blood cell (CBC) count, Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Antinuclear antibody (ANA), X-ray studies of involved joints, Synovial fluid analysis 17
Management: Nutritional and weight management counseling, Therapeutic exercise, Psychological support, Rest and joint protection, use of assistive devices, Heat and cold applications, Complementary and alternative therapies, and Reconstructive surgery. 18
Treatment:
Drug Treatment:
Vesicular drug delivery system:
Vesicular delivery systems are highly ordered assemblies comprising one or multiple concentric bilayers formulated as an outcome of the self-assembling of amphiphilic building blocks in water. These systems are critically essential for targeted drug delivery because they possess a specific capability to localize drug activity at the organ or site of action, hence reducing the concentration at other body sites.
· Liposomes
· Ethosomes
· Niosomes
· Transferosomes
· Aquasomes21,22
NIOSOMES:
Niosomes are a novel drug delivery system that entrapped non-ionic surfactant vesicles obtained by hydrating a mixture of cholesterol and non-ionic surfactants. It can be used as a carrier of amphiphilic and lipophilic drugs. A vesicle containing the medication is used in the Niosomes drug delivery system. Niosomes have flexible structural characterization and are non-immunogenic, biodegradable, and biocompatible. The particle size of the noisome ranges between 10nm and 100nm. 23
Structure of Niosome:
A typical niosome vesicle would consist of a vesicle forming amphiphilic i.e., a small quantity of an anionic surfactant, like dicetyl phosphate, which also aids in maintaining the vesicle, and a non-ionic surfactant, like Span-60, which is often stabilized by the addition of cholesterol.24
Fig. No 3: Structure of Niosome
Composition of niosomes-
The two main components that go into producing niosomes are,
1. Cholesterol
2. Non-ionic surfactants
1. Cholesterol:
Cholesterol is a steroid derivative, which is used to provide rigidity proper shape, and conformation to the niosomes preparations. The presence of steroids in the cell membrane influences the bilayer's permeability and fluidity, making them essential components of the membrane.
2. Non-ionic surfactants:
The following non-ionic surfactants are usually used in niosome preparation. The hydrophilic head and the hydrophobic tail of the non-ionic surfactants. Every bilayer generates vesicles, or folds over itself as a continuous membrane, to achieve thermodynamic stability. This prevents any exposure to hydrocarbon/water contact.
e.g., the spans are 60, 40, 20, 85, and 80. Between 20, 40, 60, and 80 tweens Brijs (30, 35, 52, 58, 72, and 76).25
Types of Niosome:
Method for Preparation of Niosomes
1. Micro fluidization methods
2. Sonication Method
3. Reverse Phase Evaporation Technique (REV)
4. Trans membranes PH gradient (inside acidic) Drug Uptake Process: or Remote Loading Technique
5. Multiple membrane extrusion method
6. Handshaking method (Thin film hydration technique)
7. Bubble method
8. Ether injection method
1. Micro fluidization Method :
A novel technique for creating unilamellar vesicles with a specified size distribution is called micro fluidization. The submerged jet principle, on which this technique is based, describes how two fluidized streams interact in precisely specified micro channels within the interaction chamber at extremely high velocities. The energy supplied to the system stays inside the region where niosomes form due to the impingement of a thin liquid sheet along a common front. As a result, the niosomes that are produced are more homogenous, smaller, and more reproducible. Niosomes made using this method are more homogeneous, smaller, and repeatable.27
2. Ether Injection Method:
The ether injection method produces niosomes by adding a volatile organic solvent (diethyl ether)-dissolved surfactant solution to warm water maintained at 60°C. The ether-dissolved surfactant solution is injected into the material's aqueous solution using a 14-gauge needle. The process of making single-layered vesicles involves vaporizing ether, a volatile organic solvent.27
3. Sonication Method:
Using this approach, the cholesterol/surfactant mixture is placed in a 10ml glass vial along with an aliquot of drug solution in the buffer. To produce niosomes, the mixture is probe sonicated using a titanium probe sonicator for three minutes at 60°C.
4. Handshaking Method (Thin Film Hydration Technique):
Using a round-bottom flask, the cholesterol and surfactant are dissolved in a volatile organic solvent (diethyl chloroform, methanol, or diethyl). Using a rotary evaporator, the organic solvent is evaporated at room temperature (20°C), leaving behind a thin coating of solid mixture that is deposited on the flask wall. Multilamellar niosomes can be produced by rehydrating the dried surfactant film with aqueous phase at 0–60°C while gently stirring.28
5. Reverse Phase Evaporation Technique (REV):
An organic solvent mixture (ether and chloroform) dissolves cholesterol and surfactant in a 1:1 ratio. After adding the aqueous medication solution, an oil-in-oil emulsion is created, with two phases that are sonicated at 4-5 degrees Celsius. In a rotating evaporator set at 40°C, the emulsion is dried to produce a semisolid gel of large vesicles. Small amounts of phosphate-buffered saline (PBS) are used to sonicate the transparent gel once again. Reduced pressure and 40°C remove the organic phase. Niosomes are produced by diluting a viscous niosomal suspension with phosphate-buffered saline and heating it in a water bath for ten minutes at 60°C.
6. Trans membranes PH gradient (inside acidic) Drug Uptake Process: or Remote Loading Technique:
Chloroform, an organic solvent, is used in the remote loading process to dissolve cholesterol and surfactants. The solvent evaporates at lower pressure, leaving a thin layer on the wall of the round-bottom flask. The film is hydrated with 300 mM citric acid (pH4.0) by vortex mixing. Before being sonicated, multilamellar vesicles undergo three cycles of freezing and thawing. For niosomal suspension, an aqueous solution containing 10 mg/ml of medication is added, and vertexing is done. After adding 1M disodium phosphate, the sample's pH rises to 7.0–7.2. After that, the mixture is heated to 60°C for ten minutes to make.29
7. Multiple membrane extrusion method:
A thin layer is produced using a rotary evaporator with a mixture of surfactant, cholesterol, and dicetyl phosphate in chloroform. The film is hydrated by aqueous drug polycarbonate membranes. After being extruded through a polycarbonate membrane, the suspension and solution are placed in a network of up to eight passages. It is a useful strategy for controlling niosome size.29
8. Bubble method:
Using organic solvents, the "Bubble" Method is a novel approach to arranging liposomes and niosomes in a single phase. A flask with a circular bottom and several additional necks to monitor the water bath's temperature make up a bubbling machine. The third neck of the first and second necks, as well as the nitrogen supply, are used to insert the thermometer and water-cooled reflux. In this buffer (pH 7.4), the cholesterol and surfactant disperse at 70°C. After 15 seconds of mixing with an improved shear homogenizer, the mixture "bubbled" with nitrogen gas at 70°C. 30
Advantages:
1. Targeted drug delivery can be achieved using niosomes where the therapeutic effect is required.
2. Many factors in the body such as enzymes, pH, and other affect the chemical and physical property of the drug, to avoid this niosome formulation are preferred.
3. Surfactants are biodegradable, biocompatible, and non-immunogenic so usually non-allergic.
4. The vesicles can act as a depot to release the drug slowly and offer a controlled release.
5. They increase the stability of the entrapped drug.
Disadvantages
a. Many times, the niosome shows aggregation if the standard method of preparations is not followed.
b. Formulation of niosome is a time-consuming process.
Applications of niosomes
· Niosomes have also been employed as delivery systems for the diagnostic drug iobitridol, which is used in X-ray imaging.
· Niosomes can be used to target drugs towards the reticuloendothelial system.
· Used in Anti-malignant Medication by extending its half-life and circulation.
· Used in Peptide Drug Delivery; the stability of the peptide was shown to be greatly enhanced by the trapping of a vasopressin derivative in niosomes, as demonstrated by an oral delivery method used in an in vitro investigation.31
Some of the research work done on niosomal formulations
|
Researcher |
Year |
Invented Studies |
Conclusion |
|
Choudhary v. et al., |
2023 |
Development and evaluation of hydrocortisone-loaded niosomal gel |
Hydrocortisone-loaded niosomal gels show improved penetration, good homogeneity and enhancement of duration of action. 32
|
|
Zhang w et al., |
2021 |
Optimization of propofol-loaded niosomal gel for transdermal delivery |
Niosomal system to deliver propofol transdermally as an alternative to an invasive route for procedural sedation in pediatric patients.33 |
|
Bhardwaja S. et al., |
2020 |
Development and Characterization of Niosomal Gel System using Lallementia royaleana Benth. mucilage for the treatment of Rheumatoid Arthritis |
The present study suggested that developed topical gel formulation provides enhance permeability and longer duration of drug action over conventional gels.34 |
|
Jamal M. et al., |
2015 |
Transdermal potential and anti-arthritic efficacy of ursolic acid from niosomal gel systems |
The URNF-gel formulation showed better skin permeation and skin absorption than the control formulation. 35 |
|
Goyal M. et al., |
2019 |
Formulation and Evaluation of Itraconazole Niosomal Gel for Topical |
The administration of the drug as a gel-type formulation enhances its penetration and release.36 |
|
Paninder k. et al., |
2018 |
Formulation and evaluation of ketoconazole niosomal gel |
The reverse phase evaporation technique is a useful method for the incorporation of poorly water-soluble drug Ketoconazole into niosomes with high entrapment efficiency.37 |
|
El-Ridy M. et al., |
2017 |
Formulation of Niosomal Gel for Enhanced Transdermal Lornoxicam Delivery: In-Vitro and In-Vivo Evaluation |
niosomal gel enhances the In-vitro and In-vivo absorption in transdermal delivery system |
|
Asthana G. et al., |
2016 |
Etodolac Containing Topical Niosomal Gel: Formulation Development and Evaluation |
Niosomal gel formulation could be the better choice for the delivery of a wide variety of drugs for transdermal administration.39 |
|
Priprem A. et al., |
2016 |
Topical Niosome Gel of Zingiber cassumunar Roxb. Extract for Anti-inflammatory Activity Enhanced Skin Permeation and Stability of Compound D2 |
Topical gel formulas of herbs like Z. cassumunar may require innovative approaches to guarantee product quality.40 |
|
Kumar k. et al., |
2012 |
Proniosomal formulation of curcumin having anti-inflammatory and anti-arthritic activity in different experimental animal models |
Proniosomes offer a versatile vesicle delivery concept with the potential for drug delivery via the transdermal route.41 |
CONCLUSION:
A novel and intriguing drug delivery technique is niosomes. They are drug carriers who help to design an efficient drug delivery system. They offer a great chance to combine medications that are lipophilic, hydrophilic, or both. Improved bioavailability, sustained release, controlled release, long circulation time, reduced dosage regimen, site specificity, and targeted delivery are all advantages of drug encapsulation in niosomes. Niosomes appear to be a better drug delivery system than liposomes because they are more stable and cost-effective. We concluded that niosomes are a very promising vesicular drug delivery technology that can enhance the overall therapeutic effectiveness of medications, based on the benefits mentioned above.
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Received on 08.11.2023 Modified on 09.12.2023
Accepted on 29.12.2023 ©Asian Pharma Press All Right Reserved
Asian J. Res. Pharm. Sci. 2024; 14(2):139-145.
DOI: 10.52711/2231-5659.2024.00021