A Review on Niosome in Ocular Drug Delivery
System and Their Current Approaches
Dimpal R. Sarkar*, Neha D. Naringe, Pankaj Dhapke,
Nitin Padole, Nilakshi Dhoble,
Jagdish R. Baheti
Kamla Nehru College of Pharmacy, Butibori, RTMNU
University, Nagpur, Maharashtra, India – 441108.
*Corresponding Author E-mail:
dimpalsarkar143@gmail.com
ABSTRACT:
The eye is a complicated organ with a number of
defense mechanisms and barriers. The provision of vital medications via the
proper delivery channels and vehicles is crucial because this organ is
susceptible to a variety of infections, hereditary abnormalities, and visual
impairments. Due to low medication absorption, the most popular method of
administration—topical—may not be as effective as it may be. Nanocarrier-based
medication delivery systems of the latest generation are safe, efficient, and
targeted, and they can get beyond restrictions brought on by the intricate
structure of the eye. Nanotechnology actively participates in ophthalmology and
ocular medication delivery systems through a variety of nanoparticles,
including niosomes, liposomes, micelles, dendrimers, and other polymeric
vesicles. Because of their affordability and storage durability,
niosomes—non-ionic surfactant vesicles—are becoming popular nanocarriers in
drug delivery applications. A hydrating mixture of cholesterol and non-ionic surfactants
self-assembles to produce niosomes. As a result, another name for them is
non-ionic surfactant vesicles (NSVs). Niosomes are non-toxic, non-immunogenic,
non-carcinogenic, and biodegradable. The niosome, its nature, preparation
techniques, and niosome-based therapeutic approaches for ocular diseases are
all covered in this review. problems with ocular drug administration, methods
for enhancing ocular bioavailability, uses, benefits and drawbacks, latest
research, and hopes for niosomal drug delivery systems in the future.
KEYWORDS: Niosome, non-ionic surfactant vesicle,
Nanocarriers, Method of Preparation, disease challenges, current approaches.
INTRODUCTION:
The eye is our soul's window. To shield this sensory
organ from its environment, the human eye has a number of defenses and
barriers. Treating ocular illnesses and delivering medications to various eye
compartments are extremely difficult because of this unique structure.
The most common kind of ocular treatment for the
anterior region of the eye, which comprises the conjunctiva, cornea, sclera,
and anterior uvea, is topical eye drops1. This drug delivery method
does have several drawbacks, though. The sorption time for medications while
using eye drops is roughly two to three minutes. As a result, administered
drops are rapidly removed from the eye's surface. Age-related macular degeneration
and diabetic macular edema are examples of posterior segment ocular diseases.
The most frequent causes of blindness and visual impairment are CMV infection,
glaucoma, and proliferative vitreoretinopathy. In certain instances, genetic
disorders may also be the cause of retinal degeneration and the ensuing
blindness2. Intravitreal injections are presented as an alternate
method of drug administration because topical ocular medications encounter
difficulties reaching the posterior regions. However, because the injection is
intrusive, new drug delivery systems must be developed in order to maintain the
medication concentration for longer periods of time and reduce the number of
doses3. In ophthalmology, nanotechnology is useful because it offers
specific carriers that provide new methods of transfer and release, increasing
the effectiveness of medications, and facilitating intracellular delivery4,5.
Anatomy
of Eye and its Barrier:
The most amazing sensory organ is the eye. It is
shielded by blinking, tears, eyelids, and eyelashes. Tears remove the
irritating substances and stop bacterial infections. Three concentric
substrates make up the eye: the fibrous tunic on the outside, the vascular
tunic on the inside, and the middle covering. The cornea and sclera are in the
outermost portion. The iris, ciliary body, and choroid are all part of the
mid-covering known as the uvea (figure 1)6.
Figure 1. Human eye anatomy, and the drug
administration routes.
(1) The cornea as a main route of drug delivery to the
anterior section.
(2) The retinal capillary endothelium and Retinal
pigment epithelium as the main barriers for systemically administered drugs.
(3) An invasive strategy to gain the vitreous called
intravitreal injection.
I.
FIBROUS TUNIC:
The anterior portion of the eye, the pupil, and the
foreside of the iris are all covered by the dome-shaped cornea. From front to
back, the cornea is made up of five layers: the epithelium, stroma, Bowman's
membrane, and Descemet's the endothelium and membrane. The "white of the
eye" is the sclera. It is a thick layer of connective tissue composed of
fibroblasts and collagen fibers.
II. VASCULAR TUNIC:
The colored part of the eye that is visible is called
the iris. Pigment granules found in the iris epithelium absorb light and
lipophilic medications. Aqueous humor generation is the primary function of the
ciliary body. It is the main source of drug-metabolizing enzymes in the eyes,
which are in charge of detoxifying and eliminating drugs from the eyes.
The choroid, which is abundant in blood vessels, lines
the back five-sixths of the sclera's inner surface.
III. RETINA:
The inside component of the eye is called the retina.
The retina uses choroid blood vessels and retinal vessels for oxygenation. When
the retina detects light, it converts it into signals, which are then sent to
the brain via the optic nerve. The anterior and posterior segments make up the
two halves of the human eye. The iris, cornea, aqueous fluid, and lens make up
the anterior region of the eye, which makes up one sixth of the whole eye. The
posterior region of the eye, which comprises the retina, vitreous body, back of
the sclera, and choroid, makes up the remaining five-sixth of the eye7.
The ocular compartment contains numerous obstacles.
The conjunctiva, sclera, and blood-retina barrier are some of the barriers that
divide the eye from the rest of the body. These obstacles make it impossible to
administer ocular medications topically and systemically. In ocular delivery,
there are three main categories of obstacles. Precorneal, static, and dynamic
barriers are the three types. The several layers of the cornea, sclera, and
retina, including the blood-aqueous barrier, make up the static barrier8.
Niosomes as Novel Drug Transport Mechanisms:
Niosome structure:
As seen in Figure 2, it is a bilayered spherical
structure made of cholesterol and non-ionic surfactant. The hydrophobic end of
the non-ionic surfactant is oriented inward, toward the lipophilic phase, in
this case. The closed lipid bi-layer that envelops solutes in the aqueous
phase, on the other hand, is created when the hydrophilic end faces outward
(toward the aqueous phase). This bi-layer resembles the outer and inner
surfaces of the hydrophilic area, sandwiched between them by the lipophilic
area 9,10. Based on the size of a vesicle, niosomes are divided into
three types, as illustrated in Figure 3 and Table 1.
Figure 2: Schematic representation of structure of
Niosome 11
Table
1: Types of Niosomes 12
|
Sr. No
|
Types
|
Size
|
|
1
|
Small unilamellar vesicle
|
0.025-0.05
|
|
2
|
Large unilamellar vesicle
|
≥ 0.05 µm
|
|
3
|
Multi lamellar vesicle
|
≥ 0.10 µm
|
Figure 3. Typical vesicle size of niosomes.
Classification:
Niosomes are divided into three groups according to
their size and number of bilayers (shown in figure 3)13:
a) Small Unilamellar Vesicles (SUV):
· It can be made from multilamellar vesicles
using the French press, extrusion, and sonication methods.
b) Large Unilamellar Vesicles (LUV):
· Due to their high aqueous/lipid compartment
ratio, large unilamellar vesicles (LUV) have the ability to entrap a greater
volume of bioactive molecules.
c) Multi Lamellar Vesicles (MLV):
· The most often utilized niosomes are called
Multi Lamellar Vesicles (MLV), which have several bilayers.
· With a diameter ranging from 0.5 to 10 µm,
MLVs are easy to produce and exhibit mechanical stability for an extended
period of storage14.
Advantages
of niosomes15:
i. Niosomes are reasonably priced.
ii. More stable than liposomes due to the
presence of phospholipids, which are readily oxidized in liposomes.
iii. They improve the stability of the entrapped medication
and are osmotically stable and active.
iv. They improve the medicines' skin
penetration.
v. Serve as a depot and release the medication
in a regulated way.
vi. Make medications that are poorly absorbed
more bioavailable orally.
vii. The surfactants in niosomes can be handled without any
particular conditions.
viii.It has the
ability to capture hydrophilic and lipophilic
medications.
The advantages of niosomes compared to other
nanoencapsulation technologies are16:
i. Compared to phospholipids in liposomes,
surfactants are more stable in niosomes.
ii. Only a straightforward preparation process
and large-scale manufacturing are needed.
iii. The cost of producing niosomes is low because the
equipment and excipients needed are inexpensive.
iv. More stable than liposomes at normal
temperature.
v. Have an extended shelf life.
Disadvantages of niosomes:
i. Treatment does not end immediately when
sustained release medicine is administered.
ii. The doctor's ability to modify the dosing
schedule is limited.
iii. Time-intensive.
iv. Specialized machinery was needed for
production.
v. It causes the contained medication to
release.
Composition of niosomes
·
The essential
components are
I.
Cholesterol
II. Non-ionic surfactants
III. Other Additives
I. Cholesterol:
The most prevalent additions in niosomal systems are
cholesterol and its derivatives. It is a waxy metabolite of steroids that is
present in cell membranes. It creates the vesicles, increases stability, and
lessens agglomeration when non-ionic surfactants are used. Additionally, it
adds stiffness to niosome formation and orientational order to the niosomal
bilayer17.
II. Non-ionic surfactants:
It has a hydrophobic tail and a hydrophilic head
group. It is the primary element involved in the production of niosomes. The
hydrophobic moiety is made up of one stearyl group, one fluro group, or two or
three alkyl chains. When entrapped in water-soluble surfactants like Tween 20,
Tween 80, etc., niosomes exhibit improved ocular bioavailability because the
surfactants function as penetration enhancers, assisting in the removal of the
mucus layer and the disruption of junctional complexes 18.
Commonly used surfactants include Tweens, which come
in Tween 20, Tween 40, Tween 60, and Tween 80, as well as span, which comes in
a variety of grades, including span 20, span 40, span 60, span 80, and span 85.
Other surfactants that are utilized include polysorbates, ether-linked,
di-alkyl-chain, ester-linked, and sorbitan esters19.
III. Other additives:
Charge inducers are primarily crucial to the formation
of niosomes. It stops vesicles from flocculating, aggregating, and fusing while
also raising the surface charge density. Diacetyl phosphate (DCP), which has a
negative charge, and stearylamine (SA), which has a positive charge, are often
employed charge inducers20.
METHOD
FOR THE PREPARATION OF NIOSOMES:
The general approach primarily entails the evaporation
of organic solvents, which forms a lipid film, and hydration, which produces
niosomes. There are several approaches to the preparation:
A.
FORMULATION OF LARGE UNILAMELLAR VESICLES:
1.ETHER
INJECTION METHOD:
Lipids are injected or introduced gradually to create
vesicles. This involves placing cholesterol and non-ionic surfactants in a
beaker with warm water and keeping the temperature at 60ºC (figure 4). Here,
the phosphate buffer is an aqueous solution. Using a 14-gauge needle, ether
containing the drug solution is gradually added to the aqueous solution. The
ether is then vaporized, resulting in the creation of single-layered niosome
vesicles. The size range of niosomes is 50–1000nm. The primary drawback of this
approach is the difficulty in eliminating the trace amount of ether present in
the vesicle suspension21.
Figure-4: Ether injection method
Figure-5:
Ethanol Injection Method.
Figure 6. Schematic representation of reverse-phase
evaporation method.
Figure 7: Thin film hydration (hand shaking) method.
2. ETHANOL
INJECTION METHOD:
This approach involves gently injecting the medication
in ethanol, cholesterol, stearic acid, and surfactant into a heated aqueous
phase using a needle (see figure 5). The ethanol solvent is then gradually
evaporated, creating an ethanol gradient across the cholesterol and surfactant
layer at the ethanol-water interface that leads to the production of vesicles 22.
3. REVERSE
PHASE EVAPORATION (REV) METHOD:
This process uses evaporation to remove
the volatile organic solvent. Add cholesterol and surfactant to the ether and
chloroform mixture in an equal ratio, or 1:1. The drug-containing aqueous phase
is added to the solution above, and the two phases that result are sonicated
for a short while. After that, phosphate buffer saline is added, and sonication
creates a transparent gel. Evaporation removes the organic phase at low
pressure.
Niosomes are formed by heating the
obtained solution on a water bath at the ideal temperature of 45ºC for 10
minutes after further diluting it with phosphate buffer saline 23.
B. FORMULATION OF MULTI LAMELLAR VESICLES:
4. THIN FILM HYDRATION METHOD (HAND SHAKING
METHOD):
Non-ionic surfactant and membrane stabilizer lipid are
combined with organic solvents such as diethyl ether, methanol, and chloroform
in a round-bottom flask. A thin layer of solid mixture is then formed on the
flask's circular bottom wall as a result of the volatile solvent's evaporation.
The film rehydrates when the solvent is added while
being gently stirred. Multi-lamellar vesicles are created using this technique 24.
5. TRANS
MEMBRANE PH GRADIENT PROCESS:
Lipid mixture was dissolved in the organic solvent,
resulting in a lipid film on the flask's round bottom wall. When this is
combined with strong agitation, an acid such as citric acid is added, which
hydrates the films and creates multi-lamellar vesicles. These are subjected to
sonication and the freeze-thaw cycle. After that, an agitated API aqueous
solution was added. Disodium phosphate was used to elevate the pH of the
mixture. Niosomes are then produced by heating the mixture to 65°C 24.
C.FORMULATION OF SMALL UNILAMELLAR VESICLES:
6. SONICATION
METHOD:
It is a standard method for creating niosome vesicles.
Using this approach, a 10-ml glass vial containing the medication, surfactant,
and cholesterol is combined with buffer. The mixture was sonicated for
approximately three minutes using a titanium probe, which produced noise 25.
7. MICRO
FLUIDIZATION:
The jet principle was applied to the creation of
niosmes. Vesicles are created when the lipid and aqueous phases contact quickly
25.
|
Figure 8: Schematic representation of the preparation
of niosomes via transmembrane pH gradient Process.
|
Figure 9: Schematic representation of Sonication.
|
Figure 10: Schematic representation of Micro
Fluidization.
8. MULTIPLE
MEMBRANE EXTRUSION METHOD:
Di-acetyl phosphate, cholesterol, and a non-ionic
surfactant were dissolved in chloroform and then evaporated. causes the aqueous
phase to hydrate when a thin layer is formed. A suspension of niosomes is
transported through a polycarbonate membrane 26.
Figure 11. Schematic representation of the preparation
of niosomes via multiple membrane extrusion method.
9.BUBBLE
METHOD:
This technique uses a round-bottom flask with three neck
sections. One each for the nitrogen supply input, thermometer, and reflux.
After being dissolved in phosphate buffer saline, the lipid mixture was put
through a high pressure homogenizer. The vesicle is then produced by supplying
nitrogen gas at 65–70°C, which causes bubbles to form26.
Figure 12: Schematic representation of Bubble method.
Niosome
based treatment strategies in ocular diseases:
1.Glaucoma:
It is a neurological condition that needs lifelong care. It
is classified as an optic neuropathy and is typified by the apoptotic death of
retinal ganglion cells (RGCs), which causes nerve axon degeneration and
abnormalities in the visual field. Different forms of glaucoma exist. The most
significant factor influencing the prognosis of Primary Open Angle Glaucoma is
elevated intraocular pressure (IOP) brought on by a buildup of aqueous humor in
the anterior chamber as a result of either an obstruction in the drainage
system or an excess of fluid production. Elevated IOP causes an imbalance in
the blood flow to the retina, which results in optic nerve degeneration. The
primary goal of treatment is to lower intraocular pressure using a variety of
techniques, such as medication, laser therapy, and surgery.
The drug delivery systems used to treat glaucoma are called
niosomes. Niosomes have numerous benefits in drug delivery, including reduced
ocular toxicity, prolonged IOP-lowering action, increased corneal penetration,
and less frequent administration27.
1. Conjunctivitis:
The inflammation or infection of the conjunctiva, the
transparent mucous membrane found in the sclera, is known as conjunctivitis.
There are several varieties of conjunctivitis, including bacterial, viral, and
allergic conjunctivitis, which can be either acute or chronic. Bacterial,
viral, fungal, parasitic, and chlamydial conjunctivitis are all considered
infectious conjunctivitis. Allergens, irritants, and toxins are the causes of
non-infectious conjunctivitis. Antibiotics, antifungals (polyenes, azoles, imidazoles,
triazoles, pyrimidines, and echinocandins), and antivirals (aciclovir,
trifluridine, and valaciclovir) are the main treatments applied topically. For
some time now, researchers have been looking into nanotechnological
formulations to boost the effectiveness of these medications. Niosomes have
been identified as the most effective ocular medication carriers, releasing the
drug in a consistent and predictable fashion28.
3.
Retinal diseases:
Retinal degeneration is the outcome of a variety of
conditions known as inherited retinal diseases (IRD). IRD is caused by gene
alterations that happened in the inner retinal layer. mutations expressed in
the retinal pigment epithelium (RPE) or photoreceptor in the majority of
instances. A new cationic niosome has been developed for use in retinal gene
delivery, and research into retinal gene delivery using niosome carriers for
non-viral vectors has been conducted29.
4.
Keratitis:
It is one of the main causes of blindness in the globe and
is caused by inflammation in the cornea brought on by infections with bacteria,
fungi, and viruses. Similar eye symptoms, including redness, discomfort,
blurred vision, and tearing, are displayed by patients. Numerous noisome
formulations were created and assessed, and they show prolonged drug release30.
Future
Prospects of niosomes:
One possible medication delivery mechanism is niosomes.
Niosomes have been effectively employed as a medication carrier during the past
thirty years to address biopharmaceutical issues such adverse effects, low
chemical stability, and insolubility of medications. Toxic anticancer,
anti-inflammatory, anti-infective, anti-AIDS, and antiviral medications, among
others, can be encapsulated in niosomes to improve bioavailability and
targeting qualities while lowering drug toxicity and adverse effects. Niosome
handling and storage don't require any particular circumstances. Niosomal drug
carriers are safer than ionic ones, which are more toxic and unstable.
Challenges
in Ocular Drug Delivery:
§ Limited Drug
Absorption: The corneal epithelium, conjunctiva, and sclera are among
the protective layers of the ocular surface that restrict medication
absorption.
§ Short Retention
Time: The therapeutic impact of drugs given topically is
diminished because tears quickly wash them away.
§ Low
Bioavailability: Ocular obstacles may cause
medications to have low bioavailability at the target site, even with
controlled-release formulations.
Current
approaches of ocular drug delivery system:
By delivering therapeutic agents straight to the eye,
ocular drug delivery devices (ODDS) minimize systemic side effects while
guaranteeing that the medication reaches the intended location. Because of its
architecture and physiology, the eye poses special difficulties, such as the
corneal epithelium, blood-aqueous barrier, blood-retinal barrier, and the short
half-life of medication formulations. In order to improve drug delivery to the
ocular tissues, a number of strategies are being developed, particularly for
the treatment of conditions like glaucoma, diabetic retinopathy, age-related
macular degeneration (AMD), uveitis, and ocular infections.
Approaches in ophthalmic drug delivery systems:
A number of approaches have been used in
the early stages for better results. These approaches, categorized into two
types, are:
·
Bioavailability
improvement and
·
Controlled release drug
delivery
Viscosity and penetration enhancers, prodrugs, gels, and
liposomes are used in the first category to optimize corneal medication
absorption and reduce precorneal drug loss. The second one uses a sustained
delivery mechanism, such as implants, inserts, nanoparticles, microparticles,
and colloids, to administer the active ophthalmic component in a regulated and
continuous manner. Traditional methods that increase bioavailability include
viscosity enhancers, gel, penetration enhancers, prodrugs, and liposomes. On
the other hand, more recent innovations like ocuserts, nanosuspension,
nanoparticles, liposomes, niosomes, and implants increase both bioavailability
and controlled drug release in the anterior segment of the eye. In the back
part of
Drugs enter the eye through periocular pathways,
subconjunctival injections, iontophoresis, and intravitreal injections31,32.
Approaches
to improve ocular bioavailability:
Use of viscosity enhancers:
Due to their ability to increase viscosity and,
consequently, the drug's penetration into the anterior chamber of the eye by
decreasing the rate of elimination from the preocular area, resulting in an
increase in precorneal residence time and transcorneal penetration,
viscosity-increasing polymers are highly preferred additives in ophthalmic
formulations. However, their effects on improving bioavailability in humans are
negligible. Polymers include methylcellulose, hydroxylethylcellulose,
hydroxylpropyl methylcellulose (HPMC), hydroxypropyl cellulose, polyvinyl
alcohol (PVA), and polyvinylpyrrolidone (PVP)33.
Gel formulation:
Gels exhibit stiffness in the
steady-state and are known to be highly diluted cross-linked systems. Although
gels are typically liquids, their three-dimensional cross-linked structure
within the liquid causes them to behave like solids34.
Niosomes and discosomes:
Drugs that are hydrophobic or amphiphilic may be delivered
using niosomes, which are non-ionic surfactant vesicles. Chemical instability,
oxidative phospholipid breakdown, and the price and purity of natural
phospholipids are the main drawbacks of liposomes. Because they can entrap both
hydrophobic and hydrophilic medicines and are more chemically stable than
liposomes, niosomes were created to circumvent this. They don't need specific
handling methods and are non-toxic35. When compared to timolol
maleate solution, Vyas and colleagues found that the ocular bioavailability of
timolol maleate encapsulated in niosomes was approximately 2.49 times higher. Not ionic Timolol maleate-loaded discoidal vesicles, or
"discomes," based on surface-active compounds were created and
evaluated for their in vivo characteristics. According to in vivo research, if
the medication was loaded using a pH gradient approach, the contents of the
discomes were released in a biphasic profile35.
CONCLUSION:
Niosomes are a new and effective method of medication
administration since they are non-ionic surfactant vesicles. The use of
niosomes for ocular medication delivery has advanced significantly in recent
years. Non-ionic surfactant and cholesterol can be used to encapsulate a
variety of medications into niosomes. Niosomes have improved stability, lessen
harmful effects, and allow continuous release of the chemical they contain.
Niosomes don't require any particular handling or storage conditions, unlike other
drug delivery systems like liposomes. In conclusion, niosomes are a very useful
tool for medication delivery in the treatment of many different disorders.
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