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Niosomes
INTRODUCTION
 Niosomes are a novel drug delivery system, in
which the medication is encapsulated in a
vesicle.
 Niosomes are non-ionic surfactant vesicles
obtained on hydration of synthetic nonionic
surfactants, with or without incorporation of
cholesterol or other lipids.
 They are vesicular systems similar to
liposomes that can be used as carriers of
amphiphilic and lipophilic drugs
 The niosomes are very small, and microscopic in size.
Their size lies in the nanometric scale.
 Niosomes are unilamellar or multilamellar vesicles.The
vesicle is composed of a bilayer of non-ionic surface active
agents and hence the name niosomes.
 Materials used to form niosomes are
 sucrose ester surfactants
 polyoxyethylene alkyl ether surfactants,
 alkyl ester,
 alkyl amides,
 fatty acids and amino acid compound.
 Structure of Niosomes :
 Niosomes are microscopic lamellar structures which are
formed on the admixture of non-ionic surfactant of the alkyl
or dialkyl polyglycerol ether class and cholesterol with
subsequent hydration in aqueous media.
 The bilayer in the case of niosomes is made up of non-
ionic surface active agents rather than phospholipids as
seen in the case of liposomes.
 Most surface active agents when immersed in
water yield micellar structures, however some
surfactants can yield bilayer vesicles which are
niosomes.
 Niosomes may be unilamellar or multilamellar depending
on the method used to prepare them.
 The niosome is made of a surfactant bilayer with its
hydrophilic ends exposed on the outside and inside of the
vesicle, while the hydrophobic chains face each other
within the bilayer.
 Hence, the vesicle holds hydrophilic drugs within the space
enclosed in the vesicle, while hydrophobic drugs are
embedded within the bilayer itself.
 Niosomes are microscopic lamellar
structures formed on admixture of non-
ionic surfactant and cholesterol with
subsequent hydration in aqueous media.
 Cholesterol manipulate and ameliorate
the bilayer of vesicles
Advantages
 vesicle suspension being water based
offers greater patient compliance over oil
based systems
 Accommodate drug molecules with a wide
range of solubilities.
 Characteristics of the vesicle formulation
are variable and controllable
 Biodegradable, biocompatible and
nonimmunogenic.
.
 The characteristics such as size, lamellarity etc.
of the vesicle can be varied depending on the
requirement.
 The vesicles can act as a depot to release the
drug slowly and of controlled release.
 They increase the stability of the entrapped drug
 Handling and storage of surfactants do not
require any special conditions
 Can increase the oral bioavailability of drugs
 Can enhance the skin penetration of drugs
 They can be used for oral, parenteral as well
topical use
 Improve the therapeutic performance of the drug
by protecting it from the biological environment
and restricting effects to target cells, thereby
reducing the clearance of the drug.
 Comparison of Niosomes v/s Liposomes :
 Niosomes are different from liposomes in that
they offer certain advantages over liposomes.
 Liposomes face problems such as –
 they are expensive
 their ingredients like phospholipids are chemically
unstable because of their predisposition to
oxidative degradation
 they require special storage and handling and
purity of natural phospholipids is variable.
 since niosomes are made of uncharged single-
chain surfactant molecules as compared to the
liposomes which are made from neutral or
charged double chained phospholipids, the
structure of niosomes is different from that of
liposomes.
 However Niosomes are similar to liposomes in
functionality. Niosomes also increase the
bioavailability of the drug and reduce the
clearance like liposomes.
Method of preparation
 A. Ether injection method.
 slowly introducing a solution of surfactant dissolved in
diethyl ether into warm water maintained at 60°C.
 The surfactant mixture in ether is injected through 14-
gauge needle into an aqueous solution of material.
 Vaporization of ether leads to formation of single
layered vesicles.
 Depending upon the conditions used, the diameter of
the vesicle range from 50 to 1000 nm
 B. Hand shaking method (Thin film hydration
technique).
 The mixture of vesicles forming ingredients like
surfactant and cholesterol are dissolved in a
volatile organic solvent (diethyl ether, chloroform
or methanol) in a round bottom flask.
 The organic solvent is removed at room
temperature (20°C) using rotary evaporator
leaving a thin layer of solid mixture deposited on
the wall of the flask.
 The dried surfactant film can be rehydrated with
aqueous phase at 0-60°C with gentle agitation.
 This process forms typical multilamellar
niosomes.
 C.Sonication.
 A typical method of production of the vesicles is by
sonication of solution.
 In this method an aliquot of drug solution in buffer is
added to the surfactant/cholesterol mixture in a 10-ml
glass vial.
 The mixture is probe sonicated at 60°C for 3 minutes
using a sonicator with a titanium probe to yield
niosomes.
 D. Micro fluidization.
 Micro fluidization is a recent technique used to prepare
unilamellar vesicles of defined size distribution.
 This method is based on submerged jet principle in which
two fluidized streams interact at ultra high velocities, in
precisely defined micro channels within the interaction
chamber.
 The impingement arranged such that the energy supplied
to the system remains within the area of niosomes
formation.
 The result is a greater uniformity, smaller size and better
reproducibility of niosomes formed
 E. Multiple membrane extrusion method.
 Mixture of surfactant, cholesterol and dicetyl phosphate in
chloroform is made into thin film by evaporation.
 The film is hydrated with aqueous drug solution and the
resultant suspension extruded through polycarbonate
membranes, which are placed in series for upto 8
passages.
 It is a good method for controlling niosome size.
 F. Reverse Phase Evaporation Technique (REV).
• Cholesterol and surfactant (1:1) are dissolved in a mixture
of ether and chloroform.
• An aqueous phase containing drug is added to this
• the resulting two phases are sonicated at 4-5°C.
• organic phase is removed at 40°C under low pressure
• The resulting viscous niosome suspension is diluted with
PBS and heated on a water bath at 60°C for 10 min to
yield niosomes
 G. Trans membrane pH gradient Drug Uptake Process.
 Surfactant and cholesterol are dissolved in chloroform.
 The solvent is then evaporated under reduced pressure to
get a thin film on the wall of the round bottom flask.
 The film is hydrated with 300 mM citric acid (pH 4.0) by
vortex mixing.
 The multilamellar vesicles are frozen and thawed
3 times and later sonicated.
 To this niosomal suspension, aqueous solution
containing 10 mg/ml of drug is added and
vortexed.
 The pH of the sample is then raised to 7.0-7.2
with 1M disodium phosphate.
 This mixture is later heated at 60°C for 10
minutes to give niosomes.
 H. The “Bubble” Method.
 It is novel technique for the one step preparation
of liposomes and niosomes without the use of
organic solvents.
 The bubbling unit consists of round-bottomed
flask with three necks positioned in water bath to
control the temperature.
 Water-cooled reflux and thermometer is
positioned in the first and second neck and
nitrogen supply through the third neck.
 Cholesterol and surfactant are dispersed
together in this buffer (pH 7.4) at 70°C, the
dispersion mixed for 15 seconds with high shear
homogenizer and immediately afterwards
“bubbled” at 70°C using nitrogen gas.
 I. Niosomes from Proniosomes.
 To create proniosomes, a water soluble carrier
such as sorbitol is first coated with the surfactant.
 The coating is done by preparing a solution of the
surfactant with cholesterol in a volatile organic
solvent, which is sprayed onto the powder of
sorbitol kept in a rotary evaporator.
 The evaporation of the organic solvent yields a
thin coat on the sorbitol particles.
 The resulting coating is a dry formulation in which a
water soluble particle is coated with a thin film of dry
surfactant.
 This preparation is termed Proniosome.
 The niosomes can be prepared from the proniosomes
by adding the aqueous phase with the drug to the
proniosomes with brief agitation at a temperature
greater than the mean transition phase temperature of
the surfactant.
Separation of Un entrapped Drug
1. Dialysis
The aqueous niosomal dispersion is dialyzed in a
dialysis tubing against phosphate buffer or normal
saline or glucose solution.
2. Gel Filtration
The unentrapped drug is removed by gel filtration of
niosomal dispersion through a Sephadex-G-50
column and elution with phosphate buffered saline or
normal saline.
3. Centrifugation
The niosomal suspension is centrifuged and the
supernatant is separated. The pellet is washed and
then resuspended to obtain a niosomal suspension
free from unentrapped drug.
 CHARACTERIZATION OF NIOSOMES :
 a) Entrapment efficiency
 After preparing niosomal dispersion, unentrapped
drug is separated by dialysis, centrifugation, or
gel filtration as described above
 and the drug remained entrapped in niosomes is
determined by complete vesicle disruption using
50% n-propanol or 0.1% Triton X-100 and
analysing the resultant solution by appropriate
assay method for the drug.
 Entrapment efficiency = (Amount entrapped /total
amount) x 100
 b) Vesicle diameter/ Vesicle Morphology :
Niosomes, similar to liposomes, assume spherical
shape and so their diameter can be determined
using
• Light Microscopy
• Photon Correlation Microscopy
• Freeze Fracture Electron Microscopy
• Confocal laser scanning Microscopy
• SEM
• TEM
 c) In-vitro release studies.
 dialysis tubing.
 A dialysis sac is washed and soaked in distilled water.
 The vesicle suspension is pipetted into a bag made
up of the tubing and sealed.
 The bag containing the vesicles is placed in 200 ml of
buffer solution in a 250 ml beaker with constant
shaking at 25°C or 37°C.
 At various time intervals, the buffer is analyzed for
the drug content by an appropriate assay method
Applications
1) Targeting of bioactive agents
a) To reticulo-endothelial system
b) To organs other than RES
2) Neoplasia
Doxorubicin Niosomal delivery of Doxorubicin to mice
bearing tumor increased their life span and decreased
the rate of proliferation of sarcoma
3) Leishmaniasis –stilbogluconate preparations
4) Delivery of peptide drugs
Oral delivery of 9-desglycinamide, 8-arginine
vasopressin entrapped in niosomes increase stability of
peptide significantly.
5) Immunological application of niosomes
enhance the antibody production in response to
bovine serum albumin
6) Niosomes as carriers for Hemoglobin
7) Transdermal delivery of drugs by niosomes
e.g. erythromycin
8. Niosomes in oncology – methotrixate formulations
 9) Other Applications
a) Sustained Release b) Localized Drug Action
10. Diagnostic imaging
11. Oral drug delivery – ergot alkaloids
Conclusion
 The concept of incorporating the drug into niosomes
for a better targeting of the drug at appropriate
tissue destination .
 They presents a structure similar to liposome and
hence they can represent alternative vesicular
systems with respect to liposomes
 Niosomes are thoughts to be better candidates drug
delivery as compared to liposomes due to various
factors like cost, stability etc.
 Various type of drug deliveries can be possible
using niosomes like targeting, ophthalmic, topical,
parentral, etc.

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Niosomes

  • 2. INTRODUCTION  Niosomes are a novel drug delivery system, in which the medication is encapsulated in a vesicle.  Niosomes are non-ionic surfactant vesicles obtained on hydration of synthetic nonionic surfactants, with or without incorporation of cholesterol or other lipids.  They are vesicular systems similar to liposomes that can be used as carriers of amphiphilic and lipophilic drugs
  • 3.  The niosomes are very small, and microscopic in size. Their size lies in the nanometric scale.  Niosomes are unilamellar or multilamellar vesicles.The vesicle is composed of a bilayer of non-ionic surface active agents and hence the name niosomes.  Materials used to form niosomes are  sucrose ester surfactants  polyoxyethylene alkyl ether surfactants,  alkyl ester,  alkyl amides,  fatty acids and amino acid compound.
  • 4.  Structure of Niosomes :  Niosomes are microscopic lamellar structures which are formed on the admixture of non-ionic surfactant of the alkyl or dialkyl polyglycerol ether class and cholesterol with subsequent hydration in aqueous media.  The bilayer in the case of niosomes is made up of non- ionic surface active agents rather than phospholipids as seen in the case of liposomes.  Most surface active agents when immersed in water yield micellar structures, however some surfactants can yield bilayer vesicles which are niosomes.
  • 5.  Niosomes may be unilamellar or multilamellar depending on the method used to prepare them.  The niosome is made of a surfactant bilayer with its hydrophilic ends exposed on the outside and inside of the vesicle, while the hydrophobic chains face each other within the bilayer.  Hence, the vesicle holds hydrophilic drugs within the space enclosed in the vesicle, while hydrophobic drugs are embedded within the bilayer itself.
  • 6.  Niosomes are microscopic lamellar structures formed on admixture of non- ionic surfactant and cholesterol with subsequent hydration in aqueous media.  Cholesterol manipulate and ameliorate the bilayer of vesicles
  • 7. Advantages  vesicle suspension being water based offers greater patient compliance over oil based systems  Accommodate drug molecules with a wide range of solubilities.  Characteristics of the vesicle formulation are variable and controllable  Biodegradable, biocompatible and nonimmunogenic.
  • 8. .  The characteristics such as size, lamellarity etc. of the vesicle can be varied depending on the requirement.  The vesicles can act as a depot to release the drug slowly and of controlled release.  They increase the stability of the entrapped drug  Handling and storage of surfactants do not require any special conditions  Can increase the oral bioavailability of drugs
  • 9.  Can enhance the skin penetration of drugs  They can be used for oral, parenteral as well topical use  Improve the therapeutic performance of the drug by protecting it from the biological environment and restricting effects to target cells, thereby reducing the clearance of the drug.
  • 10.  Comparison of Niosomes v/s Liposomes :  Niosomes are different from liposomes in that they offer certain advantages over liposomes.  Liposomes face problems such as –  they are expensive  their ingredients like phospholipids are chemically unstable because of their predisposition to oxidative degradation  they require special storage and handling and purity of natural phospholipids is variable.
  • 11.  since niosomes are made of uncharged single- chain surfactant molecules as compared to the liposomes which are made from neutral or charged double chained phospholipids, the structure of niosomes is different from that of liposomes.  However Niosomes are similar to liposomes in functionality. Niosomes also increase the bioavailability of the drug and reduce the clearance like liposomes.
  • 12. Method of preparation  A. Ether injection method.  slowly introducing a solution of surfactant dissolved in diethyl ether into warm water maintained at 60°C.  The surfactant mixture in ether is injected through 14- gauge needle into an aqueous solution of material.  Vaporization of ether leads to formation of single layered vesicles.  Depending upon the conditions used, the diameter of the vesicle range from 50 to 1000 nm
  • 13.  B. Hand shaking method (Thin film hydration technique).  The mixture of vesicles forming ingredients like surfactant and cholesterol are dissolved in a volatile organic solvent (diethyl ether, chloroform or methanol) in a round bottom flask.  The organic solvent is removed at room temperature (20°C) using rotary evaporator leaving a thin layer of solid mixture deposited on the wall of the flask.
  • 14.  The dried surfactant film can be rehydrated with aqueous phase at 0-60°C with gentle agitation.  This process forms typical multilamellar niosomes.
  • 15.  C.Sonication.  A typical method of production of the vesicles is by sonication of solution.  In this method an aliquot of drug solution in buffer is added to the surfactant/cholesterol mixture in a 10-ml glass vial.  The mixture is probe sonicated at 60°C for 3 minutes using a sonicator with a titanium probe to yield niosomes.
  • 16.  D. Micro fluidization.  Micro fluidization is a recent technique used to prepare unilamellar vesicles of defined size distribution.  This method is based on submerged jet principle in which two fluidized streams interact at ultra high velocities, in precisely defined micro channels within the interaction chamber.  The impingement arranged such that the energy supplied to the system remains within the area of niosomes formation.  The result is a greater uniformity, smaller size and better reproducibility of niosomes formed
  • 17.  E. Multiple membrane extrusion method.  Mixture of surfactant, cholesterol and dicetyl phosphate in chloroform is made into thin film by evaporation.  The film is hydrated with aqueous drug solution and the resultant suspension extruded through polycarbonate membranes, which are placed in series for upto 8 passages.  It is a good method for controlling niosome size.
  • 18.  F. Reverse Phase Evaporation Technique (REV). • Cholesterol and surfactant (1:1) are dissolved in a mixture of ether and chloroform. • An aqueous phase containing drug is added to this • the resulting two phases are sonicated at 4-5°C. • organic phase is removed at 40°C under low pressure • The resulting viscous niosome suspension is diluted with PBS and heated on a water bath at 60°C for 10 min to yield niosomes
  • 19.  G. Trans membrane pH gradient Drug Uptake Process.  Surfactant and cholesterol are dissolved in chloroform.  The solvent is then evaporated under reduced pressure to get a thin film on the wall of the round bottom flask.  The film is hydrated with 300 mM citric acid (pH 4.0) by vortex mixing.
  • 20.  The multilamellar vesicles are frozen and thawed 3 times and later sonicated.  To this niosomal suspension, aqueous solution containing 10 mg/ml of drug is added and vortexed.  The pH of the sample is then raised to 7.0-7.2 with 1M disodium phosphate.  This mixture is later heated at 60°C for 10 minutes to give niosomes.
  • 21.  H. The “Bubble” Method.  It is novel technique for the one step preparation of liposomes and niosomes without the use of organic solvents.  The bubbling unit consists of round-bottomed flask with three necks positioned in water bath to control the temperature.
  • 22.  Water-cooled reflux and thermometer is positioned in the first and second neck and nitrogen supply through the third neck.  Cholesterol and surfactant are dispersed together in this buffer (pH 7.4) at 70°C, the dispersion mixed for 15 seconds with high shear homogenizer and immediately afterwards “bubbled” at 70°C using nitrogen gas.
  • 23.  I. Niosomes from Proniosomes.  To create proniosomes, a water soluble carrier such as sorbitol is first coated with the surfactant.  The coating is done by preparing a solution of the surfactant with cholesterol in a volatile organic solvent, which is sprayed onto the powder of sorbitol kept in a rotary evaporator.  The evaporation of the organic solvent yields a thin coat on the sorbitol particles.
  • 24.  The resulting coating is a dry formulation in which a water soluble particle is coated with a thin film of dry surfactant.  This preparation is termed Proniosome.  The niosomes can be prepared from the proniosomes by adding the aqueous phase with the drug to the proniosomes with brief agitation at a temperature greater than the mean transition phase temperature of the surfactant.
  • 25.
  • 26. Separation of Un entrapped Drug 1. Dialysis The aqueous niosomal dispersion is dialyzed in a dialysis tubing against phosphate buffer or normal saline or glucose solution. 2. Gel Filtration The unentrapped drug is removed by gel filtration of niosomal dispersion through a Sephadex-G-50 column and elution with phosphate buffered saline or normal saline. 3. Centrifugation The niosomal suspension is centrifuged and the supernatant is separated. The pellet is washed and then resuspended to obtain a niosomal suspension free from unentrapped drug.
  • 27.  CHARACTERIZATION OF NIOSOMES :  a) Entrapment efficiency  After preparing niosomal dispersion, unentrapped drug is separated by dialysis, centrifugation, or gel filtration as described above  and the drug remained entrapped in niosomes is determined by complete vesicle disruption using 50% n-propanol or 0.1% Triton X-100 and analysing the resultant solution by appropriate assay method for the drug.
  • 28.  Entrapment efficiency = (Amount entrapped /total amount) x 100
  • 29.  b) Vesicle diameter/ Vesicle Morphology : Niosomes, similar to liposomes, assume spherical shape and so their diameter can be determined using • Light Microscopy • Photon Correlation Microscopy • Freeze Fracture Electron Microscopy • Confocal laser scanning Microscopy • SEM • TEM
  • 30.  c) In-vitro release studies.  dialysis tubing.  A dialysis sac is washed and soaked in distilled water.  The vesicle suspension is pipetted into a bag made up of the tubing and sealed.  The bag containing the vesicles is placed in 200 ml of buffer solution in a 250 ml beaker with constant shaking at 25°C or 37°C.  At various time intervals, the buffer is analyzed for the drug content by an appropriate assay method
  • 31. Applications 1) Targeting of bioactive agents a) To reticulo-endothelial system b) To organs other than RES 2) Neoplasia Doxorubicin Niosomal delivery of Doxorubicin to mice bearing tumor increased their life span and decreased the rate of proliferation of sarcoma 3) Leishmaniasis –stilbogluconate preparations 4) Delivery of peptide drugs Oral delivery of 9-desglycinamide, 8-arginine vasopressin entrapped in niosomes increase stability of peptide significantly.
  • 32. 5) Immunological application of niosomes enhance the antibody production in response to bovine serum albumin 6) Niosomes as carriers for Hemoglobin 7) Transdermal delivery of drugs by niosomes e.g. erythromycin 8. Niosomes in oncology – methotrixate formulations  9) Other Applications a) Sustained Release b) Localized Drug Action 10. Diagnostic imaging 11. Oral drug delivery – ergot alkaloids
  • 33. Conclusion  The concept of incorporating the drug into niosomes for a better targeting of the drug at appropriate tissue destination .  They presents a structure similar to liposome and hence they can represent alternative vesicular systems with respect to liposomes  Niosomes are thoughts to be better candidates drug delivery as compared to liposomes due to various factors like cost, stability etc.  Various type of drug deliveries can be possible using niosomes like targeting, ophthalmic, topical, parentral, etc.