SNEDDS is more effective convenient and stable as
compared to SMEDDS and SEDDS. SNEDDS is under a lipid based formulation. The
SNEDDS is compared with SMEDDS and SEDDS is reported in table-2 Physical
appearance of Nano emulsion is shown in fig-3
Mechanism/ Operation/ Method[7]:
Occurance of Self Nano-emulsification, Modification in
entropy will support the dispersion is higher than the energy is need to rise
the surface of dispersion hence the free energy of conventional emulsion[7].
Materials[8]:
1 Active pharmaceutical
ingredient
2 Excipients
1. API:
Active ingredient must be under B-C-S class 2 & 4.
Those formulations with less dissolvable in aqueous medium.
2. Excipients:
A Oil
B Surfactants
C Co-surfactant
D Co-solvent/
co-solubilizers
A). Oily-Phase:
Oily drops corresponds to main largest part essential
excipients in the SEDDS preparations were no lone secluded bottle solubilizes considered
necessary dosages with stronger oil affinity drug/facilitate
Self-emulsification besides and above all secluded it know how to pile on the
small percentage of lipophilic drug transported through the intestinal
lymphatic system, by this means maximizing the fascination rated from the GI
band contingent on the molecular features of the triglyceride. A quantity of
sustained and intermediate fasten together triglyceride (LCT and MCT) oils with
quite a lot of degrees of diffusion maintain been old for the concert of Self Nano-emulsifying
formulations.
Example- linseed oil, peanut oil, sesame oil, corn oil, palm
oil, oleic acid, hydrogenated oils, etc.
B). Surfactant[9]:
CLASSIFICATION OF SURFACTANT:
Molecules of surfactant has major four forms of classification.
They are,
1 Anionic-surfactants
2 Cationic-surfactants
3 Ampholytic-surfactants
4 Non-ionic-surfactants
1. Anionic-Surfactant:
Group of stronger water affinity-(hydrophilic) bears
-VE CHARGE known to be Anionic-Surfactant. The -VE CHARGED includes COOH,
R-SO3- [OR] SO2-.
eg,.- C12H23KO2,
NAC12H25SO4, sodium dodecyl sulfate, sodium dialkylsulfosuccinates.
2. Cationic-Surfactant:
Group of hydrophilic takes +VE CHARGE is called
cationic-Surfactant.
eg,.-Quaternary-ammonium-halide.
3. Ampholytic-Surfactants / Zwitter-ionic:
This surfactant has time with two of the CHARGES in
dual as +VE & -VE CHARGE.
eg,.–Dimethylsulfoneoacetate (dimethylsulfonio) acetate thetin.
4. Nonionic-Surfactant:
Group of stronger water affinity contains null CHARGE
but derivatives watery solvable reclusive could incorporate stronger
polar-functional-groups.
Eg,.- Polyoxyethylene (20) sorbitan monooleate.
SNEDDS-Surfactant:
Surfactants of non- ionic are second – hand in formulations
of SNEDDS. The methodical surfactant-concentration in mid values with 30–60% W/W
of the preparation in directive with appearance a steady NE. Surfactant having
height hydrophilic-lipophilic-weigh-(HLB) & stronger water affinity helps
the close preparing O/W drops and or abstention paste with preparation into
aqueous-medium. SURFACTANTS were amphiphilic- nature, and they preserve melt
away [or] dissolves moderately prominent substance of water hating
drug-compounds. Container halt rain in medical-drug inside the GUT.
Example-
Polyoxyethylene (20) sorbitan monooleate.
C). Co-Surfactant[9]:
CO-SURFACTANT is same tasks as SURFACTANT-UNIT.
CO-SURFACTANT were add on SURFACTANT-UNIT or mixing with SURFACTANT-UNIT will
appreciate the ability. SURFACTANT in upgrading watery liquid dissolvability
in less aqueous dissolvable medical-drug.
Example-
C2H5OH, CH3OH, C5H12O, C2H6O2, C3H8O2.
D). Co-Solubilizer:
Cosolvent are mainly thwart interfacial-tension &
create or giving higher plane site. Its role is to improve orally bioavailable
nature in less aqueous dissolvable drugs.
Biological Aspects:
Lipid competency is to intensify the bio availability
of poorly aqueous dissolvable drugs are well-known. Even if partially
understand, the currently accepting views is that lipids may intensify the bio
availability through a number of potential mechanisms.
1 Intensify the
effectives of long acting barbiturates
2 Elicitation of
intestinal lymphatic drug transport.
3 Change the
gastrointestinal movements.
4 Alter the skin barrier
functions.
5 Weather polar or
non-polar lipids are a major factor that influenced the Nano-emulsion and
micro emulsion.
Preparation of SNEDDS[10]:
In dual forms SNEDDS are prepared.
They are,
Liquid SNEDDS – Preparation:
The most-valuable process of preparing SNEDDS containing
ratio of Co-surfactants/surfactants and S/Co-S/Oils was elected from the phase
diagram of pseudo ternary. Numerous sequence of the preparations of
formulations are formulated by distinct concentrations of Oils or Surfactant or
Co-Surfactant. Accurate weighing of Oil and Surfactant & drug is soluble to
the mixture & mixture of solubilized drug is stored at normal room
temperature at required.
Solid SNEDDS – Preparation:
The 2nd most-valuable process of preparing
SNEDDS is solid SNEDDS preparation. SNEDDS is prepared by mixing given elect
liquid. The mixing of SNEDDS is done in mortar and pestle. As a mass of damp is
the resultant product. Passing of mixture through the fine sieve as No: 120
& mixture is dried in environmental normal temperature.
Factors influencing the preparation of SNEDDS[10]:
1 Nature and dose of the
drug.
2 Polarity of the
surfactant.
3 Surfactant is essential
part for Nano-emulsion
· Surfactant shouldn't form lyotropic liquid
crystalline.
· System contains short chain of alkanes, OH,
H2O & Surfactants forming phases using with the Co-Surfactant.
4. Enabling a new recent surface area Nano scale is
of fast coated through the emulsifying is there to inhibit to get coalesce due
to the increased surfactant.
· Befitting the required composition is
avoiding the ripening of Ostwald in the dispersed phase should be more
indissoluble in the dispersed medium.
· Intense impart duty be functional to burst
micro scales droplets to Nano ascend by as long as the stress leveling to get
hold of above the Laplace strain of the droplets with compel of 10-100 atm.
Method of preparation of SNEDDS[11]:
Method of preparation for SNEDDS includes active
pharmaceutical ingredient, excipient, polymers and emulsifier. Different
methods for the preparation of Self Nano-emulsifying drug delivery system but,
mainly divided into 2 methods:
A.
High-energy-emulsification.
B.
Low-energy-emulsification
The high-energy-emulsification method includes higher
pressurized-homogenization (HPH), Ultra sonication and Micro-fluidization. The
low-energy method includes Phase-inversion, Spontaneous emulsification. Using
combination of both technique, such as high-energy emulsification and
low-energy emulsification, for prepared reverse Self Nano-emulsifying drug delivery
system are highly viscous system[6].
A. High Energy Emulsification Method[12]:
1. High pressure homogenisation (HPH):
The preparing of Self Nano-emulsifying drug release
system want important compel homogenization. This style above all old as
higher-pressurized-homogenizer/locate-homogenizer gives Nano-emulsion particularly
muffled particle extent (up to 1nm). This scattering in 2 phases (oil-mixture
& aqueous-phase) is attained speeding mixed substance through a trivial
cove chops at exact excessive load (500-5000 psi), addresses invention
in higher disorder and hydraulic-shear develops an awfully charge particles of
emulsion.
2. Ultrasonication:
It is the more convenient method lowering drops sized
in this method, the energy-range is given through sonotrodes known to be
Sonicator-probe. It bottle hold back piezo-electric quartz precious stone that
preserves spread out & tighten the comeback of broken exciting volt. End
point in Sonicator contacts the liquid medium, its container produces
mechanical throb and captives enrolled. Formation of captives shut down vapour
cavities in liquid. Thus, ultrasounds canister straight produces an emulsion.
In this mode is above all old for laboratories purpose, everywhere
blend drop dimension is soothing as 0.2mm canister be obtained.
3. Micro-fluidization:
Micro-fluidization original addition methodology, that
employees the custom of a manoeuvre said micro-fluidizer. manoeuvre was
second-hand in above what is usual hassle affirmative disarticulation pump
(500-20000psi), which break open the produce through the interaction chamber, consequential
incredibly fair particles in the submicron range. This deal with is constant a
number of an era to get hold of a beloved range to shaped even or homogenous
Nano-emulsion system [12].
B. Low Energy Emulsification[13]:
1. Phase inversion emulsification method:
Here is a method employed a transition of phase by
applying very increased temperature route in emulsification.
2. Continuous emulsification:
In this system of emulsification is always formed. In
which, the groundwork of consistent and standardized organic resolution
consisting of grease & lipophilic-surfactant infill with tears miscible
surfactant and hydrophilic-surfactant phase. The organic point was
injected-in-aqueous stage below unbroken alluring stirring, string Oil-in-Water
was prepared. Aqueous-stage was unconcerned as fading below concentrated
pressurized.
Evaluation test for *SNEDDS* [14-19]:
1. Droplet size analysis[14]:
Droplet size psychiatry of Self-Nano-emulsifying-drug
method of arrangement were considered by a passing sense make use of
scattering-light substance range examiner (Nano-ZS90, Malvern P.v.t. Ltd, USA).
Beside calculated with correlation-spectroscopy examines variations deviating
simple owed to Brownian-motion. Droplets psychoanalysis in (NE) were in
addition behaved in Transmission-electron-microscopy (TEM)
&Photon-correlation-spectroscopy (PCS).
2. Viscosity determination[15]:
The optimized viscosity is fundamental for SNEDDS. The
stickiness of Self Nano emulsifying drug administration system was slow by means
of Brookfield-type rotatory viscometer at altered cut charge at distinct
temperature[15].
3. The content of drug[16]:
Contents of the drug of the formulation were resolute
by Ultra-Violet Spectro-photometric and hplc technique. In container U-V, the
ten microgram alike preparation-drug unfair Self Nano-emulsifying drug supply
arrangement were soluble into hundred millilitre o in the black (Drugs too
holds optimized solubility-rangy same as of solvent-range). With supply
preparation solution, capture one millilitre & watered down into ten millilitre
in the chips (chips never hold drugs -preparations overloaded NE). & Drugs makes
happy were found and result conveyed to be Lamda do well as of
drug-molecule.
4. pH:
The pH of SNEDDS was measured with the help of pH
meter. (Systronic 362μ pH system India).
5. Refractive index:
Refractive index of SNEDDS was measured with the Abbes
Refractometer. (Ningbo Biocotek Scientific Instrument, Ltd, Tokyo, China).
6. Zeta-potential[17]:
Zeta-potential calculated as rate of NE exterior plane
drop. Preparations (0.1ml) were watery with hundred era by fold Dis.tld dampen
& examined by means of Zeta-sizer.
7. Percentage transmittance:
Percentage transmittance of the optimized Self
Nano-emulsifying drug delivery system formulations of preparation was analyzed
spectrophotometrically means of UV spectrophotometer.
8. Conductivity Test:
The conductivity of the NE was measured with
conductometer model (Systronics, Pvt. Ltd, India).
9. Test of dilution:
Dilution intensity of NE what's more with O/W phase.
The adversity based on a piece of evidence that intensity of uninterrupted part
of SNEDDS not producing the puzzle NE stability. So, Oil-in-Water NE is thinned
with fill with tears and w/o NE is watery with oil drops.
10. Dye test:
A dye test was measured color uniformity of NE. in o/w
NE water-soluble dye was added taken up the color uniformity.
11. Examination of Stability:
Stability is determining a formulation tolerance. The
purity, as well as quality in SNEDDS determination, is a major part of
stability examination. SNEDDS preparations were analyzed because of NE steady
which on undergoing the machine-like strain state of affairs (centrifugation:
2000-4000rpm) with favorable preparations stored at unusual temp. Starts
as *4 ± 1°C- 40 ± 1°C* unique time-intervals. Look as machine-like strain
circumstances as a Physio-chemical steady nature of SNEDDS were experimentally
formative % point split, contravention of SNEDDS by meaning filled differing.
Studies holds not pertinent modification in the preparations then 1hour timed
centrifugation: two thousand revolution per minute.
12. Filter-paper test:
Experiment relay the piece of information in which
Oil-in-Water SNEDDS was applying results briskly as droplets in filter-paper.
Another side, Water-in-oil SNEDDS was migrating barely slowly. This sense was
not second-hand for decidedly tacky creams.
13. TEM[18]:
Methodological analysis of *SNEDDS* considered by TEM.
An arrangement of upbeat take imaging at mounting exaggeration and diffraction
modes was used, to bring to light the custom and extent of the Nano-emulsions.
To present TEM analysis, NE was thinned with hose down (1/100). A dive of the
watery Nano-emulsions was unswervingly deposited on the holey film grid and
experimental after drying.
14. Phase Behavior Study[19]:
SNEDDS was firm by via Pseudo ternary chapter diagram.
It is in addition settle on NE reality site. Ternary-pseudo point diagram oils,
water, and surfactant: Cosurfactant (S-mix) mixture were established. Follows
all set of S-mix with incorporation of given series with SURFACTANTS:
Cosurfactant (1:1, 2:1, 3:1, 4:1, 1:2 & 1:3) next to clear and
mixture-homogenous of lubricating and S-mix were twisted with peaks. Two of
the mixtures were undergone titration of a hose down & optically practical
with chapter clearings and emanate nature. Peer numbers in medical-drug in each
& every one formulations batches and depending on every stage diagram, the
Self-Nano-emulsifying-drug conveyance system province were examined and atypical
preparations selects at much-loved piece elements, a bid with-by via
Pseudo-ternary rounds of drawings pictures. It is as well uncover NE reality
site. Counterpart numbers in medical-drugs in the entire preparation groups
were depends with every different rounds of drawing pictures, the SNEDDS
section was identified and special formulations were elected as much-loved
element proposition, requisition constructs steady SNEDDS (NE).
15. In vitro dispersion study[19]:
Efficacy in self-emulsification of Nano mixture
(oral-mixture) were single-minded via customary USP-XXII closure-equipment-2.
1ml of both preparation is new to half a litre (500ml) dampen on *36 ± 0.5ºC*.
(Propeler rotating at fifty rotation per min providing mild agitation)
Pseudo-ternary
phase diagram is shown in figure-5
In vitro carrying out preparation is visually determine with
level of below Systems:
A-Grade:
Fast preparing (below 60sec), NE holds clear [OR] blue
colour is shown.
B-Grade:
On, having a bluish fair presence.
C-Grade:
Very well colour less creamy blend that created
contained by 2 min.
D-Grade:
Dull, dirty fair mixture having to some extent fatty
advent that is time-consuming into emulsifying procedure.
E-Grade:
Formulation, exhibiting both are fewer or nominal
Emulsification with great OIL globules submit on the surface.
A-Grade and B-Grade preparation stays behind as SNEDDS
was isolated in GUT. Whereas preparations declining into C-Grade may perhaps be
endorse for SNEDDS as correctly as SEDDS of formulation.
Advantages[20]:
1. SNEDDS plays many
to intensification of water solubility of poorly aqueous dissolvable drug (it
was applicable in BCS class 2, 4 drug) and increases oral drug delivery and
ultimate Bioavailability of poorly aqueous dissolvable drug (lipophilic drug).
2.
The
Nano sized drop in SNEDDS are important to gargantuan interfacial areas which
is connected with NE would influences the delight properties of drug molecules
as weighty factors for sustained as anyhow as under attack drug carriage to the
system.
3.
SNEDDS
are reports to create blood level of drug profiles and bioavailability of drugs
which are more regain and satisfied.
4.
SNEDDS
are chemically stable. It gives fortification from hydrolysis and corrosion as
drug in phases-Oil are O/W.NE is undefended to harm by water & air.
5.
It
may be used as alter for lipophilic carriers and vesicles.
6.
SNEDDS
delivers in various routes like intranasal (nose to brain), intravenous,
topical and oral administration have a rapid and efficient preparation of drug moiety.
7.
SNEDDS
have maximum solubilisation capacity than micellar solution with more shelf
life than micro emulsion.
8.
SNEDDS
have a smaller Nano sized droplet compared than micro emulsion.
9.
SNEDDS
is useful in animals as give good yield of therapeutic value.
10.
Nano
emulsion of SNEDDS have a higher area of surface and loose energy than micro
emulsion of SMEDDS.
11. In cell culture
technology, SNEDDS formulates in diversity of formulation such as liquid ,
spray, foam, cream, balm and gels and its second-hand as NE in pharmaceutical
playing field as now then as dispensing in their routes to increases oral
method of deprived soluble drugs, optical as healthy octic drug transfer system
intranasal and pulmonary drug delivery, parental nutrition.
12. SNEDDS key for OILS
hold the run to of function counting medicine as transdermal dispensing of drug
providing system, other than as foodstuff beverages, preservations.
13. SNEDDS also useful
in Indian system of drug.
14.
SNEDDS
have a specific site respond targeted drug delivery system.
15. As SNEDDS
analogize with oily solution, they provides better interfacial region for
segmentation of the drugs in case of O & W.
16.
SNEDDS
has prospective to preserve from enzymatic degradation.
17. High drug
explosive
Disadvantages[21]:
1.
SNEDDS has inadequate
Mixing/dissolving part for higher melting substances.
2. Stability of SNEDDS influenced by
parameterised environments much as pH & high temperature.
3. Surfactant should be Nontoxic for using in
pharmaceutical application.
4. The formulations of NE are rich methods see
to correct to the mass fall of drops is same tough as it requires an
exceptional humanitarian of technique and procedure method.
5. SNEDDS are extremely tricky to get ready as
it needs peak pressurised homogenizer as fully as ultrasonic-apparatus are
existing in modern years.
6. SNEDDS formulation are expensive and has
high production cost.
7. Stability of SNEDDS and its formulation was
impressed by temperature and pH
8. Low drug incompatibility.
Limitation:
Conservative SEDDS, which stay in principal formulated
as solution create and in words administered in gentle or durable gelatin
capsules, be able to fit in particular disadvantages such as astronomical
costs, trough medication inaptness and stability, medications escape and
precipitation, casing elderly. After that integrated of L-SEDDS into a firm
amount system is convincing & desirable. Recently, novel medication approach
technology Solid-SEDDS which merge a compensation of SEDDS & individual
unbroken prescribed amount forms, maintain be there evaluated.
MARKETED-FORMULATION (SNEDDS):
|
BRAND NAME
|
ACTIVE INGREDIENT
|
MANUFACTURER
|
THERAPEUTIC USE
|
|
neoral
|
Cyclosporin A/I
|
novatis
|
Immuno-suppressants
|
|
norvir
|
Ritonavir
|
Abbott lab
|
anti viral (HIV)
|
|
Fortovase
|
Saquinavir
|
Hoffmann-lapoche inc
|
anti viral (HIV)
|
|
Agenerase
|
Amprenavir
|
Galaxosmithkline
|
anti viral (HIV)
|
|
lipirex
|
Fenofibrate
|
Sanofi aventis
|
Anti Hyperlipidemic drug
|
|
Convulex
|
Valproic acid
|
Phamacia
|
Anti Epileptic drug
|
|
Gengraf
|
Cyclosporin A/III
|
Abbott laboratories
|
Immuno suppressant
|
|
Rocaltrol
|
Calcitriol
|
Roche
|
Calcium regulator
|
Applications[22]:
NE
is Target specific advance towards for Intranasal, Parenteral, Ocular,
Intravenous and Transdermal administration. Mainly proceed towards upgrading
aqueous solubility in poorly aqueous dissolvable drugs. It is novel approach
for stop the problem of first pass metabolism and it can directly absorbed in
systemic circulation for giving a cent percent bio availability. Self
Nano-emulsifying drug delivery system is applicable for treatment of numerous disease
such has, respiratory infection, diabetes mellitus and Skin infections. Another
application of Self Nano-emulsifying drug delivery system in cosmetics
industries, it is act as antimicrobial Self Nano emulsifying drug delivery
system. It plays many role to stop Biodegradations and enzymatic degradations
of drugs. It is also useful in biotechnological field[22].
CONCLUTION:
SNEDDS is a novel drug technique forms which is far
and wide old in pharmaceutical system. And it offers quite a few returns in drug
supply to its target. SNEDDS shows tremendous improvement in bioavailability.
SNEDDS is a single phase and thermodynamical stable isotropic system that
consist of mixture of emulsifying oils, water, surfactants, and co-surfactants
(smix), amphipilic molecule and aqueous phase. This technology deals the problem
of low solublization of drug and it’s been a vehicle for aqueous insoluble
drugs. SNEDDS is possible in all routes and provides prolonged action over the
disease by provided medicaments. The chore of nanoparticles in SNEDDS is either
in O/W or W/O, when it’s mixed in aqueous phase under spontaneous
emulsification and simple situation provides O/W Nano-emulsion. SNEDDS can
serves as plate form technology for delivering poor drugs-dissolvable. Self NE
betters its suspension value straight to better area of surface and
rate-absorption leading to enhancing bioavailability and better patient
compailence. Nano-emulsions were investigated to be used in the treatment of
numerous disease like AIDS, cancer, among others, but also for use in cosmetics SNEDDS gains mainly as
first priority been explored for enhancing for bio-availability in oral drug
method by lipophilic drugs. SNEDDS approaches lead prolonged release of the
drug via incorporating polymers of structure. Self NE seems as the
irreplaceable and marketable, scientifically survival for further reaches and
development need to established.
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