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A review on Self Emulsifying Drug Delivery System

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 Asian Journal of Biomaterial Research 2016; 2(5): 137-141 137

Review Article
A review on Self Emulsifying Drug Delivery System
Brijesh Kanjani, Ashish Garg, Sweta Garg*
Department of Pharmacy, Guru Ramdas Khalsa Institute of Science and technology, Jabalpur, M.P. 483001.

Received: 6 August 2016 Revised: 17 September 2016 Accepted: 18 September 2016

Abstract
Aim: To summarize various reports of self-emulsifying drug delivery systems. Material and methods: Various
research articles, review articles, short communication and books are collected and complied. Results: Drugs are most
often administered by the oral route. However, more than 40% of new chemical entities exhibit poor aqueous solubility,
resulting in unsatisfactory oral drug delivery. Recently, much attention has been focused on self-emulsifying drug
delivery systems (SEDDS) to improve the oral bioavailability of poorly aqueous soluble drugs. SEDDS are isotropic
mixtures of oil, surfactants, solvents and co‐solvents/surfactants. The principal characteristic of these systems is their
ability to form fine oil‐in‐water (o/w) emulsions or microemulsions upon mild agitation following dilution by an
aqueous phase through the gastrointestinal tract for lipophilic drugs, which display dissolution rate‐limited absorption,
SEDDS may be a promising strategy to improve the rate and extent of oral absorption. Conclusion: This article gives
an overview of various developments of SEDDS and biopharmaceutical aspects of SEDDS. The characterization of
SEDDS and application of SEDDS is also introduced, with particular emphasis being placed on the developments of
Solid self-emulsifying delivery system and dosage form of SEDDS.
Keywords: Self emulsifying drug delivery systems (SEDDS), microemulsions, Solid Self emulsifying drug delivery
systems (S‐SEDDS)

Introduction Recently a new technique, Self Emulsifying Drug Delivery

The oral route is the most preferred route of drug delivery for
treatment of a number of diseases. Nearly 35 to 40% of newly
launched drugs possess low aqueous solubility which leads to
their poor dissolution and thereby low bioavailability, resulting
in high intra & inter subject variability & lack of dose
proportionality. For these drugs absorption rate from
gastrointestinal tract is mainly governed by dissolution and
improvement in solubility may lead to enhanced bioavailability.
(Kommuru et al., 2001). There are number of techniques to
overcome such problems arising out of low solubility and
bioavailability, which may result into improved therapeutic
efficacy of these drugs. The techniques like complex formation
with cyclodextrins, solid dispersion, liposome formation, co
precipitation, micronization, salt formation, use of micelles, co
grinding and emulsification had been used for improve.
*Address for Corresponding Author:
Sweta Garg
Department of Pharmacy,
Guru Ramdas Khalsa Institute of Science and technology, Jabalpur,
M.P. 483001.
Email: swetagarg2@gmail.com
System (SEDDS) has been developed to enhance the
solubility of drug SEDDS are defined as isotropic mixtures
of natural or synthetic oils, solid or liquid surfactants or
alternatively, one or more hydrophilic solvents & co-
solvents/co-surfactants.ng the dissolution profile of drugs
with low solubility (Aungst, 1993). SEDDS formulations
can be simple binary systems: lipophilic phase and drug, or
lipophilic phase, surfactant and drug. The formation of a
SEDDS requires the use of a co‐surfactant to generate a
micro emulsion. SEDDS formulations are characterized by
in vitro lipid droplet sizes of 200 nm–5 mm and the
dispersion has a turbid appearance. Self-emulsifying drug
delivery systems (SEDDS) are mixtures of oils and
surfactants, ideally isotropic, and sometimes containing co-
solvents, which emulsify spontaneously to produce fine oil-
in-water emulsions when introduced into aqueous phase
under gentle agitation4-8,. Recently, SEDDS have been
formulated using medium chain tri-glyceride oils and non-
ionic surfactants, the latter being less toxic. Upon per oral
administration, these systems form fine emulsions (or
micro-emulsions) in gastro-intestinal tract (GIT) with mild
agitation provided by gastric mobility (Pouton, 1997).

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 Asian Journal of Biomaterial Research 2016; 2(5): 137-141
Advantage of self-emulsifying drug delivery system over
conventional system (Patel and Chaulang, 2008)
1. Protection of sensitive drug substance.
2. More consistent drug absorption.
3. Protection of drug from gut environment.
4. Control of delivery profile.
5. High drug loading efficiency.
6. Quick Onset of Action
7. Reduction in the Drug Dose
8. Ease of Manufacture & Scale-up
9. Improvement in oral bioavailability
10. Inter-subject and Intra-subject variability and food
effects
11. Ability to deliver peptides that are prone to
enzymatic hydrolysis in GIT
12. No influence of lipid digestion process
13. Increased drug loading capacity
Disadvantage of self emulsifying drug delivery system
system (Patel and Chaulang, 2008)
1. Traditional dissolution methods do not work, because
these formulations potentially are dependent on
digestion prior to release of the drug.
2. This in vitro model needs further development and
validation before its strength can be evaluated.
3. Further development will be based on in vitro - in vivo
correlations and therefore different prototype lipid
based formulations needs to be developed and tested in
vivo in a suitable animal model.
4. The drawbacks of this system include chemical
instabilities of drugs and high surfactant
concentrations in formulations (approximately 30-
60%) which GIT.
Mechanism of self Emulsification
Self emulsifying processes are related to the free energy, ΔG
given by:
ΔG= ΣN π r2 σ
Where,
N = Number of droplets with radius r
σ = Interfacial energy
It is apparent from the above equation that spontaneous
formation of interface between oil & water phase is not
favorable due to higher energy level (Reiss, 1975). The system
commonly classified as SEDDS have not yet been shown to
emulsify spontaneously in true thermodynamic sense.
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Groves & Mustafa developed a method of quantitatively
assessing the ease of emulsification by monitoring the
turbidity of oil-surfactant system in aqueous system, using
phosphate nonylphenoxylate (PNE) and phosphate fatty
alcohol ethoxylate (PFE) in n-hexaneand suggested that
emulsification process may be associated with the ease with
which water penetrates the oil-water interface, with
formation of liquid crystalline phase resulting in swelling at
interface, thereby resulting in greater ease of emulsification
(Groves et al., 1974).
Pouton has said that the emulsification capacities of
surfactant may be related to phase inversion behavior of the
system. (Pouton, 1982; Pouton, 1985, Pouton, 1997,
Pouton, 2000) If one increases the temperature of the oil in
water system which is stabilized by using non-ionic
surfactants, the cloud point of the surfactant will be reached
followed by phase inversion.
The surfactant is highly mobile at phase inversion
temperature due to which o/w interfacial energy is
minimized leading to a reduction in energy required for
emulsification.
Types of SEDDs
On the basis of the water solubility of components,
SEDDS can be classified as
A) Non-water soluble Component Systems
These systems are isotropic mixtures of lipids & lipophillic
surfactants having HLB value less than 12 that self emulsify
to form fine oil in water emulsion in aqueous medium. Self
emulsification is generally obtained at a surfactant level
above 25% w/w. But at a surfactant level of 50-60% w/w the
emulsification process may be compromised by formation
of viscous liquid crystalline gels at the oil/water interface.
This system is also known as Type-II SEDDS according to
lipid formulation classification System (LFCS). Poorly
water soluble drugs can be incorporated in SEDDS &
encapsulated in capsules (hard or soft gelatin) to produce
convenientsingle unit dosage forms (Cuine et al., 2008).
These systems offer advantages -
 They are able to generate large interfacial areas
which cause efficient partitioning of drug between
oil droplets and the aqueous phase.
 They can overcome the slow dissolution step
typically observed with solid dosage forms.
B) Non-water soluble Component Systems
These systems are isotropic mixtures of lipids & lipophillic
surfactants having HLB value less than 12 that self emulsify
to form fine oil in water emulsion in aqueous medium. Self
emulsification is generally obtained at a surfactant level
 Asian Journal of Biomaterial Research 2016; 2(5): 137-141
above 25% w/w. But at a surfactant level of 50-60% w/w the
emulsification process may be compromised by formation of
viscous liquid crystalline gels at the oil/water interface. This
system is also known as Type-II SEDDS according to lipid
formulation classification System (LFCS). Poorly water soluble
drugs can be incorporated in SEDDS & encapsulated in capsules
(hard or soft gelatin) to produce convenientsingle unit dosage
forms (Cuine et al., 2008).
These systems offer advantages -
 They are able to generate large interfacial areas which
cause efficient partitioning of drug between oil droplets
and the aqueous phase.
 They can overcome the slow dissolution step typically
observed with solid dosage forms.
C) Water soluble component system
These systems are formulated by using hydrophilic surfactants
with HLB more than 12 & co solvents such as Ethanol, Propylene
Glycol & Polyethylene glycols (Gershanik and Benita, 2000).
Type III SEDDS are commonly known as self micro-emulsifying
drug delivery systems (SMEDDS). Type III formulations can be
further divided into type III A & Type III B formulations in order
to identify more hydrophilic forms. In Type IIIB, the content of
hydrophilic surfactants and co solvents is increased and lipid
content is reduced (Strickley, 2004; Rodriquez et al., 1999).
The distinction between SEDDS & SMEDDS formulation is
commonly based on particle size and optical clarity of resultant
dispersion. Thus SEDDS formulations typically provide opaque
dispersions with particle size greater than 100 nm while
SMEDDS disperse to give small droplets with particle size less
than 100 nm and provide optically clear or slightly opalescent
dispersions. SEDDS may be solid or liquid in nature and they
may be formulated into tablets, capsules, pellets, solid
dispersions, microspheres, nanoparticles or dry emulsions
(Kommuru et al., 2001).
Formulation of SEDDs
The following points should be considered in the formulation
of a SEDDS
Selection of oils, surfactant and co-solvent based on the
solubility of the drug .The preparation of SEDDS formulation by
dissolving the drug in mixture of oil, surfactant, co-solvents. The
addition of drug to SEDDS is critical because the drug interferes
with the self emulsifying process to certain extent, which leads to
a change in optimal oil- surfactant ratio so design of optimal
SEDDS require pre-formulation solubility and phase diagram
study. More than 60% of potential drug products suffer from
poor water solubility. For the therapeutic delivery of lipophilic
active moieties (BCS class II drugs), lipid based formulations are
inviting increasing attention. Currently a number of technologies
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are available to deal with the poor solubility, dissolution rate
and bioavailability of insoluble drugs.
Excipients used in SEDDs
Pharmaceutical acceptability of excipients and the toxicity
issues of the components used makes the selection of
excipients really critical. There is a great restriction as
which excipients to be used. Early studies revealed that the
self emulsification process is specific to the nature of the
oil/surfactant pair, the surfactant concentration and
oil/surfactant ratio, the concentration and nature of co-
surfactant and surfactant/co-surfactant ratio and the
temperature at which self emulsification occurs (Patel et al.,
2008).
Important parameter for excipient to SEDDs:
 The solubility of drug in the formulation as such
and upon dispersion (for SEDDS),
 The rate of digestion (for formulations susceptible
to digestion) and possibly
 The solubilization capacity of the digested
Formulation.
Factor affecting of SEDDs
A) Nature and dose of the drug: Drugs which are
administered at very high dose are not suitable for unless
they exhibit extremely good solubility in at least one of the
components of SMEDDS, preferably lipophilic phase. The
drugs which exhibit limited solubility in water and lipids
(typically with log P values of approximately are most
difficult to deliver by SMEDD.
B) Polarity of the lipophilic phase: The polarity of the lipid
phase is one of the factors that govern the drug release from
the micro emulsions. The polarity of the droplet is governed
by the HLB, the chain length and degree of unsaturation of
the fatty acid, the molecular weight of micronized for their
propensity to inhibit crystallization and, thereby, generate
and maintain the supersaturated state for prolonged time
period.
Criteria of Drug Properties
BCS (Bio-pharmaceutical classification system) classifies
the drug based on solubility and permeability of a drug.
Mainly Class 2 (Low Solubility, High Permeability) is used
for SEDDS
E x . A z i t h ro m y ci n C a rb a ma ze p i n e C ar ved i l o l
Chlorpromazine Cisapride Ciprofloxacin.
Dosage Form of SEDDs
(1) Oral delivery
(A) Self emulsifying capsule: After administration of
capsules containing conventional liquids SE formulations,
 Asian Journal of Biomaterial Research 2016; 2(5): 137-141
microemulsion droplets form and subsequently disperse in the
GIT to reach site of absorption. If irreversible phase separation of
microemulsion occurs an improvement of drugs absorption can't
be expected. For handling this problem, sodium dodecyl sulfate
was added into the SE formulation43.
(B) Self--Emulsifying sustained / controlled release:
Combination of lipids and surfactant has presented great
potential preparing SE tablets. SE tablets are of great utility in
obviating adverse effect. Inclusion of indomethacin (or other
hydrophobic NSAID) for example, into SE tablets may increase
its penetration efficacy through GI mucosal membrane,
potentially reducing GI bleeding.
(C) Self emulsifying sustained / controlled release pellets:
Pellets, as a multiple unit dosage form, possess many advantages
over conventional solid dosage form, such as flexiability of
manufacture, reducing intra subject and inter subject variability
of plasma profile and minimizing GI irritation without lowering
drug bioavailability.
(D) Self emulsifying solid dispersions: Solid dispersions could
increase the dissolution rate and bioavailability of poorly water
soluble drugs but still some manufacturing difficulties and
stability problems existed. Serajuddin pointed out that these
difficulties could be surmounted by the use of se excipients31.
(2) Topical Delivery: Topical administration of drugs can have
advantages over other methods for several reasons, one of which
is the avoidance of hepatic first pass metabolism of the drugs and
related toxicity effects.
(3) Oculars and Pulmonary delivery: For the treatment of eye
disease, drugs are essentially delivered topically o/w
microemulsion have been investigated for ocular administration,
to dissolve poorly soluble drugs, to increase absorption and to
attain prolong release profile.
(4) Parenteral delivery: Parenteral administration of drugs with
limited solubility is a major problem in industrybecause of the
extremely low amount of drug actually delivered as target site.
Biopharmaceutical Aspects
The ability of lipids and/or food to enhance the bioavailability of
poorly watersoluble drugs is well known. Although incompletely
understood, the currently accepted view is that lipids may
enhance bioavailability via a number of potential mechanisms,
including (Porter, 2001).
a) Alterations (reduction) in gastric transit.
b) Increases in effective luminal drug solubility.
c) Stimulation of intestinal lymphatic transport
d) Changes in the biochemical barrier function
e) Changes in the physical barrier function of the GI tract.
f) The polarity of lipid phase is one of the factors that govern the
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release from the micro-emulsion.
Conclusion
SEDDS formulation can be optimized for the delivery of
hydrophobic compounds with drug loading; minimum
surfactant concentration and proper infinite dilution can be
achieved without drug precipitation. Self-emulsifying drug
delivery system can be use for the formulations of drugs
compounds with poor aqueous stability. Development of
this technology SEDDS will continue to enable novel
applications in drug delivery system. SEDDS have been
shown to be reasonably successful in improving the oral
bioavailability of poorly water-soluble and Traditional
preparation of SEDDS involves dissolution of drugs in oils
and their blending with suitable solubilizing agents.
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