SMEDDS

Tushir et al., IJPSR, 2022; Vol. 13(12): 4830-4847.
E-ISSN: 0975-8232; P-ISSN: 2320-5148
IJPSR (2022), Volume 13, Issue 12 (Review Article)
Received on 06 April 2022; received in revised form, 21 June 2022; accepted, 13 September 2022; published 01 December 2022
A CONCISE REVIEW ON NOVEL APPROACH FOR CHALLENGING PHARMACEUTICALS

THROUGH SELF – MICRO EMULSIFYING DRUG DELIVERY SYSTEM (SMEDDS)
Renu Tushir *, Bharti Gupta, Rahul Sharma and Ajesh Chauhan
Hindu College of Pharmacy, Sonipat - 131001, Haryana, India.
Keywords: ABSTRACT: SMEDDS are formulated to improve the oral bioavailability
Bioavailability, Surfactants, of lipophilic drugs. It is an isotropic mixture of compounds like oil,
Absorption, Self-micro emulsifying surfactant, co-surfactant, and drug having the unique ability to form fine o/w
drug delivery system (SMEDDS), micro-emulsion by agitation and diluted with GI fluid. Its liquid formulation
Lipophilic drugs, HLB value technique enhanced the absorption and bioavailability of poorly water-
Correspondence to Author: soluble drugs but also had a few drawbacks like long time period stability
Ms. Renu Tushir issues and storage conditions. Some special techniques convert the liquid
Assistant Professor, form into solid dosage form to overcome these problems. The present paper
Hindu College of Pharmacy, gives exhaustive information about formulation design by screening
Sonipat - 131001, Haryana, India. excipients. We study the selection and solubility of excipients, its preparation
and characterization, and the mechanism by which bioavailability can be
E-mail: renutushir8@gmail.com improved. This discussion is useful for a better understanding of SMEDDS
for its recent advancements, marketed formulation, and patents on SMEDDS.
The poorly water-soluble drugs having dissolution rate absorption limited
can be effectively formulated in the form of SMEDDS causing a stable
plasma profile. The plasma levels of the poorly aqueous soluble medicament
show the critical passage of drug absorption, i.e., dissolution. Surfactants
with a high HLB value, such as Tween 80 are said to increase the
permeability of active ingredients when administered in conjunction with the
formulation due to their loosening effect on tight junctions.
INTRODUCTION: The oral route of The issues of low oral bioavailability afflict several
administration is preferred for persistent drug therapeutic molecules including lipophilic drugs.
therapy. Scientists were facing many problems in Improvement in their bio-availability and
finding the techniques to improve the simultaneous prevention of the oral degradation of
bioavailability of poorly aqueous soluble drugs. the susceptible molecules seems to be challenging
2
Since a drug has to be dissolved in gastrointestinal . Approximately 40 % of modern drug applicants
tract (GIT) before passing through gastrointestinal have poor water solubility and hurdles to their
mucosa, poor water solubility can lead to successful oral delivery due to a complex web of
incomplete and irregular absorption 1. physical, chemical, physiological, and anatomical
factors that act independently and in concert to
QUICK RESPONSE CODE
DOI: limit drug bioavailability 3.
10.13040/IJPSR.0975-8232.13(12).4830-47
Numerous techniques are suggested to elucidate
these problems, such as the use of surfactants,
This article can be accessed online on cyclodextrin, nanoparticles, strong dispersions,
www.ijpsr.com lipids complexes, and permeation enhancers.
Particulate drug transport systems, consisting of
DOI link: http://dx.doi.org/10.13040/IJPSR.0975-8232.13(12).4830-47 nanoparticles and microspheres, were studied
International Journal of Pharmaceutical Sciences and Research 4830

Tushir et al., IJPSR, 2022; Vol. 13(12): 4830-4847. E-ISSN: 0975-8232; P-ISSN: 2320-5148
considerably for 10 years. But the toxicity of the the shell 9, 10, 11, 12. L-SMEDDS promotes drug
synthetic polymeric substances consisting of alkyl absorption via intestinal lymph by passing the first-
cyno-acrylate, poly (lactic acid), Methyl pass impact of drugs. Moreover, drug added with
methacrylate, etc. have been regularly used. The the aid of using L-SMEDDS can spontaneously
feasible accumulation and their poisonous shape micro-emulsion with a droplet size of dozens
metabolite product have also been studied 4. of nanometers inside the gastrointestinal tract after
oral administration 13, 14, 15, 16 and, therefore,
Microemulsions are being investigated as a capable enhances the absorption and bioavailability of
new colloidal provider for lipophilic drugs. poorly waters soluble drugs 17.
Microemulsions provide benefits like amazing
thermodynamic stability, excessive drug Despite many advantages, L-SMEDDS also have
solubilization capacity, progressed oral some significant drawbacks, including long-time
bioavailability and safety in opposition to stability issues, storage, transportation incon-
enzymatic hydrolysis. The best hassle with venience, and irreversible drug precipitation 18.
microemulsion is terrible palatability because of the Liquid formulations may be converted to solid
excessive lipid content which affect patient dosage forms through appropriate techniques to
compliance. Moreover, because of their water- conquer these drawbacks. A form of therapeutic
content material, microemulsions can't be solidification techniques have been explored,
encapsulated in hard gelatin and soft gelatin drugs extrusion roll technique 19, spray drying technique
20, 21
subsequently, there may be a need for anhydrous solid carrier adsorption technique 22, and so on
Self Emulsifying Drug Delivery system 5. Thus, 23
. Nevertheless, those therapeutic techniques
Self-Micro emulsifying Drug Delivery System require harsh preparation conditions. For example,
(SMEDDS) is a lipid-based system designed to extrusion roll and spray drying techniques contain
enhance oral bioavailability of lipophilic drugs. high temperatures, which can be infeasible for heat-
Few researchers have stated enhancement in sensitive drugs. Also, high temperature impacts the
bioavailability of poorly soluble capsules while drug loading capacity because of a low range of
formulated as SMEDDS. Researchers have tried volatile surfactants in L-SMEDDS. On the other
lipid-based delivery of lipophilic drugs like hand, solid carrier adsorption requires a massive
cyclosporine and concluded that cyclosporine is quantity of adsorbent, which may cause high
capable for such delivery 6. viscosity and low drug loading capacity. Thus, a
more efficient technique for curing L-SMEDDS is
Self- micro emulsifying drug delivery systems urgently demanded 24.
(SMEDDS) are described as isotropic combinations
of natural or synthetic oils, surfactants, and co- Liquid-solid compacts (LSC) are amongst the novel
surfactants which have a completely unique formulations for BCS category II medicine to
capacity of forming splendid oil-in-water (o/w) extend the drug dissolution 25, 26. In liquid-solid
micro emulsions upon slight agitation observed formulation, a non-volatile solvent may be used for
through dilution in aqueous media, together with solubilizing the drug. Therefore the resultant
GI fluids. Droplet sizes of SMEDDS ranging from mixture adsorbs onto a carrier system to make dry
300-500 nm, even much less than 500 nm can also and free-flowing powder 27. Liquid-solid compacts
form. Lipophilic drugs showing dissolution rate- are non-adherent, free-flowing powders formed by
limited absorption might additionally provide exploitation drugs, non-volatile solvents, and fine-
growth in rate and volume of absorption and grained excipients like carrier and coating material
reproducible blood-time profiles 7, 8. The SMEDDS 28
. Compared to the other dissolution enhancement
can enhance the solubility and dissolution rate of techniques, the liquid-solid technique is convenient
29, 30
the interfacial site for partitioning the medication . In the SMEDDS technique, the drug is present
among the oil and aqueous GI fluids. Generally, the in the soluble form inside the oil and ends up in
conventional liquid SMEDDS (L-SMEDDS) are fine globules when administered orally because of
encapsulated in hard or soft gelatin capsules. self -emulsification. The surfactant and co-
However, the lipid technique may also interact with surfactant reduce the interfacial surface tension of
the capsules, ensuing both hardness and softness of the system. In LSC technique, the drug is

solubilized within the non-volatilizable solvent.  Along with lipids, surfactants commonly used
Hence, these developed systems may improve the in SMEDDS formulations, such as Tween 80,
solubility of aqueous insoluble drugs. But, the Spans, Cremophors (EL and RH40), and
development of good oral bioavailability and better Pluronic's, are reported to have an inhibitory
pharmacodynamic effects are important. Out of effect on efflux transporters that help in
those two systems, in-vivo performance should be improving the bioavailability of the drugs 30, 32,
superior (PK and PD effects) 31. Therefore, there is 33, 34
. The surfactant Tocopheryl polyethylene
a tendency to work on developing an efficient glycol succinate 1000 (TPGS), which is
tablet dosage form by concurrent works exploiting produced by esterifying vitamin E succinate
the approaches of each SMEDDS-associated and polyethylene glycol 1000, has an inhibitory
liquid-solid formulation technique 32. Incorporating effect on efflux transporters such as P-
liquid SMEDDS into a solid dosage form provides glycoprotein 42. Paclitaxel from the GIT is
the benefit of SMEDDS with those of solid inhibited with a formulation containing a
formulations and overcomes the drawbacks surfactant called polysorbate 80 43.
associated with this system. With this aim, an
experimental design strategy to optimize a  Drugs that tend to be chemically and
SMEDDS formulation of the tablet can be adopted, enzymatically degraded in the GIT can be
and the simplest composition in terms of drug protected by the formulation of SMEDDS, as
dissolution properties can be selected 33. the drug is presented to the body in oil droplets
36
.
Advantages:
 Microemulsion pre-concentrate is advantageous
 The irritation caused by prolonged contact over microemulsions dispensed as liquid-filled
between the drug and the stomach wall can be soft gelatin capsules 44.
overcome with the SMEDDS formulation, as
the micro-size droplets support the broad  SMEDDS are advantageous over SEDDS, as
distribution of the drug along the GIT and are the former are less dependent on bile salts for
quickly transported through GIT 34, 35. droplet formation, so better active substance
absorption is expected compared to SEDDS 45.
 When dispersed in water, these formulations
produce fine droplets with a large interface, as  Surfactants with a high HLB value, such as
the active ingredient can easily be distributed Tween 80, are said to increase the permeability
from the oil phase to the aqueous phase, which of active ingredients when administered in
is not to be expected with oily solutions having conjunction with the formulation due to their
lipophilic active ingredients 35. loosening effect on tight junctions 46.
 Compared to emulsions, SMEDDS are Disadvantages 47, 48, 49:

advantageous in terms of stability due to their 1. One of the barriers to the development of
low energy consumption and simple SMEDDS and other lipid-based formulations is
manufacturing process. Simple mixing devices the lack of good in vitro predictive models for
are sufficient for the formulation of SMEDDS, evaluating formulations.
and the time required for preparation is lower
than emulsions 36, 38. 2. Conventional dissolution methods do not work
as these formulations may depend on digestion
 The poor water-soluble drugs having before drug release.
dissolution rate absorption limited can be 3. The drawback of this system includes chemical
effectively formulated in the form of SMEDDS instabilities of the drugs and high surfactant
causing a stable plasma profile 36. The constant concentrations in the formulations (approx. 30–
plasma levels of the poorly aqueous soluble 60%), which can irritate the gastrointestinal
medicament show the critical passage of drug tract.
absorption, i. e. dissolution 39.

4. It is known that volatile co-solvents in study by Sha et al. a greater permeability of the
conventional SMEDDS formulations migrate drug with the Labrasol surfactant was observed due
into the shells of soft or hard gelatin capsules to the opening of tight junctions 60. The inhibitory
and cause precipitation of lipophilic drugs. effect of surfactants on the p-glycoprotein helps to
improve the overall bioavailability of many drug
5. Formulations with several components become
substrates for the p-glycoprotein transporter 33.
more difficult to validate.
Although natural surfactants are less toxic, the
6. High Production cost. effectiveness of self-emulsification is limited 36.
7. Low drug compatibility. Surfactants must be carefully selected for
spontaneous emulsification to achieve an extremely
8. Due to drug leakage, it may allow fewer drug low interfacial tension 60.
loading.
The surfactant selection is based on HLB value.
Composition of SMEDDS: The self- Surfactants with a high HLB value facilitate the
emulsification process is reported to be specific to formation of o/w microemulsions 59. Surfactants
the nature of the oil surfactant pair. The procedure with a hydrophilic nature, i. e. HLB greater than
is based on 50, 51, 52 : 12, along with water-soluble co-solvents having
1. Oils. relatively low octanol: water partition coefficient
therefore to increase the solvent capacity of the
2. The surfactant concentration and the oil / formulation and the systems, very fine droplets size
surfactant ratio. smaller than 100 nm at high surfactant
3. The temperature at which self-emulsification concentrations is required 61. The lower toxicity of
occurs. non-ionic surfactants, such as oleates, polysorbates,
polyoxyl, etc. compared to ionic surfactants enables
Some of the components used in SMEDDS are:
them to be used more frequently in the formulation
Oils: Long-chain triglycerides (e. g. soybean oil) of SMEDDS 58. Lipids commonly used in
and medium-chain triglycerides (e. g. Capmul SMEDDS formulations, such as medium and long-
MCM) were used in the development of SMEDDS chain triglycerides and non-ionic surfactants such
with different degrees of saturation. Due to their as HLB-11 oleates with unsaturated acyl side
biocompatibility, oils significantly contributed to chains are more suitable excipients for effective
the success of the SMEDDS 53. Recently, medium- self-emulsification 57.
chain triglycerides have been replaced with new
Co-Solvents: Co-solvent facilitates the dissolution
medium-chain semi-synthetic triglycerides
of the surfactant and hydrophobic drug in the oil
containing compounds like Gelucire. Other suitable
phase due to their ability to enable water to enter
oils and fats for SMEEDS formulation include
the formulation 34. These excipients play the role of
olive oil, corn oil, soybean oil, and animal fats 54.
co-surfactants in the micro-emulsion system. Short-
Surfactants: A surfactant is required to take the chain alcohols such as ethanol, n-butanol,
property of self-emulsification by SMEDDS, which propylene glycol, and polyethylene glycol are used
is the main method of forming a micro-emulsion as co-solvents 36, 59. The addition of co-solvents
and is also useful for solubilizing the hydrophobic such as short-chain alcohols gives flexibility to the
drug; in turn, the dissolution rate can be improved interface, which is useful for the free movement of
34 the hydrophobic tails of the surfactant at the
. The solubilization behavior of surfactants
containing active ingredients gained popularity due interface, which in turn gives micro-emulsions
to its inhibitory effect on the precipitation of dynamic behavior 60. Alcoholic co-solvents with
actives in-vivo 59. The permeability barrier, i. e. the low molecular weight can cause drug precipitation
intestinal cell membrane, which consists of lipids, when the formulation is filled into gelatin capsules,
can be modified by the distribution of the as they are absorbed into the capsule shells 57. In
surfactant; therefore, the potency can be improved addition to nature, the co-surfactant concentration
36 also influences drug precipitation. Due to their high
. The opening of tight junctions by surfactants
helps in improved permeability, as shown in the polarity, they tend to migrate into the aqueous

phase when dispersed in aqueous media, leading to The maximum bioavailability of SMEDDS can be
the drug's precipitation. It is, therefore, advisable to achieved at very low doses, especially for drugs
formulate SMEDDS in minimal concentration 62. with high octanol: water partition coefficient. The
The selection of the suitable surfactant and co- absorption of the drug from SMEDDS depends
surfactant should consider the effectiveness, mainly on its solubility in water and lipid phase 61.
irritation, changes in effect due to repeated The compounds having poor bioavailability due to
administration of the formulation, the interaction the pre-systemic metabolism can be formulated as
with mucosal proteins and lipids, and the metabolic SMEDDS as long as the drug has a high solubility
pathway followed 56. in long-chain triglycerides (> 50 mg/ml) octanol:
water partition coefficient of more than five 55.
Active Agent: The lipid-based formulations are Some excipients used in different preparations are
mostly preferred when poor solubility is the main shown in Table 1.
reason for insufficient drug absorption 58.
TABLE 1: EXCIPIENTS USED IN DIFFERENT SMEDDS FORMULATIONS
S. no. Drug Oil Surfactant Co-Surfactant Co-Solvent Use
1 Atorvastatin Labrafil, estol, Cremophor RH40, PG, PEG 400, _ Cardio-
isopropyl, myristate Cremophor EL Transcutol vascular
2 Acyclovir Crodamol GTCC Labrasol Plurololeque CC 497 Macrogol Anti-viral
400
3 Danazol Capmul MCM Tween 80 Transcutol HP _ Endometerosi
s
4 Simvastatin Capryol 90 Cremophor EL Carbitol _ HMG CoA
Inhibitors
(statin)
Mechanism of Self-Emulsification: The free Where Δ𝐺 is the free energy is the number of
energy of the emulsion can be described by the droplets, 𝑟 is the radius of the droplets, 𝜎 is the
following equation: Interfacial energy. The mechanism is explained
Δ𝐺 = ∑𝑁Π𝑟2𝜎 (1) diagrammatically.
FIG. 1: MECHANISM OF SMEDDS 54, 60

This equation shows that the lower the interfacial emulsifies spontaneously, which is further
energy, the lower the free energy. Self- emulsified by the bile salt, resulting in the
emulsification occurs when the energy involved in formation of small oil droplets about 0.5 µm in
dispersion is greater than the energy required for size.
droplet formation 34, 36.
To understand the mechanism by which the
Factor Affecting of SMEDDS: subsequent absorption of the drug from the
emulsion system occurs, it is necessary to consider
1. Drug Dosage: Drugs that are administered in the in-vivo behavior of the constituent components
very high doses are not suitable for SMEDDS 1
.
unless they show extremely good solubility in
at least one of the SMEDDS components; Several reports point to improved absorption of
preferably in lipophilic phases, drugs show active substances from the emulsified dosage form
limited solubility in water and lipids (typically and SMEDDS 64, 65.
with log P values of about 2) are the most
difficult to administer as SMEDDS. Different Modes of Enhanced Drug Absorption
can be assumed as follows:
2. Solubility of the Drug in the Oil Phase: The
ability of SMEDDS to keep the drug in solution 1. Digestible oil phase of the emulsion can
is generally influenced by the solubility of the synthesis chylomicrons from the fat
drug in the oil phase. components due to which the drugs can be
absorbed through the lymphatic vessels.
Suppose the surfactant or co-surfactant
contributes more to the solubilization of the A lipophilic active ingredient, which preferably
drug. In that case, there is a risk of precipitation remains in the oil droplets, can mainly be
as the dilution of SMEDDS leads to a decrease absorbed together with the metabolite of the
in the solvent capacity of the surfactant or co- lipid carrier via bile salt micelles 66, 67.
surfactant 1.
2. The inhibition of gastric motility caused by the
3. Equilibrium Solubility: The equilibrium presence of the lipid phase of the emulsion
solubility measurement can be performed to could allow more time for the drug to dissolve
anticipate possible precipitations in the and be absorbed from the lipid phase.
intestine. However, crystallization could be
3. Increased mucosal permeability due to lipid
slow in the intestine's colloidal stabilization and
storage from mixed micelles and increased
solubilization environment 52.
mesenteric lymph flow can be responsible for
4. Polarity of the Oil Droplets: The polarity of improved drug absorption.
the lipid phase is one of the factors determining
4. A hydrophilic agent is less likely to be absorbed
the microemulsion's release. The length of the
via the lymphatic vessels (chylomicrons) and
HLB chain and the degree of unsaturation of
instead diffuses directly into the portal vein 63,
the fatty acid, the molecular weight of the 66, 68
.
hydrophilic component and the concentration of
the emulsifier determines the polarity of the Therefore, in this case, increasing the
droplets. In fact, the polarity reflects the affinity dissolution of the large surface area provided
of the drug for oil and water and the nature of by the emulsion can contribute to improving
the process involved. The high polarity drug absorption.
promotes rapid release of the drug into the
aqueous phase 63. 5. A relatively less focused consideration is the
presence of surfactants in the formulation,
Bioavailability Enhancement of SMEDDS: After which can also increase drug uptake 69, 70.
oral administration, when SMEDDS comes into
contact with aqueous intestinal components, it

Formulation Design: The design is depicted as shown below:
FIG. 2: FORMULATION DESIGN OF SMEDDS 36
1. Screening of Excipients: determined by mixing equal proportions of

 Solubility Studies: These are mainly useful for selected oil and surfactant with subsequent
selecting the most suitable excipients that can homogenization. When this mixture is added to
be used in the manufacture of the SMEDDS double distilled water, the number of
and in predicting the precipitation of live drugs. revolutions of the piston required to form a
The solubility of the drug in different oils, homogeneous emulsion is recorded, indicating
surfactants, and co-surfactant should be tested. the ease of emulsification. The resulting
These investigations are usually carried out microemulsion must be tested for clarity,
using the shake flask method, in which the turbidity, and percentage permeability, require
active ingredient is usually added to the low piston inversions should be chosen 76, 77.
excipient in excess and then stirred for 48 hours Similarly, co-surfactants should be screened
in a water bath shaker or an air oscillator at using the same procedure by mixing the
room temperature 73, 74. The samples should selected surfactant and the oil phase with the
then be centrifuged and filtered through a 0.45 co-surfactant 78.
µm filter, with the active ingredient content
determined. These solubility studies are 2. Construction of Pseudo-ternary Phase
generally conducted to select the oil that shows Diagram: The ternary phase diagram is used to
the maximum solubility of the drug and the study the phase behavior of three components i. e.
surfactant / co-surfactant that has the maximum oil, water, and surfactant, but in the case of
ability to solubilize the drug. The other goal is SMEDDS, the additional component, such as the
to achieve optimal drug loading with a minimal addition of co-surfactant / solvent is the most
total formulation volume. Drug precipitation common. The ternary diagram has three corners
can occur from diluted SMEDDS, which that correspond 100% to each component. If the
depends on the drug's octanol: water fourth component is added, the ternary diagram can
distribution coefficient and the degree of be referred to as a pseudo-ternary phase diagram
surfactant participation in drug solubilization since one of the corners corresponds to the mixture
drug75. of two components, such as surfactant and
surfactant78.
 Selection of Surfactants and Co-surfactants
to determine their Self-emulsifying Ability:  To construct the pseudo-ternary phase diagram,
The emulsifying ability of surfactants can be mixtures with different compositions of

microemulsion components have to be Method of Preparation:

evaluated for their emulsification efficiency 79. 1. Phase Titration Method: Microemulsions are
Different structures, such as emulsions, produced using the spontaneous emulsification
microemulsions, micelles, inverted micelle method (phase titration method) and can be
shapes, etc., can be formed in different represented with the help of phase diagrams.
compositions. The formation of these structures Creating a phase diagram is useful for studying
can be known by constructing a phase diagram. the complex series of interactions that can
This phase diagram helps to determine the occur when different components are mixed.
formulation's dilution capacity and obtain Formed along with various association
information about the different compositions structures (including emulsion, micelles,
that form transparent single-phase solutions 39. laminar, hexagonal, cubic, and various gel and
oil dispersions) depending on each component's
 Pseudo-ternary diagrams are constructed by chemical composition and concentration.
keeping the ratio of two of the four components Understanding the phase equilibrium and
constant. This ratio, along with the remaining delineating the phase boundaries is essential,
two components, generally forms three corners with each corner of the diagram representing
of the phase diagram. This fixed ratio (mixture) 100% of the component in question. The region
is usually formed by the combination of can be divided into w / o or o / w
surfactant and cosurfactant 75, 80, and can microemulsion simply by considering the
sometimes be a mixture of oil and surfactant. composition, that is, whether it is rich in oil or
This is mixed with the required volume of the water. To rule out metastable systems, careful
third phase as an oil80, 81 or cosurfactant 38; then monitoring is required 71.
the other component, which is generally water,
is added in incremental amounts, and for each 2. Phase Inversion Method: The phase inversion
addition of the fourth component, the solution of micro-emulsions takes place by adding an
must be tested for clarity, flowability, self- excess of the dispersed phase or as a reaction to
emulsification time and dispersibility 75. the temperature. Drastic physical changes occur
during phase inversion, including changes in
The total percentage concentration of all particle size that can affect drug release both in-
components in each mixture should be 100% 79. vivo and in-vitro. These methods make use of
The pseudo-ternary diagram must then be drawn changing the spontaneous curvature of the
with the aid of suitable software. Samples that form surfactant. In the case of non-ionic surfactants,
a clear solution are to be identified by appropriate this can be achieved by changing the system's
symbols in the phase diagram 82. The area that temperature, which forces a transition from a
forms when these points are connected shows the low-temperature O / W micro-emulsion to a W
existing area of the monophasic microemulsion83 / O micro-emulsion at higher temperatures
and the broad area shows good emulsification (transition phase inversion). As the system
efficiency 75. cools, it passes through a point with no
spontaneous curvature and minimal surface
3. Preparation of SMEDDS: Preparation involves tension, encouraging the formation of finely
adding the drug to the mixture of oil, surfactant, divided oil droplets. This process is known as
and cosurfactant, followed by vortexing. In some the phase inversion temperature (PIT) process.
case the drug dissolve in one of the excipients and Instead of temperature, other parameters such
the remaining excipients are added to the drug as salt concentration or pH value can be taken
solution 81. into account instead of temperature alone. In
The solution must then be properly mixed and addition, a transition of the spontaneous radius
inspected for signs of cloudiness. After of curvature can be achieved by changing the
equilibrating for 48 hours at room temperature, the volume fraction of water. By gradually adding
solution should be heated to a clear solution if water to the oil, water droplets are initially
necessary. Volume, the formulation should be formed in a continuous oil phase. An increase
stored in capsules of the appropriate size 74. in the volume fraction of water changes the

spontaneous curvature of the surfactant of have the property of efficiently interacting with
water/oil micro-emulsion, which initially the mucosal surface of the GIT. These
stabilizes an O / W micro-emulsion at the point interactions are electrostatic in nature, so strong
of inversion. Short-chain surfactants form adhesion with increased absorption can be
flexible monolayers at the o / w interface, expected.
which leads to a discontinuous micro-emulsion
at the point of inversion72. 4. Time for Emulsification: The time required
for self-emulsion for the various formulations
4. Characterization of SMEDDS can generally be assessed using a USP Type II
1. Visual Evaluation: The self-emulsification can dissolution device by adding the formulation
be assessed by visual assessment. After dilution drop-wise to the water-containing basket, and
of SMEDDS with water, an opaque and milky- the formation of a clear solution with stirring is
white appearance indicates the formation of a observed while agitation provided by paddle at
microemulsion. In contrast, a clear, isotropic, 50 rpm. Self-emulsification helps to determine
clear solution indicates the formation of a the self-emulsification efficiency of the
micro-emulsion. Precipitation of the drug in formulation 57. It was found that the
diluted SMEDDS is also possible by visual emulsification rate depends on the type of oil
evaluation. Formulations can be considered phase and the oil/surfactant ratio. A rapid rate
stable if no precipitation of the drug is evident. of emulsification is observed at a higher
Precipitation is common when the formulation surfactant concentration due to the rapid
contains water-soluble co-solvents and can be expulsion of oil droplets by penetration of
avoided by increasing the surfactant water at the interface. Visual assessment can
concentration 36, 84, 86. also determine the emulsification time after the
formulation has been placed in 0.1 N HCl with
2. Droplet Size Analysis: The droplet size shaking at body temperature, whereby GI
depends mainly on the type and concentration conditions can be simulated 76.
of the surfactant 87. The micro-emulsion formed
on dilution with water creates droplets of very 5. Cloud Point Determination: The cloud point
narrow size and size distribution for efficient is generally determined by gradually increasing
drug release, in vivo absorption, and stability. the temperature of the water bath into which the
For droplet size analysis, spectroscopic formulation is placed and measured
techniques such as photon correlation spectrophotometrically. The point, at which the
spectroscopy and microscopic techniques are permeability in% decreases means the cloud
used 36, 84. Dynamic light scattering techniques point, which is the temperature above which the
with the zeta meter can also be used for droplet clear solution changes to a cloudy solution. The
size analysis 88. Samples must be sufficiently temperature is 37 °C; formulations must have a
diluted before size determination 73, 74. cloud point higher than body temperature to
Determining the polydispersity index (PDI) retain their self-emulsifying properties. Due to
provides reasonable information about the size the susceptibility of the surfactant to
distribution 89. dehydration, phase separation and reduced
solubilization of the drug are often observed at
3. Zeta Potential Measurement: The zeta temperatures above the cloud point. The cloud
potential is generally measured with a zeta point is influenced by the drug's lipophilicity
potential analyzer or a zeta meter system. The and other formulation components 57, 77.
zeta potential value indicates the stability of the
emulsion after sufficient dilution. A higher zeta 6. Viscosity Measurements: The viscosity of the
potential indicates good formulation stability 90. diluted SMEDDS formulation, which is a
In general, the zeta potential value is negative micro-emulsion, is generally determined with
due to free fatty acids 84, but when cationic rheometers such as the Brookfield cone-plate
lipids such as oleyl-amine are used, the positive rheometer with conical spindle or a Brookfield
charge develops. Positively charged droplets rotating spindle viscometer 91, 92. During the

titration, the initial increase in viscosity 9. Percentage Transmittance: This test indicates
followed by a decrease, whereby the increase in the transparency of the diluted SMEDDS
water volume is due to the water percolation formulation. It is determined
threshold, indicates the formation of an O / W spectrophotometrically after diluting the
micro-emulsion from a W / O micro-emulsion formulation with water; the water is kept as a
with an intermediate bi-continuous phase. The blank value. The percentage transmission value
rheology of the micro-emulsion can be close to 100% indicates a clear and transparent
determined from the diagram between shear micro-emulsion formation 75.
stress and shear rate. The behavior indicates the
presence of small, spherical droplets 93. 10. Transmission Electron Microscopy (TEM)
Study: It is mainly used to study the structure
7. Dilution Studies: The effect of dilution on the and morphology of micro-emulsions formed by
clarity of the micro-emulsion can be assessed diluting SMEDDS. These studies are carried
by diluting the micro-emulsion preconcentrate out by combining bright-field images with
in various dilutions that simulate gastric increasing magnification and diffraction modes
96, 97
conditions and in various diluents such as . The grid and the morphology of the
double distilled water, simulated gastric juice perforated film can be determined. Basalious et
(SGF), and simulated intestinal juice (SIF) 94. If al. and Elnaggar et al. carried out TEM
the clarity is maintained with increasing examinations by staining the samples. In both
dilution and a change in the type of diluent, this experiments, the drop of the diluted formulation
indicates the absence of drug precipitation 81. was placed on a copper grid and, after staining
The 100-time dilution of SMEDDS with all the with suitable dyes such as uranyl acetate, dried.
diluents mentioned above can simulate in-vivo Then the droplets were visualized for
conditions 95. The influence of the pH value of morphology detection, such as droplet size and
the dilution medium can be examined by shape. Some other colorants can also be used,
diluting SMEDDS with various solvents such such as B. 1% phosphotungstic acid solution
as buffer pH 1.2, buffer pH 6.8, etc., together and 1% methylamine vanadate 88. TEM
with distilled water, and the transparency and examinations can also be used to determine the
efficiency of the self-emulsification should be uniformity of the droplet sizes 75, 76.
observed 73.
11. Differential Scanning Colorimetry: It is
8. Refractive Index: The index of refraction is mainly used to characterize micro-emulsions
the property by which the isotropic nature of formed by diluting SMEDDS with peaks
dilute SMEDDS, a micro-emulsion, can be corresponding to water. The peaks provide
determined. Karamustafa and Celebi' performed information about the state of the water as a
refractive index measurements of the optimized bound or Free State. Pure water is used as a
formulation at 4 °C and 25 °C for up to 6 hours reference, showing a large, sharp peak at
at different time intervals and concluded that around -17 ° C, indicating the freezing point.
there was no significant change in the refractive Podlogar et al. DSC experiments carried out on
index, indicating the constant microemulsion water micro-emulsions, isopropyl myristate
structure 92. The constant refractive index also system Tween 40 / Imwitor 308 and identified
indicates the thermodynamic stability of the peaks which correspond to water at a lower
formulation. Refractive index measurements temperature than pure water (approx. -45'C at
are usually carried out with refractometers 93. 15% W/W) shows the presence of the bound
The refractive index depends mainly on two state in micro-emulsions preferably bound to
factors, namely the amount of co-surfactant and surfactants. A higher water concentration than
the size of the beads. The refractive index this leads to a change in temperature. From the
decreases with increasing cosurfactant observations of thermal water behavior, they
concentration, which is due to the decrease in concluded that the high-water concentration (>
the rigidity of the micro-emulsion structure and 35% p / w) generated micro-emulsions O / W
increases with increasing bead size 89. 77, 98
.

12. NMR Techniques: These are used to evaluate useful for determining transitions in micro-
the structure of the micro-emulsions formed emulsion structures after dilution and for
after diluting SMEDDS. The diffusion behavior determining droplet size and shape 84, 99.
of the components of the micro-emulsion can
be investigated with the help of the pulsed 14. Thermodynamic Stability Studies: These
gradient spin echo (PGSE) method of Fourier studies are useful to assess the consequences of
transform. Examined with the PGSE-NMR a temperature change in the formulation. The
method. The droplet size of the micro-emulsion formulation is diluted with an aqueous phase
can be determined with 129xe NMR by and centrifuged for 15 min at 15,000 rpm 81 or
observing the shift of the signal to a higher field 30 min at 3,500 rpm. The sample in which
with the corresponding increase in the droplet phase separation is not observed is subjected to
size. Self-diffusion NMR studies are used to freezing and thawing cycles (-20 ° C and 40 °C
determine the type of micro-emulsion that temperature, respectively) and observed
forms upon dilution of SMEDDS and also to visually. Thermodynamically stable
determine transitions such as W / O to bi- formulations show no change in the visual
continuous and bi-continuous to O / W type in description 81, 96.
incremental dilution. This technique compares
15. In-vitro Dissolution Profile: The release of the
the self-diffusion coefficients of the micro-
drug from the formulation can be assessed after
emulsion components with those of the pure
placing the formulation in a hard gelatin
components. Suppose the diffusion of any of
capsule with Apparatus I of USP XXIII at 100
the components is less than that of the pure
rpm or Apparatus II of USP XXIII at 50 rpm or
component. In that case, this indicates the
with the dialysis method. at 37 ± 0.5 °C 101, 102.
presence of droplets, that is, O / W or W / O,
Samples should be taken from the medium at
and cosurfactant also diffuses slowly through
regular intervals and the active substance
these components due to the formation of a film
content estimated and compared with the
around the droplets. If the oil and aqueous
control. The polarity of the oil droplet
phases have high diffusion coefficients and are
influences the active ingredient release from
of the same size as the neat components, this
diluted SMEDDS. The higher the polarity, the
indicates the presence of a bi-continuous micro-
faster the drug will be released from the oil
emulsion. 91,99.
droplet into the aqueous phase. The polarity
13. Small-Angle X-Ray and Neutron Scattering depends mainly on the HLB of the surfactant,
Methods: Small-angle X-ray scattering the molecular weight of the hydrophilic part of
techniques are useful for characterizing the surfactant, and its concentration, together
structures formed by thinning SMEDDS. with the degree of unsaturation of the fatty acid
Assessment of the liquid crystal structures of the lipid phase. In a study performed by
formed by dilution of SMEDDS is important as Jantratid et al., a comparison is made between
they determine formulation stability, self- the drug release profile using paddle-type
emulsion and the degree of drug release. apparatus and the reciprocating cylinder using
Goddeeris et al. performed small-angle X-ray USP apparatus 3. The active ingredient release
scattering studies on formulations containing from liquid lipid dosage forms such as
different proportions of water. A random SMEDDS is more suitable than the paddle
lamellar or periodic structure was observed at method and provided reproducible results
10% w / w (lower) water concentration, and compared to the paddle method and concluded
lamellar structures were observed at 20% w / w that this behavior is due to the even breakdown
water concentration. It showed hexagonal or of the oil layer by the movement of the inner
lamellar structures at a water concentration of cylinder can be attributed to net inserts
40% w / w. The temperature increase from 25 ° compared to the paddling method 103,104.
C to 37 ° C did not significantly change the
16. Stability Assessment: Stability studies are
liquid-crystalline structures formed [100].
performed on the formulation packaged in
Methods of small-angle neutron scattering are

gelatin capsules according to ICH guidelines. properties change during storage conditions, the
Samples should be taken at regular intervals formulation can be closed as a stable
and analyzed for appearance, color, active formulation 90, 102. The various marketed
ingredient content, pH value of the diluted formulations of SMEDDS are shown in Table
formulation, and dissolution profile. If all these 2.
TABLE 2: VARIOUS MARKETED FORMULATIONS OF SMEDDS 126, 127, 128
S. no. Drug Indication Brand name Manufacturer Dosage form
1. Paclitaxel Anticancer Paclitax Cipla Ltd Intravenous injection
2. Fenofibrate Antihyperlipidemic Lipired Square pharmaceutical Ltd Hard gelatin capsule
3. Cyclosporine Immunosuppressive Genraf AbbVie Hard gelatin Capsule
4. Naproxen Analgesic Arthopan Crescent therapeutics Ltd Tablet
5. Tipranavir Anti –HIV Aptivus Boehringer Ingelheim Soft gelatin Capsule
6. Acyclovir Antiviral Ocuvir FDC Ltd Tablet
Application 106, 107, 108: Various applications of 7. Controlled Release Formulation: The
SMEDDS are discussed below: addition of polymer into the SMEDDS
composition provides a sustained/controlled
1. Improving the Solubility and Bioavailability: release of the drug. 110-112
Increasing the bioavailability of BCS class II
drugs several times by improving drug Recent Trends in Smedds 113, 125:
solubility and rate of dissolution. 1. Self-micro Emulsifying Mouth Dissolving
Film (SMMDF): SMMDF was developed for
2. Protection of the Drug from Biodegradation: water-soluble drugs. Indomethacin was made by
Many drug formulations degrade in fusing self-emulsifying segments to a solid support
physiological fluids/systems due to the change (microcrystalline cellulose [MCC], low-substituted
in pH around the drug. Since the acidic pH HPMC, and hypromellose). SMMDFs breakdown
value in the stomach leads to enzymatic or in 20 seconds, and the active ingredient was
hydrolytic degradation, an obstacle between the completely released into the disintegration medium
drug and the degrading environment is formed with a bead size of 28.81 ± 3.26 nm within 5
due to the LC phase. minutes. The units of measure complied with the
2010 Chinese Pharmacopoeia criteria for
3. No Effect of Lipid Digestion Process: This
consistency parameters. Pharmacokinetic
drug delivery system is not affected by lipolysis
parameters such as T-max, C-max, and area under
as this system is not broken down by the action
the curve (AUC) were measured compared to
of pancreatic lipases and bile salts, as this only
liquid SMMDF and SMEDDS. The C-max and
help in self-emulsification of the formulation.
AUC for SMMDF have been found to be
4. Drug Loading Capacity Improvement: significantly higher than those for normal, mouth-
Formulation excipients provide high drug dissolving films or tablets with poor water
solubility, resulting in the formulation's high solubility.
drug loading capacity. 2. Sponges Carrying SMEDDS: Sponges wear
SMEDDS to improve the solubility of lipophilic
5. SMEDDS for Herbal Medicines and
drugs, but their liquid nature has been a limitation
Traditional Medicines: A large number of
to their wide use. Its sponge expansion, created
herbal and traditional medicines are used to
using a common hydrophilic polymer, is another
develop SMEDDS because most contain
system for the SMEDDS scheme. Its nanosponge
volatile and solid oils 109.
structure focused on inspecting in electron
6. Peptide Delivery: This drug delivery system microscopy and little Edge x-pillar diffuse. The oil
offers protection against enzymatic degradation globules were dried, and 9 nm SMEDDS were
in the GIT, as this system is suitable for the found on the dry sponge. The sponge was
delivery of peptides, hormones, rehydrated and the presence of SMEDDS was
substrates/enzyme inhibitors. determined on the rehydrated sponge.

SMEDDS containing Nile Red (soluble in all dry can be expected with permanent phase separation
and rehydrated sponges) are discharged drop by of the micro-emulsion. To solve this problem,
drop from the nanosponge at a rate that depends on sodium dodecyl sulfate was used in the SE
the drying method used. The drying schedule was preparations. Supersaturated SEDDS was
found to have an incredible impact on the developed for a parallel purpose by using small
nanosponge water absorption. SMEDDS could be a amounts of HPMC (and / or other polymers) in the
way of providing a solid framework for SMEDDS formulation to prevent drug precipitation from
that can cope with the use of hydrophobic drug creating a supersaturated state in-vivo and to
delivery. maintain side effects on GIT Liquid self-
emulsifiable materials can also be filled in the solid
3. Herbal SMEDDS 117: The SMEDDs delivered or semi-solid state in capsule shells, which are
fluids that filled hard gelatin capsules that have obtained by adding solid carriers such as polymers
been considered to formulate safe and stable dose and adsorbents. For example, the presence of a
forms for herbal extracts. The formulation's solid PEG matrix did not interfere with the self-
development and selection were based on the micro-emulsification process or the solubility of the
solubility and phase diagram results. Warke et al. drug. These are typically made in liquid form or
used the improved preparation for in vitro encapsulated in soft gelatin capsules.
dissolution consisting of Cremophor RH 40 (40%),
Plurol Oleique (30%), and herbal extract (30%) and Conventional liquid SMEDDS had some
showed a complete discharge in 10 minutes. drawbacks in the manufacturing process, which
SMEDDS successfully passed its solubility testing caused high production costs, were difficult to use,
in storage conditions as per ICH guidelines for 3 and also gave rise to problems of physical
months. Improved dissolution profiles of herbal incompatibility with the shells of soft gelatin
extracts were created from SMEDDS. SMEDDS capsules, they also gave rise to storage problems.
turned out to be an amazing approach to increasing Liquid SMEDDS can be prevented by filling the
the bioavailability and solubility of herbal capsules with S-SMEDSS. In the case of semi-solid
medicines. materials, the excipients materials are first melted
and then packed in capsules. The contents of the
4. Self-micro Emulsifying Floating Dosage form capsule are solidified to room temperature 119,120.
118
: The drug, which is poor in solubility, subject to
pre-systemic metabolism and irregular absorption Solid SMEDDS (S-SMEDDS): This new
of the drug throughout the gastrointestinal tract, is technology provides an effective replacement for
faced with poor oral bioavailability. The floating traditional liquid SMEDDS for low solubility
system increases the residence time of the drugs in drugs. SMEDDS is produced by adding semi-solid
the stomach, which leads to a prolonged release of / liquid SE components in powders or
the drugs. Adsorption on a mixture of highly nanoparticles. Different solidification technique
functional excipients, matrix-forming polymers like spray drying, absorption onto solid carriers and
such as HPMC E50 LV, HPMC K4M, and melt extrusion techniques are used by which it is
NaHCO3 (a gas-generating agent) to achieve a converted into solid nanoparticles of SE, which can
floating matrix with a controlled release drug be processed into other solid pharmaceutical forms
profile. In another experiment, floating alginate of SE such as capsules, solid dispersions, dry
beads containing tetra-hydrocurcumin (SEDDS) emulsions, microspheres, nanoparticles,
were developed to improve the solubility of drugs suppositories, implants, beads, granules and tablets
115
and to increase the residence time in the stomach. .
Using different levels of calcium chloride, a water-
soluble pore former, and sodium alginate in the Future Perspective: SMEDDS could be an
bead formulation resulted in different effects on effective way to overcome the problem of drug
their ability to float and drug release rates in vitro. solubility with relatively poor solubility in GIT
fluids. The role of gut lipids in solubilizing lipid-
5. SE Capsules: In the case of conventional SE based formulations could be better understood
formulations, no improvement in drug absorption through the combination of dispersion and in-vitro

digestion. In the future, the development of Over the past few decades, self-micro emulsifying
SMEDDS eliminates all complications associated drug delivery systems have been investigated for a
with administering low-solubility drugs. Have a variety of potential applications in diagnostic and
long way to cover, before more SMEDDS products drug delivery technologies. Pharmaceutical
are brought to market as more SMEDDS needs to industries have granted various patents for self-
be used, including bioavailability research and the micro emulsifying drug delivery devices. A couple
development of in-vitro and in-vivo correlation of these issued patents are shown in Table 3.
(IVIVC) and other dosage dosage forms 119. Patents
TABLE 3: PATENTED SMEDDS FORMULATIONS 130-134
S. no. Approaches Application Patent no. Inventor
1. SMEDDS of mitotane. Method was developed to enhance the US14/802,837 Hassan (2017)
bioavailability of a poorly water-
soluble drug using a surfactant and a
polar-lipids.
2. Self-micro emulsifying Increases bioavailability of poorly EP2062571A1 Hao WH, Hsu
formulation consisting of poorly soluble drugs Paclitaxel and Docetaxel. CS, Wang JJ
soluble drugs, vitamin E, co- (2012)
solvent, bile salts and surfactant.
3. SMEDDS of Imwitor 308 Enhanced solubility of formulation, US2010033135 Legen and Igor
containing oil, surfactant, co-surfactant 6 (2010)
and co-solvent.
4. Self-micro emulsifying Taxoid are poorly water-soluble EP1498143A1 Cote S, Goudel
formulation containing taxoid, compounds having high molecular G, Peracchia MT
surfactant and co-surfactant. weight and slightly lipophilic. (2005)
It enhances oral bioavailability of
toxoids through self-emusification.
5. SMEDDS of simvastatin Method of reducing effect of intestinal US6652865 Benomeur et al.
metabolism on drug using other (2003)
excipient in formulation.
CONCLUSION: Self-micro emulsifying drug CONFLICT OF INTEREST: We have no

delivery systems are a novel and efficient approach conflict of interest to disclose.
for enhancing the oral bioavailability of many
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How to cite this article:
Tushir R, Gupta B, Sharma R and Chauhan A: A concise review on novel approach for challenging pharmaceuticals through self – micro
emulsifying drug delivery system (SMEDDS). Int J Pharm Sci & Res 2022; 13(12): 4830-47. doi: 10.13040/IJPSR.0975-8232.13(12).4830-47.
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Tushir et al., IJPSR, 2022; Vol. 13(12): 4830-4847.

E-ISSN: 0975-8232; P-ISSN: 2320-5148

IJPSR (2022), Volume 13, Issue 12 (Review Article)

A CONCISE REVIEW ON NOVEL APPROACH FOR CHALLENGING PHARMACEUTICALS

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 Compared to emulsions, SMEDDS are Disadvantages 47, 48, 49:

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FIG. 1: MECHANISM OF SMEDDS 54, 60

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Formulation Design: The design is depicted as shown below:

FIG. 2: FORMULATION DESIGN OF SMEDDS 36

1. Screening of Excipients: determined by mixing equal proportions of

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microemulsion components have to be Method of Preparation:

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CONCLUSION: Self-micro emulsifying drug CONFLICT OF INTEREST: We have no

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