The document discusses self-emulsifying drug delivery systems (SEDDS), which are isotropic mixtures of oils, surfactants, and co-solvents that can improve the oral bioavailability of lipophilic drugs. SEDDS form fine oil-in-water emulsions when exposed to aqueous fluids in the gastrointestinal tract. The document defines SEDDS and outlines their advantages, components, mechanisms of self-emulsification, evaluation methods, and formulations like capsules. SEDDS are a promising approach for improving absorption of BCS Class II and IV drugs with poor solubility.

1. Pune District Education Association’s Shankarrao Ursal College of
Pharmaceutical Sciences & Research Centre,
Kharadi, Pune-411014
Self-Emulsifying Drug Delivery System
Presented by-
Ms. Akshata More
F.Y. M. Pharm
Dept. of Pharmaceutics
Guided by-
Mrs. T. P. Shangrapawar
Dept. of Pharmaceutics
1

2. Contents
Introduction
Definition
Advantages
Disadvantages
Components
Mechanism of self emulsion
Dosage forms of SEDDS
Method of preparation
Evaluation
Conclusion
References
2

3.  Out of newly discovered drugs most of the drugs are found to be
lipophilic and out of which up to 40 % of pharmacologically
active new molecules failed to reach to market only due to
little or no water solubility.
 Therefore various formulation strategies have been investigated
to improve the solubility and the rate of dissolution to enhance
the oral bioavailability of lipophilic drugs.
 Amongst various approach self emulsifying drug delivery system
has gained more attention due to enhanced oral bio-availability.
introduction
3

4. definition
Self-emulsifying drug delivery systems(SEDDS) are defined as
isotropic mixtures of oils, surfactants and one or more co-
solvents.
Combinati
on of all
these
makes
SEDDS
Oil
Surfa
ctant
Co-
solvent
Drug
4

5. advantages
 Quick onset of action.
 Reduction in the drug dose.
 Ease of manufacture & Scale-up.
 Improvement in oral bioavailability.
 Increased drug loading capacity.
 Control of delivery profile.
 No effect of lipid digestion process.
 Protection of drug from environment in gut.
 Protection of sensitive drug substances.
 Selective targeting of drug toward specific absorption window in gut.
 They can effectively incorporate drug (hydrophobic or hydrophilic) within the
oil surfactant mixture.
 They can be used for liquid as well as solid dosage forms. 5

6. disadvantages
• Lack of good in vitro models for assessment of the formulations for SEDDS.
• Volatile co-solvents can migrate on capsule shell.
• The traditional dissolution methods does not work, because these
formulations potentially are dependent on digestion prior to release of drug.
• The large quantity of surfactant in self-emulsifying formulations(30-60%) may
cause irritation.
• High production costs.
• Low drug incompatibility.
• Drug leakage.
• Volatile co-solvents in the conventional SMEDDS formulations are known to
migrate into the shells of soft or hard gelatin capsules, resulting in the
precipitation of the lipophilic drugs.
6

7. components
1.Oil
 oils are the most important excipient.
 Help in solubilising lipophilic drug in a high amount.
 it can facilitate self-emulsification and increase absorption from GIT.
 Long-chain triglyceride and medium-chain triglyceride oils with different
degrees of saturation have been used in the design of SEDDSs.
List of oils used:
o Corn oil
o Peanut oil
o Olive oil
o Peppermint oil
o Sesame oil
o Hydrogenated soyabean oil
o Hydrogenated vegetable oils
7

8. 2. Surfactant
 Surfactant will improve bioavailability by different mechanism
Improve drug dissolution
Increase intestinal epithelial permeability
Increase tight junction permeability
 Surfactant strength ranges between 30-60% w/w of the formulation to form a
stable emulsion.
 Large quantity of surfactant may irritate the GIT.
 Non-ionic surfactants are less toxic as compared to ionic surfactants.
Examples
Liquid state Semi solid
state
waxes Fatty alcohols
• Span 80
• Span 20
• Polysorbate 20
• Polysorbate 80
• Brij 96
• Chremophore EL
• Yellow wax
• Paraffin wax
• Carnuba wax
• Cetyl alcohol
• Steryl alcohol
8

9. 3. Co-solvent/co-surfactant
 co-solvent/co-surfactant help to dissolve large amounts of hydrophilic
surfactants or hydrophobic drug in lipid base
 These solvents sometimes play the role of co-surfactant in the micro-emulsion
system
Examples
Co-solvent Co-surfactant
Ethanol
Glycerin
PEG
Propylene glycol
Span 20
Span 80
Capryol 90
9

10. 10
As, SEDDS are used to increase the solubility of poor water-soluble drugs,
BCS class II drugs are preferred.
e.g. itraconazole
nifedipine
vitamin E
ketoconazole
mefanimic acid
naproxen
carbamazepine
4. Drug

11. Mechanism of self-emulsification
• Free energy of conventional emulsion is a direct function of the energy
required to create a new surface between oil and water phases
• In emulsification process the free energy is given by the equation:
ΔG = ΣNπr2 σ
Where,
ΔG= free energy associated with the process
N=number of droplets
R=radius of droplets
σ= interfacial energy
11

12. Dosage forms of SEDDs
1.Oral delivery
A. Self-emulsifying capsule
B. Self-emulsifying controlled/sustained release tablets
C. Self-emulsifying controlled/sustained release pellets
D. Self-emulsifying solid dispersions
2. Topical delivery
3. Oculars and pulmonary delivery
4. Parenteral delivery
12

13. Method of preparation of SEDDs
A.Capsule filling with liquid and semisolid self-emulsifying
formulations
This is the simplest and most common technology for encapsulation of liquid or
solid emulsion for oral route.
Procedure for semisolid formulation
Heating the semisolid excipient
incorporation of active substance (with stirring)
Capsule filling with molt cooling to room temperature
Filling of formulation to capsules
13

14. B.Spray drying
Final SEDDS liquid formulation
Solubilized liquid formulation atomized into spray droplet
Droplet introduced into drying chamber
Volatile phase evaporate into tablet pattern
Drying of product
14

15. C.Adsorption to solid carriers
The adsorption process is simple and just involves addition of liquid on to the
carriers by mixing in a blender to obtain a free flowing powder.
D. Melt granulation
Melt granulation is a process in which powder agglomeration is obtained by
addition of a binder that melts or softens at relatively low temperature.
E. Extrusion spheronization
Melt extrusion spheronization is a solvent-free process that allows high drug
loading as well as content uniformity.
15

16. Evaluation
1.Dispersibilty test
• Performed using USP XXII dissolution apparatus 2 for dispersibility test
• 1ml solution in placed in 500ml water at 37 degree Celsius and operated at
50rpm.
• Fine milky emulsion formed within 2 mins is used for SEEDS formulation.
2. Turbidimetric evaluation
• It is done to monitor the growth of emulsification.
• Fixed quantity of sample is added to fixed quantity of suitable medium under
continuous stirring and increase in turbidity is measured using a
turbidimeter.
3. Viscosity
• SEDDS is generally administered in soft/ hard gelatin capsules. So it should be
easily pourable and must not be too thick to create a problem.16

17. 4. Refractive index
• Refractive index is measured by refractometer.
• A drop of solution is put on slide and compared it with water.
• It should be similar to that of water.
5. percent transmittance
• It is measured to prove the transparency of formulation and measured using
UV spectrophotometer at a particular wavelength
• It must be less than 99%.
6. Electro conductivity test
• Test is performed to determine electro conductive nature of system and
performed using electro conductometer.
17

18. 18
Conclusion
Self emulsifying drug delivery systems are actually mixtures of drug, lipid phase, emulsifier
and/or co-solvent. SEDDS are a promising approach for drugs with poor aqueous solubility
and hence can be more useful for BCS Class II and IV drugs as upon administration. When the
dosage form reaches G.I.T, the SEDDS system take water from its surrounding environment
and spontaneously forms oil in water emulsion which disperse into fine droplets. The finer
droplets provide higher surface area for the drug to dissolve or permeate in surrounding
medium. SEDDS are prepared generally in liquid dosage forms but solid SEDDS (tablets,
capsules, beads, microspheres etc.) are preferred due to ease in handling, transportation
and better stability.
Also it avoids GI irritation and controlled and sustained release of drug release is achievable.
Absence of suitable in vitro models explaining the state (whether dissolved or not) in G.I.T
(in vivo) for evaluation of SEDDS are major hurdles. Further, with solid SEDDS, compatibility
and interaction studies between the excipients such as adsorbent, capsule shell &
formulation components can be carried out in order to effectively harness its potential for
the benefit of mankind. The SEDDS should be suitably exploited to develop platform
technologies for improving bioavailability of BCS class II and IV drugs.

19. 19
References
Nigade P.M., Patil S.L., Tiwari S.S. (2012). “Self Emulsifying Drug
Delivery System (SEDDS)”: A Review HPBS. 2 (2), 42-52
Sarpal K., Pawar Y.B., and Bansal A.K. (2010) “Self Emulsifying Drug
Delivery System (SEDDS)”: A Strategy To improve oral bioavailability”,
(CRIPS). 11(3), 42-49
Ministry R.B., Sheth N.S., (2011) A Review: “Self Emulsifying Drug
Delivery System (SEDDS)”: IJPPS. 3(2), 23-28
https://www.ncbi.nlm.nih.gov/pubmed/15082340
Chouksey r, et al: Preparation and evaluation of the self-emulsifying
drug delivery system containing atorvastatin HMGCOA inhibiter.
International Journal of Pharmacy and Pharmaceutical Sciences 2011;
3(3): 147-152.

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 Sharma V, et al: SMEDDS: A novel approach for lipophilic drugs. International
Journal of Pharmaceutical Science and Research 2012; 3(8): 2441-2450.
 Kumar A, Sharma S, Kamble R: Self-emulsifying drug delivery system
(SEDDS): future aspects. International Journal of Pharmacy and
Pharmaceutical Sciences 2010; 2(4): 7-13.
 Patel P A, et al: Self Emulsifying Drug Delivery System: A Review. Research
Journal of Pharmacy and Technology 2008; 1(4): 313-323.
 Revathi S, Dhana Raju MD: Self-emulsifying drug delivery system: A review.
World Journal of Pharmacy and Pharmaceutical Sciences 2013; 2(1): 89-107.
 Kumar S, Gupta S and Sharma P K: Self-Emulsifying Drug Delivery Systems
(SEDDS) for oral delivery of lipid based formulations. African Journal of
Basic & Applied Science 2012; 4 (1): 07-11.
 https://www.sciencedirect.com/science/article/pii/S0753332204000319
 http://ijpsr.com/bft-article/self-emulsifying-drug-delivery-system-a-
review/?view=fulltext

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Thank you ……