This document discusses self-emulsifying drug delivery systems (SEDDS) and summarizes a research article that developed and evaluated an aceclofenac-loaded SEDDS. SEDDS are mixtures of oil, surfactant, and co-surfactant that spontaneously form fine emulsions when exposed to aqueous fluids. The research formulated 4 SEDDS using oleic acid, Tween 80 or Kolliphor EL, and PEG 400 or propylene glycol containing aceclofenac. Formulation F2 with Tween 80 and PEG 400 had the smallest particles size of 111.3 nm and highest drug release of 97.75% after 6 hours. All formulations were stable and showed higher ace

1. Self-emulsifying drug delivery systems
Presented by: Gaurav

2. INTRODUCTION
• Self emulsifying drug delivery system
(SEDDS) are defined as isotropic
mixtures of oil, surfactant & co-
surfactant
SEDDS
Drug
Co-
surfactant
Oil
Surfactant

3. Need of SEDDS
• Around 40% of new Drug shows poor aqueous solubility and poor
bioavailability.
• For BCS class II drugs (Low Solubility & High permeability)
• Selective targeting of drugs toward specific absorption window in GIT.
• Examples of BCS class II drugs:
Acetylsalicylic acid, Ibuprofen, Captopril

4. Act on Body ?
• SEDDS emulsify spontaneously to produce fine oil in water emulsions
when introduced into aqueous phase under gentle agitation (by
peristaltic movement) and absorb by lymphatic pathways.
• SEDDS produce emulsions with a droplets size 100 to 300 nm while
SMEDDS form transparent nano-emulsions with a size 50 nm and less.

5. Components for SEDDS
1. Oil
• Help in solubilizing the
lipophilic drug in high
amount.
• Facilitate self emulsification.
• Increase the fraction of
lipophilic drug transported.
• Increase absorption from GI
track
Examples:-
i. Corn oil
ii. Olive oil
iii. Soyabean oil
iv. Peanut oil
v. Palm seed oil
vi. Mixture of mono & di-
glycerides

6. 2. Surfactants
• Non- ionic surfactants with high hydrophilic-lipophilic balance (HLB)
value are used in SEDDS formulations.
• Surfactant concentration should be 30-60% w/w for the stable
formulation.
• Higher concentration may irritate GIT.
Examples:-
-Polysorbate 20 (Tween 20) -Sorbitan monooleate (Span 80)
-Polysorbate 80 (Tween 80) -Cremophor

7. 3. Co- Surfactants
• Co-Surfactant help to dissolve large amount of hydrophilic surfactants
or hydrophobic drug in lipid base.
• Co- Surfactant plays an important role in micro emulsion systems.
• Drug release is increased with increasing co-surfactant concentration
in formulation.
• Examples of Co-surfactant:
Polyethylene glycol, Glycerin, Propylene glycol.

8. Mechanism of Self Emulsification
• The free energy of the conventional emulsion is a direct function of
the energy required to create a new surface between the oil and
water phases.
• Free energy in the micro- emulsion formulation is directly
proportional to the energy required to create new surface between
the two phases and given by equation.
∆G = ∑Nπr²σ
Where,
∆G= Free energy associated with the process.
N : Number of droplets
R : Radious of droplets
σ : Interfacial energy

9. Types of dosage form
• As SEDDS may exist in liquid
or solid dosage form, but
due to better stability as
well as easy in handling and
transportation.
• Solid self emulsifying drug
delivery system are
generally preferred over
liquid SEDDS.
SEDDS
Capsules
Dry Emulsion
Suppositories
Tablets Beads
Nanoparticles
Pallets
Microspheres

10. Method of Solidification
1. Spray Drying
• Formulation contain oil, surfactant
drug & other solid carriers are
sprayed into a drying chamber
through a nozzle. The volatile vehicle
evaporate & leaving behind small
solid particles.
• This technique is use for preparation
of dry emulsion by removing water
from an ordinary emulsion.

11. 2. Spray Cooling
• Molten formulation is sprayed into cooling chamber.
• When this molten mixture comes in contact with cool air, the molten
droplets recrystallize into solid particles which collect into the bottom
of chamber in the form of fine powder.
3. Melt Extrusion
• Based on the property of materials which can be easily extruded and
spheronized.
• This technique do not require liquid excipients although constant
temp and pressure has to be maintained to achieve high drug loading.

12. Evaluation of SEDDS
1. Thermodynamim stability
studies.
a) Centrifugation
b) Freeze thaw cycle
c) Heating cooling cycle
2. Dispersibility test
3. Turbidimetric evaluation
4. Viscosity determination
5. Particle size
6. In-Vitro diffusion study
7. In-Vivo permeability studies

13. Marketed preparation
Drug Brand Name Company Formulation Indication
Cyclosporin A Sandimmun Neoral Novartis Soft gelatin capsule
Immuno-
suppressant
Ritonavir Norvir Abbott Soft gelatin capsule HIV Antiviral
Sanquinavir Fortovase Roche Soft gelatin capsule HIV antiviral
Valporic acid Convulex Pharmacia Soft gelatin capsule Antiepileptic
Amprenavir Agenerase Glaxo Smithkline
Soft gelatin capsule HIV antiviral
Calcitrol Rocaltrol Roche
Soft gelatin capsule
Calcium regulator

14. Title: Development and in vitro Evaluation
of Gastro-protective Aceclofenac-loaded
Self-emulsifying Drug Delivery
System
Journal: International Journal of nanomedicine
Impact factor: 4.47

15. Material
OIL = Oleic acid
SEDDS
PEG 400,
PG
Oleic
acid
Tween
80
surfactant =Tween 80, Kolliphor EL
co-surfactant = PEG 400, Propylene glycol
All excipients are selected on the basis of solubility study of Aceclofenac

16. Formulation
Surfactant Co-Surfactant
Oil
Smix
Surfactant: co-surfactant
1:1, 2:1, 3:1
Smix : Oil
1:1 to 1:2
Stirred slowly avoid
bubble
Group 1: Oleic acid, Tween 80 & PEG 400
Group 2: Oleic acid, Kolliphor EL & PG

18. Aceclofenac loaded SEDDS
• The entrapment efficiency of
formulation F3 shown higher
76%.
• Least entrapment efficacy was
73.1% of formulation F4.

19. Particle size
• The average globular size ranged
between 111.3 nm to 470.2 nm.
• The smallest size was shown in
formulation F2 (111.3 nm).

20. Thermodynamic stability studies
• All ACF-SEDDS formulations
showed no sign of precipitation,
cloudiness or separation.
• These data ensure the stability
of all SEDDS formulations on
different temperature and
environment fluctuation

21. In-Vivo study
• In-vitro release study were carried out in SGF & SIF. Along with
ACF suspension as control..
• In first 2 hrs of study ACF release was 24.81% (SGF) & 2.43%
(SIF)
• Drug release in SGF was significantly low.
Formulation 2 Hrs 4 Hrs 6 Hrs
F1 74% 98.13 -
F2 95% - 97.75%
F3 88.15% - 98.13%
F4 95.83 - 95.73%

22. Result summary
Formulation Composition Entrapment Drug Loading Particle Size
Thermodynamic
stability
Drug release
in SIF
F1 T80- PEG (1:9) 75.13 % 6.76 % 244.6 nm 98.13% (4 hrs)
F2 T80 – PEG (1:8) 73.20 % 7.33 % 111.3 nm 97.75% (6 hrs)
F3 KEL – PG (1:9) 76.00 % 6.60 % 389.4 nm 98.83% (6 hrs)
F4 KEL – PG (1:8) 73.10 % 7.32 % 470.9 nm 95.73% (6 hrs)

23. Conclusion
All the formulations are thermodynamically stable
Formulations shows high emulsification in short period of
time
Tween-80 & Kolliphor shows reduce drug release in SGF but
higher in SIF
ACF-SEDDS would be promising system for improve
solubility of lipophilic drugs

24. References
1. Jianxian C, Saleem K, Ijaz M, Ur-Rehman M, Murtaza G, Asim MH. Development and in vitro
Evaluation of Gastro-protective Aceclofenac-loaded Self-emulsifying Drug Delivery System.
International Journal of Nanomedicine. 2020;15:5217.
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review. Journal of drug delivery and therapeutics. 2013 Jan 14;3(1).
3. Maurya SD, Arya RK, Rajpal G, Dhakar RC. Self-micro emulsifying drug delivery systems
(SMEDDS): a review on physico-chemical and biopharmaceutical aspects. Journal of Drug
Delivery and Therapeutics. 2017 May 14;7(3):55-65.
4. Kyatanwar AU, Jadhav KR, Kadam VJ. Self micro-emulsifying drug delivery system (SMEDDS).
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5. Savale S, Chalikwar S. Self-Micro Emulsifying Drug Delivery System (SMEDDS): A Review.
Asian Journal of Biomaterial Research. 2017;3(2):12-7.
6. Sanghai B, Aggarwal G, HariKumar SL. Solid self microemulsifying drug deliviry system: a
review. Journal of Drug Delivery and Therapeutics. 2013 May 13;3(3):168-74.