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z
Dr.D.Y.Patil institute of
pharmaceutical sciences and
research.
Modern pharmaceutics
Emulsion &Smedds
Presented by – Ms.Bhosale Pratiksha Ramchandra.
Content
 Introduction of emulsion
 Type of emulsion
 Test of identification of emulsion
 Theories of emulsion
 Classification of emulsifying agents
 Instability of emulsion
 Introduction of smedds
 Formulation of Smedds
 Advantages and disadvantage
 Reference
Introduction
 Defination- biphasic system consisting of two immiscible liquids,
one of which (the dispersed phase) is finely and uniformly
dispersed as globules throughout the second phase (the
continuous phase).
 thermodynamically unstable system. the emulsifier is added to
stabilize the system by forming a thin film around the globules
of dispersed phase .
 drug solubilized may be more bioavailable. Moreover, gastrointestinal problems and
first pass metabolic effect are also avoided.

Type of emulsion
 Oil in water
 . If the oil droplets are dispersed throughout the aqueous phase, the emulsion is termed
oil-in-water (O/W) .
 They are non greasy and are easily removable from the skin surface .
 used externally- to provide cooling effect
 internally -to also mask the bitter taste of oil.
 Water in oil
 water is dispersed as globules in the oil continuous phase is termed water-in-oil emulsion (W/O)
a
 Oil soluble drugs are more quickly released from W/O emulsion. They are preferred for for-
mulation meant for external use like cream W/O emulsion is not given a positive conductivity
tests, because oil is the external phase which is a poor conductor of electricity
O/W/O emulsion
W/O/W Emulsion
 Microemulsion
 It is thermodynamically stable & optically transparent.
 It is a mixture of biphasic oil- water system stabilized with surfactant.
 Size-10-120nm
Test for identification of emulsion
Dye test
Water soluble dye will dissolve in Aquaous phase(ex-amaranth)
Oil soluble dye will dissolve in oil phase(ex-, scarlet)
Conductivity test
This test is based on the ability of water to conduct electricity if the
water is continue is the continuous phase then the emulsion conduct
the electricity . If oil is the continuous phase the emulsion fails to
conduct
Dilution test
It is based on the external phase of emulsion
O/w Emulsion is diluted with water &w/o emulsion is diluted with
oil
Fluorescence test:
 Oils give fluorescence under UV light, while water doesn’t., O/W emulsion
shows spotty pattern when observed under UV. While W/O emulsion
fluoresces.
 Cobalt Chloride test:
It is water soluble so it changes colour when encountered by O/W emulsion.
Procedure: Filter paper is Dipped in Emulsion. Filter paper changes its color
from blue to Pink
 Result – Emulsion o/w is occur only
Theories of Emulsification
Sedimentation of interfacial tension -
1) lowering of interfacial tension.
2) Emulsification is occur due to the reducing the interfacial tension between two
phases
3) So it prevent the coalsence And phase seperatIon.
Oriented-Wedge Theory: - mono molecular layers of emulsifying agents are
curved around a droplet of the internal phase of the emulsion.
Interfacial film theory: - A film of emulsifying agent prevents the contact and
coalescing of the dispersed phase.
Repulsion theory
Emulsifying agent create a film over one phase that form a globules which repels
Classification of emulsifying
agents
 Surface active agents (monomolecular film)
Surfactant at the oil water interface and form monomolecular film.
 The mono molecular film should be compact and strong enough so that
it cannot be easily disturb or broken for any reason .if the film is broken,
it should be elastic and flexible enough so that it can be reformed rapidly
on moderate agitation
Hydroophilic-Colloids –
it promote formvation of o/w emulsion
form strong film Around the globule And prevent coalscence.
increase the stabily by viscosity inducing agent like tragacanth, CMC.
Finely divided solid particles
 particles are smaller than droplet
 finely divided solid particles that are wetted to some degree by both oil and water act
as emulsifying agent.
 This result from their being concentrated at interface,where they produce a particulate
film Around the dispersed droplets to prevent coalscence .
Preparation of emulsion
 Dry Gum method
 Oil+ gum=triturate—add water- again triturate
 Wet gum method
 Water+gum= triturate –add oil--again triturate
 Bottle method
 Used for volatile and viscous oil
Instability of emulsion
 Flocculation
 Flocculation occurs when there is an attractive force between the
droplets, so they form flocs.
 Coalescence
 occurs when droplets bump into each other and combine to form a
larger droplet, so the average droplet size increases over time.
 Creaming
 occurs when the droplets rise to the top of the emulsion under the
influence of buoyancy
 Phase inversion
 The change of emulsion type from o/w tO w/O Or vice versa.
z
SMEDDS
z
• SMEDDS consists of a mixture of drugs, oils,
surfactants and/or other additives.
•Gentle mixing of these ingredients in aqueous
media generates micro-emulsions with a droplet
size in a range of 10-100 nm.
•SMEDDS has been shown to improve absorption
of drugs by rapid self-micro emulsification in the
stomach, with the micro-emulsion droplets
subsequently dispersing in the gastrointestinal tract
to reach sites of absorption
Introduction of SMEDDS
z
SMEDDS are defined as isotropic mixtures of
natural or synthetic oils, solid and liquid surfactants”.
Or alternatively, one or more hydrophilic solvents
and co-solvents/surfactants that have a unique
ability of forming fine oil-in-water (o/w) micro
emulsions upon mild agitation followed by dilution in
aqueous media, such as GI fluids.
z
Oil phase:
Oils from natural sources and their derivatives.
The extension of a microemulsion region generally depends
on the nature of oil.
Examples: castor oil, sunflower oil, seseam oil,
hydrogenated
 Surfactant:
 Compounds that lower the surface tension (or interfacial
tension) between two liquids or between a liquid and a
solid. Surfactants used to stabilize microemulsion system
may be: non-oinic, zwitterionic, cationic and anionic
surfactants
Composition of SMEDDS
z
.
 Co-surfactant
 agents used to increase the solubility of drugs
by reducing the interfacial tension to a limit
below that of the surfactants.
 Examples: short chained alcohol (ethanol,
propanol, butanol) Glycols (propylene glycols)
z
Formulation of SMEDDS
Drug has to dissolve in to oil phase(lipophilic part) of
microemulsion.
Water phase is combined with the surfactant and then
cosurfactant is added slowly with constant stirring until the
system is become transparent.
The amount of surfactant and co-surfactant to be added
and the parent oil phase that can be incorporated is
determined with the help of pseudo ternary phase diagram.
Ultrasonicator can finally used to achieve the desired range
for the dispersed phase.
It is then allow to equilibrate.
Gel may be prepared by the addition of the gelling agent to
above microemulsion.
z
Advantages
 oral bioavailability increases
 selective drug targeting towards specific absorption window in GIT
 sensitive drug protection from hostile environment in gut.
 more consistent temporal profile of drug absorption
z
Disadvantages
• Lack of good predicative in vitro models for
assessment of the formulation is the most important
problem in the development of SMEEDS.
•Production cost is high.
•Highly loaded drug May have the chance of leakage.
z
Conclusion
 Self-microemulsifying drug delivery system is a novel
approach for the formulation of drug compounds with
poor aqueous solubility
 SMEDDS improve the dissolution of the drug due to
increased surface area on dispersion and solubility
effect of surfactant.
z
Marketed preparation
: BRANDS DRUG DOSAGE FORM DOSE
(mg) INDICATION
Neoral® Cyclosporine Soft gelatin Capsules
25, 100 Immunosuppressant
Norvir® Ritonavir Soft gelatin Capsules 100
HIV antiviral
Lipire® Fenofibrate Hard gelatin Capsules
200 Lowering of TG level
Convule® Valproic acid Soft gelatin
Capsules 100, 200 Antiepileptic
Refrence
http://ijpsr.com/bft-article/self-emulsifying-drug-delivery-
system-a-review/?view=fulltext
https://www.slideshare.net/HimalBarakoti/self-
microemulsifying-drug-delivery-system-smedds
https://www.slideshare.net/sagarsavale1/self-micro-
emulsifying-drug-delivery-systemmalBarakoti
Emulsion and SMEDDS.pptx

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Emulsion and SMEDDS.pptx

  • 1. z Dr.D.Y.Patil institute of pharmaceutical sciences and research. Modern pharmaceutics Emulsion &Smedds Presented by – Ms.Bhosale Pratiksha Ramchandra.
  • 2. Content  Introduction of emulsion  Type of emulsion  Test of identification of emulsion  Theories of emulsion  Classification of emulsifying agents  Instability of emulsion  Introduction of smedds  Formulation of Smedds  Advantages and disadvantage  Reference
  • 3. Introduction  Defination- biphasic system consisting of two immiscible liquids, one of which (the dispersed phase) is finely and uniformly dispersed as globules throughout the second phase (the continuous phase).  thermodynamically unstable system. the emulsifier is added to stabilize the system by forming a thin film around the globules of dispersed phase .  drug solubilized may be more bioavailable. Moreover, gastrointestinal problems and first pass metabolic effect are also avoided. 
  • 4. Type of emulsion  Oil in water  . If the oil droplets are dispersed throughout the aqueous phase, the emulsion is termed oil-in-water (O/W) .  They are non greasy and are easily removable from the skin surface .  used externally- to provide cooling effect  internally -to also mask the bitter taste of oil.  Water in oil  water is dispersed as globules in the oil continuous phase is termed water-in-oil emulsion (W/O) a  Oil soluble drugs are more quickly released from W/O emulsion. They are preferred for for- mulation meant for external use like cream W/O emulsion is not given a positive conductivity tests, because oil is the external phase which is a poor conductor of electricity
  • 5. O/W/O emulsion W/O/W Emulsion  Microemulsion  It is thermodynamically stable & optically transparent.  It is a mixture of biphasic oil- water system stabilized with surfactant.  Size-10-120nm
  • 6. Test for identification of emulsion Dye test Water soluble dye will dissolve in Aquaous phase(ex-amaranth) Oil soluble dye will dissolve in oil phase(ex-, scarlet) Conductivity test This test is based on the ability of water to conduct electricity if the water is continue is the continuous phase then the emulsion conduct the electricity . If oil is the continuous phase the emulsion fails to conduct
  • 7. Dilution test It is based on the external phase of emulsion O/w Emulsion is diluted with water &w/o emulsion is diluted with oil Fluorescence test:  Oils give fluorescence under UV light, while water doesn’t., O/W emulsion shows spotty pattern when observed under UV. While W/O emulsion fluoresces.  Cobalt Chloride test: It is water soluble so it changes colour when encountered by O/W emulsion. Procedure: Filter paper is Dipped in Emulsion. Filter paper changes its color from blue to Pink  Result – Emulsion o/w is occur only
  • 8. Theories of Emulsification Sedimentation of interfacial tension - 1) lowering of interfacial tension. 2) Emulsification is occur due to the reducing the interfacial tension between two phases 3) So it prevent the coalsence And phase seperatIon. Oriented-Wedge Theory: - mono molecular layers of emulsifying agents are curved around a droplet of the internal phase of the emulsion. Interfacial film theory: - A film of emulsifying agent prevents the contact and coalescing of the dispersed phase. Repulsion theory Emulsifying agent create a film over one phase that form a globules which repels
  • 9. Classification of emulsifying agents  Surface active agents (monomolecular film) Surfactant at the oil water interface and form monomolecular film.  The mono molecular film should be compact and strong enough so that it cannot be easily disturb or broken for any reason .if the film is broken, it should be elastic and flexible enough so that it can be reformed rapidly on moderate agitation
  • 10. Hydroophilic-Colloids – it promote formvation of o/w emulsion form strong film Around the globule And prevent coalscence. increase the stabily by viscosity inducing agent like tragacanth, CMC. Finely divided solid particles  particles are smaller than droplet  finely divided solid particles that are wetted to some degree by both oil and water act as emulsifying agent.  This result from their being concentrated at interface,where they produce a particulate film Around the dispersed droplets to prevent coalscence .
  • 11.
  • 12. Preparation of emulsion  Dry Gum method  Oil+ gum=triturate—add water- again triturate  Wet gum method  Water+gum= triturate –add oil--again triturate  Bottle method  Used for volatile and viscous oil
  • 13. Instability of emulsion  Flocculation  Flocculation occurs when there is an attractive force between the droplets, so they form flocs.  Coalescence  occurs when droplets bump into each other and combine to form a larger droplet, so the average droplet size increases over time.  Creaming  occurs when the droplets rise to the top of the emulsion under the influence of buoyancy  Phase inversion  The change of emulsion type from o/w tO w/O Or vice versa.
  • 14.
  • 16. z • SMEDDS consists of a mixture of drugs, oils, surfactants and/or other additives. •Gentle mixing of these ingredients in aqueous media generates micro-emulsions with a droplet size in a range of 10-100 nm. •SMEDDS has been shown to improve absorption of drugs by rapid self-micro emulsification in the stomach, with the micro-emulsion droplets subsequently dispersing in the gastrointestinal tract to reach sites of absorption Introduction of SMEDDS
  • 17. z SMEDDS are defined as isotropic mixtures of natural or synthetic oils, solid and liquid surfactants”. Or alternatively, one or more hydrophilic solvents and co-solvents/surfactants that have a unique ability of forming fine oil-in-water (o/w) micro emulsions upon mild agitation followed by dilution in aqueous media, such as GI fluids.
  • 18. z Oil phase: Oils from natural sources and their derivatives. The extension of a microemulsion region generally depends on the nature of oil. Examples: castor oil, sunflower oil, seseam oil, hydrogenated  Surfactant:  Compounds that lower the surface tension (or interfacial tension) between two liquids or between a liquid and a solid. Surfactants used to stabilize microemulsion system may be: non-oinic, zwitterionic, cationic and anionic surfactants Composition of SMEDDS
  • 19. z .  Co-surfactant  agents used to increase the solubility of drugs by reducing the interfacial tension to a limit below that of the surfactants.  Examples: short chained alcohol (ethanol, propanol, butanol) Glycols (propylene glycols)
  • 20. z Formulation of SMEDDS Drug has to dissolve in to oil phase(lipophilic part) of microemulsion. Water phase is combined with the surfactant and then cosurfactant is added slowly with constant stirring until the system is become transparent. The amount of surfactant and co-surfactant to be added and the parent oil phase that can be incorporated is determined with the help of pseudo ternary phase diagram. Ultrasonicator can finally used to achieve the desired range for the dispersed phase. It is then allow to equilibrate. Gel may be prepared by the addition of the gelling agent to above microemulsion.
  • 21. z Advantages  oral bioavailability increases  selective drug targeting towards specific absorption window in GIT  sensitive drug protection from hostile environment in gut.  more consistent temporal profile of drug absorption
  • 22. z Disadvantages • Lack of good predicative in vitro models for assessment of the formulation is the most important problem in the development of SMEEDS. •Production cost is high. •Highly loaded drug May have the chance of leakage.
  • 23. z Conclusion  Self-microemulsifying drug delivery system is a novel approach for the formulation of drug compounds with poor aqueous solubility  SMEDDS improve the dissolution of the drug due to increased surface area on dispersion and solubility effect of surfactant.
  • 24. z Marketed preparation : BRANDS DRUG DOSAGE FORM DOSE (mg) INDICATION Neoral® Cyclosporine Soft gelatin Capsules 25, 100 Immunosuppressant Norvir® Ritonavir Soft gelatin Capsules 100 HIV antiviral Lipire® Fenofibrate Hard gelatin Capsules 200 Lowering of TG level Convule® Valproic acid Soft gelatin Capsules 100, 200 Antiepileptic