Self-nano emulsifying drug delivery systems (SNEDDS) are anhydrous homogeneous liquid mixtures, composed of oil, surfactant, drug, and/or cosolvents, which spontaneously form transparent nanoemulsion (20–200 nm droplet size) upon aqueous dilution with gentle agitation SNEDDS can offer the advantages of improved physical and/or chemical stability of the formulation and ability to fill them into unit dosage forms, such as soft/hard capsules, which improves their commercial viability and patient compliance/tolerability and minimizes palatability-related concerns
2. Contents
• Drug of choice
• Physiochemical properties of Glibenclamide
• Introduction
• Need for SEDDS
• Advantage
• Disadvantage
• Classification of lipid carrier
• Formulation Consideration
• Excipient used in SEDDS
• Preparation and method for SNEDDS
• Evaluation of SNEDDS
• Application
• Conclusion
• Reference
3. Drug of Choice- Glibenclamide
• Also called Glyburide.
• Glyburide is an oral second-era sulfonylurea
drug employed in the treatment of type II diabetes.
• Being a biopharmaceutical classification system
(BCS) class II drugs, it's very low water solubility
leads to incomplete and variable bioavailability.
4. Physiochemical Properties of
Glibenclamide
• MW-494
• Hydrogen bond donor count-3
• Hydrogen bond acceptor count-5
• Rotatable bond count-8
• Solubility-2.06-3 g/l
Pharmacokinetic profile-
• Excretion-
50%- Urine
50%- feces
• Clearance- 2.47-4.11 L/h
• Half life- 4.0-13.4h
5. Needs for SEDDS
• 40% of new drug candidates show poor aqueous
solubility and so poor bioavailability.
• BCS class II drugs( dissolution is rate limiting step
for absorption).
• BCS class II and Class IV needs some
improvement in their solubility.
• Enhancement of bioavailability for oral
formulation.
6. Introduction
• SNEDDS is an emulsion based system.
• It consist of isotropic anhydrous homogenous
liquid mixtures.
• These mixtures contains oil, surfactants, co-
surfactants and API.
• It will produce O/W emulsion into aqueous media.
• A nanoparticles size ranges between less than or
equal to 200nm.
• SNEDDS contains high amounts of lipids increases
absorption and bioavailability of poorly water
soluble drugs.
7. Advantage
• Thermodynamically and kinetically stable
• SNEDDS improve the solubility of BCS class II
and Class IV drugs.
• Improving dissolution as well as absorption rate.
• Novel approach for enhancing gastrointestinal
absorption of poorly water soluble drugs.
• Transparent or translucent non ionized dispersion
of O/W and W/O Nano-emulsion.
• SNEDDS can dissolved large amount of lipophilic
drugs.
10. Formulation Consideration
• The nature of the oil/surfactant pair.
• The concentration of surfactant
• Oil/surfactant ratio
• the concentration and nature of co surfactant
• Surfactant and co-surfactant ratio
• Temperature at which self emulsification occurs
15. Screening of excipient
• The solubility of Glyburide was investigated in
oils, surfactants and co-surfactants.
• An excess amount drug was added in 2 g of
selected solvent in vials and mixed with the help of
shaker for 72 h at 37±1o
C.
• The resulting samples were centrifuged at 6000×g
for 15 min.
• The supernatant was diluted with methanol and
then quantified by a validated HPLC system.
• The size of oily droplets was determined
• immediately by dynamic light scattering (DLS).
16. Characterization
• Droplet size
• Zeta potential
• Polydispersity index
• Entrapment efficiency(%)
• Drug loading capacity
• FTIR
• Thermal characterization
DSC
TGA
• SEM and TEM
17. Evaluation of SNEDDS
• Some basic method are enlisted for evaluation of
SNEDDS-
1. Thermodynamic stability of emulsion
2. Centrifugation study( 5000rpm for 30 min)
3. Heating and cooling cycle
4. Freeze thaw cycle(4oc for 24h after that 40oc for
24h then centrifuged at 3000rpm for 5min then
monitored phase separation)
5. Droplet size(Photon correlation spectroscopy)
6. Viscosity(Brookfield Viscometer)
18. Application
• SNEDDS is formulated in a variety of formulation
such as-
1. Liquids
2. Sprays
3. Foams
4. Creams
5. Ointment
6. Gel
7. Nano-emulsion
19. Conclusion
• SNEDDS is a novel approach for the formulation of drug
molecule with poor water solubility.
• SNEDDS is an isotropic mixture of oils, surfctant.co
surfactant and co solvents.
• When introduced into aqueous phase it emulsifies
spontaneously to produce O/W Nano-emulsion under mild
agitation.
• SNEDDS provide a good alternate to those drugs which have
poor solubility.
• The oral delivery of lipophilic drug can be made possible by
SNEDDS.
• According to this approach it is possible to prolong the
release of drug via incorporation of polymer in composition.
• SNEDDS seems to be appear as unique and industrially
survival approach with futuristic development.