Nanostructured lipid carriers (NLCs) were presented as a topical drug delivery system. NLCs consist of a blend of solid and liquid lipids which can incorporate drugs at high loading capacities. They were summarized to have advantages over solid lipid nanoparticles including avoidance of drug expulsion and unpredictable gelation. Methods for producing NLCs like high pressure homogenization were described. NLCs were said to increase skin permeation of drugs while providing occlusive and moisturizing properties beneficial for skin care. Several drug-loaded NLC formulations were presented including ones for flurbiprofen, minoxidil, and tacrolimus to improve their topical delivery and stability.
NIOSOMES , GENERAL CHARACTERISTICS OF NIOSOME , TYPES OF NIOSOMES , OTHERS TYPES OF NIOSOMES , NIOSOMES VS LIPOSOMES , COMPONENTS OF NIOSOMES , Non-ionic surfactant , Cholesterol , Charge inducing molecule , METHOD OF PREPARATION , preparation of small unilamellar vesicles , Sonication , Micro fluidization , preparation of large unilamellar vesicles , Reverse Phase Evaporation , Ether Injection , preparation of Multilamellar vesicles , Hand shaking method , Trans membrane pH gradient drug uptake process (remote loading) , Miscellaneous method :Multiple membrane extrusion method , The “Bubble” Method , Formation of Niosomes From Proniosomes , SEPARATION OF UNENTRAPPED DRUGS , Gel Filtration , Dialysis , Centrifugation , FACTORS AFFECTING THE PHYSICOCHEMICAL PROPERTIES OF NIOSOMES , Membrane Additives , Temperature of Hydration , PROPERTIES OF DRUGS , AMOUNT AND TYPE OF SURFACTANT
Structure of Surfactants , Resistance to Osmotic Stress , Characterization of niosomes ,Therapeutic applications of Niosomes , For Controlled Release of Drugs , To Improve the Stability and Physical Properties of the Drugs , For Targeting and Retention of Drug in Blood Circulation , Proniosomes , Aspasomes , Vesicles in Water and Oil System (v/w/o) ,Bola - niosomes , Discomes , Deformable niosomes or elastic niosomes , According to the nature of lamellarity ,Small Unilamellar vesicles (SUV) 25 – 500 nm in size.,Large Unilamellar vesicles (LUV) 0.1 – 1μm in size , Multilamellar vesicles (MLV) 1-5 μm in size , According to the size:Small Niosomes (100 nm – 200 nm) , Large Niosomes (800 nm – 900 nm),Big Niosomes (2 μm – 4 μm)
NIOSOMES , GENERAL CHARACTERISTICS OF NIOSOME , TYPES OF NIOSOMES , OTHERS TYPES OF NIOSOMES , NIOSOMES VS LIPOSOMES , COMPONENTS OF NIOSOMES , Non-ionic surfactant , Cholesterol , Charge inducing molecule , METHOD OF PREPARATION , preparation of small unilamellar vesicles , Sonication , Micro fluidization , preparation of large unilamellar vesicles , Reverse Phase Evaporation , Ether Injection , preparation of Multilamellar vesicles , Hand shaking method , Trans membrane pH gradient drug uptake process (remote loading) , Miscellaneous method :Multiple membrane extrusion method , The “Bubble” Method , Formation of Niosomes From Proniosomes , SEPARATION OF UNENTRAPPED DRUGS , Gel Filtration , Dialysis , Centrifugation , FACTORS AFFECTING THE PHYSICOCHEMICAL PROPERTIES OF NIOSOMES , Membrane Additives , Temperature of Hydration , PROPERTIES OF DRUGS , AMOUNT AND TYPE OF SURFACTANT
Structure of Surfactants , Resistance to Osmotic Stress , Characterization of niosomes ,Therapeutic applications of Niosomes , For Controlled Release of Drugs , To Improve the Stability and Physical Properties of the Drugs , For Targeting and Retention of Drug in Blood Circulation , Proniosomes , Aspasomes , Vesicles in Water and Oil System (v/w/o) ,Bola - niosomes , Discomes , Deformable niosomes or elastic niosomes , According to the nature of lamellarity ,Small Unilamellar vesicles (SUV) 25 – 500 nm in size.,Large Unilamellar vesicles (LUV) 0.1 – 1μm in size , Multilamellar vesicles (MLV) 1-5 μm in size , According to the size:Small Niosomes (100 nm – 200 nm) , Large Niosomes (800 nm – 900 nm),Big Niosomes (2 μm – 4 μm)
A Nanosuspension is a submicron colloidal dispersion of drug particles. A pharmaceutical nanosuspension is defined as very finely colloid, Biphasic, dispersed, solid drug particles in an aqeous vehicle , size below 1µm ,without any matrix material, stabilized by surfactants and polymers , prepared by suitable methods for Drug Delivery applications, through various routes of administration like oral ,topical ,parenteral ,ocular and pulmanary routes.
Colloidal particles ranging in size between 10 & 1000 nm are known as nanoparticles.
SLNs are new generation of submicron sized lipid emulsion where the liquid lipid(oil) has been substituted by a solid lipid.
Example: Capture - Dior
Introduction
Structure
Niosomes Vs. Liposome
Advantages & Disadvantages
Properties of Niosomes
Method of Manufacturing
Evaluation of Niosomes
Applications
Marketed products
Introduction
Need of Nanosuspension
Advantages of Nanosuspension
Disadvantages of Nanosuspension
Method Of Preparation
Formulation Considerations
Characterization of Nanosuspension
Current Marketed Formulations
Pharmaceutical Applications
Solid lipid nanoparticles (SLN) are most developing
formulations of nanotechnology with several applications in different fields like drug delivery, clinical medicine and research as well as in other varied sciences. SLN are defined as the spherical particles of nanometer range which immersed in water or aqueous surfactant solution either using lipophilic and hydrophilic drug. Solid lipid nanoparticle technology represents a promising new approach to lipophilic drug delivery.
A Nanosuspension is a submicron colloidal dispersion of drug particles. A pharmaceutical nanosuspension is defined as very finely colloid, Biphasic, dispersed, solid drug particles in an aqeous vehicle , size below 1µm ,without any matrix material, stabilized by surfactants and polymers , prepared by suitable methods for Drug Delivery applications, through various routes of administration like oral ,topical ,parenteral ,ocular and pulmanary routes.
Colloidal particles ranging in size between 10 & 1000 nm are known as nanoparticles.
SLNs are new generation of submicron sized lipid emulsion where the liquid lipid(oil) has been substituted by a solid lipid.
Example: Capture - Dior
Introduction
Structure
Niosomes Vs. Liposome
Advantages & Disadvantages
Properties of Niosomes
Method of Manufacturing
Evaluation of Niosomes
Applications
Marketed products
Introduction
Need of Nanosuspension
Advantages of Nanosuspension
Disadvantages of Nanosuspension
Method Of Preparation
Formulation Considerations
Characterization of Nanosuspension
Current Marketed Formulations
Pharmaceutical Applications
Solid lipid nanoparticles (SLN) are most developing
formulations of nanotechnology with several applications in different fields like drug delivery, clinical medicine and research as well as in other varied sciences. SLN are defined as the spherical particles of nanometer range which immersed in water or aqueous surfactant solution either using lipophilic and hydrophilic drug. Solid lipid nanoparticle technology represents a promising new approach to lipophilic drug delivery.
Niosomes is under the Novel drug delivery system. In which the drug are enclosed in the bilayer vesicle which is made up of the phospholipid. Niosomes are the similar to the liposomes both are made up of the bilayer of phospholipid. But in niosomes several advantages of over the liposomes.
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Pride Month Slides 2024 David Douglas School District
Nanostructured lipid carriers (NLC)
1. 02 April 2013
Seminar on
Nanostructured Lipid Carriers for Topical Drug Delivery System
Presented by: Guided by:
Mr. Sachin S. Mali Dr. A. A. Hajare
M.Pharm. (IInd Semester), Professor and Head,
Dept. of Pharm.Technology. Dept. of Pharm.Technology.
BHARATI VIDYAPEETH COLLEGE OF PHARMACY, KOLHAPUR.
1
2. »Abbreviations
NLC- Nanostructured Lipid Carrier
SLN- Solid Lipid Nanoparticles
HPH- High Pressure Homogenization
NSAID- Non Steroidal Anti Inflammatory Drug
LD- Laser Diffractometry
GRAS- Generally Recognized As Safe
PI- Polydispersity Index
2
3. » Ways to Go
» Introduction
» Excipients used in NLC
» NLC Techniques
» High pressure homogenization
» Mechanism of topical application
» Characterization
» Applications
» Conclusion
» Reference
3
4. » Introduction
» NLC which are second generation of SLN.
» NLC composed of binary mixture of solid lipid and a spatially different
liquid lipid as hybrid carrier.
» Average size between 10-500 nm.
4
5. »NLC hybrid carriers
» NLC consist of a mixture of specially blended solid lipid (long
chain) with liquid lipid (short chain), preferably in a ratio of 70:30
to 99.9:01.
5
7. » Objectives of NLC
To overcome disadvantages of SLN such as
Tendency for particle growth.
Unpredictable gelation tendency.
Poor drug loading capacity.
Drug expulsion after polymeric transition during storage.
High water content in dispersions have been observed i.e.70-99.9%.
7
8. »Excipients used in NLC
Solid lipids
A mixture of several chemical compounds which have high melting point
(higher than 40ºC).
These solid lipids are well tolerated of GRAS status.
Accepted for human use.
Also in vivo biodegradable.
Examples-
» Beeswax
» Carnauba wax
» Dynasan
» Precifac
» Stearic acid
» Apifil
» Cutina CP
8
9. » Cont...
Liquid lipids (OIL)
These solid lipids are well tolerated of GRAS status.
Accepted for human use.
Examples-
» Cetiol V
» Miglyol
» Castor oil
» Oleic acid
» Davana oil
» Palm oil
» Olive oil
9
10. » Cont...
Emulsifying agents
It is an surfactant, which is adsorbed at interfaces and lowers the interfacial
tension.
When a surfactant is present in small amounts, it enhances its colloidal
stability by decreasing either or both of the rates of aggregation.
Examples-
» Miranol ultra
» PlantaCare
» Tween 80
» Plaronic F68
» Polaxamer 188
» Phospolipon 90G
10
11. » Cont...
UV blockers
Help to protect the skin from the ultraviolet radiation of the sun.
Lowering the risk of skin cancer.
Sunscreen products contain either an organic chemical compound that absorbs
UV light.
Examples-
Avobenzone :- Absorb UV-A radiation (maximum absorption at 357 nm)
Butyl methoxydibenzoylmethane
Aquaous medium
The water used in all experiments was purified water by reverse osmosis.
11
13. » High pressure homogenization
Techniques of HPH
Hot HPH technique
Cold HPH technique
Hot HPH
Lipid and drug are melted (10oC above the melting point of the lipid) and
combined with an aqueous surfactant solution at the same temperature.
A hot pre-emulsion is formed by high shear device (e.g. using Ultra-Turrax).
The hot pre‐emulsion is then processed in a temperature controlled high
pressure homogenizer at 500 bar using piston gap homogenizer.
The obtained nanoemulsion recrystallizes upon cooling down to room
temperature forming NLC.
13
14. » Cont…
Cold HPH
Suitable for processing heat-labile drugs or hydrophilic drugs.
Lipid and drug are melted together and then rapidly ground under liquid
nitrogen forming solid lipid micro particles.
A pre‐suspension is formed by homogenisation of the particles in a cold
surfactant solution.
This pre‐suspension is then further homogenised in a HPH at or below room
temperature at predetermined homogenisation conditions to produce NLC.
Both HPH techniques are suitable for processing lipid concentrations of up to
40% and generally yield very narrow particle size distributions.
14
16. » Cont…
Advantages
Avoidance of organic solvents.
Short production time.
Possibility of production on large scale.
Disadvantages of Hot HPH
High heating temperature promotes degradation of the
labile active compounds.
Surfactant have cloud point lower than 850C therefore
high temperature may reduce the emulsifying capacity
of the surfactants this effect induce the instability to the
NLC.
16
18. » Benefits of topical application of NLC
Increase in skin occlusion and adhesiveness to skin.
Film formation, repair of stratum corneum.
Increase of skin hydration and elasticity.
Enhancement of skin permeation and drug targeting.
Enhancement UV protection system.
Enhancement of chemical stability of chemically labile
compounds.
i.e. skin healing, caring and protective effects.
18
19. » Characterization
Morphology (size and shape)
» Scanning electron microscopy (SEM)
» Transmission electron microscopy (TEM)
» Photon correlation spectroscopy (PCS)
Zeta Potential Analysis
» Zetasizer
Degree of Crystallinity and Lipid Modification
» Differential scanning calorimetry (DSC)
» X-ray diffraction (XRD)
Determination of Viscosity
» Rheometer
Drug Content and Entrapment Efficiency
» Ultracentrifugation followed by quantitative analysis by HPLC
19
20. » Cont...
In-vitro drug release study
Using Franz diffusion cell/ Keshary Chien diffusion cell and cellulose dialysis
membrane.
In-vitro skin penetration study
Using human cadaver skin/ wistar rats abdominal skin and Keshary chien
cell/modified Franz diffusion cell.
In-vitro skin occlusivity test
Prevention of water loss by the formulation will be studied. (De
Vringer, 1992, Wissing et al, 2001)
Primary skin irritation study
Will be carried out by using Draize patch test on rabbits.(Draize et
al, 1944, Verneer, 1991, Joshi and Patravale 2006).
20
21. » Applications
» Topical NLC carrier gel of flurbiprofen
Upon oral administration abdominal discomfort along with other gastrointestinal
side effects.
It has a short elimination half-life of 3.9 hours.
Flurbiprofen NSAID is used to treat gout, osteoarthritis, rheumatoid arthritis, and
sunburn.
» Minoxidil loaded NLC based hydrogel formulation
The lipophilic characteristics of this drug implies that conventional topical
formulations.
Applications of such formulations may cause severe adverse reactions.
Minoxidil has been widely used for the topical treatment of alopecia.
21
22. » Cont...
» Tacrolimus loaded NLC for topical drug delivery
The adverse effects of tacrolimus include transient burning, sensation, and
itching and having lower penetration profile.
Tacrolimus is a strong NSAID used for the management of atopic dermatitis.
» Miconazole nitrate loaded NLC improving the antifungal therapy
Poor dissolution and lack of absorption make it a poor candidate for oral
administration.
Miconazole nitrate (Bennett et al., 2001).
22
23. Advantages
» Higher drug loading capacity.
» Physical and chemical stability avoids expulsion of drugs during storage.
» Carriers are composed of physiological and biodegradable lipid.
» Exhibiting low systemic toxicity and low cytotoxicity.
» The small size of lipid particles enhance drug flux through the skin.
» Controlled release from these carriers are possible.
» The overall solid content of NLC could be increased up to 95% .
» NLC can easily be incorporated in creams, lotion.
23
25. » Conclusion
NLC are the new generation of nanoparticulate active substance vehicles and are
attracting major attention as novel colloidal drug carriers for topical use.
NLC systems with good perspectives to be marketed very successfully, reason for
this is they were developed considering industrial needs, e.g. scale up, qualification
and validation, simple technology, low cost, regulatory excipient status (e.g.
GRAS), tolerability etc.
Today HPH represents an efficient pathway for production of NLC as novel systems
composed of physiological lipid materials suitable for topical, dermal administration
novel drug delivery system.
Nanostructured lipid carriers hold great promise for reaching the goal of controlled
and site specific drug delivery and hence attracted wide attention of researchers.
25
26. »References
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B.R.Shivakumar BR, V. Ravindranath, Glutathione and protein thiol homeostasis in brain
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