An emulsion is comprised of two immiscible liquids where one liquid is dispersed in droplets within another liquid. Emulsions are thermodynamically unstable. Propofol is a potent anesthetic that exists as an oil-in-water emulsion. Injectable propofol emulsion is a nanoemulsion where nearly all particles are in the nanometer size range, though some may be in the micron range. Particles larger than 5 microns could block blood capillaries and cause embolisms, so regulatory standards require less than 0.05% of particles be above this size. Techno Drugs' propofol emulsion has a mean droplet size of only 220 nm, smaller than the smallest human

2. An emulsion is usually comprised of two or more
immiscible liquids where one liquid in the form of
droplets is dispersed (the dispersed phase) in another
liquid (the continuous phase)
The surface of each droplet is
an interface between hydrophilic
and hydrophobic molecules
Emulsion is thermodynamically
unstable
 The stability of an emulsion
can also be affected by many
external factors including
storage methods (glass vs.
plastic), time, and temperature.

3.  Propofol (2,6-diisopropylphenol) is a
potent lipophilic anesthetic that is an oil-in-
water or lipid-based emulsion.

4. Injectable Propofol emulsion is Nano
Emulsion
99% particles are in nano meter size
range (1 nano meter-500 nano meter).
Some Particles are micron range
Those bigger particles are produced
due to high pressure homogenization
inefficiency, emulsion instability or
various other factors
According to the USP 729, particles
bigger than 5 micron should be less
than 0.05%
So the boundary is size >5 micron
amount <0.05% which is called PFAT5.
Conventional Emulsion: 1-20 µm
Nano/Micro Emulsion: 10-200 nm

5. The minimum diameter of human
blood capillary is 5-7 micron.
If the injectable emulsion has fat
globules/particles larger than 5
micron it will block the blood
capillary.
The normal blood flow will be
stopped.
Thus blood vessel embolism may
cause death to a patient.

6. Histology: Oil-Red-O staining of fat
Stable Infusion Unstable Infusion
DFD-HMS-06

9.  Method I – Dynamic or Static Light Scattering
 Mean Droplet Size (MDS), expressed as the
intensity-weighted MDS, and must be < 500 nm
 Method II – Light Extinction employing Single-
Particle Optical Sensing
 Large-Diameter Tail, expressed as the volume-
weighted percentage of fat > 5 micrometers or
PFAT > 5 µm or PFAT5 , and must be < 0.05%

10. Lipid Emulsion Profiles:Lipid Emulsion Profiles:
Soybean Oil-Based ProductsSoybean Oil-Based Products
ProductProduct Lot No.Lot No. MDS (nm) PFAT5
Intralipid 10%Intralipid 10% 12202-5112202-51 286286 0.009%0.009%
Intralipid 20%Intralipid 20% 10776-7110776-71 340340 0.009%0.009%
Intralipid 30%Intralipid 30% 16115-5116115-51 420420 0.007%0.007%
Liposyn III 10%Liposyn III 10% 45351-DE45351-DE 263263 0.013%0.013%
Liposyn III 20%Liposyn III 20% 43440-DE43440-DE 307307 0.005%0.005%
Liposyn III 30%Liposyn III 30% 41395-DE41395-DE 301301 0.029%0.029%
Lipofundin N 10%Lipofundin N 10% 8085A838085A83 272272 0.001%0.001%
Lipofundin N 20%Lipofundin N 20% 8082A848082A84 332332 0.005%0.005%
Techno DrugsTechno Drugs
Propofol EmulsionPropofol Emulsion
XXXXXXXXXXXX 220220 N/AN/A
Boldface = Lipids currently available in the U.S.;= Lipids currently available in the U.S.;
USP Globule Size Limits: MDS < 500 nm; PFAT5 < 0.05%MDS < 500 nm; PFAT5 < 0.05%

11. Why Techno Drugs Propofol is UniqueWhy Techno Drugs Propofol is Unique
 Study report shows Techno Drugs Propofol emulsion contain
Smallest Mean Droplet Size (220 nm) of emulsion Fat
Globule Comparing to world famous Injectable Emulsion
 Since, 220 nm globule size is much smaller than human
smallest capillary (5-7 micron) therefore, there is no risk for
capillary blockage and embolism
 In Bangladesh market, Techno Drugs is the only company
who is using Injectable emulsion globule size analyzer from
“Particle Sizing System, USA”. The instrument is USP 729
compliance.
 For efficient homogenization of Propofol emulsion Techno
Drugs using world famous High Pressure Homogenizer from
Avestin, Canada.
 To ensure patient safety and quality of propofol emulsion
Techno Drugs using all the equipment from Europe and USA.

12. Thank
You