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Pankaj PPT.pptx
1.
2. MALARIA
Malaria, a very fatal disease, it have killed millions of people
over 30 years
caused by the parasites termed as Plasmodium.
Out of the several species of this parasite the following four are
a major cause of this disease:
Plasmodium malariae
Plasmodium ovale
Plasmodium falciparum
Plasmodium vivax
3. Malaria is transferred by the bite of female anopheles
mosquito in humans which in turn produces multiple
parasites into the body
There are 380 known species of the anopheles mosquito all
over the world out of which only 60 can cause malaria in
humans
Major carriers for the malarial parasite are listed below:
Humans and
Female anopheles mosquito
5. Currently used antimalarial drugs
Class Drug Use
4-Aminoquinoline Chloroquine For non – falciparum
malaria
8-Aminoquinoline Primaquine In treating P. Vivax & P.
ovale
Arylamino alchohol Quinine In treating extreme malaria
Mannich base antifolate Sulfadoxine Used with artesunate
8. Nanoemulsion comes under the category of novel drug
delivery systems
Size typically range from 50-200 nm
Nanoemulsions consist of oil molecules or droplets
dispersed in a watery phase or water droplets dispersed in
an oily phase depending on their method of preparation
Major difference between the emulsions and
nanoemulsions is that the exhibition of kinetic stability
and thermodynamic unstability
9. Advantages of nanoemulsions
Reduction of bad taste.
Enhances bioavailability.
Enhances the absorption rate.
Increased patient compliance.
Requirement of lesser energy.
10. Disadvantages of nanoemulsions
Large quantities of surfactant and cosurfactant is required
for nanoemulsion preparation.
Non toxic surfactant is required for nanoemulsion
preparation.
The nanoemulsion stability is effected by temperature and
pH.
12. Preparation of nanoemulsion
High energy emulsification methods
I. High pressure homogenization
The requirement of particle size in this
technique is 10-100nm. The mixture is forced
through a small inlet orifice at high pressure
giving extreme turbulent force resulting in the
formation of extremely fine particles
13. II. Sonication
Sonicator probe is used to provide energy. An
varying electric voltage is applied containing
piezoelectric qauartz crystals which expand and
contract in response to the electric voltage.
Cavitation is occurred by mechanical vibrations as
soon as the liquid medium comes in contact of the
tip of sonicator. The resultant ultrasound produces
the emulsion of droplet size 0.2mm and is mainly
used for laboratory purpose.
14. Low energy emulsification methods
Phase inversion
In this method a high temperature is applied to give the
varying phase transitions to give a nanoemulsion
Spontaneous emulsification
In this method the a homogeneous mixture of oil and
lipophilic surfactant is prepared in Hydrophilic
surfactant phase.The organic phase is injected using a
syringe in the aqueous phase with continuous
magnetic stirring resulting in the formation of the o/w
nanoemulsion. Finally the aqueous is removed by
heating the formed nanoemulsion.
18. Primaquine comes under the category of 8 aminoquinolone
which has higher efficacy in treating malaria.
Side effects include vomiting, heart failure, weakness,& cramps
Used in combination with other drugs.
The absorbtion capacity of primaquine significantly increases
when a nanoemulsion of Primaquine is used.
So primaquine is widely used in treating malaria as it is readily
absorbed by the liver in its nanoemulsion form because it is
less toxic.
19. AIMS & OBJECTIVES
AIM
“DEVELOPMENT AND EVALUATION OF LIQUID DOSAGE
FORM (EMULSION) FOR PREVENTION OF RELAPSING
MALARIA”
Objectives:
To avoid G.I. disturbances and undesirable side effects of
conventional dosage form of primaquine.
To increase patient compliance.
To avoid first pass effect of the drug.
To avoid taste masking process/cost of drug.
Minimize drug dose
20.
21. 1. Literature review
2. Selection of drug
3. Preformulation studies:
Identification of drug sample
Determination of absorption maxima (λmax)
IR determination
DSC
STD curve preparation
Selection of oils
Castor oil
Almond oil
Clove oil
Olive oil
Liquid paraffin
Selection of Smix ratio (Surfactant & cosurfactant)
Selection of emulsion (O/W & W/O)
Selection of method of preparation
High energy emulsification method
Low energy emulsification method
Phase inversion method
Spontaneous Emulsification method
22. 4. Formulation of nanoemulsion:
Preformulation study
Solubility of drugs in oils
HLB Value determination
Water and oil ratio optimization
Construction of phase diagram
Optimization of Smix ratio
5.Evaluation of nanoemulsion:
Dye test
Filter paper test
Light Microscopy
Viscosity
Zeta potential
pH
Centrifugation
Refractive index
6. Data analysis
7. Stability studies
8. Conclusion
27. LIST OF CHEMICALS USED
S. No. Name of the chemical Name of
supplier/manufacturer
1. Primaquine Gift Sample from ITL Labs,
Indore
2. Tween 80 RFCL Limited, Faridabad
3. Span 80 CDH Limited, New Delhi
4. Methyl Red Solution Fischer Scientific, Mumbai
5. Castor Oil Search Creations, Ujjain
6. Sodium Alginate CDH Limited, Delhi
7. Potassium Dihydrogen
orthophosphate
Qualigen fine chemicals,
Mumbai
8. Sodium Hydroxide CDH New Delhi
28. PREFORMULATION STUDIES
(A) Identification of drug sample:
Determination of absorption maxima (λmax at 259nm):
Absorption maxima in water:
35. Standard curve in water
y = 0.3567x
R² = 0.913
0
0.2
0.4
0.6
0.8
1
1.2
1.4
1.6
1.8
2
0 1 2 3 4 5 6
Absorbance
Cocentration
Concentration V/S Absorbance
36. STD curve preparation in 6.8 pH PBS
The plot of absorbance Vs concentration was plotted and subjected to
linear regression analysis. Drug was found to obey Beer Lambert’s law
in the concentration range of 5–25
Concentration (µg/ml) Absorption
5 0.313
10 0.559
15 0.717
20 0.905
25 1.107
37. y = 0.0387x + 0.14
R² = 0.9959
0
0.2
0.4
0.6
0.8
1
1.2
0 5 10 15 20 25 30
A
B
S
O
R
P
T
I
O
N
CONCENTRATION (µg/ml)
Calibration curve of primaquine in 6.8
pH P.B.S
39. Low energy method was used with 70% water and 30%
Oil & Smix ratio of 1:3 Tween 80: Span 80.
Surfactant and co surfactant ratio 1:3 was taken with 2ml
of castor oil followed by heating on a magnetic stirrer
with hot plate at a particular rpm.
Water drops were added by a syringe with continuous
magnetic stirring for 15 minutes followed by placing this
microemulsion on a sonicator till nanoemulsion is
formed.
40. Evaluation of dummy emulsion
pH, dye test and Refractive Index of dummy nanoemulsion
were evaluated as:
pH – 6.13
Refractive index – 1.475
43. The above procedure was repeated with varying
quantities of Smix ratio and drug.
pH, dye test, filter paper test of drug loaded
nanoemulsion were evaluated
pH was found to be 5.88
Refractive Index was found to be 1.471
45. Nano emulsion was now prepared by vortexing,
centrifugation, phase inversion, spontaneous
emulsification methods with the varying quantities of
Smix ratio and drug.
Same evaluation procedures were followed in all the
different methods accompanied by varying results.
A total of 8 formulations were prepared which is
depicted in the next slide.
51. CONCLUSION
The preparation of nanoemulsion was made by using
primaquine and castor oil
Batches F1 to F8 were prepared by using low energy
method for preparation of stable emulsion
From the results, it is clear that minimum concentration of
Smix ratio is less than 2%
The nanoemulsion of all the batches were evaluated for
different parameters like dye test, filter paper test, light
microscopy, pH (between 5 and 6.5), viscosity (between 37
to 43 cp), refractive index (between 1.450 to 1.570) & zeta
potential (between -2 to -5 mv)
52. The results of dye test, filter paper test and light
microscopy show that the emulsion is of o/w type.
Stability studies were performed on formulation
F3(final formulation) results for pH, viscosity and
refractive index showed no appreciable change up to 3
months of accelerated stability studies.
