2. CONTENTS
Introduction.
Routes of administration.
Advantages and Disadvantages.
• Classification.
• Quality control tests.
• Conclusion.
• References.
• Acknowledgement.
2vignan pharmacy college,vadlamudi,Guntur dist.,A.P.
3. • The term parenterals derived from greek word “Para” means
outside and “enteron” means intestine.
• Parenterals are sterile solutions or suspensions of drug in aqueous
or oily vehicle.
• Parenteral drug administered directly in to the veins, muscles or
under the skin or more specialized tissue such as spinal cord.
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4. ROUTES OF ADMINISTRATION
Intra dermal
Subcutaneous
Intra synovial
Intra arterial
Intra thecal or
Intra spinal
Perfusion
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college,vadlamudi,Guntur dist.,A.P.
6. Advantages
For immediate
physiological response in
conditions of cardiac arrest
asthma, shock.
Insulin and antibiotics are
not effective in oral
administration can be
given.
For unconscious patients.
It gives local effects in
dentistry and in
anesthesiology.
Disadvantages
More expensive.
Psychological distress to
the patients.
Potential for pain up on
injection.
Risk of needle stick
injuries and exposure to
blood borne pathogens by
health care workers.
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7. CLASSIFICATION
Small volume
parenterals (25-50ml)
Requires little or no
manipulation
Extended stability
Little wastage
Do not offer flexibility
in quantity
Large volume parenterals
(100-1000ml)
Free of preservative
Flexible but requires
manipulation
Volume must not exceed
1ml (except in irrigation
sols).
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9. In process quality control tests
Conductivity measurement.
Volume filled.
Temperature for heat sterility product.
Environmental control test.
Visual inspection.
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college,vadlamudi,Guntur dist.,A.P.
10. Tests for parenterals
“Finished product quality control test “.
There are mainly seven quality control tests for parenterals are
performed :
Leaker test
Pyrogen test
Particulate test
Sterility test
Clarity test.
Closure integrity test
Weight variation test or content uniformity test.
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college,vadlamudi,Guntur dist.,A.P.
11. Leaker test for ampoules is intended to detect incompletely sealed
ampoules.
Tip seals are more likely to be incompletely closed by pull seals.
Open capillaries or cracks at the point of seal results in
‘”LEAKERS”
Detection of leaker is prominent when ampoules immersed in a
bath of dye during autoclaving cycle. This has the advantage of
accomplishing both leaker detection and sterilization in operation.
RESULT : Color from the dye will be visible within a leaker .
LEAKER TEST
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college,vadlamudi,Guntur dist.,A.P.
13. LEAKER TEST PROCEDURE
• Ampoules are placed in vacuum chamber.
• Completely submerged in a deeply colored dye
solution of about 0.5 to 1% methylene blue.
• A negative pressure is applied within the ampoules
subsequent atmospheric pressure causes the dye to
penetrate an opening thus making it visible after the
ampoules has been washed.
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college,vadlamudi,Guntur dist.,A.P.
14. Draw backs of leaker test
• Capillaries of1.5µ or smaller
diameter cannot be detected
by this test.
• Vials and bottles are not
subjected to such a leaker
test as the rubber closure is
not rigid.
D
R
A
W
B
A
C
K
S
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15. 1. LAL TEST
2. RABBIT
TEST2. RABBIT TEST1.LAL TEST
PYROGEN TEST
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college,vadlamudi,Guntur dist.,A.P.
16. LAL BACTERIAL ENDOTOXIN TEST
The LAL (limulus amebocyte lysate) assay is an in vitro assay used
to detect the presence and concentration bacterial endotoxins in
drugs and biological products.
ENDOTOXINS which a type of pyrogen are lipopolysaccharides
present in the cell wall of gram positive bacteria.
Pyrogens as a class are fever inducing substance that can be harmful
or even fatal if administered to humans above certain concentration.
Water can be a source of pyrogens. So it may be import to routinely
monitor water systems using bacterial endotoxin test.
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18. PROCEDURE FOR LAL TEST
(BACTERIAL ENDOTOXIN TEST)
In-vitro test method for pyrogen utilizing Gelling property
the combination of 0.1ml of test sample +LAL reagent
After incubation for 1 hour at 37ºC the mixture analysed for
the presence of gel clot.
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19. CRITERIA FOR LIMULUS TEST RESULTS
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college,vadlamudi,Guntur dist.,A.P.
20. PYROGENTEST
SHAM TEST : It is performed to select the proper animals for the
main test.
RABBIT TEST : Qualitative fever response test.
• The rabbit pyrogen test is an in-vivo test to detect pyrogens
qualitatively.
• Rabbits have a similar pyrogen tolerance to humans, so by
observing a change in body temperature in rabbit it is possible
to make a determination of the presence of pyrogens
• This method can detect non-bacterial endotoxin pyrogens as
well as bacterial endotoxins.
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college,vadlamudi,Guntur dist.,A.P.
22. Result for Rabbit Test
Result analysis
Negative:
Increase in
temperature
Positive:
No rise in
temperature
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college,vadlamudi,Guntur dist.,A.P. 22
23. Draw backs of pyrogen test
Not for anti-
pyretic drug
Laborious
and dose
depended
Expensive
Biological
variation
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college,vadlamudi,Guntur dist.,A.P.
24. TEST RESULTS
The test is positive when
each rabbit show
increase in temperature.
If only 2 of the 3 rabbits
show increase in
temperature repeat the
using group of 5 and
test will be positive if
the 4 of the 5 rabbit
show increase in
temperature.
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29. PARTICULATE EVALUATION METHOD
• The particles of lint,rubber,insoluble chemicals and other
foreign matter can produce emboli in the vital organs of
animals and human beings.
• The USP has identified two test methods:
• Light obscuration test
• Microscopic count test
• Light obscuration test : The electronic instrument used to
count and measure the size of the particles by shadow
cost by particles as it passes through a high intensit.
• Microscopic count method: If the injection formulation is
not clear it exceeds the limits specified the light
obscuration test it is subjected to the microscopic count
method.
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32. Clarity test
All the particulate matter is of primary concern with product
given i.vly . All parenterals products should be free from
insoluble particles.
The USP has established a limit of 50 particles of 10µm and
5particles of 25µm and larger per milliliter.
If the product contain any particulate matter then
it is rejected.
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36. Key Factors for Microbial Immersion Testing:
The method that is developed for microbial immersion
testing depends on several factors:
The type and size of the container will determine
the immersion approach.
The media fill can determine if dye ingress is
more appropriate than microbial immersion.
Microbial Immersion method
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college,vadlamudi,Guntur dist.,A.P.
37. Microbial immersion technique
Standard
Approach
Customized
Approach
Vacuum or Static Vacuum approach
is standard.
Container type
may require static
approach.
Challenge
Organism
Standard method
uses challenge
organism
recommended by
Lancaster Labs.
Client
requested/specifie
d based on need.
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college,vadlamudi,Guntur dist.,A.P.
38. Quality control should be a fundamental segment of parenterals
products manufacturing.
All of the 7 basic tests which are performed are essential and
have its own importance in parental production.
All of these tests ensure that product must meet the quality.
Each test is unique and provides detailed assessment of quality
control for parenterals products.
CONCLUSION
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college,vadlamudi,Guntur dist.,A.P.
39. REFERENCES
Remington ,The science and practice of pharmacy , 21stedition
volume-I,831-833.
Ajay Semalty , Mona semalty , MSM Rawat , Essentials of
pharmaceutical technology , 258-266.
Leon Lachman , Herbert A.Lieberman ,The theory and
practice of Industrial pharmacy , Special Indian edition 2009 ,
673-675.
L.K.Ghosh , Hand book of pharmaceutical technologies ,175-
182.
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college,vadlamudi,Guntur dist.,A.P.
40. ACKNOWLEGDMENT
I express my sincere gratitude towards my guide,
Mrs.K.Pallavi mam for encouraging me to complete my
seminar and special thanks to Principal sir Dr. P. Srinivasa
babu sir and seminar committee for giving me this
opportunity.
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college,vadlamudi,Guntur dist.,A.P.