DIPHTHERIA VACCINE

1. Topic :ADSORBED
DIAPHTHIRIA VACCINE
Presented by,
R.Venkatesan.
M.Pharm 1st semester
Dept. pharmaceutical analysis
Karnataka college of pharmacy
Bangalore
Presented to,
Dr.C.Sreedhar,
Professor and HOD
Dept. pharmaceutical analysis
Karnataka college of pharmacy
Bangalore
ADVANCED PHARMACEUTICALANALYSIS

2. 01 Introduction
02 Diphtheria
03 Adsorbed diphtheria vaccine
04 Biological adsorbed diphtheria vaccine
Content

3. Introduction
• Vaccine
a substance used to stimulate the production of antibodies and
provide immunity against one or several diseases, prepared from the
causative agent of a disease, treated to act as a antigen without
inducing the disease.
• Examples
 Adsorbed tetanus vaccine
 Adsorbed diphtheria vaccine
 Rabies vaccine
KARNATAKA COLLEGE OF PHARMACY 3

4. Toxoid vaccines
• Some bacteria release toxins (poisonous proteins) when they attack the
body, and it is the toxins rather than the bacteria itself that we want to be
protect against.
• The immune system recognizes these toxins in the same way what it
recognizes other antigens on the surface of the bacteria, and is able to
mount an immune response to them.
• Some vaccines are made with inactivated versions of these toxins
KARNATAKA COLLEGE OF PHARMACY 4

5. • They are called ‘toxoids’ because they look like toxins but are
not poisonous.
• They trigger a strong immune response.
• Examples
Diphtheria vaccine
Tetanus vaccine
Pertussis vaccine
KARNATAKA COLLEGE OF PHARMACY 5

6. Diphtheria
• Diphtheria is a serious infection caused by strains of bacteria called
corynebactrium diphtheriae that make toxins (poison).
• A sheet of thick, grey matter covers the back of the throat, making
breathing hard.
• Symptoms:
Difficulty breathing
Heart failue,
Paralysis,
Death in severe cases
KARNATAKA COLLEGE OF PHARMACY 6

7. • Diagnosis:
Detection of tox gene by PCR, ELISA
• Treatment:
Treatments include antibiotics (penicillin) and an antitoxin that
neutralizes the diphtheria toxin. A vaccine is available.
• History :
1883, pierre bretonneau gave the disease the name diphtheria
1883 Edwin klebs identify the bacteria named it klebs Loeffler
bacterium.
KARNATAKA COLLEGE OF PHARMACY 7

8. Adsorbed diphtheria vaccine
• Diphtheria vaccine (adsorbed) is a preparation of diphtheria formol
toxoid with a mineral adsorbent (hydrated aluminium hydroxide or
alumunium phosphate).
• Mineral adsorbent an ingredient used in some vaccines that helps
create a stronger immune response in people receiving the vaccine.
• The formol toxoid is prepared from the toxin produced by the growth
of Corynebacterium diphtheria.
• It is a toxoid type of vaccine.
KARNATAKA COLLEGE OF PHARMACY 8

9. Biological assay of adsorbed diphtheria
vaccine
1. Intradermal challenge method
2. Lethal challenge method
KARNATAKA COLLEGE OF PHARMACY 9

10. 1.Intradermal challenge method
• Principle
The potency of adsorbed diphtheria vaccine is determined by
comparing the dose necessary to protect guinea pigs against the
erythrogenic effects of range of intradermal injections of diphtheria
toxin with the dose of the standard preparation of adsorbed diphtheria
toxoid necessary to give the same protection.
KARNATAKA COLLEGE OF PHARMACY 10

11. procedure
• Standard preparation
Standard preparation consisting of toxoid adsorbed on a
aluminium hydroxide with polygeline.
• Test animal:
White guinea pig
Weight between 250 – 350 gm.
KARNATAKA COLLEGE OF PHARMACY 11

12. Determination of potency of vaccine
Vaccine dilute with saline solution
Inject guinea pig subcutaneously (1ml)
After 28 days shave both flanks of each guinea pig
0.2ml challenge toxin solution inject guinea pig-intradermally
After 48 hours, record the incidence of diphtheria erythema
Tabulate the intradermal score
KARNATAKA COLLEGE OF PHARMACY 12

13. 2. Lethal challenge method
• Test animal
Guinea pig weight between 250g – 350g.
All guinea pigs should have same sex.
KARNATAKA COLLEGE OF PHARMACY 13

14. Determination of potency of the vaccine
• Three dilution of sample and standard vaccine prepared in saline
solution.
• Intermediate conc inject subcutaneously into guinea pigs.
• This should intermediate conc protect 50% animals from lethal effect
of subcutaneous injection.
KARNATAKA COLLEGE OF PHARMACY 14

15. After 28 days
Immunized guineig challenged with toxin
Test challenged toxin dilution
1ml inject to 4 groups of 4-guinea pigs subcutaneously
After 5 days count the number of survival animals
KARNATAKA COLLEGE OF PHARMACY 15

16. THANK YOU