Sterile dosage form (parenteral)

For diploma in pharmacy and B.pharmacy, M.Pharmacy

1. MATOSHRI EDUCATION SOCITY’S
M.A.B.D DIPLOMA COLLEGE OF
PHARMACY.
BabhulgaonTal.-Yeola, Dist.-Nashik, Maharashtra
423401.
PHARMACEUTICS-II
STERILE DOSAGE FORM
By-
Prof. Mr. DeoreA. B
M.Pharm(Pharmaceutics-II)

2. STERILE DOSAGE FORM
What is Sterile dosage form
-Sterile dosage form can be defend as its dosage form are
free form microorganism, intended for administration by
injection, infusion or implantation into the human or animal
body is called as sterile dosage form such as Injection,
Saline, Eye drop etc.
Parenteral Dosage Forms -The term parenteral is derived
from two Greek words ‘‘para’’ and ‘‘enteron’’ meaning ‘to
avoid the intestine’.

3. STERILE DOSAGE FORM
Characteristics of parenteral dosage forms
All parenteral products must be sterile.
All parenteral products must be free from pyrogenic
(endotoxin) contamination.
Injectable solutions must be free from any visible
particulate matter.

4. STERILE DOSAGE FORM
Parenteral preparations may require the use of excipients,
for example:
To make the preparation isotonic with respect to blood.
To adjust the pH, to increase solubility.
To prevent deterioration of the active substances.
To provide adequate antimicrobial properties, but not to
adversely affect the intended medicinal action of the
preparation or, at the concentrations used, to cause
toxicity or undue local irritation.

5. STERILE DOSAGE FORM
Several categories of parenteral preparations may be
distinguished:
Injections
Infusions
Implants
Concentrates for injections or infusions
Powders for injections or infusions
Gels for injections: Gels for injections are sterile gels with
a viscosity suitable to guarantee a modified release of the
active substance(s) at the site of injection.

6. STERILE DOSAGE FORM
Advantages of Sterile dosage form
Avoid first pass metabolism effect.
Some drug are admiration by oral that time design
parenteral dosage form.
Patient may be vomiting or may unconscious, patient may
not able to take oral dosage form that time design
parenteral dosage form.
Fast onsite of action.
This route gives a quick response to the emergency
situation

7. STERILE DOSAGE FORM
Disadvantages of Sterile dosage form
Injection or Saline is pain full treatment.
Patient doesn't compliance.
For the Administration Parenteral dosage form Trained
person are mandatory.
It is difficult to save a patient when over dose is given
him.
More expensive and costly to produce
Sterilization is the necessary step in the production of
parenteral dosage forms.

8. STERILE DOSAGE FORM
PARENTERAL ROUTES OF ADMINISTRATION
Drugs may be injected into almost any organ or area of
the body, including the joints, joint fluid area, spinal
column, spinal fluid, arteries, and in an emergency, even
the heart. However, most injections go into a vein, into a
muscle, into
the skin, or under the skin.

9. STERILE DOSAGE FORM

10. STERILE DOSAGE FORM
General requirements for Parenteral Dosage Forms
The formulation of Parenteral products involve careful
consideration of the following requirements
Stability-The stability of parenteral preparation is very
important. The physical as well as chemical stability of
Parenteral preparation must be maintained during
storage.
Sterility-The parenteral preparations should be free from
all types of micro -organisms. An aseptic conditions are
required to be maintained during the preparation of
Parenteral products and its administration. The parenteral
product must pass the test of Sterility.

11. STERILE DOSAGE FORM
Sterility-The parenteral preparations should be free from
all types of micro -organisms. An aseptic conditions are
required to be maintained during the preparation of
Parenteral products and its administration. The parenteral
product must pass the test of Sterility.
Free from pyrogens-The parenteral preparations should be
free from toxin and pyrogens. It is necessary that the
parenteral product must pass the test for pyrogen,
because contaminated parenteral product causes rise in
body temperature after its administration.
Free from foreign particles-The parenteral product should
be free from foreign particles such as dust and fibres. To
ensure this, the parenteral products must pass the clarity
test.

12. STERILE DOSAGE FORM
Isotonicity-The parenteral preparations should be
isotonic with the blood plasma and body fluids. It is very
important in order to avoid any complications on the
administration of parenteral products.
Specific gravity-The parenteral products meant for intra-
spinal injections should have the same specific gravity as
that of spinal fluid into which the same are to be
injected.
Chemical purity-The parenteral products should be free
from chemical impurities or it should be within certain
limit as specified in the monograph of that preparation in
the pharmacopoeia.

13. STERILE DOSAGE FORM
Particulate matter is defined as unwanted mobile
insoluble matter other than gas bubbles present in the
given product. The presence of foreign matter in
parenteral preparations is very dangerous especially when
its particle size is larger than the size of RBC. It can block
the blood vessel.

14. STERILE DOSAGE FORM
Types of parenteral dosage form
1.Small volume parenteral.
e.g.-Injection.
2.Large volume Parenteral.
e.g. Saline.
Types of parenteral formulation.
1.Solution.
2.Suspension.
3.Emulsion.
e.g. Chloramphenicol.
4.Solid.
e.g. Benzyl penicillin G sodium injection.
5.Fluid.
e.g.-Rngersolution, Saodiumchloride injection, dextrose injection etc.

15. STERILE DOSAGE FORM
Containers and Closures used for Parenteral Products
Materials:
Glass
Plastic
Metals
Rubbers

16. STERILE DOSAGE FORM
Requirements for Containers and Closures -
It should not yield foreign substances to the product.
It should be transparent to allow visual inspection of the
content in it.
It should not have any adverse effect on the product.
It should be compatible (physical and chemical) with the
product.

17. STERILE DOSAGE FORM
Processing of Parenteral preparations-
Cleaning of containers, closures and equipment's.
Collection of materials.
Pre-sterilization.
Preparation of parenteral products.
Filtration.
Filling.
Sealing.
Sterilization.
Evaluation.
Labelling and Packaging

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22. STERILE DOSAGE FORM
Evaluation of Parenteral Preparations
Various tests and assays should be performed on the
finished preparation to ensure that it meets the required
specifications.
1. Sterility test
2. Pyrogentest
3. Clarity test
4. Leaker test

23. STERILE DOSAGE FORM
Sterility Test
Sterility Testing-
It is a testing procedure applied to products intended to be
sterile before marketing, to check that these products are
free from all living microorganisms. Sterility tests are
performed on random samples from the batch and must be
carried out under aseptic conditions in order to avoid
accidental contamination of the product during the test
using, for example, a laminar air flow cabinet. Growth of
microorganisms, if present in samples under test, is usually
checked by incubating over specified culture Media at
specified temperature for specified time.

24. STERILE DOSAGE FORM
PyrogenTesting-
Pyrogentesting defines a process used by drug
manufacturers to determine if bacterial toxins are present in
vaccines and drugs that might cause fever when used on
humans.
Sham test
Rabbit method (Old method, In-Vivo test)
3. Limulus Amebocyte Lysate test (New method, In-vitro
test)

25. STERILE DOSAGE FORM
Leakage test
It is desirable that all the parenteral preparation which
are filled in ampoules must be hermetically sealed.
The ampoules are immersed in 1% methylene blue solution
in a vaccumchamber under negative pressure.
When the vaccumis released the coloured solution will
enter those ampoules having defective sealing. The
presence of dye in the ampoule confirms the leakage and
hence rejected.

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27. STERILE DOSAGE FORM

28. REFERENCES
recent_innovation_in_parenterals.pdf (weebly.com)
R.M.Mehta, Pharmaceutics-II, VallabhPrakashan, 4
th
Edition, Page No. 244-269.
https://www.google.com/search?q=sterile+dosage+form&rlz=1C1CHBD_enIN948IN9
48&sxsrf=ALeKk00C0P87_cnEuZKAp4FZwGESiWqL4w:1622525114574&source=lnms&
tbm=isch&sa=X&ved=2ahUKEwjz9N6I2fXwAhVbzzgGHdgZBXIQ_AUoAnoECAEQBA&bi
w=1366&bih=657#imgrc=tJGxbH_gKDlTJM
https://images.medindia.net/patientinfo/450_237/types-of-parenteral-routes-of-
administration.jpg
https://www.thepharmaeducation.com/2018/12/parenteral-dosage-forms-
sterile.html
https://www.facebook.com/StudyMaterialForPharmaStudents/posts/general-
requirements-for-parenteral-dosage-forms-the-formulation-of-parenteral-
p/1360848767320805/

29. REFERENCES
http://www.mespharmacy.org/wp-content/uploads/2020/06/Parenteral-
dosage-form-Introduction.pdf
https://image.slidesharecdn.com/parenteralproduction-
170227124241/95/parenteral-production-19-638.jpg?cb=1538550174
https://image.slidesharecdn.com/parenteralproduction-140929000858-
phpapp01/95/parenteral-production-5-638.jpg?cb=1411949432
https://image.slidesharecdn.com/parenterals-140427015041-
phpapp01/95/parenterals-13-638.jpg?cb=1398563917
https://image.slidesharecdn.com/parenterals-140427015041-
phpapp01/95/parenterals-12-638.jpg?cbu003d1398563917
https://1.bp.blogspot.com/-
GAPJh0hXo9E/T5zGyUgxCPI/AAAAAAAAAfQ/CyV_qtOOtyc/s1600/thank+you+a
3.gif