This document provides an overview of parenteral products including their definition, history, manufacturing process, quality control, packaging, types, and routes of administration. Parenterals are sterile preparations intended for injection through the skin rather than orally. Their manufacturing must ensure sterility, lack of pyrogens, and stability. Quality is tested through sterility, pyrogen, leakage, and particulate matter tests. Parenterals are packaged in containers like ampules, vials, prefilled syringes and infusion bags. They are classified as small or large volume and administered via intravenous, intramuscular or subcutaneous routes.

1. PRESENTED BY:
Anum Yousaf
AtiaGulzar
Ayesha Arshad
FatimaMuhammad
Kainat Zahra
NidaJavaid
NosheenRehman
PRESENTED TO:
Dr. Sobia
DATE OF PRESENTATION
APRIL 27TH, 2015

2. • Introduction
History
Why parenteral?
Necessary condition of
parenteral
• Methods of preparation
• Quality control
• Packaging
• Types of parenteral products
• Routes of administration
• advantages/ disadvantages
• conclusion

3. Introduction:
The administration of drugs into the patient by
injection under one or more layer of the skin or
mucous membrane.
The term parenteral is derived from two Greek
words:
PARA (OUTSIDE)
ENTERON (INTESTINE)
It donate the route of administration other

4. Definition of parenterals:
 Parenterals are those
preparations intended for
injection through the skin
or other external boundary
tissue, rather than through
the alimentary canal, so
that the active substances
they contain are
administered using gravity
or force directly into a
blood vessel, organ, or
tissue.

5. History:
 1657: first recorded injection in animals- Sir Christopher
Wren
 1855: first subcutaneous injection of drugs using hypodermic
needles - Dr. Alexander wood
 1920:proof of microbial growth resulting in infections
- Dr. Florence Seibert
 1926: inclusion in the national formulary
 1931: commercial intravenous solution(Baxter)
 1946:organization of parenteral drug association
 1965:development of total parenteral nutrition

6. Necessities of parenteral preparations:
• Sterility (must)
• Free from pyrogen (must)
• Free from particulate
matter
• Clarity (must)
• Stability (must)

7.  Isotonicity (should)
 Solvents and vehicles used
must meet special purity and
other standard
 Do not use coloring agents
 Must be prepared under
aseptic conditions
 Specific and high quality

8. MANUFACTURING PROCESS:
• A suitable test method for the preservative
properties of the formulation are provided under
Efficacy of antimicrobial preservation.
• Methods designed to ensure sterility and to avoid
the introduction of contaminants and the growth of
micro-organisms follow the method of sterilization.
• Water used in the manufacture of parenteral
preparations complies with the requirements of
water for injections
• The design and maintenance of the equipment and
the method of manufacture must be such as to
ensure the stability of the active substance and of
the final product and sterility of the injection.

9. PARENTERAL PREPARATIONS
 DEFINITION:
Parenteral preparations are sterile preparations which may consis
of one or more active ingredients intended for administration by
injection, infusion or implantation into the body.
 REQUIRED EXCIPIENTS:
• Solvents
• substances to enhance solubility
• suspending agents
• buffering agents
• substances to make the preparation isotonic with blood and
• stabilizers or antimicrobial preservatives

10. TESTS
• Parenterals are tested for particulate
contamination: sub-visible particles.
• For preparations for human use, solutions
for infusion or solutions for injection
supplied in containers with a nominal
content of more than 100 ml comply with
the test.
• Sterility. Parenteral preparations comply
with the test for sterility.

11. STORAGE
Store in a sterile, airtight, tamper-proof
container.
LABELLING
The label states :
— the name and concentration of any
added antimicrobial preservative,
— where applicable, that the solution is to
be used in conjunction with a final filter,
— where applicable, that the preparation is
free from bacterial endotoxins or that it is
apyrogenic.

12. Precautions:
• The manufacturing process should meet the
requirements of good manufacturing
practices (GMP)
• The addition of excipients is kept to a
minimum.
• When excipients are used they do not
adversely affect the stability, bioavailability,
safety or efficacy of the active ingredient(s),
or cause toxicity or undue local irritation.
• There must be no incompatibility between
any of the components.
• Sterilization may be omitted, provided that
the preparation is subject to terminal

13. Quality control
• “In a pharmaceutical
organization, the quality
control deals with testing,
sampling, specification and
documentation- a procedure
which ensures that all tests
are actually carried out prior
to release of material for sale
or use”.

14. Quality tests
there are 4 types of
quality tests.
• Sterility tests
• Pyrogen tests
• Leaker test
• Particulate matter
testing

15. Sterility test
• Sterility is the most
important test.
• Sterility means the removal
of micro-organisms.
• It is essential test for the
parenteral.
• There are two methods for
sterility.
Direct transfer method
Membrane filtration method

16. Direct transfer method
It is a traditional sterility test
method which involves a direct
transfer. This method is simple
in theory but difficult in practice
involving inoculation of require
volume of a sample in two test
tube containing a culture
medium that is FTM,SCDM.• Membrane filtration method:
• this method is basically
involve filtration of a sample
through membrane filters of
porosity 0.22 micron and

17. Pyrogen test
• Pyrogen are product of metabolism in
micro organism .
• Gm-ve bacteria produce more potent
pyrogen.
• When these are injected in to the body
then they cause ache and fever(rise in
body temperature) with in one hour.
• Two types of test are present
 Rabbit test
 LAL test

18. Leakage test
• The leakage test is
intended to detect the
incompletely sealed
ampoules.
• Any crack may be
present at the base and
the seal of the ampule
due to the improper
handling.
• The crack is usually
detected by the negative
pressure produced due

19. Particulate matter testing
• Particulate matter is primary concern in
parenteral products given by i.v route, all
parenteral product should be free from
insoluble particles.
• In this all containers are visually inspected.
• It is done by holding the ampule by its neck
against highly illuminated screens
• White screen for detection of black and black
for white particles
• A method utilizing the video image projection
could detect a moving particle with out

20.  Parenteral Preparations and other
sterile products must be packaged in
a way that :
 Maintains product sterility until the
time of use .
 Prevents contamination of contents
packaging

21. A . Types of containers
There are five types of containers:
1 . Ampules,
-the oldest type of Parenteral product
containers, are made entirely of glass.
-Single use only.
Disadvantages .Because glass
particles may become dislodged
during ampule opening, the product

22. 2. Vials:
-are glass or plastic containers closed with a
rubber stopper and sealed with an aluminum
crimp.
Vials have several
advantages over
ampoules.
a. Vials can be
designed to hold
multiple doses.
b. The drug product is
easier to remove from
vials than from
ampules.
c. Vials eliminate the

23. • b. However, Vials also
have certain
disadvantages
a. The rubber stopper
can become cored,
causing a small bit of
rubber to enter the
solution.
b. Multiple withdrawals
(as with multiple-dose
vials) can result in
microbial

24. 3. Some drugs come in vials that may be attached to
an diluents containing bag for reconstitution and
administration (ADD-Vantage by abbott) .
a. The ADD-Vantage Vial is screwed into the top of
an ADD- Vantage diluent bag, and the rubber
diaphragm is dislodged from the vial, allowing the
diluent solution to dissolve the drug.
b. The reconstituted ADD-Vantage vial and IV bag are
ready for administration when hung.

25. 4. Prefilled syringes:
 Prefilled syringes and cartridges are
designed for maximum convenience .
 Drugs administration in an emergency
b. Prefilled cartridges
 Are ready-to-use parenteral
packages that offer improved
sterility and accuracy.
 They consist of a plastic
cartridges holder and prefilled
medication cartridge with a
needle attached.

26. 5. Infusion solutions.
Are divided into two
categories:
 Small-volume
parenterals(SVPs), Those
having a volume less than 100
mL.
 large-volume
parenterals(LVPs), Those
having a volume of 100 mL or

27. B. Packing materials
 Out of the two types
of packaging
materials used, one is
glass
 1. Glass, The original
Parenteral packaging
material, has superior
clarity,
 Compared to plastic,
2. Plastic polymers
used for parenteral
packages include
polyvinylchloride (PVC)
and polyolefin.
a. PVC is flexible and
non rigid.
b. Polyolefin is semi
rigid; it can be stored
upright.

28. Parenterals are classified into two main
types:
1. Small Volume Parenterals(SVP),
2. Large Volume Parenterals(LVP).
3. Powder parenterals
Classification of parenterals

29. Small Volume Parenterals
They include ampules of 1ml, 2ml, 3ml up to 30
ml and vials of 1 ml up to 30 ml.
They are administered by various routes.
The most widely used small volume parenterals
are various insulin preparations used for
treatment of Diabetes Mellitus.
EXAMPLES:
-DIGOXIN solutions are administered
intravenously and are used as cardiotonics.
Procaine Penicillin G- used for treatment of
bacterial infections.

30. • : LVP are Parenterals designed to provide Fluids,
Calories, Electrolytes or a combination of these.
• Volume 101-1000mL
• IV infusion technique is “Venoclysis”.
• They provide nutrition.
• Used in cases where there is loss of water,
vomiting and diarrhea or when the patient cannot
consume oral nutrition for long periods.
Large volume parenterals

31. Examples of lvp’s
1. Electrolytes:
• Sodium chloride solutions.
• Potassium chloride solutions
2. non –electrolytes:
• Dextrol solutions.
• Mannitol solutions.

32. Powder parenterals
• Dry powders available in
market are soluble in
water or any other sterile
solvent for injection prior to
use.
• They are suitable for
certain formulations
which degrade by
hydrolysis.
• For example:

33. Routes of administration

34. Intravenous is a term
that means “into the
vein”.
The needle is introduce
in vein near the elbow,
wrist, or on the back of
the hand. Different sites
1) Intravenous

35. 2) intramuscular
Intramuscular (IM)
injections are made
into the striated
muscle fibers that are
under the
subcutaneous layer of
the skin.
Needles used for the

36. It can be used for both short term and very long
term therapies.
The injection of a drug or the implantation of a
device beneath the surface of the skin is made
in
1. loose interstitial tissues of the upper arm
2. the anterior surface of the thigh
3) Subcutaneous

39. Advantages
As compared to other dosage forms, parenteral
administration offers some selective advantages.
1. An immediate physiological response can be achieved if
necessary.
2. It provides a direct route for achieving the drug effect
within the body.
3. Modification of the formulation can however slow down
the onset and prolong the action. This may also be
achieved by the change in the route of injection.
4. When food cannot be taken by mouth, total nutritional
requirement can be supplied by the parenteral route.

40. 5. Low drug concentration
6. Low toxicity as
compared to solid dosage
form
7. Most suitable route for
those drugs which are
degraded or erratically or
unreliably absorbed when
administered orally
8. Most suitable if the
patient is unconscious,
difficult to swallow drug etc.

41. Disadvantages
The main disadvantages of parenteral products
are:
1. Requirement of aseptic technique in
production, compounding and handling of
product
2. Requirement of trained personnel for
administration
3. Real or psychological pain associated with the
injection
4. Highly risky if any mistake at happens any
point

42. CONCLUSION
 The parenteral route of administration is the
most effective route for the delivery of
active pharmaceutical substances specially
when drugs cannot be taken orally.
 Parenteral administration of drugs usually
provides an alternative route for the drugs
that are highly hydrophobic as these drugs
cannot pass through cell membranes.

43. Thankyou!!