DATE OF PRESENTATION
APRIL 27TH, 2015
Necessary condition of
• Methods of preparation
• Quality control
• Types of parenteral products
• Routes of administration
• advantages/ disadvantages
The administration of drugs into the patient by
injection under one or more layer of the skin or
The term parenteral is derived from two Greek
It donate the route of administration other
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
1657: first recorded injection in animals- Sir Christopher
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
Necessities of parenteral preparations:
• Sterility (must)
• Free from pyrogen (must)
• Free from particulate
• Clarity (must)
• Stability (must)
Solvents and vehicles used
must meet special purity and
Do not use coloring agents
Must be prepared under
Specific and high quality
• 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.
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.
• substances to enhance solubility
• suspending agents
• buffering agents
• substances to make the preparation isotonic with blood and
• stabilizers or antimicrobial preservatives
• 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
• Sterility. Parenteral preparations comply
with the test for sterility.
Store in a sterile, airtight, tamper-proof
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
• The manufacturing process should meet the
requirements of good manufacturing
• The addition of excipients is kept to a
• 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
• “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
there are 4 types of
• Sterility tests
• Pyrogen tests
• Leaker test
• Particulate matter
• Sterility is the most
• Sterility means the removal
• It is essential test for the
• There are two methods for
Direct transfer method
Membrane filtration method
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
• Pyrogen are product of metabolism in
micro organism .
• Gm-ve bacteria produce more potent
• 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
• The leakage test is
intended to detect the
• Any crack may be
present at the base and
the seal of the ampule
due to the improper
• The crack is usually
detected by the negative
pressure produced due
Particulate matter testing
• Particulate matter is primary concern in
parenteral products given by i.v route, all
parenteral product should be free from
• 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
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
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
-are glass or plastic containers closed with a
rubber stopper and sealed with an aluminum
Vials have several
a. Vials can be
designed to hold
b. The drug product is
easier to remove from
vials than from
c. Vials eliminate the
• b. However, Vials also
a. The rubber stopper
can become cored,
causing a small bit of
rubber to enter the
b. Multiple withdrawals
(as with multiple-dose
vials) can result in
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.
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
5. Infusion solutions.
Are divided into two
having a volume less than 100
having a volume of 100 mL or
B. Packing materials
Out of the two types
materials used, one is
1. Glass, The original
material, has superior
Compared to plastic,
2. Plastic polymers
used for parenteral
a. PVC is flexible and
b. Polyolefin is semi
rigid; it can be stored
Parenterals are classified into two main
1. Small Volume Parenterals(SVP),
2. Large Volume Parenterals(LVP).
3. Powder parenterals
Classification of parenterals
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.
-DIGOXIN solutions are administered
intravenously and are used as cardiotonics.
Procaine Penicillin G- used for treatment of
• : 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
• Dry powders available in
market are soluble in
water or any other sterile
solvent for injection prior to
• They are suitable for
which degrade by
• For example:
Intravenous is a term
that means “into the
The needle is introduce
in vein near the elbow,
wrist, or on the back of
the hand. Different sites
injections are made
into the striated
muscle fibers that are
subcutaneous layer of
Needles used for the
It can be used for both short term and very long
The injection of a drug or the implantation of a
device beneath the surface of the skin is made
1. loose interstitial tissues of the upper arm
2. the anterior surface of the thigh
As compared to other dosage forms, parenteral
administration offers some selective advantages.
1. An immediate physiological response can be achieved if
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.
5. Low drug concentration
6. Low toxicity as
compared to solid dosage
7. Most suitable route for
those drugs which are
degraded or erratically or
unreliably absorbed when
8. Most suitable if the
patient is unconscious,
difficult to swallow drug etc.
The main disadvantages of parenteral products
1. Requirement of aseptic technique in
production, compounding and handling of
2. Requirement of trained personnel for
3. Real or psychological pain associated with the
4. Highly risky if any mistake at happens any
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.