INJECTION

Dr. Henny Rachdiati

2009
 Parenteral Product
Dosage forms that are delivery to the patient by a
route outwith the alimentary canal
Is often used for drugs that cannot be given orally
In practice, parenteral product are often regarded a
dosage form that are implanted, injected or infused
directly into vessel, tissue spaces or body
compartments.
From the site of administration the drug is then
transported to the site of action
Parenteral therapy is being used outwith the
hospital or clinic environment.
Parenteral therapy is used to
Produce a localized effect
Administer drug if the oral route cannot be
used
Deliver drug to the unconscious patient
Rapidly correct fluid and electrolyte
imbalances
Ensure delivery of the drug to the target
tissue
Administration Procedure
 Administration Procedure (cont.)
1. Intra Venous (i.v)Injection And Infusions :
Provide strict control of the drug concentration in
the circulating blood (include needle or catheter)
The fluid is administered into a superficial vein
commonly on the back of hand or in the internal
flexure of the elbow
The intravenous route is widely use to administer
parenteral product, but it must not be used to
administer water in-oil emulsions or suspensions
 Intravenous
Intravenous pyelogram Intravenous Line intravenous catheterizations
 Intravenous Product
Intravenous cannula Intravenous devices intravenous fluids 1000ml
 Intravenous Product (cont.)

Intravenous bottles Intravenous infuse intravenous drip

 Administration Procedure (cont.)
2. Subcutaneous (s.c) Injection :
Injected into the loose connective and adipose tissue
immediately beneath the skin,
Volume injected does not exceed 1 mL
Injection site include the abdomen, the upper back and the
lateral upper hips
This route is used if the medicine cannot be administered
orally.
The site of the injection, the body temperature, age of the
patient and the degree of massaging of the injection site affect
drug distribution
Absorption after s.c.injection is lower and less predictable
than i.v. route
Subcutaneous
Subcutaneous Sites
 Administration Procedure (cont.)
3. Intramuscular (i.m) Injection :
Small-volume aqueous solution (oil and suspension)
Administered directly into the body of a relaxed
muscle (gluteal muscle in the buttock, deltoid muscle
in the shoulder and the vactus lateralis of the thigh
In adult the gluteal muscle is often used as a larger
volumes can be tolerated
In infants and small children the vactus lateralis of
the thigh is usually more developed
Intramuscular
Intramuscular
 Administration Procedure (cont.)

4. Intradermal Injection :
Volume of about 0,1 mL
Injected into the skin between epidermis and the
dermis
Absorption from intradermal injection is slow
This route is often used for diagnostic test of
allergy or immunity
Used administer some vaccine
Intradermal
 Administration Procedure (cont.)

5. Intra-arterial Injection :
Administered directly into artery
Drug fast flow of blood in artery, drug will be
rapidly dispersed throughout on blood system
Absorption from intradermal injection is slow
This route to specific organ or tissue
Intra-arterial
 Administration Procedure (cont.)

6. Intracardiac Injection :
Aqueous solution
Administered in emergency directly into
ventricle or the cardiac muscle for a local effect
Intracardiac
 Administration Procedure (cont.)

7. Intraspinal Injection :
Aqueous solution is volumes less than 20 mL
Administered into particular areas of the spinal
column
They are categorized as intrathecal, subarachnoid,
intracisternal, epidural and peridural injections
Intraspinal
 Administration Procedure (cont.)

8. Intra-articular Injection :
Aqueous solution or suspension into synovial
fluid in a joint cavity
They are often used for the local administration
of anti-inflammatory agents
Intra-articular
 PRODUCT FOR PARENTERAL USE

Parenteral product : sterile formulation that

are administered into the body by various
routes including injection, infusion and
implantation
 INJECTIONS

• Small volume parenteral fluid

• Large volume parenteral fluid (up 100 mL)
• Sterile, pyrogen free
Small volume parenteral fluid

• Single-dose ampoules
• Multiple-dose vials
• Prefilled syringes
 Single-dose ampoules

Packaged as either ampoules or vials

Thin walled container made of Type I borosilicate glass
Injections packaged in glass ampoules are manufactured by filling the product into the ampoules that are then heat sealed
The packaged solution must be sterile and practically free of particles (prepare in clean room condition)
Using glass ampoules relates to hazards of opening them, because the product may become contaminated with glass particle
Opening is easier with glass ampoules with a weakened neck
 Single-dose ampoules
Plastic ampoules are prepared filled and sealed
by procedure known as blow-fill-seal.
Medicine package in ampoules are intended for
single use only
These product do not contain chemical
antimicrobial preservative
The ampoules must contain in a slight excess
volume of product
 Multiple-dose vials
These are composed of a thick-walled glass
container that is sealed with a rubber closure
The closure is kept in position by an aluminium
seal that is crimped to the neck of the glass vial
These closure covered with a plastic cap
The cap is removed before a needle, attached to
a syringe, is inserted through the rubber to
withdraw a dose of product
 Multiple-dose vials
The glass vial packaging system has the advantage of
increased dose flexibility and decreased cost per unit
dose
Fragments of the closure maybe released into the
product when the needle is inserted through the
closure
Risk of interaction between the product and the
closure
Repeat withdrawal of injection solution from these
containers increases the risk of microbial
contamination of the product
These product must contain an antimicrobial
preservative
 Prefilled Syringe
The injections solution is aseptically filled into
sterile syringes
The pack solution has a high level of sterility
assurance and does not contain an antimicrobial
preservative
Expensive and so only limited product are
packaged in this way
 Vehicles for Injections
1. Water for Injection
Most extensively used in parenteral formulation
Well tolerated by the body
Ionizable electrolytes readily dissolve in water
Free pyrogens
High level and chemical purity
Only prepared by distillation in order to
produce a consistent supply of the required
quality of water (BP)
 Preparation of Water for
Injection
• Usual method is distillation
• Source water used potable water
• The high standards required is improved by
suitable pretreatment before it is supplied
• Pretreatment involves chemical softening,
filtration, deionization, and pH adjusment
• Treated by reverse osmosis to yield purification
• To conform with the quality standards of the BP
(2001) and EP (2002)
 Quality Standard of Water for Injection
Total organic carbon Not more than 0.5 mg/L
Chlorides Not more than 0.5 p.p.m.
Ammonia Not more than 0.1p.p.m.
Nitrates Not more than 0.2 p.p.m.
Heavy metals Not more than 0.1 p.p.m.
Oxidizables substances Not more than 5 p.p.m.
pH 5.0 – 7.0
 Storage Water for Injection

1. Batch Storage
2. Dynamic Storage (stainless steel)
 Distribution Water for Injection
1. The water in the distribution systems can become
contaminated with organism
2. The water in the stainless steels pipes is constantly circulated
from the tank to avoid stagnation and to maintain the
temperature
3. Use may not require high temperature
4. The cooling system may be fitted close to the point of use
5. Microbial growth in the cooled water
6. Sealed container
7. The container is moist heat sterilized and yield free pyrogens
8. Sterilized water for injections is used to dissolve/ dilute
parenteral preparations before administration to the patients
 Pyrogens
1. Pyrogens are fever producing substances
2. Microbial pyrogens arise from component of
Gram negative and Gram positive bacteria,
fungi and viruses
3. Non microbial pyrogens such as some steroids
and plasma component
4. The most important pyrogen in pharmacy
products are high molecular weight endotoxin
(outer membrane of Gram negative bacteria)
 Test for Pyrogens
1. The rabbit test included in the BP (2001) and
the EP (2002)
2. The rabbit test that is used to identify the
presence of wide range of pyrogens does have
problems for testing pharmacy product
3. Is spesific test for endotoxins of bacterial origin
4. Bacterial endotoxin is the main pyrogen found
in parenteral products
 Vehicles for Injections
2. Non Aqueous Solvent
Water miscible co solvents, such as glycerin
and propylen glycol
Used to increase the solubility of drugs and
stabilize drugs degraded by hydrolysis
Metabolizable oils are used to dissolve drugs
that are insoluble in water
Steroids, hormones and vitamins dissolved in
vegetable oil
Administered by intramuscular injections
 Special Injections

Suspensions
Dried Injections
Non aqueous injections
 Large Volume Parenteral
Products
Infusion fluids
Total parenteral Nutrition Solutions
Intravenous antibiotic
Patient-controlled analgesia
Dialysis fluids
Irrigation solutions
 Container and Closures
Large – volume parenteral fluids

Glass bottles
PVC collapsible bags
Semi rigid polythene containers
 Container and Closures
The containers and closures that are used
for packaging parenteral products must :

Maintain the sterility of the packed fluids

Withstand sterilization
Be compatible with the packed fluid
Allow withdrawal of the content
Infusion Fluid Container
Infusion Fluid Container
 Labelling
The label on parenteral Fluid should include :
Product identity and details of fluids of the
contained volume
Solution strength in term of the amount of
active ingredient in a suitable dose volume
Batch number and product expiry date
Storage requirement
For Total Parenteral Nutrition (TPN) solutions,
the name of the patient, the unit number, ward
and infusion rate