Parenterals are sterile solutions or suspensions meant for injection under the skin or into body cavities. They include various types of containers like ampules, vials, prefilled syringes and infusion bags. Parenterals can be solutions, suspensions, emulsions or solids administered through different routes like intravenous, intramuscular, subcutaneous etc. They contain active ingredients, excipients like buffers and antimicrobials, and a vehicle for delivery. Parenterals are manufactured under sterile conditions, which includes cleaning, preparation, sterilization and filling. They undergo various quality tests for sterility, pyrogens and leakage before release.

1. PARENTERALS
PRESENTED BY –
VEENA SURESH

2.  The term ‘Parenteral’ is derived from two Greek
words,
1. Para (outside )
2. Enteron (Intestine)
 These are the preparations which are given other
than the oral routes(i.e., G.I.T).
 Def.: Parenteral preparation or injectable are the
sterile solutions or suspensions of drug in aqueous
or oily vehicles meant for introduction into the
body by means of an injection under or through
one or more layers of the skin or mucous
membrane.

3.  Based on types of packaging
1) Single dose units: ampules, infusions and prefilled disposable syringes
2) Multiple dose units: multiple dose vials
 Based on the production and control
1) Small volume parenteral: volume < 100ml
2) Large volume parenteral: volume =/> 100ml
 Based on clinical use
1) Solutions for irrigation
2) Ophthalmic solution
3) Dialysis solution
4) Diagnostic agent
5) Allergic extracts
6) Implants
 Based on physical state of product
1) Sterile solutions
2) Sterile suspensions
3) Sterile emulsions
4) Sterile solids

4.  There are five types of containers –
1) Ampules : The oldest type of parenteral product containers, are made entirely of
glass.
2) Vials: are glass or plastic containers closed with a rubber stopper and sealed with an
aluminium crimp.
3) ADD-Vantage by abbott: some drugs come in vials that may be attached to an diluent
containing bag for reconstitution and administration.
4) Prefilled syringes: are designed for maximum convenience. Drugs administered in an
emergency.
Prefilled cartridges: 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.
5) Infusion solutions: These are divided into 2 categories:
a) Small volume parenteral (SVP): Those having a volume less than 100ml
b) Large volume parenteral(LVP): Those having a volume of 100ml or greater.

5. Ampules Vials
ADD-Vantage
Prefilled syringe and cartridge

6.  Intra Muscular (IM)
 Intra dermal (ID)
 Intravenous (IV)
 Subcutaneous/Hypodermic (SC)
 Intra articular
 Intra spinal
 Intrarterial
 Intra cardiac
 Intra cisternal
 Intra peritoneal
 Intrapleural

7.  Powder for injection – Eg.: Cefuroxime for injection
 Colloidal solution – Eg.: Iron dextran
 Injectable emulsion – Eg.: Propofol USP
 Injectable suspension – Eg.: Methylprednisolone acetate
 Oily injection(solution) – Eg.: Dimercaprol injection
 Infusion fluid

8. 1. Solutes (API)
2. Added substance
 Antimicrobial agent
 Buffers
 Antioxidants
 Tonicity agents
 Cryoprotectant
 Suspending agent
 Emulsifying agent
3. Vehicle
 Aqueous – Water for injection
 Non-aqueous Eg: Arachis oil
4. Containers
 Glass
 Plastic
 Rubber closure with aluminium caps

9.  Cleaning and washing of container, closures
 Preparation of solutions
 Sterilization (Filtration)
 Filling
 Packaging

10.  Sterility tests
 Direct transfer method: inoculation of require volume of sample in two test tube
containing a culture medium
 Membrane filtration method: involve filtration of a sample through membrane filters
of porosity 0.22micron and diameter 47mm
 Pyrogen test
 Rabbit test: measuring the rise in body temperature in healthy rabbits by the
intravenous injection of a sterile solution of the substance
 Leakage test
 Particulate matter testing: all containers are
visually inspected.A method utilizing the video
image projection could detect a moving particle.

11.  Heat method of sterilization
 Moist heat methods (Boiling, Pasteurization, By use
of steam - Autoclave)
 Dry heat methods (Flaming, Incineration, Hot air
oven)
 Radiation sterilization
 Non-ionic radiations (UV)
 Ionizing radiation sterilization (X-rays, γ-rays, etc.)
 Chemical method of sterilization
 Filtration

12. Thank You
From –
Pharm D III Year
Sree Dattha
Institute of Pharmacy