Parenteral products - Definition
• Injections are sterile, pyrogen-free (endotoxin units [EU] limited)
preparations intended to be administered parenterally.
• The term parenteral refers to the injectable routes of administration. It
derives from the Greek words para (outside) and enteron (intestine) and
denotes routes of administration other than the oral route.
• Pyrogens, or bacterial endotoxins, are organic metabolic products shed from
gram negative bacteria, which can cause fever and hypotension in patients
when they are in excessive amounts in intravenous (IV) injections.
• In general, the parenteral routes are used when rapid drug action is desired,
as in emergencies; when the patient is uncooperative, unconscious, or
unable to accept or tolerate oral medication; or when the drug itself is
ineffective by other routes.
Parenteral Routes of Administration
• Drugs may be injected into almost any organ or area of the body,
including the joints (intra articular), joint fluid area (intrasynovial),
spinal column (intraspinal), spinal fluid (intrathecal), arteries (intra-
arterial), and, in an emergency, even the heart (intracardiac).
• However, most injections go into a vein (intravenous, IV), into a
muscle (intramuscular, IM), into the skin (intradermal, ID;
intracutaneous), or under the skin (subcutaneous, SC; sub-Q, SQ;
hypodermic, hypo)
Reference: Ansels Pharmaceutical Dosage Forms and Drug Delivery Systems
Advantages and Limitations
• Parenteral Advantages:
• If drug is not absorbed orally it can be given parenterally.
• Drug which is unstable in GIT can be given parenterally.
• Drugs which are undergoing extensive first pass metabolism are given parentally which
avoid the first pass metabolism.
• When patients need rapid drug action in emergency situations as onset of action of
parenterals is rapid.
• Patient is uncooperative/unconscious (accident, surgery etc.).
• Complete drug bioavailability (upto 100%) is possible.
• Prolonged drug action is possible.
• Parenteral therapy provides the means of correcting serious disturbances of fluid and
electronic balances.
• When food cannot be taken by mouth, total nutritional requirement can be supplied by the
parenteral route.
• Patient compliance problems are largely avoided.
Advantages and Limitations
• Parenteral Disadvantages:
• Most inconvenient route of administration /pain upon injection.
• Generally need medical expert for administration (like physician or nurse usually
in hospital or clinic).
• If administered by patients themselves, need good training.
• It requires strict adherence to aseptic procedures.
• It requires more time than those administered by other routes.
• Chances of improper dosing are more.
• Chances of adverse effects are more.
• Danger of blood clot formation is there.
• Drug cannot be recovered in adverse conditions as it is irreversible.
• The manufacturing and packaging requirements of parenteral dosage forms are
more costly than other dosage forms.
Official types of Injections
• According to the USP, injectable materials are separated into five general types.
These may contain buffers, preservatives, and other added substances:
• 1. Injection: Liquid preparations that are drug substances or solutions thereof (e.g.,
Insulin Injection, USP)
• 2. For injection: Dry solids that, upon addition of suitable vehicles, yield solutions
conforming in all respects to the requirements for injections (e.g., Cefuroxime for
Injection, USP)
• 3. Injectable emulsion: Liquid preparation of drug substance dissolved or
dispersed in a suitable emulsion medium (e.g., Propofol, USP)
• 4. Injectable suspension: Liquid preparation of solid suspended in a suitable liquid
medium (e.g., Methylprednisolone Acetate Suspension, USP)
• 5. For injectable suspension: Dry solid that, upon addition of suitable vehicle,
yields preparation conforming in all respects to the requirements for injectable
suspensions (e.g., Imipenem and Cilastatin for Injectable Suspension, USP)
Types of Parenterals
• Based on route of administration - Intravenous (IV) • Intramuscular (IM) •
Subcutaneous (SC) • Intradermal (ID) • Intraarticular • Intrasynovial •
Intraosseous • Intracerebral • Intraspinal • Intrathecal • Intra-arterial • Intracardiac
• Endotracheal • Vein • Muscle • Under the skin • Into the skin • Joints • Joint-
fluid area • Bones • Brain • Spinal column • Spinal fluid • Arteries • Heart • Down
the trachea
• Based on volume - Small volume parenterals (SVP) and Large volume parenterals
(LVP):
• (i) Small volume parenterals (SVP): These are sterile, pyrogen free injected
products that are usually packed in volumes up to 100 ml. These are aqueous
preparations, usually administered by IV because of local irritation. These SVP’s
are packed into Ampoules or Vials.
• (ii) Large volume parenterals (LVP): These are sterile, pyrogen free injected
products that are usually packed in volumes more than 100 mL(ranging from 101
ml to 1000 ml).
SVP and LVP
• SVP – According to USP – an injection that is packaged
in containers labeled as containing 100 ml or less.
• LVP – They are given in multi-dose and volume 100 ml
or more. Generally these provides electrolytes nutrition
to the body.
Types of Parenterals
• Based on the composition
• These products can be administered by Intra or Extra vascular routes. These
LVP’s are packed into either glass or plastic container of 1 lit capacity.