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Definition

 PARENTERAL: Administration of agents


(drugs/solution) by injection through
different routes other than GIT.
 PARENTERAL PRODUCTS: The sterile
products of drugs/medicine deliver
directly into the skin layers, muscles
and blood vessels/veins with different
angle and depth. Intra-spinal route
Types of parenterals
1. SMALL VOLUME PARENTERALS (SVP):
 Single –dose glass ampoules:
they do not contain any
antimicrobial preservatives.
 Multiple-dose vials: they supply
as glass container, sealed with
rubber closure by an aluminum
Formulation of parenterals
seal and plastic cap.
1. -Vehicles: they should be non-toxic,
2. LARGE VOLUME PARENTERALS:(LVP) compatible with medicaments, they are:
They includes: 1. water for injection,
 Infusion fluids, 2. Non-aqueous fluids like cottonseed oil,
 Total parenteral nutrition solutions corn oil, peanut oil, olive oil, etc,
(TPN), DNS. normally used for IM injections.
 IV antibiotics, 3. 50% alcohol is used to enhance
solubility of some drugs like
 Dialysis fluids.
Phenobarbital in water.
4. 30% glycerin, propylene glycols etc.
3.SPECIAL INJECTIONS: They includes:
 Dried injections: sterile drug powder in 2. -Stabilizers: To prevent the degradation of
sterile vial and it is reconstituted with products by
sterile vehicle/water for injection. oxidation and hydrolysis. eg: Ascorbic acid,
 Non-aqueous injections: drugs soluble in tocopherols, sodium metabisulfite etc.
oily vehicle like ARACHIS and SESAME 3. -Buffers: To maintain the pH at precise
OIL are formulated in this injections. levels. eg; Acetates, citrates and phosphates.
4. -Solubilizers: To enhance poor drug
Suspensions injections: It contain less than 5%
solubility eg; sodium benzoate, sodium
of solid drug with particle diameter of 5-10µm.
salicylate.
Various routes of parenteral 5. -Preservatives: To inhibit the growth and
multiplication of microorganisms, eg: 1-2%w/v
Benzyl alcohol, 0.1-0.3%w/v Chlorocresol, 0.2-
0.6%w/v Phenol.

administration of drugs.
6. -Wetting agents: To maintain particle size of  On line testing,
drug and to prevent caking of drug particles.  Capping or outer sealing,
eg; Tween-80, Sorbian trioleate.  Evaluation of product,
7. -Suspending agents: To prevent flocculation  Labeling of product.
of drug particles. eg: acacia, gelatin, sodium
CMC,MC. 2.Preparation of LVP: Medicated fluids are
Evaluation of parenterals transferred from a bulk container into
1. Pyrogen Test: This involves IV product container using high speed filling
injecting of sample sterile solution machine, just before filling fluids are
into the ear vein of healthy mature passed through in line membrane filter,
rabbits and recording fever by immediately after filling neck of container
inserting thermometer into their is sealed and sterilized by moist heat
anus i.e., if rabbits show rise in body sterilization and label. this all process
temp, means sample is not sterile. should be carried under strict aseptic
pyrogen: They are lipid polysaccharide condition.
of metabolism of microorganisms and Containers of parenterals.
produced fever.
2. Clarity test: To check the clarity of  Container for SVP: svp are packed in
preparations and determination of solid Glass vials and ampoules with
particulate, fibers in LVP can be done by rubber closure sealed by aluminum
filtering through filter discs with pore size cover.
of 8µ followed by microscopic examination
of filter discs and using different
instruments like photo-Nephelometer,
coulter counter. sterile solutions should be
inspected against a black and white
background using strong light source.
3.Sterility test: refer unit-7.
4.Leakage test: By immersing the glass
ampoules in a dye ( 1% methylene blue )  Container for LVP: LVP are packed
solution and applying a negative vacuum into glass bottles, PVC collapsible
pressure for minimum 15minutes, this
bags and semi rigid bags
pressure will force the dye solution into
weak seal glass ampoules and defective  PVC bags are used for infusion fluids.
ampoules (improper sealed) will contain
blue solution and that ampoules fails the  Semi rigid bags are used 3litres for
test. TPN, 100ml for electrolyte solutions
Preparation of parenterals
and 5litres for dialysis fluid.
1. Preparation of SVP: Common steps
involved in preparation of SVP is as
follows:
 Preparation of product,
 Filling of product,
 Sterilization of product,
 Aseptic sealing,
Labeling of parenterals
 Labels of SVP, LVP:
1. Product identity and details of
contained volume,
2. Strength of solution in terms of
active ingredients and dosage
statement,
3. Batch no, bar code, and storage
condition,
4. Date of manufacturing and expiry,
5. WARNING: To discard remaining
product, if treatment is complete.