In this slide , formulation of different types of parenteral dosage forms are being well discussed and explained.

1. INDUSTRIAL PHARMACY UNIT IV
Parenteral Products
Unit -IV
B.Pharmacy 5th semester
Presented By
Miss Sudipta Roy
Designation: Associate Professor
B.Pharmacy & Master of Pharmacy (Pharmaceutics)
Agra public pharmacy college Artoni

2. CONTENTS: FORMULATION OF PARENTERAL
PREPARATION.
 Vehicles for Parenteral products.
 Additives for Parenteral products.
 Containers and Closures for Parenteral
products.

3. VEHICLES
 Aqueous vehicles : water is used as vehicle for
majority of injections.
 The aqueous vehicles used are:
 Water for injection.
 Water for injection free from carbon dioxide.
 Water for injection free from dissolved air. Water for
injection is sterile water that must be free from
volatile, non volatile impurities and also from
pyrogens that is by product of bacterial metabolism,
thermostable, soluble in water, unaffected by
bactericide that can be passed through bacteria proof
membrane filter, Seitz filter, filter leaf etc.

4. NON AQUEOUS VEHICLES
 Oils and alcohol are commonly used as non aqueous
vehicles. Example: fixed oil( arachis oil, cottonseed oil,
almond oil, and sesame oil are used as vehicle. Oily
vehicles are generally used when a Depot effect of drug
is required or the medicaments are insoluble or slightly
soluble in water or the drug is soluble in oil.
 Eg. Dimercaprol injection by using arachis oil as
vehicle.
 Ethyl alcohol is used in the preparation of
hydrocortisone injection. Hydrocortisone is insoluble in
water.
 Propylene glycol is used as a vehicle in the preparation
of digoxin injection.

5. ADDITIVES.
 Additives are used and added to Formulation to
increase the stability or quality of the product. These
additives must be compatible with the entire formulation
physically and chemically.
 Additives are used in preparing the stable Parenteral
preparation:
 Solubilising agents: It helps to increase the solubility of
drug using different types of co solvent on basis of
solvation theory like propylene glycol, glycerol or
surface active agents like tweens, polysorbate, sodium
lauryl sulphate that is also known as solubility enhancer
and this type of technology is known as solubility
enhancement method.

6.  Stabilizers: These substances are basically used to
stabilize the Parenteral Preparation from light, heat,
oxygen, moisture. Different types of antioxidants are
used in different concentration to make the
formulation Long term stable preventing oxidation in
formulation,
 eg: thiourea, ascorbic acid, sodium metabisulphite, to
prevent oxidation air tight container can be used or
nitrogen/carbon dioxide filled container can be used.
Hydrolysis can be prevented by using non aqueous
vehicles or adjusting pH of the preparation.

7.  Buffering agents:
 To prevent degradation of preparation that is
due to change in pH can be prevented by
adding a suitable buffer to maintain the
desired pH. Eg: Citric Acid, Sodium Citrate,
Acetic acid and sodium acetate.

8.  Antibacterial Agents:
 These agents are used to prevent the growth
of microorganisms during storage that acts
as preservatives added in single dose
containers, multi dose containers whereas
Parenteral preparation are sterilized by
filtration method through bacteria proof
membrane filter.

9. SS
 Chelating agents:
 Chelating agent such as EDTA ( Ethylene
diamine tetra Acetic acid) and it's salts,
sodium or potassium salts of citric acid are
added in the formulation to chelate the
metallic ions present in the formulation
preventing destabilization .

10.  Suspending, emulsifying and wetting agents:
 Suspending agents ,like methyl cellulose,
carboxymethyl cellulose, gelatin and accacia
are commonly used to improve the viscosity ,
stability for Parenteral suspension.
 Emulsifying agents like agar, acacia, gum
acacia is used in parenteral emulsion or
sterile emulsion to improve stability.

11.  Tonicity:
 Parenteral Preparation should be isotonic with
blood plasma or other body fluids.
 Units of concentration:
 1. Weight per unit volume: eg. Atropine sulphate
injection 600 mcg/ml.
 2. Percentage weight/volume : eg. Dextrose
intravenous infusion 5% w/v.
 Mill moles per unit volume : eg. Potassium
chloride Solution strong 2m moles each of K+
and Cl-/ml.

26.  Containers and Closures :
 The pharmacopoeia requires the following conditions
for a container of Parenteral preparations.
 Container should be free of foreign substances ,
adverse effect , diffusion to walls yielding to product.
 Container should be transparent for visual inspection
for any types of microbial spoilage or destabilization
by color and to prevent thermal degradation using
amber color glass bottle/ampoules/vials.

27. Containers and Closures :The
pharmacopoeia requires the
following conditions for a
container of Parenteral
preparations.
Container should be free of
foreign substances , adverse
effect , diffusion to walls yielding
to product.
Container should be transparent
for visual inspection for any
types of microbial spoilage or
destabilization by color and to
prevent thermal degradation
using amber color glass
bottle/ampoules/vials.

28. Type 1 glass is known
as borosilicate glass or
neutral glass that is
sterilized by autoclave,
high hydrolytic
resistance due to
chemical composition.
Type 3 glass , soda lime
silicate glass with
moderately hydrolytic
resistance suitable for non
aqueous preparation and
powders for reconstitution,
containers for human blood
and blood components is
prohibited to reuse
Type 2 glass is also known
as soda lime silicate glass
with high hydrolytic
resistance as a result of
treatment with moist sulphur
dioxide at high temperature ,
suitable for acidic and
neutral aqueous
preparation.
Mainly three types of
glasses are used for
storing Parenteral
preparation. Plastic
containers made from
synthetic polymers eg.
Polyethylene, polyvinyl
chloride, polypropylene .

29.  Thank You.