PRESERVATIVES

28.08.
2014
PRESERVATIVES
By: R.Ph Dr. Saba Inayat Ali
Lecturer
DCOP
LEARNING OBJECTIVES
At the end of this topic, students will be able to:
Define Preservatives.
List the criteria for selecting a suitable preservative.
Classify preservatives as antimicrobial and
antioxidants.
Discuss the properties of alcohol, Acids, Esters &
Quaternary Ammonium compounds as preservatives.
Preservatives
Preservatives are substances that are commonly
added to various foods and pharmaceutical products in
order to prolong their shelf life.
The addition of preservatives to such products,

especially to those that have higher water content, is
essential for avoiding alteration and degradation by
microorganisms during storage.
Microbes will grow in an
aqueous solution.
Therefore, it is necessary
that formulator should add
a preservative to the
product to decrease the
probability of product
contamination.
SELECTION OF PRESERVATIVE
The major criteria that should be considered in
selecting a preservative are as follows:
1- Effective against a wide spectrum of
microorganisms.
2- Stable for the shelf life of the formulation.
3- Nontoxic.
4- Non-sensitizing.
5- Relatively free of taste and odour.
6- should not be Adsorbed on to the container
7- should be compatible with other formulation
additives.
8- Its efficacy should not be decreased by pH.
Classification of preservatives
Preservatives are classified into two main classes:
1. Antimicrobial preservatives
2. Antioxidant
Antimicrobial preservatives
Antimicrobial preservatives are
included in the preparations to kill or
to inhibit the growth of micro-
organisms inadvertently introduced
during manufacture or use.
They are used in sterile

preparations such as eye drops and
multidose injections to maintain
sterility during use.
They may be also added to aqueous
injections that cannot be sterilized in
their final containers and have to be
prepared using aseptic precautions.
Preservatives are also used in

cosmetics, foods, and non sterile
pharmaceutical products such as oral
liquids and creams to prevent
microbial spoilage.
Antimicrobial preservatives are classified into two main
sub-groups:
Anti-fungal preservatives.
Anti-bacterial preservatives.
ANTI-FUNGAL PRESERVATIVES
Anti-fungal preservatives include compounds such as
benzoic acid, ascorbic acids and their salts.
phenolic compounds, methyl, ethyl, propyl and butyl p-

hydroxybenzoate (parabens).
ANTIBACTERIAL PRESERVATIVES
Antibacterial preservatives include compounds such as
quaternary ammonium salts

alcohols, phenols
Mercurials
biguanidines.
Antioxidants
Antioxidants are included in the pharmaceutical products
to prevent deterioration from oxidation.
Examples
ascorbic acid
citric acid
potassium and sodium salts of sulphurous acid.
Types
Preservatives may be grouped into a number of classes
depending upon their molecular structure, including:
Alcohols
Acids
Esters
Quaternary Ammonium compounds
1) Alcohols
Ethanol is useful as a preservative when it is
used as a solvent; however, its dose need a
relatively high concentration to be effective.
13-50%
1) Alcohols
Propylene glycol is also used as a solvent in
oral solutions and topical preparations, and it
can function as a preservative in the range of
15 to 30%.
1) Alcohols
Chlorobutanol and phenylethyl alcohol are
used in lower concentrations of about 1% for
preservative action.
2) Acids
Benzoic acid has a low solubility in water. (1 g/300
mL) of water
0.1 to 0.5%.
Benzoic acid/sodium benzoate is ineffective in solutions
with a pH above 5.
Benzoic acid/sodium benzoate is widely used as a
preservative, especially in foods. It has most of the
properties of an ideal preservative. Its biggest drawback
is the pH dependence of its effectiveness.
2) Acids
Sorbic acid has also a low solubility in water. (1 g/400
mL) at 30°
Patassium sorbate
Sorbic acid is widely used as a preservative in food in
conc. of 0.05 to 0.2%.
3) Esters
Parabens are esters of p-hydroxybenzoic acid and
include the methyl, ethyl, propyl and butyl derivatives.
These compounds are used widely in Pharmaceutical

products and are effective and stable over a pH range of
4 to 8.
0.2%
Parabens
Sometimes used in combination to exhibit a wide
spectrum of activity.
The most widely used preservatives are mixture of

Methyl parahydroxybezoate in a 0.2% concentration and
Propyl parahydroxybenzoate in a 0.02% concentration.
 They are suitable for both external and internal use.

4) Quaternary Ammonium compounds
Benzalkonium chloride is used at relatively low
concentration, 0.002 to 0.02%, depending on the nature
of the pharmaceutical product.
This class of compounds has an optimal activity over the

pH range of 4 to 10 and is quite stable at room
temperature.
It is used generally in preparations for external use or those

solutions that come in contact with mucous membranes.

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28.08.

The addition of preservatives to such products,

They are used in sterile

Preservatives are also used in

benzoic acid, ascorbic acids and their salts.

phenolic compounds, methyl, ethyl, propyl and butyl p-

quaternary ammonium salts

These compounds are used widely in Pharmaceutical

The most widely used preservatives are mixture of

 They are suitable for both external and internal use.

This class of compounds has an optimal activity over the

It is used generally in preparations for external use or those

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