According to the regulatory authorities each and every batch of shampoos must be evaluated prior to marketing. Evaluation is a measure of activity and safety. It also notifies the toxicity, if nowadays most of the shampoos are prepared, from synthetic detergents, hence evaluation becomes an essential factor.
EVALUATION OF SHAMPOO
According to the regulatory
authorities each and every batch of shampoos must be evaluated prior to
marketing. Evaluation is a measure of activity and safety. It also notifies the
toxicity, if nowadays most of the shampoos are prepared, from synthetic
detergents, hence evaluation becomes an essential factor. However, there is
also a need to evaluate herbal shampoo, since it may contain natural ingredient
which are liable to contamination.
Shampoos are evaluated for the
following aspects.
(I)
Evaluation
of Safety
(II)
Evaluation
of Antimicrobial Property
Safety is an important aspect which
must first and foremost parameter of
evaluation. As stated earlier the shampoos are made from synthetic detergents,
which are liable to irritate skin, scalp and eye. Hence, it becomes essential
to evaluate the safety of a shampoo. Over all, the shampoo must be non-toxic
and non-irritative. The safety is usually evaluated it, terms of toxicity i.e.,
if the preparation is found to be non toxic then it is regarded as safe and
vice-versa. However, the toxicity is determined by using “Draize test” which
suggests two separate methods for testing skin and eye toxicity respectively.
The methods are as follows:
(a)
Skin Toxicity Test: The steps involved in this test
are as follows:
A set of six albino rabbits are
selected. They should weigh about 2 kgs.
On the skin of each rabbit, a round
patch is made by removing hair.
Dilute preparation (8-10%) of
shampoo is usually applied onto the patches of a rabbits.
The shampoo is allowed to react for
a period of 3-4 hours. After that it is removed completely from the skin.
After efficient washing, the skin is
examined for any adverse reactions such as erythema, edema etc.
Based on the results obtained the
shampoo is considered as either safe or toxic.
Usually, there might be chances of
adverse reactions because the shampoo was kept in contact for 4 hours. But usual
practice of shampooing in human being is for 10-15 minutes. Alternatively, the
skin test is also performed on human being.
(b)
Eye Toxicity Test: The steps involved in this test are
as follows:
A set of six adult albino rabbits
are selected. They must weigh about 2 kgs.
One eye of each rabbit is considered
as test eye and another as control eye.
To each of the six test eyes of six
rabbits, the product (shampoo) is applied.
Washing is done after 20 seconds
pith 200 ml of tap water.
The eyes are rewashed after 5
minutes and then after 24 hours.
The control eye are also washed on
first day and then after 24 hours.
The test eyes are observed at 1, 24,
48 and 72 hours respectively. They are also examined on 7th and 14th
day.
The product is said to be toxic, if
there is a development of iris and corneal lesions which remains for more than
7 days.
Shampoos
are liquid or viscous preparations, they
are liable to microbial growth. Hence, preservative is usually added to prevent
midi growth .The added preservative should have following properties.
·
It
should be non toxic.
·
It
should be compatible with other ingredients.
·
It
should be effective at low concentration,
·
It
should be effective against wide variety of microorganism.
However, all the above points are
considered prior to the selection of preservative. Evaluation of preservative
usually involves the study of antimicrobial activity is generally done by using
a method called as "Challenge Study". According to this study, the
product is said to be preserved when it does not support microbial growth even
after repeated attacks of various micro-organisms.
Procedure
(Challenge Study):
Initially an appropriate strain of
microorganism is selected and is considered as test organism. Usually the
species of Pseudomonas are selected
i.e., P aeruginosa, P. Putida
etc.
A culture of any one of the above
test organisms is prepared.
The product (shampoo) is then
inoculated repeatedly in the culture medium and the studies are carried out for
a period of 10 to 12 weeks.
The inoculums usually contain 5
lakhs to1 crore micro organisms/ gm of product. Along with the test, control
samples are also prepared and reserved for reference. Usually two types of
control samples are prepared i.e., one sample with preservative and another
without preservative.
The test comes to a conclusion only
when it has been proven that the product has not supported the microbial
growth.
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