EVALUATION OF
OINTMENT
OINTMENT
Ointments are soft semi solid
preparation meant for external
application to the skin / mucous
membrane.
CHARACTERISTICS OF
IDEAL OINTMENT
It should be chemically & physically
stable.
It should be free from grittiness.
It should melt / soften at body
temperature & be easily applied.
The base should be non irritating &
should have no therapeutic action.
Medicament should be finely divided &
uniformly distributed throughout the
base.
CLASSIFICATION OF
OINTMENT
1. According to therapeutic
properties based on penetration:
According to penetration ointments are
divided into 3 classes.
(a). Epidermic: These ointments are
intended to produce their action on the
surface of the skin & produce local
effects.
They are not absorbed.
These ointments acts as protectives,
antisceptics, local anti infective &
parasiticides.
(b). Endodermic Ointment: These
ointments are intended to release
medicaments that penetrates into the
skin.
They are partially absorbed & act as
emollients, stimulants & local irritants.
(c). Diadermic Ointment: These
ointments are intended to release the
medicaments that passes through the
skin & produce systemic effects.
ACCORDING TO
THERAPEUTIC CLASS
According to therapeutic class ointments are further
classified as:
Anti Eczimatous
Antibiotics
Anti inflamatory
Anti fungal
Anti pruritic
Astringent
Counter irritant
Ointments used for dandruff treatment
Emolients
Parasiticide
Protectant
Keratolytic (used to remove or soften the horny layer of
the skin. Eg: Salicylic acid)& keratoplastic (substance
PHYSICAL APPEARANCE
Main characteristics needs to be
checked;
Cracking of creams: separation of oil and
water.
Development of granular & lumpy
appearance.
Marked changes in viscosity.
Crystal growth.
Microbial contamination.
PARTICLE SIZE
DETERMINATION
Dilute suitable quantity of preparation
with equal volume of glycerol or liquid
paraffin as specified.
Mount on glass slide & examine under
light microscope.
Count the no: of particles with diameter
above / below than that specified in
monographs.
Compare the percentage with official
limits.
WEIGHT VARIATION TEST
Applies to those products in which labeled net
weight is not more than150gram.
Select 10 filled containers, remove the label & weigh
individually.
Remove the contents by cutting the containers &
wash with suitable solvent.
Dry & weigh each container together with its
corresponding parts, take difference as the weight of
contents.
The average net weight of contents of 10 containers
should not be less than the labeled amount.
The net weight of content of any single container
should not be less than 90% of the labeled amount
(for 60 gram or less than 60 grams)
Not less than 95% for the labeled
amount (60-150 grams).
If this requirement is not met repeat the
procedure on additional 20 containers.
The average net weight of 30 containers
should not be less than the labeled
amount.
Contents of not more than one out of 30
units should be less than 90 % of the
stated amount (for 60 gram or less than
60 grams).
Not less than 95% for the labeled
METAL PARTICLES IN
OPHTHALMIC OINTMENTS
Extrude completely the contents of 10
containers separately into flat petri dishes &
cover it.
Heat at 85C for 2 hours & cool slowly to
solidify.
Remove the cover & invert on the stage of
microscope adjusted to 30 times
magnification & equipped with eye piece
micrometer disc calibrated for this
magnification.
Additional illuminator may be used.
Examine the entire bottom of petri dish for
metal particles.
Count the metal particles of 50µm or
larger.
The requirement is met if total no: of such
particle in all 10 tubes does not exceed 50.
Not more than one tube contain more than
8 such particles.
If not met then repeat the test with 20 more
tubes.
The requirement is met if total number of
such particle in 30 tubes is not more than
150.
And not more than 3 containers allowed to
contain more than 8 particles.
STERILITY TEST
Ophthalmic ointments should be free
from aerobic bacteria, anaerobic
bacteria & fungi.
Sterility test can be performed on
ointment either by;
1. Membrane filtration Technique
2. Direct inoculation technique .
MEMBRANE FILTRATION
TECHNIQUE
In this solution of test product(1%) is prepared in
isopropyl myristate & allowed to penetrate cellulose
nitrate filter with pore size less than 0.5µm.
If necessary gradual suction or pressure is applied to
aid filtration.
The membrane is finally incubated for 14 days in
fluid thio glycolate (FTG) & Soyabean casein
digest(SBCD) medium .
Growth on FTG medium indicates presence of
aerobic & anaerobic bacteria & SBCD medium
indicates Fungi and aerobic bacteria.
Absence of growth in both of these media indicates
that the product is sterile i.e free from any micro
organism.
DIRECT INNOCULUM
In this technique 1 part of product is diluted with 10
parts of sterile & fluid specified in monographs with
the help of an emulsifying agent & incubated in FTG
& SBCD media for 14 days.
Growth on FTG medium indicates presence of
aerobic & anaerobic bacteria & SBCD medium
indicates Fungi and aerobic bacteria.
Absence of growth in both of these media indicates
that the product is sterile i.e free from any micro
organism.
Sample for sterility test depend upon batch size of
product.
If batch size is less than 200 containers than 5% or 2
containers are taken.
If the batch size is more than 200 containers than 10
containers are used for sterility test.
