Discuss the following tests of OINTMENT

EVALUATION:
•Physical methods
•Microbiological methods

•Quality control tests for ointment

 Physical methods
• Test of rate of absorption
• Test of non-irritancy
• Test of rate of penetration
• Test of rate of drug release
• Test of rheological properties
• Test of content uniformity
Microbiological methods
• Test of microbial content
• Test of preservative efficacy
• Ointments are evaluated for the rate of
absorption of drugs.

• Procedure: Apply ointment on skin by

rubbing.
• At regular intervals of time, serum and urine
samples are analyzed to find rate of
absorption i.e., the amount of drug absorbed
per unit time.
21-Day patch test.

• Procedure: Select 24 human volunteers and

apply ointment under occlusion (closed dressing)
daily on forearm for 21 days & observe daily.

• Result: No visible reaction or erythema

/intense erythema with edema & vesicular
erosion should occur.
• Apply weighed quantity of ointment on
selected area of skin for definite time period

• Ointment left over, is collected and weighed.

• Amount of ointment penetration= W1 _ W2

• Rate of penetration = W1 - W2
Time
• The test should be repeated twice or thrice
• In a clean test tube, coat the internal surface
with ointment as a thin layer.

• Saline or serum is poured into the test tube.

• After a certain period of time, the saline

is analyzed for the quantity of the drug.
•
Rate of drug release = Amount of drug in saline
Time
Test of Microbial contents
• Solutions of samples of ointment are made.
• Each sample is inoculated into separate volumes of
0.5 ml of rabbit's plasma under aseptic conditions
and incubated at 37°C
for 1-4 hours.
• No formation of the clot in the incubated mass
indicates the absence of the micro-organisms.
Test of Preservative Efficacy
• Pour plate technique

Prepare the Solutions of ointment & mixed with

Tryptone Azolectin (TAT) broth separately.
• All cultures of the micro-organisms are added into
each mixture, under aseptic conditions.
• All mixtures are incubated.
• The number of micro-organisms in each sample
are counted on 7th, 14th, 21st and 28th days of
inoculation.
Contd….
MICROBIAL LIMITS:
• On 14th day, the number of vegetative cells
should not be more than 0.1% of initial
concentration.
• On 28th day, the number of organisms should be
below or equal to initial concentration.
Physical appearance
Cracking of emulsion (separation of oil and water
phase)
 Development of granular or lumpy appearance
Marked changes in viscosity
 Crystal growth Gross microbial contamination
Particle size determination
 Dilute suitable amount of the preparation with
equal amount of glycerol or liquid paraffin (as
specified in monograph).
Mount the mixture on the slide and examine
under high resolving power microscope.
 Count the number of particles with diameter
above or below than the specified limit in the
monograph. Compare the percentage with the
official limits.
Weight Variation Test
Also known as minimum fill test.
Select the 10 filled containers
 Remove any label that could lead to weight
variation
Cleanse the outer thoroughly, dry and weigh each
unit individually, Cut the lateral part of containers,
remove their contents by washing, dry them and
 weigh each unit along with its corresponding parts
Difference between the weights give the weight of
the content.
 Calculate the average weight of the contents.
 SPECIFICATIONS
 The average net weight of the content should not be less than
the labelled amount.
 The net weight of the contents of any single container should
not be less than 90% of the labelled amount (for 60g or less)
and not less than 95% of the labelled amount (for more than
60g but not more than 150g).
 If the requirements are not met, weigh the contents of 20
additional containers.
 Average net weight of the contents of 30 containers must not
be less than the labelled amount. Contents of not more than 1
out of 30 containers should be less than 90% of the labelled
amount (for 60g or less) and not less than 95% of the labelled
amount (for more than 60g but not more than 150g ).
 USP-2008, pp:298, vol I, general chapter <755>
Solubility test
The contents should be soluble in 9parts of water
and in 1.7 parts of hot water.
The contents should be miscible with alcohol,
ether and chloroform.
Viscosity shall be determined as specified in the
individual monograph for Viscosity determination
Assay of active contents
Assay of active contents should be performed
according to official monograph and percentage
should be within the official limits.
Sterility test for ophthalmic
ointments
This test is performed according to the official
monograph by any of the following method
specified ;
1- Membrane filtration method
2- Direct inoculation method
Metal Particles in Ophthalmic
Ointments
 Melt the contents of 10 tubes.
 individually/separately in 60mm Petri dishes.
 Cover the dishes and heat at 85 ° C for 2hours; if
needed, slightly increase the temperature to achieve
full fluidity.
 Allow each to cool at room temperature and solidify.
 Invert the Petri dish on the stage of microscope
furnishing 30times magnification and equipped with
calibrated eye piece micrometer In addition to usual
light source, direct an illuminator from the above at an
angle of 45 °
 Examine the bottom of the entire Petri dish for metal
particles
SPECIFICATIONS
 Count the particles greater than 50µm in any
dimension.
 Not more than one tube should contain 8 such
particles and total number of such particles in all 10
tubes should not exceed 50.
 If the requirements are not met, perform the test on
20 additional containers.
 Not more than 3 out of 30 tubes should contain more
than 8 particles and the total number of such
particles in all 30 tubes should not exceed 150.
 USP-2008,pp:298, vol I, general chapter <751>
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