Solid Dosage form evaluation test

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The quantitative evaluation and assessment of a tablet‘s
chemical, physical and bioavailability properties are important
in the design of tablets and to monitor product quality.
These properties are important since chemical breakdown or
interactions between tablet components may alter the physical
tablet properties, and greatly affect the bioavailability of the
tablet system.
There are various standards that have been set in the various
pharmacopoeias regarding the quality of pharmaceutical
tablets.
 These include the diameter, size, shape, thickness, weight,
hardness, disintegration and dissolution characters.
 General Appearance

The general appearance of a tablet, its identity and general

elegance is essential for consumer acceptance, for control of
lot-to-lot uniformity and tablet-to-tablet uniformity.
The control of general appearance involves the measurement
of size, shape, color, presence or absence of odor, taste etc.
Size & Shape
It can be dimensionally described & controlled.
The thickness of a tablet is only variables.
Tablet thickness can be measured by micrometer or
by other device.
Tablet thickness should be controlled within a ± 5%
variation of standard value.
 Hardness (Fracture-resistance test ):

 Tablets require a certain amount of strength or hardness. Why?

 1. Withstand mechanical shocks of handling in manufacture,
packaging and shipping.
 2. Withstand reasonable abuse when in the
hands of the consumer.

 3. The relationship of hardness to tablet

disintegration, dissolution .
 Tablet Hardness: the force required to break a tablet along its
diameter by applying compression loading.

Test Description:
 A tablet is placed between two anvils, force is applied to the anvils, &
the crushing strength that just causes the tablet to break is recorded
(in kg).
 Hence, Hardness is thus sometimes termed the tablet crushing
strength.

 Tablet hardness should be between 5 – 10 kg

Hardness Variation:
 It depends on:
 - compression force,
 - concentration and type of binding agent

If the tablet initially is too hard, it may not disintegrate

in the requisite period of time.
If it is too soft, it may not withstand the necessary
multiple shocks occurring during handling, shipping, and
dispensing.
 Friability (attrition-resistance test):
It's another measure of a tablet's strength.
This test is only used for Compressed/Uncoated or plane tablet.
Friability of Coated tablet(Sugar/film/enteric)do not perform

 Why measure friability?

 Tablets that tend to powder& fragment when handled:

 1. lack elegance & consumer acceptance,
 2. Create excessively dirty processes in areas of manufacturing as coating
& packaging.
 3.Can also add to a tablet's weight variation or content uniformity
The laboratory friability tester is known as the
Roche friabilator.
 It subjects a number of tablets to the combined effects of
abrasion & shock
by utilizing a plastic chamber that revolves at 25 rpm,
dropping the tablets with each revolution.
 A preweighed tablet sample is placed in the friabilator,
which is then operated for 100 revolutions.
The tablets are reweighed.
Apparatus:
Drum: It is made up transparent
synthetic polymer with polished
internal surface
It have internal diameter 283-291 mm
Its one side is removeable.
Inside drum, have a curved
projection having radius of
75.5-85.5 mm.
Tablets are then dusted and reweighed.
 Conventional compressed tablets that lose less than 1.0% of
their weight are generally considered acceptable. It is given by
following formula:

% friability = (Wi – Wf / Wi) x %.

Where,
Wi = initial weight, Wf = final weight.
Specifications:
According to B.P
Max. loss of mass NMT 1.0%
According to U.S.P
Max. loss of mass NMT 0.8%
Effervescent/ chewable tablets have different
specifications.
In case of hygroscopic tablets avoid humidity(humid
enviroment)
Disintegration
Complete disintegration is defined as that state in
which any residue of the unit, except fragments of
insoluble coating or capsule shell, remaining on the
screen of the test apparatus or adhering to the lower
surface of the disk is a soft mass having no palpably
firm core.

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Disintegration Test (U.S.P.):
The U.S.P. device to test disintegration uses 6 glass tubes that
are 3” long; open at the top and 10 mesh screen at the bottom
end.
To test for disintegration time, one tablet is placed in each tube
and the basket rack is positioned in a 1-Litre beaker of water,
simulated gastric fluid or simulated intestinal fluid at 37 ± 0.5
C such that the tablet remain 2.5 cm below the surface of liquid
on their upward movement and not closer than 2.5 cm from the
bottom of the beaker in their downward movement.
Move the basket containing the tablets up and down through a
distance of 5-6 cm at a frequency of 29 to 32 cycles per minute.
Apparatus used for D.T
Apparatus A Apparatus B
 Tab and capsule not greater Tab and capsule > 18 mm
than 18 mm long long
6 open ended tubes 3 tubes
 77.5±2.5 mm long 77.5±2.5 mm long
 21.85±1.15mm internal 33.0±0.5 mm internal
diameter diameter
Tubes held by two plates Tubes held by two plates
 Diameter 90±2mm Diameter97 mm
 Having 6 holes of diameter Having 3 holes of diamter
24±2mm slightly more than 33 mm
 Cylindrical discs
Cylindrical discs
 Diameter 20.7±0.15mm
Diameter 31.4±0.13 mm
 B.P
USP

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Beaker
Height 149±11 mm
Internal diameter 106±9mm
Thermostatic arrangement
37±2°C
Device for lowering and raising baskets
29-32 cycles/min
Through Distance 55±2 mm
Time for upward stroke=time for downward stroke
Upward stroke 15 mm below the surface of fluid
Downward stroke atleast 25 mm above bottom of
vessel
1. Enteric coated tablets
Step 1: Acid stage
0.1 N HCl for 2 hrs(BP) 1 hr (USP)
no discs are added
No cracks or sign of itegration
Step 2: Buffer stage
Phosphate buffer pH 6.8 for 1 hr(BP) and 2 hr(USP)
add discs
Criteria: all 6 tablets should distegrate
2. Uncoated tablets
single layer tablet and multi layers tablet
Medium: Water
time: within 15 mins
3. Coated tablets
Film coated time within 30 mins(BP)
other than film coated tab within 60 mins
4. Effervescent tablets
Medium 200 ml water
temp 15-25°C and should disintegrate within 5 mins
5. Soluble tablets
these are uncoated/film coated tablets intended to be dissolve in water before
administration, solution produced may be slightly opalescent(not clear)
Medium: Beaker (200 ml water)
temp 15-25°C
time: within 3 minutes
6. Dispersible tablets
same as soluble tablets

7. Oro-Dispersible tablets
same as above
8. Modified release tablets
This test is not performed for them
9. Sublingual tablets
apply the test to uncoated tablets
Omit the use of discs
all 6 tab should disintegrate within specified period of time in individual
monograph
Time: within 2 mins
10. Capsules
Time: within 30 mins
Medium: water(unless otherwise specified in the monograph)
Disc: always use discs
Floating of the tablets can be prevented by placing perforated
plastic discs on each tablet.

According to the test the tablet must disintegrate and all

particles must pass through the 10 mesh screen in the time
specified.
 If any residue remains, it must have a soft mass.
Weight Variation test
The term 'uniformity of dosage unit' is defined as the degree of uniformity in
the amount of the active substance among dosage units. Therefore, the
requirements apply to each active substance being comprised in dosage units
containing one or more active substances, unless otherwise specified
elsewhere in this Pharmacopoeia.
Take 20 tablet and weighed individually.
Calculate average weight and compare the individual tablet weight to the
average.
The tablet pass the U.S.P. test if no more that 2 tablets are outside the
percentage limit and if no tablet differs by more than 2 times the percentage
limit.
How to calculate %age deviation

Specifications According to B.P

Average 18 Tab NMT 2 Tab None
Mass/Weight
80 mg or less ±10% ±20% >±20%
more than ±7.5% ±15% >±15%
80 mg and
less than 250
mg
250 mg or ±5% ±10% >±10%
more
According to USP
Average 18 Tab NMT 2 tab None
Mass/weigh
t
130 mg or ±10% ±20% >±20%
less than 130
mg
More than ±7.5% ±15% >±15%
130 and less
than 324 mg
More than ±5% ±10% >±10%
324 mg
According to U.S.P
Average weight Percent difference

130mg or less ±10

More than 130mg through 324mg

±7.5
More than 324mg ±5
According to B.P
Average weight Percent difference

80mg or less ±10

More than 80mg through 250 mg

±7.5
More than 250mg ±5
Weight variation Test for Capsules
Average wt/Mass 18 cap NMT 2 cap None
Less than 300 mg ±10% ±20% >±20%
300 mg or more ±7.5% ±15% >±15%
than 300 mg

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DISSOLUTION
Dissolution is the process by which a solid solute
enters a solution. In the pharmaceutical industry, it
may be defined as the amount of drug substance that
goes into solution per unit time under standardized
conditions of liquid/solid interface, temperature and
solvent composition.
Dissolution is considered one of the most important
quality control tests performed on pharmaceutical
dosage forms and is now developing into a tool for
predicting bioavailability, and in some cases,
replacing clinical studies to determine
bioequivalence. Dissolution behavior of drugs has a
significant effect on their pharmacological activity. In
fact, a direct relationship between in vitro dissolution
rate of many drugs and their bioavailability has been
demonstrated and is generally referred to as in vitro-
in vivo correlation, IVIVC
Apparatus-1 (Basket Type): A single tablet is placed in
a small wire mesh basket attached to the bottom of
the shaft connected to a variable speed motor. The
basket is immersed in a dissolution medium (as
specified in monograph) contained in a 1000 ml flask.
The flask is cylindrical with a hemispherical bottom.
The flask is maintained at 37±0.5°C by a constant
temperature bath. The motor is adjusted to turn at
the specified speed and sample of the fluid are
withdrawn at intervals to determine the amount of
drug in solutions.
Apparatus-2 (Paddle Type ): It is same as apparatus-1,
except the basket is replaced by a paddle.
The dosage form is allowed to sink to the bottom of
the flask before stirring.
For dissolution test U.S.P. specifies the dissolution
test medium and volume, type of apparatus to be
used, rpm of the shaft, time limit of the test and assay
procedure for the API.
The test tolerance is expressed as a % of the labeled
amount of drug dissolved in the time limit.
The content uniformity test
 is used to ensure that every tablet contains the amount of
drug substance intended with little variation among tablets
within a batch.
the content uniformity test has been included in the
monographs of all coated and uncoated tablets and all
capsules intended for oral administration where the range
of size of the dosage form available include 50mg or
smaller sizes.
Tablet monographs with a content uniformity requirement
do not have weight variation requirements.
Content Uniformity Test:
 Randomly select 30 tablets.
Ten of these assayed individually.
The Tablet pass the test if 9 of the 10 tablets must contain
not less than 85% and not more than 115% of the labeled
drug content and the 10th tablet may not contain less than
75% and more than 125% of the labeled content.
 If these conditions are not met, remaining 20 tablet
assayed individually and none may fall out side of the 85
to 115% range.
Thanks My Dear Students
M
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W L
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