QUALITY CONTROL TESTS OF TABLETS
III/IV BPHARMACY (5TH SEMESTER)
Dosage form technology including cosmetics (503)
DEPARTMENT OF PHARMACEUTICS
CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES 1
SNO CONTENTS SLIDE NO
1 QUALITY CONTROL TEST DEFINITION 1
2 INPROCESS QC TESTS FOR TABLETS 5
FOR UNCOATED TABLET
FOR COATED TABLET
3 OFFICIAL TESTS FOR TABLETS
WEIGHT VARIATION TEST 16
FRIABILITY 19
DISINTEGRATION TEST 24
DISSOLUTION 29
2
QUALITY CONTROL TEST :
QC refers to produce (or) a set of steps taken during
manufacturing of a product to ensure that it meets requirements
QC is the monitoring process through which manufacturer
measures actual quality performance compares it with standards
& finds out the causes of deviation from standard to ensure
quality product not once but every time .
3
UNOFFICIAL TESTS :
Appearance
Size and shape
Hardness
OFFICIAL TESTS
Friability
Weight variation test
Content uniformity tests
Dissolution test
Disintegration test
4
INPROCESS QC TESTS FOR TABLETS
For coated tablet :
Appearance
Dimensions
Adhesion test
Resistance to abrasion
For uncoated tablet :
Appearance
Dimensions
5
COATED TABLET :
These are the tests conducted when the tableting is under process
Appearance :
The tablet should be free from cracks, depression ,pinholes etc.
Dimensions :
The dimensions of the tablets, thickness and diameter
Measured by using digital vernier calipers or screw guage
6
Adhesion test :
This measured by using tensile strength testers
The force required to peel the film from the tablet surface is
measured
Resistance to abrasion :
The ability of the coating to remain stuck to the tablet surface is
tested
Any defects in the formulation of coating solution can be tested
7
UNCOATED TABLETS :
Appearance :
It should be free from cracks ,depression, pinholes etc.
Colour & polish of the tablet should be uniform on
whole surface
There should be no signs of coating
Surface should be smooth
8
Dimensions :
The dimensions of the tablets, thickness & diameter are
measured by using digital vernier calipers and screw
guage
play
9
HARDNESS :
It is defined as the crushing strength of the tablet or force
required to break a tablet across the diameter
Hardness of the tablet is the indication of strength
Why do we do hardness test for tablets ?
tablet should be stable to mechanical stress &
transportation
Degree of hardness varies with different manufacturers &
different tablets
10
It is a valuable test ,which influence the tablet dissolution &
disintegration
Depending upon the type & concentration of the binding
agent the hardness varies
Binding agents (eg) ; acacia mucilage ,starch paste , sugar
syrup , methyl cellulose dispersion etc.
The force is measured in kilograms & the hardness of about
4kg is considered to be satisfactory for uncoated tablet
play
11
Various types of hardness testers used are :
Monsanto tester
The tablet is placed across the spindle & anvil. Knob is adjusted to
hold the tablet in position. The reading of the pointer is adjusted to
zero. Pressure is slightly increased to break the tablet
12
Pfizer tester
It works on the mechanical principle as a pair of pliers
Tablet is compressed between holding anvil & a piston connected
to the direct force reading guage
13
Erweka tester
Tablet is placed on the lower anvil & the anvil is
adjusted so that the tablet just touches the upper test
anvil
14
Schleuniger tester
Operates in horizontal position
An anvil is driven by an electric motor presses the tablet at a
constant load rate against a stationary anvil until the tablet
breaks
These testers Does not produce same results for the same tablet
15
Weight variation test for tablets
USP – OFFICIAL LIMITS BP - OFFICIAL LIMITS
Tablet weight limit Tablet weight limit
130mg or less ±10 % 80mg or less ±10 %
130 – 324 mg ±7.5 % 80mg – 250 mg ±7.5 %
> 324 mg ±5 % > 250mg ±5%
IP – OFFICIAL LIMITS
Tablet weight limit
80mg or less ±10 %
80mg – 250 mg ±7.5 %
> 250mg ±5%
16
Test procedure :
30 tablets were randomly selected for the test .every tablet in
each batch should have uniform weight .
20 tablets are weighed individually. Average weight is
calculated from individual weight of all tablets
Individual weight is compared with average weight.
The percentage difference in the weight variation should be with
in the permissible limits.
The percentage deviation is calculated by using the formula:
% weight variation = individual weight – average weight
---------------------------------------------×100
individual weight 17
Result :
Out of 20 tablets , if 2 tablets deviate the limit perform
test for other 10 tablets
Out of 30 tablets , if more than 2 tablets deviate the limit
the batch passes the test
play
18
Friability test :
It is used to measure the strength of the tablet
It is used to measure tablet to withstand mechanical shock &
abrasion without crumbling during the handling of manufacturing
,packaging, shipping , and consumer use.
The friability of tablets is indicated by chipping , capping (or)
breaking
Friability is strictly adhered to coated tablets
Friability problem is encountered with thin tablets ,large diameter
tablets ,granules (excessively dried or excessive fine granules )
19
The extent of friability is measured by using Roche
Friabilator
It rotates at a rate of 25 rpm .10 tablets are weighed collectively &
placed in the chamber of friabilator.in the friabilator the tablets are
exposed to rolling resulting from free fall of the tablets within the
chamber of friabilator
20
After 100 revolutions (4 min ) the tablets were taken out from the
friabilator and intake tablets were again weighed collectively.
% friability is calculated by using the formula :
friability = W1 – W2
--------------- × 100
W1
W1 = Weight of the tablet before test
W2 = Weight of the tablet after test
21
Content uniformity test :
This test is applied to assure uniform potency for tablets of low
dose drugs
The test is applicable to tablets that contain 10mg / < 10mg (or)
< 10%w/w of active ingredients
procedure :
Select 30 tablets randomly from the batch
Atleast 10 of them are assayed individually
Out of 10 tablets 9 tablets must contain not less than 85% not
more than 115% of labelled drug content
10 th tablet may not contain < 75% or > 125 % of labelled drug
content. 22
Result :
Batch passes the test
If there is any deviation then perform the assays individually
for 20 tablets
Out of 30 tablets 3 tablets can be within 75 – 125 % & the
others should be within 85 – 115 %
23
Disintegration test (D T) :
Disintegration is the process of breakdown of tablet into
smaller particles or granules .
There is no correlation between dissolution & disintegration .
Disintegration is a pre-requisite for the dissolution .
24
DISINTEGRATION TEST
APPARATUS
25
It has a basket rack assembley .
Basket has 6 cylinders (77.5 mm long,21.5 mm internal diameter ,
2mm thick )
Tubes are held vertically by 2 super imposed plastic plates
(90mm in diameter 6.75 mm thick ) and have perforations of size
of cylinders.
Lower plate has woven stainless steel (ss) wire atachment .
Upper plate is covered by ss disc perforated by 6 holes .
Plates are held rigidly in position & 77.5mm part by vertical
metal rod at the periphery
26
Metal rod is fixed at the centre (or) upper plate to enable the
assembly to be attached to the device for raising & lowering it
smoothly at constant frequency of between 28 – 32 cycles per
minute through a distance of 50 – 60 mm
DISCS :
Discs are used to prevent the floating of tablet & to impart
abrasive action to the tablet.
Dimensions : 20.7mm in diameter ,9.5 mm thick.
They are made up of transparent plastic & pierced with 5holes
each 2mm in diameter 1 in centre &4 are equally spaced on the
circle.
play 27
TABLET TYPE DISINTEGRATION TIME
Uncoated 15 minutes
Plain coated tablet 60 minutes
Enteric coated tablet 3 hours
Dispersible tablet 3minutes
Effervescent tablet ˂ 3 minutes
Sublingual tablet 4 hours
Buccal tablet 4 hours
Vaginal tablet 60minutes
chewable tablet not required
28
DISSOLUTION TEST :
Dissolution is a process in which a solid substance
solubilises in a given solvent ( mass transfer from the
solid surface to the liquid phase.
or
It is a process by which drug released from solid dosage
form & immediately goes into molecular solution .
Rate of drug absorption for drugs is often determined by
rate of drug dissolution from the tablet
29
30
Based on sink (or) non sink conditions dissolution
apparatus are classified as :
Closed compartment apparatus
Open compartment apparatus
Types of dissolution apparatus (official)
According to IP :
TYPE I : PADDLE
TYPE II : BASKET
According to BP :
TYPE I : BASKET
TYPE II : PADDLE
TYPE III : FLOW THROUGH CELL
31
According to U S P :
TYPE I : ROTATING BASKET
TYPE II : PADDLE
TYPE III : RECIPROCATING CYLINDER
TYPE IV : FLOW THROUGH CELL
TYPE V : PADDLE OVER DISC
TYPE VI : ROTATING CYLINDER
TYPE VII : RECIPROCATING DISC
32
TYPE I : BASKET TYPE :
Design :
Vessel Made up of borosilicate glass
Hemispherical bottom
Inner diameter 98 to 106 mm
Capacity 1000 ml
Height 160 to 210 mm
shaft Stainless steel 316
Rotates smoothly without significane .
Wooble positioned in such a way that its axis is
not more than 2mm from vertical axis of the
vessel 33
BASKET TYPE
34
Basket stainless steel 316
made of # 22mesh
gold coatings upto 0.0001 inch
placed at a distance of 2cm from bottom
Water bath maintained at 37 ± 0.5 ˚c
Agitation 100RPM
Use capsules ,tablets , delayed release , suppositories ,
floating dosage forms.
35
TYPE II : PADDLE TYPE
DESIGN :
Shaft The blade passes through shaft so that
bottom of the blade fuses with bottom of the shaft
Stirring elements made up of tefflon
for laboratory purposes
stainless steel 316
Water bath maintain at 37± 0.5 ˚c
Sinkers platinum wire is used to prevent capsule /
tablet from floating
Agitation 50 to 75 RPM
Basket mesh size ranges from 10 to 80 can be used 36
37
TYPE II PADDLE APPARATUS
38
TYPE III : RECIPROCATING CYLINDER :
DESIGN :
Vessel cylindrical flat bottom glass vessel.
Agitation type reciprocating generally 5 to 35 RPM
Volume of dissolution fluids 200 – 250 ml
water bath maintained at 37± 0.5 ˚c
Use extended release eg : chloramphenicol
chewable tablets eg : carbamazepine
39
RECIPROCATING CYLINDER
40
Type IV : FLOW THROUGH CELL :
DESIGN :
Reservoir For dissolution medium
Pump forces dissolution medium through cell
holds the sample
flow rate 10 – 100 ml / min
laminar flow is maintained
peristalic / centrifugal pumps are not
recommended
Water bath 37± 0.5 ˚c
41
42
TYPE V : PADDLE OVER DISC :
DESIGN :
Sample holder disc assembly that hold the product in
such a way that release surface is parallel with paddle
Paddle is directly attached over disc assembly
Samples are drawn away between the surface of medium &
top of the paddle blade
Volume 900ml
Water bath 32 ˚c
43
TYPE VI : ROTATING CYLINDER :
DESIGN :
Vessel In place of basket ,cylinder is used
Cylinder stainless steel 316
Sample mounted to cuprophan ( inner porous cellulosic
material ) an entire system is adhere to cylinder
Dosage unit is placed in cylinder & released from
outside
water bath maintained at 37± 0.5 ˚c
Use transdermal patches 44
TYPE VII :RECIPROCATING DISC :
Vessel flat bottom cylindrical vessel
volume of dissolution medium 50 – 200ml
Sample is placed on disc shaped holders
Agitation reciprocation
reciprocating frequency 30 cycles / min
Water bath maintained at 37± 0.5 ˚c
Use transdermal patches
45
Limits :
Dissolution testing & interpretation can be done by 3 stages
(S1,S2,S3)
In stage 1 : 6 tablets were tested & are acceptable if all of the tablets
are not less than Q + 5%
In stage 2 : additional 6 tablets were tested .if all average of 12 tablets
is greater than or equal to Q & no unit is less than Q – 15%
If the tablets fails the test
In stage 3 : all the average of 24 tablets is greater than or equal to
Q & if not more than tablets are less than Q - 15 %
play
46
Conclusion :
quality control tests are used for evaluating the quality of
tablets
Inorder to maintain quality very batch of formulation
should be tested according to compendial standards
47
REFERENCES :
http://www.accessdata.fda.gov/scripts/cder/dissolution/dsp_Searc
hResults_Dissolutions.cfm?PrintAll=1
http://apps.who.int/phint/en/p/docf/
United states pharmacopeia – 2007 page no 2154 (701),2155 –
2164 (711)(721)(724).
Indian pharmacopeia – 2007 volume 1 page no 177-185
British pharmacopeia - 2009
Leon lachman , Herbert A.Liberman,theory &practice of
industrial pharmacy .pg no 296 - 303
48
49
