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
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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 .

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UNOFFICIAL TESTS :
Appearance
Size and shape
Hardness

OFFICIAL TESTS
Friability

Weight variation test

Content uniformity tests

Dissolution test

Disintegration test
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 INPROCESS QC TESTS FOR TABLETS

For coated tablet :

Appearance

Dimensions

Adhesion test

Resistance to abrasion

For uncoated tablet :

Appearance

Dimensions
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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

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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

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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

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 Dimensions :

The dimensions of the tablets, thickness & diameter are

measured by using digital vernier calipers and screw
guage

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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
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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

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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

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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
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Erweka tester

Tablet is placed on the lower anvil & the anvil is

adjusted so that the tablet just touches the upper test
anvil
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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

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 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%

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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

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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 )

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 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
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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

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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 %

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 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 .

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 DISINTEGRATION TEST
APPARATUS
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 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
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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.
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 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
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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

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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
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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

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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
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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.

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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
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TYPE II PADDLE APPARATUS
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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

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RECIPROCATING CYLINDER
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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

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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
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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

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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 %

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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

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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
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