quality control tablet

8/10/2019 quality control tablet

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QUALITY CONTROL TESTS

FOR TABLETS AND

CAPSULES
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Quality Control of Tablets

General Appearance:

-Size, shape, and thickness:

This is important to facilitate packagingand to decide which tablet compressing

machine to use.

-Organoleptic properties:which include color and odor of the

tablets.
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Official Standards as per B.P.

/I.P./ U.S.P.

COMPARISON OF DIFFERENTPHARMACOPOEIAL QUALITY CONTROLTESTS

BRITISH PHARMACOPOEIA

FOR ALL TABLETS:

Content of active ingredients

Disintegration

Uniformity of content

Labeling


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Uncoated tablet:-Disintegration test-Uniformity of weight

Effervescent tablet:

-Disintegration test-Uniformity of weight

Coated tablet:-Disintegration test-Uniformity of weight
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Gastro resistant tablet:

-Disintegration test

Modified release tablet:

-Uniformity of weight.

Dispersible tablet:

-Disintegration test-Uniformity of dispersion

-Uniformity of weight
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INDIAN PHARMACOPOEIA

Uncoated tablet:

-Uniformity of container content

-Content of active ingredient

-Uniformity of weight

-Uniformity of content


Enteric coated tablet:

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Dispersible tablet:

-Uniformity of dispersion

-Disintegration

Soluble tablet:

-Disintegration testEffervescent tablet:

-Disintegration/ Dissolution / Dispersion

test
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UNITED STATES PHARMACOPOEIA

Physical tests applicable to tablet formulation:

-Bulk density /Tapped density of powder

-Powder fineness

-Loss on drying

-Disintegration test-Tablet friability

-Dissolution test

-Drug release testing-Uniformity of dosage form

-Container permeation test

-Labeling of inactive ingredients


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Official and unofficial tests:

Official Tests:Weight variation, disintegration,

dissolution, drug content.

Non-Official Tests:Hardness, friability.


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I- Non official tests:

Hardness (crushing strength):

It is the load required to crush the tablet whenplaced on its edge.

Why do we measu re hardness?

To determ ine the need for pressu readjustments on the tablet ing mach ine.

Hardness can affect the dis integrat ion . So

if the tablet is too hard, i t may no tdis integrate in the required per iod of t ime.

And i f the tablet is too so ft , i t wi l l no t

w i thstand the handl ing dur ing subsequent


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process ing such as coat ing or

packaging.>In general, if the tablet hardness is too

high, we first check its disintegration

before rejecting the patch. And if thedisintegration is within limit, we accept the

patch.

>If H. is high + disintegration is within time accept the batch.


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Factors Affecting the Hardness:

Compression of the tablet and

compressive force.Amount of binder. (More binder more

hardness)

Method of granulation in preparing thetablet (wet method gives more hardnessthan direct method, Slugging method givesthe best hardness).

Limits:

5 kilograms minimum and 8 kilogramsmaximum.


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>Make hardness test on 5 tablets and then

take the average hardness.

Friabi l i ty:

It is the tendency of tablets to powder,

chip, or fragment and this can affect the

elegance appearance, consumeracceptance of the tablet, and also add to

tablets weight variation or content

uniformity problems.


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Friability is a property that is related to

the hardness of the tablet.

An instrument called friabilator is used toevaluate the ability of the tablet to

withstand abrasion in packaging,

handling, and shipping.


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Procedure:

1. Weigh 20 tab altogether = W1

2. Put these tablets in the friabilator and adjust theinstrument at 100 rpm (i.e. = 25 rpm for 4 min)

3. Weigh the 20 tablets (only the intact ones) = W2

4. Friability (% loss) =

It must be less than or equal to1% but if more wedo not reject the tablets as this test is non-official.

Perform this test using 20 tablets that were usedfirst in the weight variation test


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II- Official Tests:Disintegration:

It is the time required for the tablet to break

into particles, the disintegration test is ameasure only of the time required under a

given set of conditions for a group of

tablets to disintegrate into particles.


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Liquids used in

disintegration

Water,

simulated gastric fluid

(PH = 1.2 HCl),

or Simulated intestinalfluid (PH = 7.5,

KH2PO4 (phosphate

buffer) + pencreatin

enzyme +NaOH)


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Limits:

For Uncoated tablets:

Medium Temper

ature

Time

limit

According toU.S.P.

Simulatedgastric

fluid

37oC Notexceed

30min

According to

B.P.

water 37oC Not

exceed

15min


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U.S.P. method for uncoated tablets:

Start the disintegration test on 6 tablets.

If one or two tablets from the 6 tablets fail

disintegrate completely within 30min

repeat the same test on another 12 tablet.

(i.e. the whole test will consume 18tablets).

Not less then 16 tablets disintegrate

completely within the time if more then two tablets (from the 18) fail

to disintegrate, the batch must be rejected.


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For Coated tablets:

1. To remove or dissolve the coat, immerse

the tablet in distilled water for 5min. Put the tablet in the apparatus in water or

HCL for 30min at 37oC (according to the

U.S.P). If not disintegrated, put in intestinalfluid.

>If one or two tablets fail to disintegrate,repeat on 12 tablets. So 16 tablets from the

18 must completely disintegrate within thetime >>if two or more not disintegrated thebatch is rejected.


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U.S.P. Method for Enteric coated tablets:

1. Put in distilled water for five minutes to

dissolve the coat.

2. Then put in simulated gastric fluid (0.1M

HCL) for one hour.

3. Then put in simulated intestinal fluid for

two hours.

If one or two tablets fail to disintegrate,

repeat this test on another 12 tablets. So 16tablets from 18 should completely

disintegrate. If more than two fail to

disintegrate the patch must be rejected.


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B.P. method for Enteric coated tablets:

1. Put in distilled water for five minutes to

dissolve the coat. 2. Put in simulated gastric fluid for two

hours (emptying time).

3. Put in phosphate buffer (PH 6.8) for onehour.

4. If one or two tablets fail to disintegrate

repeat on 12 tablets. So 16 tablets shoulddisintegrate. If more than two tables fail to

disintegrate reject the batch.


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Weight Variation (uniformity of weight) oftablets:

1. Weigh 20 tablet selected at random,each one individually. X1, X2, X3 Xz

2. Determine the average weight. X=(X1+X2 +X3++ Xz)/20

Lim its accord ing to U.S.P

Weight of tablet 130 mg or less then%error = 10%

Weight of tablet 130-324 mg then%error = 7.5%

Weight of tablet 324 mg or more then

%error = 5%


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Limit:

Upper limit = average weight + (average

weight * %error) Lower limit = average weight - (average

weight * %error)

The individual weights are compared withthe upper and lower limits.

>>Not more than two of the tablets differ from

the average weight by more than the %error listed, and no tablet differs by more

than double that percentage.


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Quality control tests of capsules

B.P. method for disintegration of capsules: Introduce one capsule into each tube and suspend the

apparatus in a beaker containing 600 ml water @37oC.

If hard capsules float on the surface of the water, thediscs may be added.

Operate the apparatus for 30 minutes; remove theassembly from the liquid.

>The capsules pass the test if

No residue remains on the screen of the apparatus or,

If a residue remains, it consists of fragments of shellor
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Uniform i ty of Weight o f capsules:

It is to be done on 20 capsules. Limit:

Not more than two of the individual weights

deviate from the average weight by morethan the percentage deviation shown in the

table, and none deviates by more than

twice that percentage.
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Average Weight ofCapsule

Percentage Deviation

Less than 300 mg 10

300 mg or more 7.5

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