Contents Introduction

Importance of IPQC

General IPQC tests

IPQC tests for tablets

Documentation

IPQC Tests For Tablets: Hardness

Friability

Thickness

Disintegration

Weight variation

Content uniformity

Dissolution

Leakage testing for strip and blister packaging

Hardness (crushing strength):

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

Why do we measure hardness?

To determine the need for pressure adjustments on the tabletingmachine.

Hardness can affect the disintegration. So if the tablet is too hard, it may not disintegrate in the required period of time. And if the tablet is too soft, it will not withstand the handling during subsequent processing such as coating or packaging.

>In general, if the tablet hardness is too high, we first check its disintegration before rejecting the patch. And if the disintegration is within limit, we accept the patch.

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

Factors Affecting the Hardness: Compression of the tablet and compressive force.

Amount of binder. (More binder à more hardness)

Method of granulation in preparing the tablet (wet method gives more hardness than direct method, Slugging method gives the best hardness).

Limits:

5 kilograms minimum and 8 kilograms maximum.

>Make hardness test on 5 tablets and then take the average hardness

Some of devices used to test tablet hardness are :

1. Monsanto tester

2. Strong-cobb tester

3. Pfizer tester

4. Erwica tester

• MONSANTO TESTER• PFIZER TESTER

Friability:• It is the tendency of tablets to powder, chip, or fragment and this can affect the

elegance appearance, consumer acceptance of the tablet, and also add to tablet’sweight variation or content uniformity problems.

• Friability is a property that is related to the hardness of the tablet.

• An instrument called friabilator is used to evaluate the ability of the tablet towithstand abrasion in packaging, handling, and shipping.

• Commonly used friabilator in industries is Roche Friabilator

Procedure:

1. Weigh 20 tab altogether = W1

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

3. Weigh the 20 tablets = W2

4. Friability (% loss) =

It must be less than or equal to1%.

THICKNESS TEST:

The thickness of a tablet depends

on the upper and lower punches at

the moment of compression. it can

be tested using vernier calipers.

The range varies with +/- 5.0%.VERNIER

CALIPERS

Disintegration:

It is the time required for the tablet to break into particles, the disintegration test is a measure only of the time required under a given set of conditions for a group of tablets to disintegrate into particles.

The disintegration USP device uses 6 glass tubes that are 3

inches long open at the top and held against a 10mesh screen

at the bottom end of the basket rack assembly.

Frequency of basket is 28-32 cycles/min . The test is done

on 6 tablets and the test is passed when all the 6 tablets

disintegrate.

DISINTEGRATION TEST

Liquids used in disintegration

Water,

simulated gastric fluid (PH = 1.2 HCl),

or Simulated intestinal fluid (PH = 7.5, KH2PO4 (phosphate buffer) + pencreatin enzyme +NaOH)

Limits:

For Uncoated tablets:

Medium Temper

ature

Time

limit

According to

U.S.P.

Simulated

gastric

fluid

37oC Not

exceed

30min

According to

B.P.

water 37oC Not

exceed

15min

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 18 tablets).

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.

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 intestinal fluid.

>If one or two tablets fail to disintegrate, repeat on 12 tablets. So 16 tablets from the 18 must completely disintegrate within the time >>if two or more not disintegrated the batch is rejected.

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 16 tablets from 18 should completely disintegrate. If more than two fail to disintegrate the patch must be rejected.

Disintegration time (min)

Type of

tablet

IP BP USP

Un coated 15 15 5

Coated 60 30 _

Film 30 _ _

Enteric 120 _ 1+2hr

Dispersible 3 3 3

Weight variation :•The volumetric fill of the die cavity determines the weight of the compressed tablet . The weight of the tablet is the quantity of the granulation that contains the labeled amount of the therapeutic ingredient. •After the tablet machine in operation the weights of the tablets are routinely checked to ensure that proper tablet weights are made.•Procedure :•Take 20 tablets •Determine the individual weights of each tablets•Take average weights of 20 tablets•Compare the individual weight of tablets with avg weight.•Not more than 2 tablets should deviate from avg weight by percent deviaton and none should deviate more than twice the percentage

Limits according to U.S.P· Weight of tablet 130 mg or less then % deviation ±10%· Weight of tablet 130-324 mg then %deviation= ±7.5%· Weight of tablet 324 mg or more then %deviation = ±5%

Content uniformity :• This test is done to ensure that every tablet contains the amount of

drug substance intended with little variation within a batch• Procedure :• In this test 30 tablets are randomly selected for the sample and

atleast 10 of them assayed individually .

• 9 of the 10 tablets must contain not less than 85% or more than 115 %of labeled drug content.• 10th tablet may not contain less than 75% or more than 125% of labeledcontent .• If this conditions are not meet the tablet remaining from the 30 mustbe assayed individually and none may fall outside 85 to 115 %

DISSOLUTON TEST

According to USP

Apparatus 1(Rotating basket)

Apparatus 2(Rotating paddle)

Dissolution Acceptance Criteria

Stage No Of

Dosage

Units Tested

Acceptance Criteria

1 6 No dosage unit is <Q+5%

2 6 Avg of 12 units > or =Q% and dosage unit is

<Q-15%

3 12 Avg of 24 units > or =Q% and not more

than 2 units are <Q-15% and no unit is <Q-

25%

Leak testing for Strips and Blister packing :

1. Take the required number of strips / blisters as mentioned in annexure . Check the quality of strips/ blisters for any damages.

2. Tie the collected strips / blisters with a rubber band.3. Ensure that all strips / blisters are dipped in water and

closethe lid.4. Connect opening of the desiccator to the vacuum

pump.5. Apply a vacuum of 300 mm of Hg and close the knob

of thedesiccator.6. Keep the vacuum for 30sec.

7. Release the vacuum by opening the knob of the desiccator slowly and open the lid remove the strips / blisters.

8. Wipe out the traces of water from the strips / blisters byusing lint free duster .

9. Open the pocket of strips by using scissors to remove the tablets / capsules.

10. Open the blisters manually.

11.Check for any traces of water inside the strips / blisters.

12. Number of tablets or capsules, which have become wet,should not be more than 1%

Documentation

Reference Leon Lachman Herbert A.Lieberman, The Theory and

Practice of Industrial Pharmacy,

N.K.Jain,Pharmaceutical Product Development

Thank You