Friability - Pharmacopoeial Comparison

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Tablet friability test is
mainly adapted for uncoated tablets. The specification of friability test as
per IP and USP.

Indian
Pharmacopoeia (IP)
United
States Pharmacopeia
(USP)
Japanese Pharmacopoeia (JP)

Section 2.5.6. contents of
packaged dosage forms gives the definition of friability test as follows

This test
is applicable to compressed tablets & intended to determine the physical
strength of tablets

Under general
information section 1216 explains the guidelines for the friability
determination of compressed, uncoated tablets
JP XIV tablet friability test defines the friability test as a method to determine the physical strength of uncoated tablets upon exposure to mechanical shock or attrition

Apparatus:

Drum with polished internal
surface made up of transparent synthetic polymer

One side drum is removable

Curved projection with an
inner radius of 75.5 - 85.5 mm extending from the middle of the drum to the
outer wall (enables the tumbling)

Outer diameter of central ring
is 24.5 - 25.5 mm

Drum is attached to the
horizontal axis

Rotation speed : 25 +- 1 Rpm

Minimum static build-up

Diameter : 283-291 mm

Depth : 36-40

Method: Tablets with
average weight of 0.65 g or less means whole tablets corresponding to 6.5 g to
be tested

Tablets with average weight
more than 0.65 g sample of 10 tablets to be tested

After tumbling dedust the
tablets and weight the required number of tablets

Rotation : 100 times

Test is run only once
unless the results are difficult to interpret or weight loss is greater than
the target value

Maximum allowable weight
loss should not be more than 1 %

Irregular
shapes and size tablets should undergo friability test by keeping the base of
the drum in angle of about 100

Apparatus:

Drum with polished internal
surface made up of transparent synthetic polymer

Minimum static build-up

Diameter : 283-291 mm

Depth : 36-40

Apparatus: It consists of drum and motor

inside diameter: 287 mm

depth : 38 mm

material : transparent synthetic polymer with polished internal surface not subjected to static builup

one side of the drum is removable

Method: Tablets with
average weight of 0.65 g or less means whole tablets corresponding to 6.5 g to
be tested

Tablets with average weight
more than 0.65g sample of 10 tablets to be tested

After tumbling dedust the
tablets and weight the required number of tablets

Rotation : 100 times

Test is run only once
unless the results are difficult to interpret or weight loss is greater than
the target value

Maximum allowable weight
loss should not be more than 1 %

Irregular shapes and size
tablets should undergo friability test by keeping the base of the drum in angle
of about 100

New formulations
- weight loss of 0.8% would be permitted.

Method: Tablets with
average weight of 650mg or less means whole tablets corresponding to 6.5 g to
be tested

Tablets with average weight
more than 650mg sample of 10 tablets to be tested

After tumbling dedust the
tablets and weight the required number of tablets

Rotation : 100 times

Test is run only once
unless the results are difficult to interpret or weight loss is greater than
the target value

Maximum allowable weight
loss should not be more than 1 %

Irregular shapes and size
tablets should undergo friability test by keeping the base of the drum in angle
of about 100

New formulations
- weight loss of 0.8% would be permitted.

Method: Tablets with average weight of 650mg or less means whole tablets corresponding to 6.5 g to be tested

rotation : 24 - 26 Rpm


EP - European Pharmacopoeia : 2.9.7 page no 278

BP - British Pharmacopoeia : 5.8 friability of uncoated tablets

Reference

USP, <1216>, page no. 2745 (accessed on 20-07-10)

IP 2007, 2.5.6. contents of packaged dosage forms vol 1, page no. 183 (accessed on 20-07-10)

JP XIV, tablet friability test, page no. 1326 (accessed on 20-07-10)

http://www.pharmacopeia.cn/v29240/usp29nf24s0_c1216.html (accessed on 22-07-10)

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002778.pdf (accessed on 24-07-10)

About the Author

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Author: Vijay Chand

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