EVALUATION

OF TABLET

Devender Singh

B Pharm 3rd Year 6TH Sem

Dayanand Dinanath Institute Of College of

Pharmacy

ACCORDING TO INDIAN PHARMACOPOEIA

PHARMACEUTICAL TABLET ARE SOLID , FLAT

OR BICONVEX DISHES ,UNIT DOSAGE FORM

,PREPARED BY A DRUG BY COMPRESSING A

MIXTURE OF DRUG OR DRUG WITH OR

WITHOUT DILUENT

EVALUATION PARAMETER

Size and shape

Hardness and friability

Weight variation

Disintegration

Dissolution

SIZE AND SHAPE

Measured by :-

Micrometer

Sliding caliper scale

Tablet thickness should be controlled within

±5% variation of standard value .

More likely to cause capping problem

WEIGHT VARIATION

ACCORDING TO USP ACCORDING TO IP

Average wt of tablet (mg)

130 or less less than

85

130 – 324 85 - 324

MT 324 MT 324

Max percentage

difference

allowed

10

7.5

5

INSTRUMENT USED FOR MEASUREMENT OF

HARDNESS

Monsanto tester

Strong & cobb tester

Pfizer tester

Erweka tester – kilogram

FRIABILITY TEST

Pre weighed tablet sample placed in friabilator

Operated 100 revolution (25 rpm for 4 min)

Dropping tablet a distance 6 inch

Tablet are then dusted and reweighed

Conventional compressed tablet that lose less

than 0.5 to 1%of their weight are generally

acceptable

DISINTEGRATION

6 test tube 3 inch long

10 mesh screen

1 L beaker of water (0.1 N HCl) simulated gastric fluid or

simulated intestinal fluid

Temp 37±2 C

Up and down 5 – 6 cm

Frequency – 28 -32 cycle / min

As per Indian

Pharmacopoeia

Official range not less than 95 %

Majority of tablet has disintegration time of

30 min.

Enteric coated tablet disintegration time is 2

hr in monograph

DISSOLUTION TEST

Stage no of unit dosage acceptance unit test criteria

S1 6 no dosage unit should be less

than Q+5

S2 6 average of 12 (S1

+S2)dosage unit should be ≥ Q% and no dosage unit

should be less than Q-15%

S3 12 average of 24 (S1 + S2 +S3)≥ Q% and not more than

two dosage unit areless than Q – 15%and no dosage unitare less than Q – 25 %

Q percentage of drug content dissolved in giventime period

Acceptance citria based on Q value

12

OFFICIAL DISSOLUTION MONOGRAPHS

United States Pharmacopeia• USP XXX (30)

European Pharmacopoeia• Ph. Eur. 5th Edition, Supplement 5.3

British Pharmacopoeia• BP 2007

Japanese PharmacopoeiaJP XIV (14)

OFFICIAL DISSOLUTION APPARATUS

Rotating Basket (Ph.Eur./BP/JP)

Paddle (Ph.Eur./BP/JP)

Flow Through Cell

(Ph.Eur./BP/JP)

Paddle Over Disk (Ph.Eur.)

APPARATUS 1 - BASKET

Useful for

• capsules

• beads

• delayed release / enteric

coated dosage forms

• floating dosage forms

• surfactants in media

Standard volume

• 900/1000 ml

• 1, 2, 4 liter vessels

APPARATUS 1 - BASKET

Advantages

• breadth of experience

(more than 200 monographs)

• full pH change during the test

• can be easily automated

which is important for routine

investigations

APPARATUS 1 - BASKET

Disadvantages

• disintegration-dissolution

interaction

• limited volume

sink conditions for poorly

soluble drugs ?

APPARATUS 2 - PADDLE

Useful for

• tablets

• capsules

• beads

• delayed release / enteric

coated dosage forms

Standard volume

• 900/1000 ml

Method of first choice !!!

APPARATUS 2 - PADDLE

Advantages

• easy to use

• long experience

• pH change possible

can be easily automated

which is important for

routine investigations

Disadvantages

• pH/media change is often difficult

• limited volume sink conditions for poorly

soluble drugs ?

APPARATUS 3 – PADDLE OVER DISK

Useful for• transdermal patches

Standard volume

• 900 ml

APPARATUS 3 – PADDLE OVER DISK

Advantages• standard equipment

(paddle) can be used, only

add a stainless steel disk

assembly

Disadvantages

• disk assembly restricts

patch size

Thanks for your kind

attention!!!

Thank

You