This document evaluates different parameters for testing tablets, including size, shape, hardness, friability, weight variation, disintegration, and dissolution. It discusses how these parameters are measured using various instruments and test methods. The key parameters are evaluated to ensure tablets meet specifications according to pharmacopoeia standards like the USP and IP.

1. EVALUATION
OF TABLET
Devender Singh
B Pharm 3rd Year 6TH Sem
Dayanand Dinanath Institute Of College of
Pharmacy

2. 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

3. EVALUATION PARAMETER
 Size and shape
 Hardness and friability
 Weight variation
 Disintegration
 Dissolution

4. 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

5. 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

6. INSTRUMENT USED FOR MEASUREMENT OF
HARDNESS
 Monsanto tester
 Strong & cobb tester
 Pfizer tester
 Erweka tester – kilogram

7. 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

8. 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

9.  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

10. 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%

11. S3 12 average of 24 (S1 + S2 +
S3)≥ Q% and not more than
two dosage unit are
less than Q – 15%
and no dosage unit
are less than Q – 25 %
 Q percentage of drug content dissolved in given
time period
 Acceptance citria based on Q value

12. 12
OFFICIAL DISSOLUTION MONOGRAPHS
United States Pharmacopeia
• USP XXX (30)
European Pharmacopoeia
• Ph. Eur. 5th Edition, Supplement
5.3
British Pharmacopoeia
• BP 2007
Japanese Pharmacopoeia
JP XIV (14)

13. 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.)

14. 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

15. 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

16. APPARATUS 1 - BASKET
Disadvantages
• disintegration-dissolution
interaction
• limited volume 
sink conditions for poorly
soluble drugs ?

17. APPARATUS 2 - PADDLE
Useful for
• tablets
• capsules
• beads
• delayed release / enteric
coated dosage forms
Standard volume
• 900/1000 ml
Method of first choice !!!

18. APPARATUS 2 - PADDLE
Advantages
• easy to use
• long experience
• pH change possible
can be easily automated
which is important for
routine investigations

19. Disadvantages
• pH/media change is often difficult
• limited volume  sink conditions for poorly
soluble drugs ?

20. APPARATUS 3 – PADDLE OVER DISK
Useful for
• transdermal patches
Standard volume
• 900 ml

21. 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

22. Thanks for your kind
attention!!!

23. Thank
You