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1
Mr. Pankaj Sharma
INTRODUCTION
EVALUATION OF TABLET
Non-official Tests:
1) General appearance
I) Organoleptic property
II) Size & Shape
2) Hardness
3) Friability
Official tests:
1) Weight Variation
2) Content uniformity
3) Dissolution
4) Disintegration
2
T
ablets:-
Tabletsare the solid unit dosage forms
containing amedicament or mixture ofmedicament
&excipients compressed or moulded into solid .
TYPEOFTABLETS:-
I) Compressed tablets
Ex:Coated & Uncoated tablets.
II) Molded tablets
Ex:Dispensing & Hypodermic tablets.
3
.
4
The general appearance
of a tablet, its visual identity and overall “elegance”
is essential for consumer acceptance, for control of
lot-to-lot uniformity
Appearance of a tablet involved the measurements
of a tablet’s:-
 Size
 Shape
 Colour
 Odour
 Taste
 Surface texture
5
Many pharmaceutical tablets use color as a
vital means of rapid identification and
consumer acceptance
The color of a product must be uniform
within a single tablets
6
Caliper scale 7
Tablets require a certain amount of strength, or
hardness and resistance to friability, to withstand
mechanical shocks of handling in manufacture,
packing and shipping
Hardness thus sometimes termed the tablet
crushing strength
Tablet hardness tester are:-
 Monsanto tester
 Pfizer tester
 Strong-cobb tester
 Erweka tester
 Scleuniger tester
8
9
The friability test is official in USPbut not in BP
and IP
10
Friability tester is known as the Roche friabilator
Tablet hardness is not an absolute indicator
of strength since some formulations,when
compressed into very hard tablets
Roche friabilator
11
The weight of the tablet being made is
routinely measured to help ensure that a tablet
contains the proper amount of drug
 As per indian pharmacopoeia (IP)
weight 20 tablets selected at random and
determine the average weight
12
13
 The potency of tablets is expressed in the
terms of grams, milligrams, or micrograms of
drug per tablet and is given as the label
strength of the product
 Determine the amount of active ingredient by the
method in the Assay;
 The result lies within the range for the content of
active ingredient stated in the monograph
14
This test is applicable to tablets that contain
less than 10mg or less than 10% w/w of the
15
active ingredient
It is not applicable to tablets containing
multivitamin and trace element
Ten tablets are taken at random, there
content of active ingredient is determine in
each of 10 tablets and the average value is
calculated
The sample passes the test is not more than one of
the individual value is the out side the limit of 85
to 115% of the average value 16
If two or three of the individual tablets are
outside limits 85 to 115% of the average value
and the none is the outside the limit 75 to 125%
The test is repeated using another
20 tablets 17
In the total sample of 30 tablets
18
Not more than three of the individual values
are outsides the limit 85 to 115% and none is
outside the limits 75 to 125% of the average
value
19
20
21
22
23
24
pharmacopoeia
25
26
27
28
29
30
31

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tablets evalution.pptx

  • 2. INTRODUCTION EVALUATION OF TABLET Non-official Tests: 1) General appearance I) Organoleptic property II) Size & Shape 2) Hardness 3) Friability Official tests: 1) Weight Variation 2) Content uniformity 3) Dissolution 4) Disintegration 2
  • 3. T ablets:- Tabletsare the solid unit dosage forms containing amedicament or mixture ofmedicament &excipients compressed or moulded into solid . TYPEOFTABLETS:- I) Compressed tablets Ex:Coated & Uncoated tablets. II) Molded tablets Ex:Dispensing & Hypodermic tablets. 3
  • 4. . 4
  • 5. The general appearance of a tablet, its visual identity and overall “elegance” is essential for consumer acceptance, for control of lot-to-lot uniformity Appearance of a tablet involved the measurements of a tablet’s:-  Size  Shape  Colour  Odour  Taste  Surface texture 5
  • 6. Many pharmaceutical tablets use color as a vital means of rapid identification and consumer acceptance The color of a product must be uniform within a single tablets 6
  • 8. Tablets require a certain amount of strength, or hardness and resistance to friability, to withstand mechanical shocks of handling in manufacture, packing and shipping Hardness thus sometimes termed the tablet crushing strength Tablet hardness tester are:-  Monsanto tester  Pfizer tester  Strong-cobb tester  Erweka tester  Scleuniger tester 8
  • 9. 9
  • 10. The friability test is official in USPbut not in BP and IP 10 Friability tester is known as the Roche friabilator Tablet hardness is not an absolute indicator of strength since some formulations,when compressed into very hard tablets
  • 12. The weight of the tablet being made is routinely measured to help ensure that a tablet contains the proper amount of drug  As per indian pharmacopoeia (IP) weight 20 tablets selected at random and determine the average weight 12
  • 13. 13
  • 14.  The potency of tablets is expressed in the terms of grams, milligrams, or micrograms of drug per tablet and is given as the label strength of the product  Determine the amount of active ingredient by the method in the Assay;  The result lies within the range for the content of active ingredient stated in the monograph 14
  • 15. This test is applicable to tablets that contain less than 10mg or less than 10% w/w of the 15 active ingredient It is not applicable to tablets containing multivitamin and trace element
  • 16. Ten tablets are taken at random, there content of active ingredient is determine in each of 10 tablets and the average value is calculated The sample passes the test is not more than one of the individual value is the out side the limit of 85 to 115% of the average value 16
  • 17. If two or three of the individual tablets are outside limits 85 to 115% of the average value and the none is the outside the limit 75 to 125% The test is repeated using another 20 tablets 17
  • 18. In the total sample of 30 tablets 18 Not more than three of the individual values are outsides the limit 85 to 115% and none is outside the limits 75 to 125% of the average value
  • 19. 19
  • 20. 20
  • 21. 21
  • 22. 22
  • 23. 23
  • 24. 24
  • 26. 26
  • 27. 27
  • 28. 28
  • 29. 29
  • 30. 30
  • 31. 31