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1. Industrial Pharmacy-1
Difference in the IP ,BP, USP procedure of coated
tablet evaluation test
Class:- T.Y.B.pharm (A)
Presented by :-
Bagul Guruprit (3007)
Bambale ankita pandurang (3008)
Battewar Rameshwar prabhu (3009)
Bhagat pragati dhananjay (3010)
Bhoge Priti narayan (3011)
Bhosale payal rajesh (3012)
Guided by:- Dr.
U.C. galgatte

2. Index
1.Introduction
2.General appearance
3.Hardness
4.Friability
5.Weight Variation
6.Content uniformity
7.Moisture content
8.Dissolution
9.Disintegration

3. INTRODUCTION::
Tablets:-
Tablets are the solid unit dosage form containing a
medicament or mixture of medicaments and excipients
compressed or moulded into solid.
Types of tablet :-
) Compressed tablets
Ex:Coated and Uncoated tablets.
II) Moulded tablets
Ex: Dispensing and Hypodermic tablets.

4. Evaluation Of Tablet :
Non-official Tests:
1) General appearance:
I) Organoleptic property
II) Size and Shape
2) Hardness
3) Friability
Official tests:
1) Weight Variation
2) Content uniformity
3) Dissolution
4) Disintegration

5. Non- official tests:1) General appearance:
“ The general apperance 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

6. 1) Organoleptic Properties:
Many pharmaceutical tablets use colour
as a vital means of rapid identification
and consumer acceptance
 The colour of a product must be
uniform within a single tablets
II) Size and shape:
Measured by :-
Micrometre
• Sliding calliper scale
• Tablet thickness should be
controlled within ±5%
variation standard value

7. IP BP USP
Evaluated visually for
coating defects and
uniformity
Similar usual
inspection for the
defect and smooth
Focus on the colour,
texture and film
uniformity
Apperance:

8. 2) Hardness:
Tablets require a certain amount of strength hardness and
resistance to friability, to withstand mechanical shocks of
handling in manufacturing, 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

9. Hardness :
IP BP USP
Tablet hardness tester
(e.g., Monsanto, Pfizer,
Strong-Cob, or digital).
Same as IP Monsanto,
Pfizer, or automated
tester.
Any calibrated hardness
tester capable of applying
diametral compression
force.
Measures resistance to
crushing (e.g., in kg or N)
Measures resistance to
crushing (e.g., in kg or N)
Measures resistance to
crushing (e.g., in kg or N)

10. 3) Friability:-
“FRIABILITY is the phenomenon where the surface of the
tablet is damage or shown a site of damage due to
mechanical shock.”
Equipment used in this test: Roche friabilator tester is
most commonly used for determining % friability of tablet.
PURPOSE:-
 To evaluate the ability of the tablets to withstand the
breakage during the transportation and handling.
 It means Surface Erosion by certain mechanical shock
and lost of material from intact tablet.

11. Friability
PROCEDURE:
1.Take 20 tablets and take initial weight of it and put it into friabilator.
2.Now rotate the drum at 25 rpm per min or 100 rpm for 4 mins.
3.During this,tablet gets dropped on plastic from 6 inches, it will pass through
mechanical shocks.
4.After 4 minutes, calculate final weight of tablets and that of % friability.
% Friability can be calculated by following formula:-
% Friability = W1 – W2/W1 × 100
Where,
W1 = weight of tablets before testing
W2 = weight of tablets after testing.

12. Friability
Parameter IP BP USP
Instrument Roche friabilator Roche friabilator Roche friabilator
Procedure 20 tablets (or sample
of ~6.5 g) rotated at
25 rpm for 4 minutes
(100 rotations).Then
weigh and calculate %
weight loss.
Same as IP Same procedure as
IP . but tablets are
dusted before
weighing.
Limit ≤1% weight loss
acceptable.
≤1% weight loss
acceptable.(≤1.5% in
some cases.)
≤1% weight loss
acceptable.

13. 4) Weight variation:-
Tablets generally are manufactured to contain a
certain amount of active ingredients in a certain
weight of tablet.
In this test, samples of 20 tablets are removed
from a batch from time to time during
compression, and then are weighed to determine
whether they conform to the required weight
criteria.
• There still may be a difference in the individual
weights even when 20 tablets show the expected
total weight. Twenty tablets are weighed
individually.

14. Weight variation:-
Individual weights are compared with the average weight. If
no more than two tablets are outside the percentage limit,
and if no tablet differs by more than two times the
percentage limit, the tablets pass the USP weight variation
tests.
If the drug occupies the greater part of the tablet mass:
Any weight variation reflects variations in the content of
active ingredient.
• In case of potent drugs: The excipients form the greater
part of the tablet weight & so the relationship between
tablet weight and amount of active ingredient is poor.

16. General Principles:
- All three pharmacopoeias (IP, BP, USP) require coated tablets to meet uniformity of
content requirements.
- Testing involves analyzing a sample of tablets for their active ingredient content.
Key Differences:
- USP's two-stage testing procedure differs from IP and BP's single-stage test.
- Acceptance criteria for Stage 2 in USP (AV ≤ 25) are more lenient than IP and BP's
criteria (AV ≤ 15).
Considerations for Coated Tablets:
- The coating process may affect the uniformity of content, and the pharmacopoeial
tests account for this variability.
- It's crucial to validate the analytical method for coated tablets to ensure accurate
results.
5 ) Content uniformity:-
The AV is calculated using the formula:
AV = |M - X
̄ | + kS
Where:
- M = reference value (label claim)
- X
̄ = mean of individual contents
- k = acceptability constant
- S = sample standard deviation

17. Aspect IP(Indian
pharmacopoeia)
BP (British
pharmacopoeia)
USP(united states
pharmacopeia)
Testing procedure Single-stage test Single-stage test Two-stage testing
procedure
Acceptance value
(AV)calculation
used used used
Acceptance criteria AV<,=15 AV<,=15 Stage 1:AV<,=15(10
tablets) stage 2:AV<,=25
(additional 20 tablets
Number of tablets
tested
Not specified(typically
follows general
guidelines)
Not specified(typically
follows general
guidelines)
Stage 1 :10 tablets stage
2: 30 tablets total)

18. General Principles:*
- All three pharmacopoeias (IP, BP, USP) require testing for moisture content in
coated tablets.
- Testing methods include:
- Loss on Drying (LOD)
- Karl Fischer titration
Key Differences:
- USP provides more detailed procedures for Karl Fischer titration and LOD.
- Acceptance criteria (limits) may vary between pharmacopoeias, depending on
the specific monograph or general chapter.
Considerations for Coated Tablets:
- Moisture content can affect the stability and quality of coated tablets.
- Testing for moisture content helps ensure the product meets specifications
and remains stable during storage.
6) Moisture content :-
Calculate LOD: Use the formula: LOD = [(Initial
Weight - Final Weight) / Initial Weight] × 100

19. aspect IP( Indian
pharmacopoeia)
BP( British
pharmacopoeia)
USP( united states
pharmacopeia)
Testing methods LOD or karl fischer
titration
LOD or karl fischer
titration
LOD or karl fischer
titration (with
detailed procedures)
limits Specified in individual
monographs
Specified in individual
monographs or
general chapters
Specified in individual
monographs or
general
chapters<921>(water
determination)
Procedural details General specificationsGeneral specifications Detailed procedures
for karl fischer
titration and LOD
Acceptance criteria Varies by monograph Varies by monograph
or general chapter
Varies by monograph
or general
chapter<921>

20. 6) Dissolution:-
• The administration of drugs via oral dosage forms is one of the most common and
effective means of delivering treatments to patients.
• When a dosage form is swallowed, the rate at which it releases the active ingredient is
critical to ensure that the drug is delivered properly.
• The rate at which the drug is released is called the dissolution rate. Several dissolution
apparatuses exist. In (USP),there are seven dissolution apparatuses standardized and
specified.
• They are:
• (A)USP Dissolution Apparatus 1 – Basket (37 °C)
• (B)USP Dissolution Apparatus 2 – Paddle (37°C)
• (C)USP Dissolution Apparatus 3 – Reciprocating Cylinder(37 °C)
(D)USP Dissolution Apparatus 4 – Flow-Through Cell (37 °C)
(E) USP Dissolution Apparatus 5- Paddle-Over-Disk(37 °C)
(F) USP Dissolution Apparatus 6- Rotating Cylinder (37 °C)
(G) USP Dissolution Apparatus 7- Reciprocating Disk(37 °C)
According to I.P
Type I: Paddle type apparatus
Type II: Basket type apparatus

21. Rotating basket apparatus:
Assembly consists of:
A covered vessel
Metallic drive shaft
Basket Shaft
Cylindrical basket
Motor
Sampling Point
Vessel
Sample port
Water bath holding temperature
37°C ± 0.5°C
• Acidic media or alkaline media
Dissolution:-
Rotating basket apparatus

22. Rotating paddle apparatus:
Assembly consists of:
A covered vessel
Metallic drive shaft
Stainless steel paddle
Motor
Sinker to prevent floating of
• Water bath holding tempe –
rature at 37°C ± 0.5°C
Acidic media or alkaline
media
Dissolution:-

23. Parameter IP BP USP
Apparatus Apparatus I (basket) or II
(paddle)
Same as IP Same as IP
Medium Specified per monograph
(usually water, 0.1N HCl,
buffer).
Same Same
Volume Usually 900 mL Usually 900 mL Usually 900 mL
Temperature 37 ± 0.5°C 37 ± 0.5°C 37 ± 0.5°C
Speed Specified per monograph
(commonly 50-100 rpm).
Same Same
Sampling Specified intervals (e.g., 5,
10, 15, 30 min).
Same Same
Acceptance Criteria As per monograph (e.g., NLT
80% in 30 min).
Same Same
Dissolution:-

26. Disintegration time refers to
the amount of time required for
a tablet or capsule to break
down into smaller particles
under specific conditions, as
tested using a disintegration
test apparatus in accordance
with pharmacopeial standards
(like IP, BP, USP).
7) Disintegration

27. • Basket-rack assembly:
• 6 or more cylindrical tubes with
mesh at the bottom.
Moves up and down in a beaker of
medium.
Temperature maintained at 37 ± 2 °C
• Medium used:
Water
0.1 N HCl (simulated gastric fluid)
Phosphate buffer pH 6.8 (simulated
intestinal fluid)
Disintegration

28. Dosage Form IP BP USP
Film-coated
tablets
≤ 30 min ≤ 30 min ≤ 30 min
Sugar-coated
tablets
≤ 60 min ≤ 60 min ≤ 60 min
Enteric-coated
tablets
No
disintegration
for 2 hrs in 0.1
N HCl, then ≤
60 min in pH
6.8 buffer
Same as IP Same as IP