Inprocess as per usp ip bp tablets

1. TABLETS
General chapter

2. TABLETS
• Tablets are solid dosage form each containing a
unit dost of one or more medicament
• Intended for oral administration
• Some tablets are swallowed whole or after being
chewed
• some are dissolved or dispersed in water before
administration
• some are retained in the mouth where the active
ingredient is liberated.

3. TABLETS
• Because of their composition, method of
manufacture or intended use, tablets present a
variety of characteristics and consequently
there are several categories of tablets.
• Unless otherwise stated in the individual
monograph, tablets are uncoated.

4. Different types of tablets
• Uncoated tablets
• Film Coated
• Sugar Coated
• Dispersible Tablets
• Effervescent Tablets
• Modified-release Tablets
• Enteric-coated Tablets
• Prolonged- release Tablets
• Soluble Tablets
• Tablets for Use in the Mouth

5. In-process Tests
• Uniformity of container contents
• Content of active ingredients
• Uniformity of content
• Uniformity of weight
• Dissolution
• Disintegration
• Friability
• Hardness
• Leak test
Pharmacopoial
Non- Pharmacopoial

6. Uniformity of container contents /
Contents of Packaged Dosage Forms (IP)
• The following tests and specifications apply to oral dosage forms and
preparations intended for topical use that are packaged in containers in
which the labeled net quantity is not more than 100 g or 300 ml or 1000
units, as the case may be
• For higher labeled quantities the test and limits given in the standards of
Weights and Measures (Packaged commodities) Rules, 1977 may be
followed.

7. Contents of Packaged Dosage Forms
• Test Method
• Select a sample of 10 containers and count the number of tablets in each
container.
• The average number of the contents in the 10 containers is not less than the
labeled amount and the number in any single container is not less than 98 per
cent and not more than 102 per cent of the labeled amount
• If this requirements is not met, count the number of the contents in 10
additional containers. The average number in the 20 containers is not less
than the labeled amount, and the number in not more than 1 of the 20
containers is less than 98 per cent or more than102 per cent of the labeled
amount.

8. • This test is applicable to tablets that contain 10 mg or less than 10 mg or less
than 10 per cent w/w of active ingredient (As per IP).
• This test is applicable to tablets that contain less than 25 mg or less than 25
per cent w/w of active ingredient (As per BP/USP ).
• For tablets containing more than one active ingredient carry out the test for
each active ingredient that corresponds to the aforementioned conditions.
• The test is also applicable to coated tablets other than film coated tablets,
irrespective of their content of active substance(s).
• The test for Uniformity of content should be carried out only after the content
of active ingredient(s) in a pooled sample of the tablets has been shown to be
within accepted limits of the stated content.
• The test for Uniformity of content is not applicable to tablets containing
multivitamins and trace elements.
Uniformity of content

9. • The test for uniformity of content of single-dose preparations is based on the
assay of the individual contents of active substance(s) of a number of single-
dose units to determine whether the individual contents are within limits set
with reference to the average content of the sample.
• Method.
• Determine the content of active ingredient(s) in each of 10 dosage units taken
at random using the method given in the monograph or by any other suitable
analytical method.
• Acceptance limits
• The preparation complies with the test if each individual content is 85 to 115
per cent of the average content. The preparation fails to comply with the test if
more than one individual content is outside these limits or if one individual
content is outside the limits of 75 to 125 per cent of the average content.
Uniformity of content

10. • If one individual content is outside the limits of 85 to 115 percent of the
average content but within the limits of 75 to 125 per cent, repeat the
determination using another 20 dosage units. The preparation complies with
the test if not more than one of the individual contents of the total sample of
30 dosage units is outside 85 to 115 per cent of the average content and none
is outside the limits of 75 to 125 per cent of the average content.
Uniformity of contents

11. Uniformity of Weight of Single-Dose
Preparations (IP/BP/USP)
• Weigh individually 20 units selected at random or, for
single dose preparations in individual containers, the
contents of 20 units, and calculate the average weight.
• Not more than two of the individual weights deviate
from the average weight by more than the percentage
shown in the table and none deviates by more than
twice that percentage.

12. Disintegration Test
• For the purpose of this test, disintegration does not imply complete
solution of the dosage unit or even of its active constituent.
• Disintegration is defined as that state in which no residue of the unit
under test remains on the screen of the apparatus or, if a residue
remains, it consists of fragments of disintegrated parts of capsule
component parts such as insoluble coating of the of capsule shells, or
of any melted fatty substance from the pessaries or suppository or is a
soft mass with no palpable core.
• If discs have been used with capsules, any residue remaining on the
lower surfaces of the discs consists only of fragments of shells.
• 28-32 cycle (strokes) per minute IP
• 29-32 cycle (strokes) per minute BP/USP

13. Method
• Unless otherwise stated in the individual monograph, introduce one
tablet or capsule into each tube and, if directed in the appropriate
general monograph, add a disc to each tube. Suspend the assembly in
the beaker containing the specified liquid and operate the apparatus for
the specified time.
• Remove the assembly from the liquid. The tablets or capsules pass the
test if all of them have disintegrated.
• If 1 or 2 tablets or capsules fail to disintegrate, repeat the test on 12
additional tablets or capsules; not less than 16 of the total of 18 tablets
or capsules tested disintegrate.
• If the tablets or capsules adhere to the disc and the preparation under
examination fails to comply, repeat the test omitting the disc. The
preparation complies with the test if all the tablets or capsules in the
repeat test disintegrate.

14. For enteric-coated tablets
• Method.
• If tablets having soluble external sugar coating, immerse the basket in
water at room temp for 5 min (USP).
• Put one tablet into each tube, suspend the assembly in the beaker
containing 0.1M hydrochloric acid and operate without the discs for (2
hour as per IP/BP) (1 hour as per USP) , unless otherwise stated in the
individual monograph. Remove the assembly from the liquid.
• No tablet shows signs of cracks that would allow the escape of the contents
or disintegration, apart from fragments of coating.
• Replace the liquid in the beaker with mixed phosphate buffer pH 6.8, add
a disc to each tube and operate the apparatus for a further 60 minutes.
• Remove the assembly from the liquid. If the tablet fails to comply because
of adherence to the disc, repeat the test on a further 6 tablets without the
discs. The tablets pass the test if all six have disintegrated.

15. Disintegration testing condition and interpretation (IP)
Sr.
No
Type of tablets Medium Temperatu
re
Limit
1 Uncoated Water/buffer 37 °± 2 °C 15 min or as per individual
monograph
2 Film coated Water 37 °±2 °C 30 min or as per individual
monograph
3 Sugar coated Water/0.1 N
HCl
37 °±2 °C 60 min or as per individual
monograph
4 Dispersible
Tablets
Water 25 °±1 °C 03 min or as per individual
monograph
5 Effervescent
Tablets
Water 25 °±5 °C 05 min or as per individual
monograph
6 Enteric-coated
Tablets
0.1 M HCl
mixed
phosphate
buffer pH 6.8
37 °±2 °C 02 hour in HCl: no disintegration
60 min in buffer : disintegrate
7 Soluble Tablets Water 20 °±5 °C 03 minutes

16. Disintegration testing condition and interpretation (BP)
Sr.
No
Type of tablets Medium Temperatu
re
Limit
1 Uncoated Water/buffer 37 °± 2 °C 15 min or as per individual
monograph
2 Film coated Water 37 °±2 °C 30 min or as per individual
monograph
3 Sugar coated Water/0.1 N
HCl
37 °±2 °C 60 min or as per individual
monograph
4 Dispersible
Tablets
Water 20 °±5 °C 03 min or as per individual
monograph
5 Effervescent
Tablets
Water 20 °±5 °C 05 min or as per individual
monograph
6 Enteric-coated
Tablets
0.1 M HCl
mixed
phosphate
buffer pH 6.8
37 °±2 °C 02 hour in HCl: no disintegration
60 min in buffer : disintegrate
7 Soluble Tablets Water 20 °±5 °C 03 minutes

17. Disintegration testing condition and interpretation (USP)
Sr.
No
Type of tablets Medium Temperatu
re
Limit
1 Uncoated Water/as specified
in monograph
37 °± 2 °C As per individual monograph
2 Coated Water/as specified
in monograph
37 °±2 °C As per individual monograph
4 Enteric-coated
Tablets
Simulated gastric
fluid TS
Simulated
intestinal fluid TS
37 °±2 °C 01 hour in Simulated gastric fluid
TS: No disintegration
As per individual monograph:
Simulated intestinal fluid TS
5 Buccal Tablets Water/as specified
in monograph
37 °± 2 °C 4 hour
6 Sublingual
tablets
Water/as specified
in monograph
37 °± 2 °C As per individual monograph

18. Dissolution Test
• Use Apparatus 1 unless otherwise directed.
• Use the dissolution medium specified in
• the individual monograph. If the medium is a buffered
solution, adjust the solution so that its pH is within 0.05
units of the pH specified in the monograph.
• Time. Where a single time specification is given in
the monograph, the test may be concluded in a shorter
period if the requirement for the minimum amount
dissolved is met. If two or more times are specified,
specimen are to be withdrawn only at the stated times,
within a tolerance of ± 2 per cent.

19. • Assemble the apparatus and warm the dissolution
medium to 36.5 ° to 37.5 °C unless otherwise stated
• Within the time interval specified, or at each of the
times stated, withdraw a specimen from a zone midway
between the surface of the dissolution medium and the
top of the rotating blade or basket, not less than 10 mm
from the wall of the vessel.
• Except in the case of single sampling, add a volume of
dissolution medium equal to the volume of the samples
withdrawn.
• Perform the analysis as directed in the individual
monograph.

20. Acceptance criteria
Conventional-release dosage forms (IP)
• Unless otherwise specified, the requirements are met
if the quantities of active substance dissolved from
the dosage units conform to Table below . If the
results do not conform to the requirements at stage
S1 given in the table, continue testing with
additional dosage units through stages S2 and S3
unless the results conform at stage S2.

21. As per IP

22. Acceptance criteria
• Conventional-release solid dosage forms (BP/USP)
• Unless otherwise specified, the requirements are met if
the quantities of active substance dissolved from the
dosage units tested conform to Table below. Continue
testing through the 3 levels unless the results conform
at either S1 or S2.
• The quantity Q, is the specified amount of dissolved
active substance, expressed as a percentage of the
labeled content; the 5 per cent, 15 per cent, and 25 per
cent values in the Table are percentages of the labeled
content so that these values and Q are in the same
terms.

23. As per (BP/USP)

24. Immediate release dosage form
pooled sample (USP)
• Unless otherwise specified, the requirements are met if
the quantities of active substance dissolved from the
pooled sample conform to Table of pooled sample below.
• If the results do not conform to the requirements at stage
S1 given in the table, continue testing with additional
dosage units through stages S2 and S3 unless the results
conform at stage S2.
• The quantity Q is the amount of dissolved active
ingredient specified in the individual monograph,
expressed as a percentage of the labeled content

25. As per USP

26. Prolonged-release dosage forms (IP)
• Unless otherwise specified, the requirements are met if
the quantities of active substance dissolved from the
dosage units conform to Table below.
• If the results do not conform to the requirements at stage
L1 given in the table, continue testing with additional
dosage units through stages L2 and L3 unless the results
conform at stage L2.
• The limits embrace each value of D, the amount dissolved
at each specified dosing interval.
• Where more than one range is specified, the acceptance
criteria apply to each range.

28. Prolonged-release dosage forms
(BP/USP)
• Unless otherwise specified, the requirements are met if
the quantities of active substance dissolved from the
dosage units tested conform to Table below.
• Continue testing through the 3 levels unless the results
conform at either L1 or L2.
• Limits on the amounts of active substance dissolved are
expressed in terms of the percentage of labeled
content. The limits embrace each value of Qi, the
amount dissolved at each specified fractional dosing
interval. Where more than one range is specified, the
acceptance criteria apply individually to each range.

30. Modified-release dosage forms (IP)
There are 2 method A & B
Method A & B
Acid stage.
• 750 ml/1000 ml of 0.1M hydrochloric acid
• 36.5º to 37.5º.
• 2 hours
• Perform the analysis of the aliquot using a suitable assay method.
Buffer stage.
• Complete the operations of adding the buffer and adjusting the pH within 5
minutes.
• 250 ml of a 0.2 M buffer and solution
• 36.5º to 37.5º.
• 6.8 ± 0.05
• 45 minutes, or for the specified time.

31. Acceptance criteria (IP)
• ACID STAGE
• The requirements of the test are met if conform to Table below.
Continue the testing through the 3 levels unless the results of
both acid and buffer stages conform at an earlier level

32. Acceptance criteria (IP)
• BUFFER STAGE
• The requirements of the test are met if conform to Table below.
Continue the testing through the 3 levels unless the results of both acid
and buffer stages conform at an earlier level
• The value of D in Table is 75 per cent dissolved unless otherwise
specified.
• The quantity, D, is the specified total amount of active substance
dissolved in both the acid and buffer stages, expressed as a percentage
of the labeled content.

33. Prolonged-release solid dosage forms
(BP/USP)
There are 2 method A & B
Method A & B
Acid stage.
• 750 ml/1000 ml of 0.1M hydrochloric acid
• 36.5º to 37.5º.
• 2 hours
• Perform the analysis of the aliquot using a suitable assay method.
Buffer stage.
• Complete the operations of adding the buffer and adjusting the pH within 5
minutes.
• 250 ml of a 0.2 M buffer and solution
• 36.5º to 37.5º.
• 6.8 ± 0.05
• 45 minutes, or for the specified time.

34. Acceptance criteria (BP/USP)
• ACID STAGE
• Unless otherwise specified, the requirements of this portion of the test are
met if the quantities, based on the percentage of the labeled content of
active substance dissolved from the units tested conform to Table 2.9.3.-3.
Continue testing through the 3 levels unless the results of both acid and
buffer stages conform at an earlier level.

35. Acceptance criteria (BP/USP)
• BUFFER STAGE
• The requirements are met if active substance dissolved from the units tested
conform to Table 2.9.3.-4.
• Continue testing through the 3 levels unless the results of both stages conform at
an earlier level.
• The value of Q in Table 2.9.3.-4 is 75 per cent dissolved unless otherwise specified.
• The quantity, Q, is the specified total amount of active substance dissolved in
both the acid and buffer stages, expressed as a percentage of the labeled
content.
• The 5 per cent, 15 per cent and 25 per cent values in the Table are percentages of
the labeled content so that these values and Q are in the same terms.

36. Dissolution testing condition and interpretation (IP)
Sr.
No
Type of tablets Medium Temperature Limit
1 Uncoated Water/buffer 37 °± 5 °C As per tables shown before or As
per individual monograph
2 Film coated Water 37 °±5 °C As per tables shown before or As
per individual monograph
3 Sugar coated Water/0.1 N
HCl
37 °±2 °C As per tables shown before or As
per individual monograph
4 Enteric-coated
Tablets
0.1 M HCl &
Mixed
phosphate
buffer pH 6.8
37 °±2 °C 02 hour in HCl & 60 min in buffer
As per tables shown before or As
per individual monograph
5 Prolonged-
release Tablets
Water/buffer 37 °±2 °C As per tables shown before or As
per individual monograph

37. Uniformity of dispersion
• Applied to Dispersible Tablets
• Method:
• Place 2 tablets in 100 ml of water and stir
gently until completely dispersed. A smooth
dispersion is obtained which passes through a
sieve screen with a nominal mesh aperture of
710 mm (sieve number 22).

38. Friability of Uncoated Tablets• This test is applicable to compressed tablets and is intended to determine
the physical strength of tablets.
• Apparatus.
• A drum of transparent synthetic polymer with polished internal surfaces
• Diameter of 283-291 mm and a depth of 36-40 mm
• One side of the drum is removable.
• Inner radius of 75.5 mm to 85.5 mm
• Outer diameter of the central ring is 24.5 mm to 25.5 mm.
• Rotates at 25 ± 1 rpm.
• It should be ensured that with every turn of the drum the tablets roll or slide
and fall onto the drum wall or onto each other.

39. Method
• For tablets with an average weight of 0.65 g or less take a sample of
whole tablets corresponding to about 6.5 g and for tablets with an average
weight of more than 0.65 g take a sample of 10 whole tablets.
• Place the tablets in the drum and rotate it 100 times.
• Remove the tablets and weigh them accurately.
• The test is run only once unless the results are difficult to interpret or if the
weight loss is greater than the targeted value, in which case, the test is
repeated twice and the mean of the three tests is determined.
• A maximum loss of weight (from a single test or from the mean of the
three tests) not greater than 1.0 per cent is acceptable for most tablets.
• If obviously cracked, chipped or broken tablets are present in the sample
after tumbling, the sample fails the test.
• If the size or shape of the tablet causes irregular tumbling, adjust the drum
base so that it forms an angle of about 10º with the horizontal and the
tablets do not bind together when lying next to each other, which prevents
them from falling freely.