Tablets
Experimental
method:
1.
20 tablets are weighed previously. The
average weight is determined.
2.
The tablets are weighed individually and
for each tablet is determined, the percentage deviation of its weight from the
average weight.
3.
The deviation of individual weight from
the average weight should not exceed the limits given below.
Average weight
of tablet
|
Deviation (%)
|
Number of
tablets
|
Less than 80
mg
|
+ 10.0
+ 20.0
|
Minimum 18
Maximum 2
|
80 mg to 250
mg
|
+ 7.5
+ 15.0
|
Minimum 18
Maximum 2
|
More than 250
mg
|
+ 5.0
+ 10.0
|
Minimum 18
Maximum 2
|
Capsules
Experimental method:
1.
20 capsules are selected at random.
2.
One capsule is weighed. The capsule is
opened and the contents are removed as completely as possible. The emptied
shells are weighed. The net weights of the contents are determined by
subtracting the weight of the shells from the weight of the intact capsule.
3.
The procedure is repeated with other 19
capsules.
4.
The average net weight is determined from
the sum of the individual net weights.
5.
The percentage deviation is determined
from the average net weight for each capsule. The deviation of individual net
weight should not exceed the limits given below:
Average net
weight of capsule
|
Deviation (%)
|
Number of
tablets
|
Less than 300
mg
|
+ 10.0
+ 20.0
|
Minimum 18
Maximum 2
|
300 mg or more
|
+ 7.5
+ 15.0
|
Minimum 18
Maximum 2
|
Result
and calculation:
Tablet
Bil
|
Weight (mg)
|
Deviation (%)
|
1
|
351.3
|
-0.3687
|
2
|
348.9
|
-1.0493
|
3
|
347.8
|
-1.3613
|
4
|
352.8
|
0.0567
|
5
|
356.0
|
0.9643
|
6
|
362.1
|
2.6943
|
7
|
356.8
|
1.1912
|
8
|
352.3
|
-0.0851
|
9
|
353.1
|
0.1418
|
10
|
352.6
|
0.000
|
11
|
354.0
|
0.3971
|
12
|
351.1
|
-0.4254
|
13
|
351.0
|
-0.4538
|
14
|
352.0
|
-0.1702
|
15
|
354.2
|
0.4538
|
16
|
350.7
|
-0.5389
|
17
|
351.4
|
-0.3403
|
18
|
355.0
|
0.6807
|
19
|
349.4
|
-0.9075
|
20
|
351.3
|
-0.3687
|
Average weight
|
7053.8 /20
=352.6 mg
|
Percentage
deviation: (weight of individual tablet- average weight of tablet) x 100
=
Average weight of tablet
Example tablet 1: (351.3-352.6) x 100 = -0.3687 %
352.6
Capsules
Bil
|
Capsule (g)
|
Emptied capsule (g)
|
Net weight (g)
|
Deviation (%)
|
1
|
0.4699
|
0.0814
|
0.3885
|
1.4625
|
2
|
0.4747
|
0.0776
|
0.3971
|
3.7085
|
3
|
0.4459
|
0.0743
|
0.3716
|
-2.9512
|
4
|
0.4573
|
0.0743
|
0.3830
|
0.0261
|
5
|
0.4577
|
0.0743
|
0.3834
|
0.1306
|
6
|
0.4585
|
0.0745
|
0.3841
|
0.3134
|
7
|
0.4392
|
0.0774
|
0.3618
|
-5.5106
|
8
|
0.4338
|
0.0763
|
0.3575
|
-6.6336
|
9
|
0.4695
|
0.0791
|
0.3904
|
1.9587
|
10
|
0.4686
|
0.0752
|
0.3934
|
2.7422
|
11
|
0.4545
|
0.0807
|
0.3738
|
-2.3766
|
12
|
0.4698
|
0.0780
|
0.3918
|
2.3244
|
13
|
0.4730
|
0.0762
|
0.3968
|
3.6302
|
14
|
0.4629
|
0.0794
|
0.3925
|
2.5072
|
15
|
0.4443
|
0.0794
|
0.3649
|
-4.7010
|
16
|
0.4406
|
0.0773
|
0.3633
|
-5.1188
|
17
|
0.4742
|
0.0765
|
0.3977
|
3.8652
|
18
|
0.4639
|
0.0784
|
0.3855
|
0.6790
|
19
|
0.4714
|
0.0763
|
0.3951
|
3.1862
|
20
|
0.4614
|
0.0764
|
0.3850
|
0.5484
|
Total
net weight = 7.6572
Average = 0.3829
|
||||
Percentage deviation = (net weight of capsule –average weight of capsule) x 100 =
Average
weight of capsule
= (0.3885-
0.3829) x 100 = 1.4625 %
0.3829
Discussion:
Test
of uniformity of weight for the tablet and capsules are carried out to ensure
accurate and consistent dosage form to be administered by the patients.
In
the experiment, since the average weight obtained for 20 tablets is 352.6 mg
that greater than 250 mg thus this tablet should have minimum 18 tablets and
not deviate from the limits given. The minimum 18 tablets should in the range ±
5% and maximum 2 tablets that in range of ± 10.0%. For our experiment, it is
found that all the tablets follow the limits given.
The maximum percentages of
deviation for tablets are 2.6943%.The
average weight for the capsule is 0.3829g or 382.9mg. It is shown that the
average net weight of the capsule is more than 300 mg. Therefore the capsule
should have minimum 18 capsules that in range of ±7.5% and maximum 2 number of
capsules in the range of ±15%. The maximum percentages of deviation for the
capsules are -6.6336%.
Conclusion:
The uniformity in weigh
the tablet and capsule are very important and useful in quality control during
the process of manufacturing of the medicines. The dosage form must give the
best therapeutic effects and appearance to the patients.
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