Procedure :
1. 10 tablets were selected and tests were carried
out for uniformity of diameter, thickness and hardness using the Tablet Testing
Instrument (PHARMATEST PTB 311).
2. The deviation of individual unit from the mean
diameter should not exceed ±5% for tablets with diameter of less than 12.5 and
±3% for diameter of 12.5 mm or more.
Results and Calculation :
Tablet
|
Diameter (mm)
|
Thickness (mm)
|
Hardness (N)
|
1
|
12.04
|
4.69
|
171.86
|
2
|
14.63
|
4.87
|
181.81
|
3
|
12.25
|
4.94
|
150.00
|
4
|
12.11
|
4.92
|
151.95
|
5
|
12.08
|
4.83
|
160.12
|
6
|
12.08
|
4.90
|
100.77
|
7
|
12.04
|
4.90
|
151.95
|
8
|
12.05
|
4.89
|
161.19
|
9
|
12.02
|
4.94
|
174.16
|
10
|
12.06
|
4.90
|
175.59
|
Average of diameter (mm) = 12.34
Average of thickness (mm) = 4.88
Average of hardness (N) = 157.94
Deviation = (initial
–average diameter) x 100%
Average diameter
Tablet 1:
Deviation = (12.04 –
12.34) x 100% = 2.43%
12.34
Tablet 2:
Deviation = (14.63 – 12.34)
x 100% = 18.56%
12.34
Tablet 3:
Deviation = (12.25 – 12.34)
x 100% = 0.73%
12.34
Tablet 4:
Deviation = (12.11 – 12.34) x 100% =
1.86%
12.34
Tablet 5:
Deviation = (12.08 –
12.34) x 100% = 2.11%
12.34
Tablet 6:
Deviation
= (12.08 – 12.34) x 100% = 2.11%
12.34
Tablet 7:
Deviation = (12.04 – 12.34) x 100% =
2.43%
12.34
Tablet 8:
Deviation = (12.05 –
12.34) x 100% = 2.35%
12.34
Tablet 9:
Deviation = (12.02 –
12.34) x 100% = 2.59%
12.34
Tablet 10:
Deviation = (12.06 –
12.34) x 100% = 2.27%
12.34
Discussion :
The aim of this experiment is to determine the
diameter, thickness and hardness of the tablets. The uniformity in diameter involves in
pharmacopoeial standards whereas thickness and hardness involve in
non-pharmacopoeial standards. The diameter and shape of tablets depends on the
die and punches selected for making the tablets. There are various in sizes and
shapes of tablets which are prepared, but usually circular shape (flat or
biconvex faces). From the results, the diameter for all ten tablets has such
similar values and the average of the diameter of the tablets is 12.34 mm. it is important to produce tablets with
similar or uniform diameter and size. The
uniform size of tablets help to increase the patient compliance and avoid them
from being confuse with different size of the tablets as they might think that
the drugs or tablets have different amount of active ingredient. From the
tolerances, we know that if the diameter of tablets is more than 12.5 mm, thus
the deviation should be ± 3%. If the diameter of tablets is less than 12.5 mm,
thus the deviation should be ±5%. From the results, we find that only tablet 2 has
more than 12.55 mm. So, the deviation should be ±3%. The other 9 tablets are
less than 12.5mm thus, the deviation is ±5%. The results for diameter are
inaccurate. This means that the
tablets generally have no uniform diameter and size. The second aspect is the
thickness. Which is an important quality control test for tablet packaging?
Very thick tablet affects
packaging either in blister or plastic container. From the result, we find that
the mean of the thickness is 4.88 mm. It is generally the same as each of the
individual tablet. So, it means that the tablets also have uniformity in the
thickness. The third one is
hardness. The hardness aspect is important in order to predict the breaking
point and structural integrity of a tablet under conditions of storage,
transportation, and handling before usage. From the result, we find that the
average of hardness of the tablets is 157.94N.
Conclusion :
Thus, the value indicates that 157.94N forces are needed to break the tablets.
Conclusion :
Thus, the value indicates that 157.94N forces are needed to break the tablets.
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