Objectives:
To
test the uniformity of tablets in diameter, thickness and hardness.
Introduction:
The
standards that are found in the British Pharmacopoeia and United Pharmacopoeia
including the uniformity of diameter, uniformity of weight, content of active
ingredient, uniformity of content, disintegration and dissolution. The uniformity
of diameter is to increase the patient compliance due to their uniform size of
appearance.
The uniformity
of tablet is important and is used to make sure that every tablet contains the
same amount of drug substances with a little variation within a batch to make
sure that the equal effectiveness of tablets. Related to this reason, there is
experiment conducted to test on the uniformity of diameter, hardness and
thickness of the tablets which will influence the efficiency of the tablets to
delivery drugs.
PHARMATEST
PTB 311 is one of the most popular instruments for measuring thickness up to
15mm, diameter up to 40mm and hardness up to 300N. Uniformity of the diameter
of tablet follows the pharmacopoeia standard. According to the theory, 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%.
All of this test could be done by using
PHARMATEST PTB 311. The thickness and hardness test are both under
non-pharmacopoeia standards and is widely used by the manufacturers itself.
Materials
and Apparatus:
10 Redon tablets, Tablet Testing Instrument
(PHARMATEST PTB 311)
Procedure
:
1. 10
tablets were selected and tests were carried out to determine the 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
|
12.74
|
3.97
|
258.27
|
2
|
12.83
|
4.28
|
270.47
|
3
|
12.74
|
3.96
|
278.78
|
4
|
12.74
|
4.04
|
249.78
|
5
|
12.74
|
4.07
|
265.29
|
6
|
12.76
|
4.00
|
263.08
|
7
|
12.75
|
4.10
|
259.94
|
8
|
12.74
|
4.02
|
267.51
|
9
|
12.74
|
4.02
|
260.12
|
10
|
12.74
|
4.00
|
206.55
|
Average of diameter (mm) = 12.75
Average of thickness (mm) = 4.05
Average of hardness (N)
= 257.98
Deviation = (initial –average diameter) x
100%
Average diameter
Tablet 1:
Deviation = (12.74 – 12.75) x
100% = 0.08%
12.75
Tablet 2:
Deviation = (12.83 – 12.75) x 100%
= 0.94%
12.75
Tablet 3:
Deviation = (12.74-12.75) x
100% = 0.08%
12.75
Tablet 4:
Deviation = (12.74 – 12.75) x
100% = 0.08%
12.75
Tablet 5:
Deviation = (12.74 – 12.75) x
100% = 0.08%
12.75
Tablet 6:
Deviation = (12.76– 12.75) x
100% = 0.08%
12.75
Tablet 7:
Deviation = (12.75 – 12.75) x
100% = 0%
12.75
Tablet 8:
Deviation = (12.74 – 12.75) x
100% = 0.08%
12.75
Tablet 9:
Deviation = (12.74 – 12.75) x
100% = 0.08%
12.75
Tablet 10:
Deviation = (12.74 – 12.75) x
100% = 0.08%
12.75
Discussion :
This experiment is to
determine the uniformity of diameter, thickness and hardness of the tablets. The diameter and shape of
tablets depends on the die and punches which are used to make the tablets.
There are a lot of different manufacturers using dies and punches with various
sizes and shapes and therefore, different diameter and shape of tablets are
available, however circular shape is more common in the market. From the
results, the diameter for all ten tablets determined are very similar with the
average diameter of the tablets which is 12.75mm. It is important to produce
tablets with uniform diameter within the same batch of tablets so that patients’
compliance can be increased. 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 all the tablets have more than 12.50mm. So, the deviation
should be within the range of ±3%. The results for diameter of the tablets in
this experiment are accurate because generally the tablets are having uniform
diameter and size. Besides, the thickness of tablets is the other aspect which
must be taken care of during manufacturing tablets for tablet packaging because
thickness of tablets can affect the choice of packaging used either in blister
or plastic container. From the result, we find that the mean of the thickness
is 4.05 mm. It is generally the same for each tablet that been examined. Therefore,
we can conclude that all the tablets used in this experiment are having uniform
thickness. The third aspect which determined in this experiment is the hardness
of tablet. Besides, the hardness of tablets must be taken control of because hardness
of tablets can affect the disintegration of tablets. If the tablets produced
are too hard, the tablets might be too hard to be dissolved and vice versa.
Besides, hardness of tablets is an important aspect to predict the breaking
point and to determine the suitable conditions of storage and transportation
for the tablets. From the results, we can conclude that the hardness of tablets
are 257.98N.
Conclusion :
The uniformity of the diameter, thickness and hardness is important to design drugs with equal size, shape and the most importantly is the effectiveness of every tablet.
Conclusion :
The uniformity of the diameter, thickness and hardness is important to design drugs with equal size, shape and the most importantly is the effectiveness of every tablet.
From
this experiment, it is indicated that 257.98 N of force are needed to break the
Redon tablets.
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