Objective
To test &
determine the uniformity of diameter, thickness and hardness.
Materials
10 tablets (Paralgin)
Apparatus
Weighing boat, Tablet Testing Instrument (PHARMATEST PTB 311)
Procedures
1) 10 tablets
are selected and been tested for uniformity of diameter, thickness and hardness
which carried out by 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.
Result
TABLET
|
THICKNESS
(mm)
|
DIAMETER
(mm)
|
HARDNESS
(N)
|
STANDARD DEVIATION
(THICKNESS)
|
STANDARD DEVIATION
(DIAMETER)
|
STANDARD
DEVIATION
(HARDNESS)
|
1
|
4.09
|
12.77
|
234.2
|
-0.49
|
-0.08
|
-11.29
|
2
|
4.02
|
12.77
|
267.8
|
-2.19
|
-0.08
|
+1.44
|
3
|
4.04
|
12.77
|
276.4
|
-1.70
|
-0.08
|
+4.70
|
4
|
4.05
|
12.78
|
279.5
|
-1.46
|
0
|
+5.87
|
5
|
4.05
|
12.77
|
264.7
|
-1.46
|
-0.08
|
+0.27
|
6
|
4.02
|
12.78
|
273.6
|
-2.19
|
0
|
+3.64
|
7
|
4.01
|
12.77
|
274.0
|
-2.43
|
-0.08
|
+3.79
|
8
|
4.67
|
12.85
|
227.0
|
+13.63
|
+0.55
|
-14.02
|
9
|
4.03
|
12.77
|
282.2
|
-1.95
|
-0.08
|
+6.89
|
10
|
4.07
|
12.78
|
260.3
|
-0.97
|
0
|
-1.41
|
AVERAGE
|
4.11
|
12.78
|
264.0
|
|||
Discussion
In this experiment,we were able
to determine the diameter, thickness and hardness of the Paralgin tablets. In
pharmacopoeial standards,uniformity in diameter,thickness and hardness are
important factors. As the uniform size of tablets may help to increase the
patient compliance and avoid them from being confuse with different size of the
tablets. Beside, different size of the tablets may cause the patient to think
that the drugs or tablets have different amount of active ingredient. From the
table, 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
diameters of the tablets are more than 12.55 mm. So, the deviation should be
+/- 3%. The results for diameter are accurate because all the deviations of the
tablets are less than +/- 3%. This means that the tablets generally have
uniform diameter and size.
Meanwhile,the second aspect is
thickness which important to prevent the patient reduce from 2 times a day to 1
times a day as they thought big tablet is more potency or more efficient
compared to small tablet. In this experiment, the thickness within range
between of 4.01 -4.67 . Hence,the
thickness of tablet is not in uniform size because of many factor such as
compressive forces during manufacturing ,type of tabletting method and depends
on the die of the tablet and the force used to compress the powder. It also can
be influenced by the difference density of granules and the speed of
compression.
Another aspect is the hardness
of tablets depends on the weight of the material used, space between the upper
and lower punches at the time of compression and pressure applied during the
compression. Hardness is important in order to predict the breaking point and
structural integrity of a tablet under conditions of storage, transportation,
and handling before usage. As
increase the hardness as increase the disintegration period. From the result
obtained, it seems that Paralgin tablet did not have equally hardness of each
tablet as the percentage deviation is very different.This may due to many
factor such as amount of binder,compression of tablet and compressive forces
and method of granulation in preparing the tablet.
Conclusion
There are three
important aspects in determination quality of tablets and capsules which are
diameter,thickness and hardness. The uniformity of the diameter is important in
order to design drugs with similar size and shape, so that the patient will not
confuse either the drugs have different amount of active ingredients or not.
The thickness of the tablets is important in order to package the tablets
either in blister or plastic container. The hardness of the tablets is
important in order to ensure the drugs or tablets have effective hardness that
will makes them dissolve in dissolution, but cannot easily break due to any
pressure or forces applied to them.
References
No comments:
Post a Comment