OBJECTIVE
1.To test the uniformity of hardness, diameter and
thickness for 10 samples of tablet.
2.To determine the ability for tablet to withstand
sufficient mechanical strength and fracture/erosion during manufacturing and
handling.
3.To enhance the patient compliance to drug with
suitable hardness and
attractive appearance
INTRODUCTION
Each tablet and capsule will have similar reaction
when metabolized in the body with the uniformity in disintegration and
dissolution of the tablet and capsule .There are also non-pharmacopoeial
standard involve bioavailability of the tablets and capsules.
Besides,there are a number of procedures which apply
specifically to tablets and capsules, not only to ensure that a tablet or a
capsule exerts its full pharmacological actions, but also to determine the
uniformity of the physical properties of the official tablet/capsule,
irrespective of the manufacturer.
All the experiments below that will be conducted
will show the application of a number of selected physical and dosage
performance tests on the samples of commercially available tablets and
capsules.
MATERIALS AND APPARATUS
Materials: 10 tablets
Apparatus: Weighing boat, Tablet Testing Instrument,
forceps
PROCEDURES
1.10 tablets are selected and the tests for
uniformity of diameter, thickness and hardness are carried out 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.
Tablets used in this experiment are Redon.
Results :
Tablets
|
Thickness(mm)
|
Hardness(N)
|
Diameter(mm)
|
Deviation of diameter(%)
|
1
|
4.06
|
236.11
|
12.75
|
0
|
2
|
4.17
|
268.25
|
12.75
|
0
|
3
|
4.08
|
241.28
|
12.74
|
-0.08
|
4
|
4.02
|
284.88
|
12.77
|
0.16
|
5
|
4.22
|
245.71
|
12.74
|
-0.08
|
6
|
3.96
|
221.14
|
12.74
|
-0.08
|
7
|
4.03
|
239.25
|
12.74
|
-0.08
|
8
|
3.99
|
261.05
|
12.74
|
-0.08
|
9
|
4.06
|
267.70
|
12.76
|
0.08
|
10
|
4.00
|
228.53
|
12.74
|
-0.08
|
Average
|
4.06
|
249.39
|
12.75
|
0
|
Deviation of diameter(%) = x
100%
Where x is the diameter of each individual tablet
DISCUSSION
From the tolerances, we
know that if the diameter of tablets is more than 12.55 mm, so the deviation should
be +/-3%. If the diameter of tablets is less than 12.55 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.
The second aspect is
the thickness. The thickness of
tablets is critical to their therapeutic effectiveness. All tablets, where the
active ingredient comprises a major part of the tablet are required to meet a
weight variation test. It is assumed that providing the weight of the tablet is
kept within defined limits that the amount of active drug available to the user
will remain the same.
Tablet thickness is an
important quality control test for tablet packaging.Very thick tablet affects
packaging either in blister or plastic container. Tablet thickness can vary
without any change in its weight. This may 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. From the result,
we find that the mean of the thickness is 4.06 mm. It is generally the same as
each of the individual tablet. So, it means that the tablets also have
uniformity in the thickness.
Furthermore,the third
aspect is hardness. 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. 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 249.39
N which means equal to about 25.42 kg. The instrument measures the force
required to break the tablets. Thus, the value of 249.39 N shows that 249.39 N
forces are needed to break the tablets.
Oral tablets normally
have a hardness of 4 to 10kg. However, hypodermic and chewable tablets are
usually much softer which have a hardness of 3 kg and some sustained release
tablets are much harder which have a hardness of 10 -20 kg. Since the tablets which
have been test have hardness of 25.42kg, so we assume that the tablets are
sustained release tablets. If the tablets are too hard, it may be difficult to
be dissolve during the dissolution test and if the tablets are too soft, it may
be cannot stand the pressure or force that applied to it. Therefore, we must
design tablets that have medium level of hardness to ensure that it can easily
dissolve and not easily break.
CONCLUSION
1.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.
2.The
thickness of the tablets is important in order to package the tablets either in
blister or plastic container.
3.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
2.http://www.slideshare.net/mallikarjunvasm/quality-control-tests-for-tablets
3.http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm377938.pdf
No comments:
Post a Comment