Objective:
To test
uniformity on diameter, thickness and hardness of the tablets by using Tablet
Testing Instrument
Introduction:
Tablet uniformity is important and is
used to make sure that every tablet contains the amount of drug substances
intended with only little variation among tablets within a batch. Due to the
increased awareness of physiological availability, the uniformity test has been
included for all coated and uncoated tablets. Among the various oral dosage
forms, tablets are the most common and easiest way to be administered. Tablets
are defined as solid preparations each containing a single dose of one or more
active ingredients and obtained by compressing uniform volumes of particles. Besides,
tablets are used mainly for systemic drug delivery but also for local drug
action. 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
pharmacopoeial standard. All of the percentage average deviation value must not
exceed ± 5% for tablets with diameter less than 12.5 and ± 3% for diameter of
12.5 mm or more. All of this test could be done by using PHARMATEST PTB 311.
The thickness and hardness test are both under non-pharmacopoeial standards and
is widely used by the manufacturers itself.
Materials and Apparatus:
10 Uphamol
Cold and Flu tablets, Tablet Testing Instrument (PHARMATEST PTB 311)
Procedure:
1. 10 tablets of Uphamol Cold and Flu are selected
and then, the test for diameter uniformity, thickness, and hardness is carried
out by using the Tablet Testing Instrument (PHARMATEST PTB 311).
2. Then the value of the diameter, thickness, and
hardness is taken. The deviation of each is calculated and 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.
Discussion:
In this experiment, 10 Uphamol Cold and
Flu tablets are used to measure their thickness, diameter and also hardness. From
the results that we obtained, the diameter of all the tablets is less than 12.50mm
and the deviation does not exceed ± 5% based on the calculation. Thus, the uniformity
of the diameter of tablet follows the pharmacopoeial standard. Each tablet with diameter more than 12.5mm,
the deviation should not exceed ±3% while for tablet with diameter less than
12.5mm, the deviation should not exceed ±5%. From the measurement done by the PHARMATEST PTB 311, we can conclude that all the tablets pass
the test as the deviation of each diameter for each tablet is not out of the
range required.
The
deviation can be calculated based on the equation below:
Based
on the calculation, for diameter of tablets which is bigger than the mean
diameter, the deviation obtained will be a positive value. On the other hand,
for tablet with diameter smaller than the mean diameter, the deviation obtained
will be a negative value. However, errors may occur if the deviations are out
of the required range. The slight deviations of diameter of the tablets may either be due to
an uneven feeding of granules into die or may be due to the irregular movement
of lower punch.
(PHARMATEST PTB 311 is used to measure the
thickness, diameter and also hardness of tablets.)
Tablets usually need to have certain hardness
or strength to withstand and overcome mechanical shock so that they do not
break easily. In addition, tablets should be able to withstand reasonable
abrasion and friction. Adequate tablet hardness and resistance to powdering and
friability are necessary requisites for consumer acceptance. It also may influence
tablet disintegration and affect the dissolution rate. It may be especially
important to carefully monitor tablet hardness for drug products that possess
real or potential bioavailability problems or are sensitive to altered
dissolution-release profiles as a function of the compressive force employed.
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. In the real manufacturing process, tablet uniformity is
important and is used to make sure that every tablet contains the amount of
drug substances intended with only little variation among tablets within a
batch. If these test has been conducted and the percentage deviation is exceed
than it should be, the manufacturer need to remake the tablets by modifying the
ingredients used whether in amount of ingredients or change the types of
ingredient that had been choose. This test is important to make sure the drugs
in form of tablets could be supply to the patients and it give the therapeutic
effect effectively by having good properties such as good dissolution rate,
good disintegration within the body and have a good metabolism to avoid any
negative side effects.
Conclusion:
In this experiment, all the 10 tablets
have uniform diameter, thickness and hardness by the measurement from Tablet
Testing Instrument. All tablets obey the standard properties
required.
Reference:
- http://www.pharmainfo.net/tablet-evaluation-tests/content-uniformity
- http://www.pharma-test.de/ptb311e/
- http://www.slideshare.net/mallikarjunvasm/quality-control-tests-for-tablets#btnNext
- http://hussain-ku.blogspot.com/2010/11/quality-control-tests-for-tablets.html
- http://pharmlabs.unc.edu/labs/tablets/evaluation.htm
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