QUALITY CONTROL TESTS FOR TABLETS

There are various quality control tests for tablets.Following is brief explanation of some important quality control
tests for tablet.

TABLET HARDNESS:
The test measures crushing strength property defined as the compressional force applied diametrically to a tablet
which just fractures it. Among a large number of measuring devices, the most favored ones are Monsanto tester,
Pfizer tester, and Strong cobb hardness tester. All are manually used. So, strain rate depends on the operator.
Heberlein Schleuniger, Erweka, Casburt hardness testers are motor driven.

FRIABILITY TEST:
The tablet may well be subjected to a tumbling motion. For example, Coating, packaging, transport, which are
not severe enough to break the tablet, but may abrade the small particle from tablet surface. To examine this,
tablets are subjected to a uniform tumbling motion for specified time and weight loss is measured. Roche
friabilator is most frequently used for this purpose.

Tablet Diameter:
Tablet diameter is also an ipmortant test. We use pFizer tester for checking the diameter of the tablet,screw
guage and calliper are also used. Tablet thickness can be measured by micrometer or by other device.
Tablet thickness should be controlled within a ± 5% variation of standard value.

Tablet thickness:
Tablet thickness is an important qc test for tablet packaging.Very thick tablet affects packaging either in blister or
plastic container.Tablet thickness is determine by the dia of the tablet.Pfizer tester is used for checkaging tablet
thickness.

Weight Variation:
Take 20 tablet and weighed individually. Calculate average weight and compare the individual tablet weight to
the average. The tablet pass the U.S.P. test if no more that 2 tablets are outside the percentage limit and if no
tablet differs by more than 2 times the percentage limit.
Content Uniformity Test:
Randomly select 30 tablets. 10 of these assayed individually. The Tablet pass the test if 9 of the 10 tablets must contain not
less than 85% and not more than 115% of the labeled drug content and the 10th tablet may not contain less than 75% and
more than 125% of the labeled content.
If these conditions are not met, remaining 20 tablet assayed individually and none may fall out side of the 85 to 115% range.

Disintegration Test :
The breakage of tablet into smaller fragments is called disintegration of tablet.

The U.S.P. device to test disintegration uses 6 glass tubes that are 3” long; open at the top and 10 mesh screen
at the bottom end. To test for disintegration time, one tablet is placed in each tube and the basket rack is
positioned in a 1-L beaker of water, simulated gastric fluid or simulated intestinal fluid at 37 ± 20 C such that the
tablet remain 2.5 cm below the surface of liquid on their upward movement and not closer than 2.5 cm from the
bottom of the beaker in their downward movement. Move the basket containing the tablets up and down through
a distance of 5-6 cm at a

frequency of 28 to 32 cycles per minute. Floating of the tablets can be prevented by placing perforated plastic discs on each
tablet.
According to the test the tablet must disintegrate and all particles must pass through the 10 mesh screen in the time
specified. If any residue remains, it must have a soft mass.
Disintegration time: Uncoated tablet: 5-30 minutes
Coated tablet: 1-2 hours

Dissolution test:
The release of drug from the tablet into solution per unit time under standardize condition is
called dissolution test.

Apparatus-1 (Basket Type): A single tablet is placed in a small wire mesh basket attached to the
bottom

of the shaft connected to a variable speed motor. The basket is immersed in a dissolution medium (as
specified in monograph) contained in a 1000 ml flask. The flask is cylindrical with a hemispherical
bottom. The flask is maintained at 37±0.50C by a constant temperature bath. The motor is adjusted to
turn at the specified speed and sample of the fluid are withdrawn at intervals to determine the amount
of drug in solutions.

Practical 7 : Exp 5 : Content

Of Ibuprofen (Assay)
December 27, 2013Experiment 4
TITTLE: Content of Ibuprofen

OBJECTIVE:

To determine the given formulation of Ibuprofen

INTRODUCTION:

Ibuprofen is NSAID mean non steroidal anti-inflammatory drug. Ibuprofen is used to

reduce fever and treat pain or inflammation caused by many conditions such as
headache, toothache, back pain, arthritis, menstrual cramps, or minor injury. It
works by reducing hormones that cause inflammation and pain in the body.as for
precaution do not use ibuprofen before or after heart surgery.

EXPERIMENTAL METHOD:

1. 20 ibuprofen tablets which is previously selected at random is weighed and

powdered.

2. A quantity of powder containing 0.5 g ibuprofen with 20 ml chloroform is extracted

for 15 minutes and filtered through a sintered glass crucible (BS Porosity No. 1).

3. The residue with 3 × 10 ml chloroform is washed and then combined. Filtrate is

gently evaporated just to dryness in a current of air. Then the residue is dissolved in
100 ml with ethanol (96%) previously neutralized to phenolphthalein solution.

4. The solution with 0.1M sodium hydroxide is titrated to end point with
phenolphthalein solution as the indicator. The content of ibuprofen if each ml of 0.1M
sodium hydroxide is equivalent to 0.02063 g of C13H18O2 is calculated.

RESULT AND CALCULATION:

During titration

Initial reading of the burrete is =0.00ml

Final reading of the burrete is =24.70ml

It is stated that 1ml of 0.1m solution NAOH has 0.02063 g of C13H18O2

So,

24.70ml x 0.02063 = 0.50956g Ibuprofen is present

Percentage error: 0.50956g-0.5g/0.5g x 100= 1.92%

DISCUSSION:

In this experiment the weight of Ibuprofen obtained is 0.50956g which is slightly

different from the actual weight that is 0.5g .Actual range is around 0.4 and 0. 6g.the
percentage error is 1. 92% which show that only less error occurred during this
experiment. However some error could also occur as they were unavoidable. Among
the errors is parallax error which occurs during measuring the chloroform the
chloroform. This will cause excess addition of NaOH so the colour becomes too
purple. Other than that during crushing of the Ibuprofen tablet, it does not become
uniform powder and this will affect the powder flow thus will cause some undissolved
ibuprofen. Besides that, incomplete washing of ibuprofen with chloroform also
occurred and this also affects the final result.

CONCLUSION:

As conclusion the weight of ibuprofen obtained is 0.50956g and the percentage error
is 1.92%. Therefore, this test is suitable to determine the accurate near value of
ibuprofen content.

Practical 7 : Exp 4 : Dosage

Performance Tests.
December 21, 2013Experiment 4
Practical 7 : Exp 4 : Dosage Performance Tests.

DATE: 9/12/2013

TITLE: Disintegration test for sugar-coated tablet

AIM : To investigate the compliance of tablets with the disintegration test.

INTRODUCTION:

Tablet disintegration testing is used as a quality-assurance measure. This is

because, for some cases if the disintegration time is too high; it means that the tablet
is too highly compressed or the capsule shell gelatine is not of pharmacopoeial
quality. Also if the disintegration time is not uniform in a set of samples being
analysed, it indicates batch inconsistency and lack of batch uniformity. It is not a true
predictor of how well the dosage form will release its active ingredient in vivo.

APPARATUS & MATERIALS:

 Tablets

Copley Disintegration Tester

Beaker 1000ml, Thermometer and Distilled Water

PROCEDURE:

1. Fill up the beaker with distilled water until 800ml.

2. Placed the beaker at the disintegration tester and let the water heated up until
37⁰C.

3. One tablet was introduce into each tube, giving it 6tablets*2 = 12tablets.

 3 tablets – Uphamol Cold & Flu Tablet (Pink)

 3 tablets – Paralgin Tablet (Brown)
 6 tablets – Mefe Film-coated Tablets (Yellow)

4. When it reached the required temperature, set the timer to 1hour and let the
machine operate. The machine consists of a basket rack holding six plastic tubes
open at the top and bottom. The bottom is covered with a 10 mesh screen. The rack
is immersed in a suitable liquid at 37 degrees C. It moves up and down at a specified
rate.

5. The time to disintegrate and fall through the screen is noted.

6. Tablets comply with the test if all tablets disintegrate in 60 minutes. If not, repeat
the procedure using 6 new tablets but using 0.1M hydrochloric acid as the
disintegration medium.

RESULTS:

NO TABLETS MEDIUM TIME TAKEN TO DISINTEGRATE

(min)

1. Uphamol Cold & Flu Tablet Water 6

2. Paralgin Tablet Water 18

3. Mefe Film-coated Tablets Water 1

DISCUSSION:

It has long been recognized that before a tablet/hard gelatin capsule can dissolve
and hence allow the active drug to be absorbed into the body, it must first
disintegrate into smaller particles.

During testing, the basket assembly is raised and lowered in simulated gastric fluid
at 37 degrees C whilst the tablet is continually “hammered” by a plastic disk of
defined proportions to simulate in vivo conditions. The tablet is said to pass the test
providing that no tablet residue remains on the mesh after the designated test
period.

But as mentioned earlier, this test is not a true predictor of how well the dosage form
will release its active ingredient in vivo. This is because of some limitations it cannot
follow. Firstly, It does not mimic conditions of gastrointestinal tract such as the
muscle movement. Thus there’s no guarantee of clinical efficacy. Secondly, this test
is controlled by experimental variables.

In the experiment conducted, 3 types of tablets are used:

NO TABLETS TYPE OF TABLET ACTIVE INGREDIENT

 1. Uphamol Cold & Flu Tablet Uncoated Paracetamol B.P

2. Paralgin Tablet Uncoated Paracetamol B.P

3. Mefe Film-coated Tablets Film-coated Mefenamic acid B.P

Time taken to disintegrate Uphamol Cold & Flu Tablet, Paralgin Tablet and Mefe
Film-coated Tablets are 6 min, 18 min and 1 min each. The tablets passed the test
providing that no tablet residue remains on the mesh after the designated test
period.

CONCLUSION:

All of the tablets passed the disintegration test as it disintegrates completely in less
than the specified time which is 1 hour.

—————————————————————————————————————
——

TITLE: Dissolution test for tablet

AIM : To investigate the percentage amount of ibuprofen dissolved.

INTRODUCTION:

The dissolution test for tablet is necessary to perform as to ensure the tablet
dissolution rate is at a desired one. If it is not what we predicted, we will have to
reformulate or find out what went wrong during the preformulation of tablets.
Besides, it is also allow us to know the bioavailability of the active ingredient in the
body and giving expected pharmacological effects effectively. We also able to know
the specific pH at which the drug dissolved best.

PROCEDURE:

1. The dissolution vessels are filled up with buffered solution to 900 mL mark. The
temperature was set to 37 °C.

2. The temperature of the dissolution medium was checked to ensure that it is ± 0.5
°C.

3. One Ibuprofen Tablet was put into each of the dry basket.
4. The stirring speed was set to 150 rpm. Then, the baskets was lower assembly into
the position in the vessel and the operation was started.

5. After 30 minutes, 10 ml of the samples of the dissolution medium from each of the
vessel was withdrawn for analysis and the solution was filtered using a syringe filter.
Sampling should be done from middle point between the surface of the dissolution
medium and the top of rotating basket, and not less than 10 mm form the wall of the
vessel. The volume of aliquot withdrawn for analysis was replaced with the same
volume of same dissolution medium.

6. A standard solution of ibuprofen was prepared by diluting 10.0 mg of ibuprofen

reference to 50 ml with dissolution medium.

7. Each of 2.0 ml of sample solution and 2.0 ml of standard solution were diluted to
25 ml with dissolution medium in separate volumetric flasks.

8. The absorption of both solutions were measured in a 1 cm cell at a wavelength of

221 nm.

9. The percentage of amount of ibuprofen dissolved was calculated by using the

following formula:

At/As X W/50 X 2/25 X P X 900 X 25/2 X 100/200

Where

At = absorbance of sample solution

As = absorbance of standard solution

W = weight of ibuprofen reference standard used.

P = purity of ibuprofen reference standard

10. From the result obtained, the tablet compliance with the requirements of the
United States Pharmacopoeia was determined.

USP limits : Not less than 75% of the stated amount of ibuprofen dissolved in 30
minutes.

RESULTS:

At = 0.987

As = 3.913
Percentage of amount of amount of ibuprofen dissolved = 22.24%

Percentage error = (75 – 22.34)/75 X 100% = 70.35%

DISCUSSION:

The percentage error is 70.35% and this is a huge value which indicates that the
experiment conducted may have made some errors.

One of the errors is the quality and expiry date of the sample of ibuprofen. The
ibuprofen sampled may have expired and this may greatly affected the poor
dissolution and absorption of wavelength during spectrophotometer.

Besides, the temperature of the dissolution vessel is one of the factors. We did not
monitor the temperature which must have to maintain at 37 degree Celsius with ± 0.5
degree Celsius. Low temperature may cause poor dissolution while high temperature
may alter the composition of the ibuprofen tablet.

Moreover, the stirring speed may not reached or set at 150 rpm. This will cause the
dissolution rate to be slow as low speed is applied and affected the results. Besides,
the time for stirring may not set at 30 minutes or it was set less than that. This will
significantly cause errors.

Furthermore, the presence of dissolved gas in the dissolution medium or buffered

solution might lead to inaccuracy of results. The dissolution rate will be slowed.

The syringe filter used may absorb some of the sample during withdrawing of
sample. This will reduces the percentage of dissolved ibuprofen for analysis. Thus,
less ibuprofen sample was detected.

PRECAUTION :

1. We must make sure the sample tested must in good condition and not an expiry
tablets.

2. We must make sure the dissolution vessel is calibrated before used so that we
can obtain accurate results.

3. Besides, we must always double check on the setting of temperature, stirring

speed and time required for stirred to avoid unnecessary errors.

4. For the presence of dissolved gas in dissolution medium or buffered solution, it is

advisable to put the solution in ultrasonic water bath or by performing filtration under
vacuum.
5. We must also make sure the syringe filter is cleaned and non-absorbent type to
ensure that the sample is not absorbed onto it.

CONCLUSIONS:

The At = 0.987, As = 3.913 and the percentage of amount of ibuprofen dissolved is

22.24%.

Practical 7 : Exp 3 :
Uniformity Of Weight Of
Tablets And Capsule
December 21, 2013Experiment 4
Experiment 3

Title: Uniformity Of Weight Of Tablets And Capsule

Introduction:
Weight variation (WV) test can be done only on certain unit dose as shown in Table
1. Other unit dose will need to undergo content uniformity (CU) test.

In weight variation test, measurement of contents is done by estimation of contents

based on weight. Pharmacists often use and misuse this WV test by doing this test
on all dosage units. If it is used correctly, this WV test can be used to measure
content uniformity (CU). There are some conditions in which the weight difference
can determine the percentage difference in the API in the individual dosage units.
Hence this WV test can be useful in the quality control of drug production.
WV test should be used only for the types of dosage forms indicated in Table 1.

Experimental Method:

Tablets:

1. 20 tablets previously selected at random were weighed. The average weight was
determined.
2. Tablets were weighed individually and the percentage of deviation of its weight
from the average weight was determined for each tablet.
3. The deviation if individual weight from the average weight should not exceed the
limits given below.

Capsules:

1. 20 capsules were selected at random.

2. One capsule was weighed. The capsule was opened and the contents were
removed as completely as possible. The emptied shells were weighed. The net
weight of it’s contents was determined, that was by subtracting the weight of the
shells from the weight of the intact capsule.
3. The procedure was repeated with other 19 capsules.
For each capsule, the weight of intact capsule was first weighed. Then, the capsule
was opened and its content was removed, leaving only empty shell. The empty shell
was weighed. By subtracting weight of empty shell from weight of the intact capsule,
the weight of content was known.
4. The average net weight was determined from the sum of the individual net
weights.
5. The percentage deviation from the average net weight of each capsule was
determined. The deviation of individual net weight should not exceed the limits given
below:

Results And Calculations:

Tablets:
Capsules:
The formula used in calculating the deviation(%) was:

Discussion:

For tablets, since our average weight is 623.9 mg, the deviation of individual net
weight should not exceed the limits given below:
From the results, we can see that the 7 tablets weighed 664.5 mg, 672.2 mg, 658.3
mg, 676.1 mg, 666.2 mg, 666.7 mg and 661.2 mg respectively are having standard
deviation of ± 10.0. This is exceeding the limit of only maximum 2 tablets having this
type of deviation. This may indicate the ununiformed weights of the tablets and at the
same time may indicate the occurrence of errors. The errors might include the
presence of tablet fragments or dust on the tablets when weighed. It can also be the
systematic error caused by the inaccuracy of the weighing balance. Environmental
factors such as vibration of the table or wind from the air-conditioning may also
cause the fluctuation in the value presented by the weighing balance.

However, the variation in the weight of the tablets may be explained by the following.
Factors such as the flowing properties of the powder, the speed of tableting
machine, the pressure used in compression and the type of machines used in
tableting may affect the weight of a tablet. However the two most common causes of
weight variation are the differences in the bulk densities and particle size distribution
during compression.

For capsules, since our average weight is 295.9 mg, the deviation of individual net
weight should not exceed the limits given below:

From the results, all our capsules are having a deviation of ± 10%, which means that
all capsules have uniform weights. This may indicate the uniformity of the capsules
production. At the same time, this uniformity may also be caused by the usage of a
good weighing balance. The weighing balance used for measuring the weight of
capsule is more accurate as it is a more advanced balance.

If the weight variation in capsule exceeds the limit, this may be due to the defect of
the capsule filling machine. The machine may have misalignment of the upper and
lower capsule segments or problem in filling the capsule with the target fill weight.

Conclusion:
The tablets tested have failed the test of weight uniformity while the capsules tested
have passed the test of weight uniformity. The non-uniformity of the tablets may be
caused by the systematic error of the weighing balance itself. It may also be caused
by the non-uniformity in the particle size distribution and bulk densities during
compression of the tablets.

References:

1. Don Jacob. (9 May 2012) Citing Websites. Tablet weight variation and uniformity
of weight of single dose preparations – Pharmacopeal requirements IP/BP/USP.
Retrieved date. 21st December 2013.
From http://pharmatreasures.blogspot.com/2012/05/tablet-weight-variation-and-
uniformity.html

2. Donald K. Lightfoot. (n.d.) Answers To 10 Common Questions About Capsule

Filling. Retrieved date. 21st December 2013.
From http://capsugel.com/media/library/answers-to-10-common-questions-about-
capsule-filling.pdf

3. Dshravani. (2013) Citing Websites. Quality Control Of Capsules. Retrieved date.

21st December 2013. From http://www.pharmainfo.net/quality-control-capsules

4. The United States Pharmacopeial Convention. (2011) Citing Websites. 〈905〉

Uniformity of Dosage Units. Retrieved date. 21st December 2013.
From http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/2011-02-
25905UNIFORMITYOFDOSAGEUNITS.pdf.

5. The International Pharmacopoeia Fourth Edition – Pharmacopoeia Internationals

Editio Quarta. (n.d.) Citing Websites. Methods of Analysis: 5. Pharmaceutical
technical procedures: 5.2 Uniformity of mass for single-dose preparations. Retrieved
date. 21st December 2013. From http://apps.who.int/phint/en/p/docf/

Practical 7 : Exp 1 :
Assessment Of Quality Of
Tablets And Capsules
December 16, 2013Experiment 4
Introduction:

Oral dosage forms such as tablets and capsules have to follow the pharmacopoeial
standards which involve “added substances” that may influence their toxicity,
interference with analytical method and so on. 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 and weight may increase
the patient compliance due to their uniform size of appearance. The uniformity of
active ingredient and content will make sure the dosage supplied to the patients is
correct and preventing from overdose cases and so on. Uniformity in disintegration
and dissolution will make sure that each tablet and capsule will have similar reaction
when metabolized in the body. There are also non-pharmacopoeial standards that
are not included in the British Pharmacopoeia and United Pharmacopoeia, but still
influence the properties of the tablets and capsules. The non-pharmacopoeial
standards involve hardness, friability and bioavailability of the tablets and capsules.
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.

Experiment 1

Materials: 10 tablets

Apparatus: Weighing boat, Tablet Testing Instrument

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.
Results:
Tablet Thickness (mm) Hardness (N) Diameter (mm) Deviation of Diameter (%)
1 5.60 167.41 12.84 0.12
2 5.59 116.41 12.84 0.12
3 5.36 73.93 12.79 -0.27
4 5.68 138.62 12.83 0.04
5 5.60 136.31 12.85 0.19
6 5.59 129.74 12.82 -0.04
7 5.48 132.40 12.80 -0.19
8 5.45 130.09 12.83 0.04
9 5.72 126.54 12.83 0.04
10 5.66 137.56 12.82 -0.04
Average of thickness (mm) =5.57
Average of hardness (N) =128.901
Average of diameter (mm) =12.825

Calculation:

Deviation= [Initial diameter-Average diameter] x 100%

Average diameter

Tablet 1:
Deviation=[Initial diameter-Average diameter] x 100%
Average diameter
=[12.84-12.825] x 100% =0.12%
12.825

Tablet 2:
Deviation=[Initial diameter-Average diameter] x 100%
Average diameter
=[12.84-12.825] x 100% =0.12%
12.825

Tablet 3:

Deviation=[Initial diameter-Average diameter] x 100%

Average diameter
=[12.79-12.825] x 100% =-0.27%
12.825

Tablet 4:

Deviation=[Initial diameter-Average diameter] x 100%

Average diameter
=[12.83-12.825] x 100% =0.04%
12.825

Tablet 5:

Deviation=[Initial diameter-Average diameter] x 100%

Average diameter
=[12.85-12.825] x 100% =0.19%
12.825

Tablet 6:

Deviation=[Initial diameter-Average diameter] x 100%

Average diameter
=[12.82-12.825] x 100% =-0.04%
12.825

Tablet 7:

Deviation=[Initial diameter-Average diameter] x 100%

Average diameter
=[12.80-12.825] x 100% =-0.19%
12.825

Tablet 8:

Deviation=[Initial diameter-Average diameter] x 100%

Average diameter
=[12.83-12.825] x 100% =0.04%
12.825

Tablet 9:

Deviation=[Initial diameter-Average diameter] x 100%

Average diameter
=[12.83-12.825] x 100% =0.04%
12.825

Tablet 10:

Deviation=[Initial diameter-Average diameter] x 100%

Average diameter
=[12.82-12.825] x 100% =-0.04%
12.825

Discussion:

This experiment is carried out 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. Anyway,
now the thickness and hardness also involve in the pharmacopoeial standards. The
diameter size and shape of tablets depends on the die and punches selected for
making the tablets. There are various sizes and shapes of tablets which are
prepared, but usually they are in circular shape with either flat or biconvex faces.
From the results, the diameter obtained for all the ten tablets have such similar
values and the average of the diameter of the tablets is 12.825 mm. This aspect is
very important in producing the tablets which have similar or uniform diameter and
size. The uniform size of tablets may help to increase the patient compliance and
avoid them from being confuse with different size of the tablets. Different size of the
tablets may cause the patient to 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 12.55 mm, thus 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. 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
5.57 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 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 128.901 N which means equal to about 13.14 kg. The instrument measures
the force required to break the tablets. Thus, the value of 128.901 N shows that
128.901 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 13.14 kg, 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. Thus, we must design tablets that have medium level of
hardness to ensure that it can easily dissolve and not easily break.

Conclusion:

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:

1) http://hussain-ku.blogspot.com/2010/11/quality-control-tests-for-tablets.html
2) http://www.slideshare.net/mallikarjunvasm/quality-control-tests-for-tablets
3) http://www.preservearticles.com/2011122319102/seven-most-important-
characteristic-of-tablets.html
4) http://www.pharmainfo.net/tablet-evaluation-tests/mechanical-strength-
tablets/hardness-or-crushing-strength
5) Michael E. Aulton, Aulton’s Pharmaceutics The Design and Manufacture of
Medicines, Third Edition, Page 461-466

Questions:
1) What are the objectives of the tests for uniformity of diameter and uniformity of
content?
-The objectives of the tests for uniformity of diameter are to increase the patient
compliance by increasing the quality of product appearance and also to prevent any
confusion towards the patient about the dosage of the medications. The objectives of
the tests for uniformity of content are to ensure uniform dosage supplied to the
patient and prevent from overdose cases due to non uniform amount of active
ingredients in the capsules or tablets.

2) State the types of tablets and capsules that must be tested for the uniformity of
diameter and uniformity of content.
– Uniformity of diameter tests involves all the uncoated and coated tablets except for
the enteric tablets, film-coated tablets and sugar-coated tablets. For uniformity of
content tests, it involves all tablets.

3) Give reasons for the non-compliance to test for uniformity of weight.

-The reasons for non-compliance to test for uniformity of weight are uneven feeding
of granules into the die and due to irregular movement of the lower punch that cause
variation in capacity die space.

4) Why does dissolution test suitable to be used for batch to batch quality control?
-Dissolution test suitable to be used for batch to batch quality control because
samples for analysis are easily obtained without changing the dissolved drug
concentration and to guarantee the quality of the pharmaceutical products in order to
prove consistency and also the bioequivalence testing.

5) Explain the difference found in the procedure for dissolution test in the United
States Pharmacopoeia and the British Pharmacopoeia.
-The difference found in the procedure for dissolution test in the Unites States
Pharmacopoeia and the British Pharmacopoeia. In Unites States Pharmacopoeia,
typical acceptance criteria for the amount of active ingredient dissolved, expressed
as a percentage of the labeled content (Q), are in the range of 75% to 80%
dissolved. In British Pharmacopoeia, the amount of active ingredient dissolves must
not less than 70%. In US Pharmacopoeia, if the test failed, a retest may be carried
out in three stages with different amount of tablets. In British Pharmacopoeia, if the
test failed, a retest may be carried out using the same number of units of tablets.