Experiment 1 : Physical Appearance
Procedure
1. A
random tablet and capsule were randomly picked from the provided samples. The
shape, colour, diameter and other physical characteristics were examined from
the sample assigned.
Result
Tablet  |
Capsule  |
||||||||||
Colour
|
White
|
White and red
|
|||||||||
Shape
|
Round
|
Caplet
|
|||||||||
Marking
|
RMB
|
|
|||||||||
Line
|
Has a line which can separates the
tablet into half
|
_
|
|||||||||
Branding
|
Pharmaniaga
|
Pharmaniaga
|
|||||||||
Diameter
|
0.91 cm
|
0.70 cm
|
|||||||||
Length
|
-
|
2.12 cm
|
|||||||||
Hardness
|
Harder
|
Hard
|
|||||||||
Thickness
|
0.4 cm
|
-
|
Discussion
Tablet is being defined as circular in shape with either flat or convex faces and prepared by
compressing the medicament or mixture of medicaments, usually with added
substances. While capsule is being defined as an edible packaging made from
gelatin which is filled with medicines to produce a unit dose and is mainly
being used orally. Every capsule has different colour, size, marking and shape
for their identification. These identifications help in preventing patient from
taking the wrong drugs for their treatment. The diameter, length and thickness
of the capsule and tablet were measured using a Vernier calliper. Vernier
calliper is being used to measured these properties to obtained an accurate
result as Vernier calliper has an accurate measurement of two decimal places.
The line present in the middle of the tablet indicates that the tablet is
allowed to be separated into half. Thus, we can conclude that both tablet and
capsule are different in their physical appearance even though their main aim
is to deliver drug to its site of action.
There are several
advantages and disadvantages of using capsule and tablet to deliver drug. The
advantage of using a tablet is that it is easy to be swallowed rather than
tablet. However, the disadvantage of capsule is that their contents are bulkier
compared to tablet and capsule also have a short half-life compared to tablet.
Next, tablet can easily be split into two due to the presence of the notches in
the middle of the tablet. This will makes it easier for patient to split the
tablet dose. The disadvantage of tablet is that tablet has a poor dissolution.
We can conclude that each type of oral delivery drug has different advantages
and disadvantages due to their physical appearance.
Experiment
2 Uniformity of diameter, thickness and hardness
Procedure
1. 10
tablets were selected and test for
uniformity of diameter, thickness and hardness was carried out using Tablet
Testing Instrument (PHARMATEST PTB 311)
2. The
diameter of individual unit from the mean diameter of less than 12.5 and ±3%
for diameter of 12.5mm or more.
Result
Tablets
|
Thickness(mm)
|
Hardness(N)
|
Diameter
|
|
Length(mm)
|
Deviation(%)
|
|||
1
|
5.44
|
132.46
|
13.12
|
0
|
2
|
5.49
|
118.79
|
13.17
|
+0.38
|
3
|
5.54
|
184.01
|
13.11
|
-0.08
|
4
|
5.48
|
167.38
|
13.12
|
0
|
5
|
5.44
|
141.15
|
13.12
|
0
|
6
|
5.47
|
161.84
|
13.10
|
-0.15
|
7
|
5.49
|
161.84
|
13.11
|
-0.08
|
8
|
5.44
|
139.67
|
13.13
|
+0.08
|
9
|
5.46
|
135.60
|
13.11
|
-0.08
|
10
|
5.45
|
102.53
|
13.12
|
0
|
Mean
|
13.12
|
|||
Discussion
Tablet test for uniformity of
thickness, diameter and hardness was carried of to ensure the consistency of
these traits. This is very important and become one of the vital test before a
batch of tablet being marketted to the consumer. Based on the experiment, all
the tablet selected have the deviation value below ±3% which means all of the
tablet are valid to be taken by consumer.
Before conducting the experiment,
samples were taken from the bulk packaged tablets and was kept aside before examine them using
Tablet Testing Instrument. This type of packaging was considered quite
unsuitable for this experiment due to the tablet might hit with each other of
the wall of the container which result in parts of the tablets detached as
small fragments and causing in the reduction in size of the tablets. Apart fro
that, the pressence of moisture from the
surrounding also affect the tablet properties.
It is strongly suggested that the
samples must be taken from Unit-of-Use packaged tablets. Apart from the tablet
are unable to move freely,they are also kept from moisture which can affect the
result obtained.
Experiment
3 Tablet friability
Procedure
1. 10
tablets were selected and weighed.
2. All
the tablets are being put into the drum of the tablet abration and friability
tester. The rate of rotation which is 25 rpm, time to 10 minutes have been set
and the operation was started.
3. At
the end of the operation, all the tablets were removed and ensured freedom from
dust or powder by using the brush. The tablets were reweight. The percentage
loss of weight was determined.
4. Compressed
tablet should nor lose more than 1
od its weight.
od its weight.
Result
Initial
weight (g)
|
5.7604
|
Final
weight (g)
|
5.7306
|
Difference
in mass (g)
|
0.0298
|
Discussion
The
strength of a tablet plays a very important role in its marketing and
dissolution. The mechanical strength of tablet or granules can be determined by
its hardness and through friability test. In friability test, the tablets are
prone to abrasion hence enable to check for the tablet strength under application
of force in different manner. In this experiment, Roche friabilator was used to
stimulate the conditions that the product will be exposed to during the process
of production. This test is a method to determine physical strength of uncoated
tablets upon exposure to mechanical shock and attrition. Conventional
compressed tablet that lose less than 1
of weight are considered acceptable. Based on
the result of the friability test that has been done, the percentage of weight
loss of the tablet is 0.52, meaning that the
tablet used has passed the quality assessment of friability. One of the
precautions that should be consider during friability test is the condition of
the friabilator which can affected the result. For instance, punches that are
in poor condition or worn out at their surface edges will result in
‘whiskering’ at the tablet edge and show higher than normal friability values.
of weight are considered acceptable. Based on
the result of the friability test that has been done, the percentage of weight
loss of the tablet is 0.52, meaning that the
tablet used has passed the quality assessment of friability. One of the
precautions that should be consider during friability test is the condition of
the friabilator which can affected the result. For instance, punches that are
in poor condition or worn out at their surface edges will result in
‘whiskering’ at the tablet edge and show higher than normal friability values.
Conclusion
Through this practical, we were able to demonstrate some
of quality tests required by referring to official pharmacopoeias as a
guideline. The assessment of quality of tablets and capsules are important in
the design of tablets and to monitor product quality. There are various
standards that have been set in the various pharmacopoeias regarding the
quality of pharmaceutical tablets. These include the uniformity of diameter,
size, shape, thickness, weight, hardness, disintegration and dissolution
characters. These properties are important since chemical breakdown or
interactions between tablet components may alter the physical tablet
properties, and greatly affect the bioavailability of the tablet system.
Experiment
4 Uniformity of weight of tablets and
capsules.
Procedure
Tablets
1.
20 tablets which were previously selected
at random were weighed. The average weight were determined.
2.
The tablets were weighed individually and
the percentage deviation of its weight was determined from the average weight for
each tablet.
3.
The deviation of individual weight from
the average weight should not exceed the limits given below.
Average
weight of tablet
|
Deviation
(%)
|
Number
of tablets
|
Less
than 80 mg.
|
10.0
|
Minimum
18
|
20.0
|
Maximum
2
|
|
80
mg to 250 mg
|
7.5
|
Minimum
18
|
15.0
|
Maximum
2
|
|
More
than 250 mg.
|
5.0
|
Minimum
18
|
10.0
|
Maximum
2
|
Capsules
1.
20 capsules were selected at random.
2.
One capsule was weighed. Capsule was
opened and the contents were removed as completely as possible. The emptied
shells were weighed. The net weight of its contents, that is by subtracting the
weight of the shells from the weight of the intact capsule were determined.
3.
The procedure was repeated with other 19
capsules.
4.
The average net weight was determined from
the sum of the individual net weights.
5.
The percentage deviation was determined from
the average net weight for each capsule. The deviation of individual net weight
should not exceed the limits given below:
Average
net weight of capsule
|
Deviation
(%)
|
Number
of tablets
|
Less
than 300 mg.
|
10.0
|
Minimum
18
|
20.0
|
Maximum
2
|
|
300
mg or more
|
7.5
|
Minimum
18
|
15.0
|
Maximum
2
|
|
Results
Tablets
Average
weight = 0.6569 g
No.
|
Weight (g)
|
Deviation from average (%)
|
1
a |
0.6530
|
-0.590
|
2
|
0.6523
|
-0.700
|
3
|
0.6467
|
-1.550
|
4
|
0.6741
|
2.620
|
5
|
0.6741
|
2.620
|
6
|
0.6477
|
-1.400
|
7
|
0.6515
|
-0.820
|
8
|
0.6763
|
2.950
|
9
|
0.6549
|
-0.300
|
10
|
0.6679
|
1.670
|
11
|
0.6588
|
0.280
|
12
|
0.6575
|
0.090
|
13
|
0.6637
|
1.040
|
14
|
0.6577
|
0.120
|
15
|
0.6532
|
-0.560
|
16
|
0.6471
|
-1.490
|
17
|
0.6382
|
-2.850
|
18
|
0.6550
|
-0.290
|
19
|
0.6487
|
-1.250
|
20
|
0.6570
|
0.015
|
Capsules
Average
net weight = 0.3876 g
No.
|
Total weight (g)
|
Shell weight (g)
|
Net weight (g)
|
Deviation from average (%)
|
1
|
0.4654
|
0.0786
|
0.3868
|
-0.206
|
2
|
0.4702
|
0.0788
|
0.3914
|
0.980
|
3
|
0.4708
|
0.0760
|
0.3948
|
1.858
|
4
|
0.4703
|
0.0766
|
0.3937
|
1.574
|
5
|
0.4719
|
0.0765
|
0.3954
|
2.012
|
6
|
0.4763
|
0.0785
|
0.3978
|
2.632
|
7
|
0.4176
|
0.0758
|
0.3418
|
-11.82
|
8
|
0.4687
|
0.0750
|
0.3937
|
1.574
|
9
|
0.4769
|
0.0798
|
0.3971
|
2.451
|
10
|
0.4689
|
0.0742
|
0.3947
|
1.832
|
11
|
0.4599
|
0.0733
|
0.3866
|
-0.258
|
12
|
0.4672
|
0.0781
|
0.3891
|
0.387
|
13
|
0.4560
|
0.0735
|
0.3825
|
-1.316
|
14
|
0.4691
|
0.0780
|
0.3911
|
0.903
|
15
|
0.4697
|
0.0776
|
0.3921
|
1.161
|
16
|
0.4557
|
0.0791
|
0.3766
|
-2.838
|
17
|
0.4479
|
0.0743
|
0.3736
|
-3.612
|
18
|
0.4621
|
0.0792
|
0.3829
|
-1.213
|
19
|
0.4623
|
0.0745
|
0.3878
|
0.052
|
20
|
0.4770
|
0.0748
|
0.4022
|
3.767
|
Questions
1.
What are the objectives of the tests for
uniformity of diameter and uniformity of content?
The objective of the
tests for uniformity of diameter is to increase the quality of product
appearance so the patient’s compliance could be increase, as well as to prevent
any confusion from the patient towards the dosage of the medication. On the
other hand, the objective of the tests for uniformity of content is to ensure
uniform dosage is supplied to the patient so that overdose cases due to
non-uniform amount of active ingredients in capsules or tablets can be
prevented.
2.
State the types of tablets and capsules that
must be tested for uniformity of diameter and uniformity of content.
Uniformity of diameter
tests involves all uncoated and coated tablets, soft and hard capsules but it
is not applicable for enteric tablets and sugar-coated tablets. For uniformity of
content tests, all tablets are involved.
3.
Why is it important that tablets and
capsules have uniform weight and content?
It is important that
tablets and capsules have uniform weight and content to ensure that the
patients take a precise pharmaceutical dose. For example in tablet splitting
practice, uniform weight and content of tablets and capsules is important to
ensure every obtained halves contain required strength. Uneven splitting of a
tablet product may result in fluctuations of the administered dose, where this
problem could be clinically significant especially for drugs with a narrow
therapeutic range.
4.
Give reasons for the non-compliance to
test for uniformity of weight.
- Uneven feeding of
granules into the die.
- Irregular movement of
the lower punch causing variation in capacity die space.
5.
Explain why is it beneficial for any
tablets or capsules to have distinctive or identifying features.
Tablets and capsules need to have identifying features
to help patients identify and understand their medication easily. The
appearance of a tablet or capsule may influence the first impression of the
patient. Tablets or capsules must have identification which is relevant to its
indication. By this way, medication errors can be reduced, correct usage of drug
can be increased and treatment cost can be saved.
Discussion
For tablets, since the
average weight is 656.9 mg, so the deviation of the individual tablet net
weight should not exceed the limits given:
Average
weight of tablet
|
Deviation
(%)
|
Number
of tablets
|
More
than 250 mg.
|
±
5.0
|
Minimum
18
|
±
10.0
|
Maximum
2
|
From the results
obtained, all of the 20 tablets tested have the deviation range of ±5.0%, which
follows the limits given. Hence all tablets are considered as uniform in the
form of weight.
For capsules, the average
net weight is 387.6 mg, so the deviation of an individual capsule should not
exceed the limits given:
Average
net weight of capsule
|
Deviation
(%)
|
Number
of tablets
|
300
mg or more
|
±
7.5
|
Minimum
18
|
±
15.0
|
Maximum
2
|
|
From the results, of 20
capsules tested, 19 capsules have deviation range of ±7.5% while 1 capsule has
deviation range of ±15.0%. The results obey the limits given which considers
that the capsules have uniform weight. However, some errors might arise during
the experiment which causes slight inconsistency to the result. Some powders
might still get stuck inside the capsule shells and the powders are not
completely removed, thus cause the measurement of emptied shells not accurate.
Besides, systematic error caused by the inaccuracy of weighing balance may have
influenced the results. Environmental factors such as wind from the
air-conditioning may also cause the fluctuation in the value represented by the
weighing balance.
The uniformity of weight
of tablets and capsules may be due to the good manufacturing practice (GMP)
applied by the manufacturing company.
Conclusion
The tablets and capsules
tested have passed the weight uniformity test.
Experiment 5: Content of Ibuprofen
(assay)
Procedure
1.
Powder containing 0.5 g Ibuprofen was extracted with 20 mL chloroform for 15
minutes and filtered through sintered glass
crucible.
2.
The residue was washed with 3×10 mL chloroform and the combined filtrate was
gently evaporated just to dryness in a
current of air. The residue was dissolved in
100 mL ethanol (96%) that was previously
neutralized to phenolphthalein solution.
3.
The solution was titrated with 0.1M sodium hydroxide to end point with
phenolphthalein solution as the indicator.
4.
The content of ibuprofen is calculated with each mL of 0.1M sodium hydroxide,
NaOH is equivalent to 0.02063g of C13H18O2.
Result
Weight
of Ibuprofen powder: 10.97 g
Volume
of NaOH used to achieve end point = 11.2 mL
1
tablet of Ibuprofen = 400 mg
For
20 tablets of Ibuprofen = 20 × 400 mg
=
8000 mg
= 8
g
To
obtain 0.5 g of Ibuprofen
The
weight of Ibuprofen : The weight of Ibuprofen powder
8 g : 10.97 g
x g : 0.5 g
The
weight of Ibuprofen = 
= 0.6872
g
NaoH
+ C13H18O2 
C13H17ONa
+ H2O
C13H17ONa
+ H2O
1
mol of NaoH = 1 mol of C13H18O2
No.
of mole of NaoH = MV
=
(0.1)(11.2×10-3)
=1.12×10-3
mol
Hence,
1 mol of C13H18O2 = 1.12×10-3 mol
Each
mL of NaOH is equivalent to 0.02063 g
=
11.2 × 0.02063
=
0.2311 g Ibuprofen
Calculation
for assay = 
=
= 46.22%
Discussion
From
the experiment, the obtained weight of Ibuprofen is 0.2311g. This amount is
slightly different from the actual weight that is 0.5 g. The difference between
the experimental and theoretical values could happens due to some errors during
the experiment is conducted.
Firstly,
the ibuprofen that was used may had expired. Loss of active ingredients in the
tablets may occur due to decomposition process. Therefore, unexpired Ibuprofen
should be used to increase the accuracy of the experiment. Besides, loss of
active ingredient can also occur due to the drying of solution. The solution
may not dry completely.
Moreover,
some of the tablets do not break completely. The tablets should be crushed
completely to avoid loss of Ibuprofen. Besides, the solution are not filtered
through a sintered glass crucible but using filter funnel and filter paper.
This will cause some of the powder that do not dissolved in the chloroform to
pass through the conical flask.
Conclusion
As
a conclusion, the content of Ibuprofen from the experiment is 0.2331 g which is
slightly different with theoretical value, 0.5 g. This can happen due to some
errors during the experiment is conducted.
Reference
3 Best Uses for a Vernier Calliper. http://www.doityourself.com/stry/3-best-uses-for-a-vernier-caliper
Abdel Naser Zaid et. al. Weight and content uniformity of lorazepam
half-tablets: A
study of correlation of a low drug content product.
Difference between Capsules and Tablets. http://www.differencebetween.com/difference-between-capsules-and-vs-tablets/
Neha
et al. 2015. Evaluation of Quality Control Parameterson Various Brand of
Paracetamol Tablet Formulation. World
Journal of Pharmacy and Pharmaceutical Sciences. 4(7): 976-984
The
Colouration of Tablets and Capsules. http://www.manufacturingchemist.com/technical/article_page/The_colouration_of_tablets_and_capsules/34905
WHO. Revision of monograph
on tablets, Final text for addition to The
International Pharmacopoeia. March 2011.
