Acknowledgement
Foremost, I would like to express my sincere gratitude to my honourable teacher and supervisor
Dr. MdAbdus Salam, Profession, Department of Chemistry, University of Dhaka for his
continuous support, patience, motivation, enthusiasm and immense knowledge.
Besides my supervisor, I would like to thank Dr. Zakir Sultan, Senior Scientist, Center for
Advance Research in Science (CARS), University of Dhaka .
My sincere thanks also goes to Mr. Konik Kumar Sarkar, Laboratory attendance, Centre for
Advance Research in Science (CARS), University of Dhaka.
Last but not the least paper would not be possible without all of them.; I would like to thank my
parents, my classmates and well-wishers for providing advice, help and support. This project
would not be possible without all of them.
Abstract
Although the tablet has been produced in large quantities for a long time, there is a need for better
understanding of the manufacturing process. Through the Process Analytical Technology – the
pharmaceutical industries have been encouraged to build rather than test quality into the products.
This project deals with compression analysis for assessment of physical properties like hardness,
friability, disintegration of tablets of five different companies V, W, X, Y, Z. The experimental data
was recorded in tabulated form and standard deviation was calculated. It was observed that there was
variation in these physical parameters especially in disintegration of tablets of same company as well
as of different companies. The goal is to the understanding of the ingredients, binders and the
powder material during the tableting process.
Introduction
Substances used in treatment, cure and diagnosis of diseases. Solid tablets are perhaps the most
commonly used doses form for pharmaceuticals. Tablets comprise a mixture of active substance
and excipients. The excipients can include diluents, binders or granulating agents. Drugs are
considered as one of the most important necessities of all of us.
In this project we will discuss about some physical properties of tablets. These physical
properties include uniformity of weights, thickness and diameter, hardness, friability and
disintegration. Tablets having same group, Metformin HCl, but of different pharmaceutical
companies of Bangladesh were collected from different places of Dhaka city.
Variations of the physical properties mentioned above of tablets of same pharmaceutical
company as well as different companies areshown. Knowing these physical properties of a soliddose tablet can provide valuable information for optimizing material constituents and the
manufacturing process. The types of binders used, the nature of the active ingredient, and the
composition of the ingredient in the tablet can be assumed. These factors must be controlled
during production and verified after manufacture. The physical properties mentioned above vary
from companies to companies and thus we can have important information about metformin HCl
and also the effectiveness of tablet of different pharmaceutical companies
Aim of work
Objective of this project is to compare the quality of Metformin HCl tablet formulation
manufactured by various pharmaceutical companies of Bangladesh. The tablet formulations of
five different brand manufactured by local companies were tested for various parameters like
hardness, friability, disintegration, uniformity of weight, size shape and thickness compare with
international standard. These parameters are very much important effectiveness in quality
control, handling transport purposes. Variation in these parameters in the tablet formulation can
give the idea about the local companies that they maintain the international standard or not.
Discussion about Metformin HCl
Metformin HCl is a white to off white crystalline compound with a molecular formula
C4H11N5HCl and a molecular weight of 165.62.Metformin HCl is freely soluble in water and
insoluble in acetone ether and chloroform. The pKa of metformin is12.4 .The pH of a 1%
aqueous
solution
of
metformin
HCl
is
6.68.
Each
tablet
contain
the
inactive
ingredientprovidencemicrocrystalline cellulose, croscurmellose sodium and magnesium stearate
.In addition the coating for the 500mg ,850 and 1000mg tablet contain polyethylene glycol
polyvinyl alcohol titanium dioxide, talc, gum, acacia propylene glycol and natural flavors.
Structure of MetforminHCl
Mechanism of Action
Metformin is an ant hyperglycemic agent which improves glucose tolerance in patients with type
2 diabetes, lowering both basal and post pradial plasma glucose .Metformin decreases intestinal
absorption of glucose and improves insulin sensitivity ley increasing peripheral glucose uptake
and utilization.
Common Metformin Side Effects
Metformin HCl doses have been studied thoroughly in clinical trials, with many people having
been evaluated. In these studies, side effects occurring in a group of people taking the drug are
always documented and compared to side effects that occur in a similar group of people not
taking the medicine. Based on these studies, the most common metformin side effects include:

Diarrhea -- occurring in up to 53.2 percent of people

Nausea or vomiting -- in up to 25.5 percent

Gas -- in up to 12.1 percent

Weakness -- in up to 9.2 percent

Indigestion -- in up to 7.1 percent

Abdominal discomfort (or stomach discomfort) -- in up to 6.4 percent

Headache -- in up to 5.7 percent.
Materials and Methods
To evaluate of tablets or standardize of tablets the following standards or quality
control tests are carried out on compressed tablets.
•
Diameter size and shape.
•
Uniformity of weight.
•
Thickness.
•
Hardness.
•
Friability.
•
Rate of disintegration.
Diameter Size and Shape
The diameter size and shape of tablets depends on the die and punches selected for making the
tablets. The tablets of various sizes and shapes are prepared, but generally they are circular with
either flat or biconvex faces.
Uniformity of weight.
It is desirable that all the tablets of a particular batch should be uniform in weight. If any weight
variation is there, that should fall within that prescribed limit (generally ± 10% for tablets
weighing 120 mg or less, ± 7.5% for tablets weighing 120 mg to 300 and ± 5% for tablets
weighing more than 300 mg). The tests are considered correct if not more than two tablets fall
outside this range if 20 tablets are taken for the test and not more than one tablet falls outside this
range if only ten tablets are taken for the test. The difference of weight in the tablets can lead to
variation in doses. Therefore, all the tablets of a batch must conform to this test. For carrying out
this generally 20 tablets at random are taken and weighed. The average weight is calculated, then
each tablet is weighed individually and weight noted. The weights of individual tablets are then
compared with the average weight already calculated and see that not more than two tablets fall
outside the range. This test is repeated after short intervals of time to ensure that the tablets of
required weight are produced.
Thickness.
The thickness of a tablet can vary without any change in its weight. This is generally due to the
difference of density of the granules, pressure applied for compression and the speed of
compression. The thickness of a tablet can be determined with the help of micrometer calipers.
The thickness variation in thickness leads to counting and packing problems.
Hardness of tablets
Tablet hardness testing is also called tablet breaking force testing. For this test the tablets are
placed between two plates. One of the plates moves in order to damage the tablet. The breaking
force is the force required to break or damage the tablets in a specific plane. Tablet breaking
force measurement is frequently used as an alternative to compression force measurement. This
is an essential quality control parameter since compression influences many tablet properties
including disintegration, dissolution and friability
Hardness is also called crushing strength. It is the load required to crush the tablet when placed
on its edge. There are a variety of presentations for tablets as delivery systems for
pharmaceutical agents, such as rapidly disintegrating, slowly disintegrating, eroding, chewable,
and lozenge. Each of these presentations places a certain demand on the bonding, structure, and
integrity of the compressed matrix. Tablets must be able to withstand the rigors of handling and
transportation experienced in the manufacturing plant, in the drug distribution system, and in the
field at the hands of the end users (patients/consumers). Manufacturing processes such as
coating, packaging, and printing can involve considerable stresses, which the tablets must be able
to withstand. For these reasons, the mechanical strength of tablets is of considerable importance
and is routinely measured. Tablet strength serves both as a criterion by which to guide product
Development and as a quality control specification. Measure of the mechanical integrity of
tablets is their breaking force, which is the force required to cause them to fail (i.e., break) in a
specific plane. The tablets are generally placed between two platens, one of which moves to
apply sufficient force to the tablets to cause fracture
Apparatus For Measuring Hardness
1. Monsanto Hardness Tester or Stokes Hardness tester (1930).
2. Pfizer Hardness Tester (1950).
3. Strong cob Hardness Tester.
4. Heberlain Hardness Tester or Schleeniger Hardness tester.
5. Logan Hardness tester (HTD 300F)
Apparatus and description
The Logan HDT-300F Hardness Tester tests tablets, sweets or capsule shaped samples. A
microprocessor controlled measurement system provides accuracy and versatility. All the test
results are shown on the digital LCD display and can be printed out for a permanent record of the
test results. The hardness can be tested within a 5-200N
range.
can be tested within a 2.0-35.0 mm range. The hardness
measurement can be calculated in N, Kp or Sc. The
diameter and thickness measurement can be calculated
in mm’s or inches. With its advanced features the HDT300F is 4 times faster than the previous model and easy
to operate. The user lifts the top cover and loads the
sample onto the sample carrier. The test may then
proceed on automatic (for up to 99 samples) or manual mode. A removable waste tray under the
measurement compartment and a small hand held brush is provided to neatly retrieve sample
fragments. The instrument calibration is
simple to perform on any flat surface with standard
tools.
The operation and design of the Logan HDT-300F Hardness Tester are in full compliance to the
monograph for the USP and EP, CP and JP. The load cell provides results that are 10 times more
accurate than required. The instrument is made from high quality metal, which fully meets all
GLP requirements
Friability
Friability is the tendency for a tablet to chip, crumble or break following compression. This
tendency is normally confined to uncoated tablets and surfaces during handling or subsequent
storage. It can be caused by a number of factors including poor tablet design (too sharp edges),
low moisture content, insufficient binder, etc.For obvious reasons, tablets need to be hard enough
such that they do not break up in the bottle but friable enough that they disintegrate in the
gastrointestinal tract. The friability tester has now become an accepted standard throughout the
pharmaceutical industry for determining the resistance of uncoated tablets to the abrasion and
shock experienced in manufacturing, packing and shipping operations.
Friability Testing
Friability (the condition of being Friable) testing is a method, which is employed to determine
physical strength of uncoated tablets upon exposure to mechanical shock and attrition. In simple
words, friability test tells how much mechanical stress tablets are able to withstand during their
manufacturing, distribution and handling by the customer. Throughout pharmaceutical industry,
friability testing has become an accepted technology and the instrument used in to perform this
process is called Friabilator or Friability Tester.
In friability test, samples are counted and weighted then tumbled in rotating drums with baffles,
when the process is stopped; samples are moved out from the instrument, wiped-off dust and
weighted again. The difference between the weight before and after the process is determined as
Friability and should not exceed 1%, which is considered an ideal percentage. In some cases,
where diameter of tablets is greater than 13mm, such tablets are tested on drums 10° tilted.
Apparatus And Description
The FAB-2S Friability Tester is the latest device to test the mechanical strength of tablets,
meeting all current USP and BP requirements. The FAB-2S is designed for use with both
friability and abrasion drums, and either one or two drums can be used at a time. The speed of
the rotation is fixed at 25 RPM as per the USP requirement. In use, the operator loads the tablets
into the drum, and places it on the drive shaft.
Logan FAB-2S
Fig: Friability tester
The test time or number of rotations can be selected and easily entered via the keypad. The
inputted data and rotation or time countdown are clearly indicated on the LED display. The
drums are constructed from plexiglass and separated into two parts, the drum body and the drum
cover. The cover is easily removed to facilitate filling or discharging of the samples and cleaning
the inside of the drum. The FAB-2S is made of high quality metal with an acid resistant finish
and meets all GLP requirements.
Standard Operating Procedure
Friability Tester With Abrasion Drum
Definitions :
Abrasion Drum: Consists of 12 standardized internal plastic baffles used to test the abrasion
strength of the table .
Friability/Abrasion Tester: Consists of a drive unit that rotates a transparent plastic drum at a
standard 25rpm.
Friability Test: Provides a standardized, reproducible method for measuring the tendency of a
tablet to chip or powder when subjected to the mechanical stresses of the manufacturing,
packaging and transportation processes of the tablet.
Procedure
1.Connect the power cord to an appropriate electrical outlet.
2.Unscrew the locking nut to release the drum.
3. Brush any loose dust from the tablets to be tested. 4. Accurately weigh the tablets. 5: Load the
tablets into the drum. 6. Place the plastic cover over the drum. 7. Hold the
cover firmly in place
and slide the drum body onto the shaft.8. Place the locking nut onto the end of the shaft. 9.
Tighten the locking nut into position. 10. Turn the knob to the desired number of rotations. 11.
Wait until the drum returns to a stationary position. 12. Remove locking nut
13. Carefully remove the drum from the shaft. 14. Remove the tablets and brush away any loose
powder from them. 15. Check for any obvious cracked, cleaved or broken tablets since this will
indicate that the sample tablets have failed the friability test. 16. Reweigh the tablets.
17. Calculate the percentage of weight loss using the following formula
Maintenance
1. Routinely check drums for signs of cracks or chips.
2. Inspect electrical connections for signs of corrosion and damage.
3. Immediately wipe any spills from the exterior of the equipment using a moistened clean cloth.
4. Clean drums thoroughly after each use using deionised water and dry with a soft cloth.
Disintegration
An orally administered drug must disintegrate to attain good absorption of its active substance.
The first step toward dissolution is usually the break-up of the tablet, a process described as
disintegration. The disintegration test results in a time necessary to disintegrate a group of tablets
into small particles under standard conditions. The disintegration test is a valuable tool in quality
control environments. The test is used for batch release and trending of lot-to-lot variations
during manufacturing of tablets. However, it is not a bioavailability indicator.
Purpose
Disintegration testers are performed as per the pharmacopoeial standards. Disintegration is a
measure of quality of oral dosage form like tablets and capsules. The disintegration test is
performed to find out the time it takes for a solid oral dosage form like tablets and capsules to
completely disintegrate. The time of disintegration is a measure of quality .This is because, for
example, if the disintegration time is too high; it means that the tablet is too highly compressed
or the capsule shell gelatin is not of pharmacopoeial quality or it may imply several others
reasons. And also if the disintegration time is not uniform in a set of samples being analysed, it
indicates batch inconsistency and lack of batch uniformity.
Operating process
1.Connect power cord to an appropriate electrical outlet 2.Brush any loose dust from tablets
3.Accurately weigh tablets 4.Load table into drum 5.plastic cover over drum 6.Hold cover firmly
in place and drum onto the shaft 7.Place locking nut onto the end of the shaft 8.Tighten locking
nut into position 9.Turn timer to the desired number of rotations 10.Remove locking nut 11.Wait
until drum returns to stationary position 12.Carefully remove drum from shaft 13.Remove tablets
and brush away any loose powder 14.Reweigh tablets 15. calculate the percentage weight loss
using the following formula:% Weight Loss = (Initial weight - Final weight) / Initial Weight x
100% 16.Any cracked, cleaved or broken tablets 17.Tablets sample has failed the friability test
Apparatus And Description
The tube is suspended in a bath of water or suitable a liquid which is thermostatically maintained
at a temperature of 37oC. The tube is allowed to move up and down at a constant rate, i.e. 30
times per minute through a distance of 75 mm. The Volume of the liquid and distance of
movement is adjusted in such a way that at the highest point the mesh screen just breaks the
surface of the liquid to give a turbulent movement about 2.5 cm.
Logan DST-3
Fig. Tablet disintegration test apparatus
Above the bottom of the container. About five tablets are placed in the tube along with a plastic
disk over the tablets unless otherwise stated in the monograph. The plastic disk does not allow
the tablets to float and imparts a slight pressure on the tablets. The tube is allowed to move up
and down and disintegration time noted when all the tablets have passed through the sieve. This
time should comply with the time stated in the monograph for that tablet. The test fails if all the
tablets do not pass through the sieve within specified time. Generally the disintegration time for
uncoated tablets is 30 minutes and for coated tablets one hour.
Description :
The DST-3 automated disintegration tester is the latest device specifically designed for USP
required testing of the disintegration time threshold for solid dosage medication. The design uses
a programmable microprocessor to control and monitor the testing process. The single in-line
layout allows all baskets to easily be viewed throughout each run. With its advanced features it is
simple to set up and operate. All units come with the Logan Height Adjustment Kit, which
makes USP height calibration simple and easy. In use, the operator inputs the length of the run,
loads the tablets, and presses the Start button. A series of beeps alert the user that the test will
end in one minute. At the end of the run, the basket assemblies are automatically lifted out of the
beakers and left in a fully raised position for ease of viewing. The DST-3 main lift unit is made
of high quality metal with an acid resistant finish. All operating parameters meet or exceed USP
specifications.
Statistical Calculation
Calculation of relative standard deviation:
s = sample standard deviation, s = (Σ(xi- X)2)/(n-1)
n= number of unit tested, xi= individual values of the units tested, X= mean of the values
obtained from the units tested.
RSD= relative standard deviation (the sample standard deviation, expressed as percentage of
the mean)
RSD =100*s/X
Calculation:
% of loss =(( Initial weight – final weight) /Initial weight) *100
• RESULT AND DISCUSSION:
Table1: Determination of uniformity of weight of Metformin tablets
Sample
Code V-001
Code W-002
Code X-003
Code Y-004
Code Z-005
Number
Weight(g)
Weight(g)
Weight(g)
Weight(g)
Weight(g)
1
0.7027
0.5990
0.7250
0.7498
0.6164
2
0.6935
0.5978
0.7423
0.7559
0.6184
3
0.6888
0.6022
0.7175
0.7487
0.6245
4
0.6827
0.5933
0.7190
0.7413
0.6221
5
0.6868
0.5942
0.7393
0.7616
0.6213
Mean(𝑥̅ )
0.6909
0.5973
0.7286
0.7515
0.6205
SD
0.0065
0.0032
0.0103
0.0068
0.0028
RSD
0.9408
0.5357
1.4136
0.9048
0.4512
Standard RSD
{reff)
5%
From above data it can be designed that all values are accepted. Uniformity of tablet weights is
well. The trend of weights variation is X-003> V-001> Y-004> V-005> Z-002
Table2: Determination of thickness of Metformin tablet
Sample
Code V-001
number
Code W-002
Code X-003
Code Y-004
Code Z-005
Thickness(mm) Thickness(mm) Thickness(mm) Thickness(mm) Thickness(mm)
1
7.39
6.66
5.76
6.70
6.02
2
7.37
6.62
5.86
6.72
6.09
3
7.13
6.60
5.72
6.27
6..08
4
7.12
6.71
5.73
6.24
6.13
5
7.27
6.66
5.85
6.26
6.10
7.26
6.65
5.78
6.44
6.44
SD
0.1145
0.0379
0.0597
0.2224
0.0363
RSD
1.5777
0.5699
1.0328
3.4534
0.5636
Mean
The variation in thickness leads to counting and packing problems
The trends of variation of thicknes : Y-003> V-002> X-001>W-001>Z-005
According to this result uniformity of thickness range 1.57 to 0.56 This is accepted range. So
all these companies are accepted.
Table3: Determination of hardness of Metformin tablet
Sample
number
Code V-001
Hardness
(kg/cm2)
Code W-002
Hardness
(kg/cm2)
Code X-003
Hardness
(kg/cm2)
Code Y-004
Hardness
(kg/cm2)
Code Z-001
Hardness
(kg/cm2)
1
11.59
BDL
BDL
BDL
16.10
2
12.87
BDL
BDL
BDL
14.83
3
10.09
BDL
BDL
BDL
16.33
4
13.93
BDL
BDL
BDL
14.45
5
13.47
BDL
BDL
BDL
16.71
12.39
----
----
----
15.68
SD
1.3927
----
----
----
0.8901
RSD
11.2405
----
----
----
5.6766
Mean
BDL = Bellow Detection Limit
If the finished tablet is too hard, it may not disintegrate in the required period of time and if the
tablet is too soft it may not withstand the handling during packing and transporting. Therefore, it
is very necessary to check the hardness of tablets.
The trends of hardness V-001> Z-004
Generally the range of hardness is 4 kg to 7 kg [ musa et aL 2010]. So this companies tablets are
more compact.
4. Determination of uniformity of diameter of Metformin tablet
Sample
Code V-001
Code W-002
Code X-003
Code Y-004
Code Z-005
number
Diameter(mm)
Diameter(mm)
Diameter(mm)
Diameter(mm)
Diameter(mm)
1
12.06
17.92
17.64
17.20
17.04
2
12.82
17.82
17.69
17.23
17.02
3
12.84
17.96
17.73
17.23
16.99
4
12.02
17.89
17.66
17.07
17.04
5
12.10
17.90
17.74
17.23
17.02
12.37
17.89
17.69
17.23
17.0
SD
0.3810
0.0464
0.0387
0.0621
0.0180
RSD
3.0800
0.2593
0.2187
0.3604
0.1059
Mean
awujksqW
5. Friability determination of calcium tablet
Friability test:
Table-1: Friability of metformin tablet for sample V-001
Sample
No
01
02
03
04
05
06
07
08
09
10
Initial
weight(g)
0.6920
0.6792
0.6850
0.6926
0.6800
0.6803
0.6845
0.6909
0.6812
0.6798
Final
weight(g)
0.6919
0.6787
0.6849
0.6925
0.6799
0.6802
0.6843
0.6907
0.6810
0.6797
Weight lost
0.0001
0.0005
0.0001
0.0001
0.0001
0.0001
0.0002
0.0001
0.0001
0.0001
% weight
lost
0.0145
0.0736
0.0146
0.0144
0.0147
0.0147
0.0146
0.0289
0.0147
0.0147
Table-2: Friability of metformin tablet for sample W-002
Sample
No
01
02
03
04
05
06
07
08
09
10
Initial
weight(g)
0.5990
0.5991
0.5978
0.5965
0.6022
0.5949
0.5933
0.6033
0.5942
0.5985
Final
weight(g)
0.5985
0.5987
0.5974
0.5964
0.6017
0.5947
0.5928
0.6032
0.5939
0.5983
Weight lost
0.0005
0.0004
0.0004
0.0001
0.0005
0.0002
0.0005
0.0001
0.0003
0.0002
% weight
lost
0.0835
0.0668
0.0704
0.0168
0.0830
0.0334
0.0843
0.0166
0.0505
0.0334
Table-3: Friability of metformin tablet for sample X-003
Sample
No
01
02
03
04
05
06
07
08
09
10
Initial
weight(g)
0.7599
0.7314
0.7061
0.7019
0.7220
0.6828
0.7300
0.7073
0.7127
0.7258
Final
weight(g)
0.7589
0.7304
0.7055
0.7010
0.7210
0.6517
0.7293
0.7065
0.7120
0.7249
Weight lost
0.0010
0.0010
0.0006
0.0009
0.0010
0.0011
0.0007
0.0008
0.0007
0.0009
% weight
lost
0.1316
0.1367
0.0850
0.1282
0.1385
0.1611
0.0959
0.1131
0.0982
0.1240
Table-4: Friability of metformin tablet for sample Y-004
Sample
No
01
02
03
04
05
06
07
08
09
Initial
weight(g)
0.7488
0.7416
0.7545
0.7471
0.7529
0.7573
0.7436
0.7378
0.7414
Final
weight(g)
0.7476
0.7403
0.7537
0.7464
0.7523
0.7567
0.7428
0.7372
0.7407
Weight lost
0.0012
0.0013
0.0008
0.0007
0.0006
0.0006
0.0008
0.0006
0.0007
% weight
lost
0.1603
0.1783
0.1060
0.0937
0.0797
0.0792
0.1076
0.0813
0.0944
10
0.7489
0.7481
0.0008
0.1068
Table-5: Friability of metformin tablet for sample Z-005
Sample
No
01
02
03
04
05
06
07
08
09
10
Initial
weight(g)
0.6122
0.6242
0.6223
0.6135
0.6223
0.6184
0.6204
0.6288
0.6212
0.6184
Final
weight(g)
0.6062
0.6186
0.6151
0.6047
0.6176
0.6139
0.6163
0.6251
0.6163
0.6241
Weight lost
0.0060
0.0056
0.0072
0.0088
0.0047
0.0045
0.0041
0.0037
0.0049
0.0057
% weight
lost
0.9801
0.8971
1.1570
1.4344
0.7533
0.7277
0.6609
0.5884
0.7888
0.9217
6. Determination of rate of disintegration of calcium tablet
Sample
Code A001
Code B-002
Code C-003
Code D-004
Code E-002
(min)
(min)
(min)
(min)
(min)
IT
FT Diff
IT
FT
Diff
IT
FT
Diff
IT
FT
Diff
IT
FT
Diff
.
1.
0.26 8.4
2.
0.28 9.2
3.
0.23 8.
36
0.29 9.
15
9.0
0.28
4.
5.
7
1
1
8.2
1
8.5
3
8.1
3
8.4
6
8.3
3
0.09
6.12
6.03
0.08
7.33
7.25
0.30 9.05 8.35 0.15 9.02 8.47
0.12
7.08
6.56
0.09
8.34
7.25
0.32 8.52 8.20 0.12 8.52 8.40
0.13
7.15
7.02
0.08
7.50
7.42
0.28 9.00 8.32 0.21 9.20 8.59
0.10
6.41
6.31
0.07
7.29
7.22
0.30 9.09 8.39 0.14 8.15 8.01
0.09
6.38
6.29
0.08
7.08
7.00
0.25 8.39 8.14 0.19 9.14 8.55
Average
Time
8.33
6.62
7.23
8.28
8.40
(min)
The rate of disintegration test is very important and necessary for all the tablets, coated or
uncoated to be swallowed because the dissolution rate depends upon the time of disintegration
which ultimately affects the rate of absorption of drugs.
The trends of disintegration time is Z-003 > V-004 > Y-002 > X-005 > W-001
From above data it is observed that uniformity of weight of tablet code Z -005 is better than
others. Variation is maximun in X-003. RSD value of Z-005 is the lowest and it is the highest in
X-003 . Variation of thickness of tablet with code Z-005 is maximum and with Code Y-004 is
minimum. Tablets of all the companies are in accecptabe range in uniformimity of thicknes.
Hardness of tablets of company with code W-002, X-003, Y-004 was so high that the instrument
could not measure.
The rate of disintegration of tablet with code A-00z is lower than others and is highest in the
tablets with code X-003. The average percentage loss of tablet is maximum with code Z-005 and
with code V-001 is minimum. Friability of tablets of all the companies are in very much
acceptable range.
Conclusion
Acceptable values of the physical properties like hardness, friability, disintegration of
pharmaceutical tablets is key to successful drug and process development. These physical
properties can have an impact on the material's bulk properties, product performance,
processability, stability and product appearance. This project shows these parameters
quantitatively and also the variations of these properties from company to company. It can also
address the assumption about tablets of a definite pharmaceutical company for physical
characterization which can assist with formulation or process development and quality control
purposes.
Reference
1. Ashok Gupta K. Introduction to pharmaceutics-1,
CBS Publisher and Distributors, Delhi, India,2007, 270,271.
2. David Jones, Pharmaceutics-Dosage Form and Design, 2008,132,133.
3. Lachman and Lieberman, The Theory and Practice of Industrial Pharmacy, Third
edition, Apex Publications.293,294,295.
4. Micheal Aulton E. Pharmaceutics: The design and manufacture of medicine,
2013,78,115.
5. S. Kanna Babu, P. Udhay Shankar, The Eastern Pharmacist, 1996,126.