PHARMACEUTICAL ANALYSIS (LAB)

Bulk/Tap/Apparent Density and Angle of Repose

BULK DENSITY

Definition and Principle

The bulk density of a powder is the ratio of the mass of an untapped powder
sample and its volume including the contribution of the interparticulate void volume.
Hence, the bulk density depends on both the density of powder particles and the spatial
arrangement of particles in the powder bed. The bulk density is expressed in grams per
milliliter (g/mL) although the international unit is kilogram per cubic meter (1 g/mL =
1000 kg/m3 ) because the measurements are made using cylinders. It may also be
expressed in grams per cubic centimeter (g/cm3 ).

The bulking properties of a powder are dependent upon the preparation,

treatment and storage of the sample, i.e. how it was handled. The particles can be
packed to have a range of bulk densities and, moreover, the slightest disturbance of the
powder bed may result in a changed bulk density. Thus, the bulk density of a powder is
often very difficult to measure with good reproducibility and, in reporting the results, it is
essential to specify how the determination was made.

Bulk density, defined as the ratio of the mass of a bulk solid to its volume,
determines the space occupied by a given amount of material. It is a technique used in
the pharmaceutical industry to characterize a material in order to assess its behavior
during process operations (1), e.g., blending, compaction, etc., and can be used to
identify material changes, e.g., particle size or shape, caused by process attrition (2).
The technique is a key parameter in understanding likely performance of a material, and
provides an opportunity to monitor changes. As such, the need to capture the
information is recognized by key Pharmacopeia, including the USP/ National Formulary.
The main challenge when measuring bulk density is obtaining a relevant measure of the
bulk volume.

The bulk density of a powder is determined by measuring the volume of a known

mass of powder sample, that may have been passed through a sieve into a graduated
cylinder (Method 1), or by measuring the mass of a known volume of powder that has
been passed through a volumeter into a cup (Method 2) or a measuring vessel (Method
3). Method 1 and Method 3 are favoured
Application, Operation, Picture of Instrument, Parts and function and Calculation

1.1.Method 1: Measurement in a Graduated Cylinder

1.1.1. Procedure

Pass a quantity of powder sufficient to complete the test through a sieve

with apertures greater than or equal to 1.0 mm, if necessary, to break up
agglomerates that may have formed during storage; this must be done gently to
avoid changing the nature of the material. Into a dry graduated cylinder of 250
mL (readable to 2 mL), gently introduce, without compacting, approximately 100
g of the test sample (m) weighed with 0.1 per cent accuracy. Carefully level the
powder without compacting, if necessary, and read the unsettled apparent
volume (V0 ) to the nearest graduated unit. Calculate the bulk density in g per
mL by the formula m/V0. Generally, replicate determinations are desirable for the
determination of this property. If the powder density is too low or too high, such
that the test sample has an untapped apparent volume of either more than 250
mL or less than 150 mL, it is not possible to use 100 g of powder sample.
Therefore, a different amount of powder has to be selected as test sample, such
that its untapped apparent volume is 150 mL to 250 mL (apparent volume
greater than or equal to 60 per cent of the total volume of the cylinder); the mass
of the test sample is specified in the expression of results. For test samples
having an apparent volume between 50 mL and 100 mL a 100 mL cylinder
readable to 1 mL can be used; the volume of the cylinder is specified in the
expression of results.

Video link: https://www.youtube.com/watch?v=OwgxgjZ_wis&t=434s

Calculation:

Bulk density = Weight of powder/ Bulk volume of the powder

Weight of the powder = 2.21g

Bulk Volume of the powder = 17.5 mL

Bulk density = Weight of powder/ Bulk volume of the powder

 Bulk density = 2.21 g/ 17.5 mL

Bulk density = 0.13 g/mL

1.2.Method 2: Measurement in a Volumeter

1.3.1.2.1. Apparatus

The apparatus(1) (Fig. 3.01-1) consists of a top funnel fitted with a 1.0 mm
sieve. The funnel is mounted over a baffle box containing four glass baffle plates
over which the powder slides and bounces as it passes. At the bottom of the
baffle box is a funnel that collects the powder and allows it to pour into a cup
mounted directly below it. The cup may be cylindrical (25.00 ± 0.05 mL volume
with an inside diameter of 30.00 ± 2.00 mm) or a cubical (16.39 ± 0.20 mL
volume with inside dimensions of 25.4± 0.076 mm).

1.2.2. Procedure

Allow an excess of powder to flow through the apparatus into the sample receiving
cup until it overflows, using a minimum of 25 cm3 of powder with the cubical cup
and 35 cm3 of powder with the cylindrical cup. Carefully, scrape excess powder
from the top of the cup by smoothly moving the edge of the blade of spatula
perpendicular to and in contact with the top surface of the cup, taking care to keep
the spatula perpendicular to prevent packing or removal of powder from the cup.
Remove any material from the side of the cup and determine the mass (m) of the
powder to the nearest 0.1 per cent. Calculate the bulk density in g per mL by the
formula m/V0 in which V0 is the

volume of the cup and record the average of 3 determinations using 3 different
powder samples.
Video link: https://www.youtube.com/watch?v=rpKytUC7lwg&t=214s

Calculation:

Bulk density = weight of the powder/ volume of the cup calculation

Mass = weight of the cylindrical cup with powder - weight of the empty cylindrical
cup

Mass = 295.16 - 261.63g

Mass = 33.53 g

Bulk density = weight of the powder/ volume of the cup

Bulk density = 33.53/25

Bulk density = 1.34 g/mL

A cylindrical receiving cup having a capacity of 25 ml /- 0.05 ml.

1.4.Method 3: Measurement in a Vessel

1.5.1.3.1. Apparatus

1.6.The apparatus consists of a 100 mL cylindrical vessel of stainless steel with

dimensions as specified in Fig. 3.01-2.
1.3.2. Procedure

Pass a quantity of powder sufficient to complete the test through a 1.0 mm sieve, if
necessary, to break up agglomerates that may have formed during storage and allow
the obtained sample to flow freely into the measuring vessel until it overflows. Carefully
scrape the excess powder from the top of the vessel as described for Method 2.
Determine the mass (m0 ) of the powder to the nearest 0.1 per cent by subtraction of
the previously determined mass of the empty measuring vessel. Calculate the bulk
density (g/mL) by the formula m0 /100 and record the average of 3 determinations using
3 different powder samples.

Video link: https://youtu.be/GvSaz7pWz5A

Calculation:

Bulk density = weight/volume

Bulk density = weight/volume

Bulk density = 25g/43 mL

Bulk density = 0.5813 g/mL

 TAP DENSITY

PRINCIPLES

A specified amount of powder in a container is tapped by means of a tapping

apparatus until no further decrease in the volume of the powder takes place. The mass
of the powder divided by its volume after the test gives its tap density. Tap Density
Tester is used to measure the tapped density of bulk powders, as well as granulated or
flaked materials by standardized and repeatable procedures

Tapped density is measured by first gently introducing a known sample mass into
a graduated cylinder and carefully leveling the powder without compacting it. The
cylinder is then mechanically tapped by raising the cylinder and allowing it to drop under
its own weight using a suitable mechanical tapped density tester that provides a suitable
fixed drop distance and nominal drop rate

DESCRIPTION

Tapped density of a powder is the ratio of the mass of the powder to the volume
occupied by the powder after it has been tapped for a defined period of time. The
tapped density of a powder represents its random dense packing.

Tapped density measurement protocol has been standardized by modern

pharmacopeias. Although used for decades, these protocols are based on old
techniques inducing a lack of accuracy and repeatability. However, accurate and
repeatable characterization methods are now required to develop or improve powder
grades and production processes.

APPLICATION

The tapped density is a very popular measure for powder characterization

because of both the simplicity and the rapidity of the measurement. The ability of a
powder sample to pack under taps gives a measure of the powder cohesiveness which
can be linked to its flowability. Powders can thus be easily classified for quality control
and process optimization.
OPERATION

1. Choose how the taps will be done with the Time/Count button. Pressing this button
will illuminate the corresponding light on the display.
· Time: a desired amount of time for tapping can be entered in the
format hh:mm:ss. Press Enter after putting in the time. OR
· Count: a desired number of taps can be entered, up to 999,999.
Press Enter after putting in the number of taps.
· One method is to start with one tap, and double the number of taps
each time until the powder volume no longer changes.

2. Press Start/Stop to begin tapping. The machine will automatically stop when it has
completed the specified time or number of taps. If you need to stop the test before it is
complete, press the Start/Stop button again to immediately stop the tapping.

3. Shut the acoustic cabinet while tapping to reduce the noise.

4. After each set of taps, record the volume of powder. Divide the initial mass by the
volume to determine the density. When this density no longer changes with increasing
the number of taps, this is the tapped density of the powder.
· One way to determine if you have reached the tapped density is to plot
the density versus the total number of taps. The density where the curve
levels off is the tapped density.

METHODS (from the video)

1. Weigh accurately 25 grams of powder

2. Place it in a dried graduated measuring cylinder and note volume as V1 ml.

3. Place the cylinder containing sample in bulk density apparatus. Adjust apparatus
for 100 tapping and operate it. Record the volume occupied by powder as V2 ml.

4. Place sample in both cylinders of apparatus for balance of the arms.

METHOD 1

Apparatus. The apparatus consists of the following :

– a 250 mL graduated cylinder (readable to 2 mL) with a mass of 220 ± 44 g ;
– a settling apparatus capable of producing, per minute, either nominally 250 ± 15
taps from a height of 3± 0.2 mm, or nominally 300 ± 15 taps from a height of 14 ± 2 mm.

The support for the graduated cylinder, with its holder, has a mass of 450 ± 10 g.
Procedure. Proceed as described above for the determination of the bulk volume (V0).
Secure the cylinder in the support. Carry out 10, 500 and 1250 taps on the same
powder sample and read the corresponding volumes V10, V500 and V1250 to the nearest
graduated unit. If the difference between V500 and V1250 is less than or equal to 2 mL,
V1250 is the tapped volume. If the difference between V500 and V1250 exceeds 2 mL,
repeat in increments of, for example, 1250 taps, until the difference between successive
measurements is less than or equal to 2 mL. Fewer taps may be appropriate for some
powders, when validated. Calculate the tapped density in grams per milliliter using the
formula m/Vf (where Vf is the final tapped volume). Generally, replicate determinations
are desirable for the determination of this property. Specify the drop height with the
results. If it is not possible to use a 100 g test sample, use a reduced amount and a
suitable 100 mL graduated cylinder (readable to 1 mL) weighing 130± 16 g and
mounted on a support weighing 240 ± 12 g. If the difference between V500 and V1250 is
less than or equal to 1 mL, V1250 is the tapped volume. If the difference between V500 and
V1250 exceeds 1 mL, repeat in increments of, for example, 1250 taps, until the difference
between successive measurements is less than or equal to 1 mL. The modified test
conditions are specified in the expression of the results.

METHOD 2

Procedure. Proceed as directed under Method 1 except that the mechanical tester
provides a fixed drop of 3 ± 0.2 mm at a nominal rate of 250 taps per minute.

METHOD 3
Procedure. Proceed as described under Method 3 for measuring the bulk density,
using the measuring vessel equipped with the cap shown in Figure 2.9.34.-2. The
measuring vessel with the cap is lifted 50-60 times per minute by the use of a suitable
tapped density tester. Carry out 200 taps, remove the cap and carefully scrape excess
powder from the top of the measuring vessel as described under Method 3 for
measuring the bulk density. Repeat the procedure using 400 taps. If the difference
between the 2 masses obtained after 200 and 400 taps exceeds 2 per cent, repeat the
test using 200 additional taps until the difference between successive measurements
is less than 2 per cent. Calculate the tapped density in grams per millilitre using the
formula Mf/100 (where Mf is the mass of powder in the measuring vessel). Record the
average of 3 determinations using 3 different powder samples. The test conditions,
including tapping height, are specified in the expression of the results.

FORMULA

Pt = M / Vt

Pt – Tapped density

M – weight of powder

Vt – minimum volume occupied after tapping

CALCULATION

Tap density = mass of the powder / minimum volume occupied after tapping

Mass of the powder = 25 g

Tapped volume = 36 ml

Tap density = 25 g / 36 ml

Tap density = 0.6944 g / ml

Tap density of given granules was found to be 0.6944 g / ml

VIDEO

https://www.youtube.com/watch?v=GvSaz7pWz5A
 MEASURES OF POWDER COMPRESSIBILITY

In recent years the compressibility index and the closely related Hausner ratio
have become the simple, fast, and popular methods of predicting powder flow
characteristics. The compressibility index has been proposed as an indirect measure of
bulk density, size and shape, surface area, moisture content, and cohesiveness of
materials because all of these can influence the observed compressibility index. The
compressibility index and the Hausner ratio are determined by measuring both the bulk
volume and the tapped volume of a powder.

Bulk Density

The ratio of a mass of an untapped powder sample and its volume including the
interparticulate void volume.

- Give the values of particles without filling more spaces.

Tapped Density

Obtained by mechanically tapping a graduated measuring cylinder or vessel containing

the powdered sample.

- Able to fill more spaces within the powders.

Formula:

Clarification for % compressibility index and hausner ratio calculation:

There are 2 ways to solve - (1) using the volume of bulk and tapped and (2) using the
density of bulk and tapped.

• If you’re using the volume, the formulas are %CI = {(Volume of bulk - volume of
tapped) /volume of bulk} x 100

hausner ratio = volume of bulk/volume of tapped

• If you’re using the density, the formulas are %CI = {(density of tapped - density of

bulk/density of tapped} x 100 hausner ratio = density of tapped/density of bulk

 APPARENT DENSITY

● Apparent density is the bulk density of the powder. It provides the mass per unit
volume of loose packed powder
● Unit measurement in (g/cm3 or kg/m3)
● Apparent density is based on the apparent or external volume of the dry
material/specimen.
● This value is a first, low-cost evaluation of a powder to determine consistency
from lot to lot.
● A low apparent density can be an indication of fine particles
● A high apparent density can be an indication of large particles.
● A change in apparent density can also indicate a change in the surface
roughness of the powder

Apparent Density Tester

The Apparent Density Tester – Likely similar and has the same functions to Bulk
Density Testers. These testers are used to measure apparent density, bulk factor, and
where applicable, the pourability of plastic materials such as molding powders

Principle/Method

There are three methods according to ASTM D 1895 that are applicable to various
forms of these materials that are commonly encountered, these range from fine
powders and granules to large flakes and cut fibers.

Method Use Test

A For fine granules and Test is performed by pouring the material

powders that can be through a funnel into a cylinder of known
poured through a small volume. The apparent density is
funnel. calculated by dividing the weight of the
material in the cylinder by the volume of
the cylinder.
B For coarse, granular Test is performed by pouring the material
materials that either through a funnel into a cylinder of known
can't be poured or that volume. The apparent density is
pour with difficulty calculated by dividing the weight of the
through the funnel material in the cylinder by the volume of
from Method A. the cylinder.

C For coarse flakes, Test is performed by pouring the material

chips, cut fibers or into a graduated cylinder and allowing a
strands that can't be 2300g plunger to pack the material for one
tested with Methods A minute. The apparent density is taken as
or B. the mass of the material divided by the
settled volume.

Picture of the Instrument

Description

The apparatus consists of a measuring cup which is polished inside and a funnel.
Parts and function

Solder/Funnel

Ring Holder/Stand

Tubing

Measuring/calibration cup/density cup

Adjustment knob

Application

Operation

1. Raw powder/material will be poured into the funnel

2. Permit the material to flow in the funnel into the center of density cup
3. Testing apparatus should not be move during the filling
4. Rotate the funnel 90 degree in a horizontal plane when the density cup is already
full so that the remaining powder falls away from the cup
5. Using a non-blade spatula, with a blade held perpendicular to the top of the cup,
the powder should be leveled off flushed for the top of the density cup
6. Density cup should be tapped on the side to settle the powder and to avoid
spilling
7. The powder will be then weighed to the balance

Method for Determination of Apparent Density of Free-Flowing Metal Powders Usi…

Calculation

A raw material with volume of 20.0cm3 is used to produce a drug, the determined mass
of the material is 60.0g. What is the apparent density?

Formula:

ρ0= m/v0

where:
ρ0= apparent density

m= mass

v0= volume in natural state (l x w x h)

=60.0g/20.0cm3

= 3.0g/cm3

Angle of Repose

Principle

● Maximum angle between the surface of pile and horizontal plane

● A parameter commonly used for the evaluation of interparticle force
● Important physical property used for characterization of the bulk of particulate
foods such as seeds, grains, flours, grits, and fruits.
● Granular solids are piled on a flat surface, the sides of the pile are at a definite
reproducible angle with the horizontal leveled surface
● Important for the design of processing, storage, and conveying systems of
particulate materials

● When the grains are smooth and rounded, the angle of repose is low. For very
fine and sticky materials the angle of repose is high
Picture of instrument

The angle of repose attachment comprises

a 100 mm diameter circular test platform
together with a digital height gauge having
a range of 0-300 mm. For this particular
test, the funnel is normally equipped with a
special 10 mm with nozzle mounted 75 mm
above the test platform.

Parts and Function

Test stand

Powder flow tunnel

Nozzles

Stirrer

Test platform and digital height gauge

Application

Indicates the flowability of the powders in drug manufacturingi

Operation

1. Take the powder and gently put it in the funnel

2. Stir the sample if necessary
3. Once the powder is full in the platform, measure the highest point or peak
to the lowest point or in the platform (Measure in mm)

Angle of Repose Explained | LFA Machines

CALCULATION

Formula:

Where:

= the angle of repose

h= height in cm

r= radius in cm

If Given:

h= 10cm

d= 19.62cm

● What is the radius?

● What is the angle of repose?

A. r=d/2 (19.62/2) B.

r= 9.81cm =tan^-1 (10cm/9.81cm)

=tan^-1 (10cm/9.81cm)

=tan^-1 (1.02cm)

=45.56 degrees
Angle of Repose Expected flow

25-30 Excellent

31-35 Good

36-40 Fair

41-45 Passable

46-55 Poor- needs agitation

56-65 Very poor

>66 Very, very poor

 NOTRE DAME OF DADIANGAS UNIVERSITY
Marist Ave, General Santos City, 9500 South Cotabato

WRITTEN REPORT ON
DISINTEGRATION

Submitted to:
Stephanie Lois R. Sanchez, RPh, MSPh

Submitted by:
Roselle Joy Siasol
Chelsea Signar
Frances Ashleigh Reign Solongon
 INTRODUCTION

According to Merriam-Webster, the word disintegrate means “to break or

decompose into constituent elements, parts, or small particles”. Disintegration is a
measure of the quality of the oral dosage form like tablets and capsules.

DISINTEGRATION TESTING

Disintegration testing is a pharmaceutical method developed to evaluate and

ascertain how well (and if at all) a tablet/sample breaks apart in the human body.
Disintegration tests evaluate how well a sample breaks apart from its manufactured form
into smaller, looser, more free flowing structures that are then able to continue to form a
solute with the liquid they have broken down in. In simplistic terms, the disintegration test
measures if the sample crumbles into a powder, or remains as a solid block in tablet form.
(Total Laboratory Services, 2021a)

DISINTEGRATION TESTERS
Disintegration testers are the machines which carry out the disintegration test.
They are often found inside Quality Control laboratories in pharmaceutical and life science
organisations. The primary purpose of disintegration testers is to measure the amount of
time it takes a tablet (sample) to totally disintegrate inside a liquid medium. Disintegration
testers are built by a variety of different suppliers, but all to the same USP regulations,
which govern the uniformity of the testing conditions, so that global compliance and
quality standards can be maintained across different companies and manufactures
throughout the world. (Total Laboratory Services, 2021b)

A. PRINCIPLES ON HOW DISINTEGRATION TESTER WORKS

The test is recorded as successful/passed if a tablet/sample successfully breaks down to

a crumbled mixture. If the sample does not break down, however, it is considered a failure.
Discs are employed in the disintegration test to prevent the tablet from floating when
immersed in the medium, ensuring that all of the tablets are disintegrated evenly.
For most dose formulations, the most common medium is water (neutral). However, we
do use acidic and basic mediums in specific circumstances. For instance, enteric coated
tablets and sugar coated tablets. If any of the sugar coated pills from the initial test have
not decomposed, the test must be redone with hydrochloric acid. All six tablets must
crumble. To dissolve the enteric phalate layers that simulate the intestinal environment,
enteric coated tablets must be immersed in hydrochloric acid to replicate the gastric fluid
medium.
In general, temperature specification is not required for solid dosage forms; however,
temperature specification is required for semisolid dosage forms consisting of lipids to
avoid lipid melting.

B. PICTURES OF THE INSTRUMENT

Figure 1. Figure 2. Figure 3. Figure 4.

C. DESCRIPTION

4 Most Common Disintegration Tester Machines you can find in the market:

1. Fully Automated Tablet Disintegration Tester Machine

This type of Disintegration Tester detects the individual disintegration periods of
tablets or other solid dosage forms automatically. They work autonomously, as the
name automatic implies. They are equipped with temperature sensors that allow
them to operate within the specified temperature range. The USP standards are
met by all Fully Automated Tablet Disintegration Testers.
2. Semi-automated Tablet Disintegration Testing Machine
They appear in single, double, triple, and four station configurations, among others.
Each Disintegration basket can function on its own. Furthermore, they are fully
equipped and comply with current USP criteria.
3. 2- Station Semi-automatic Disintegration Tester Machines
The beaker can be heated individually. This enables product testing at two distinct
temperatures. They follow the same USP/IP guidelines as other apparatus. They
usually have programmable timers, alarms, and temperature controls.
4. Single Disintegration Tester Machines
Since it just has one basket, the machine is called a single. Depending on the
company, it can be operated manually or automatically. The current USP, EP, and
 other pharmacopeias are all met by this machine. The baths are clear to allow for
optimum visual observation
The following are some of the most fundamental reasons why disintegration apparatus
is necessary:

I.To determine the ability of tablets and capsules to disintegrate according to

pharmacopoeial standards such as USP, BP, and IP.

II. Monitor the quality and performance of various dosage forms, such as the time it
takes for a formulation to dissolve.

III. For quality control, a disintegration tester allows the researcher to examine the in
vitro breakdown of powdered substances.

IV. In the pharmaceutical business, it can also be used to verify the consistency and
compliance of a batch of tablets or capsules. This also aids the production crew in
adhering to established guidelines such as USP requirements.

Disintegration Testers, in general, serve a vital role in quality control. Furthermore, it

facilitates and simplifies research. Many technological advancements have occurred
since the invention of the Disintegration Tester. Furthermore, there is a great demand
for accurate and efficient testing equipment.

D. PARTS AND FUNCTIONS OF DISINTEGRATION APPARATU

a) Bath

It is the medium for the disintegration process. Normally, the bath liquid (water) helps in
achieving an even temperature for the disintegration processes to take place. In the bath,
there can be a powerful pump that helps to circulate water.

b) Bath cover

It covers the bath, acting as a shield from external temperatures and conditions that would
otherwise alter the process and ultimately the results.

c) Basket Assembly

As the name suggests, these are groups of baskets. A complete basket design comprises
of a basket, sieves, and discs. They all comply with the USP, EP and other standards.
For automatic disintegration tester, the equipment parks out the beater once the process
is complete. Normally, this occurs in the top most position.

d) Control Knob

It enables the machine to operate easily with very little knowledge. This is the START
button that the operator uses to start the machine manually. Of course, you can also use
it to stop the operation. However, this will depend on the design of the disintegration tester
apparatus.

e) Reciprocating arm

Raises and lowers the basket in and out of the vessel for fifteen minutes, and during this
time the friction of the test media on the sample initiates the disintegration. This movement
mimics the flow and friction that would be experienced inside the human body.

f) Temperature probe

Can be defined as a type of sensor which is used to measure temperature. It works by

monitoring the change in resistance of the given area: solid, liquid or gas and converting
it into a usable format for the operator.

g) Vessel

Sits inside a bath of warmed water, used to replicate the temperature of the human body.
This vessel sits inside a heated water bath which mimics the human body temperature.
Inside the vessel is the test media, which has a ph. level similar to that of the human
stomach.

h) MPU

MPU helps to automatically control the temperature, time and frequency of the nacelle
back and forth. The MPU is an acronym for Microprocessor Unit or a Microprocessing
unit. It is a device that implements the core elements of a computer system on a single
integrated circuit. Or, as a few integrated circuits operating as a cohesive circuit.

i) A large LCD screen Display

Test screen shows run-time information once a disintegration test starts. The total testing
time for each station or the single station is indicated at the end of the test.

j) Alpha–numeric keyboard

This helps in editing product and test information such as target disintegration time for
each station. Take for example in 2 or 3 Station Disintegration Testers. Bath and median
temperature can also be keyed in with the help of the keyboard and noted from the LCD
Display. The keyboard can be in the form of control buttons or LCD screen.

k) Calculator

This helps in working out the disintegration time of the particular dosage particle being
tested. Other parameters can also be worked on using the calculator. It can be optional
in some Disintegration Testers.

l) A Built in Heating System

This system is thermostatically controlled. It warms the water in the bath up to 37⁰ Celsius.
This pre-selected temperature is automatically adjusted by a control sensor. In some
Disintegration Testers, there may be a second sensor that acts as a safety device. It
switches off the heater should the temperature rise above the optimal temperature.

Applications of Disintegration test:

1. Disintegration test is a simple test which helps in the preformulation stage to the
formulator.
2. It helps in the optimisation of manufacturing variables, such as compressional
force and dwell time.
 3. This test is also a simple in-process control tool to ensure uniformity from batch to
batch and among different tablets
4. It is also an important test in the quality control of tablets and hard gelatine
capsules.

E. OPERATION OF DISINTEGRATION APPARATUS

Disintegration tests determine how long it takes for a tablet (sample) to completely
dissolve in a liquid medium. Researchers and quality control personnel can use
disintegration testers to see if a tablet breaks down inside the human body and how
long it takes. This can provide information that can be used to improve and manufacture
pharmaceutical medications, as well as validate that compliance and regulation
standards are being met.

Disintegration testers operate by raising and lowering a 'basket' in and out of the test
medium in an attempt to create movement, similar to the conditions inside the human
stomach. At no point does the basket raise itself completely out of the test medium, so
the tablet is always submerged throughout the disintegration tester's operation.

The test medium is contained within the vessel, which is contained within a bath of
warmed water, the temperature of which is 37 degrees Celsius to replicate the
temperature of the human body. It also has different time limits depending on the type of
capsule or tablet used.

The test failed if there is residue on the mesh. If there is no residue present, the test is
considered a pass. If there is no residue on the mesh disk, it means the sample has
crumbled into a powder and fallen through the mesh, indicating that disintegration was
successful.

All samples must disintegrate in less than 15 minutes, according to USP regulations.
The USP also specifies the mechanical requirements for all disintegration testers, such
as the speed of the moving arm, basket dimensions, vial and mesh size, ph level of the
test media, and water tank temperature.

F. INTERPRETATION OF GENERATED RESULTS

Standards for Disintegration Time Test (British Pharmacopoeia)

Types of Tablets Medium Temperature Limit

Uncoated Tablet Water/ buffer 37 ± 2°C 15 min as per BP

Sugar Coated Water/ 0.1 M HCl 37 ± 2°C 60 min as per BP

Tablet

Film Coated Tablet Water 37 ± 2°C 30 min as per BP

Enteric Coated 0.1 M HCl 37 ± 2°C No evidence of

Tablets DT disintegration after 2-3
hours

Phosphate buffer 37 ± 2°C 60 mins as per BP

pH 6.8

Dispersible Tablets Water 20 ± 5°C 3 min ( 15- 25º C ) as per

BP
Effervescent Water 20 ± 5°C 5 min ( 15- 25º C )
Tablets
as per BP

Soluble Tablets Water 20 ± 5°C 3 min ( 15- 25º C ) as per

BP

Gastro resistant 0.1 M HCl and 2 hrs in 0.1 M HCl and

capsule DT phosphate buffer phosphate buffer pH 6.8
pH 6.8 for further 60 min as per
BP

Hard gelatin - - 30 min as per BP

capsule DT

Soft gelatin - - 30 min as per BP

capsule DT

Oral lyophilizates 200 mL of non- 15 °C–25 °C 3 min Using a beaker

DT agitated water containing 200 mL of
water at 15 °C–25 °C

Standards for Disintegration Time Test (United States Pharmacopoeia)

Types of Tablets Medium Temperature Limit

Uncoated Tablet Water/ buffer 37 ± 2°C 30 min as per USP

Sugar Coated Water/ 0.1 M 37 ± 2°C As per individual

Tablet HCl monograph

Buccal tablets Water 37 ± 2°C 4 hours as per USP

Enteric Coated Simulated 37 ± 2°C 1 hour in Simulated
Tablets DT gastric fluid TS gastric fluid TS: No
disintegration

As per individual
Simulated monograph
intestinal fluid 37 ± 2°C
TS

Sublingual Tablets Water 37 ± 2°C As per individual

monograph

Hard gelatin - - 30 min as per USP

capsule DT

USE OF DISK

Dosage form Specifications

Vitamin-Mineral Add a disk to each tube unless otherwise specified in

the individual monograph.

Botanical Omit the use of disks unless otherwise specified in the

individual monograph.

Dietary supplements Omit the use of disks unless otherwise specified in the
individual monograph.

Take note: The use of disks for enteric-coated tablets is not permitted.
Conclusion:

In most cases, the test is only performed once. If, at the end of the time limit, 1 or 2
tablets do not completely disintegrate, repeat the test with 12 additional tablets. If at
least 16 of the total of 18 tablets tested disintegrate, the requirement is met.
 GROUP 6 - DISSOLUTION
Members: Junio, Kusain, and Lamentac

INTRODUCTION:
● Dissolution test is the release of a drug from the tablet into solution per unit time
under standardized conditions.
● Dissolution testing measures the extent and rate of solution formation from a
dosage form, such as tablet, capsule, ointment, etc.
○ In other words dissolution is the process by which a drug particle
dissolves.
● The dissolution of a drug is important for its bioavailability and therapeutic
effectiveness.
○ As its significance is based on the fact that for a drug to be effective, it
must first be released from the product and dissolve in the gastrointestinal
fluids before absorption into the bloodstream can happen.
To properly evaluate the dissolution of drug products, it is critical for procedures to be
standardized. This standardization helps to show consistent quality in production and
may serve as a predictive measure of efficacy.
A dissolution test uses an apparatus with specific test conditions in combination with
acceptance criteria to evaluate the performance of the product. Dissolution includes 7
standardized apparatus which are the basket, paddle, reciprocating cylinder,
flow-through cell, paddle over disc, rotating cylinder, and reciprocating disc.

TYPES OF DISTILLATION APPARATUS:

● Basket Type (Apparatus I)
● Paddle Type (Apparatus II)
● Reciprocating Cylinder (Apparatus III)
● Flow Through Cell (Apparatus IV)
● Paddle Over Disc (Apparatus V)
● Rotating Cylinder (Apparatus VI)
● Reciprocating Disc (Apparatus VII)
 1. BASKET TYPE (APPARATUS I)
● The rotating basket apparatus consists of a cylindrical basket held by a
motor shaft.
● The basket holds a drug sample that is being spun, dissolving the drug in
a uniform manner.
○ This apparatus is one of the most commonly used methods in
dissolution testing. The rotating basket apparatus consists of a
cylindrical basket held by a motor shaft. The basket holds a drug
sample that is being spun, dissolving the drug in a uniform manner.
DESCRIPTION:
● It comprises borosilicate glass and holds a capacity of up to 1000 ml.
○ Borosilicate glass is used with this apparatus because of its durability and
resistance to chemical changes.
● The shape is semi-hemispherical at the bottom while its shaft is made out of
stainless steel, which holds the cylinder basket.
● The mesh is non-reactive.
○ It is non-reactive so that it will not affect the result.
● The common speed limit for rotation is 100 rpm (revolutions per minute).
● It is used for capsules or tablets, suppositories, and floating dosage forms.

PARTS AND FUNCTIONS:

● Rotating Shaft - Causes the paddle to rotate.
● Medium - Solvent used (mainly water) that are in different temperatures.
● Evaporation Cover - Prevents excess evaporation
● Vessel - Container of both drug and medium
● (Mesh) Basket - Where the drug is attached inside and is connected to the
rotating shaft. It is made of non-reactive material to avoid unnecessary reactions.
 2. PADDLE TYPE (APPARATUS II)
● This apparatus together with apparatus 1 are the most commonly used
methods in dissolution testing. Paddle type is almost the same as the
basket type. The only difference is that the paddle type has a paddle
stirrer and a capsule sinker.
● The paddle apparatus consists of a special, coated paddle that minimizes
turbulence due to stirring.
● Drug is held by a capsule sinker and the paddle stirs, dissolving the drug
in a uniform manner.

DESCRIPTION:
● This apparatus consists of a coated paddle that reduces the disturbance from the
stirring.
● It has a blade that comes in contact with the bottom of the shaft.
● The paddle is designed from stainless steel and a platinum wire.
○ Stainless steel and a platinum wire are used since they are non-reactive
materials.
● The paddles motor speed is usually at 40 rpm and the paddle is kept at 37
degrees Celsius.
● It is used for capsules and suppositories.

PARTS AND FUNCTIONS:

● The parts and function of paddle type is the same with basket type, except the
paddle and the capsule sinker.
● Rotating Shaft - holds the paddle and causes the paddle to rotate.
● Paddle - It stirs the medium & promotes uniform mixture. It is made of
non-reactive material to avoid unnecessary reactions.
● Evaporation Cover - Prevents excess evaporation.
● Vessel - Container of both drug and medium.
● Medium - Solvent used (mainly water) that are in different temperatures.
 ● Capsule Sinker - It is attached to drugs that would float in a medium.
○ Capsule sinker is used because floating dosage forms rarely dissolve at a
reproducible rate. Using a sinker in Apparatus 2 fixes the dosage form to a
certain point and aids reproducibility. Sinkers can also be useful where
dosage forms may stick to the sides of the vessel.

3. RECIPROCATING CYLINDER (APPARATUS III)

● A cylinder tube is installed on a shaft in a machine.
○ Shaft - holds the cylinder basket
● The shaft in the cylinder tube that contains the drug moves in a pump-like
action dissolving the drug in a uniform manner.
○ Pump-like action (the upward and downward movement which
dissolves the drug in a uniform manner).

DESCRIPTION:
● This dissolution apparatus is considered in product development for controlled
release preparations.
○ The reason for this is to aid the release of products especially in our GI
tracts by exposing them to various physicochemical and mechanical
conditions.
● It is an easy method for drug testing and it does not pose any problem with the
pH values of its solution.
○ It is because it enables the product to be subjected to different dissolution
media and agitation speeds in a single run. Therefore, if problems occur, it
can be easily solved since it will automatically be subjected to other
dissolution media to assess the problem.
● It is used for extended release, and chewable tablets.
○ Extended release tablets are designed to last longer in your body.

PARTS AND FUNCTIONS:

● Medium - Solvent used (mainly water) that are in different temperatures.
 ● Evaporation Cover - Prevents excess evaporation.
● Vessel - Container of both drug and medium.
● Pump-Action Shaft - Causes the cell to move in an upward and downward
motion.
○ This upward and downward movement is the one who will dissolve the
drug inside.
● Internal Cylinder/Cell - The drug is placed inside this container and is attached to
the Pump-Action Shaft.

4. FLOW THROUGH CELL (APPARATUS IV)

● A drug sample is held by a holder and below that are ruby beads & glass
beads inside a cell reservoir.
○ Ruby beads (to protect the inlet tube); glass beads (to form a glass
bead bed, it is where the tablet will be positioned); cell reservoir
(serves as a buffer that helps redistribute membrane area when
cells need to stretch or change shape and size).
● A pump pushes the media through the port, dissolving the drug in a
uniform manner.

DESCRIPTION:
● The flow through cell apparatus is designed like a reservoir and is commonly
used for implants.
○ Reservoir serves as storage.
● It has two types: open system and closed system.
○ for easier differentiation: The open system is selected for samples that
require high volume of media (i.e., low solubility compounds; ex: Silver
chloride), and the closed system is selected when a low volume of
medium is required.
● Open system has a fresh dissolution medium pumped through cells and then the
fractions received.
 ● Closed system is where the dissolution medium is pumped into the circle but not
replaced by a fresh medium.
○ The only thing you need remember if we say flow through cell is that it is
consists of a reservoir for the dissolution medium.
○ 6 samples are tested during the testing and the medium is maintained at
37 degrees celsius.

PARTS AND FUNCTION:

● Medium - Solvent used (mainly water) that are in different temperatures.
● Glass/Ruby beads - Prevents drug to mix with the medium and slows the flow of
the medium in order to create a uniform flow.
● Vessel - Container of both drug and medium.
● Internal Cylinder/Cell - The drug is placed inside this container.

5. PADDLE OVER DISK (APPARATUS V)

● A transdermal patch sample is placed over the disc together with specified
dissolution medium.
○ It is used for the dissolution testing of transdermal patches, it is
offered in a variety of sizes, and is used with a standard dissolution
apparatus.
● The paddle spins, causing the patch to react and dissolve in a uniform
manner.
○ Paddle is like a stick or a tube and then it spins in order for the
patch to react and then dissolve in a uniform manner.

DESCRIPTION:
● It has a shaft and disk assembly that can hold the product so that the surface will
be leveled with the paddle.
○ Shaft and disk – shaft is like a stick and disk it serves as a boundary in
the surface.
● Its volume capacity is 900 ml.
 ● It is used for the dissolution testing of transdermal patches.

PARTS AND FUNCTION:

● Medium - Solvent used (mainly water) that are in different temperatures.
● Paddle - stirs the medium & promotes uniform mixture.
● Vessel - Container of both drug and medium.
● Disk Assembly - ·It is where the transdermal patch is applied.
○ minimizes any dead volume (serves as a boundary in the surface area)
dead volume – this is the excess volume that is not uniformly swept or not
moving in a uniform strength.

6. ROTATING CYLINDER (APPARATUS VI)

● A transdermal patch is being attached to a cylinder inside a vessel.
○ Its volume capacity is 900 ml.
● The cylinder that is submerged in a medium, spin in a rapid motion,
causing the patch to dissolve/react in a uniform manner.

DESCRIPTION:
● It uses a rotating cylinder instead of a basket cylinder.
● The shaft and cylinder are made up of stainless steel.
● The rotation speed is 25-50 rpm and the water bath is maintained at a
temperature of 32 degrees Celsius.
● It is mainly used in transdermal patches.

PARTS AND FUNCTION:

● Rotating Shaft - Causes the paddle to rotate.
● (Rotating)Cylinder – It is where the transdermal patch is applied. It is made of
non-reactive material to avoid unnecessary reactions.
● Medium - Solvent used (mainly water) that are in different temperatures.
● Evaporation Cover - Prevents excess evaporation.
● Vessel - Container of both drug and medium.
 ● Capsule Sinker - It is attached to drugs that would float in a medium.

7. RECIPROCATING DISK (APPARATUS VII)

● A drug or a transdermal patch is attached inside a capsule sinker.
● The disk moves in a pump-like action dissolving the drug in a uniform
manner.

DESCRIPTION:
● This apparatus has a flat bottom cylinder shaped vessel with a volume capacity
of 50-200 ml.
● It is usually placed on a disk-shaped holder.
● It also produces transdermal patches and the dosage quantity is extracted in the
water bath.
● It is used for controlled release formations and only applies to small dosages.

PARTS AND FUNCTIONS:

● Medium - Solvent used (mainly water) that are in different temperatures.
● Capsule Sinker - It is attached to drugs that would float in a medium.
● Vessel - Container of both drug and medium.
● Pump-Action Shaft - Causes the cell to move in an upward and downward
motion.
● Disk - Attached to a Pump-Action shaft and moves in an upward and downward
motion..

OPERATION:
● Ensure that the working bench and instrument is clean and calibrated.
● Switch on the main power.
● Fill the vessel with medium up to the marked level.
● When the power is on, the display will show the previously set time, RPM and the
temperature display shows the vessel temperature.
● Place the vessel filled with the medium onto the machine.
 ● Install the stirrer/apparatus (paddle, basket, disk, etc.) onto the shaft according to
the machine specifications.
● Press the temperature set switch and rotate the setting knob until the display
shows the desired Degree Celsius.
● Change the mode switch to RPM mode and switch on the motor.
● Using the speed knob, adjust the RPM to required level and switch off the motor.
● Drop the drug on top of the vessel
● Set alarm to the required time and wait until dissolution test is complete
● After the test is completed the instrument will stop which is indicated by beep
sound.
● Lift the stirrer/apparatus unit and take the required amount of the sample from
the jars and clean.
● Switch off the instrument.

VIDEO:
1st video: In this first video, we will show an example of how a Paddle type Dissolution
Machine is being used.
2nd video: In this second video, we will show an example of how a Rotating-cylinder
Dissolution Machine is being used.

APPLICATION:
● It is an important tool for characterizing the performance of oral solid dosage
forms.
● It is a requirement for all solid oral dosage forms.
● It is used throughout the development life-cycle for product release and stability
testing.
○ This means a drug should behave as stated by manufacturers. For
instance, if a drug dissolves too slowly, or a controlled release formulation
dissolves too quickly, it is considered non-consumable for there must be
no errors in the drug as an industry standard when consumed by a patient.
 ● It is an analytical test used for detecting physical changes in an active
pharmaceutical ingredient and formulated product.
○ The drug must be in accordance to the industry standard, identifying if the
drug dissolves uniformly or are there parts that would become chunks that
would not dissolve, the dissolution rate and how the drug dissolves will
show how the drug if it will be metabolized properly by the liver or how it
will flow in the bloodstream.
● It tests the effectiveness of oral solid dosage form drug after it undergoes
dissolution.
● It detects any key changes in product performance
● Correct optimization of the drug
○ For instance, we can test in batches if a couple of controlled-release
tablets. In this test, it will show the drug if it dissolves differently or
dissolves in a uniform standard. With that in mind, we can then identify
what drug batches are behaving properly based on industry standard, and
thus, we could sort the good drug batches from the bad drug batches and
find out the cause of said malfunctions in the bad drug batches.

CONCLUSION:
Dissolution testing is an important tool for characterizing the performance of oral
solid dosage forms. Therefore, studying the various types of apparatuses and knowing
how to use these tools are important when it comes to dissolution testing because it
maximizes the performance of the dissolution tester which ensures consistency
between production batches.
Group 1 PHARMCHEM 60
Althea Albania
Jamaica Alvarina
Tricia Amores

FRIABILATOR
Detailed Report Script
I. Good day everyone. I am Althea together with Jamaica and Tricia. We are the
reporters for today’s discussion. We will be discussing the laboratory instrument
called Friabilator. Before we begin, let us know our objective and for us to be
guided with the contents of the discussion:
II. Objectives:
At the end of the reporting, we should be able to
● To define friability and know the instrument used in friability test
● To know the parts of friabilator and its functions
● To discuss how the friabilator operates
● To interpret and analyze the results with the given criteria and formula
III. Introduction:

● Tablets are constantly subjected to mechanical shocks during the manufacturing,

packing and transportation process.
○ The stress put on the tablets can lead to capping, aberration or even
breakage of the tablets.
○ It is therefore important that the tablet is formulated to withstand such stress.
○ In order to monitor the resistance of tablets to such stress and to decide on
their suitability for further processing such as coating, tablets are routinely
subjected to friability test.
● Before we go deeper in our discussion, let us first define some terms:
○ Friable: A friable substance is any substance that can be reduced to finer
particles by the action of a small pressure or friction, such as rubbing or
inadvertently brushing up against the substance.
○ Friability: Defined as the percentage of weight loss by tablets due to
mechanical action during the test. Tablets are weighed before & after testing.
Friability is expressed as a percentage loss on pre-test tablet weight.
○ Friability test:
■ Other Names of Friability Test
● Drop Test
● Abrasion Test
● Attrition Resistance Test
■ It is done to check the ability of the compressed tablet to avoid
fracture & breaking during the transport.
Now, let us discuss further about friability test

IV. Principles on how the instrument works:

● Friability test is done for uncoated or core tablets.
○ Friability testing of Coated tablets is not required because coating gives
strength to the tablets.
● Tablet friability can be used to measure efficiency of tabletting equipment or as an
indicator of formulation suitability as well as routine Quality Control functions.
● It can also be thought of as measuring “dusting”.
● Tablets are rotated in a plastic drum for a specified period of time. It rotates at the
speed of 25±1 rpm in 4 minutes. The meaning rpm is revolution per minute

○ A gravimetric determination is then made to quantitate the amount of surface

material that has worn off.
● Effervescent tablets and chewable tablets may have different specifications as far
as friability is concerned. In the case of hygroscopic tablets and moisture sensitive
products, an appropriate temperature and humidity controlled environment is
required for testing.
● Drums with dual scooping projections, or an apparatus with more than one drum,
for the running of multiple samples at one time, are also permitted.

V. Description

The apparatus used for friability testing is known as Friabilator. To get an overview of the
instrument, let us watch a quick video: https://www.youtube.com/watch?v=Zjy70Mgf8LY

● This apparatus consists of a drum of transparent synthetic polymer with polished

internal surfaces and is subject to minimum static build-up. One side of the drum is
removable. It has a curved projection which extends from the middle of the drum to
the outer wall, enabling the tumbling of the tablets at each turn of the drum. The
drum is attached to the horizontal axis of a device. It rotates at 25 more or less ± 1
rpm for 4 minutes.
● Friability apparatus diameter as per Pharmacopeias:
1. Internal diameters: 283.0 to 291.0 mm ( 287.0 more or less ± 4.0mm)
2. Depth: 36.0 to 40.0 mm ( 38.0 more or less ±2.0mm )
3. Outer diameters: outer diameter of central ring 24.5 to 25.5 mm (25.0 more
or less ±0.5mm )
4. Drop height of friability apparatus is around 6 inches or 156 more or less
±2.0mm
5. Friability apparatus revolution/ minutes = 24 to 26 (25 more or less ± 1)
6. Total Revolution / Test = 100 Revolutions / 4 Minutes
VI. Parts and Functions

A. Calibration system: It quickly checks the machine to ensure it is ready for

operation. The machine has to be calibrated so that the test results desired can be
reported.
B. Drum/ drums: This is where the tablets are loaded. It is made from Plexiglas.
● Normally, it has two parts, that is, the drum and its cover.
● The cover can be removed when you want to clean it or load tablet samples.
● Also, it is made using high-quality stainless steel which meets the GLP
requirements.
● Once it is loaded, it is covered and ready for running.
● Inside the drum, there is a curved scoop.
● It pushes the tablets up and down at a predetermined height and speed.
C. Silent DC gear motor
● Helps in rotating the drums at a fixed speed of 25 rpm or according to how it
has been set. It aids in settings of the time and rotation modes.
D. Click wheel navigator: Used to navigate the menu on the LCD screen.
E. Integrated report printer
● Weight loss is calculated here automatically.
● It generates reports for tests and copies of the reports are saved in a USB
connected to it.
F. Discharge collector tray
● Is made from clear Plexiglas and magnetically fixed to the base of the
instrument. It can be removed for cleaning and returned back easily.

To view the parts and specifications of the friabilator, let us watch this video:
https://www.youtube.com/watch?v=GzBMxsmasUo
VII. Operation: Now let us discuss how to perform friability test using friabilator.
● The tablets are selected according to the specifications of weight
○ If individual tablet weight is equal to or less than 650 mg then take as many
tablets as close to get an average weight of 6.5 grams.
○ If individual tablet weight is more than 650 milligrams then take 10 tablets for
friability testing.
● After taking the required number of tablets, the tablets are de-dusted to remove any
fine powder or loosely attach powder with the help of pharma compliant brush.
● After de-dusting the average weight of the tablets is checked on the weighing
balance and this weight is known as initial weight or W1.
○ Initial weight = 6.536gm
● The initial weight or W1 is noted and tablets are placed in the drum of the friabilator.
● On one side the drum has a glass opening to add tablets and it also has an arch
which gives an attrition effect to the tablets.
● After placing tablets inside, the glass cover is closed and the rotation of the drum is
turned on.
● The drum rotates for 4 minutes at a speed of 25 rpm meaning in 4 minutes it
completes 100 rounds.
● After the completion of 4 minutes, the drum is stopped automatically and tablets are
removed from the drum.
● After removing from the drum,tablets are physically checked for chipping or
breaking and again weight is checked after dedusting and this weight is known as
final weight or W2.
● Use the following formula to calculate the friability

We have here another video for us to visually see how to operate the friabilator:
https://www.youtube.com/watch?v=vvnj4_5Jvvc

[ Althea ]
VIII. Calculation of Friability
● Friability is the percentage of weight loss by tablets due to mechanical action during
the test.
● In order for us to calculate the percentage loss of the tablet weigh, we need this
formula:

● Friability is equal to the Initial weight (W1) - Final weight (W2) / Initial weight (W1)
×100
● The initial weight is gathered before performing the test while the final weight is
gathered after the test is performed.
● Accepted Criteria: A maximum loss of weight (from a single test or from the mean
of the three tests) not greater than 1.0 percent (1%) is acceptable for most tablets.

IX. Interpretation
● Value of friability should not be more than 1% for most of tablets.
● If the value of friability for the first test is greater than 1%, then repeat the test twice
& mean value of weight loss of three tests is determined.
 ● If the mean value of three tests is less than 1% tablets, it passes the friability test,
otherwise the tablet fails the test.
● If the tablets are broken , chipped or cracked during the test, the tablets fail the
friability test.

X. Sample

Here we have 20 sample tablets. As you can observe, the individual tablet weight is equal
to or less than 650 mg thus we take the 20 tablets. However, in some cases that the
individual tablet weight is more than 650 milligrams then we need take 10 tablets for
friability testing.
● Our initial weight (w1) = 10093 mg or 10.093 g
● After performing the friability test, we gathered the final Weight (W2) of 9985 mg or
9.985 g
● To test the friability, we need the formula:

● Friability (%) = 10.093 g - 9.985 g / 10.093 g x 100 = 1.07 %

● Analysis: The value doesn't meet the accepted criteria, hence, repeat the test twice.
● If the mean value of three tests is less than 1% tablets passes the friability test,
otherwise the tablet fails the test.

XI. Application

● Helps to determine the resistance of uncoated tablets to abrasion and shock during
manufacturing, packing, and shipping.
 ● Provides pharmaceutical companies with an opportunity to carry out research.
Knowledge about the cause of breakage of the tablets during testing could reduce
company loses.
● Controls the stability of uncoated tablets in pharmaceutical industries, hospitals,
and drug testing institutions.
● Provides data for sugar-coated tablets which is reliable.

XII. Conclusion
● To conclude our report, let us watch this summarized video:
https://www.youtube.com/watch?v=JbeuwFqqu_w
LOSS ON DRYING (PHARMACEUTICAL OVEN)
AND MOISTURE ANALYZER/KARL FISCHER
METHOD WRITTEN REPORT

Submitted by:

Fulgar, Aldrin

Fulgar, Aldwin

Janoras, Earll Divine

Submitted to:
Ms. Stephanie Lois Sanchez, RPh, MSPh
 LOSS ON DRYING METHOD

WHAT IS LOSS ON DRYING METHOD?

● Is a widely used test method to determine the moisture content of a sample.
● This method uses the principle of drying a sample of the product and comparing
the weight before and after drying.

PHARMACEUTICAL OVEN
● Pharmaceutical ovens are high tech equipment that provides an economical and
fast mode of drying materials in the pharmaceutical industry laboratories.
● Use to dry materials such as powders, granules, and herbs among other
functions.

PRINCIPLES ON HOW PHARMACEUTICAL OVEN WORKS:

● Hot air ovens/Pharmaceutical ovens use extremely high temperatures over
several hours to destroy microorganisms and bacterial spores.
● The ovens use conduction to sterilize items by heating the outside surfaces of
the item, which then absorbs the heat and moves it towards the center of the
item.
● It can remove excess moisture due to its high temperature.

PARTS AND FUNCTIONS OF PHARMACEUTICAL OVEN:

1. External Cabinet - the External cabinet is made of stainless sheets, and covers
the inner chamber.
2. Glass wool insulation The space between the inner chamber and external
cabinet is filled with Glass wool. It provides insulation to the hot air oven.
3. Inner chamber - the inner chamber of the hot air oven is made of Stainless
steel.
4. Tubular air heaters - they help to generate heat within the inner chamber. Two
Tubular air heaters are located on both sides of the inner chamber.
5. Motor-driven blower - it helps in uniformly circulating the air within the chamber.
6. Temperature sensor - it measures the temperature within the hot air oven and
displays it on the controller screen.
7. Tray slots - the inner wall of the chamber contains several try slots that hold the
trays.
8. PID temperature controller - it maintains the accurate temperature during the
entire cycle. It controls the temperature and also displays the temperature
values.
9. Load indicator - it indicates the hot air oven is overloaded.
10. Mains on/off switch - it helps to turn on/ turn off the hot air oven.
 11. Safety thermostat - it is also known as an over-temperature protection device. It
keeps your oven and specimen safe in case of controller malfunction.

APPLICATIONS:
Pharmaceutical Oven is used in the following applications;
1. Drying - pharmaceutical ovens offer reliable, precise, and safe heating and
getting rid of excess moisture from different research materials.
2. Sterilization - pharmaceutical ovens produce a substantial amount of heat which
is capable of eliminating and killing transmissible agents.
- It gets rid of transmissible agents including fungi, prions, bacteria and viruses
from different pharmaceutical materials.
3. Tempering - you can use it to remove brittleness in hardened pharmaceutical
products thus getting rid of the internal strain within pharmaceutical products.
4. Testing - you can use the pharmaceutical oven to test different pharmaceutical
products through the application of different heat levels.
5. Burn-in Test - It assists in determining the functionality of different products
before releasing them to the public.
6. Vulcanization - pharmaceutical ovens produce enough heat that you can use in
the hardening of different pharmaceutical products.
7. Heat Storage and Conditioning - pharmaceutical ovens assist in the
conditioning of different pharmaceutical materials to increase the shelf life under
storage.

CALCULATION:

Apparatus Used:
Porcelain
Meter Balance
Pharmaceutical Oven
Dessicator

Steps:
Wt of empty porcelain = 69.87 grams
Wt of drug taken = 0.5 grams
Wt of porcelain + wt of crude drug (before drying) = 70.37 grams
Wt of porcelain + wt of crude drug (after drying) = 70.34 grams
Note: Decrease in weight after drying is due to the loss of moisture present in crude
drug before drying
To get the moisture content, we need to subtract weight of porcelain with crude drug
before drying and the weight of porcelain with crude drug after drying

Moisture content = wt of porcelain with crude drug (before drying) – wt of porcelain

with crude drug (after drying)

= 70.37 grams – 70.34 grams

= 0.03 grams

Percent moisture content:

0.5 grams of crude drug content = 0.03 grams of moisture

So how much moisture in 100 grams

100 grams of crude drug content = 0.03 𝑔𝑟𝑎𝑚𝑠 𝑜𝑓 𝑚𝑜𝑖𝑠𝑡𝑢𝑟𝑒 X 100

0.5 𝑔𝑟𝑎𝑚𝑠 𝑜𝑓 𝑐𝑟𝑢𝑑𝑒 𝑑𝑟𝑢𝑔

= 6% moisture content
What is a Moisture Analyzer?

● This analysis is used in coverage of a variety of methods used in analyzing the

contents of solids and liquids or gasses, specifically in analyzing moistures in
contents for the process of manufacturing and assuring process quality control.
● Often referred to as moisture balance or moisture meter, it consists of
components of infrared weighing and heating units.

Principal on how Moisture Analyzers works:

● Moisture analyzers utilize Loss On Drying (LOD) method to measure moisture.

● In this method, the moisture analyzer weighs a sample, heats it up to dry it, and
weighs it again once it's dry. The weight after drying is subtracted from the weight
before, so the loss of moisture is determined using the loss of mass.

PARTS OF MOISTURE ANALYZERS

● Vents – to adjust temperature
● Open Cover – stop heat automatically
● Close Cover – begin to heat again
● Operation panel
● Level bulb
● Lamp protection - protection, maintenance, and adhesion
● Halogen Lamp - produces a continuous spectrum of light, from near ultraviolet to
deep into the infrared.
● Temperature Sensor - resistance temperature detector, that provides
temperature measurement in a readable form through an electrical signal. A
thermometer is the most basic form of a temperature meter that is used to
measure the degree of hotness and coolness.
● SST304 pan
● Big Dot-matrix LCD
● Adjust Level Feet

Application
Moisture Analyzer is used for:

1. FOOD INDUSTRY
- Moisture control is paramount in the food industry. Too much moisture can lead to
staleness or bacterial growth. Many items are sold by weight, so it's important to
make sure customers aren't overpaying for water weight. Too little moisture can
reduce the calorie count or make the food dry. Moisture affects taste,
consistency, shelf life, appearance and more.
2. LABORATORY INDUSTRY
- Moisture analyzers are frequently used in quality control labs and other
laboratories. Moisture analysis is used in many fields, to determine the water
content in crude oil, fuel, sewage sludge and many other chemicals, solids and
liquids.

Calculation

MC = Regarded as Moisture content

w = Regarded as Wet content

d = Regarded as Dry Content

Formula: MC (w-d) / w * 100

Sample : sample weighing in 20 mg when wet, then weighed of the Sample when dried
is 10mg.

Steps:

1. First, determine the weight of the object while wet - using a scale, we find the
object to be 20g while wet.
2. Next, determine the weight while dry - after drying the object, we weigh it
again and find that the weight is 10g.
3. Finally, calculate the moisture content - using the formula we find the
moisture content to be 50%.

Solution:

MC = (20mg - 10mg) / 20 mg X 100

= (10mg / 20mg) X 100

= 0.5 X 100

= 50 mg

Conclusion: Moisture Content be 50 mg

How can I measure the moisture content in pharmaceuticals?

● The standard method for measuring moisture in pharmaceuticals is loss on

drying using a drying oven and a laboratory balance. However, this is a
time-consuming and labor-intensive process. A halogen moisture analyzer is a
viable alternative for determining moisture content that meets regulations and
provides fast, precise and reliable measurements.

How do the results of the moisture analyzer compare to the drying oven?

● It is vitally important to develop moisture content drying methods that provide the
same results as the official drying oven method. To save you valuable time and
effort, The apparatus METTLER TOLEDO offers tried and tested drying methods
for some of the most common pharmaceutical samples and excipients so you
can be sure your results will match those of the official method.

KARL FISCHER METHOD

What is Karl Fischer Method?

● The Karl Fischer method is a method for the determination of moisture content.
● Developed in the year 1935 by a German Chemist who name it after himself
"Karl Fischer"
● It is based on a reagent which reacts with water and converts the water into a
non-conductive chemical. The process uses an organic base (B), Sulfur dioxide,
iodine, and alcohol. which provides for the specific detection of water content in a
product

What is the Karl Fischer Reaction?

● The alcohol reacts with sulfur dioxide (SO2) and base to form an intermediate
alkylsulfite salt, which is then oxidized by iodine to an alkylsulfate salt. This
oxidation reaction consumes water.
 ● The reactive alcohol is typically methanol or 2-(2-Ethoxyethoxy)ethanol, also
known as diethylene glycol monoethyl ether (DEGEE), or another suitable
alcohol.

NOTE: Classic Karl Fisher reagents contain pyridine, a noxious carcinogen, as

the base. The reagents most frequently used today are pyridine-free and contain
imidazole or primary amines instead.

What is Karl Fischer Titration?

● Karl Fischer titration is a widely used analytical method for quantifying water
content in a variety of products.
● The fundamental principle behind it is based on the Bunsen Reaction between
iodine and sulfur dioxide in an aqueous medium. Karl Fischer discovered that this
reaction could be modified to be used for the determination of water in a
non-aqueous system containing an excess of sulfur dioxide.
● He used a primary alcohol (methanol) as the solvent, and a base (pyridine) as
the buffering agent.

How does it work?

Water and iodine are consumed in a 1:1 ratio in the above reaction. Once all of the
water present is consumed, the presence of excess iodine is detected volumetrically by
the titrator’s indicator electrode. That signals the end-point of the titration.

The amount of water present in the sample is calculated based on the concentration of
iodine in the Karl Fisher titration reagent (i.e., titer) and the amount of Karl Fisher
Reagent consumed in the titration.

How do you calculate the Karl Fischer Method?

The water equivalence factor F is determined according to the formula 0.1566 x w / v in

mgs of H2O per ml of reagent, where W is the sodium tartrate weight in mgs, and V is
the reagent volume in ml.

What are the two types of Karl Fischer Titration?

1) Volumetric KFT
 ● In volumetric Karl Fischer, iodine is added mechanically to a solvent containing
the sample by the titrator’s burette during the titration. Water is quantified on the
basis of the volume of Karl Fischer reagent consumed.
● Volumetry is best suited for determination of water content in the range of 100
ppm to 100%.

2) Coulometric KFT

● In coulometric Karl Fischer, iodine is generated electrochemically in situ during

the titration. Water is quantified on the basis of the total charge passed (Q), as
measured by current (amperes) and time (seconds)
● Coulometry is best suited for determination of water content in the range of 1
ppm to 5%.

How does a Volumetric Titrator work?

- The titrator performs the following three key functions:

1) It dispenses KF titrating reagent containing iodine into the cell using the burette

2) It detects the endpoint of the titration using the double platinum pin indicator
electrode

3) It calculates the end result based on the volume of KF reagent dispensed using the
onboard microprocessor

How does a Coulometric Titrator work?

- The titrator performs the following three key functions:

1) It generates iodine at the anode of the titration cell, instead of dispensing KF reagent
as in volumetric titration.

2) It detects the endpoint of the titration using the double platinum pin indicator
electrode.

3) It calculates the end result based on the total charge passed (Q), in Coulombs, using
the on-board microprocessor.

- - -
 Written Report

in

Pharmaceutical Analysis 2

(Instrumental Method of Analysis) Laboratory

Submitted to: Ms. Stephanie Lois R. Sanchez, SME

Submitted by: Buhia, Cabigas, and Camzar

 Tablet Hardness Tester and Tablet Thickness and

Diameter Tester

The title of the topic that we are going to discuss is “Tablet Hardness Tester and

Tablet Thickness and Diameter Tester”. At the end of the discussion, we will be able

to identify different instruments used in determining the Thickness, Diameter, and

Hardness of the tablet . To lay down the procedure for operating Micrometer, Vernier

caliper, Monsanto, Strong-Cobb, and Pfizer crushing strength tester. To calculate the

measurements of the selected tablets using testing instruments and to examine the

results if they are up to quality control standards.

Introduction

Tablet Hardness Tester and Tablet Thickness and Diameter Tester are instruments

used in the pharmaceutical industry. The Tablet hardness testing instrument Found

in USP Chapter <1217> “Tablet Breaking Force” is the preferred term now used in the

industry, this term is commonly used in the pharmaceutical and nutraceutical industry.

The purpose of this instrument was used to test the breaking point and structural

integrity of a tablet prior to storage, transportation, and handling before usage. The

measurement of tablet breaking force quantifies the amount of force required to make

the sample mechanically fail. The tablets are generally placed between two parallel

platens, one of which moves and applies sufficient force to cause fracture. The results

of these measurements are easy to obtain. Early devices used to measure tablet

breaking force were hand operated usually by compressing a spring against the sample
being tested. This resulted in variations of reported results which were influenced by

human factors in the operation of the device. Later instruments were designed with

motors and electronic controls which eliminate d the effects of variable human

influences. The measurement of tablet breaking force is a key factor in laboratory and

in-process quality control.

On the other hand, Thickness and Diameter Tester are instruments that measure the

thickness of tablets in millimeters and measure the diameter of the tablet. You can

measure the tablet thickness and diameter using either mechanical or digital

instruments. The objective of the tests is to maintain uniformity of diameter and

thickness of the tablet. By maintaining the uniformity regarding the thickness and

diameter of tablets may lead to increased patient compliance by increasing the quality

of product appearance and also to prevent any confusion towards the patient about the

dosage of the medications.

Tablet Thickness Test

The amount of tablet material and the relative positions of the punches during

compression determine this. The smaller the distance between the punches, the thicker

the tablet, the more pressure is exerted during compression, and the tablet is

sometimes harder. The diameter of the tablet determines its thickness. Tablet thickness

is measured with a micrometer and a vernier caliper. Thickness should be controlled

within ± 5% variation of a standard value.

Tablet Diameter

The compression die and punches are what determine this. A die is a mold that

is used to form a product into the desired form. A punch is what forces the product

through the die making sure it takes the desired shape. They are important in the

consistency of the appearance of the tablet.

Tablet Hardness Test

Also known as “Crushing Strength Test”. For an acceptable tablet, a force of

around 4 kg is regarded as the minimum needed. A minimum of ten tablets are normally

used for measurement.

The tablet's resistance to chipping, abrasion, and fracture during storage,

transportation, and handling prior to use is called harness. In a diametric compression

test, it is the force required to break a tablet. To survive mechanical shocks during

manufacturing, packaging, and transportation, tablets require a particular level of

strength or hardness. Hardness test tablet is put between the anvils and the crushed

force that causes the tablet to break is measured.

The crushing strength of tablets is usually tested using Monsanto or Stokes

hardness tester, Schleuniger hardness tester, and the Pfizer crushing strength tester.

Factors affecting hardness:

Amount of binder- The more binder, the more hard the tablet

Method of granulation in preparing the tablet- wet method gives more

hardness than direct method. Wet method uses binder like starch and

liquid glucose.

Compression force
In testing the hardness, thickness and diameter of a tablet we used different

apparatuses such as Stokes-Monsanto Hardness Tester, Pfizer Hardness

Tester, Schleuniger Apparatus, Vernier Caliper and Micrometer caliper. These

instruments have different PRINCIPLES ON HOW THEY WORK.

First, we have the Stokes-Monsanto Hardness Tester. The working Principle of Stokes-

Monsanto Hardness Tester is that the force generated by a coil spring is applied

diametrically to break the tablet.

Next, The working principle of the Pfizer Hardness Tester works on the same

mechanical principle as ordinary pliers. The force required to break the tablet is

recorded on a dial and may be expressed in either kilogram or pounds of force. These

instruments are some of the manual apparatuses on testing the hardness of the tablet.

Meanwhile , the working principle of Schleuniger Apparatus operates without manual

involvement. Just press on the power button and place the tablet on the plunger, then

the plunger will move the tablet and exert a force required to break the tablet.

The Vernier caliper is used for measuring thickness and diameter of an object. To get a

more precise reading, the vernier caliper exploits the principle of line segment

alignment. Between the two jaws of the vernier calipers, the length of the object to be

measured is inserted. And lastly the micrometer caliper . This micrometer caliper

works on the principle of a screw and nut. It enables you to rotate the barrel-like

structure, also known as the Thimble, which is used to measure the object's distance. A

micrometer's screw is attached to the thimble, a concentrated cylinder attached to the

micrometer.
DESCRIPTION

Stokes-Monsanto Hardness Tester consists of a barrel containing a compressible

spring held between 2 plungers. The tablet is placed on the lower plunger, and the

upper plunger is lowered onto it. When its plier-like handles are gripped, the Pfizer

tester compresses the pill between a retaining anvil and a piston attached to a force-

reading gauge. The Dr.Schleuniger Pharmatron tester or Schleuniger Apparatus is used

in a horizontal position. An anvil is driven by an electric motor that compresses a tablet

at a steady rate. The tablet is cracked by being pressed on a fixed anvil. A scale

indicator is used to get a reading.

The Vernier caliper is an accurate linear measuring tool invented by Pierre

Vernier of France in 1631. It has two graduated scales: a primary scale that looks like a

ruler and a specifically graded auxiliary scale called the vernier that glides parallel to the

main scale and allows readings to be taken to a fraction of a division on the main scale.

Vernier calipers are widely used in scientific laboratories and in manufacturing for

quality control measurements. Micrometer is a C-shaped frame with a moveable jaw

driven by an integrated screw that is used to make exact linear measurements of solid

body measurements such as diameters, thicknesses, and lengths.

Regarding the PARTS AND and FUNCTIONS of the mentioned instruments. The

Stokes-Monsanto Hardness Tester has different parts and each of them has different

functions. First, the Moving jaw and fixed jaw is where the tablet is placed in between.

Moving jaw used to move the tablet and the pressure required to break the tablet apply
by the means of the screw knob. The point where the tablet breakdown will be recorded

in the scale as kg/cm².

As you can see in the picture, the Pfizer tablet hardness tester on the right side, this

manual tablet hardness tester has different Parts and functions. It has Bolts and

Piston which used to hold the loads. Press part is where you apply force to squeeze.

The Dial needle is a measurement that shows the hardness of the tablets in kg and

lastly, the Small knob is screwed at the left of the dial and it is only meant for adjusting

the needle at zero.

Schleuniger Apparatus (Tablet Hardness Tester 8M ) has different parts and functions

also. On the first image as you can see in the screen, Standard jaw is Ideal for testing

most tablet shapes. Second picture is the Grooved tongue used to assist with tablet

orientation of convex shaped tablets. Third is the Special jaw, Type I specifically

designed to test elliptically shaped tablets, fourth is the the Special jaw, Type II a 3-

point-measurement for determination of bending strength, fifth is the Special jaw, Type

III use to test the breaking force of large and small ampoules and lastly the Special

jaw, Type IV which was used as a Flexible adapter for large test objects (32 – 65mm

diameter).

Vernier calipers have different Parts and each of them has different functions. As we

can see in the picture, it has Outside jaws, Inside jaws, Depth probe (stem), Main

scale, Vernier scale, and Retainer. Outside jaws part used to measure external

diameter or width of an object opposite to it is the Inside jaws which is used to

measure internal diameter of an object.The Depth probe (stem) used to measure

depths of an object or a hole. Main scale gives measurements in mm. The

Vernier scale gives measurements up to one decimal place in mm. The vernier caliper

is a smaller scale attached to the main scale and can move along the main scale as the

jaws are opened or closed. This vernier scale provides accuracy to the reading of the

main scale by further dividing the lowest reading of the main scale into increments.

Lastly the Retainer used to block movable parts to allow the easy transferring of a

measurement.

Micrometer tool has different Parts and functions, those are Ratchet knob, Frame, Anvil,

Thimble,spindle, and lock nut. Ratchet knob was used to stop the finely threaded screw

when the pressure on the object being measured is sufficient. The Frame is like a

horse-shoe-shaped part that supports the anvil and a graduated device from which the

measurement is read. Anvil is a cylindrical part that is attached to the frame of the

micrometer to support the object to be measured. The Thimble is a graduated cylindrical

part that is activated by the finely threaded screw and measures the thickness

with precision. Spindle is a cylindrical end of the finely threaded screw. Lastly, the Lock

nut is a ring-shaped part that locks or controls the spindle movement.

APPLICATIONS

Tablet Thickness and Diameter Test

This test is employed in order to determine the correct uniformity of the produced

tablets to ensure standardization and quality control requirements. The usage of a

handheld or electronic micrometer and/or a vernier caliper helps in measuring the drug

product’s accurate measurement - which is essential in the pharmaceutical industry.

Tablet Hardness Test

Tablet hardness tests are required to be employed on tablets as a way of

knowing how sturdy or just to have a perspective on how the drugs last in its shelf life or

when shipping and it undergoes blunt force from being thrown around. Sturdiness is a

vital attribute of drugs as they are manufactured and are placed inside parcels and then

shipped into warehouses and lastly to pharmacies which also has an effect to the drug’s

bioavailability.

OPERATION

There are several devices operating to test tablet hardness. We have Monsanto or

Stokes hardness tester, Pfizer crushing strength tester, and Schleuniger Apparatus

hardness tester.

Monsanto or Stokes hardness tester: https://youtu.be/GEsZkte2rR0

1. Place the sample tablet in the vertically holding edges of the anvil

of Monsanto Hardness Tester.

2. Adjust the pointer at zero position on the scale by rotating the

screw in forward direction.

3. Now rotate the screw till break point of the tester.

4. The breakage of the tablet shows hardness on the scale.

5. Repeat the procedure 8-10 times for average reading. Record the

observation.

Pfizer crushing strength tester: https://youtu.be/N-6k7XoIDrI (2:10 start)

 1. Place the sample tablet in between the grips of the bolt and the

piston.

2. Squeeze the cross handle like scissors.

3. During pressing , the piston goes upward and pushes the dial

needle.

4. The dial needle stops where the tablet breaks which shows the

hardness of the tablets in kgs.

Schleuniger Apparatus hardness tester: https://youtu.be/gao5NO55_X8

1. Tablets are placed in the machine individually and by hand.

2. Press and hold ‘start’.

3. Press start again to select “set valid number of measurements”

4. Press stop if done

These are the ways to operate instruments in measuring their Thickness.

Vernier caliper:

1. Unlock the lock screw and press the thumb crew down. Open the

jaws.

2. Close the jaws around the object you want to measure or, for inside

measurements, open them until the fill gap you wish to measure, or

insert the depth rod into the hole you wish to measure.

3. Tighten the lock screw so that the jaws do not move.

4. Now read the scale.

Micrometer:

1. Open the micrometer by turning the thimble or ratchet.

 2. Place the object to be measured between the spindle and anvil

3. Close the spindle by turning the ratchet. (The ratchet prevents

excess pressure on the object being measured, so you don’t

squash it and get a false reading.

4. Now read the scale.

The pharmacopoeial standard for tablet diameter uniformity is followed. According to

Pharmacopoeia standard, for tablets with a diameter of less than 12.5 mm, the

percentage average deviation value must not exceed ± 5% , and for tablets having a

diameter of 12.5 mm or more, it must not exceed ± 3%. In order to identify whether the

tablet's diameter be accepted or rejected based on the standard, it is being calculated

first.

CALCULATIONS

As we are only conducting this report online we’ve gathered sample calculations

from the internet which demonstrates how the numbers we get from the instruments are

calculated and how we are able to arrive at an accurate measurement.

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.
 2. Then the value of the diameter, thickness, and hardness is taken.

The

deviation of each is calculated and the deviation of individual units 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:

The table indicates the results for the 10 sample tablets. With each column

describing the factor by which tablets are measured using the proper instruments. Both

thickness and diameter were recorded with millimeters as its units while on the other

hand tablet hardness was recorded with Newtons - in order to clearly depict the

processes these sample tablets were subjected into.

The deviation can be calculated based on the equation below:

In order for us to be able to solve and understand why there is deviation in the results

for the tablets’ diameters we can employ this formula.

By following this formula we were able to obtain these results as seen in the table.

For the interpretation of the results,

The thickness, diameter, and hardness of 10 Uphamol Cold and Flu tablets are

measured in this experiment. Based on the results, the diameter of all the tablets is less

than 12.50mm, and the variance does not exceed 5% based on the calculations. As a

result, the uniformity of tablet diameter adheres to the pharmacopoeial standard. Each

tablet with a diameter greater than 12.5mm should have a variance of no more than 3%,
whereas tablets with a diameter less than 12.5mm should have a deviation of no more

than 5%. We can infer that all of the tablets pass the test based on the PHARMATEST

PTB 311 measurements, as the deviation of each diameter for each tablet is within the

acceptable limit on pharmacopoeial standard

CONCLUSION

Through this presentation we can conclude that It's essential to keep tablet

hardness, diameter, and thickness - consistent in order to make high-quality tablets, as

each characteristic has its own purpose. Moreover, the therapeutic impact of good

tablets will be enhanced which results in better health outcomes for patients.