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.