DISINTEGRATION TESTS

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Table of Contents
Section
I 2. 3 4 5 6

Section Name
Introduction of Disintegration test Application and Uses Advantages and disadvantage General Principles involved in testing Different Methods Instrumentation (Models)

Disintegration Tests

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Disintegration Test
It is a measure of the time required under a given set of conditions for a group of tablets to disintegrate into particles which will pass through a 10 mesh screen. The test is useful as a quality assurance tool for conventional dosage forms.

Introduction of Disintegration Tests

For a drug to be absorbed from a solid dosage form after oral administration, it must first be in solution, and the first important step toward this condition is usually the breakup of the tablet; a process known as disintegration.
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Disintegration Test
It is a method to determine the resistance or disintegration of solid preparations for internal use in the test fluids. Dosage forms: Tablets, tablet coated with suitable coating agents, pills, capsules, granules or enteric coated preparations.

Introduction of Disintegration Tests

This method is not applied for preparations exceeding 20.00 mm in diameter, for sustained release preparations, or for preparations which subject to the Dissolution Test.
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1.To find out the time it takes for a solid oral dosage form to completely disintegrate. The time of disintegration is a measure of the quality
Ex: Disintegration time too high Tablet too highly compressed Capsule shell gelatin not of pharmacopoeial quality

Application and Uses:

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2.Disintegration test is a simple test which helps in the preformulation stage to the formulator. 3. It helps in the of manufacturing variables, such as compressional force and dwell time.

Application and Uses:

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4.This test is also a simple in-process control tool to ensure uniformity from batch to batch and among different tablets. 5.It is also an important test in the quality control of tablets and hard gelatin capsules.

Application and Uses:

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Advantages:
This test is simple in concept and in practice. It is very useful in preformulation, optimisation and in quality control.

Advantages and disadvantages:

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Disadvantages:
Disintegration test cannot be relied upon for the assurance of bioavailability.

Advantages and disadvantages:

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Principles Involved in Disintegration Apparatus

Discs are used in the disintegration test to avoid the Floating of tablet when immersed in the medium ,so that equal disintegration occurs in all the tablets under testing.

Principles Involve

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Principles Involve
Ex: Enteric coated ones the usual procedure is first we are dipping in HCl to mimic the gastric fluid medium and then we are using an alkaline medium to dissolve the enteric coated phalate layers mimicking the intestinal environment. |
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The usual medium used is water (neutral) for most of the dosage forms; In some cases we are using acidic and basic medium case

Principles Involve
In general the specification of temperature is not so important in case of solid dosage forms where as in case of semi-solid dosage forms being made of lipids temperature should be specified in-order to avoid melting of lipids. The use of discs is to avoid floating of dosage units ensuring uniform exposure of medium to all the surfaces of the dosage unit.

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Disintegration Test Methods

The disintegration test for each dosage form is given in the pharmacopoeia. There are some general tests for typical types of dosage forms. However, the disintegration test prescribed in the individual monograph of a product is to be followed.

Methods or Procedures

 If the monograph does not specify any specific test, the general test for the specific dosage form may be employed.

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Disintegration Test Methods

General Procedure: 1. Attach the basket-rack assembly to the bearing, immerse in fluid in a beaker, and adjust the apparatus so as to raise and lower the basket smoothly at a constant frequency of 29 to 32 cycles per minute through a distance of 53 to 57 mm.

Methods or Procedures

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Disintegration Test Methods

General Procedure:

Methods or Procedures

2. At the lowest point of the downward stroke, the wire mesh must be 25 mm distant from the bottom of the beaker and the volume of the fluid in the beaker is such that, at the lowest point of the downward stroke, the top of the basket is on a level with the surface of the fluid. Maintain the temperature of the fluid at 37 2oC during the test.

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Disintegration Test Methods

General Procedure: 3. Place the Sample, except for granules, to be tested in each of the 6 tubes of the basket, immerse the basket in a suitable volume of test fluid, maintained in a beaker at the desired temperature, and operate the apparatus for the directed period of time.

Methods or Procedures

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Disintegration Test Methods

General Procedure:

Methods or Procedures

4. At the end of that period, lift the basket gently from the fluid to permit the observation of the samples in the glass tubes. When it is directed to put auxiliary disks in the tubes, place a sample in each tube, then put the disk gently in each tube with the upper side up, and proceed as directed above. If the determination is difficult, the auxiliary disk may be omitted.
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 Hard Gelatin Capsules

Apply the test for Uncoated Tablets. Attach a removable wire cloth, which has a plain square weave with 1.8- to 2.2-mm mesh apertures and with a wire diameter of 0.60 to 0.655 mm, as described under BasketRack Assembly, to the surface of the upper plate of the basket-rack assembly.

Methods or Procedures

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 Hard Gelatin Capsules

Observe the capsules within the time limit specied in the individual monograph: all of the capsules have disintegrated except for fragments from the capsule shell.

Methods or Procedures

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 Soft Gelatin Capsules

Proceed as directed under Hard Gelatin Capsules.

Methods or Procedures

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 Uncoated Tablets
Place 1 tablet in each of the six tubes of the basket and operate the apparatus, using distilled water as meduim and maintained at 37oC the immersion uid unless otherwise specied in the individual monograph. 15 minutes

Methods or Procedures

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 Uncoated Tablets
At the end of the time limit specied in the monograph, lift the basket from the uid, and observe the tablets: all of the tablets have disintegrated completely.

Methods or Procedures

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 Plain Coated Tablets

Apply the test for Uncoated Tablets, but the time of operation is 30 minutes.

Methods or Procedures

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 Delayed-Release (Enteric Coated) Tablets

Place 1 tablet in each of the six tubes of the basket and, Suspend the assembly in a beaker with 0.1 M Hcl. Operate without discs for 2 hrs. (Unless otherwise stated in the monograph). Remove the set up from the liquid.

Methods or Procedures

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 Delayed-Release (Enteric Coated) Tablets

Replace the liquid in beaker with mixed phosphate buffer of pH 6.8 and, Add a disc to each tube and operate the apparatus for further 1 hr. Remove the apparatus from the liquid. If no residue remains on the screen, then the six tablets are said to be completely disintegrated.

Methods or Procedures

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 Delayed-Release (Enteric Coated) Tablets

Operate the apparatus, using simulated intestinal uid TS maintained at 37 C as the immersion uid, for the time specied in the monograph. Lift the basket from the uid, and observe the tablets: all of the tablets disintegrate completely.

Methods or Procedures

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 Buccal Tablets
Apply the test for Uncoated Tablets. After 4 hours, lift the basket from the uid, and observe the tablets: all of the tablets have disintegrated.

Methods or Procedures

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 Sublingual Tablets
Apply the test for Uncoated Tablets. Observe the tablets within the time limit specied in the individual monograph: all of the tablets have disintegrated.

Methods or Procedures

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 Pessaries and Suppositories

Place a pessary or a suppository on the lower perforated disc of the metal device. Insert the device into the cylinder and attach this to the sleeves. The same operation is repeated with further two pessaries or suppositories and metal devices and sleeves.

Methods or Procedures

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 Pessaries and Suppositories

If specified, place each piece of apparatus in a vessel containing 4 liters of water at a temperature of 36-37 c, fitted with a slow stirrer and a means of holding the top of apparatus 90 mm below the surface of water. Alternatively, all the three pieces of apparatus may be placed together in a vessel containing 12 liters of water.

Methods or Procedures

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 Pessaries and Suppositories

After each 10 min invert each apparatus without removing from the liquid. Disintegration is said to be completed when the moulded pessary or suppository: is completely dissolved has dispersed into its component parts or remains on the surface (in the case of melted fatty substances)

Methods or Procedures

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 Pessaries and Suppositories

sinks to the bottom(in the case of insoluble powders) dissolves (in the case of soluble components) Or may be distributed in one or more of these ways: - has become soft with appreciable change in shape - consisting of only a soft mass having no solid core which cannot be pressed with a glass rod.

Methods or Procedures

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Formulation

United States Pharmacopoeia 2009

Hard Gelatin Capsules

Same as uncoated tablets. Use a circular cloth mesh of diameter 0.600.655mm & 1.8-2.2mm square mesh size. No palpable material to remain on the mesh. Same as uncoated tablets. Use a circular cloth mesh of diameter 0.600.655mm & 1.8-2.2mm square mesh size. No palpable material to remain on the mesh.

Soft gelatin capsules

USP Specifications |
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Formulation

United States Pharmacopoeia 2009

Uncoated tablets

Uses disintegration apparatus with specified liquid medium & for specified time as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative. Same as uncoated tablets. Uses disintegration apparatus with specified liquid medium & for 4 hours or as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

Chewable tablets

USP Specifications |
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Formulation

United States Pharmacopoeia 2009

Non-film coated tablets

Same as uncoated tablets. Uses disintegration apparatus with specified liquid medium & for specified time as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative. Same as uncoated tablets. Uses disintegration apparatus with specified liquid medium & for specified time as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

Film coated tablets

USP Specifications |
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Formulation

United States Pharmacopoeia 2009

Gastro resistant tablets (Enteric Coated)

Uses disintegration apparatus with stimulated gastric fluid TS at 37+-2OC for 1 hour, if there is no cracking or breaking of coat, continue with stimulated intestinal fluid at same temperature for specified time as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

USP Specifications |
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Formulation

United States Pharmacopoeia 2009

Buccal Tablets

If 1 or 2 tablets fail to disintegratecompletely,

repeat the test on 12 additional tablets: not less than 16 ofthe total of 18 tablets tested disintegrate completely. If 1 or 2 tablets fail to disintegrate completely, repeat the test on 12 additional tablets: not less than 16 of the total of 18 tablets tested disintegrate completely.

Sublingual Tablets

USP Specifications |
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Formulation

United States Pharmacopoeia 2009

Suppositorie s

Uses disintegration apparatus with water R or specified liquid medium & for 30 min. for suppositories with fatty base and for 60 min. for suppositories with water soluble base. If 12 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

Effervescent A total of 6 units tested Uses 200ml of water tablets R at 15-25OC. Disintegrates within 5 min. or as per monograph. If 1-2 fail, repeat for 12 different units. 16 out of 18 indicate test is affirmative.

USP Specifications |
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Formulation

United States Pharmacopoeia 2009

Modified release Disintegration test not applicable capsules Modified release Disintegration test not applicable tablets

USP Specifications |
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Apparatus for Tablets and Capsules:

It consists of: Basket-rack assembly Beaker (1 L capacity) Thermostat arrangement Mechanical device (raising and lowering the basket) Immersion fluid.

Instrumentations:

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Basket- rack assembly

Basket made of transparent polyvinyl or other plastic material It consists of six cylindrical glass tubes (length: 77.5+/- 2.5 cm long, internal diameter: 20.7 - 23 mm, wall thickness: 1.0-2.8 mm).

Instrumentations:

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Basket- rack assembly

The tubes are held in position by two superimposed transparent plastic plates, perforated by six holes having the same diameters as the tubes. (Diameter: 8.8-9.2mm thickness: 5-7mm)

Instrumentations:

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Basket- rack assembly

To the underside of the lower plastic plate is a woven stainless steel wire cloth with a plain square weave with 1.82.2mm mesh apparatus and with a diameter of 0.600.665mm.

Instrumentations:

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Basket- rack assembly

The upper plate is covered with a six holed stainless steel disc, each about 24+/- 2 mm in diameter, which fits over the tubes and holds them between the plastic plates.

Instrumentations:

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Basket- rack assembly

Instrumentations:

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Disc
A cylindrical disc made of transparent plastic is provided for each tube, (Diameter: 20.7+/0.15 mm; thickness: 9.5+/- 0.15; relative density: 1.18- 1.20).

Instrumentations:

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Disc
In each disc there are five holes (diameter of 2mm) one in the center and four surrounded equidistantly on a circle of radius 6 mm from the centre are provided.

Instrumentations:

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Disc
Four equally trapezoidal shaped grooves are cut in the lateral surface of the disc they are 9.5 mm wide and 2.25mm deep at the lower surface 1.6mm square.

Instrumentations:

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Disc
disks with metal contact ring and metal needles

Instrumentations:

Disks with ring (no needle)

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Disc
disks and metal contact plate

Instrumentations:

Standard Disintegra tion USP/EP Disks

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Medium
The assembly is to be suspended in a 1L beaker. The volume of the liquid is such that the wire mesh at its highest point is atleast 25mm below the surface of the liquid, and its lowest point is atleast 25 mm above the bottom of the beaker; one must make sure that the top of the basket rack assembly shouldnt be submerged.

Instrumentations:

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Heating Device
There is a thermostat arrangement for heating the liquid and maintaining the temperature at 35 and 39oC

Instrumentations:

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Instrumentations: Mechanical Device Basket-rack assembly Heating Device Individual glasstube Disc Sieve meshes
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Diagram of Assembly Apparatus Basket-rack Assembly Basket-rack Assembly Cylinder in down position Level f Liquid at 37oC 2.5L of Medium

Instrumentations:

Support

Device for Raising and lowering Basket-Rack Assembly

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Diagram of Glass Tube, Plastic Disk, and Plunger

Wire Rod (3.2 cm x 9 cm) 12 Holes

6 Holes

2 mm Wall Inside diameter of NLT 21.0mm and NMT 22.5mm Disk Screen
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Apparatus for Pessaries and Suppositories

A transparent sleeve made of glass or plastic. (Height: 60mm, Internal Diameter: 52 mm; appropriate wall thickness). A metal device consisting of two stainless discs; each of which contains 39 holes, each 4 mm in diameter.

Instrumentations:

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Apparatus for Pessaries and Suppositories

The discs are separated by a distance of 30 mm. The metal device is attached to the outer sleeve by means of three equally shaped hooks; also the diameter of disc is closely similar to the internal diameter of the sleeve.

Instrumentations:

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Suppositories Disintegration Tester

3 independent test stations perform tests simultaneously All test cylinders turn 180 o C ( 10 mins) Test cylinders turning interval can be programmed from 1 min to 99 min Removable thermostat can be programmed to maintain temperature between 30 o C to 50 o C (+/- 0.5 o C) in the bath

Instrumentations:

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Suppository Disintegration Test PTS-3E

According to the Pharmacopoeia monograph 3 samples are tested at the same time. The total testing period can be pre-set within a range of 1 minute to 10 hours. When used to test suppositories the sample baskets will turn automatically each 10 minutes through 180 degrees as specified in the relevant monograph.

Instrumentations:

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Suppository Disintegration Test PTS-3E

Automatic rotation through 180 degrees when suppositories are tested Selectable cycling time for 1 - 10 Min. Programmable testing time for 1 min. to 10 hours Digital display of elapsed testing time Recall pre-set total time

Instrumentations:

Basket sample Holder Complete

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Suppository Disintegration Test PTS-3E

Built-in circulation thermostat, adjustable for 30C - 40C +/- 0.5C accuracy Simultaneous test of 3 samples possible as per EP monograph Heating system protected against grease intrusion Water bath volume > 12 L

Instrumentations:

Basket Including Suppository

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Single Basket Disintegration Apparatus

The cylinder moves up and down 30 to 32 cycles/min. In one liter beaker filled with distilled water, maintained at 37 c + 2 c by thermostatically controlled hot plate complete with beaker of `borosil` to work on 220/230 volts, with wire and plug, ready to switch on

Instrumentations:

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Double Basket Disintegration Apparatus

Double basket unit , equipped with water bath designed to conduct disintegration tests as per new IP & USP standards. Temperature of the water bath is precisely controlled by sensitive thermostat.

Instrumentations:

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Triple Basket Disintegration Apparatus

It is suitable for tablet and capsule disintegration testing as per USP<701/2040> and EP<2.9.1/2.9.1.2> Operates 3 Baskets which are connected to a central stroke arm

Instrumentations:

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Automatic Tablet Disintegration Testing

Automatic measuring of tablet thickness Graphical display of disintegration characteristics over time (curve) Precise inductive measuring technology Corrosion-free Self-centering magnetic baskets Fast and easy cleaning 100% USP and EP compliant design

Instrumentations:

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Instrumentations:

Automatic tablet disintegration tester with single testing station

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Instrumentations:

Automatic tablet disintegration tester with two independent testing stations

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Instrumentations:

Automatic tablet disintegration tester with three independent testing stations

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Instrumentations:

Automatic tablet disintegration tester with four independent testing stations

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Manual Disintegration Testing

Pharmacopoeia compliance and qualification Simple operation Quick-release basket design One-piece water bath Independent heater / circulator Low liquid-level sensor

Instrumentations: Acoustic signal at end of test Constant monitoring of time and temperature (displayed on LCD screen)

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Instrumentations:

Manual Disintegration Testing

ONE TEST STATION

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Instrumentations:

Manual Disintegration Testing

TWO TEST STATION

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Instrumentations:

Manual Disintegration Testing

THREE TEST STATION

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Instrumentations:

Manual Disintegration Testing

THREE TEST STATION

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Thank you

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