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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.
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.
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
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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.
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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.
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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.
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Disadvantages:
Disintegration test cannot be relied upon for the assurance of bioavailability.
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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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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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Methods or Procedures
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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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Methods or Procedures
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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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Methods or Procedures
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Methods or Procedures
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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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Methods or Procedures
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Methods or Procedures
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Methods or Procedures
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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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Methods or Procedures
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Methods or Procedures
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Methods or Procedures
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Methods or Procedures
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Formulation
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.
USP Specifications |
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Formulation
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
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.
USP Specifications |
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Formulation
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
Buccal Tablets
Sublingual Tablets
USP Specifications |
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Formulation
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
Modified release Disintegration test not applicable capsules Modified release Disintegration test not applicable tablets
USP Specifications |
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Instrumentations:
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Instrumentations:
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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:
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Disc
disks and metal contact plate
Instrumentations:
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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
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6 Holes
2 mm Wall Inside diameter of NLT 21.0mm and NMT 22.5mm Disk Screen
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Instrumentations:
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Instrumentations:
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Instrumentations:
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Instrumentations: Acoustic signal at end of test Constant monitoring of time and temperature (displayed on LCD screen)
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Instrumentations:
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Instrumentations:
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Instrumentations:
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Instrumentations:
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Thank you
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