Disintegration Test Apparatus Usages and Calibration
This article describes about Disintegration Test , Apparatus used for this test, Usages/operation and calibration of apparatus.
What is mean by Disintegration Test
Disintegration is defined as that state no residue of the unit under test remains on the screen of the apparatus or if residue remains it consists of Fragments of disintegrated parts of tablets components parts such as insoluble coating of tablets or of capsule shell. If discs is used with the capsule any residue remaining on the lower surface of the discs consists only fragments of shell.
Why Disintegration Test is important as a in process checks in OSD Formulations ?
Disintegration testing is an important in-process check in oral solid dosage (OSD) formulations because it ensures that the tablet or capsule will break down and release the active pharmaceutical ingredient (API) in a timely manner.
In the disintegration test, the tablet or capsule is placed in a disintegration apparatus that simulates the physiological conditions of the gastrointestinal tract. The time taken for the tablet or capsule to disintegrate into small particles is recorded. The disintegration time of a tablet or capsule should comply with the pharmacopeial standards to ensure that the drug product is of good quality.
If the disintegration time of a tablet or capsule is too long, it may result in delayed or incomplete release of the active ingredient, leading to reduced efficacy.
Therefore, the disintegration test is an important in-process check that ensures that the OSD formulation meets the required quality standards and provides optimal therapeutic benefit to the patient.
volume of water in beaker during disintegration test as per IP
As per Indian Pharmacopeia the volume of the liquid is such that the wire mesh at its highest point is at least 25 mm below the surface of the liquid and its lower point is at least 25 mm above the bottom of beaker.
If product is complying to USP/BP/EP then during disintegration test, water level should be maintained in such a way that above specification should comply. beakers should be calibrated and marked accordingly.
volume of water in beaker during disintegration test as per USP 701/BP/EP 2.9.1
The Volume of the liquid is such that when the assembly is in the highest position, the wire mesh is at least 15 mm below the surface of the liquid and when the assembly is in the lowest position the wire mesh is not less than 25 mm above the bottom of beaker.
Calibrations of Disintegration test Apparatus :
1) Procedure to check Stroke/Minute :
2) Procedure to check Distance covered by shaft :
Step V : Repeat the procedure for Three Times and results should comply as per specified limit
3) Procedure to check Temperature of Beaker water:
Step IV : Repeat the procedure for Three Times and results should comply as per specified limit
4) Procedure to check Aperture size of the basket wire mesh :
Methodology to check the disintegration testing :
- Switch on the instrument
- Wait till temperature of the water in the beaker up to 37 degree Celsius.
- Put the Six tablet in each Tube and start the apparatus
- Check visually in all tube after every stipulated time to check the disintegration time
- wait Till last tablet disintegrate from the mesh and then apparatus will be stopped
- Then starting of the apparatus to till stopping of the apparatus will be your disintegration time of the tablets.
Specification Limit for Disintegration of Uncoated , Film Coated Tablets/Capsule :
If one or two tablets or capsules fails to disintegrate, repeat the test on 12 additional tablets or capsules. Not less than 16 of the total 18 tablets or capsules tested should be disintegrate.
For Disintegration Test general chapter as per USP 701 plz click on below link
https://www.usp.org/sites/default/files/usp/doc
For Disintegration Test general chapter as per European Pharmacopeia or EP 2.9.1 plz click on below link
http://uspbpep.com/ep50/2.9.1.%20disintegration%20of%20tablets%20and%20capsules.pdf
