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Disintegration Testing of Oral Solid Dosage Forms

This module answers the “why” and “how” of a disintegration test, and best practices to follow while performing disintegration testing.

  • Introduction to disintegration and dissolution and their role in bioavailability of drugs in the human body.

  • Factors impacting disintegration and disintegration test

  • Disintegration testing apparatus A and B

  • Setting up of the apparatus and its calibration

  • Setting the disintegration specifications such as temperature, strokes per minute etc.

  • Conducting the test and evaluating results as per the acceptance criteria

  • Precautions to be followed while handing the disintegration apparatus

Why it matters

Efficacy of many drugs is dependent on its disintegration in solution.. Disintegration is the process that breaks the drug down into smaller particles or granules\, thereby helping it in solubilization and absorption in the patient body. Disintegration testing is used to determine whether tablets or capsules disintegrate within a specified time under prescribed experimental conditions. Therefore\, it is important to be trained to perform this test accurately.

Who is it for

This course is ideal for quality control and quality assurance team members who conduct and evaluate test results prior to batch releases

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