The specifications of the disintegration test apparatus are crucial to ensure accurate and consistent results when evaluating the quality of immediate-release tablets. Each component and the movement of the apparatus are precisely designed to simulate conditions within the human body, ensuring reliable drug release.

Importance of the Apparatus Design:

1. Basket-Rack Assembly: The vertical movement of the basket-rack ensures that all tablets are evenly exposed to the disintegration medium. The absence of horizontal motion means the tablets are affected only by the fluid, not by mechanical forces, ensuring consistent disintegration.
2. 1000-mL Beaker: The beaker’s size is specified to provide sufficient space for the basket-rack assembly and the fluid. This ensures the tablets are fully immersed in the medium, facilitating proper disintegration as it would occur in the digestive system.
3. Temperature Control: Maintaining the fluid at a temperature of 35°C to 39°C is essential, as it mimics the human body’s natural temperature. This is critical for ensuring that the tablets disintegrate under conditions similar to those in the gastrointestinal tract.
4. Cycle Frequency and Stroke Distance: The apparatus moves the basket at a rate of 29 to 32 cycles per minute, with a stroke distance of 53 to 57 mm. These parameters are important to apply consistent mechanical stress to the tablets, promoting uniform disintegration.
5. Fluid Volume and Immersion: The basket stays 15 mm below the surface of the fluid at its highest point and descends to at least 25 mm from the bottom at its lowest point. This ensures the tablets remain submerged throughout the test, without the basket becoming fully immersed, which could interfere with accurate results.
6. Smooth Motion Transition: The smooth change between upward and downward strokes prevents abrupt movements, which could cause irregularities in tablet disintegration. This helps simulate the natural conditions in the body more effectively.

Why This Is Important:

This detailed apparatus setup is critical for ensuring that the disintegration test produces reliable, repeatable results. It verifies that immediate-release tablets break down within the required time, ensuring they release their active ingredients appropriately for absorption. By adhering to these precise conditions, the test helps guarantee the tablet’s efficacy in real-world use.