Disintegration Testing in Pharmaceutical Industry

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What is the rationale for using the disintegration test?

To assess the availability of the drug in the body

What is the purpose of the disintegration test?

To determine the time required for a solid dosage form to disintegrate into its constituent particles

What does the disintegration test offer no assurance of?

The release of the drug in solution at an appropriate rate

What is the composition of the disintegration apparatus?

A basket and rack assembly with six open-ended transparent tubes

Why must a drug be in solution to be readily available to the body?

To facilitate absorption and distribution in the body

What is the relationship between tablet breakdown and drug availability in the body?

Increased tablet breakdown leads to increased drug availability

What is the definition of complete disintegration?

When any residue remains as a soft mass with a palpable firm core

What is the immersion fluid for uncoated tablets, buccal tablets, and sublingual tablets?

Water at about 37˚C

What factor affects the disintegration time by decreasing the tablets' wettability?

Quantity and quality of the disintegrant and lubricant

What happens if after 1 hour in the acid stage no evidence of disintegration is observed for delayed-release tablets?

Proceed to buffer stage

What is the temperature requirement for the buffer stage of delayed-release tablets?

37 ±2°C

What is the criteria for effervescent tablets to be considered fully disintegrated?

Numerous bubbles of gas are evolved after 5 minutes

What is the requirement for uncoated USP tablets' disintegration time?

As low as 5 minutes to 30 minutes

How many tablets need to disintegrate when 6 tablets are tested for uncoated or plain coated tablets?

All 6 tablets

What is the requirement if 18 tablets are tested for uncoated or plain coated tablets?

At least 16 tablets need to disintegrate

Test your knowledge about disintegration testing, which is used to check the complete breakdown of tablets and capsules into smaller particles or granules within a standard time period. Understand the significance of disintegration in making drugs readily available for the body.

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