Disintegration Testing in Pharmaceutical Industry

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 Signup and view all the answers

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

To facilitate absorption and distribution in the body Signup and view all the answers

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

Increased tablet breakdown leads to increased drug availability Signup and view all the answers

What is the definition of complete disintegration?

When any residue remains as a soft mass with a palpable firm core Signup and view all the answers

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

Water at about 37˚C Signup and view all the answers

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

Quantity and quality of the disintegrant and lubricant Signup and view all the answers

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

Proceed to buffer stage Signup and view all the answers

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

37 ±2°C Signup and view all the answers

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

Numerous bubbles of gas are evolved after 5 minutes Signup and view all the answers

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

As low as 5 minutes to 30 minutes Signup and view all the answers

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

All 6 tablets Signup and view all the answers

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

At least 16 tablets need to disintegrate Signup and view all the answers