Disintegration Testing in Pharmaceutical Industry

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Questions and Answers

What is the rationale for using the disintegration test?

To increase the surface area of the tablet for faster dissolution

To ensure that the resultant particles will release the drug in solution at an appropriate rate

To break down the tablet into smaller particles or granules

To assess the availability of the drug in the body (correct)

What is the purpose of the disintegration test?

To assess the availability of the drug in the body

To check the dissolution of a tablet and capsule in a standard time period

To ensure that the resultant particles will release the drug in solution at an appropriate rate

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

What does the disintegration test offer no assurance of?

The readiness of the drug to be available to the body

The release of the drug in solution at an appropriate rate (correct)

The complete breakdown of a tablet and capsule

The availability of the drug in the body

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

Study Notes

Disintegration Test Overview

The disintegration test is crucial for assessing how quickly a tablet breaks down in the digestive system.
Ensures drugs are delivered in a timely manner, influencing their effectiveness and bioavailability.
This test does not guarantee dissolution; disintegration is only one step in the absorption process.

Disintegration Apparatus

The apparatus generally includes a stainless steel basket, a rack to hold tablets, and immersion fluid.
Immersion fluid varies for different tablet types (e.g., water or a specific buffer for uncoated, buccal, and sublingual tablets).

Drug Availability

A drug must be in solution for optimal bioavailability, allowing it to be absorbed efficiently by the body.
There is a direct relationship between how fast a tablet disintegrates and how quickly the drug becomes available in systemic circulation.

Definitions and Standards

Complete disintegration is defined as the total breakdown of a tablet into particles that can dissolve and be absorbed.
For uncoated tablets, the immersion fluid is typically water; buccal and sublingual tablets may require specific solutions to simulate conditions in the mouth.

Factors Influencing Disintegration

Wettability influences disintegration time; poor wettability can prolong the time required for a tablet to dissolve.
If no disintegration is observed after one hour in the acid stage for delayed-release tablets, it indicates potential failure for intended release.

Buffer Stage Requirements

Delayed-release tablets must undergo a specific temperature requirement during the buffer stage to ensure proper transition to the gastrointestinal tract.

Criteria for Tablet Types

Effervescent tablets are considered fully disintegrated when they completely dissolve in liquid, producing effervescence.
Uncoated USP tablets must disintegrate within specified time limits, typically within 15-30 minutes.

Testing Parameters

In a test of six uncoated or plain coated tablets, at least five must disintegrate within the allotted time.
If eighteen tablets are tested, fifteen must comply with the disintegration criteria to meet quality standards.

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Description

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.