Evaluation of tablets Disintegration test

Summary

In this video, Amit Belekar from Tips and Tricks by AMB introduces the disintegration test, a key evaluation method for tablets. The video explains the importance of disintegration in ensuring drug absorption and details the apparatus and procedure for the test. The video also covers the operational modifications for various tablet types, including uncoated, coated, and enteric-coated tablets, while outlining criteria for passing the test. Amit concludes by summarizing the key points and encouraging viewers to subscribe and engage with the content.

Takeaways

• 💊 Tablets must undergo disintegration tests to ensure consistent effectiveness after administration.
• 📊 Disintegration is the process of breaking a tablet into smaller pieces, and disintegration time is the period it takes for this to occur.
• 📏 The disintegration test apparatus consists of a basket-rack assembly, a beaker, and cylindrical guide discs.
• 🕒 The disintegration time is generally set at 15 minutes unless specified in a specific monograph.
• 📐 The test procedure differs based on the type of tablet (e.g., uncoated, coated, enteric-coated).
• 📦 For uncoated tablets, the test passes if all tablets disintegrate within the specified time, and specific rules apply if one or two fail.
• 💧 Coated tablets require an additional step of testing in water and, if needed, in 0.1 N HCl for confirmation.
• 🧪 Enteric-coated tablets are tested in an acid medium (0.1 N HCl) for 2 hours and later in a phosphate buffer solution at pH 6.8.
• ⏱ Disintegration times for dispersible and effervescent tablets are 3 minutes and 5 minutes, respectively.
• 📋 Disintegration is crucial for drug absorption as it directly impacts dissolution and effectiveness.

Q & A

What is the purpose of the disintegration test for tablets?

The disintegration test is used to evaluate how long it takes for a tablet to break into smaller pieces or particles after administration. This ensures that each tablet will start to take effect in the body at the same time after ingestion.

When is the disintegration test required, and when is it not necessary?

The disintegration test is required for tablets that are swallowed orally. It is not necessary for tablets dissolved in the mouth (e.g., lozenges), chewable tablets, or tablets that are dissolved in water before administration, such as effervescent tablets.

What factors influence the disintegration time of a tablet?

The disintegration time of a tablet depends on the composition of the tablet, specifically the excipients used in its formulation.

What is the standard disintegration time for a tablet if not specified in a drug’s monograph?

If the disintegration time is not specified in the drug’s monograph, it is typically considered to be 15 minutes.

What are the main components of the disintegration test apparatus?

The main components of the disintegration test apparatus are the basket-rack assembly, a beaker, and cylindrical guide discs. The basket-rack holds the tablets in glass tubes and moves them in the liquid medium to simulate disintegration.

How is the disintegration test for uncoated tablets performed?

For uncoated tablets, six tablets are placed in the tubes of the basket-rack assembly, which is then immersed in a liquid medium at 37 ± 2°C. The basket-rack moves up and down at 28 to 32 times per minute, and the test lasts 15 minutes. The tablets must completely disintegrate for the test to pass.

What additional steps are taken when testing coated tablets?

For coated tablets, the tablets are first immersed in water at room temperature for 5 minutes before the discs are added. After that, the apparatus is operated in a liquid medium at 37 ± 2°C. If any tablets fail to disintegrate after 60 minutes, the test is repeated with 0.1 N HCl.

What is the procedure for testing enteric-coated tablets?

Enteric-coated tablets are first tested in 0.1 N HCl (which simulates stomach conditions) for 2 hours. If no signs of disintegration are seen, the test continues in mixed phosphate buffer (pH 6.8, simulating intestinal conditions) for 60 minutes. The tablets must disintegrate in the buffer for the test to pass.

What is the disintegration time for dispersible and effervescent tablets?

The disintegration time for dispersible tablets is 3 minutes, while for effervescent tablets, it is 5 minutes.

What are the key points summarized in the presentation regarding disintegration?

The key points include the definition of disintegration (breaking the tablet into smaller particles), its importance for dissolution and absorption, the apparatus used for the test, and the criteria for passing the disintegration test based on different tablet types.