Evaluation of tablets Dissolution test

Summary

In this video, Amit Belekar from Tips and Tricks by AMB explains the dissolution test, an official evaluation test for tablets used to measure the time a drug takes to dissolve in vitro under specific conditions. The video covers the components of the dissolution test apparatus, the detailed procedure, and how results are interpreted. The test ensures tablet quality by evaluating the dissolution time of the active ingredient, with multiple stages of testing if criteria are not met. Amit encourages viewers to subscribe for more informative content.

Takeaways

• 😊 The presentation covers the dissolution test, which is an official evaluation test for tablets.
• 💊 Dissolution refers to the drug going from the tablet into a solution, simulating how it would dissolve in the body.
• 🧪 The apparatus used for the dissolution test includes a cylindrical vessel, paddle or basket, water bath, thermostat, and electric motor for controlling rotation speed.
• 🌡️ The water in the vessel must be maintained at 37 ± 2°C to mimic body conditions during the test.
• 🔬 The test measures the time required for a specified percentage of the drug to dissolve under specified conditions in vitro (outside the body).
• 📏 Different types of apparatuses exist: Type I (paddle) and Type II (basket), with specific dimensions for the paddle and basket.
• 📝 The procedure involves placing a tablet in water, adjusting rotation speed, and measuring the amount of dissolved drug after a set time.
• 📊 The results are compared to the D-value (specified drug amount in the solution), and the sample passes if certain criteria are met across multiple stages of testing.
• 🧮 If tablets fail the test, it is repeated with additional sets of tablets (6, 12, or 24 in total) and compared to D-value thresholds for each stage.
• 👍 The conclusion emphasizes the importance of dissolution testing in quality control and encourages viewers to subscribe, like, and share the content.

Q & A

What is the dissolution test in tablet evaluation?

The dissolution test measures the time required for a specified percentage of the drug in a tablet to dissolve into a solution under controlled conditions, simulating the body environment.

Why is it necessary to simulate in vitro conditions during a dissolution test?

Even though the test is performed outside the body, simulating in vitro conditions is essential to ensure the environment is similar to what the tablet would experience inside the human body, which affects how the drug dissolves.

What are the two main types of dissolution test apparatuses?

The two types are the Paddle type apparatus (Type-I) and the Basket type apparatus (Type-II). Each has different mechanisms for holding the tablet and stirring the solution.

What is the D-value in the context of dissolution tests?

The D-value is the percentage specified in the drug's monograph, usually 70%, that indicates the minimum amount of the drug that must dissolve in solution for the tablet to pass the dissolution test.

What are the main components of a dissolution test apparatus?

A dissolution test apparatus consists of a cylindrical glass vessel, a water bath to maintain the solution at 37±2°C, a thermostat, a paddle or basket for the tablet, and an electric motor to rotate the paddle or basket.

What happens if two or more tablets fail to meet the D-value in the first stage?

If two or more tablets fail to meet the D-value, the test must be repeated with an additional 6 tablets. The test passes if the average dissolution of 12 tablets meets the specified criteria.

How is the amount of active ingredient in the solution calculated?

After withdrawing the solution from the vessel at the specified time, the amount of active ingredient is determined by filtering and using the method specified in the monograph of the drug.

What is the temperature range for the liquid medium during a dissolution test?

The temperature of the liquid medium in the vessel is maintained at 36.5 to 37.5°C, simulating the human body's temperature.

What are the steps involved in performing a dissolution test?

The steps include placing 1000 ml of water at the correct temperature into the vessel, inserting the tablet, adjusting the apparatus to the desired speed, withdrawing samples after the specified time, and analyzing the active ingredient content.

How is the dissolution test result evaluated across multiple stages?

The test is evaluated in stages: first with 6 tablets, then 12 if necessary, and finally 24. At each stage, the average active ingredient must meet or exceed the D-value, and individual tablets must not fall below specific thresholds.