Disintegration Test for Delayed-Release Tablets and Capsules: A Step-by-Step Guide

Are you curious about how delayed-release tablets and capsules are tested to ensure they dissolve at the right time? In the world of pharmaceuticals, it’s crucial that these medicines don’t break down too early or too late in the body. Here’s an easy-to-follow guide that explains the process in a simplified manner, based on the USP guidelines.

Step 1: Prepare the Dosage Units

• First, place one tablet or capsule into each of the six tubes of the disintegration test basket.
• If the tablets or capsules don’t have a sugar coating, move directly to the next step, the Acid Stage.
• If they do have a sugar coating, soak the basket in room-temperature water for 5 minutes, then proceed to the Acid Stage.
• If the test procedure mentions it, place a disk in each tube.

Step 2: The Acid Stage – Simulating the Stomach

• Immerse the dosage units in 0.1 M hydrochloric acid (or simulated gastric fluid) to mimic the stomach’s acidic environment.
• Keep the temperature at a body-like 37 ± 2°C.
• Let the dosage units sit in this solution for 1 hour.
• The key to passing this stage? After 1 hour, none of the tablets or capsules should show signs of disintegration, cracking, or softening.

Step 3: The Buffer Stage – Simulating the Intestine

• If the dosage units pass the acid test, we move on to the buffer stage, where we mimic the conditions of the intestine.
• Immerse them in a pH 6.8 phosphate buffer (or simulated intestinal fluid).
• Keep the temperature steady at 37 ± 2°C, just like before.
• The time they remain in this solution depends on the individual monograph for the medicine being tested.

Step 4: Final Check

• Acid Stage: None of the dosage units should disintegrate or soften within the first hour.
• Buffer Stage: Now, they need to pass the criteria for regular tablets or capsules, ensuring they disintegrate just at the right time.