Page 60 - Practical Technology 2025

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Clinical Pharmacy-Pharm D Level Three 2 Semester 2024/2025 Pharmaceutical Technology (PT 607)

Apparatus & materials:

USP Disintegration Tester

Disintegration Tester that consists of:

1. Heater, with thermostat to regulate temperature (37°C).

2. Tank supplied with proper liquid (1 Litter).
3. Six glass tubes, open at the top, and ended by screen (10 mesh) at the bottom.

4. Perforated plastic disks: may also be used in the test. These disks are placed on the

top of the tablets that float.

Method:

1. Six tablets were placed in the device (one tablet is introduced into each tube).
2. The basket rack is positioned in a one-liter beaker of water or simulated gastric or

intestinal fluid.
3. The beaker is placed at the disintegration tester and let the water heated until 37± 2⁰C.

4. When it reached the required temperature, set the timer to 1 hour and let the machine

operate. (It moves up and down at a specified rate).
5. The time to disintegrate and fall through the screen is noted.

The range of disintegration time according to USP is (5-30 min) & according to BP
(5-15 min).
Limit

If 1 or 2 tablets fail the test, repeat the test on 12 additional tablets. Not fewer than 16 of

total of 18 tested tablets must disintegrate completely.

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