Page 59 - Practical Technology 2025

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

Lab (7): Tablets Disintegration Test

Tablet disintegration testing is used as a quality-assurance measure for the following
causes:

• If the disintegration time is too high; it means that the tablet is too highly compressed.

• If the disintegration time is not uniform in a set of samples being analyzed, it indicates
lack of batch uniformity.

• It is also a very important test, because it gives an idea to measure the time required for

the tablet, to be converted into small particles, that to be ready to dissolve in the body
fluid. For most tablets the first important step to enter the solution is the breakdown of

the tablet into smaller particles or granules, this process is known as disintegration
Factors affect disintegration

Factors related to the disintegration test:

• The medium used,
• The temperature of the medium,

• The operator recording the results can have a significant effect on disintegration time.

Factors related to tablets' formula and method of manufacture:

• Pressure applied on the tablet (compression force) (disintegration time increases with
an increase in pressure).

• Disintegrating agent, especially the quantity and quality (type) of this agent.
N.B: Disintegrating agent is added to the tablet, to accelerate the rapture of tablet

into granules

• The nature of the drug.
• The diluents used.

• The binder and its amount.

• The type and amount of lubricant.

• The method of incorporation of all these additives.

Correlation between disintegration & dissolution:
Since the dissolution of a drug from the fragmented tablet appears to partially or completely

control the appearance of the drug in the blood, disintegration is still used as a guide to the

formulator in the preparation of an optimum tablet formula and as in-process control test to
ensure batch uniformity.

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