Pharmaceutical Tablet Cracking

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Pharmaceutical Tablet Cracking

1.10.1.4 Pharmaceutical Tablet Cracking (1)

Definition: Small, fine cracks observed on the upper and lower central surface of tablets, or very rarely on the sidewall are referred to as 'Cracks'.

Reason: It is observed as a result of rapid expansion of tablets, especially when deep concave punches are used.

Table.33. The Causes And Remedies Of Cracking Related To Formulation (Granulation)

Sr. No.

CAUSES

REMEDIES

1.

Large size of granules.

Reduce granule size. Add fines.

2.

Too dry granules.

Moisten the granules properly and add proper amount of binder.

3.

Tablets expand.

Improve granulation. Add dry binders.

4.

Granulation too cold.

Compress at room temperature.

Table.33. The Causes And Remedies Of Cracking Related To Formulation (Granulation)

Sr. No.

CAUSES

REMEDIES

1.

Tablet expands on ejection due to air entrapment.

Use tapered die.

2.

Deep concavities cause cracking while

removing tablets

Use special take-off.

1

About the Author

Dr.Mukesh Gohel's picture
Author: Dr.Mukesh Gohel

Dr. Mukesh Gohel is principal, professor at the LMCP, Ahmedabad served in academics for more than 40 years. He provides training in leading pharmaceutical industries in the areas of Design of Experiments and Quality by Design. His current areas of interest are direct compression and improvement of drug dissolution.

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