Pharmaceutical Tablet Mottling

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Tablet Mottling Problem and  Solution

1.10.1.8

Mottling in Tablets and Its Solution

(1)

Definition: 'Mottling' is the term used to describe an unequal distribution of colour on a tablet, with light or dark spots standing out in an otherwise uniform surface.

Reason: One cause of mottling may be a coloured drug, whose colour differs from the colour of excipients used for granulation of a tablet.

Table.41. The Causes And Remedies Of Mottling

Sr. No.

CAUSES

REMEDIES

1.

A coloured drug used along with colourless or white-coloured excipients.

Use appropriate colourants.

2.

A dye migrates to the surface of granulation while drying.

Change the solvent system,

Change the binder,

Reduce drying temperature and

Use a smaller particle size.

3.

Improperly mixed dye, especially during 'Direct Compression'.

Mix properly and reduce size if it is of a larger size to prevent segregation.

4.

Improper mixing of a coloured binder solution.

Incorporate dry colour additive during powder blending step, then add fine powdered adhesives such as acacia and tragacanth and mix well and finally add granulating liquid.

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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