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30/10/2025, 00:02  Pharmaceutical Solutions & Sterile Dosage Forms

6. Coloring agents

They are added to pharmaceutical preparations to enhance their appearance or to increase their
patient acceptability.

Colors have often matched to the flavor of preparation, e.g. a yellow color for a banana-flavored
preparation, green with mint, red with cherry flavor.

Their coloring power should be high so only small quantities are required and free from
unacceptable taste or odor.

All coloring agents used in pharmaceutical formulations must be approved by to FDA and FD&C
(Food Drug and Cosmetic)

Natural colorants

are most likely to meet this criterion and include materials derived from plants. e.g. carotenoids,
chlorophylls, saffron, red beet root extract.

Mineral colors:

Titanium dioxide, ferric oxides

Synthetic Colors:

(FD& C colors)

                   Now, Colors are less frequently used in pharmaceutical formulations, especially in
                   children's medicines.

                   Some consumers see their use as unnecessary and some coloring agents, e.g. tartrazine,
                   have been implicated in allergic reactions and hyperactivity of children.

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