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Colouring agents are very useful in pharmaceutical formulations because it provides the possibility of different appearance for the pharmaceutical dosage forms. The different appearance of dosage forms is important for various reasons, such as identification of the product, help to maintain the stability of light-sensitive APIs and some cases can improve patient compliance. Colouring agents can be divided into two main groups: dye and pigments.
It is important to note that a list of approved colourants allowed by regulatory bodies can vary from country to country. In addition, it is important when developing the formulation to think about factors that affect the shade and stability of the colour agent in order to achieve a final product with the same colour during the whole shelf life.

Dyes - Water soluble colouring agents
Pigments - Water insoluble colouring agents, they can be dispersed. Example: Iron Oxide
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Benefits / Claims
Colourants can be classified as water-soluble "dyes" and water -insoluble "pigments" or "lakes".
Soluble colourants offer tinctorial strength exhibited when dissolved.
Water insoluble colourants may offer better opacity and stability, no problems with colour migration.
Suitable for
Hard Gel Capsules
Softgel Capsules
Oral Suspensions
Oral Syrup
Oral Solutions

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