ABSTRACT
Coloring agents are widely used in the pharmaceutical industry and are an important component of many oral solid dosage forms. A coloring agent, or colorant, may be defined as an excipient that imparts color when added to a drug product. Colorants may be incorporated into solid dosage forms by adding them directly to the dosage form (e.g., adding a colorant to a tablet granulation); incorporating the colorant into capsule shells; or adding the colorant to a coating formulation that would be applied onto the surface of a drug product. Coloring agents may be added to pharmaceutical coatings for a number of reasons including the following:
To enhance product appearance, esthetic appeal, and product elegance To improve or facilitate product identification for the manufacturer, healthcare professional, and patient To provide protection from light for photosensitive compounds To provide a brand image and help differentiate the drug product from competitive products To help reduce or prevent counterfeiting
Although coloring agents do not provide any direct therapeutic effects, by improving the appearance of the drug product, they can contribute to increasing patient compliance. The use of coloring agents helps to provide drug products
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