Excipient (pharmacologically inactive substance)

What is it?

FDA performs regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. FD&C Blue No. 1 Aluminum Lake is a FDA-approved color commonly used to dye dosage forms such as tablets and capsules. FD&C Blue No. 1 Aluminum Lake is approved for use in foods, drugs and cosmetics.

FD&C colors are the colors certified by the FDA for safe use according to specifications. The FD&C notation specifies the color is approved for use in foods, drugs and cosmetics. D&C notation specifies that the color can be used in drugs and cosmetics, but not food. According to the FDA, FD&C Blue No. 1 Aluminum Lake may be used safely as a color additive.

Lakes are formed by reacting straight colors (such as FD&C Blue No. 1 Aluminum) with precipitants and salts. Lakes may be used as color additives for tablet coatings due to their stability.^[1][2]