Color has emerged as a critical design component of a medicine. Why? Color can have a big impact on patient compliance and is a great tool for brand recognition. Research shows that patients associate colors with certain feelings. Orange, for example, is perceived as warm, lively and stimulating, making it the preferred color for many stimulants. Colors can also differentiate a brand, improving recognition. Take Nexium for example – many people in the US likely know it as “the purple pill” that treats heartburn, and that the darker purple dosage form corresponds to the larger dose.
Another important point is security. Patients with a high pill burden may not be able to distinguish between various medicines of the same color. In fact, a few years ago, a diuretic drug had to be withdrawn after it was suspected that some packs contained a sedative. In fact, a geriatric patient had mistakenly taken the wrong pill because she had two different tablets that were both white and similar in size. If one had been a different color, the outcome may have been avoided. In addition, some colors may be easier for a child to accept rather than a white capsule or tablet.
Despite its importance, decisions about which color to use are often made far too late in the development process. Formulators often start the development with whatever color capsules are available in their laboratory. But deciding to change the color much later means completely redoing the development phase as regulatory authorities only accept stability data generated with the final color of the dosage form. Choosing the right combination of fill and capsule color is crucial to success in developing your product right from the start.
Allow me to share a story from one of our customers. This company was racing to be “first to file” with the FDA and they launched development and stability studies for a pilot batch using standard colored capsules from their stock. But due to accelerated storage conditions, the capsules became crosslinked and the stability failed, requiring another stability test with that colored capsule. The failure prevented the company from filing the application and the stability process phase had to be conducted again. The direct estimated cost to reformulate was more than $100,000 and the risk of losing exclusivity linked to missing the “first of file” opportunity was even greater. By using a capsule that provides flexibility in the final color choice, the costly outcome could have been avoided.
Ensuring you make the right decision early is key, but deciding on the final color isn’t easy for formulators who may not be aware of its importance. One way of getting around this problem is to use a capsule that provides flexibility in the choice of the final color, regardless of decisions made during the development stage. How? You can opt for a capsule that allows formulators to evaluate the stability of the fill with a large number of broadly accepted dyes and pigments at the same time.
Even with greater flexibility, expert advice is still often needed to guide formulators through complex regulations, and to refine their color composition to make it compliant in different markets. For example, some markets have restrictions on iron uptake, like in the US or Japan; or on dyes; for example, R3 is banned in Russia. It’s much more complicated than just choosing the red or the blue pill!
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