What's in a color? Just ask AstraZeneca. The drugmaker has had enormous success marketing Nexium as The Purple Pill. Then theres Pfizer, which has done equally well promoting Viagra as the little blue pill. The engineering behind those pretty pills transformed them from mere medicines to Madison Avenue icons.
Now, though, the possibility exists to do the same thing with other prescription drugs. A chemical company recently received approval from the Food and Drug Administration to add pearlescent pigments to their tablets, which can produce a sparkly metallic sheen or shimmery finish.
But EMD, which first sought FDA approval eight years ago, believes that pharmaceutical companies will want to use its technology to build brand identification, reduce medical errors by making it easier for older people to identify the correct pill to take, and add an additional manufacturing step to thwart counterfeiting.
"What were offering is the potential to differentiate a product by adding a luster or different effect on the pill," says Dan Giambattisto, sales and marketing director for Candurin pigments at EMD. "We went through a color additive petition process at the FDA it was similar to filing a New Drug Application. But now we have the infrastructure in place to market the products."
At the heart of its request, EMD asked the FDA for permission to increase the level of the resulting pigments to up to 3% of the weight of a finished prescription pill, and a maximum iron oxide content no greater than 55% in pigments containing iron oxide, according to FDA documents.
"Our materials arent generally used in the actual pill; they are used in the coating," Giambattisto explains. "Typically, companies use a film coating on the tablet, and the ideal location for our product would be in the film coating. What were doing is adding a special ingredient to the coating to give it a special effect, that lustery look."
An industry consulant, Dan Egbert, who is manager of research operations at Best Practices in Chapel Hill, N.C., notes that color has always been an important element in determining how a pill looks, but that the additional options can be expected to appeal to the pharmaceutical industry.
One drugmaker agreed. "This gives drug companies another tool to help them differentiate their products," says John Landis, senior vice president of pharmaceutical sciences at Schering-Ploughs research unit, who notes that many dyes have been taken off the market over the last 25 years. "If we made all our medicines small, round and white, theyd be easily copied and mixed up by patients."
Bearing out this statement were the results of a recent survey of 150 U.S. pharmacists. Sponsored by the coating specialist Colorcon, Inc., the survey found that color, shape and printed identification markers could be extremely helpful in eliminating medication errors. Ideally, a colored tablet with a unique shape, pearlescent finish, drug name and dose imprint, aroma and flavor could result in an eight-fold improvement in identifying medications and reducing errors, the study found.