A whole palette of globally compliant flavors and aromas for use in tablet film coating systems has been developed. Not only
are these sensory additions recognizable by humans, but aroma and taste scanning detectors also are available for electronic
identification of specific aroma and flavor profiles.
On-tablet technologies not only protect against counterfeiting and product diversion, but they also create a higher profile
image that can enhance branding and marketability. Two of the best known Rx examples are Nexium, the purple pill, and Viagra,
the blue diamond-shaped tablet. Much as the Coca Cola bottle was the first US trademarked object, a uniquely designed Rx
product can be established as a trademark globally. This serves to maintain the uniqueness of the tablet design. Not to mention,
the visual branding of a tablet reinforces the product identification with patients every time they take the medication.
Rules and Regulations
Before incorporating these technologies into their products, pharma companies may ask: What type of change notification requirements
will there be with the FDA? Here's a summary of regulatory information for each technology:
Pearlescent coatings FDA's Scale-up and Post-Approval Changes Guidance for Immediate Release Products (SUPAC-IR) Level 1 allows for the deletion
or partial deletion of a colorant and allows the film coat weight gain to vary by up to one percent. The addition of a pearlescent
coating to a tablet, adding less than one percent weight gain, would involve a qualitative change, but there would be no effect
on tablet dissolution. Such coatings can provide a multitude of colors with the same pigment chemistry, allowing for the same
label claim for different colored tablets.
High definition, logos and bar codes SUPAC and FDA guidance for changes to a new drug application or supplement application (NDA/ANDA) already allow for the addition
or modification of a code imprint when the ink components have been previously used on an approved drug.
Covert chemical markers (taggants) FDA has said that a trace marker can be added to the coating of an existing IR solid oral dosage form with the only requirement
being notification to FDA. The markers must be either a GRAS (generally regarded as safe) substance or an inactive ingredient
already present in a CDER-approved product. The addition of parts-per-million or parts-per-billion levels of food or excipient
grade markers to a film coating on an existing drug should not affect drug dissolution.
Flavors and aromas Supac-IR allows for the deletion or partial deletion of a flavorant as a Level 1 annual reportable change. Flavors are typically
added at low levels into the film coating and have minimal contact with the drug, therefore, the addition of a flavor is not
likely to affect dissolution.
Here are a few sources for more information about the prevalence of counterfeit drugs.
Physician's News Digest, "Vulnerability to Counterfeit Drugs," May 2004, available at: http://
FDA News, "FDA/U.S. Customs Import Blitz Exams Reveal Hundreds of Potentially Dangerous Imported Drug Shipments," September 29, 2003,
available at: http://
Chemical and Engineering News, "Counterfeit Drugs—Sophisticated Technologies and Old-fashioned Fraud Pose Risks to the Prescription Drug Supply in the
U.S.," November 10, 2003
National Drug Intelligence Center, "Pharmaceuticals Drug Threat Assessment," November 2004; available at: http://
David R. Schoneker is director of global regulatory affairs for Colorcon. For more information, contact (800) 452-3207 or firstname.lastname@example.org