Pearlescent pigments may help halt counterfeiting, says Merck KGaA
metallic, satiny and shimmery finishes on drug coatings could be
used as one additional step in the fight against counterfeiting,
say its developers, EMD Chemicals - part of part of German drug
giant Merck.
Counterfeit drugs is one of the most critical issues facing the pharma industry today, having evolved into a burgeoning global industry which is estimated to grow 13 per cent a year to reach $75bn (€58.5bn) in 2010, a 92 per cent increase from 2005 - compared to just 7.5 per cent estimated annual growth for global pharmaceutical commerce.
A number of technology firms have been scrambling to develop next-generation 'track and trace' and product authentication technologies, primarily involving RFID, to address this problem, although such technologies are still in their infancy and have yet to provide the industry with a suitable solution.
However, Merck spokesperson Miriam Becker told In-PharmaTechnologist.com that while adding very little to the actual cost of making the tablet, using these newly-available pearlescent pigments could be just one additional step that pharmaceutical companies can take to differentiate their products and make it harder for their drugs to be copied, in addition to the different tablet shapes and logos already being used.
"Nothing is easier to copy than a plain white tablet - but the more variations to a tablet you make, the more difficult it is to counterfeit," said Becker.
"However, it is not a stand-alone anti-counterfeiting measure," she stressed.
The pigment is simply added as an extra ingredient into the coating formulation that companies already use to coat their tablets or capsules at the end of the manufacturing process - Merck will provide its customers with any extra technical advice required, said Becker.
"No extra quality control is needed, it's just a modernisation of an existing step."
Use of these pigments in pharmaceuticals was finally approved by the US Food And Drug Administration (FDA) last month - eight years after Merck first sought their approval.
The pigments, available under the brand name of Candurin, are developed by coating the mineral mica with either synthetic iron oxide or titanium dioxide and there are 16 variations that companies can choose from in shades of silver, gold, orange/red/brown iron oxide and paler hues of gold, red, green and blue, termed "interference" colours.
These pigments can be either mixed with each other, or other existing colours to create an infinite number of desired combinations.
Concerns have been raised by consumer groups over the use of such pigments in drugs for cosmetic purposes, particularly over the question of whether they would produce iron salt contaminants.
However, both the FDA and Merck have given assurances that there are no grounds for concern.
"The pigments approved by the FDA are manufactured specifically and specially for use with drugs, and to good manufacturing practice (GMP) standards," Merck spokesperson Sandra Ramge told In-PharmaTechnologist.com.
"Extensive studies performed on these pigments clearly demonstrate that they are an extremely poor source of soluble iron and that, because of their chemical makeup, the use of the Candurin pigments in drug products would not interfere with double-blind clinical studies or interact with prescription medicines."
A reference drug containing the pigment is already in use within France.
The pigments are available for use worldwide now and the company expects several new drugs that are currently in development to be using the pigments "in a few months time," said Becker.
"We have received a high degree of interest from pharmaceutical companies who have been waiting for us to finally receive FDA approval for the product."
