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The clear coating is USDA organic certified and approved for use in North America.
The first certified-organic tablet coating meets demands for natural-ingredient dietary supplements. The clear coating is USDA organic certified and approved for use in North America, says supplier Colorcon Inc. (Harleysville, PA).
Made with plant-derived ingredients-and no synthetic polymers or GMO materials-the Opadry NutraPure tablet coating also excludes allergens typically associated with gluten, wheat, eggs, soy, nuts, yeast, or dairy, Ali Rajabi-Siahboomi, PhD, Colorcon’s vice president and chief scientific officer, tells Nutritional Outlook. All Opadry NutraPure ingredients are approved for food and dietary supplements.
Opadry NutraPure answers industry calls for a more natural coating system, said Cornelis van de Muyzenberg, Colorcon’s vice president of global business development, in a press release. Most tablet-coating systems use cellulosic polymers like hydroxypropyl methylcellulose (HPMC), “which do have plant-based origins but have been chemically altered or further processed in some fashion,” Rajabi-Siahboomitells us.
The coating gives tablets exceptional shine and gloss and makes tablets easier for consumers to swallow.
Finding the right, alternative, high-performance materials was challenging, Rajabi-Siahboomitells Nutritional Outlook.
“In traditional film coatings, the polymers that are used produce strong films on a wide variety of tablets. Since these traditional polymers cannot be used in organic applications, it was very challenging to develop a coating with only food materials that would not only adhere to the surface of the tablet, but also provide gloss and shine to the tablets,” Rajabi-Siahboomisays. “We were also constrained in our choice of materials, as we wanted them to be non-GMO and free of allergens.”
Achieving USDA organic certification was a way to assure customers that Opadry NutraPure’s ingredients are natural-especially because the word natural currently has no formal regulatory definition, the company says.
“As consumer awareness of food ingredient labeling has increased, we have had increased interest from our customers in more label-friendly ingredients in our coatings. Interestingly, while some of our customers have asked us for ‘natural’ coatings, there is no statutory definition of the term natural in the marketplace. We took that on board and said, ‘We could have our own internal definition of what natural means, but what would that mean for the market?’” Rajabi-Siahboomi explains.
“One way we could show that the product is natural is to go through the certification process for organic, where we looked at the origin of the substance (coming from natural sources) and manufactured/processed by methods considered to be minimal, which do not intentionally modify the chemical nature of the substance,” Rajabi-Siahboomi says. “We felt that the requirements set out by the USDA Organic program best met these criteria.”
Simply put, Opadry NutraPure gives formulators-and consumers-more options. “The consumer-friendly product label ingredients will provide supplement manufacturers an edge in marketing their products in this highly competitive market,” van den Muyzenberg says.
Colorcon worked with Quality Assurance International to earn the USDA certification. The company says it plans to pursue similar alternative coatings for capsules.
Nutritional Outlook magazine