The ingredient, which is based on Ribus’s rice extract technology, has been under development for several years. Steve Pierce, CEO of Ribus, says testing completed only recently by Biogrund shows the ingredient can perform as well as stearic acid, a common lubrication excipient that would not be compatible with an organic claim.
Ribus, based in St. Louis, MO, specializes in ingredients derived from rice bran. The company has offered both Nu-Flow, an anti-caking agent and Nu-Rice, a lubrication excipient that is the based for the improved formula. Biogrund, based in Hünstetten, Germany, with a US base in Virginia, is a solid dosage form specialist active in both the pharmaceutical and dietary supplement industries that offers help with coatings, colors and excipients.
Excipients have been seen as among the primary stumbling blocks for both organic and non GMO claims in supplements and foods. Organic standards allow for non-organic trace ingredients needed for manufacturing considerations to be used in situations where no organic alternatives exist. In the case silicon dioxide, a widely-used anti-caking agent, Ribus’s Nu-Flow now offers an accepted organic alternative.
And with the help of Biogrund, Pierce said an organic alternative to stearic acid and, by extension, to magnesium stearate is now possible, too. While Pierce said the team was confident during the development process that they would reach this goal, it’s only in the past few weeks that he has had the hard data in hand to prove his claim.
“Biogrund did some tablet release data studies,” Pierce told NutraIngredients-USA. “They measured the force required to eject the tablet. When compared to stearic acid, a common lubricant used in the industry, the organic Nu-Rice Extra Lube performed as well as the control.”
More tests in the offing
Pierce said that more tests will be done, which will help refine the best usage limits for the new excipient. This initial study was done using the Nu-Rice-based ingredient at a 1% inclusion rate, while the stearic acid was used at a 0.5% rate. Further tests will be done using different inclusion rates for the Nu-Rice Extra Lube, which could cut the suggested rate down to, say, 0.75%, Pierce said. Future tests will also pit Nu-Rice Extra Lube against what is the most common lubrication excipient, magnesium stearate. Nevertheless, even with the preliminary data in hand, Pierce said there is enough experience in the industry judging the relative performance of the two non organic excipients that he can say with fair certainty that Nu-Rice Extra Lube will match the performance of magnesium stearate as well.
“The Biogrund people said that there might be about a 5% difference between the magnesium stearate and the stearic acid,” Pierce said.
Biogrund’s long formulation expertise helped refine the base Nu-Rice ingredient, making it more attractive to a wider variety of customers, Pierce said. The label declaration of the new ingredient will be “rice extract blend,” Pierce said. That will include Nu-Rice, gum arabic, an organic vegetable oil and Ribus’s Nu-Flow anti-caking ingredient to act as a carrier for that oil.
“We understand about how to bring excipients together to get the proper synergy,” said Felix Specht, Biogrund’s managing director for the US. “In some formulations it may take a little more or a little less of the Nu-Rice Extra Lube.”
As with many other organic choices, the new ingredient will carry a price premium. But Pierce said that if a customer is using a high quality non organic excipient, the difference might only be about 30%. And even with the preliminary nature of the data and the higher price point, Pierce said a customer who has been doing its own testing with a sample batch has already placed a sizable order for the new ingredient, which was just certified organic by Oregon Tilth.
But Pierce said that slight extra cost will likely be willingly borne by those companies committed to organic claims.
"If you have an organic active, a 100% organic supplement in a tablet form is now possible," Pierce said.