Ora-curcumin formulation on its way to health product market

Newswise — When Hemachand Tummala was a child, his grandmother gave him hot milk laced with turmeric, the yellow spice that flavors Indian curry, and black pepper to treat a sore throat.

“This remedy has been used for thousands of years because it works—and now we know why,” explained Tummala, an associate professor of pharmaceutical sciences at South Dakota State University.  The main component in turmeric is curcumin, an antioxidant that also reduces inflammation, but curcumin does not dissolve in water.

“This is where anecdotal history becomes science,” Tummala continued. “Curcumin is soluble in oil, so boiling the milk then partitions it into the oil droplets. When we drink the turmeric milk, the curcumin gets into our blood along with the milk fat.” Piperine, the active ingredient in black pepper, has been shown to increase the absorption of curcumin.

Harnessing the power of curcumin

Scientists have been trying to figure out how to use curcumin for decades. Although animal studies looked promising, several human clinical trials have failed, dampening enthusiasm among the scientific community, Tummala noted. “Accessing the anti-inflammatory benefits of curcumin is difficult because it is not water soluble. If it does not dissolve, it will be excreted rather than absorbed, so there is no point in consuming it.”

Tummala’s group uses Eudragit® group of polymers to produce an Ora-Curcumin technology which can be engineered to release curcumin either in the stomach to treat gastric cancer and H. Pylori infection or in the colon to target ulcerative colitis and colon cancer. The research was funded by the South Dakota Board of Regents, SDSU Scholarly Excellence Funds, the College of Pharmacy and Allied Health Professions and Profile by Sanford.

The patented technology was licensed to Academic Technology Ventures Inc., (ATV), which will develop and market commercial products through startup company Turmeric Ultra Inc. (www.curcumaxxultra.com). The company will conduct human safety trials and obtain FDA Generally Recognized as Safe (GRAS) certification as a food additive or dietary supplement.

Tummala also acknowledged Will Aylor, former vice president for technology transfer and commercialization and Licensing Coordinator Camila Fuhr Diel for their work in securing the patents and crafting the licensing agreement.

Integrating into health products

“This formulation will allow the development of nutraceutical products by increasing the bioavailability of curcumin,” said Tummala, who also serves as a technical consultant to help ATV promote the technology to potential investors. 

“People dealing with chronic inflammatory diseases, such as arthritis, Alzheimer’s disease, and irritable bowel syndrome, are looking for natural products such as turmeric to help reduce symptoms,” Tummala explained. The Ora-Curcumin®  formulation can be integrated into beverages, including sports drinks and sparkling water, and food products, including protein bars and even chewing gum.

In addition to reaching the American market, the company hopes to pursue international markets. Consumers can reap the health benefits of the curcumin formulation through the products ATV markets and that will then fuel the research and testing necessary for therapeutic applications. Joint health, gut health, cosmetics and pet health are potential global markets for Ora-Curcumin.

Advancing drug development

Using Eudragit® EPO polymers, Tummala and his doctoral student Siddharth Kesharwani developed Ora-Curcumin E that dissolves in the acidic pH of the stomach, where it can then target stomach cancer and H.Pylori infection. “This formulation enhanced curcumin solubility up to 20,000 times,” he said.  “Our technology not only removes the roadblocks in translating curcumin for human use but also provides a unique site-specific targeting ability that can reduce side effects in other places,” Siddharth emphasized with high enthusiasm.

An American Cancer Society study found colorectal cancer rates are increasing among adults age 50 and younger, which makes developing a means of reducing colon inflammation a priority for the National Institutes of Health.

Therefore, Tummala and Kesharwani developed a second formulation using Eudragit^® S100, which is approximately 90 percent soluble only at pHs above 6.7, to treat colon inflammation and target ulcerative colitis and colon cancer.

“The formulation, known as Ora-Curcumin S, does not let any curcumin into the blood, but releases it in the lumen of the colon for local treatment of colon cancer,” Tummala said. “It is more like treating the colon inflammation locally after consuming the medicine by mouth rather than enduring painful procedures, such as enema.”

Kesharwani’s work on the two formulations was recognized with the 2016 Eudragit Award for North America from the Evonik Corporation, which makes several FDA-approved polymers including Eudragits. The work was published in the Journal of Controlled Release.

To advance Ora-Curcumin S as a drug, Tummala collaborated with Dr. Amar Singh, a gastrointestinal biochemist and associate professor at the University of Nebraska Medical Center and a researcher at the Fred & Pamela Buffett Cancer Center in Omaha. A double-blind pilot study showed mice that began receiving the Ora-Curcumin-S two days before being subjected to a chemical that causes colon ulcers and bleeding had less colon damage and inflammation.

Singh, along with ATV, will be major partners on the drug discovery path aimed at inflammatory bowel disease and colorectal cancer. “We are so excited about this technology’s potential to improve people’s health and treat chronic diseases, however, cautious about the long pathway of drug discovery,” Tummala said.