Most people don’t think about how well an ingredient dissolves in a drug or a nutritional supplement but to the companies that make these products it can be a big problem. If an active ingredient or nutrient dissolves poorly into the product, much of it literally ends up flushed down the toilet.
Phytoption wants to address these problems with technology that improves the solubility of tough-to-dissolve ingredients. The West Lafayette, IN-based company has developed a biomaterial derived from plants that helps the molecules of the target ingredient distribute within a liquid, says Joanne Zhang, Phytoption’s co-founder and president. Dissolution helps enable the ingredient to achieve its intended effect.
“I always wanted to make a new technology usable for human health,” Zhang says. And she adds that there’s a deeper mission here. “I think we need to pursue more natural ingredients. That’s a personal goal.”
Drugs are formed with active ingredients, which produce a therapeutic effect, and inactive ingredients called excipients, which play a role in stabilizing a formulation or adding bulk to it. Making difficult-to-dissolve active ingredients soluble is important to pharma companies. According to Durham, NC-based contract drug manufacturer Patheon (NYSE: PTHN), as much as 70 percent of new drugs don’t dissolve well in water and need “enhancement” in order to improve solubility. Better solubility improves how a drug is absorbed by and distributed throughout the human body, which can make a drug more effective, Zhang says. The Phytoption biomaterial is an excipient whose role is to help the active ingredients dissolve.
Phytoption isn’t the first company to address this problem. Patheon offers pharmacy companies different technologies to enhance the solubility of active pharmaceutical ingredients. Chemical giants such as Dow Chemical (NYSE: DOW) and BASF (FWB: BAS) offer their own approaches to improve drug solubility. For its part, Phytoption’s submission for a federal grant claimed that its research showed its biomaterial is capable of making drugs soluble that other drug excipients have difficulty dissolving.
Besides drugs, the Phytoption technology has potential applications in food and nutritional products. Some food colorings, for example, do not dissolve well in water. Zhang says improving the solubility of these colorings would enable food companies to use more colors. The technology can also improve antimicrobial agents that are added to some products, such as cheese, to extend shelf life, she says.
In addition, solubility problems can prevent consumers from receiving the full benefit of nutritional supplements, Zhang says. Poorly dissolved vitamins and nutrients won’t be absorbed by the body, and they instead pass through the digestive system, becoming waste. Chemicals, such as surfactants, offer one way to improve solubility. But as a plant-derived product, Zhang says Phytoption’s approach should be more attractive to food and cosmetics companies that want to woo consumers seeking natural alternatives.
Phytoption has developed two products addressing solubility: SolvPhy is used for food and cosmetics and SoluPhy is for pharmaceuticals. Zhang does not expect many regulatory hurdles for food applications. Because the biomaterial is derived from edible crops, such as corn, it’s already classified as food. Several food and cosmetic companies are working with Phytoption to evaluate the technology with different ingredients; confidentiality agreements bar Zhang from disclosing their names, though she says some are Fortune 500 companies and others are smaller businesses.
For pharmaceutical applications, the Phytoption biomaterial would need FDA approval as a new drug excipient. Zhang says Phytoption has one pharma partner evaluating the technology for potential use in its drugs.
Phytoption traces its origins to Purdue University, where the company’s scientific co-founder was conducting biomaterials research. Founded in 2011, the company operates from the Purdue Research Park in West Lafayette. Last year, Phytoption won the 2015 BioCrossroads New Venture Competition, earning a $25,000 cash prize. The company isn’t drawing revenue from product sales yet, Zhang says, though it has some financial support from the partners that are evaluating the solubility technology.
Federal grants support Phytoption’s research efforts. Earlier this year, the company was awarded $749,785 through a Small Business Innovation Research grant. Henry Havel, a retired Eli Lilly (NYSE: LLY) scientist, joined Phytoption in March to lead the company’s R&D.
The startup is now trying to raise $2 million from investors, which Zhang says will be applied toward pilot manufacturing and commercialization of the technology. For food and cosmetics companies, Phytoption would become an ingredient supplier. To the pharma industry, Phytoption would become a vendor, making and supplying its ingredient to drug makers.
The length of the FDA’s typical approval process for a new drug excipient means that Phytoption’s first commercial uses will likely be in food and cosmetics. The company is targeting premium cosmetic applications, such as natural cosmetics, or high functionality, such as anti-aging products comprised of tough-to-deliver ingredients that current technologies can’t dissolve.
Zhang, who held business roles for food ingredient company Danisco in Asia and the United States prior to starting Phytoption, acknowledges that the food market will be tougher to crack because of the low profit margins associated with most food products. To break into the food industry, she says Phytoption will pursue niche applications where competing technologies can’t achieve solubility. But just as tough will be winning over businesses that may be reluctant to change longstanding food processing practices. Zhang says Phytoption must prove to them the technology’s cost advantage.
“Sometimes in industry, especially in established companies, people may not be willing to explore new things to tackle that problem,” she says. “But once you have something ready to solve that problem with a feasible cost, then that becomes attractive.”
Photo courtesy of Flickr user U.S. Department of Agriculture via a Creative Commons license.