Nutraceutical brand Pharmactive announced that its flagship saffron extract, Affron, has been granted a U.S. patent for its use in mood support applications. The patent serves as a recognition of the company’s unique process in the formulation of saffron extract, and clinical trials demonstrating its efficacy to assist individuals with issues related to low mood.
 
The new patent protects the proprietary composition of the ingredient and its dosages, which make it uniquely effective as a natural mood support agent, the company said.
 
“This new accreditation marks a momentous milestone for Affron as it positions it as a leading-edge formulation at the forefront of the U.S. cognitive health category,” Marguerite Gerritsen, managing director for Pharmactive, said.
 
Pharmactive’s saffron ingredient is based on an all-natural and low-energy consumption extraction process of saffron. Affron is manufactured using a unique, proprietary AFF ON Cool-Tech actives-saver extraction procedure, which is specifically designed to optimize the preservation and concentration of the key active ingredients with minimal industrial processing, without chemicals, and with minimal energy use. Pharmactive has demonstrated that the formulation is fast-acting and highly bioavailable in a pharmacokinetics study, and the company reports that the extract has the lowest dose threshold on the market to achieve clinical efficacy, with a daily dose of 28 mg per day.
 
Affron is standardized to a high concentration of crocins and safranals, the carotenoid pigments responsible for saffron’s bioactivity, crimson color, and organoleptic qualities. This is verified using HPLC.
 
Six human clinical trials to date have demonstrated a positive effect on multiple aspects of mental well-being, earning it a reputation as a far-reaching cognitive support ingredient, the company said. Research has provided evidence that Affron could relieve stress, improve mood, induce positive feelings, and promote sleep quality, and the company said that it is the first commercial botanical extract with clinical support as a mood supplement in teenagers.
 
“Affron’s mood-enhancement capabilities are owed largely to its role in the inhibition and reuptake of mood-related neurotransmitters, according to the broader spectrum of scientific literature,” Alberto Espinel, head of strategic R&.D in Active and Functional Ingredients for Pharmactive, said. “This capacity not only balances levels of key neurotransmitters, such as serotonin and dopamine, but also fights the oxidative stress that stress produces in the brain.”
 
Pharmactive’s patent request specifically delineated the effective dose and appropriate concentrations of safranal and crocin compounds in the final extract as a critical condition for exerting a positive effect on disorders related to mood. Part of the extraction process includes a technique that the company introduced which is an improved step in separating the active substances that is based solely on water resulting in an ingredient that is clean of any solvents or alcohols.
 
The patent also comes concurrently with a new ‘Informed Ingredient’ certification, in recognition of the safety profile and quality credentials of Affron. This is in addition to Affront’s previously-earned quality and safety seals awarded by internationally-accredited organizations, including EU Organic, DNA certification (True-ID) which confirms the authenticity of the botanicals, Doping-Free, Kosher, and Halal. Affron is manufactured in a GMP-certified facility, complying with ISO22000 for safety management, ISO9001 for quality management, and ISO 14001 for commitment to sustainability. Pharmactive has also adopted saffron in the American Botanical Council’s Adopt-an-Herb botanical research and education program.
 
“Pharmactive is able to provide nutraceutical and pharma industry players with a truly effective, wholly trustworthy botanical alternative for use in connection with low mood related issues,” Gerritsen said. “It also ensures our position as the ideal partner in the U.S. market for natural, botanical mood help.”