d9 Designs Inc. Announces Groundbreaking Advancement in Caffeine Technology

d9-Caffeine offers prolonged and safe stimulant effects

• d9-Caffeine is an alternative to conventional caffeine for those seeking prolonged effects, lower dosing, or for those with tolerance issues to caffeine’s metabolites
• d9-Caffeine is the first innovation in the caffeine molecule
• d9 Designs to present on d9-Caffeine at the International Society of Sports Nutrition (ISSN) Conference being held from June 18-20, 2024

d9 Designs Inc. announces a groundbreaking advancement in caffeine technology: the development of d9-Caffeine. d9 Designs Inc., a consumer products manufacturer focused on commercializing the use of Deura9™ (d9-Caffeine), has achieved Generally Recognized As Safe (GRAS) status for d9-Caffeine as a food ingredient in the United States. d9-Caffeine is a longer-lasting version of caffeine that is enriched with a naturally occurring form of hydrogen known as “deuterium.”

Caffeine is the most widely consumed stimulant in the world with 85% of the U.S. population consuming it on a daily basis [1]. The worldwide market for caffeine-containing products exceeds $300 billion USD/year [2].

“As the first innovation in the caffeine molecule, d9-Caffeine is a once-in-a-generation disruptive technology that has the potential to transform the worldwide caffeinated beverage industry and adjacent markets,” said Bradford C. Sippy, Co-Founder of d9 Designs.

Addressing caffeine’s limitations

While effective, the advantages of caffeine have a brief duration, and excessive consumption can lead to anxiety, jitters, gastrointestinal distress, and other side effects. In many individuals, a tolerance to caffeine may arise, requiring a progressively higher quantity to achieve the same desired effect and leading to excessive consumption of caffeinated beverages. Caffeine is also extremely bitter; therefore, many manufacturers add "bitter blockers" to meet the demand for higher caffeine levels, which results in the addition of unnecessary artificial ingredients that leave an unpleasant aftertaste.

Benefits of d9-Caffeine

• Rapid and prolonged effects: d9-Caffeine is rapidly absorbed and provides the same stimulatory effects of conventional caffeine, but it lasts 3+ times longer.
• Less is more: Because d9-Caffeine lasts longer, a lower amount is needed with the potential to reduce excessive consumption of caffeinated beverages.
• Tolerability: d9-Caffeine reduces the formation of caffeine’s metabolites that may contribute to anxiety, jitters, and other negative effects in certain consumers.
• Consistency: Unlike conventional caffeine, slow and rapid metabolizers of caffeine handle d9-Caffeine similarly, with rapid metabolizers less likely to build tolerance to it.
• Better tasting: Because less d9-Caffeine is needed to achieve a prolonged stimulatory effect, fewer if any artificial bitter blockers are needed.
• Broad application: Because d9-Caffeine has the same physical properties as caffeine, it can replace conventional caffeine in almost any existing application.

“As our next step, we look forward to the first commercial introductions of Deura9™(d9-Caffeine) in both beverage and cosmetics products to demonstrate the potential of this highly differentiated new form of caffeine,” said Sippy.

Studies and GRAS Status

The Generally Recognized As Safe (GRAS) status of d9-Caffeine was based on established scientific procedures following evaluations of the comparative pharmacokinetic, pharmacodynamic, genotoxicity potential, and overall safety and tolerability between d9-Caffeine and conventional caffeine. The full text of the peer-reviewed published studies supporting d9-Caffeine are available here [3] and here [4].

Across all domains of assessment, d9-Caffeine exhibited a similar safety profile as conventional caffeine, while maintaining the same stimulatory effects, but with a prolonged duration of exposure and marked reduction in the downstream metabolites of conventional caffeine. d9-Caffeine was determined by an independent panel of food safety experts to be GRAS under conditions of use such that the total daily consumption of d9-Caffeine from all sources was less than or equal to 90 mg d9-Caffeine/day.

Participation at ISSN 2024

Representatives from d9 Designs will be presenting data on d9-Caffeine at the ISSN Conference in Bonita Springs, FL on June 18-20, 2024. d9 Designs is presenting a plenary session presentation entitled “Introduction to d9-Caffeine: a New Form of Caffeine” on Thursday, June 20th at 2PM.

About d9-Caffeine

Deura9™ (d9-Caffeine) is a deuterium enriched version of caffeine. Structurally identical to caffeine, d9-Caffeine exhibits similar physical properties, stimulatory properties, rate of absorption, and safety properties of conventional caffeine but in humans has a higher Cmax, a markedly longer half-life, and 5-10-fold lower exposure to the primary metabolites (paraxanthine, theobromine, theophylline) of caffeine [3, 4]. d9 Designs holds exclusive rights to Deura9™ (d9-Caffeine) worldwide.

About Deuterium

Deuterium is a naturally occurring, stable, non-toxic isotope of hydrogen, with an additional neutron in its nucleus [5]. Selectively substituting protium (the most prevalent form of hydrogen) with deuterium, or deuteration, is a way to alter a molecule’s metabolic profile while maintaining its core physical and pharmacodynamic characteristics [6]. Deuteration is a commonly used technology in the pharmaceutical industry and other industries, with several FDA approved products based on it [6].

About d9 Designs Inc.

d9 Designs is a consumer products manufacturer focused on commercializing the use of Deura9™(d9-caffeine), a Generally Recognized As Safe (GRAS) food ingredient, in food, beverage, and cosmetic applications. d9 Designs Inc. is a subsidiary of Lennham Pharmaceuticals, Inc.

Deura9™ is a trademark of Lennham Pharmaceuticals, Inc under license to d9 Designs Inc.

d9-Caffeine is protected by US Patents 10,582,716, 10,765,130, 11,547,127, 11,666,073 – and corresponding global applications.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

References

1. D.C. Mitchell et al. Caffeine intakes in the U.S., Food Chem. Toxicol. (2014)
2. www[dot]prnewswire[dot]com/news-releases/global-caffeinated-beverage-market-2019-2025-300985581.html
3. Parente, R.M.; Tarantino, P.M.; Sippy, B.C.; Burdock, G.A. (2022) Pharmacokinetic, pharmacological, and genotoxic evaluation of deuterated caffeine. Food and Chemical Toxicology. 160:112774.
4. Sherman, M.M.; Tarantino, P.M.; Morrison, D.N.; Lin, C.H.; Parente, R.M.; Sippy, B.C. (2022) A double-blind, randomized, two-part, two-period crossover study to evaluate the pharmacokinetics of caffeine versus d9-Caffeine in healthy subjects. Regulatory Toxicology and Pharmacology. 133:105194.
5. International Atomic Energy Agency, What is deuterium? February 2023. www[dot]iaea[dot]org/newscenter/news/what-is-deuterium; site visited on June 2, 2024.
6. Di Martino, Rita Maria Concetta, Brad D. Maxwell, and Tracey Pirali. "Deuterium in drug discovery: progress, opportunities and challenges." Nature Reviews Drug Discovery 22.7 (2023): 562-584.