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 basis1. The
worldwide market for caffeine-containing products exceeds $300
billion USD/year2.
“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 here3 and here4.
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 caffeine3, 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 nucleus5. 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
characteristics6. Deuteration is a commonly used technology in the
pharmaceutical industry and other industries, with several FDA
approved products based on it6.
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.
For more information, please visit www.d9designs.com.
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
- D.C. Mitchell et al. Caffeine intakes in the U.S., Food Chem.
Toxicol. (2014)
-
https://www.prnewswire.com/news-releases/global-caffeinated-beverage-market-2019-2025-300985581.html
- 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.
- 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.
- International Atomic Energy Agency, What is deuterium? February
2023. https://www.iaea.org/newscenter/news/what-is-deuterium; site
visited on June 2, 2024.
- 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.
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