PROBLEMS

1. Evidence from numerous literatures revealed that curcumin has poor absorption, biodistribution, metabolism, bioavailability and poor aqueous solubility

2. Mislabeled or adulterated product content of herbal dietary supplements and nutraceuticals have led to product removal in several states.



SOLUTION

Develop a pharma-grade Cyclodextrin-complexed curcumin

1. Cyclodextrin has been used to improve curcumin’s delivery and bioavailability via its encapsulation.

2. Cyclodextrin-complexed curcumin exhibits anti-inflammatory and antiproliferative activities superior to those of curcumin through higher cellular uptake.

VOLT03

Complexed Curcumin

Curcumin has been shown in various studies to be effective in treating several diseases including: Alzheimer’s, Cancer, Cardiovascular, Central Nervous System, Neurology, Oncology and inflammation. There are currently over 100 ongoing curcumin trials. In phase II studies at MD Anderson, curcumin, at doses of 8 grams a day was found to be effective in treating pancreatic cancer. The large 8g/day dose was required due to the poor solubility and bioavailability of curcumin. However, patients have trouble taking such high doses for long periods of time. While the study gave an excellent proof of concept, curcumin’s use as a therapeutic is inhibited by its poor solubility and bioavailability.

VOLT03 is the only pharmaceutical-grade complexed curcumin and the only product to have head-to-head comparison data versus standardized curcumin and an approved prescription anti-inflammatory product (indomethacin). It will also possess solubility and stability advantages over marketed curcumins. Pharma-grade will overcome the mislabled or adultered issues seen in numerous commercial supplements and nutraceuticals, including some curcumins, by insuring stringent Quality Control, Quality Assurance and Good Manufacturing Processes are embedded into every capsule. It will allow for international distribution, where nutraceuticals require regulatory approval, and entry into the prescription market.




SUPERIOR PRECLINICAL DATA


The efficacy of VOLT03 was compared to native curcumin, indomethacin and placebo in a carrageenan mouse paw edema model.

 Methods: The paw was measured at 3 hours after oral gavage of curcumin (30 mg/kg), Indomethacin (5 mg/kg), and VOLT03 (30 mg/kg) to mice.

Results: After 3 hours, the swelling was 0.59 mm for VOLT03, 0.66 mm for curcumin, 0.73 mm for indomethacin, and 0.78 mm for vehicle control. The difference between VOLT03 and curcumin/indomethacin was statistically significant, with p<0.05.

PUBLICATIONS

Coming Soon



ADVANTAGES OF VOLT03


  1. Only curcumin product to demonstrate statistically significant anti-inflammatory properties vs standard curcumin and an NSAID (indomethacin).
  2. Highly purified pharmaceutical-grade ingredients.
  3. Manufactured under cGMP in FDA-approved site.Ability to move quickly into OTC & international markets.
  4. Enhanced bioavailability allows for less frequent dosing.
  5. Highly soluble; thus final dosage form will be in a small vegetable capsule.


Nutent Therapeutics will commercialize pharmaceutical-grade products that will be differentiated through successful clinical trials across multiple therapeutic areas.

Our Contact

3651 FAU Boulevard Suite 400 Boca Raton, FL 33431 United States

Phone : 561-208-3033

rbecker@nutenttherapeutics.com

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