TriNT All-Natural Curcumin Nanoparticle Encapsulation Study To Determine Pharmacokinetics, Pharmacodynamics of an All-Natural Formulation replacement to Synthetic Pain Management Medications

T.N. Lucas, C.r Carrasco-Lopez, D. Deodato, C. Ameho, E. Seidel
NuShammah Pharmaceuticals, Inc.,
United States

Keywords: quantum nanotechnology, drug delivery system, all natural

Summary:

Within the nutraceutical, pharmaceutical and other industries, there is a need for advanced delivery systems which can offer increased bioavailability, absorption enhancement, improved solubility and membrane penetration, increased shelf-life, thermal stability and taste and odor masking in the final product. Increasing the absorption via solubilization technologies can improve the biological efficacy of hydrophobic compounds in lipid-based systems. While this can be done with various delivery technologies, there is a need to develop hypoallergenic encapsulation material and non-protein delivery systems due to allergenicity issues. Currently, many of the non-protein delivery systems are chemically modified and are therefore not appealing to companies looking for a natural compound delivery system. Our curcumin self-assembling nanoparticles is a biosynthetic nature-made encapsulation system which is considered GRAS by the U.S. FDA. Our achieved 1nm-2nm nanoparticle contains NO METALS, NO SURFACTANTS, NO EMULSIFIERS, NO PRESERVATIVES, and NO STABILIZERS within our curcumin nano-encapsulation scaffold which under pends our theory that our curcumin nanoparticle can potentially carry compounds across organ barriers (e.g., Blood Brain Barrier, Pancreas, etc.) at a higher percentage and even potentially deliver compounds at a successful therapeutic dose to parts of the body not yet achieved by mankind. Further, our human and animal studies have shown dosage reduction by more than 50% with the same therapeutic outcome, addressing issues such as nerve pain, back disc pain, neuropathy, opioid pain replacement, enhanced cognitive ability, hydration and recovery. Our innovation focuses on an all-natural curcumin delivery system made of self-assembling nanoparticles consisting of hypoallergenic, non-protein, non-micro-plastics and non-liposomal material whose scaffold is made of all GRAS compliant ingredients. In August 2021, the NIH published a paper which discuss nano formulation techniques of curcumin nanoparticles for effective drug delivery. Liposomal curcumin formulations, require the use of chemicals and expensive equipment in its formation. Nanogel nanoparticles are 10nm to 100nm in size and is created with polymers. Comparatively, our curcumin nanoparticle delivery system is confirmed to be 1nm-2nm in size by Rice University and contains only GRAS compliant ingredients in the formation of its scaffold and is capable of: • Keeping cargo compound(s) 100% pure • Removing taste and odor up to 100% • Encapsulating two or more insoluble compounds to create a molecular fully soluble nano-system • Converting hydrophobic compounds, including oil-based compounds, into a water-soluble powder In an article, “Improving Active Pharmaceutical Ingredient (API) Solubility using API Processing” written by Sigma Aldrich, the article states, “With an estimated share of 70–90% of drugs currently under development being poorly water soluble (BCS Class II and IV), finding adequate solutions to address this challenge becomes increasingly important....API solubility is necessary for the final drug to succeed in terms of therapeutic efficacy. In the case of solid and liquid oral formulations, good API solubility is a prerequisite for sufficient absorption of the API by the body. If an API is insoluble, it cannot pass the gastrointestinal membrane and enter systemic circulation. Thus, their intended physiological effect will not be realized.”