NuCell-Direct™

NuCell-Direct™ is the most advanced and unique delivery system that imitates the composition of a human cell membrane. Opti-path™ in combination with NuCell-Direct™ leads the way in biological information transfer (BIT) in living organisms. Opti-Path™ and NuCell-Direct™ technologies creates various active Nanocomplexes targeting various dysfunctions.

The bioactive substances utilized in Opti-Path™ technology are incorporated into the wall membrane of NuCell-Direct™ delivery system creating a Nanocomplex. This technique allows to  stabilize multiple bioactive substances with different chemical structures, different functional activity and allows for timed release effects. These bioactive substances in Nanocomplexes act synergistically, imitating a normally functioning living system.

 

NuCell-Direct™ stabilizes very unstable biologically active substances and delivers them to targeted areas, dwarfing the current high-end liposome delivery systems. A liposome structure doesn’t contain any proteins or carbohydrates, only contains natural/modified phospholipids, and can either encapsulate water-soluble actives or predominantly oil-soluble actives. Liposomes capacity to deliver bioactive substances are very limited and these substances are encapsulated inside the liposome. The walls of the liposome are very fragile and easily rupture with minimal force (temperature, pressure, chemicals, freeze dried process, pH and etc.). Once ruptured the efficacy of the contained actives are lost. Rupturing NuCell-Direct™ is difficult due to the composition and strength of the membrane wall. If ruptured there is minimal loss of efficacy because the bioactive substances are part of the wall membrane unlike the liposome delivery system.

Why is it so important to have a proper delivery system?

  • To imitate the physiological process in a living organism, it is necessary to use bioactive substances (signaling substances) that naturally exist in this living environment. Very often those bioactive substances are naturally unstable with an average shelf life of a few hours to a few days. It is necessary to use substances indigenous to the human body because these substances are what trigger the self healing process as well as adaptation mechanism to stress and extreme conditions. 
  • It is important to deliver multiple bioactive substances in Nanocomplexes simultaneously for the cell to intake all the nutrients(signaling systems) it needs at the same time. If you look at the span of a human life we require water, food, air and sun all at the same time. If we have one at a time we would not thrive in that environment and the same is true of cells. 

What is NuCell-Direct™ and what does it do?

  1. An imitation of a human cell membrane - NuCell-Direct™ is an empty delivery system for bioactive substances and for Opti-Path™ Nano-modules™: 
    • Structural integrity - NuCell-Direct™ delivery system is more resilient and resistant to chemical and physical factors than the liposome delivery system.
    • Bioactive substances - bioactive substances / Opti-Path™ Nano-modules™ are integrated into the cell membrane wall.
    • Stabilizer of unstable bioactive substances / Opti-Path™ Nano-modules™.
    • Various Bioactive's - NuCell-Direct™ can simultaneously incorporate various bioactive substances with different chemical structures and different biological activity  into a single delivery vehicle.
  2. Multiple delivery vehicles / forms - NuCell-Direct™ can be formulated for different forms of application: 
    • Topical application
    • Parenteral application (Injection)
    • Enteral application (Oral)
  3. Simultaneous action - To normalize dysfunctional cell metabolism in a living system, it is critical to restore biological information transfer (BIT) which can only happen thru simultaneous action of multiple bioactive signaling substances involved in the pathogenesis of the problem. This requires the usage of bioactive substances in Nano/Pico quantities to mimic the concentration that is found in healthy living cells. Unlike NuCell-Direct™ the liposome requires a high dosage of a singular bioactive substance to achieve any type of effect and it can not contain multiple bioactive substances with different chemical structure.
  4. Reduction of Side effects - Using bioactive substances in Nano/Pico quantities (within buffering range of living systems) reduces the possible side effects.
  5. Time release - NuCell-Direct™ can be formulated with controllable time release effects while not overloading BIT.
  6. Shelf life - Nanocomplexes (combination of Opti-Path™ and NuCell-Direct™) can be freeze dried, allowing for long term storage. In comparison liposomes are unable to go thru the freeze drying process and are usually in a liquid form limiting their shelf life.

These powerful features of NuCell-Direct™ effectively make obsolete the Liposome delivery system currently used by pharmaceutical, nutritional, and skin care industries. 


 

 

Composition and structure of NuCell-Direct™ Delivery system:

 

Stabilizing Media

The stabilizing media of NuCell-Direct™ delivery system comprises of purified water and adjuvants such as protein stabilizers, antioxidants, cryoprotectants, chelating agents, protease inhibitors, preservatives, bile acids, stabilizers, and other reagents. Depending upon the particular use of the delivery system, specific adjuvants are added in minor amounts to perform their designated purposes. 

Lipid Fraction

NuCell-Direct™ delivery system contains a lipid fraction. The lipid fraction is composed of a mixture of bioactive lipids. The optimum amount of different lipids found in NuCell-Direct™ is 9 to 15 but can have as low as 5. Exact composition of lipid fraction depends on active ingredient/bioactive complex(s) chemical structure(s) to be incorporated, level of stability necessary to achieve and place of delivery of substrate. 

 

The amount of each of the lipid in the composition varies within limits depending on the intended use of the particular delivery system. One of the major components of lipid fraction of NuCell-Direct™ is hydrogenated phospholipid. To increase the stability and reduce linkage of the actives from NuCell-Direct™ it is necessary to use various types of modified phospholipids with long chain lipids, like DMPE (C:14), DMPG*Na (C:14), DPPC (C:16), DPPE (C:16), DPPG*Na (C:16), DSPC (C:18), DSPG*Na (C:18), DSPE (C:18) and others. 

 

To stabilize the system and to increase physicochemical stability of actives it is also necessary to use multiple types of Saturated Fatty Acids with long chain lipids (C18:0 – C30:0) along with Sterols, which increases the rigidity and reduces the fusion of the system. C18 - C22 Triacylglycerols with Saturated fatty acids increases the potency of NuCell-Direct™, while C18 – C22 Triacylglycerols with Unsaturated Fatty acids increases flexibility and fusion of the system. Sphingolipids and/or Glycosphingolipids can be added to the lipid fraction if it's necessary to incorporate transmembrane cellular factors and are useful in applications were it is necessary to obtain specific biological effects.

 

Carbohydrate Fraction

NuCell-Direct™ also contains a biologically active carbohydrate component. The carbohydrate component is preferably composed of a mixture of one or more Glycosaminoglycans, Glycoproteins, Mono & Disaccharides, and Attachment Matrix Factors.

 

The amount of each of these components in the composition varies within limits depending on the intended use of the particular delivery system. To increase the stability and reduce linkage of the actives from NuCell-Direct™ it is necessary to use various types of Glycosoaminoglycans, particularly various types of Chondroitin Sulfates and Hyaluronic Acid. Heparin and Glycoproteins reduces the fusion of the NuCell-Direct™ delivery system. Mono & Disaccharides increases the stability of incorporated active ingredients. 

 

Protein Fraction

Another vital fraction of NuCell-Direct™ delivery system is the protein components. The amount of each component of protein fraction in the composition varies within limits depending on the intended use of the particular delivery system. The major components of protein fraction of NuCell-Direct™ is a structural proteins - Collagen and Elastin. To increase the strength, stability, and reduce linkage of the actives from NuCell-Direct™, it is necessary to use various types of collagens. Another essential structural protein, Elastin allows increasing strictness and reducing fusion from NuCell-Direct™. Cytoskeleton and extracellular matrix proteins are useful in applications were it is necessary to obtain additional specific biological effects as well as to incorporate transmembrane cellular factors. 

 

 

 

Attachment Matrix Factors

NuCell-Direct™ delivery system also contains attachment matrix factors component. Usually attachment matrix factors are represented by carbohydrate and protein components. The attachment matrix factors component may be comprised of a single carbohydrate or a single protein, but it is preferable to have it composed of a mixture of carbohydrate and protein components. 

 

The amount of each attachment matrix factor components in the composition varies within limits depending on the intended use of the particular delivery system. The major component of attachment matrix factor of NuCell-Direct™ is an Acid Soluble Collagen, and various types of Poly-D-Lysine Hydrobromides with different molecular weights. To increase the adhesive ability of NuCell-Direct™ delivery system components and to improve physical stability of the incorporated active ingredients it is necessary to use protein and/or glycoprotein, and carbohydrate components of the attachment matrix factors.

 

Only Nano and Pico quantities of protein and carbohydrate attachment matrix factors in conjunction with specialized carbohydrates, lipids, and proteins allow incorporating active compound(s) into the NuCell-Direct™ matrix. This can be created as a result of the specific technological process of the above-mentioned fractions. 

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