Transmucosal polymeric molecular delivery systems.

The means by which a molecule or compound is introduced to the body is as important as the compound itself that is being delivered. It is imperative that the exogenous substance administered within the polymer matrix to the blood stream be maintained at a level that can provide maximum therapeutic benefit.

When a therapeutic compound is created, one must consider how to transport the compound to the appropriate receptor sites. This is not a trivial issue; in some cases, the development of the delivery system can be as difficult as the therapeutic compound itself.

Controlled release (DDS) serves two functions. The first, delivery, involves the transport of the therapeutic compound into the body and to specific receptor sites. This can be accomplished in a number of ways: intravenously, orally, transdermally, and via the oral mucosa or buccal ducts.

The second function is that of controlled release. This describes the rate at which the therapeutic compound is made to the body once it has been delivered.

Most controlled release systems fall into one of three categories: diffusion, solvent activated release, and polymeric degradation.

In a diffusion system, the therapeutic compound is either encapsulated in a polymer membrane or suspended within a polymer matrix. Typically the course of events is as follows: water diffuses into the membrane or matrix, the therapeutic compound is then diffused out of the polymer.

Solvent activated systems use one of several mechanisms. The most common employs a semi permeable membrane that contains a small hole. Within the membrane there is a high concentration of an osmotic agent that causes water to enter through the membrane. The therapeutic compound is then forced out.

Polymeric degradation and with the diffusion method, the therapeutic compound is contained within the polymer membrane or matrix. The polymer is designed to degrade and release the therapeutic compound at a specific location in the body. As the polymer degrades, the therapeutic compound is released and made available to the body.

Degradation occurs via three major mechanisms. In the first, water soluble polymers are made insoluble by cross linking them together. When the cross-links are broken at some point in the body, the polymer will dissolve. In the second mechanism, water insoluble polymers are made soluble by hydrolysis or ionization of side groups. Finally, the third approach applies the use of insoluble polymers that are cleaved into soluble monomers. Many degradation systems use a combination of these mechanisms.

Many matrix systems use what is known as bulk degradation. This means that degradation occurs throughout the polymer structure in a rather random fashion. The erosion rate is dependent upon the volume of the matrix rather than its thickness. Other matrix systems use surface degradation other than bulk degradation. This polymer is highly hydrophobic yet contain water labile linkages. Thus, diffusion of water into the matrix and internal degradation are minimized. The therapeutic compound release rate is proportional to the polymer degradation rate; with the proper surface geometry, zero order degradation kinetics is possible.

The group of poly(lactide) polymers and the lactide/(glycolide) copolymers has a proven track record concerning their biocompatibility. They ultimately degrade into lactic acid and glycolic acid, nontoxic components that are consequently excreted via the Krebs cycle as water and carbon dioxide. There are many other compounds that can be used for polymeric degradation. Copolymers such as styrene and hyrdoxymethacrylate, calcium pectinate, (a water soluble a (1 4) linked polysaccharide, consisting of D galacturonic monomers with several methyl ester constituents). Other polymers are hydroxypropl methylcellulose acetate succinate. The D galacturonic units that are cleaved from the polymer are water soluble , they may be then absorbed by the body and enter the metabolic pathway. As the matrix degrades, the therapeutic compound is then made available to the body.

We take a substring molecule, remove its DNA, replace it with a polymer matrix designed to sustain the integrity of the hGH molecule, then introduce the new strain to sodium cynobrohydrate and proprionaldehyde which kicks off 4 + electrons rendering the molecule with a strong positive charge.

Then we introduce it to the negatively charged recombinant hGH and the new molecular structure reclaims its static imbalance by literally ingesting the hGH molecule by static force. Next we coat the outer protein layer of this new strain with a bacterium and incubate into colonies. Once we have sufficient quantities, the bacterium is removed and what we have left is a still a positively charged molecular structure which is ready for use.

Now, since the molecule is positively charged and the human body is negative, when introduced to the oral mucosal tissues the polarity of the new molecule stretches like two opposing magnetic fields. The new molecule elongates and as a result it becomes very thin much like a spaghetti and because hGH molecules in the 191 amino acid structure is wound like a conch shell with few crossovers, it now can retain its integrity and be thin enough to pass threw the mucosal walls and into the system without process of liver function.

This is why small dosages in nanograms has the suspect purported efficacy that of injected hGH. The best part is this system encourages the anterior pituitary to secrete exacting supplies that are commensurate with individual requirements of independent subjects. The body's own cellular memory is what sets up the transmissions of neuro transmitters and neuro receptor sites and guides the ambient hormonal chain in the creation and replication of natural body function.




* These statements have not been evaluated by the FDA and are not intended to diagnose, treat, cure, mitigate or prevent any disease.  OTC AEON is produced according to the guidelines of the HPUS. Furthermore, with respect to our AEON and Somastatin products, in order to comply with current FTC requirements, we must state all anti-aging benefits mentioned are associated with the injectable form of Somatotropin and not our OTC HPUS products.