- The bioavailability enhancement.
In Pharmacopoeial standards, bioavailability is the extent to which the therapeutic constituent of a pharmaceutical dosage form intended for oral or topical use is available for absorption. It is influenced by a variety of factors. Among the inherent factors known to affect absorption are the method of manufacture or method of compounding; the particle size and crystal form or polymorph of the drug substance; and the diluents and excipients used in formulating the dosage form, including fillers, binders, disintegrating agents, lubricants, coatings, solvents, suspending agents, and dyes. Lubricants and coatings are foremost among these. The maintenance of a demonstrably high degree of bioavailability requires particular attention to all aspects of production and quality control that may affect the nature of the finished dosage form.
In normal conditions, the white powder gold and more generally ORMUS products, doesn't dissolve or do it very low. However, ORMEs can remain in water solution if properly preliminarily separated according certain methods and technology. It was therefore necessary to study a form, the most bioavailable possible, avoiding the addition of synthetic ingredients and starting from what the extraction process offers in terms of biosorption. In such a way, the following requirements were met:
- Improvement of solubility that may limit dissolution in the gastro-intestinal tract;
- Increasing of dissolution rate;
- Improvement of permeability across biological membranes;
- Control drug release;
- Avoid the first-pass metabolism/presystemic metabolism via lymphatic absorption;
- Avoid any addition of synthetic excipient for assure fully natural identity.
Sub-nano biosolution process (SNBP) was studied by Chymia engineers to provide an alternative for the formulation of poorly soluble compounds. Chymia Laboatorium SA applies wet media milling technology to formulate poorly water soluble ORMEs base as sub-nanocrystalline particles. Sub-nano biosolution have a smaller particle size distribution of the dispersed API compared to microsuspensions (micrometer-range) and common nanodispersion (nanometer-range) which is favorable for the dissolution rate of poorly water soluble APIs because of the increased surface area, and hence can increase the bioavailability. Micrometer-sized ORMEs bases crystals are media milled using Zirconium oxide beads in an aqueous solution stabilized by the addition of polymers and surfactants.
The nanosuspension is then purified from the polymers and surfactants, dried and then re-diluted in ultrapure water for the subnano reduction. From the concentrated solution, it’ll be obtained subnano dimensional crystals, by a proprietary technology.
A physically stable biosolution of sub-nanometer-sized ORMEs base crystals is obtained. Sub-nano biosolutions are characterized by particle size (laser diffraction), zeta potential and dissolution. Sub-nano biosolutions are suitable for oral and also parenteral (IV, SC, IM) administration (an unusual condition in ORMEs, never tried before). Sub-nano biosolutions can be converted in solid dosage forms, like tablets and capsules, by spray drying or bead layering.
This is therefore the key to obtaining two definitive classes of remedies based on ORMEs.
- The ultrapure unitary and ternary ORMEs (m-Unitaries and m-Ternaries), composed largely of single m-state elements, or groups of m-state elements, where one particularly psycho-biophysically active will prevail. They are in solid form, or better supported by a ORMEs matrix of Mg, Na, Ca based soluble minerals (opportunely increase in spin).
- The nanosolute ORMEs (not colloidal), also knew with the brand name Q-ORMEs, a more evolved product where the support matrix is represented by a liquid form more quickly assimilate, consisting of Ca, Na, Mg ions in pharmaceutical grade water, and the m-state integrally preserved with their very highest spin. This special status determines the specific orientation for ritual use, lucid dreaming, OBE and consciousness hyper-enhancement.
The present time, we are also exploring a method of m-state elements implant directly operated at the atomic structure of bioavailable substrates. In this case, may be produced directly both injectable remedies and medical gases loaded with high concentrations of monatomic elements, in the perfectly bioavailable and stable form.
- In search of stability improvement.
The term “stability,” with respect to a drug dosage form, refers to the chemical and physical integrity of the dosage unit and, when appropriate, the ability of the dosage unit to maintain protection against microbiological contamination. The shelf life of the dosage form is the time lapse from initial preparation to the specified expiration date. The monograph specifications of identity, strength, quality, and purity apply throughout the shelf life of the product.
The stability parameters of a drug dosage form can be influenced by environmental conditions of storage (temperature, light, air, and humidity), as well as the package components. Pharmacopeial articles should include required storage conditions on their labeling. These are the conditions under which the expiration date shall apply. The storage requirements specified in the labeling for the article must be observed throughout the distribution of the article (i.e., beyond the time it leaves the manufacturer up to and including its handling by the dispenser or seller of the article to the consumer). Although labeling for the consumer should indicate proper storage conditions, it is recognized that control beyond the dispenser or seller is difficult. The beyond-use date shall be placed on the container label.
Out of Parmacopoeias’ regulations, shelf life for ORMUS solid form is usually three years in closed container, away from light (blue or brown glass vial), while in liquid form, the conservation is reduced to one year when the solution contain 9% -14% alcohol. Many people tend to freeze the product, but we don’t recommend it more. Freezing may alter seriously the characteristics of spin.
Thus, chemical deterioration, microbiological pollution, bioenergetic rate and spin orientation decay caused by magnetic fields and high frequencies, or the displacement of the m-state spin in ordinary spin, are among the causes of ORMUS product biological and energetic inefficacy over time.
One major challenge was to find solutions that would increase the stability of the remedy over time. Alongside sterile and pharmaceutical grade methods for processing, packaging and storage already respected in our GMP, we thought about something that could also affect the molecular and atomic structure of final product (solid and liquid) and could provide excellent biological and energetic effects stability in the product itself.
- The Vibralicht Methode®.
VibraLicht Methode®is an innovative technology, fully environmentally friendly, applied to our ORMEs products manufacturing. It’s a totally green and sustainable process that guarantee zero emission, 100% biodegradability and total absence of acids and polluting byproducts all along the production chain. The process is fully automated, pharmaceutical compliant, with constant in-line QC and monitoring, and with a very limited human intervention. Every process is conducted in a sealed chain of operations, constantly validated. Any single engineer involved in the production chain is responsible for his actions regarding the conduct of dedicated operation and certify personally it. A simple anomaly in the process stops the production chain and don’t allows to continue until the issue has been solved.
This is the true pride of Chymia Laboratorium SA, patented in over 30 countries worldwide, together with our products, QC and GMP standards and excellent human resources.
VibraLicht Methode® consists of five main operations:
1) Raw matter preparation (selection, QC, screening, microgrinding, sterile cleaning);
2) Volatilization of m-state elements by confined plasma m-state separative process - CPMSP®;
3) Condensation and stabilization of m-state elements by high pressure photoreaction (HPPR®);
4) Purification of pure m-state elements in ionic state;
5) Sub-nano biosolution (liquid form) or inoculation (solid form) of m-state in bioavailable support
For pure metals, i.e., we apply the high temperatures by plasma vaporization method, causing Au volatilization in Ar-Ne atmosphere. This process of volatilization isolates a series of m-state elements in a volatile cloud, which may be further condensed by means of high pressure (500 atm) and stabilization at simultaneous action of high frequency and photoreaction. Subsequently to this, we can choose two different paths:
- Separation of monatomic gold and other 11 monatomic elements by sonocavitation and relative sub-nano biosolution in ultra pure water (pharmaceutical grade) for greater bioavailability for the body. In this manner we heavily reduce all heavy metals accumulation creating a buffering of Mg, Na, Ca ions.
- Condense and reinoculate the m-state elements in the solid starting matrix, formerly reduced to insoluble lime by calcination. At this second level we can still choose from:
- keep the finished product insoluble. At this level the Ormes will be directly released when the powder is added to common water, since they are only polar-bonded to the matrix of transport (or, if ingested, they'll be released directly to the mucosa while the excipient will be ejected with feces). Nevertheless, this method does not ensure a perfect and true bioavailability of the active ingredient (m-state elements), and can cause the presence of toxic metals "masked" by m-state elements (false m-state), thus difficult to separate at this stage. We have currently abandoned it and replaced with better performing methods described above (see sub-nano biosolution).
- Bringing the final product to the soluble state, reducing the matrix in the form of complex Mg, Na, Ca soluble salt polar-bonded with true m-state elements, easily bioavailable because soluble in water.
Many passages in the description have been omitted for obvious reasons of secrecy, but it all makes sense. The important fact is that starting raw matter is rich in m-state elements and that synthetic products are not added.
Disclaimer & Copyright
Medical Disclaimer: Although all GMP protocols for production and testing of our products are conduced according FDA, EMEA and Swiss Medic Standards and Regulations, the medical statements enclosed herein have not been evaluated by the Food and Drug Administration (FDA). The products and information mentioned on this article are not intended to diagnose, treat, cure, or prevent any disease. Information and statements made are for research and educational purpose only and are not intended to replace the advice of your treating doctor. If you feel that medical interventions are necessary, please check with your physician.
Copyright: Unless otherwise specified, all product names and Company logos such as Chymia Laboratorium SA™ and Chymia Monoatomics™, Q-ORMEs™, m-Unitaries™, m-Ternaries™, FarmeX™, the technical and scientific terminology such as confined plasma m-state separative process®, high pressure photoreaction®, sub-nano biosolution®, false m-state®, false m-state®, the abbreviations CPMSP® and HPPR®, appearing in all our Internet sites are trademarks owned by or licensed to Chymia Laboratorium SA, its subsidiaries Chymia Monoatomics or affiliates. No use of any Chymia trademarks, trade name, or trade dress in this site may be made without the prior written authorization of Chymia Laboratorium SA, except to identify the product or services of the company. The terms m-state, white powder gold, monatomic, monoatomic, ORME, ORMUS are terms coined by David Hudson for describe matter in the monoatomic state.