METHODS UTILIZING NATURAL BIOLOGICALLY ACTIVE COMPLEXES AND NOVEL DELIVERY SYSTEMS THEREFOR
M.M Danielov, MD, Ph.D.
BioNova, Inc.
102-05 63 Road, Forest Hills, New York 11375, USA
Tel: (718)897-8225; Fax: (718)897-8225; e-mail: BioNova@ix.netcom.com
BioNova, Inc. formed in 1990 to market the second generation of modular bioactive complexes and to focus relentlessly on our customers through offering technologically state-of-the-art individually formulated and biotechnologically produced products which will provide solutions in biopharmaceutical, cosmeceutical, and nutroceutical industries. BioNova develops, manufacturers, and markets active ingredients, as well as finished products for various industries.
Concept of Information Transfer
Normal body function relies on a pathway of inter-and intracellular communication. Biological information transfer is a multi-step process and can be divided into three basic levels. Primary messengers interact with specific receptors on the cell surface. This interaction triggers a cascade of secondary and tertiary messengers along a specific pathway. A feedback mechanism along the pathway controls the speed and duration of the cellular communication. If one or more of the messengers or components in the pathway is malfunctioning or missing then the cell functions will be disturbed. The problem can occur at any of the steps in the pathway. A common problematic condition is likely to have unique causes (different disturbances within the same pathway) among different people. The outcome is a manifestation of undesirable effects.
Restoration of biological information transfer is possible only by:
restoring the genetically determined chain of information transfer by acting simultaneously on all the levels of the information transfer mechanism;
ensuring the stability of information flow of the organism by supporting all the basic elements responsible for biological information transfer;
The basic idea of this concept is that restoration of the natural biological information transfer is possible by creating Bioactive Complexes containing all the necessary information ensuring normal biological information transfer on all levels.
OptiPathTM Natural Biologically Active Complexes
OptiPathTM, BioNova’s proprietary technology created for restoration the body’s cellular communication system. OptiPathTM represent an absolutely new generation of active ingredients which, rather than creating new physiological ways of informational transfer, restore the body’s own biological information transfer system. The OptiPathTM technology is based on the correction of biological information transfer in organisms where various metabolic disruptions have occurred. The bioactive complexes in the OptiPathTM are formulated to contain all the necessary molecules to restore normal function of a chosen pathway. The type, concentration and quantity of the substances in the OptiPathTM complexes depend on the pathway being corrected.
The OptiPathTM complexes are based on the substances, which are equivalent to those which are physiologically produced in the human organism. Namely, OptiPathTM are 100% physiological to the human organism. They contain only what the human body has already produced, but which for different reasons cannot accept at the cellular level. Each combination in OptiPathTM biologically active complexes targets a particular pathway by combining specific active ingredients in the proportions that are equivalent to their normal levels within the human body. Thus each combination provides distinctive effects.
Many of the components in cellular communication pathways are very unstable. Substances, which participate in all cellular functions require multiple specific intracellular transmitters, coenzymes, growth factors, PK stimulators, etc. active compounds. Many of the components in the chain of information transfer are very unstable. This instability prevents the use of these components in existing delivery systems and required the development of BioNova’s proprietary delivery system, CellDirectTM.
CellDirectTM Novel Delivery System
CellDirectTM Novel Delivery System, also called Substitute Cell Membrane (SCM) is another BioNova’s proprietary technology, created for stabilization and delivery in bioavailable form of unstable active ingredient from what OptiPathTM Biologically Active Complexes are composed.
The most important aspect of any therapeutical method is the delivery of the active ingredient to the target receptors or cell of the organism. The delivery system utilized must provide stability for the incorporated active ingredient, while allowing its absorption and delivery. For therapy to be useful it is necessary that both requirements be met by the drug delivery system. Especially in the areas of topical and parenteral administration, it is critical to efficacy to provide a delivery system, which crosses the cell membrane and allows the active agent or agents to exert their effects.
BioNova, Inc. has developed a new generation of proprietary delivery systems, CellDirectTM, specifically designed for the stabilization and proper delivery of very unstable active ingredients. Each specially designed CellDirectTM delivery system imitates the cell's own design, and provides a unique and effective system for the delivery active ingredients across the skin membrane. The CellDirectTM SCM technology provides maximum flexibility in choice and quantity of active ingredient delivered.
BioNova's proprietary CellDirectTM delivery system is thus not only useful as a topical and parenteral vehicle for the bioactive substances/complexes, but also can be used as a penetration enhancer for topical application of other skin treating agents. Bioactive agents/complexes are incorporated into the CellDirectTM SCM, which enhances the absorption of the bioactive substances into the cell, thereby providing a useful therapeutic tool for both cosmetic and medical applications.
The composition of the CellDirectTM SCM has an integrated structure, close to that of a human cell membrane and consists of the substances vital for a human body. The CellDirectTM SCM is composed of highly specialized proteins, lipids, and carbohydrates; the very same ones that comprise the human cell membrane. The CellDirectTM SCM has a more sophisticated composition and integrated structure than liposomes, the most advance delivery system currently available. In terms of physical stability, the choice of liposomes is often limited. In the CellDirectTM SCM architecture of the multiple long chain lipids and saturated alkyl acids, simultaneously with carbohydrates, proteins, and attachment matrix factors provide rigid bilayers with low permeability for small, non-bilayer interacting compounds. The actives are actually entrapped within the CellDirectTM SCM and are an intricate part of the SCM as opposed to being encapsulated in the liposomes and other delivery. In other words, active substances become an integrated part of the Substitute Cell Membrane. That is why, even if the entire structure of the SCM for some extreme reasons is collapsed, crumpled or partially destroyed, active substances will continue to be protected.
The CellDirectTM SCM is capable of delivering both, water soluble as well as oil soluble active substances. Using CellDirectTM SCM technology it is possible to incorporate or attach many different active substances which in other delivery systems are very unstable. Each CellDirectTM SCM is specially designed to maximize the effectiveness of the specific bioactive complex which is being stabilized and delivered. Using proprietary algorithms, BioNova efficiently creates specific CellDirectTM SCM’s matched to the active substance. CellDirectTM SCM technology is capable of providing modulated time release effects.
BioNova’s OptiPathTM and CellDirectTM technologies allows creation of highest efficacy and stability products addresses to a specific end result in biopharmaceutical, nutraceutical, and cosmeceutical areas.