PMA-zeolite

PMA-zeolite

PMA (Panaceo Micro Activation) is a technology of Panaceo Active Mineral Production GmbH.

It is the name of the process which allows to enhance some physical properties of the substances (mainly minerals). It is a mechanical treatment which increase particles properties and ion exchange capability. 

The micronization machines used – also known as activators – have been researched, designed and produced by an independent team of scientists. They are fundamentally counter-rotating pin mills which are very effective in micronizing zeolite.
The PMA activation takes place via the acceleration of zeolite particles which collide with one another at high speed. Through micronisation, both the contact surface of the particles as well as their negative surface charge are multiplied. Thus the surface area of activated zeolite is increased.

This yields better ion exchange effect and more effective molecular filtering with activated natural zeolite in comparison to a “raw” natural zeolite. Attracted by the negative charge, the positively charged toxins are bound even more strongly. 


The greater surface area of the activated particles makes the molecular sieve more efficient as with the same quantity of ingested zeolite, much greater effect can be realised. 



PMA- zeolite is produced through double activations treatments with PMA technology.


It is a dehydrated, micronized and activated zeolite to be used in the cosmetic and pharmaceutical field characterized in that it has particle size dimensions in the range 1-60 μm and negative ζ potential, preferably in the range from -24 to -30 mV, and having for about 70% - 90% a molar ratio Si/Al ranging between 1:1 and 1:4

PMA-zeolite® web site
on the left: Prof. K. Pavelic.


Prof. Dr. Rudolf Taschner from the Institute of Analysis and Scientific Computing Technical University of Vienna, Austria Vienna, 16th of February 2015 made a 'Calculation of the “effective” surface for the purpose of ion exchange of the active substance produced by the Panaceo Company'

This result shows that, with a total depth of penetration into the pores of the active substance , one gram has an effective surface area of about four thousand square metres
Methodology of the study and proof of effectiveness

In order to comply with the regulations and requirements of a certified medical product and guarantee consumers the highest safety and efficacy, Panaceo Medical devices undergo the following phases during study planning and implementation:

1. Safety
2. Mechanism of action
3. Operative hypotheses and proofs of efficacy
a. Intended main effect (clinical/Gold Standard)
b. Validation of secondary effects (basic research or application observations)


1) Studies on product safety/toxicology
(evidence on the safety of application)
2) Investigation of the mechanism of action or the basic physical principle (binding of pathogenic substances in the GIT)
3) Elaboration of operative hypotheses based on the proven mechanism of action
(protective effect(s) through the binding of harmful or damaging substances)
3-1) Evidence-based proof of the intended main effect (gold standard study; protection of the barrier function of the gut)
3-2) Further validation of the main action or secondary effects (relief of the body through reduced exposure to pollutants and strengthening of the intestinal wall barrier; in vitro, in vivo, application monitoring)
Product safety: 

Ongoing research activities represent an important basis for fulfilling the safety aspects of Class IIa certified medical products. The chemical and physical characterisation of the specific PMA-Zeolite is fundamental. The pH stability to acids and bases as well as temperature stability and the appropriate particle shape (round and no needle-shaped particles) should be demonstrated. According to ISO standard, recording of safety entails tests for cytotoxicity, sensitisation, and irritation. In addition to the tests required by the MPG, toxicological studies (sub-acute, acute, and chronic) as well as tests for genotoxicity and reproductive/developmental toxicity must be performed in order to ensure additional safety. The safety-relevant aspects were examined and evaluated by both the designated notified body as well as experts in the field.

Thanks to these tests (including expert reports), the safety of PMA-Zeolite for human use and the reach of efficacy of the gastrointestinal tract were clearly defined.

Mechanism of action:  
Based on the clear evidence for safety, the mechanism of action was defined. With regard to the recognised detoxifying potential of zeolite-clinoptilolite, as part of the basic research, the capacity of PMA-Zeolite with respect to environmental toxins (including the heavy metals lead, cadmium, arsenic, chromium, and nickel a well as the metabolic end product ammonia) was analysed in vitro using a gastrointestinal model. In this case, the ion exchange capability, and the resultant selective binding of defined pathogenic substances, was clearly proven. Details on the structure and mechanism of action of PMA-Zeolite can be found in the background information section.

Operative hypotheses and proof of efficacy:The defined main mechanism of action plays a fundamental role in demonstrating the mode of action of PMA-Zeolite at the site as well as validating various operative hypotheses based on this defined mechanism of action. The data, insights, and trends from preclinical studies (in vitro and in vivo) – especially clinical gold standard studies – form the basis for further validation (human applications).


Evidence-based proof of the intended main effect:One hypothesis based on the main mechanism of action (selective binding of pollutants in vitro gastrointestinal model) is the strengthening of the functionality of the intestinal wall barrier. This promising hypothesis was proven in a randomised placebo-controlled clinical gold standard study in which a significant decrease in the bio-marker zonulin (and thus an improvement/strengthening of intestinal wall function/integrity) was achieved. This represents the main intended action of PMA-Zeolite.

 

Gold Standard Study 

Effects of zeolite supplementation on parameters of intestinal barrier integrity, inflammation, redoxbiology and performance in aerobically trained subjects (download)

Manfred Lamprecht,corresponding author Simon Bogner, Kurt Steinbauer, Burkhard Schuetz, Joachim F. Greilberger, Bettina Leber, Bernhard Wagner, Erwin Zinser, Thomas Petek, Sandra Wallner-Liebmann, Tanja Oberwinkler, Norbert Bachl, and Gert Schippingerl

Reduction of Toxins, free Radicals, Ammonium (ion) and heavy Metals is to be considered as helping factors for all pathologies which are related with the integrity of the Gastro Intestinal Wall.
Evidence-based proof of the intended main effect:

One hypothesis based on the main mechanism of action (selective binding of pollutants in vitro gastrointestinal model) is the strengthening of the functionality of the intestinal wall barrier. 

This promising hypothesis was proven in a randomised placebo-controlled clinical gold standard study in which a significant decrease in the bio-marker zonulin (and thus an improvement/strengthening of intestinal wall function/integrity) was achieved. This represents the main intended action of PMA-Zeolite.

 
RESEARCH AND DEVELOPMENT
Research Report

Recently we developed a research with the scientific direction of Prof . Maurizio Memo, University of Brescia on the neuro-protective properties of PMA-Zeolite (Zeolite-Act 2 in the graphic below).

The research confirmed this properties and proved that a non-systemic substance crossing the intestine can reduce toxicity at the level of neuronal area response.

download: 
Neurodegeneration. Dietary zeolite supplementation reduces oxidative damage and plaque generation in the brain of an Alzheimer's disease mouse model
Overview of organic chlorogenic compounds that are absorbed by PMA-Zeolite
Overview of organic chlorogenic compounds 
that are absorbed by PMA-Zeolite
Prof. Kresimir Pavelic

The detoxifying potential of PMA-Zeolite

The in vitro studies performed in July 2014 at the University of Rijeka under the direction of Dr Krešimir Pavelić demonstrate that zeolites can absorb environmental contaminants such as organochlorine pesticides and heavy metals. They can thus make a substantial contribution to the detoxification of the human body.


Summary of the findings:

In an artificial gastrointestinal model, it was demonstrated that PMA-Zeolite binds heavy metals such as lead, cadmium, arsenic, chromium, and nickel as well as the residues of pesticides such as organic chlorogenic compounds originating from foodstuffs according to the physical mechanism of action. The overall stress on the gastrointestinal tract is reduced, thereby proving the selective binding or detoxification potential of PMA-Zeolite.
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