Zeolite clinoptilolite activated for pharmaceutical use


PMA ACTIVATION

 

Raw Material

 

We dig only mechanically, without using mines, by separating the material with the highest content of clinoptilolite zeolite (volcanic mineral).

Each batch is checked after an initial thermal activation of the material.  

We check the structure and mineralogical properties ensuring the presence of all the ions and components of the structure. We do not process any unsatisfactory batch.

 

Activation

  

It is developed by a team of engineers under the guidance of inventor Jakob Hraschan.

PMA technology (PANACEO MICRO ACTIVATION) is a micronization technology that uses mills with counter-rotating blades; these rotate with a thrust of 2400 km/h. The opposite air flows created by the two rotors cause the self-collision of the particles, which occur at 3/4000 collisions per second and at temperatures of approx. 400 ° Celsius.  

Activation helps to increase the surface charge of the particles and to increase the total cation exchange surface area. (after two activations cycle particles reach 4000 square meters per gram - mathematical calculation by Prof. Dr. Rudolf Taschner of the University of Vienna).

 

 

 

SCIENTIFIC RESEARCH

 

 

Quality Control and Continuous Auditing

    

 

The powders are filtered by devices that detect the size, they get analyzed with spectrophotometry to confirm that the original mineral composition is not altered. Chemical and bacteriological analyses follow.

We are subject to continuous checks to update our standards and practices.

Our technical dossier on PMA-zeolite is the most advanced and complete in the EU.  

 

 

Clinical Studies and Research

                                       

These are studies funded by hospitals and universities. The areas in which we do research are gastroenterology, neuro-degeneration, oncology and bone physiology.

We currently have several ongoing studies in Italy, Austria and Germany.
Our scientific committee, coordinated by Prof. Kresimir Pavelic, carries out continuous audits and studies, which are followed by publications. (Scientific Committee)

 

 

 

 

 

Toxicology



It is the only zeolite to have performed a complete study on toxicity, acute, sub-chronic and chronic. (prof. K. Pavelic). Because the activated molecule is very different from the starting mineral.

And we constantly study the conditions of intake of the mineral. Being an aluminosilicate, i.e. composed of aluminium, silicon and oxygen, a study on the release of pollutants is particularly necessary.  

Patents 

 

The patents on PMA-zeolite on polyneuropathy, neuroprotection, bone diseases, lactate reduction are as follows

-N° WO2013098049
-N° EP2600840
-N° WO2008077174 
-N° EP1938825 
-N° EP1480659 

 

APPLICATIONS

 

 

 

 

 

 

 

 

Applications

PMA-zeolite is used in accordance with the regulations of the individual states:  

Food Supplements (USA, Canada)

Pharmaceuticals (Sud America, India, Cina) 

Class IIa, IIb Medical devices for oral use (EU)

PMA-zeolite can be activated once or twice to achieve maximum cation exchange and surface charge properties (zeta potential)

Companies that use 

Detoxpharma srl

Erba Vita Group Spa

Legren srl 

Named Spa

Similia srl 

To check if a brand is a class IIa medical device go to the Ministry of Health website (click)

 

NOT ALL ZEOLITIES ARE EQUALS

How to recognize Class IIa Oral Medical Devices 0000

 

The CE mark must appear, followed by a number.

If only this brand appears  

these are devices that can not remain in the body for more than 60 minutes or, more often, of medical devices of class I for topical use.

If you find indications of oral use, report it to the ministry

   Click here

Regulations in EU

In EU, PMA-zeolite is used to package Class IIa devices for oral use.

Council Directive 90/385 / EEC and Council Directive 93/42 / EEC constitute the Union regulatory framework for Class II medical devices.

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, amending Directive 2001/83 / EC, Regulation (EC) 178/2002 and the regulation (CE) n. 1223/2009 and repealing Council Directives 90/385 / EEC and 93/42 / EEC.