Can MANC® particles break down in acid and poison me with aluminium like other clinoptilolite zeolite products do?

No. MANC® particles will not break down in stomach acid and will not poison you.

To ensure your safety as a user, MANC® particles and the Toxaprevent medical devices developed from them went through all product tests and analyses to assess safety and biocompatibility (even before the products were brought onto the market as certified medical devices)

Above all, the possible exposure to aluminium was investigated, since the MANC® particle is an alumino-silicate. Lead was also examined because it is an endogenous trace component found in clinoptilolite.

These tests go through several stages before the products are released, processed and placed on the market.

A comprehensive evaluation of data from clinical studies, and in vitro and in vivo investigations with the raw materials and products showed that the products based on MANC® particles are safe.

The form of the products has been tested by various test bodies, independent doctors, biochemists and medical assessors in the form of biocompatibility tests in accordance with the EN ISO 10993 series and this was confirmed again in 2019.

Toxicity tests:

• Testing the cytotoxicity according to EN ISO 10993-5: 2009 (GLP mode). Result: not cell-toxic, does not lead to any biological-toxicological damage to the test cells

• Tests for systemic toxicity (acute) according to EN ISO 10993-11: 2009. Result: no systemic toxicity.


Studies:

• Studies showed that the endogenous aluminum and lead components are not removed and therefore not absorbed through the intestine. This has been demonstrated by absorption tests under clinical observation on the human body.

• Clinical studies showed that clinical chemistry and hematology, and mineral status of users did not change.


Further pre clinical research showed that clinoptilolite:

• can bind heavy metals such as lead in vitro in a simulated gastrointestinal environment

• caused a decrease in aluminum concentrations in the plasma, liver and bones of animals poisoned with aluminum

• in the mouse model, can reduce cytotoxicity caused by lead and the lead concentration in the organism decreased.

Other quality features to completely rule out unlikely residual risks:

• Use of gastro-resistant capsules (Medi PURE and Medi ACUTE), which consists of harmless fiber (HPMC, gellan). This avoids the interaction of MANC® particles with gastric acid, which completely prevents the removal of trace elements in an acidic environment.

• The second measure is to add pH-increasing additives, such as calcium carbonate and magnesium carbonate, to the MANC® particles in Medi PLUS Sachets, allowing for passage through the gastric acid without the need for enteric-coated capsules. The same applies to the admixtures of HALISTOP® Chewable Tablets.

The structure of clinoptilolite zeolite is made from aluminium and silica and it is known that this structure breaks down and releases aluminium in stomach acid. All products containing clinoptilolite must therefore be specifically formulated and prepared to ensure aluminium is not released from the structure of clinoptilolite particles.

Unlike other clinoptilolite products, MANC® particles will not break down and will not release aluminium into the body

Toxaprevent PLUS Sachets have added magnesium carbonate and calcium carbonate to increase the pH level of stomach, thereby reducing the acidity in the stomach. This ensures that the stomach acid is not acidic enough to break MANC® particles, and allows them to reach the intestinal tract safely and intact. The pH level in the intestinal tract is too high to break the particle down so aluminium will not be released from the particle. Similarly, the HALISTOP® Chewable Tablets contain ad-mixtures which increase the pH of the stomach to allow for the safe passage of MANC® particles into the intestinal tract without poisoning the body with aluminium.

MANC® particles in capsule form (PURE and ACUTE Capsules) completely by-pass the stomach acid due to the gastro-resistant capsules used. The capsules allow MANC® particles to completely avoid acid in the stomach and only open in the intestinal tract where the acidity level is too high to break MANC® particles down.

In vivo and in vitro studies have proved this. The aluminium levels in long-term users of products containing MANC® particles (Toxaprevent) as well as the aluminium content of the MANC® particles were checked. Patients were given MANC® particles in their various forms. Stool samples were collected and analysed, and showed that the aluminium content of MANC® was higher after it had been excreted, meaning that MANC® particles were in fact binding and removing aluminium from the body, and was not poisoning the body with aluminium. All patients reported undetectable levels of aluminium after using MANC® particles for various periods of time. MANC® is completely safe to use with no risk of aluminium poisoning.

As such, any products containing clinoptilolite must meet the rigorous high standards which MANC® particles meet in order to be considered safe for human consumption and to avoid poisoning with aluminium from clinoptilolite. This is just one of the many reasons why MANC® particles are the safest form of clinoptilolite zeolite available today.

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