WHAT DO MEDISTUS® ANTIVIRUS LOZENGES CONTAIN?
Medistus® Antivirus lozenges contain Kistosyn® 200 extract. Medistus® Antivirus is a novel Class IIa medical device ( 0481). Efficacy and safety have been tested according to the European Medical Device Directive (93/42/EEC).
Medistus® Antivirus is a novel medical device with an active ingredient complex containing plant-based substances. The Kistosyn® 200 extract forms through its natural active substances a protective film over the oral and pharyngeal mucosa. This protective barrier leads to a physical (mechanical) protection against viruses (cold viruses) and bacteria, which helps prevent their penetration into body cells and their further propagation. The Kistosyn® 200 extract supports through its natural active substances the barrier function of the oral and pharyngeal mucosa by forming a natural film on it. As a result, external irritations can significantly be reduced. In addition, the Kistosyn® 200 extract supports the protection of the oral mucosa from inflammations and thereby the alleviation of cough and dry cough. Due to this physical effect resistance development is not possible.
IN VITRO STUDIES
Adhesion of Staphylococcus aureus bacteria to bronchial epithelial cells
In vitro tests were performed on the adhesion of Staphylococcus aureus bacteria to bronchial epithelial cells. It was investigated whether Medistus® Antivirus lozenges affect the adhesion of bacteria to cells, resulting in preventing or reducing the infection. For this purpose, one line of cells (BEAS-2B human bronchial epithelium) was incubated with bacteria (2.9×106 CFU / ml – 3.0×106 CFU / ml) for an hour with the solution of Medistus® Antivirus lozenges, whereas another line of cells and bacteria did not receive any treatment. After the test period and the rinse of the nonadhesive bacteria, the number of adhesive germs was determined by the lysis of the epithelial cells.
Result: On the cell layer treated with Medistus® Antivirus solution, the bacterial adhesion decreased by 95% compared to the untreated cell layer.
Adhesion of Streptococcus pneumoniae bacteria to bronchial epithelial cells
The same method was used to test the adhesion of Streptococcus pneumoniae bacteria to bronchial epithelial cells. The initial germ number used for the incubation was set in this case to 1.7×106 CFU / ml – 1.9×106 CFU / ml. The determination of the number of adhesive germs after the test period delivered an outstanding result.
Result: On the cell layer treated with Medistus® Antivirus solution, no living streptococcus bacteria could be detected after the one-hour incubation.
The test results clearly indicate the powerful effect of Medistus® Antivirus lozenges in inactivating bacteria.
Efficacy study about the antiviral effect of Medistus® Antivirus against H1N1 and H2N2 viruses
The antiviral effect of Medistus® Antivirus lozenges against the common seasonal flu (H1N1) was succesfully tested in an accredited, highly recognised German test laboratory.2
The test was performed according to DIN EN 14476. The viruses in the mucosa were mixed with a solution of Medistus® Antivirus lozenges. The study included both normal and OECD heavy load conditions.3 Medistus® Antivirus proved exceptionally effective against the common flu virus. The results show clearly that both in clean and OECD heavy load conditions H1N1 viruses got inactivated in just 15 seconds.
After the very successful test against common flu, Medistus® Antivirus lozenges were put to a more severe test: the most tenacious Asian avian flu type H2N2 (duck) was merged in the mucosa. This virus type is extremely resistant due to its strong capsid (protein coat). Even in such an adverse environment, Medistus® Antivirus could inactivate the virus in 5 minutes in clean conditions. When applying a heavy load with a protein mix according to OECD guidelines, Medistus® Antivirus lozenges could reduce the virus count by 3 log units in only 10 minutes. (Remark: Since Medistus® Antivirus lozenges exert their effect in the mouth well beyond the guideline test limits, the assumption is well supported that even the tenacious avian flu virus gets completely inactivated in real life conditions.)
The test results clearly indicate the powerful effect of Medistus® Antivirus lozenges in inactivating influenza viruses.
Efficacy study about the antiviral effect of Medistus® Antivirus against the surrogate enveloped virus MVA
The antiviral activity of Medistus® Antivirus lozenges has been demonstrated in several previous in-vitro tests. In 2020, the virucidal activity of the lozenges was tested against the MVA virus in accordance with the requirements of DIN EN 14476 by an accredited laboratory in Germany.4
The Modified Vaccinia Virus Ankara (MVA) is a type of vaccine virus which was developed in vaccine research. It is widely applied as a surrogate virus representing all enveloped viruses to replace these in in-vitro tests. Enveloped viruses include any virus that is surrounded by a lipoprotein envelope that makes viruses more resistant to environmental influences and helps them adapt to the host cell. All viruses which pose a threat of global epidemics affecting the human population, are enveloped viruses such as influenza viruses, herpes viruses, HIV, ZIKA, Ebola virus, and SARS coronaviruses (SARS-CoV).5
The purpose of the in vitro test was to verify the effectiveness of Medistus® Antivirus lozenges against enveloped viruses causing upper respiratory infections under laboratory conditions. The MVA virus used for testing is a generally accepted surrogate in professional communities and official bodies as surrogate virus for enveloped viruses.6
During the laboratory test, the solution of the soft lozenges mixed with artificial saliva was tested by two methods. First, by the so-called “Clean conditions” method, in which the virucidal effect of the test substance is measured without adding interfering substances. The other applied testing method was the test according to “OECD conditions” which is performed under high load conditions by adding proteins, mucin and yeast to the test solution. The inclusion of proteins and yeasts pose an aggravating testing condition. It interferes with the mechanism of action of Medistus® Antivirus soft lozenges by reducing its efficacy, yet producing results close to real ‘in vivo’ conditions.
The number of residual viruses was counted in the same intervals in both test methods. In the “clean conditions” method, the virucidal effect of Medistus® Antivirus soft lozenges were clearly confirmed in only 5 minutes. It reduced the initial virus load by 4 log10 and inactivated all viruses. Under OECD conditions with high protein, mucin and yeast load, Medistus® Antivirus reduced the original virus concentration by 3.5 log10 after 5 minutes and by 3.67 log10 in 10 minutes. This translates into a virus load reduction > 99.9% in 10 minutes contact time.
These test results clearly support and confirm the antiviral effect of Medistus® Antivirus lozenges against enveloped viruses that may cause epidemics.
(1) BioTeSys GmbH: In vitro Studie zur Untersuchung des Effekts von Lutschpastillen auf die Bakterienadhärenz an Epithelzellen. BTS1259/18. Datum: 06.09.2018. Esslingen/Germany
(2) BioTeSys GmbH: In-vitro Studie zur Untersuchung des Effekts von Lutschpastillen auf die Viruslast. BTS 1114/2017. Datum: 13.11.2017. Esslingen/Germany
(4) BioTeSys GmbH: Virucidal activity of the lozenge Medistus Antivirus against Modified vaccinia virus Ankara, 16.06.2020, Esslingen / Germany
(5) For more information, see Fauquet, C.M. et al., Eds .: Virus Taxonomy, eighth report of the international committee on taxonomy of viruses. Elsevier Academic Press, San Diego, 2005
(6) „Activity against enveloped viruses can be claimed when MVA = Modified Vaccinia virus Ankara is tested in a (modified) EN 14675 test.” Guidance on the Biocidal Products Regulation Volume II Efficacy – Assessment and Evaluation (Parts B + C) Version 3.0 April 2018.
Evaluation of the antiviral properties of Medistus® Antivirus against SARS-Related Coronavirus 2
The worldwide COVID-19 Pandemic made it an imperative to submit the Medistus ® Antivirus Lozenges an in-vitro test against the SARS-Related Coronavirus 2, the cause of the COVID-19 Pandemic. The test took place in 2021, and it was carried out in accordance with the requirements of ASTM E 1052 (Standard Test Method for Efficacy of Antimicrobial Agents Against Viruses in Suspension) by an accredited laboratory in the USA. 1 The Isolate USA-WA1/2020 strain of SARS-Related Coronavirus 2 used for this study was deposited by the Centers for Disease Control and Prevention and obtained through BEI Resources, NIAID, NIH (BEI Resources NR-52281). 2
The purpose of the in-vitro test was to evaluate the antiviral properties of the Medistus ® Antivirus Lozenges against SARS-Related Coronavirus 2 when exposed (in suspension) for a specified exposure period. At each pre-determined exposure time an aliquot was removed, neutralized by serial dilution, and assayed for the presence of virus. The presence of virus (infectivity) is determined by monitoring the virus specific cytopathic effect (CPE) 3 on the appropriate indicator cell line, Vero E6. The indicator cell line chosen is capable of supporting the growth of SARS-Related Coronavirus 2. Antiviral properties of the product were evaluated and compared at the specified concentrations and time intervals.
The results of the in-vitro test demonstrated significant antiviral activity of Medistus Antivirus, showing a viral titer reduction up to 99,8% at the longest exposure time of 30 minutes.
The study report reads the following conclusion:
“Under the conditions of this investigation and in the presence of a 1% fetal bovine serum organic soil load, Medistus Antivirus Lozenge (Lot 0C0906), diluted 200mg/ml defined as 2.0g of test substance + 10mL of artificial saliva, demonstrated a 68.4% reduction in viral titer following a 120 second exposure time, a 90.0% reduction in viral titer following a 5 minute exposure time, 99.4% reduction in viral titer following a 10 minute exposure time, 99.0% reduction in viral titer following a 20 minute exposure time, and a 99.8% reduction in viral titer following a 30 minute exposure time to SARS-Related Coronavirus 2 as compared to the titer of the corresponding virus controls. The log reductions in viral titer were 0.50 log10, 1.00 log10, 2.25 log10, 2.00 log10, and 2.75 log10 respectively.”
The result shows that even after 10 minutes exposure time, a 99,4% reduction in the viral titer could be achieved. Due to the long mucoadhesion time of Medistus Antivirus lozenges, demonstrated in a laboratory test performed by the German Food Technology Institute 4 all exposure times between 120 sec and 30 minutes can be regarded as a period in which the active ingredients are able to exert their effects.
1) „Evaluation of Antiviral Properties of a Product Using a Virucidal Suspension Assay, Protocol Number: INNOO7122920.SARS2.” Revised report date. April 13, 2021.Analytical Lab Group MIDWEST 1285 Corporate Center Dr, Ste 110 Eagan, MN 55121
2) Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2), isolate USA-WA1/2020 was isolated from an oropharyngeal swab from a patient with a respiratory illness who had recently returned from travel to the affected region of China and developed clinical disease (COVID-19) in January 2020 in Washington, USA.
3) Cytopathic effect (CPE), structural changes in a host cell resulting from viral infection. CPE occurs when the infecting virus causes lysis (dissolution) of the host cell or when the cell dies without lysis because of its inability to reproduce
4) Mucoadhesion-test of Medistus Antivirus Lozenges, Report 13/01/2021, Deutsches Institut für Lebensmitteltechnik e.V., Quakenbrück / Germany
Active substance: Kistosyn® 200 extract
Other ingredients: maltitol, sorbitol, purified water, ascorbic acid, citric acid, flavour, vegetable oil, stevia extract, peppermint oil.
No preservatives and colorants.
Sugar, glutenand lactose free.
Store in a cool, dry place, protected from light.
Natural health protection at increased infection risk
FORM AND CONTENT
Original packaging with 10 lozenges.
Keep out of reach of small children. Suitable for children older than 6 years.
There are no side effects known.
There are no counter indications known.
To avoid interactions, in case of taking medicines internally, please leave a pause of 2 hours between the intakes or consult your doctor.
The Medistus figurative trademark and the Kistosyn word trademark are registered international trademarks of Vitaplus Ltd.
For more information about the product and for medical information
please write to: or call us at: +36 1 239 0432.