Inhibition of SARS-CoV-2 by bentonite-based nasal drops

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is the etiology of COVID-19 (Coronavirus Disease 2019). To date, the COVID-19 pandemic has confirmed more than 190 million SARS-CoV-2 infections and more than 4 million COVID-related deaths.

This pandemic follows the last two global pandemics. Coronavirus, 2002-2003 SARS and 2012 Middle East Respiratory Syndrome (MERS). With a new variant of SARS-CoV-2, the crisis poses an imminent threat despite vaccination programs and ongoing mitigation measures. In addition, personal protection against infection needs to be improved.

SARS-CoV-2 infection is mainly transmitted from aerial virions. The main site of infection in the human body is the nasopharyngeal epithelium, especially the ciliated cells. The lining of the epithelium of the nose is an essential portal for viral infections. It is also an important site for virus replication.

Therefore, the nose is an important target for prevention and treatment.In a recent study posted on bioRxiv* Preprint server, Fabio Fais et al. We have developed a safe and easy-to-use nasal spray AM-301. This is a medical device sold as Bentrio to protect against infection by SARS-CoV-2 and other viruses.

Researchers test safety and Effectiveness of AM-301 countered SARS-CoV-2 and was shown to be safe for the nasal epithelium. The study also significantly reduced virus titers.

The mechanism of action of AM-301 is physical. In other words, the ingredients are non-pharmaceutical because they are neither metabolized nor absorbed. As an additional benefit, researchers noted that sprays could be used against a variety of viruses, allergens, and contaminants in the air.

Researchers have developed a simple and safe intervention to protect and enhance the nasal barrier function against SARS-CoV-2 using natural substances with a wide range of pharmaceutical applications and virus-capturing properties such as clay. did.

Bentonite

Bentonite is a clay mineral composed of a thin sheet of aluminum silicate with a net negative charge. The team has developed a nasal drop containing bentonite (aluminum silicate) in a matrix consisting of monoglyceride, diglyceride, triglyceride, propylene glycol, xanthan gum, mannitol, EDTA disodium, citrate, and water.

Bentonite has long been known to be able to capture viruses, but this study is the first application in the capture of aerial viruses.

The formulation AM-301 is characterized as a white to light beige, odorless, tasteless aqueous gel emulsion with a pH of 6.0. “When we applied it to our own nasal mucosa or palm skin, it had a coherence like a soothing non-irritating lotion,” the paper’s researchers explained. ..

“We have selected only inactive ingredients, such as pharmaceutical additives and generally accepted substances, to minimize potential side effects and promote frequent and compliant use.”

MucilAir

Researchers used MucilAir, an established model of the human primary nasal epithelium, to prevent AM-301 from 1) infecting SARS-CoV-2 and 2) previously established with MucilAir. We have demonstrated that we can reduce the infections that have occurred. processing.

AM-301 in alleviation of SARS-CoV-2 infection. A bar graph containing A, B means and individual data points. The test material was applied 24 hours or 30 hours after the start of the experiment (Protocols 1 and 2 respectively). C linear mixed effect model. The log-linear scatter diagram shows the individual log-transformed data and concave curves of the negative control samples (untreated, saline and matrix treated inserts, dashed curves) and AM-301 treated inserts (continuous curves) (t =). 3.68, p <0.01). This model shows a slowdown in exponential growth, as is usually observed in sigmoid motion.

AM-301 did not adversely affect Mucil Air, except for a slight decrease in ciliary beating frequency, despite repeated application for 4 days. Researchers believe that this may be due to the viscosity of the formulation.

“The positive effect of AM-301 on reducing SARS-CoV-2 infection is supported by observations from a linear mixed-effects model that showed a significant slowdown in viral titer growth in both prophylactic and mitigation assays. Has been done. “

In the early stages of SARS-CoV-2 infection, the nasal passages are known to be infected with high levels of virus. As a result, infected individuals are highly contagious and are at risk of developing lower respiratory tract infections due to aspiration along the nasal-oropharynx-pulmonary axis. “Therefore, the nasal microenvironment plays a major role in SARS-CoV-2 infection and the clinical course,” the researchers observed.

The nasal passages provide two lines of protection: the physical line of protection, the epithelium of the nasal mucosa, and the immune protection provided by immune cells present in the nasopharyngeal lymphoid tissue.

“Together, mucous fimbria clearance and immune response should protect the nasal epithelium from pathogens, but infection can occur in the case of high viral exposure or dysfunction of these mucosal defenses.”

Despite the strong nasal barrier, the virus often succeeds in invading the body. No cure is currently available. AM-301 can be used as a non-pharmacological nasal spray to prevent SARS-CoV-2 infections or to mitigate existing infections.

The promising results of this study require further investigation In vivo In humans, researchers are writing to further evaluate AM-301 as a medical device with a wide range of effects on a range of viruses, allergens, and pollutants.

*Important Notices

bioRxiv Publish preliminary scientific reports that should not be considered definitive as they are not peer-reviewed, guide clinical practice / health-related behaviors, and should not be treated as established information.