DE202023103058U1 - Composition for antiviral treatment - Google Patents

Abstract

Composition, in particular pharmaceutical composition, for use in the prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity, wherein the composition contains octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, as antiviral active ingredient.

Description

The present invention relates to the field of medicine and in particular to the technical (i.e. medical-pharmaceutical) field of the treatment or therapy of viral diseases or viral infections (viral infectious diseases or viral infections), in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19.

In particular, the present invention relates to a composition for use in the prophylactic or therapeutic topical (local) treatment of viral diseases (synonymously also referred to as "(virus) infections" or the like), in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2 (synonymously also referred to as "corona infections", "corona(virus) infections" or the like), in particular of COVID-19, or the use of a composition (for the manufacture of a medicament or drug) for the prophylactic or therapeutic topical treatment of the previously described viral diseases or (virus infections). In the context of the present invention, octenidine and/or its salts and/or its esters, preferably octenidine dihydrochloride, are used as the antiviral active ingredient.

In this context, the present invention also relates to octenidine and/or its salts and/or its esters, preferably octenidine dihydrochloride, for the prophylactic or therapeutic topical treatment of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, in particular COVID-19. In this regard, the present invention also relates to the use of octenidine or its salts or esters, preferably octenidine dihydrochloride, (for the preparation of a medicament or drug) for the prophylactic or therapeutic topical treatment of the diseases mentioned above.

Furthermore, a method for the prophylactic or therapeutic topical (local) treatment of viral diseases is described here.

Coronaviridae is a family of viruses within the order Nidovirales. The coronavirus family owes its name to the proteins on the surface of the virus particle, which give the virus a crown-like appearance when viewed under an electron microscope. The viruses within this virus family are also colloquially known as coronaviruses and are among the RNA viruses with the largest genomes. The first coronaviruses were discovered and described in the mid-1960s. The viruses, which are roughly spherical in the electron microscope image, are noticeable for a ring of petal-like extensions that are reminiscent of a solar corona, which gives this virus family its name.

Members of the Coronaviridae virus family cause very different diseases in all four classes of terrestrial vertebrates (i.e. mammals, birds, reptiles and amphibians). They are highly genetically variable and can therefore infect several types of hosts and also develop new virus variants.

In humans, several types or species of coronaviruses are important as pathogens of mild respiratory infections (especially colds or flu) through to the so-called severe acute respiratory syndrome (SARS). The most well-known human coronaviruses are SARS-CoV-1 (Severe Acute Respiratory Syndrome Coronavirus-1), MERS-CoV (Middle East Respiratory Syndrome Coronavirus) and SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2 or COVID-19). These coronaviruses are the triggers of the SARS pandemic in 2002/2003, the MERS epidemic in 2012 and the COVID-19 pandemic from 2019 onwards.

The World Health Organization (WHO) has given the disease caused by SARS-CoV-2 the official name COVID-19. COVID-19 (i.e. the abbreviation for Coronavirus Disease 2019, colloquially also referred to as Coronavirus Disease/Infection or the like) is an infectious disease that results from infection with the coronavirus SARS-CoV-2. The disease was first described in Wuhan/China at the end of 2019, then developed into an epidemic in January 2020, initially in the People's Republic of China, and finally spread worldwide to become the COVID-19 pandemic.

Transmission or infection with SARS-CoV-2 generally occurs through droplets (droplet transmission or droplet infection) or aerosols that are produced when speaking, coughing and sneezing. The virus can cause infection via the respiratory tract, eyes, nose and mouth or throat. throat area into the body. The risk of infection can be reduced, but not eliminated, by wearing mouth and nose coverings, consistent hand hygiene (regular hand washing) and coughing and sneezing into the crook of the arm. So-called social distancing can also reduce the transmission of SARS-CoV-2.

The incubation period of SARS-CoV-2 is on average five to six days, although sometimes up to fourteen days can pass between infection and the onset of the first symptoms, and in isolated cases the first symptoms can appear within 24 hours of infection with SARS-CoV-2. The most common symptoms are fever, dry cough and fatigue. Less common symptoms include muscle pain, a stuffy nose, headache, conjunctivitis, sore throat, diarrhea, loss of taste or smell, or a rash or discoloration of fingers or toes.

Even infected people without symptoms or with mild disease can pass on the virus. If the disease is mild, symptoms generally subside within two weeks. If COVID-19 is more severe, recovery can take three to six weeks or even longer.

COVID-19 can therefore also manifest itself with a general feeling of severe illness. As the disease progresses, severe shortness of breath can develop due to an infection of the lower respiratory tract and even pneumonia. This can be accompanied by chest pain similar to pleurisy. Around 85% of seriously ill COVID-19 patients develop lymphopenia. Severely ill patients also often develop hypercytokinemia (so-called cytokine storm), whereby this cytokine storm is caused by an overreaction of the immune system; this overreaction is characterized by a significant increase in inflammation-relevant cytokines, such as interleukin-6, interleukin-8, interleukin-1beta and TNF-alpha. The increased release of these cytokines leads to an overproduction of immune cells, especially in the lung tissue.

In general, however, the overall registered infections often involve a mild course of the disease with fever or mild pneumonia. However, as previously mentioned, a smaller proportion of cases have a severe course, which can even require intensive care or ventilation for affected persons. SARS-CoV-2 can lead to particularly severe disease courses, particularly in older and immunocompromised people, as well as in people with pre-existing medical conditions. Overall, an infection with SARS-CoV-2 is therefore associated with different disease courses with regard to COVID-19. Symptom-free courses and symptomatic courses, including severe and even fatal courses, can exist or occur.

As far as clinical symptoms and laboratory signs of disease are concerned, it is sometimes difficult to differentiate from other viral diseases, such as influenza, based on symptoms alone. COVID-19 can be diagnosed in particular through laboratory diagnostics, in particular by means of specific virus and antibody detection.

The replication cycle of SARS-CoV-2 is particularly important for the pathomechanism underlying the disease. The virus that causes COVID-19 typically enters the host cell by binding to the enzyme ACE2 (angiotensin-converting enzyme 2) anchored in the cell membrane of a (human) host cell, with the virus interacting with ACE2 via its spike protein. ACE2 is involved in the breakdown of angiotensin II, which increases blood pressure and has pro-inflammatory effects. Binding to the spike protein inhibits the function of ACE2, which can promote inflammatory reactions. ACE2 is also downregulated by the viral infection. The involvement of the serine protease TMPRSS2 (transmembrane serine protease 2) is also relevant for the infection process. This endogenous and membrane-derived protease is required by SARS-CoV-2 for entry into the host cell (and release from the host cell).

During infection, SARS-CoV-2 is taken up into the host cell via endosomes. Viral RNA is released from these, which is needed for the formation of viral proteins and for the synthesis of new genetic material. Newly formed viruses, in turn, leave the host cell through exocytosis and can infect other cells or be released into the environment and infect other people.

COVID-19 and the pathogen underlying this disease, SARS-CoV-2, are the subject of intensive research, also with the aim of providing causal therapies and vaccinations.

As far as the drug prevention of COVID-19 is concerned, effective vaccines are now available that make a significant contribution to preventing infection, reducing severe disease progression and controlling the infectious disease and its spread. Depending on the type of vaccination, antigens or nucleic acids from SARS-CoV-2 are administered (the nucleic acids in the body are used to form the corresponding viral proteins), which triggers an immune response and in particular leads to the formation of antibodies that protect against infection or reduce the risk of infection or, in the event of infection, lead to less severe disease progression.

Since the global outbreak of SARS-CoV-2, a large number of COVID-19 vaccines have been developed, including so-called mRNA vaccines, DNA vaccines, vaccines based on inactivated coronaviruses and so-called subunit vaccines, which are based on proteins of the virus. The main focus of the vaccines is the spike protein of SARS-CoV-2, which is responsible for binding the virus to the host cell and uptake into the cells, as previously explained. In general, the vaccines lead to a certain immunity to SARS-CoV-2, which can also reduce the occurrence of severe courses of the disease. However, complete immune protection or only conditional immunity is not always provided, including with regard to newly emerging virus variants or the like.

Mild illnesses can be treated symptomatically, e.g. with antipyretics, painkillers, cough suppressants or antitussives and expectorants or secretolytics. Decongestant nasal sprays can also be used. Antiviral agents can be used for causal therapy. These include, for example, so-called RNA polymerase inhibitors or nucleoside analogues such as remdesivir. Remdesivir is an antiviral agent for the treatment of COVID-19. Remdesivir has a broad spectrum of activity and is effective against coronaviruses, among other things, inhibiting viral RNA synthesis and virus replication. The drug is administered as an intravenous infusion. Antiviral agents from the group of 3CL protease inhibitors are also available for the treatment of COVID-19, with the effect being based on the inhibition of the viral protease 3CL. This disrupts or inhibits the processing of viral proteins and enzymes as well as virus replication. Furthermore, active substances that inhibit the protease TMPRSS2 (which, as previously mentioned, is important for the uptake of SARS-CoV-2 into the host cells) can be considered. Furthermore, drugs in the form of fusion inhibitors, monoclonal antibodies or the like are important. In addition, immunosuppressants or immunomodulators such as dexamethasone should also be considered. Such active substances can control an excessive and endogenous immune reaction in connection with COVID-19, which is partly responsible for symptoms and complications.

Overall, there are now causal therapeutic approaches available for the treatment of COVID-19. However, these are often associated with undesirable or excessive side effects and focus primarily on a purely systemic approach with a therapeutic emphasis after the manifestation or outbreak of the disease and often require intensive monitoring under close medical supervision.

According to current knowledge, the SARS-CoV-2 virus will establish itself as an endemic virus in the long term even after the pandemic situation has subsided, so that the virus will continue to circulate in parts of the population. This means that infections can still occur in the long term, which can continue to lead to severe courses of COVID-19 disease. In addition, new virus variants of SARS-CoV-2 can develop, which can also at least partially evade the protective effect of existing vaccinations.

Overall, this means that in addition to the available vaccinations, comprehensive diagnostics for the early detection of infected persons and the available symptomatic and causal therapies, further active substances or treatment concepts are required that can be used to treat COVID-19 or to combat SARS-CoV-2.

In particular, there is still a great need for the provision of new or complementary treatment concepts that are effective against the virus, in addition to are low in effectiveness and are also easy to handle and highly safe to use. There is also a great need to provide preventive or prophylactic concepts on the basis of which infection and the transmission of the virus can be prevented or the transmission and risk of infection can be reduced. There is also a need to provide appropriate active ingredients that can be used co-therapeutically with known active substances.

Against this background, one object of the present invention is to provide an efficient (treatment) approach to viral diseases caused by corona viruses, in particular SARS-CoV-2, or to viral infections caused by corona viruses (viral infections), in particular COVID-19, whereby the previously described disadvantages of the prior art should also be at least largely avoided or at least mitigated.

The present invention is based in particular on the object of finding or providing a suitable active ingredient and a composition containing this active ingredient, which is/are each suitable for the efficient prophylactic or therapeutic treatment of viral diseases which are caused in particular by corona viruses (i.e. corona (virus) infections), preferably SARS-CoV-2, preferably within the framework of an efficient prophylaxis or therapy.

In particular, a further object of the present invention is to find or provide a suitable active ingredient and a composition containing this active ingredient, which is/are suitable for use in the prophylactic or therapeutic treatment of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19.

In this context, a further object of the present invention is to find or provide a corresponding active ingredient or a composition containing this active ingredient, which should be highly effective against the viruses in question and also easy to administer or use and also well tolerated, combined with few side effects.

Yet another object of the present invention is to find or provide a corresponding active ingredient or a related composition which is suitable for infection prophylaxis or for reducing the viral load of an infected person.

Furthermore, a further object of the present invention is to find or provide a corresponding active ingredient or a related composition which can be used as part of a (total) medication with other active ingredients, in particular antiviral active ingredients, also with a view to providing an enhanced or supplemented effect in the treatment of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19.

In a completely surprising manner, the applicant has now discovered that octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, are unexpectedly and efficiently suitable as an antiviral active ingredient for the prophylactic or therapeutic topical (local) treatment of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19. The same applies equally to a composition based thereon, in particular a pharmaceutical composition, which contains octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, as an active ingredient. According to the invention, the focus is in particular on topical (local) application in the mouth, throat and/or nasal cavity, in particular in the mouth and throat, in particular on the basis of a lozenge.

To solve the problem described above, the present invention therefore proposes - according to a first aspect of the present invention - the composition according to the invention, in particular pharmaceutical composition, for use in the prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, according to claim 1. In each case advantageous Further developments and refinements of this aspect of the invention are the subject of the relevant subclaims and subsidiary claims.

A further subject matter of the present invention - according to a second aspect of the present invention - is also the inventive use of a composition, in particular a pharmaceutical composition (for producing a medicament or drug) for the prophylactic or therapeutic topical (local) treatment of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, according to the relevant independent claims. Advantageous further developments and embodiments of this aspect of the invention are the subject of the corresponding subclaims.

Likewise, the subject matter of the present invention - according to a third aspect of the present invention - is octenidine or its salts or esters, preferably octenidine dihydrochloride, for use in the prophylactic or therapeutic topical (local) treatment of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, according to the relevant independent claim. Advantageous further developments and embodiments of this aspect of the invention are the subject matter of the relevant subclaims.

Yet another subject matter of the present invention - according to a fourth aspect of the present invention - is also the inventive use of octenidine or its salts or esters, preferably octenidine dihydrochloride, (for the production of a medicament or drug) for the prophylactic or therapeutic topical (local) treatment of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19. Advantageous further developments and embodiments of this aspect of the invention are the subject matter of the relevant subclaims.

The present invention also describes a method for the prophylactic or therapeutic topical (local) treatment of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19.

It goes without saying that embodiments, embodiments, advantages and the like which are listed below only for one aspect of the invention for the purpose of avoiding repetition, naturally also apply accordingly with regard to the other aspects of the invention without this requiring separate mention.

Furthermore, it goes without saying that the following information on values, numbers and ranges is not to be understood as limiting; it goes without saying for the person skilled in the art that, depending on the individual case or application, the specified range or information can be deviated from without departing from the scope of the present invention.

Furthermore, for all relative or percentage, particularly weight-related, quantity information given below, it should be noted that these details must be selected or combined by the person skilled in the art with regard to the reference system used (e.g. dosage form or composition) in such a way that the total - if necessary including other components or ingredients or additives or constituents, in particular as defined below - always results in 100% or 100% by weight. However, this goes without saying for the person skilled in the art.

In addition, all values or parameter specifications or the like mentioned below can in principle be determined using standardized or explicitly specified determination procedures or using determination methods that are familiar to the person skilled in the art.

Furthermore, for the description of the present invention, the features of the present invention cited in connection with the specific configurations, embodiments, advantages, examples or the like are also deemed to be disclosed in their combination. Thus, higher-level combinations of individual or multiple features which are cited for respective configurations, embodiments, application examples or the like are also deemed to be disclosed.

In particular, for the features characterizing the invention, all possible combinations of these features are deemed to be disclosed, whereby embodiments of comparable or corresponding preference of the various features in their combination are preferred (e.g. amounts or ranges of amounts of the relevant active ingredients and ingredients of the same preference or the like).

In particular, it also applies that for the quantity details given below relating to the various ingredients, in particular active ingredients, of the composition according to the invention or the like, in particular relative quantity details or absolute quantity details of the same preference or the same level of preference, respective combinations relating to the various ingredients, in particular active ingredients, with corresponding preference or preference are also disclosed. Likewise, all other combinations (i.e. combinations based on different preferences or different levels of preference) are also disclosed.

• Gegenstand der vorliegenden Erfindung - gemäß einem ersten Aspekt der vorliegenden Erfindung - ist somit die erfindungsgemäße Zusammensetzung, insbesondere pharmazeutische Zusammensetzung, zur Verwendung bei der prophylaktischen und/oder therapeutischen topischen (lokalen) Behandlung, insbesondere prophylaktischen und/oder therapeutischen antiviralen topischen Behandlung, von viralen Erkrankungen, insbesondere von durch Corona-Viren, vorzugsweise SARS-CoV-2, hervorgerufenen (Virus-)Erkrankungen, bevorzugt von COVID-19, insbesondere zur topischen Anwendung im Mund-, Rachen- und/oder Nasenraum und/oder zur topischen Anwendung auf die Schleimhäute des Mund-, Rachen- und/oder Nasenraums,
• wobei die Zusammensetzung als antiviralen Wirkstoff Octenidin und/oder dessen Salze und/oder Ester, vorzugsweise Octenidindihydrochlorid, enthält.

Having said that, the present invention will now be explained in detail below:

• The subject matter of the present invention - according to a first aspect of the present invention - is thus the composition according to the invention, in particular pharmaceutical composition, for use in the prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity,
• wherein the composition contains octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, as antiviral active ingredient.

Because - as previously stated - the applicant has found in a completely surprising way that octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, are unexpectedly and efficiently suitable as an active ingredient for the topical (local) treatment of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2 (i.e. viral infections or corona (virus) infections), preferably COVID-19.

The special, new and inventive application or medical indication for octenidine or its salts and/or esters, preferably octenidine dihydrochloride, surprisingly discovered by the applicant within the scope of the present invention, has not been described in the prior art to date and has not been considered or recognized, even though octenidine or its salts or esters, preferably octenidine dihydrochloride, are basically an active ingredient known per se.

As explained in more detail below, the composition according to the invention is in particular in a solid dosage form for sucking, in particular in the form of a lozenge, wherein the composition according to the invention contains a therapeutically effective amount of octenidine or its salts and/or esters, preferably octenidine dihydrochloride.

In the context of the present invention, the term "topical treatment" or "topical application" refers in particular to the local prophylactic or therapeutic treatment of the (viral) disease in question or to the application of the composition in the mouth, throat and/or nasal cavity, preferably the mouth and/or throat. In particular, the aforementioned term refers to the mucous membranes of the mouth, throat and/or nasal cavity, in particular mucous membranes of the mouth and/or throat. In this context, the applicant has found, completely surprisingly, that octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, has an antiviral effect when applied topically or locally, in particular against corona viruses, preferably SARS-CoV-2.

In this context, the applicant has surprisingly found that octenidine or its salts and/or esters, preferably octenidine dihydrochloride, are excellently suited for targeted topical application in the mouth, throat and/or nasal cavity, in particular the mouth and throat, or for topical application to mucous membranes of the mouth, throat and/or nasal cavity, in particular the mouth and throat, with regard to the prophylactic or therapeutic topical treatment of viral diseases which are caused in particular by corona viruses, preferably SARS-CoV-2, namely Covid-19.

In this context, the targeted and purposeful topical or local application of octenidine or its salts or esters, preferably octenidine dihydrochloride, as demonstrated by the applicant, leads to a significant reduction in the viral load in the mouth, throat and/or nasal cavity, so that on this basis symptoms associated with the disease can also be alleviated.

On this basis, the symptomatic course of the disease can also be positively influenced for infected people, along with a reduction in underlying symptoms or complaints. This counteracts both the systemic spread of the virus in the body of an infected person and the transmission or release of the virus into the environment, so that there is a lower risk of infection for other or third parties.

To illustrate, the composition according to the invention acts in particular at the entry point for the virus, namely in the mouth, throat or nasal cavity, so that the risk of infection itself is reduced and, in addition, the risk of a systemic attack or systemic spread of the virus is reduced.

According to the invention, it is also completely surprising that the composition according to the invention based on octenidine or its salts or esters can also be used, for example, as part of infection or exposure prophylaxis. This is because the antiviral effect of octenidine or its salts or esters, preferably octenidine dihydrochloride, can effectively reduce the viral load in the mouth, throat and/or nose, which is associated with a reduced risk of (self-)infection and also of infection of other or third parties. In this context, the composition according to the invention can thus surprisingly be used for infection prophylaxis and exposure prophylaxis, in particular for post- or pre-exposure prophylaxis, as also stated below.

In addition, the composition according to the invention is also suitable for use as part of co-medication with other antiviral active ingredients or the like, including systemic active ingredients. In particular, the composition according to the invention can be used for the accompanying or supplementary and/or supportive treatment of the underlying viral diseases, in particular COVID-19. In particular, the composition according to the invention can also be integrated into corresponding treatment or therapy concepts.

In addition, the composition according to the invention with topical application in the mouth, throat or nose is easy to handle and has good application properties. In addition, particularly as a result of the local or topical administration of the active ingredient, the composition according to the invention is generally well tolerated and at the same time highly effective.

The present invention is based on a completely surprising discovery of a particularly local influence (namely in the mouth, throat or nasal cavity) of octenidine or its salts or esters, preferably octenidine dihydrochloride, in particular on corona viruses, such as SARS-CoV-2, in particular as a result of a local antiviral effect, which represents a valuable contribution to protection, in particular against SARS-CoV-2 (namely with regard to the treatment of COVID-19 or efficient infection or exposure prophylaxis as well as the reduction of the risk of a systemic attack by the virus).

The term “pharmaceutical composition” as used in the context of the present invention is to be understood very broadly and includes not only pharmaceutical preparations or pharmaceuticals and medicinal products as such, but also so-called medical devices, foods or nutritional supplements.

The term "antiviral", as used according to the invention for octenidine or its salts or esters, preferably octenidine dihydrochloride, or the composition according to the invention and with regard to the underlying topical treatment of viral diseases, is to be understood very broadly in the context of the present invention and refers in particular to an effectiveness directed against the underlying viruses, in particular corona viruses, preferably SARS-CoV-2. The antiviral effectiveness cited according to the invention with respect to octenidine or its salts or esters, preferably octenidine dihydrochloride, can, for example and in a non-limiting manner, refer to an inactivation of viruses or virus particles, in particular also outside of their host cells, or to a "Killing" the viruses. Likewise, the antiviral effectiveness can also refer, for example, to preventing or reducing the proliferation or formation of viruses or virus particles, particularly in host cells, or to preventing or reducing the release of viruses or virus particles from host cells. In addition, the antiviral effectiveness in this context and in an equally non-limiting manner can refer to preventing or reducing the (viral) replication cycle. In addition, the antiviral effect can also refer to the formation of a barrier function ("protective film"), so that the penetration of viruses into host cells is made more difficult. In general and in summary, the term "antiviral", as used in the invention, refers, by way of example and without wishing to refer to or limit itself to the underlying mechanisms, to inactivating or "killing" the viruses, preventing or reducing the proliferation or replication of the viruses, forming a protective film or a barrier function against the viruses or the like.

The terms “salts” or “esters”, as used here with regard to the active ingredients or constituents listed, refer in particular to the respective pharmaceutically acceptable or harmless salts or esters of the active ingredients or constituents listed.

Based on the concept of the invention, virus proliferation or viral load can be reduced or prevented even within the first few days after an infection, which also reduces or prevents the occurrence of disease-specific symptoms and counteracts the occurrence of severe disease progression or systemic infection. In addition, as a result of the reduction in the viral load in the mouth, throat or nose, locally occurring disease symptoms can also be reduced or prevented. In addition, the probability of infection after exposure can be reduced and the transmission of the virus to other or third parties can be prevented or reduced.

In the context of the present invention, it is equally surprising that the special topical application of the composition according to the invention, in particular the topical application in the mouth, throat or nasal cavity, preferably in the mouth and throat, is associated with high efficiency and effectiveness against the underlying viruses, in particular corona viruses, preferably SARS-CoV-2. In this context, the special dosage form of the composition according to the invention or the underlying galenics is also of great importance, according to which the composition according to the invention is present or administered in a solid dosage form or a liquid dosage form, preferably a solid dosage form, namely in particular a lozenge, as explained in more detail below. In this way, a good active ingredient distribution and exposure time in relation to the tissue can be achieved on the basis of a liquid dosage form. In addition, the special dosage form, in particular the solid dosage form based on lozenges, achieves a defined and time-optimized release of the active substance, particularly in the mouth and throat area, which also leads to a further improved antiviral effect against the viruses in question.

The pharmaceutical potential of octenidine or octenidine dihydrochloride in relation to the topical (local) treatment of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, with the relevant application in the mouth, throat or nasal cavity, preferably in the mouth and throat, and in particular also in solid dosage form for sucking, has so far remained unrecognized. This discovery goes back to the applicant. It was only the applicant who applied the active ingredient octenidine or octenidine dihydrochloride to a special topical application in the mouth, throat or nasal cavity, preferably in the mouth and throat, for the targeted prophylactic or therapeutic antiviral topical treatment of the viral diseases mentioned according to the invention, preferably on the basis of or in the form of a solid galenic preparation for sucking, in particular in the form of a lozenge. In this way, the potential of octenidine or octenidine dihydrochloride with regard to its special antiviral effect, especially against corona viruses and in particular SARS-CoV-2, is particularly effective and used, along with its high effectiveness with regard to the prophylactic or therapeutic antiviral topical treatment of the underlying viral diseases, especially with regard to COVID-19.

The active ingredient used according to the invention, octenidine (CAS No.: 71251-02-0) or octenidine dihydrochloride (CAS No.: 70775-75-6), belongs to the group of quaternary ammonium compounds or to the chemical group of bipyridines. In this context, octenidine or octenidine dihydrochloride has two cationic centers. Octenidine dihydrochloride is the international nonproprietary name for 1,1'-(1,10-decanediyl)bis[4-(octylamino)pyridinium] dichloride or for 1,1'-decamethylene[(1,4-dihydro-4-octylimimo)pyridinium] dichloride.

For further details on octenidine or its salts or esters or octenidine dihydrochloride, reference can be made, for example, to Römpp Chemielexikon, 10th edition, volume 4, 1998, Georg-Thieme-Verlag, Stuttgart/New York, page 2986, keyword: “Octenidine dihydrochloride”, whereby the entire disclosure content, including the literature cited therein, is hereby fully incorporated by reference.

According to a preferred embodiment of the invention, the composition according to the invention can contain the octenidine and/or its salts and/or esters, as mentioned above, in the form of a hydrochloride salt, preferably octenidine dihydrochloride. According to the invention, according to a preferred embodiment, the octenidine and/or its salts and/or esters is an octenidine hydrochloride salt, preferably octenidine dihydrochloride.

The composition according to the invention particularly preferably contains octenidine dihydrochloride as an antiviral active ingredient. The use of octenidine dihydrochloride is associated with a particularly high level of effectiveness and a defined spectrum of activity of the composition according to the invention.

According to the invention, the composition according to the invention contains the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, in pharmaceutically and/or therapeutically effective amounts, in particular in pharmaceutically and/or therapeutically antivirally effective amounts.

According to the invention, it is particularly provided that the composition contains the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, in a (relative) amount in the range from 0.001% by weight to 10% by weight, in particular in the range from 0.005% by weight to 7.5% by weight, preferably in the range from 0.01% by weight to 5% by weight, preferably in the range from 0.02% by weight to 4% by weight, particularly preferably in the range from 0.03% by weight to 2% by weight, more preferably in the range from 0.05% by weight to 1% by weight, based on the composition.

The effectiveness of the composition according to the invention can be further increased or tailored by adding at least one local anesthetic to the composition. According to the invention, it can therefore be provided that the composition according to the invention contains at least one local anesthetic. This can, for example, be used to specifically treat local pain symptoms associated with the (viral) disease, particularly in the mouth, throat or nasal cavity, preferably in the mouth and throat. This also protects the affected tissue, for example as a result of reduced throat clearing or normalized swallowing behavior, and supports the action of octenidine or octenidine dihydrochloride.

As far as the local anesthetic that can be used according to the invention is concerned, in principle all local anesthetics suitable for topical application can be used. For details on local anesthetics, reference can be made, for example, to E. Mutschler et al., “Mutschler Drug Effects - Textbook of Pharmacology and Toxicology”, 8th edition, Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart, 2001, pages 267 et seq., and Römpp Chemistry Encyclopedia, 10th edition, Volume 3, Georg Thieme Verlag, Stuttgart/New York, 1997, pages 2442 , keyword: “local anesthetics” as well as the literature referred to therein.

According to the invention, the local anesthetic can in particular be a local anesthetic based on an organic acid ester or acid amide, preferably acid amide. In this context, the local anesthetic can be selected from the group of local anesthetics of the ester type and local anesthetics of the amide type and combinations and mixtures thereof, preferably local anesthetics of the amide type.

According to the invention, the local anesthetic can be selected from the group of benzocaine, procaine, tetracaine, lidocaine, etidocaine, prilocaine, mepivacaine, bupivacaine and S-ropivacin and their salts and esters as well as their combinations and mixtures, in particular lidocaine and its salts and esters, preferably lidocaine hydrochloride.

According to a preferred embodiment of the invention, the local anesthetic can be selected from the group of lidocaine (2-diethylamino-N-(2,6-dimethylphenyl)acetamide) and its salts and esters, preferably lidocaine hydrochloride.

According to the invention, it can be provided in particular that the composition contains, in particular as a local anesthetic, lidocaine (2-diethylamino-N-(2,6-dimethylphenyl)acetamide) and/or its salts and/or esters, preferably lidocaine hydrochloride.

Lidocaine is a local anesthetic of the amide type, particularly the aminoamide type, which has good local efficacy, rapid onset of action and good tolerability. Lidocaine reversibly blocks voltage-dependent sodium channels in the cell membranes of nerve cells. In particular, lidocaine inhibits the influx of sodium ions into the nerve cells via voltage-dependent sodium channels, which leads to a reduced excitability of nerve fibers, since the increase in sodium permeability required to develop an action potential is reduced. This reduces the sensation of pain.

In particular, the local anesthetic can be selected from the group of lidocaine and its pharmaceutically acceptable salts and esters. According to a preferred embodiment of the invention, the local anesthetic is used in the form of lidocaine hydrochloride. In comparison to lidocaine, lidocaine hydrochloride is particularly more water-soluble. This - without wishing to rely on or limit itself to this theory - further improves the release of the active ingredient upon contact with liquid or saliva, which also leads to improved active properties. In addition - equally without wishing to rely on or limit itself to this theory - the inflamed tissue associated with the (viral) diseases present, particularly in the mouth/throat area, has a lower pH value than normal or non-inflamed tissue, particularly as a result of local lactic acidosis. Lidocaine hydrochloride therefore also has good penetration properties, since the protonated form is already present in this regard.

According to the invention, the composition can contain the local anesthetic, in particular lidocaine and/or its salts and/or esters, preferably lidocaine hydrochloride, in pharmaceutically and/or therapeutically effective amounts, in particular in pharmaceutically and/or therapeutically local anesthetically effective amounts.

According to the invention, the composition can contain the local anesthetic, in particular lidocaine and/or its pharmaceutically and/or physiologically acceptable salts, preferably lidocaine hydrochloride, in a (relative) amount in the range of 0.01 wt.% to 5 wt.%, in particular in the range of 0.05 wt.% to 4 wt.%, preferably in the range of 0.1 wt.% to 2.5 wt.%, preferably in the range of 0.2 wt.% to 0.6 wt.%, based on the composition.

For further information on lidocaine, please refer to RÖMPP Chemielexikon, 10th edition, volume 3, 1997, Georg Thieme-Verlag, Stuttgart/New York, keyword: “Lidocain” and to the literature referred to therein, the entire content of which is hereby fully incorporated by reference. In addition, reference can be made to the information in Lidocaine Hydrochloride, European Pharmacopoeia (Ph. Eur.), 9th edition (January 2017). In addition, with regard to lidocaine, reference can be made to European Pharmacopoeia 8.0, European Directorate for the Quality of Medicines and Healthcare, pages 2620/2621 , keyword: “Lidocaine”. In addition, with regard to Lidocaine hydrochloride on European Pharmacopoeia 8.0, European Directorate for the Quality of Medicines and Healthcare, pages 2620/2621, keyword: "Lidocaine Hydrochloride" to get expelled.

• Gemäß einer erfindungsgemäßen Ausführungsform kann die Zusammensetzung nach der Erfindung mindestens ein Antiphlogistikum, insbesondere Benzydamin und/oder dessen Salze und/oder Ester, bevorzugt Benzydaminhydrochlorid, enthalten.

The composition according to the invention can also contain the active ingredients or substances listed below:

• According to an embodiment of the invention, the composition according to the invention can contain at least one anti-inflammatory agent, in particular benzydamine and/or its salts and/or esters, preferably benzydamine hydrochloride.

In particular, the composition can contain the anti-inflammatory agent, in particular benzydamine and/or its salts and/or esters, preferably benzydamine hydrochloride, in pharmaceutically and/or therapeutically effective amounts, in particular in pharmaceutically and/or therapeutically anti-inflammatory effective amounts.

In the context of the present invention, it can be provided in particular that the composition contains the anti-inflammatory agent, in particular benzydamine and/or its salts and/or esters, preferably benzydamine hydrochloride, in a (relative) amount in the range from 0.001% by weight to 10% by weight, in particular in the range from 0.005% by weight to 7.5% by weight, preferably in the range from 0.01% by weight to 5% by weight, preferably in the range from 0.02% by weight to 4% by weight, particularly preferably in the range from 0.03% by weight to 2% by weight, more preferably in the range from 0.05% by weight to 1% by weight, based on the composition.

Benzydamine is a benzylated indazole derivative from the group of anti-inflammatory drugs. Benzydamine has anti-inflammatory, pain-relieving and slightly antimicrobial properties. In conjunction with the use of benzydamine, pain and irritation in the mouth and throat area can be treated symptomatically in conjunction with the other active ingredients and ingredients when using the composition according to the invention. The symptoms of the disease associated with the infection can therefore also be alleviated, especially since benzydamine also reduces fever.

According to a further embodiment of the present invention, it can further be provided that the composition according to the invention contains at least one non-steroidal anti-inflammatory drug (NSAID active ingredient). In this regard, the non-steroidal anti-inflammatory drug (NSAID active ingredient) can be selected from the group of flurbiprofen, ibuprofen, dexibuprofen, naproxen, ketoprofen, dexketoprofen, tiaprofenic acid, diclofenac and acetylsalicylic acid and their salts and esters and their combinations and mixtures, in particular flurbiprofen and its salts and esters, preferably flurbiprofen. In particular, it can be provided according to the invention that the composition contains flurbiprofen and/or its salts and/or esters, preferably flurbiprofen.

Furthermore, the composition can contain the non-steroidal anti-inflammatory drug (NSAID), in particular flurbiprofen and/or its salts and/or esters, preferably flurbiprofen, in pharmaceutically and/or therapeutically effective, in particular in pharmaceutically and/or therapeutically non-steroidal anti-inflammatory effective amounts.

In this context, the composition can contain the non-steroidal anti-inflammatory drug (NSAID), in particular flurbiprofen and/or its salts and/or esters, preferably flurbiprofen, in a (relative) amount in the range of 0.001 wt.% to 10 wt.%, in particular in the range of 0.005 wt.% to 7.5 wt.%, preferably in the range of 0.01 wt.% to 5 wt.%, preferably in the range of 0.02 wt.% to 4 wt.%, particularly preferably in the range of 0.03 wt.% to 2 wt.%, more preferably in the range of 0.05 wt.% to 1 wt.%, based on the composition.

Flurbiprofen, which is preferably used as a non-steroidal anti-inflammatory drug in the context of the present invention, is generally included in the group of phenylalkanoic acid derivatives of non-steroidal anti-rheumatics or anti-inflammatory drugs. Flurbiprofen is said to have an anti-inflammatory, pain-relieving and decongestant profile. In particular, it can be used for targeted local treatment of sore throats or pain in the mouth and throat, and equally in conjunction with the other active ingredients and components of the composition according to the invention.

In particular, the composition according to the invention can contain at least one acidifying agent, in particular in the form of an organic acid and/or its salts and/or esters, preferably tartaric acid and/or citric acid, preferably tartaric acid. In this context, the composition can contain the acidifying agent in a (relative) amount in the range from 0.01% by weight to 10% by weight, in particular in the range from 0.1% by weight to 5% by weight, preferably in the range from 0.2% by weight to 1% by weight, based on the composition.

The use of an acidifying agent can also further improve or adjust the organoleptic properties of the composition according to the invention. When the composition is used or administered, particularly based on a solid dosage form such as a lozenge, the acidifying agent can also specifically induce or increase saliva flow or saliva production, thereby positively influencing the release of the active ingredient.

Furthermore, the composition can contain at least one anise oil, in particular star anise oil. In this context, the composition can contain the anise oil, in particular star anise oil, in a (relative ven) amount in the range of 0.005 wt.% to 5 wt.%, in particular in the range of 0.05 wt.% to 2 wt.%, preferably in the range of 0.1 wt.% to 0.75 wt.%, based on the composition.

Star anise oil can generally be obtained from real star anise, botanically Illicium verum, whereby an extraction can be carried out in particular from the ripe fruits of the plant. Star anise oil contains trans-anethole as its main component, in particular in an amount of 80% to 90% by weight, based on the essential oil. Star anise oil can also contain estragole, foeniculin, limonene and/or cineole. For further details on star anise oil, please refer to RÖMPP Lexicon of Natural Substances, first edition, Georg Thieme Verlag, Stuttgart/New York, 1997, page 609 , keyword: “Star Anise” and the literature cited therein, the entire contents of which are hereby incorporated by reference.

Anise oil, especially star anise oil, can be used to adjust the taste of the composition. Anise oil or star anise oil also has expectorant and antispasmodic properties.

Furthermore, the composition can contain at least one essential oil, in particular peppermint oil. In this context, the composition can contain the essential oil, in particular peppermint oil, in a (relative) amount in the range from 0.001% by weight to 1% by weight, in particular in the range from 0.005% by weight to 0.5% by weight, preferably in the range from 0.01% by weight to 0.1% by weight, based on the composition.

The peppermint oil can be obtained in particular from the above-ground parts of the peppermint, botanically Mentha piperita, in particular from the leaves. Peppermint oil used according to the invention can in particular contain menthol, preferably in amounts of 25% by weight to 45% by weight, menthone, preferably in amounts of 20% by weight to 30% by weight, and/or menthyl acetate, preferably in amounts of 2% by weight to 10% by weight, in each case based on the essential oil. For further details on the peppermint oil that can be used according to the invention, reference can also be made to RÖMPP Lexicon of Natural Substances, first edition, Georg Thieme Verlag, Stuttgart/New York, 1997, pages 478 and 479 , keyword: “peppermint oil” and the literature cited therein, the entire contents of which are hereby incorporated by reference.

By using an essential oil, in particular peppermint oil, the taste of the composition according to the invention can be further adjusted. In addition, the essential oils or peppermint oil have an antibacterial or antifungal effect, which is of further advantage with regard to the underlying topical application, for example with regard to secondary infections or the like.

In addition, the composition can contain at least one coffee extract and/or tea extract, in particular coffee extract. In this regard, the composition can contain the coffee extract or tea extract in a (relative) amount in the range from 0.001% by weight to 10% by weight, in particular in the range from 0.01% by weight to 5% by weight, preferably in the range from 0.1% by weight to 1% by weight, based on the composition. For example, dry extracts or aqueous extracts can be used.

In general, the composition according to the invention can also contain polypropylene glycol. In this context, the composition can contain polypropylene glycol in a (relative) amount in the range from 0.001% by weight to 5% by weight, in particular in the range from 0.01% by weight to 1% by weight, preferably in the range from 0.1% by weight to 0.5% by weight, based on the composition.

When the composition according to the invention is administered to the mouth, throat or nose, polypropylene leads to an increased mucoadhesive effect and thus to a longer contact time of the composition with the active ingredient with the underlying tissue or mucous membranes. This is accompanied by a longer exposure time of the active substances.

Furthermore, the composition according to the invention can contain at least one mucilaginous drug or its extract.

For the composition according to the invention, it can be provided in particular that the mucilaginous drug is present in a (relative) amount in the range of 0.01 wt.% to 20 wt.%, in particular in the range of 0.1 wt.% to 15 wt.%, preferably in the range of 1 wt.% to 10 wt.%, based on the composition.

In general, the mucilaginous drug or its extract within the scope of the present invention can be selected from the group of Iceland moss (Lichen islandicus), marshmallow (Althaea officinalis L.), ribwort plantain (Plantago lanceolata L.), mallow (Malva sylvestris L. and M. neglecta WALLR. and others), fenugreek (Trigonella foenum-graecum L.), salep and quince (Cydonia oblonga MILL.) and combinations and mixtures thereof, preferably Iceland moss (Lichen islandicus) and/or marshmallow (Althaea officinalis L.).

According to the invention, the mucilaginous drug can be used and/or present in the form of the drug, in particular in the form of crushed or powdered plant parts or plant components. In addition, the mucilaginous drug can be used and/or present in the form of an extract, in particular in the form of a dry extract. As far as the mucilaginous drug optionally used according to the invention is concerned, this can be added to the composition in the form of the drug itself, in particular in the form of crushed or powdered plant parts or plant components. Furthermore, the mucilaginous drug can be used in the form of an extract, in particular a dry extract, which is obtainable, for example, from an aqueous, alcoholic or aqueous-alcoholic extract of the drug. The use of an extract of a mucilaginous drug offers the advantage over the use of the drug that high concentrations of the mucilaginous drug are used, so that a particularly good effect is also achieved.

Mucus drugs or their extracts have a particularly soothing and covering effect. They also reduce the urge to cough (antitussives).

The respective mucilaginous drugs or their extracts as such are known to the expert. For further details on mucilaginous drugs and their preparations, effects and applications, please refer to H. Wagner “Pharmaceutical Biology - Drugs and their Ingredients”, Gustav Fischer Verlag, Stuttgart/New York, 1985, especially pages 280 ff .

According to the invention, the composition can further contain at least one excipient (carrier), preferably a pharmacologically and/or physiologically acceptable excipient (carrier). This allows the composition according to the invention to be further adjusted or tailored in terms of its galenics. On this basis, the release of active ingredient or availability of active ingredient can also be specifically adjusted or controlled.

According to the invention, the composition according to the invention can also contain at least one further active ingredient and/or ingredient, in particular pharmaceutical additive and/or excipient, in particular selected from the group of processing aids, stabilizers, emulsifiers, antioxidants, preservatives, humectants, sweeteners and sweeteners, pH adjusters, pH buffer substances, thickeners, flavorings, antiseptics, colorants, buffers, fragrances, scents, extenders, binders, wetting agents and/or preservatives and combinations and mixtures thereof. In this context, the composition can comprise the further active ingredient or ingredient in a (relative) amount in the range from 0.01% by weight to 15% by weight, in particular in the range from 0.1% by weight to 10% by weight, preferably in the range from 0.5% by weight to 5% by weight, based on the composition.

According to a preferred embodiment, the invention can provide that the composition contains at least substantially no phenoxyethanol (2-phenoxyethanol). According to the invention, it can thus be provided in particular that the composition is at least substantially free of phenoxyethanol (2-phenoxyethanol). In particular, the composition can be present in the absence of phenoxyethanol (2-phenoxyethanol). According to the invention, it is thus provided in particular that the composition contains no phenoxyethanol (2-phenoxyethanol) or is free of phenoxyethanol (2-phenoxyethanol). The applicant has surprisingly found that the use of octenidine or its salts or esters, in particular octenidine dihydrochloride, is associated with an excellent antiviral effect. This makes it possible to provide a further optimized spectrum of activity with minimal side effects.

In this context, it can also be provided according to the invention in particular that the composition according to the invention contains octenidine and/or its salts and/or esters, in particular octenidine dihydrochloride, as the sole antiviral active substance or that the composition according to the invention is free of antiviral active substances other than octenidine and/or its salts and/or esters, in particular octenidine dihydrochloride. According to the invention in particular it can be provided that the composition contains octenidine and/or its salts and/or esters, in particular octenidine dihydrochloride, as the sole active substance, in particular as the sole pharmaceutical active substance.

In summary, according to the invention it can be provided in particular that the composition contains octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, as the sole antiviral active ingredient, in particular as the sole pharmaceutical active ingredient, preferably as the sole active ingredient.

However, according to an alternative and less preferred embodiment according to the invention, it can basically be provided that the composition according to the invention contains phenoxyethanol (2-phenoxyethanol). In this context, the composition can contain the phenoxyethanol (2-phenoxyethanol) in a (relative) amount in the range from 0.1% by weight to 10% by weight, in particular in the range from 0.5% by weight to 5% by weight, preferably in the range from 0.75% by weight to 3% by weight, based on the composition.

In addition, it can also be provided according to the invention that the composition contains essentially no n-propanol (propan-1-ol) and/or at least essentially no isopropanol, in particular at least essentially no primary alcohol. According to the invention, it can in particular be provided that the composition is at least essentially free of n-propanol (propan-1-ol) and/or at least essentially free of isopropanol. In particular, the composition can be free of a primary alcohol. In particular, the composition can be present in the absence of n-propanol (propan-1-ol) and/or in the absence of isopropanol, in particular in the absence of a primary alcohol. This can also improve the tolerability of the composition according to the invention.

As far as the composition according to the invention is concerned, the absolute amounts or dose of the active ingredients or constituents used are also of great importance, including with regard to providing optimized effectiveness and defined application properties of the composition according to the invention. The term "dosage unit" as used in the context of the present invention, particularly in connection with the absolute amounts or doses, refers in particular to the individual application (single application) administered to a patient or to a single dose (single dose) of the prepared dosage form (e.g. lozenge) of the composition according to the invention (see also the following explanations).

• So kann die Zusammensetzung das Octenidin und/oder dessen Salze und/oder Ester, vorzugsweise Octenidindihydrochlorid, in einer (absoluten) Menge und/oder Dosis im Bereich von 0,05 mg bis 15 mg, insbesondere im Bereich von 0,1 mg bis 12,5 mg, vorzugsweise im Bereich von 0,2 mg bis 10 mg, bevorzugt im Bereich von 0,3 mg bis 7,5 mg, besonders bevorzugt im Bereich von 0,5 mg bis 5 mg, bezogen auf eine Darreichungseinheit der Zusammensetzung, enthalten.

According to the invention, in this context it can behave in particular as follows:

• Thus, the composition can contain the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, in an (absolute) amount and/or dose in the range of 0.05 mg to 15 mg, in particular in the range of 0.1 mg to 12.5 mg, preferably in the range of 0.2 mg to 10 mg, preferably in the range of 0.3 mg to 7.5 mg, particularly preferably in the range of 0.5 mg to 5 mg, based on a dosage unit of the composition.

In addition, the composition can contain the local anesthetic, in particular lidocaine and/or its salts and/or esters, preferably lidocaine hydrochloride, in an (absolute) amount and/or dose in the range of 0.1 mg to 50 mg, in particular in the range of 1 mg to 20 mg, preferably in the range of 3 mg to 15 mg, preferably in the range of 4 mg to 10 mg, based on a dosage unit of the composition.

In addition, the composition can contain the anti-inflammatory agent, in particular benzydamine and/or its salts and/or esters, preferably benzydamine hydrochloride, in an (absolute) amount and/or dose in the range of 0.1 mg to 50 mg, in particular in the range of 0.5 mg to 20 mg, preferably in the range of 1 mg to 15 mg, preferably in the range of 2 mg to 10 mg, based on a dosage unit of the composition.

In addition, the composition may contain the non-steroidal anti-inflammatory drug (NSAID), in particular flurbiprofen and/or its salts and/or esters, preferably flurbiprofen, in an (absolute) th) amount and/or dose in the range of 0.1 mg to 50 mg, in particular in the range of 0.5 mg to 20 mg, preferably in the range of 1 mg to 15 mg, more preferably in the range of 2 mg to 10 mg, based on a dosage unit of the composition.

Furthermore, the composition can contain the acidifying agent, in particular in the form of an organic acid and/or its salts and/or esters, preferably tartaric acid and/or citric acid, preferably tartaric acid, in an (absolute) amount and/or dose in the range from 0.5 mg to 100 mg, in particular in the range from 1 mg to 50 mg, preferably in the range from 2 mg to 20 mg, based on a dosage unit of the composition.

In addition, the composition can contain the anise oil, in particular star anise oil, in an (absolute) amount and/or dose in the range of 0.2 mg to 80 mg, in particular in the range of 0.5 mg to 40 mg, preferably in the range of 0.75 mg to 15 mg, based on a dosage unit of the composition.

Furthermore, the composition can contain the essential oil, in particular peppermint oil, in an (absolute) amount and/or dose in the range of 0.01 mg to 5 mg, in particular in the range of 0.05 mg to 3 mg, preferably in the range of 0.1 mg to 1 mg, based on a dosage unit of the composition.

Furthermore, the composition may contain the coffee extract and/or tea extract, in particular coffee extract, in an (absolute) amount and/or dose in the range of 0.05 mg to 100 mg, in particular in the range of 0.5 mg to 50 mg, preferably in the range of 1 mg to 20 mg, based on a dosage unit of the composition.

Furthermore, the composition may contain the propylene glycol in an (absolute) amount and/or dose in the range of 0.05 mg to 50 mg, in particular in the range of 0.5 mg to 20 mg, preferably in the range of 1 mg to 10 mg, based on a dosage unit of the composition.

Going further, the composition may contain the mucilaginous drug and/or its extract in an (absolute) amount and/or dose in the range of 0.5 mg to 200 mg, in particular in the range of 1 mg to 100 mg, preferably in the range of 5 mg to 50 mg, based on a dosage unit of the composition.

If it is provided according to the invention that the composition contains phenoxyethanol (2-phenoxyethanol), this can be present in an (absolute) amount and/or dose in the range from 0.1 mg to 1 mg, in particular in the range from 0.5 to 50 mg, preferably in the range from 0.75 to 30 mg, based on a dosage unit of the composition. As stated above, however, it is preferred according to the invention that the composition according to the invention is present in the absence of phenoxyethanol (2-phenoxyethanol).
With regard to the above information on the (absolute) amounts or doses, the respective (absolute) amount and/or dose is the (single) amount and/or (single) dose administered with a single application (single application) of the composition and/or the (single) amount and/or (single) dose administered with a single application (single application) of a prepared dosage form of the composition or that the dosage unit is a single application (single application) of the composition and/or a single application (single application) of a prepared dosage form of the composition.

In particular, the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, can be administered at a daily dose in the range of 0.15 mg/diem to 120 mg/diem, in particular in the range of 0.15 mg/diem to 120 mg/diem, preferably in the range of 0.3 mg/diem to 100 mg/diem, preferably in the range of 1.5 mg/diem to 60 mg/diem, particularly preferably in the range of 2.25 mg/diem to 120 mg/diem, further preferably in the range of 2.5 mg/diem to 40 mg/diem.

According to the invention, the composition can thus be prepared for the administration of octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, in a daily dose in the range of 0.15 mg/diem to 120 mg/diem, in particular in the range of 0.15 mg/diem to 120 mg/diem, preferably in the range of 0.3 mg/diem to 100 mg/diem, preferably in the range of 1.5 mg/diem to 60 mg/diem, particularly preferably in the range of 2.25 mg/diem to 120 mg/diem, further preferably in the range of 2.5 mg/diem to 40 mg/diem.

• Im Allgemeinen kann es erfindungsgemäß vorgesehen sein, dass die Zusammensetzung nach der Erfindung als feste Dosierungsform oder als flüssige Dosierungsform, insbesondere als feste Dosierungsform, vorliegt bzw. ausgebildet ist.

As previously mentioned, the galenic or the design of the dosage form of the composition according to the invention is equally important:

• In general, it can be provided according to the invention that the composition according to the invention is present or designed as a solid dosage form or as a liquid dosage form, in particular as a solid dosage form.

According to a preferred embodiment of the invention, it is provided within the scope of the present invention that the composition is present and/or designed as a solid dosage form in the form of a tablet, a dragee, a pill, a lozenge or the like, in particular in the form of a lozenge, preferably hard caramel, or that the composition is present or designed as a tablet, dragee, pill, lozenge or the like, in particular a lozenge, preferably hard caramel.

According to an alternative embodiment of the present invention, it can also be provided that the composition is present or designed as a liquid dosage form in the form of a fluid, a mouthwash, a mouth rinse, a juice, a gargle solution, a spray, in particular a mouth and/or throat spray or nasal spray, or the like, or that the composition is present or designed as a fluid, mouthwash, mouth rinse, juice, gargle solution, spray, in particular a mouth and/or throat spray or nasal spray, or the like.

The information regarding the solid or liquid state of the composition according to the invention generally refers to the relevant formation of the composition at room temperature (20 °C) and ambient pressure (1,013.25 hPa).

In the following, the preferred embodiment according to the invention is first described in more detail, according to which the composition according to the invention is present as a solid dosage form: Thus, it is preferred according to the invention that the composition is present or designed as a solid dosage form.

The composition according to the invention can be present or designed as a solid dosage form in the form of a tablet, a dragee, a pill, a lozenge or the like, in particular in the form of a lozenge, preferably hard caramel. Consequently, the composition can be present or designed as a tablet, dragee, pill, lozenge or the like, in particular a lozenge, preferably hard caramel.

According to the invention, the solid dosage form, in particular the tablet, the dragee, the pill or the lozenge, in particular the lozenge, preferably the hard caramel, can have a total weight in the range from 0.5 g to 7 g, in particular in the range from 1 g to 6 g, preferably in the range from 2 g to 5 g. In particular, the tablet, the dragee, the pill or the lozenge, in particular the lozenge, preferably the hard caramel, can have a total weight in the range from 0.5 g to 7 g, in particular in the range from 1 g to 6 g, preferably in the range from 2 g to 5 g. The aforementioned weight information refers to a single dosage form, e.g. a single tablet, dragee, pill, lozenge or hard caramel.

In the preferred embodiment of the pharmaceutical composition according to the invention in the form of a lozenge, in particular based on hard caramel, the total weight of the lozenge can be in the range from 0.5 g to 7 g, in particular in the range from 1 g to 6 g, preferably in the range from 2 g to 5 g.

According to the invention, it is further preferred that the composition, in particular the solid dosage form, is a lozenge, in particular in the form of a hard caramel.

In this context, the composition, in particular the solid dosage form, can be based on a lozenge or can be present or designed as a lozenge, in particular hard caramel. On this basis, the composition, in particular the solid dosage form, can release a therapeutically effective amount of active ingredients and/or ingredients, in particular octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, when sucked, when the composition, in particular the solid dosage form, is administered and sucked in the mouth and throat of a patient.

In general, the pharmaceutical composition according to the invention, in particular the solid dosage form, preferably a lozenge, contains the active ingredients and/or constituents in a solid matrix or mass. The active ingredients and/or constituents are thus incorporated or stored in a matrix in particular, so that they are effectively protected and, in addition, in particular, homogeneously distributed.

The applicant has found that the active ingredient octenidine and/or its salts or esters or octenidine dihydrochloride in the form of a solid galenic preparation, in particular for sucking, preferably in the form of a lozenge, has optimal effectiveness with regard to the prophylactic or therapeutic topical treatment of the underlying diseases, in particular COVID-19. Without wishing to be limited to or rely on this theory, the preferred embodiment according to the invention, according to which the composition is in the form of a solid dosage form, in particular in the form of a lozenge, is accompanied by an optimized release behavior of the active ingredient, both in terms of the time-related release amount or the release rate and the duration of action, so that the antiviral effectiveness is therefore also improved accordingly.

The solid dosage form for sucking and the incorporation of the active ingredients and/or ingredients into a solid matrix or mass offers a number of advantages in this context: Firstly, the active ingredients and ingredients can be dosed better in this way, i.e. improved dosing accuracy is achieved. Secondly, the application and ingestion options are improved, i.e. the patient can take the medication anywhere (e.g. when travelling, outdoors, etc.), as no special preparation forms have to be mixed. In addition, the solid dosage form offers the advantage that the active ingredients in solid preparations are generally stable in storage. Furthermore, the solid dosage form ensures a defined residence time or residence time in the mouth and throat and thus efficient and controlled therapy. Finally, the solid dosage form, particularly by incorporating the active ingredients and ingredients into the matrix, enables an improved combination with other active ingredients and their even, homogeneous distribution across the matrix.

According to the invention, the composition, in particular the solid dosage form, can contain at least one sugar and/or at least one sugar substitute, in particular as an excipient (carrier), preferably a pharmacologically and/or physiologically acceptable excipient (carrier).

Sugars of all kinds and/or sugar substitutes of all kinds are particularly suitable as a matrix or mass for storing the active ingredients and components.

In this context, the sugar can be selected from the group of sucrose, glucose, especially dextrose, and fructose.

In addition, the sugar substitute can be selected from the group of sugar alcohols, preferably from the group of mannitol, xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructooligosaccharides, glucans, polyglucose and combinations and mixtures thereof, particularly preferably isomalt and mannitol and combinations and mixtures thereof, very particularly preferably isomalt. On this basis, calorie-reduced or tooth-friendly or non-cariogenic compositions can be provided.

According to the invention, with regard to the solid dosage form, it is therefore particularly provided that the composition, in particular the solid dosage form, comprises the active ingredients and/or ingredients in a solid matrix and/or mass, in particular in a matrix and/or mass based on sugars and/or sugar substitutes, in particular as previously defined.

In particular, the composition, in particular the solid dosage form, can comprise the sugar and/or the sugar substitute in a (relative) amount in the range of 50 wt.% to 99.95 wt.%, in particular in the range of 70 wt.% to 99.5 wt.%, preferably in the range of 80 wt.% to 99.25 wt.%, preferably in the range of 90 wt.% to 99 wt.%, based on the composition, in particular the solid dosage form.

In particular, the sugars and/or sugar alcohols form the matrix and/or the solid mass of the composition in solid dosage form. Thus, the amount of matrix mass (ie sugars and/or sugar substitutes) can generally be in the range of 50 wt.% to 99.95 wt.%, in particular in the range of 70 wt.% to 99.5 wt.%, preferably in the range of 80 wt.% to 99.25% by weight, preferably in the range of 90% by weight to 99% by weight, based on the composition, in particular the solid dosage form.

While sugar and sweeteners are collectively referred to as sweeteners, sugar substitutes - in contrast to the intensely tasting sweeteners - are used technologically like sucrose, i.e. they have a "body" and a physiological calorific value ("nutritive sugar substitutes"). The sweetening power is broadly equivalent to that of sucrose. The physiological advantage of sugar substitutes compared to sucrose is that they are metabolized independently of insulin (advantageous for diabetics, for example) and that they have a partially reduced cariogenic effect. An anti-cariogenic effect has been described for some sugar substitutes (e.g. xylitol).

The term "sugar alcohol" is the group name for the polyhydroxy compounds formed from monosaccharides by reducing the carbonyl group. These are not sugars, but nevertheless taste sweet and can therefore be used as sugar substitutes. These generally crystalline, water-soluble polyols are divided into so-called tetrites, pentites, hexites, etc. according to the number of hydroxy groups contained in the molecule. Naturally occurring sugar alcohols include glycerine, threitol and erythritol, adonitol (ribitol), arabitol (formerly: lyxitol) and xylitol, dulcitol (galactitol), mannitol and sorbitol (glucitol).

For further details on the terms ‘sugar’, ‘sugar substitutes’ and ‘sugar alcohols’, please refer to Römpp Chemistry Encyclopedia, 10th edition, Volume 6, Georg Thieme Verlag, Stuttgart/New York, 1999, pages 5096 to 5100 , Keywords: “sugar”, “sugar alcohols” and “sugar substitutes”.

Furthermore, the residual moisture of the composition, in particular in the form of the solid dosage form, is also of great importance. In particular, the composition, in particular the solid dosage form, can have a residual moisture or a residual moisture content of at most 10 wt. %, in particular at most 5 wt. %, preferably at most 3 wt. %, based on the composition, in particular the solid dosage form. Likewise, the composition, in particular the solid dosage form, can have a residual moisture or a residual moisture content in the range from 0.1 wt. % to 10 wt. %, in particular in the range from 0.5 wt. % to 5 wt. %, preferably in the range from 1 wt. % to 3 wt. %, based on the composition, in particular the solid dosage form.

In connection with the defined residual moisture content, optimal disintegration and release properties are also present when the composition according to the invention is administered orally in the form of the solid dosage form. In addition, the (storage) stability is increased.

The pharmaceutical composition according to the invention is prepared in a manner known per se. For further details in this regard, reference can also be made to the following examples.

When producing lozenges based on hard caramel, for example, the procedure can be such that the active ingredients and components are first weighed - if necessary after crushing - and then mixed into the previously heated base substance based on sugars or sugar substitutes (e.g. isomalt), followed by shaping the lozenges and subsequent cooling. Such manufacturing processes are well known to those skilled in the art.

Hard candies can typically be produced as follows: When producing lozenges according to the invention, in particular in the form of hard candies, the sugar or sugar substitutes are first dissolved in water, then heated at temperatures (e.g. to temperatures between 120 and 140 °C) and finally vacuum-packed. The active ingredients and constituents, i.e. octenidine and optionally other ingredients, such as local anesthetic, mucilaginous drugs or their extracts, colorings, flavors, sweeteners, etc., can then be added to this heated or hot mass in solid or liquid form. After controlled cooling (e.g. to temperatures below about 75 °C), the hard candies can be embossed in the desired shape. The shapes can be round or polygonal, for example, as desired. Finally, the hard candies can be cooled to room temperature in a controlled manner and sorted. The hard candies produced in this way can be packaged individually in blisters or sachets or collected in bags or pouches.

• So betrifft die vorliegende Erfindung gemäß dem vorliegenden Aspekt auch eine erfindungsgemäße Zusammensetzung, insbesondere pharmazeutische Zusammensetzung, zur Verwendung bei der prophylaktischen und/oder therapeutischen topischen (lokalen) Behandlung, insbesondere prophylaktischen und/oder therapeutischen antiviralen topischen Behandlung, von viralen Erkrankungen, insbesondere von durch Corona-Viren, vorzugsweise SARS-CoV-2, hervorgerufenen (Virus-)Erkrankungen, bevorzugt von COVID-19, insbesondere zur topischen Anwendung im Mund-, Rachen- und/oder Nasenraum und/oder zur topischen Anwendung auf die Schleimhäute des Mund-, Rachen- und/oder Nasenraums, insbesondere eine wie zuvor definierte Zusammensetzung zur Verwendung,
• wobei die Zusammensetzung als antiviralen Wirkstoff Octenidin und/oder dessen Salze und/oder Ester, vorzugsweise Octenidindihydrochlorid, enthält,
• wobei die pharmazeutische Zusammensetzung als feste Dosierungsform in Form einer Lutschtablette, insbesondere auf Hartkaramellenbasis und/oder als Hartkaramelle, vorliegt und/oder ausgebildet ist, wobei die Lutschtablette ein Gesamtgewicht im Bereich von 0,5 g bis 7 g, insbesondere im Bereich von 1 g bis 6 g, vorzugsweise im Bereich von 2 g bis 5 g, aufweist, enthaltend je Lutschtablette:
  • - Octenidin und/oder dessen Salze und/oder Ester, vorzugsweise Octenidindihydrochlorid, in einer (absoluten) Menge und/oder Dosis im Bereich von 0,05 mg bis 15 mg, insbesondere im Bereich von 0,1 mg bis 12,5 mg, vorzugsweise im Bereich von 0,5 mg bis 10 mg, bevorzugt im Bereich von 0,75 mg bis 7,5 mg, besonders bevorzugt im Bereich von 1 mg bis 5 mg;
  • - gegebenenfalls mindestens einen weiteren Wirk- und/oder Inhaltsstoff, insbesondere pharmazeutischen Zusatz- und/oder Hilfsstoff, insbesondere ausgewählt aus der Gruppe von Verarbeitungshilfsstoffen, Stabilisatoren, Emulgatoren, Antioxidantien, Konservierungsstoffen, Feuchthaltemitteln, Süßstoffen und Süßungsmitteln, pH-Stellmitteln, pH-Puffersubstanzen, Verdickungsmitteln, Aromastoffen, Antiseptika, Färbe-, Puffer-, Riech-, Duft-, Streck-, Binde-, Netz- und/oder Konservierungsstoffen sowie deren Kombinationen und Mischungen, in Mengen im Bereich von 0,1 mg bis 500 mg, insbesondere im Bereich von 0,5 mg bis 250 mg, vorzugsweise im Bereich von 1 mg bis 100 mg;
  • - mindestens einen Zucker und/oder mindestens einen Zuckeraustauschstoff, insbesondere als Exzipient (Träger), vorzugsweise pharmakologisch und/oder physiologisch unbedenklicher Exzipient (Träger); insbesondere wobei der Zucker ausgewählt ist aus der Gruppe von Saccharose, Glucose, insbesondere Dextrose, und Fructose und/oder insbesondere wobei der Zuckeraustauschstoff ausgewählt ist aus Zuckeralkoholen, vorzugsweise aus der Gruppe von Mannit, Xylit, Sorbit, Isomalt, Maltitsirup, Lactit, Leucrose, Fructooligosacchariden, Glucanen, Polyglucose und deren Kombinationen und Mischungen, besonders bevorzugt Isomalt und/oder Mannit, ganz besonders bevorzugt Isomalt; und/oder insbesondere in Mengen zur Bereitstellung und/oder Erhalt des Gesamtgewichts der Lutschtablette.

According to the present aspect, the present invention also relates to the following compositions, which are also in the form of a solid dosage form:

• Thus, according to the present aspect, the present invention also relates to a composition according to the invention, in particular a pharmaceutical composition, for use in the prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity, in particular a composition as defined above for use,
• wherein the composition contains as antiviral active ingredient octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride,
• wherein the pharmaceutical composition is present and/or designed as a solid dosage form in the form of a lozenge, in particular based on hard caramel and/or as hard caramel, wherein the lozenge has a total weight in the range of 0.5 g to 7 g, in particular in the range of 1 g to 6 g, preferably in the range of 2 g to 5 g, containing per lozenge:
  • - octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, in an (absolute) amount and/or dose in the range of 0.05 mg to 15 mg, in particular in the range of 0.1 mg to 12.5 mg, preferably in the range of 0.5 mg to 10 mg, more preferably in the range of 0.75 mg to 7.5 mg, particularly preferably in the range of 1 mg to 5 mg;
  • - optionally at least one further active ingredient and/or ingredient, in particular pharmaceutical additive and/or excipient, in particular selected from the group of processing aids, stabilizers, emulsifiers, antioxidants, preservatives, humectants, sweeteners and sweeteners, pH adjusters, pH buffer substances, thickeners, flavorings, antiseptics, colorants, buffers, fragrances, scents, extenders, binders, wetting agents and/or preservatives and combinations and mixtures thereof, in amounts in the range from 0.1 mg to 500 mg, in particular in the range from 0.5 mg to 250 mg, preferably in the range from 1 mg to 100 mg;
  • - at least one sugar and/or at least one sugar substitute, in particular as an excipient (carrier), preferably a pharmacologically and/or physiologically acceptable excipient (carrier); in particular wherein the sugar is selected from the group of sucrose, glucose, in particular dextrose, and fructose and/or in particular wherein the sugar substitute is selected from sugar alcohols, preferably from the group of mannitol, xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructooligosaccharides, glucans, polyglucose and combinations and mixtures thereof, particularly preferably isomalt and/or mannitol, very particularly preferably isomalt; and/or in particular in amounts to provide and/or maintain the total weight of the lozenge.

• - Octenidin und/oder dessen Salze und/oder Ester, vorzugsweise Octenidindihydrochlorid, in einer (absoluten) Menge und/oder Dosis im Bereich von 0,05 mg bis 15 mg, insbesondere im Bereich von 0,1 mg bis 12,5 mg, vorzugsweise im Bereich von 0,5 mg bis 10 mg, bevorzugt im Bereich von 0,75 mg bis 7,5 mg, besonders bevorzugt im Bereich von 1 mg bis 5 mg;
• - gegebenenfalls mindestens ein Lokalanästhetikum, insbesondere Lidocain, bevorzugt Lidocainhydrochlorid, in einer (absoluten) Menge und/oder Dosis im Bereich von 0,1 mg bis 50 mg, insbesondere im Bereich von 1 mg bis 20 mg, vorzugsweise im Bereich von 3 mg bis 15 mg, bevorzugt im Bereich von 4 mg bis 10 mg;
• - gegebenenfalls mindestens einen weiteren Wirk- und/oder Inhaltsstoff, insbesondere pharmazeutischen Zusatz- und/oder Hilfsstoff, insbesondere ausgewählt aus der Gruppe von Verarbeitungshilfsstoffen, Stabilisatoren, Emulgatoren, Antioxidantien, Konservierungsstoffen, Feuchthaltemitteln, Süßstoffen und Süßungsmitteln, pH-Stellmitteln, pH-Puffersubstanzen, Verdickungsmitteln, Aromastoffen, Antiseptika, Färbe-, Puffer-, Riech-, Duft-, Streck-, Binde-, Netz- und/oder Konservierungsstoffen sowie deren Kombinationen und Mischungen, in Mengen im Bereich von 0,1 mg bis 500 mg, insbesondere im Bereich von 0,5 mg bis 250 mg, vorzugsweise im Bereich von 1 mg bis 100 mg;
• - mindestens einen Zucker und/oder mindestens einen Zuckeraustauschstoff, insbesondere als unbedenklicher Exzipient (Träger), vorzugsweise pharmakologisch und/oder physiologisch unbedenklicher Exzipient (Träger); insbesondere wobei der Zucker ausgewählt ist aus der Gruppe von Saccharose, Glucose, insbesondere Dextrose, und Fructose; und/oder insbesondere wobei der Zuckeraustauschstoff ausgewählt ist aus Zuckeralkoholen, vorzugsweise aus der Gruppe von Mannit, Xylit, Sorbit, Isomalt, Maltitsirup, Lactit, Leucrose, Fructooligosacchariden, Glucanen, Polyglucose sowie deren Kombinationen und Mischungen, besonders bevorzugt Isomalt und/oder Mannit, ganz besonders bevorzugt Isomalt; und/oder insbesondere in Mengen zur Bereitstellung und/oder Erhalt des Gesamtgewichts der Lutschtablette.

In addition, according to the present aspect, the present invention also relates to a pharmaceutical composition according to the invention for use in the prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity, in particular a composition as defined above for use,
wherein the composition contains octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, as antiviral active ingredient
wherein the pharmaceutical composition is present and/or designed as a solid dosage form in the form of a lozenge, in particular based on hard caramel and/or as hard caramel, wherein the lozenge has a total weight in the range of 0.5 to 7 g, in particular in the range of 1 to 6 g, preferably in the range of 2 to 5 g, containing per lozenge:

• - octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, in an (absolute) amount and/or dose in the range of 0.05 mg to 15 mg, in particular in the range of 0.1 mg to 12.5 mg, preferably in the range of 0.5 mg to 10 mg, more preferably in the range of 0.75 mg to 7.5 mg, particularly preferably in the range of 1 mg to 5 mg;
• - optionally at least one local anaesthetic, in particular lidocaine, preferably lidocaine hydrochloride, in an (absolute) amount and/or dose in the range of 0.1 mg to 50 mg, in particular in Range of 1 mg to 20 mg, preferably in the range of 3 mg to 15 mg, preferably in the range of 4 mg to 10 mg;
• - optionally at least one further active ingredient and/or ingredient, in particular pharmaceutical additive and/or excipient, in particular selected from the group of processing aids, stabilizers, emulsifiers, antioxidants, preservatives, humectants, sweeteners and sweeteners, pH adjusters, pH buffer substances, thickeners, flavorings, antiseptics, colorants, buffers, fragrances, scents, extenders, binders, wetting agents and/or preservatives and combinations and mixtures thereof, in amounts in the range from 0.1 mg to 500 mg, in particular in the range from 0.5 mg to 250 mg, preferably in the range from 1 mg to 100 mg;
• - at least one sugar and/or at least one sugar substitute, in particular as a harmless excipient (carrier), preferably a pharmacologically and/or physiologically harmless excipient (carrier); in particular wherein the sugar is selected from the group of sucrose, glucose, in particular dextrose, and fructose; and/or in particular wherein the sugar substitute is selected from sugar alcohols, preferably from the group of mannitol, xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructooligosaccharides, glucans, polyglucose and combinations and mixtures thereof, particularly preferably isomalt and/or mannitol, very particularly preferably isomalt; and/or in particular in amounts to provide and/or maintain the total weight of the lozenge.

• - Octenidin und/oder dessen Salze und/oder Ester, vorzugsweise Octenidindihydrochlorid, in einer (absoluten) Menge und/oder Dosis im Bereich von 0,05 mg bis 15 mg, insbesondere im Bereich von 0,1 mg bis 12,5 mg, vorzugsweise im Bereich von 0,5 mg bis 10 mg, bevorzugt im Bereich von 0,75 mg bis 7,5 mg, besonders bevorzugt im Bereich von 1 mg bis 5 mg;
• - gegebenenfalls mindestens ein Lokalanästhetikum, insbesondere Lidocain, bevorzugt Lidocainhydrochlorid, in einer (absoluten) Menge und/oder Dosis im Bereich von 0,1 mg bis 50 mg, insbesondere im Bereich von 1 mg bis 20 mg, vorzugsweise im Bereich von 3 mg bis 15 mg, bevorzugt im Bereich von 4 mg bis 10 mg;
• - gegebenenfalls mindestens einen weiteren Wirk- und/oder Inhaltsstoff, insbesondere pharmazeutischen Zusatz- und/oder Hilfsstoff, insbesondere ausgewählt aus der Gruppe von Verarbeitungshilfsstoffen, Stabilisatoren, Emulgatoren, Antioxidantien, Konservierungsstoffen, Feuchthaltemitteln, Süßstoffen und Süßungsmitteln, pH-Stellmitteln, pH-Puffersubstanzen, Verdickungsmitteln, Aromastoffen, Antiseptika, Färbe-, Puffer-, Riech-, Duft-, Streck-, Binde-, Netz- und/oder Konservierungsstoffen sowie deren Kombinationen und Mischungen, in Mengen im Bereich von 0,1 mg bis 500 mg, insbesondere im Bereich von 0,5 mg bis 250 mg, vorzugsweise im Bereich von 1 mg bis 100 mg;
• - mindestens einen Zucker und/oder mindestens einen Zuckeraustauschstoff, insbesondere als Exzipient (Träger), vorzugsweise pharmakologisch und/oder physiologisch unbedenklicher Exzipient (Träger); insbesondere wobei der Zucker ausgewählt ist aus der Gruppe von Saccharose, Glucose, insbesondere Dextrose, und Fructose; und/oder insbesondere wobei der Zuckeraustauschstoff ausgewählt ist aus Zuckeralkoholen, vorzugsweise aus der Gruppe von Mannit, Xylit, Sorbit, Isomalt, Maltitsirup, Lactit, Leucrose, Fructooligosacchariden, Glucanen, Polyglucose sowie deren Kombinationen und Mischungen, besonders bevorzugt Isomalt und/oder Mannit, ganz besonders bevorzugt Isomalt; und/oder insbesondere in Mengen zur Bereitstellung und/oder Erhalt des Gesamtgewichts der Lutschtablette,

wobei die Zusammensetzung bzw. Lutschtablette zumindest im Wesentlichen kein Phenoxyethanol (2-Phenoxyethanol) enthält und/oder wobei die Lutschtablette zumindest im Wesentlichen frei ist von Phenoxyethanol (2-Phenoxyethanol) und/oder wobei die Zusammensetzung bzw. Lutschtablette in Abwesenheit von Phenoxyethanol (2-Phenoxyethanol) vorliegt. Furthermore, according to the present aspect, the present invention also relates to a composition according to the invention, in particular a pharmaceutical composition, for use in the prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity, in particular a composition as defined above for use,
wherein the composition is present and/or designed as a solid dosage form in the form of a lozenge, in particular based on hard caramel and/or as hard caramel, wherein the lozenge has a total weight in the range of 0.5 to 7 g, in particular in the range of 1 to 6 g, preferably in the range of 2 to 5 g, containing per lozenge:

• - octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, in an (absolute) amount and/or dose in the range of 0.05 mg to 15 mg, in particular in the range of 0.1 mg to 12.5 mg, preferably in the range of 0.5 mg to 10 mg, more preferably in the range of 0.75 mg to 7.5 mg, particularly preferably in the range of 1 mg to 5 mg;
• - optionally at least one local anesthetic, in particular lidocaine, preferably lidocaine hydrochloride, in an (absolute) amount and/or dose in the range from 0.1 mg to 50 mg, in particular in the range from 1 mg to 20 mg, preferably in the range from 3 mg to 15 mg, preferably in the range from 4 mg to 10 mg;
• - optionally at least one further active ingredient and/or ingredient, in particular pharmaceutical additive and/or excipient, in particular selected from the group of processing aids, stabilizers, emulsifiers, antioxidants, preservatives, humectants, sweeteners and sweeteners, pH adjusters, pH buffer substances, thickeners, flavorings, antiseptics, colorants, buffers, fragrances, scents, extenders, binders, wetting agents and/or preservatives and combinations and mixtures thereof, in amounts in the range from 0.1 mg to 500 mg, in particular in the range from 0.5 mg to 250 mg, preferably in the range from 1 mg to 100 mg;
• - at least one sugar and/or at least one sugar substitute, in particular as an excipient (carrier), preferably a pharmacologically and/or physiologically acceptable excipient (carrier); in particular wherein the sugar is selected from the group of sucrose, glucose, in particular dextrose, and fructose; and/or in particular wherein the sugar substitute is selected from sugar alcohols, preferably from the group of mannitol, xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructooligosaccharides, glucans, polyglucose and combinations and mixtures thereof, particularly preferably isomalt and/or mannitol, very particularly preferably isomalt; and/or in particular in amounts to provide and/or maintain the total weight of the lozenge,

wherein the composition or lozenge contains at least substantially no phenoxyethanol (2-phenoxyethanol) and/or wherein the lozenge is at least substantially free of phenoxyethanol nol (2-phenoxyethanol) and/or wherein the composition or lozenge is present in the absence of phenoxyethanol (2-phenoxyethanol).

• - Octenidin und/oder dessen Salze und/oder Ester, vorzugsweise Octenidindihydrochlorid, in einer (absoluten) Menge und/oder Dosis im Bereich von 0,05 mg bis 15 mg, insbesondere im Bereich von 0,1 mg bis 12,5 mg, vorzugsweise im Bereich von 0,5 mg bis 10 mg, bevorzugt im Bereich von 0,75 mg bis 7,5 mg, besonders bevorzugt im Bereich von 1 mg bis 5 mg;
• - gegebenenfalls mindestens ein Lokalanästhetikum, insbesondere Lidocain, bevorzugt Lidocainhydrochlorid, in einer (absoluten) Menge und/oder Dosis im Bereich von 0,1 mg bis 50 mg, insbesondere im Bereich von 1 mg bis 20 mg, vorzugsweise im Bereich von 3 mg bis 15 mg, bevorzugt im Bereich von 4 mg bis 10 mg;
• - gegebenenfalls mindestens ein Säuerungsmittel, insbesondere in Form einer organischen Säure oder deren Salze oder Ester, bevorzugt Weinsäure und/oder Citronensäure, bevorzugt Weinsäure, in einer (absoluten) Menge und/oder Dosis im Bereich von 0,5 mg bis 100 mg, insbesondere im Bereich von 1 mg bis 50 mg, vorzugsweise im Bereich von 2 mg bis 20 mg;
• - gegebenenfalls mindestens ein Anisöl, insbesondere Sternanisöl, in einer (absoluten) Menge und/oder Dosis im Bereich von 0,2 mg bis 80 mg, insbesondere im Bereich von 0,5 mg bis 40 mg, vorzugsweise im Bereich von 0,75 mg bis 15 mg;
• - gegebenenfalls mindestens ein ätherisches Öl, insbesondere Pfefferminzöl, in einer (absoluten) Menge und/oder Dosis im Bereich von 0,01 mg bis 5 mg, insbesondere im Bereich von 0,05 mg bis 3 mg, vorzugsweise im Bereich von 0,1 mg bis 1 mg;
• - gegebenenfalls mindestens ein Kaffee-Extrakt und/oder Tee-Extrakt, insbesondere Kaffee-Extrakt, in einer (absoluten) Menge und/oder Dosis im Bereich von 0,05 mg bis 100 mg, insbesondere im Bereich von 0,5 mg bis 50 mg, vorzugsweise im Bereich von 1 mg bis 20 mg;
• - gegebenenfalls Propylenglykol in einer (absoluten) Menge und/oder Dosis im Bereich von 0,05 mg bis 50 mg, insbesondere im Bereich von 0,5 mg bis 20 mg, vorzugsweise im Bereich von 1 mg bis 10 mg;
• - gegebenenfalls mindestens eine Schleimdroge und/oder deren Extrakt in einer (absoluten) Menge und/oder Dosis im Bereich von 0,5 mg bis 200 mg, insbesondere im Bereich von 1 mg bis 100 mg, vorzugsweise im Bereich von 5 mg bis 50 mg;
• - gegebenenfalls mindestens einen weiteren Wirk- und/oder Inhaltsstoff, insbesondere pharmazeutischen Zusatz- und/oder Hilfsstoff, insbesondere ausgewählt aus der Gruppe von Verarbeitungshilfsstoffen, Stabilisatoren, Emulgatoren, Antioxidantien, Konservierungsstoffen, Feuchthaltemitteln, Süßstoffen und Süßungsmitteln, pH-Stellmitteln, pH-Puffersubstanzen, Verdickungsmitteln, Aromastoffen, Antiseptika, Färbe-, Puffer-, Riech-, Duft-, Streck-, Binde-, Netz- und/oder Konservierungsstoffen sowie deren Kombinationen und Mischungen, insbesondere in einer (absoluten) Menge und/oder Dosis im Bereich von 0,1 mg bis 500 mg, insbesondere im Bereich von 0,5 mg bis 250 mg, vorzugsweise im Bereich von 1 mg bis 100 mg;
• - mindestens einen Zucker und/oder mindestens einen Zuckeraustauschstoff, insbesondere als Exzipient (Träger), vorzugsweise pharmakologisch und/oder physiologisch unbedenklicher Exzipient (Träger); insbesondere wobei der Zucker ausgewählt ist aus der Gruppe von Saccharose, Glucose, insbesondere Dextrose, und Fructose und/oder insbesondere wobei der Zuckeraustauschstoff ausgewählt ist aus Zuckeralkoholen, vorzugsweise aus der Gruppe von Mannit, Xylit, Sorbit, Isomalt, Maltitsirup, Lactit, Leucrose, Fructooligosacchariden, Glucanen, Polyglucose sowie deren Kombinationen und Mischungen, besonders bevorzugt Isomalt und/oder Mannit sowie deren Kombinationen und Mischungen, ganz besonders bevorzugt Isomalt; und/oder insbesondere in Mengen zur Bereitstellung und/oder Erhalt des Gesamtgewichts der Lutschtablette,

insbesondere wobei die Zusammensetzung bzw. Lutschtablette zumindest im Wesentlichen kein Phenoxyethanol (2-Phenoxyethanol) enthält und/oder insbesondere wobei die Lutschtablette zumindest im Wesentlichen frei ist von Phenoxyethanol (2-Phenoxyethanol) und/oder insbesondere wobei die Zusammensetzung bzw. Lutschtablette in Abwesenheit von Phenoxyethanol (2-Phenoxyethanol) vorliegt.In addition, according to the present aspect, the present invention also relates to a composition according to the invention, in particular a pharmaceutical composition, for use in the prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity, in particular a composition as defined above for use,
wherein the composition is present and/or designed as a solid dosage form in the form of a lozenge, in particular based on hard caramel and/or as hard caramel, wherein the lozenge has a total weight in the range of 0.5 to 7 g, in particular in the range of 1 to 6 g, preferably in the range of 2 to 5 g, containing per lozenge:

• - octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, in an (absolute) amount and/or dose in the range of 0.05 mg to 15 mg, in particular in the range of 0.1 mg to 12.5 mg, preferably in the range of 0.5 mg to 10 mg, more preferably in the range of 0.75 mg to 7.5 mg, particularly preferably in the range of 1 mg to 5 mg;
• - optionally at least one local anesthetic, in particular lidocaine, preferably lidocaine hydrochloride, in an (absolute) amount and/or dose in the range from 0.1 mg to 50 mg, in particular in the range from 1 mg to 20 mg, preferably in the range from 3 mg to 15 mg, preferably in the range from 4 mg to 10 mg;
• - optionally at least one acidifying agent, in particular in the form of an organic acid or its salts or esters, preferably tartaric acid and/or citric acid, preferably tartaric acid, in an (absolute) amount and/or dose in the range from 0.5 mg to 100 mg, in particular in the range from 1 mg to 50 mg, preferably in the range from 2 mg to 20 mg;
• - optionally at least one anise oil, in particular star anise oil, in an (absolute) amount and/or dose in the range from 0.2 mg to 80 mg, in particular in the range from 0.5 mg to 40 mg, preferably in the range from 0.75 mg to 15 mg;
• - optionally at least one essential oil, in particular peppermint oil, in an (absolute) amount and/or dose in the range of 0.01 mg to 5 mg, in particular in the range of 0.05 mg to 3 mg, preferably in the range of 0.1 mg to 1 mg;
• - optionally at least one coffee extract and/or tea extract, in particular coffee extract, in an (absolute) amount and/or dose in the range of 0.05 mg to 100 mg, in particular in the range of 0.5 mg to 50 mg, preferably in the range of 1 mg to 20 mg;
• - optionally propylene glycol in an (absolute) amount and/or dose in the range of 0.05 mg to 50 mg, in particular in the range of 0.5 mg to 20 mg, preferably in the range of 1 mg to 10 mg;
• - optionally at least one mucilaginous drug and/or its extract in an (absolute) amount and/or dose in the range of 0.5 mg to 200 mg, in particular in the range of 1 mg to 100 mg, preferably in the range of 5 mg to 50 mg;
• - optionally at least one further active ingredient and/or ingredient, in particular pharmaceutical additive and/or excipient, in particular selected from the group of processing aids, stabilizers, emulsifiers, antioxidants, preservatives, humectants, sweeteners and sweeteners, pH adjusters, pH buffer substances, thickeners, flavorings, antiseptics, colorants, buffers, fragrances, scents, extenders, binders, wetting agents and/or preservatives and combinations and mixtures thereof, in particular in an (absolute) amount and/or dose in the range from 0.1 mg to 500 mg, in particular in the range from 0.5 mg to 250 mg, preferably in the range from 1 mg to 100 mg;
• - at least one sugar and/or at least one sugar substitute, in particular as an excipient (carrier), preferably a pharmacologically and/or physiologically acceptable excipient (carrier); in particular wherein the sugar is selected from the group of sucrose, glucose, in particular dextrose, and fructose and/or in particular wherein the sugar substitute is selected from sugar alcohols, preferably from the group of mannitol, xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructooligosaccharides, glucans, polyglucose and combinations and mixtures thereof. particularly preferably isomalt and/or mannitol and combinations and mixtures thereof, most preferably isomalt; and/or in particular in amounts to provide and/or maintain the total weight of the lozenge,

in particular wherein the composition or lozenge contains at least substantially no phenoxyethanol (2-phenoxyethanol) and/or in particular wherein the lozenge is at least substantially free of phenoxyethanol (2-phenoxyethanol) and/or in particular wherein the composition or lozenge is present in the absence of phenoxyethanol (2-phenoxyethanol).

• - Octenidin und/oder dessen Salze und/oder Ester, vorzugsweise Octenidindihydrochlorid, in einer (absoluten) Menge und/oder Dosis im Bereich von 0,05 mg bis 15 mg, insbesondere im Bereich von 0,1 mg bis 12,5 mg, vorzugsweise im Bereich von 0,5 mg bis 10 mg, bevorzugt im Bereich von 0,75 mg bis 7,5 mg, besonders bevorzugt im Bereich von 1 mg bis 5 mg;
• - gegebenenfalls mindestens ein Lokalanästhetikum, insbesondere Lidocain, bevorzugt Lidocainhydrochlorid, in einer (absoluten) Menge und/oder Dosis im Bereich von 0,1 mg bis 50 mg, insbesondere im Bereich von 1 mg bis 20 mg, vorzugsweise im Bereich von 3 mg bis 15 mg, bevorzugt im Bereich von 4 mg bis 10 mg;
• - gegebenenfalls mindestens ein Antiphlogistikum, insbesondere Benzydamin und/oder dessen Salze und/oder Ester, bevorzugt Benzydaminhydrochlorid, in einer (absoluten) Menge und/oder Dosis im Bereich von 0,1 mg bis 50 mg, insbesondere im Bereich von 0,5 mg bis 20 mg, vorzugsweise im Bereich von 1 mg bis 15 mg, bevorzugt im Bereich von 2 mg bis 10 mg,
• - gegebenenfalls mindestens ein nichtsteroidale Antiphlogistikum (NSAR-Wirkstoff), insbesondere Flurbiprofen und/oder dessen Salze und/oder Ester, bevorzugt Flurbiprofen, in einer (absoluten) Menge und/oder Dosis im Bereich von 0,1 mg bis 50 mg, insbesondere im Bereich von 0,5 mg bis 20 mg, vorzugsweise im Bereich von 1 mg bis 15 mg, bevorzugt im Bereich von 2 mg bis 10 mg;
• - gegebenenfalls mindestens ein Säuerungsmittel, insbesondere in Form einer organischen Säure oder deren Salze oder Ester, bevorzugt Weinsäure und/oder Citronensäure, bevorzugt Weinsäure, in einer (absoluten) Menge und/oder Dosis im Bereich von 0,5 mg bis 100 mg, insbesondere im Bereich von 1 mg bis 50 mg, vorzugsweise im Bereich von 2 mg bis 20 mg;
• - gegebenenfalls mindestens ein Anisöl, insbesondere Sternanisöl, in einer (absoluten) Menge und/oder Dosis im Bereich von 0,2 mg bis 80 mg, insbesondere im Bereich von 0,5 mg bis 40 mg, vorzugsweise im Bereich von 0,75 mg bis 15 mg;
• - gegebenenfalls mindestens ein ätherisches Öl, insbesondere Pfefferminzöl, in einer (absoluten) Menge und/oder Dosis im Bereich von 0,01 mg bis 5 mg, insbesondere im Bereich von 0,05 mg bis 3 mg, vorzugsweise im Bereich von 0,1 mg bis 1 mg;
• - gegebenenfalls mindestens ein Kaffee-Extrakt und/oder Tee-Extrakt, insbesondere Kaffee-Extrakt, in einer (absoluten) Menge und/oder Dosis im Bereich von 0,05 mg bis 100 mg, insbesondere im Bereich von 0,5 mg bis 50 mg, vorzugsweise im Bereich von 1 mg bis 20 mg;
• - gegebenenfalls Propylenglykol in einer (absoluten) Menge und/oder Dosis im Bereich von 0,05 mg bis 50 mg, insbesondere im Bereich von 0,5 mg bis 20 mg, vorzugsweise im Bereich von 1 mg bis 10 mg;
• - gegebenenfalls mindestens eine Schleimdroge und/oder deren Extrakt in einer (absoluten) Menge und/oder Dosis im Bereich von 0,5 mg bis 200 mg, insbesondere im Bereich von 1 mg bis 100 mg, vorzugsweise im Bereich von 5 mg bis 50 mg;
• - gegebenenfalls mindestens einen weiteren Wirk- und/oder Inhaltsstoff, insbesondere pharmazeutischen Zusatz- und/oder Hilfsstoff, insbesondere ausgewählt aus der Gruppe von Verarbeitungshilfsstoffen, Stabilisatoren, Emulgatoren, Antioxidantien, Konservierungsstoffen, Feuchthaltemitteln, Süßstoffen und Süßungsmitteln, pH-Stellmitteln, pH-Puffersubstanzen, Verdickungsmitteln, Aromastoffen, Antiseptika, Färbe-, Puffer-, Riech-, Duft-, Streck-, Binde-, Netz- und/oder Konservierungsstoffen sowie deren Kombinationen und Mischungen, in einer (absoluten) Menge und/oder Dosis im Bereich von 0,1 mg bis 500 mg, insbesondere im Bereich von 0,5 mg bis 250 mg, vorzugsweise im Bereich von 1 mg bis 100 mg;
• - mindestens einen Zucker und/oder mindestens einen Zuckeraustauschstoff, insbesondere als Exzipient (Träger), vorzugsweise pharmakologisch und/oder physiologisch unbedenklicher Exzipient (Träger); insbesondere wobei der Zucker ausgewählt ist aus der Gruppe von Saccharose, Glucose, insbesondere Dextrose, und Fructose und/oder insbesondere wobei der Zuckeraustauschstoff ausgewählt ist aus Zuckeralkoholen, vorzugsweise aus der Gruppe von Mannit, Xylit, Sorbit, Isomalt, Maltitsirup, Lactit, Leucrose, Fructooligosacchariden, Glucanen, Polyglucose sowie deren Kombinationen und Mischungen, besonders bevorzugt Isomalt und/oder Mannit sowie deren Kombinationen und Mischungen, ganz besonders bevorzugt Isomalt; und/oder insbesondere in Mengen zur Bereitstellung und/oder Erhalt des Gesamtgewichts der Lutschtablette,

insbesondere wobei die Zusammensetzung bzw. Lutschtablette zumindest im Wesentlichen kein Phenoxyethanol (2-Phenoxyethanol) enthält und/oder insbesondere wobei die Lutschtablette zumindest im Wesentlichen frei ist von Phenoxyethanol (2-Phenoxyethanol) und/oder insbesondere wobei die Zusammensetzung bzw. Lutschtablette in Abwesenheit von Phenoxyethanol (2-Phenoxyethanol) vorliegt.Likewise, according to the present aspect, the present invention also relates to a composition according to the invention, in particular a pharmaceutical composition, for use in the prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity, in particular a composition as defined above for use,
wherein the composition is present and/or designed as a solid dosage form in the form of a lozenge, in particular based on hard caramel and/or as hard caramel, wherein the lozenge has a total weight in the range of 0.5 g to 7 g, in particular in the range of 1 g to 6 g, preferably in the range of 2 g to 5 g, containing per lozenge:

• - octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, in an (absolute) amount and/or dose in the range of 0.05 mg to 15 mg, in particular in the range of 0.1 mg to 12.5 mg, preferably in the range of 0.5 mg to 10 mg, more preferably in the range of 0.75 mg to 7.5 mg, particularly preferably in the range of 1 mg to 5 mg;
• - optionally at least one local anesthetic, in particular lidocaine, preferably lidocaine hydrochloride, in an (absolute) amount and/or dose in the range from 0.1 mg to 50 mg, in particular in the range from 1 mg to 20 mg, preferably in the range from 3 mg to 15 mg, preferably in the range from 4 mg to 10 mg;
• - optionally at least one anti-inflammatory agent, in particular benzydamine and/or its salts and/or esters, preferably benzydamine hydrochloride, in an (absolute) amount and/or dose in the range from 0.1 mg to 50 mg, in particular in the range from 0.5 mg to 20 mg, preferably in the range from 1 mg to 15 mg, preferably in the range from 2 mg to 10 mg,
• - optionally at least one non-steroidal anti-inflammatory drug (NSAID), in particular flurbiprofen and/or its salts and/or esters, preferably flurbiprofen, in an (absolute) amount and/or dose in the range from 0.1 mg to 50 mg, in particular in the range from 0.5 mg to 20 mg, preferably in the range from 1 mg to 15 mg, preferably in the range from 2 mg to 10 mg;
• - optionally at least one acidifying agent, in particular in the form of an organic acid or its salts or esters, preferably tartaric acid and/or citric acid, preferably tartaric acid, in an (absolute) amount and/or dose in the range from 0.5 mg to 100 mg, in particular in the range from 1 mg to 50 mg, preferably in the range from 2 mg to 20 mg;
• - optionally at least one anise oil, in particular star anise oil, in an (absolute) amount and/or dose in the range from 0.2 mg to 80 mg, in particular in the range from 0.5 mg to 40 mg, preferably in the range from 0.75 mg to 15 mg;
• - optionally at least one essential oil, in particular peppermint oil, in an (absolute) amount and/or dose in the range of 0.01 mg to 5 mg, in particular in the range of 0.05 mg to 3 mg, preferably in the range of 0.1 mg to 1 mg;
• - optionally at least one coffee extract and/or tea extract, in particular coffee extract, in an (absolute) amount and/or dose in the range of 0.05 mg to 100 mg, in particular in the range of 0.5 mg to 50 mg, preferably in the range of 1 mg to 20 mg;
• - optionally propylene glycol in an (absolute) amount and/or dose in the range of 0.05 mg to 50 mg, in particular in the range of 0.5 mg to 20 mg, preferably in the range of 1 mg to 10 mg;
• - optionally at least one mucilaginous drug and/or its extract in an (absolute) amount and/or dose in the range of 0.5 mg to 200 mg, in particular in the range of 1 mg to 100 mg, preferably in the range of 5 mg to 50 mg;
• - optionally at least one further active ingredient and/or ingredient, in particular pharmaceutical additive and/or excipient, in particular selected from the group of processing aids, stabilizers, emulsifiers, antioxidants, preservatives, humectants, sweeteners and sweeteners, pH adjusters, pH buffer substances, thickeners, flavorings, antiseptics, colorants, buffers, fragrances, scents, extenders, binders, wetting agents and/or preservatives and combinations and mixtures thereof, in an (absolute) amount and/or dose in the range from 0.1 mg to 500 mg, in particular in the range from 0.5 mg to 250 mg, preferably in the range from 1 mg to 100 mg;
• - at least one sugar and/or at least one sugar substitute, in particular as an excipient (carrier), preferably a pharmacologically and/or physiologically acceptable excipient (carrier); in particular wherein the sugar is selected from the group of sucrose, glucose, in particular dextrose, and fructose and/or in particular wherein the sugar substitute is selected from sugar alcohols, preferably from the group of mannitol, xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructooligosaccharides, glucans, polyglucose and combinations and mixtures thereof, particularly preferably isomalt and/or mannitol and combinations and mixtures thereof, very particularly preferably isomalt; and/or in particular in amounts to provide and/or maintain the total weight of the lozenge,

in particular wherein the composition or lozenge contains at least substantially no phenoxyethanol (2-phenoxyethanol) and/or in particular wherein the lozenge is at least substantially free of phenoxyethanol (2-phenoxyethanol) and/or in particular wherein the composition or lozenge is present in the absence of phenoxyethanol (2-phenoxyethanol).

As previously mentioned, the composition according to the present invention aspect can also be in the form of a liquid dosage form according to an alternative embodiment of the present invention. This is described in more detail below.

According to the invention, it can therefore basically be provided that the composition is present or designed as a liquid dosage form. In particular, the composition can, as also previously stated, be present or designed as a liquid dosage form in the form of a fluid, a mouthwash, a mouth rinse, a juice, a gargle solution, a spray, in particular a mouth and/or throat spray or nasal spray, or the like, in particular where the composition is present and/or designed as a fluid, mouthwash, mouth rinse, juice, gargle solution, spray, in particular a mouth and/or throat spray or nasal spray, or the like. This enables simple application with good distribution of the active ingredients in the mouth, throat or nasal cavity.

In general, the composition according to the invention, in particular the liquid dosage form, can be aqueous, alcoholic or aqueous-alcoholic based.

In this regard, the composition, in particular the liquid dosage form, can contain the active ingredients and/or ingredients together with at least one excipient (carrier), preferably pharmacologically and/or physiologically acceptable excipient (carrier), wherein the excipient (carrier) is selected from the group of solvents, solubilizers, emulsifiers and the like, in particular wherein the carrier is selected from the group of water, ethanol, isopropanol, ethyl carbonate, ethyl acetate, benzyl alcohol, benzyl benzoate, propylene glycol, 1,3-butyl glycol and combinations and mixtures thereof.

In particular, the composition, in particular the liquid dosage form, can comprise at least one sugar and/or sugar substitute, in particular wherein the at least one sugar is selected from the group of sucrose, glucose, in particular dextrose, and fructose and/or in particular wherein the at least one sugar substitute is selected from sugar alcohols, preferably from the group of mannitol, xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructooligosaccharides, glucans, polyglucose, particularly preferably maltitol syrup.

In this regard, the composition, in particular the liquid dosage form, can contain water. For this purpose, the water can be present in an amount of at least 10% by weight, in particular at least 20% by weight, preferably at least 30% by weight, based on the composition, in particular the liquid dosage form. In particular, the composition can contain the water in an amount in the range from 10% by weight to 98% by weight, in particular in the range from 20% by weight to 95% by weight. % by weight, preferably in the range of 30% by weight to 90% by weight, based on the composition, in particular the liquid dosage form.

Furthermore, with respect to the composition according to the invention in general, within the scope of the present invention, it may behave as follows.

In particular, the composition as defined above and/or the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, can be used as a co-therapeutic agent and/or as a co-medication in the context of a basic COVID-19 therapy and/or wherein the composition and/or the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, are used as a combination therapeutic agent for a basic COVID-19 therapy and/or existing COVID-19 therapy.

According to the invention, the composition and/or the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, can be used for exposure prophylaxis, in particular post-exposure prophylaxis and/or pre-exposure prophylaxis, against viruses, in particular against corona viruses, preferably SARS-CoV-2.

Furthermore, the composition and/or the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, can be used for the prophylaxis of infection against viruses, in particular against corona viruses, preferably SARS-CoV-2.

According to the invention, it can further be provided that the composition and/or the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, is used to reduce the viral load, in particular the viral load of corona viruses, preferably SARS-CoV-2, preferably to reduce the viral load in the mouth, throat and/or nasal cavity.

In general, the composition and/or the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, can be used in the presymptomatic stage and/or postsymptomatic stage, in particular in the presymptomatic stage, of (viral) diseases caused in particular by viruses, in particular corona viruses, preferably SARS-CoV-2, preferably COVID-19.

Furthermore, the composition and/or the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, can be used in asymptomatic courses of (viral) diseases caused by viruses, in particular corona viruses, preferably SARS-CoV-2, preferably COVID-19.

In addition, the composition and/or the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, can be used in symptomatic courses of (viral) diseases caused by viruses, in particular corona viruses, preferably SARS-CoV-2, preferably COVID-19.

According to the invention, it can moreover behave in particular in such a way that the composition, in particular the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, inactivates or kills the corona viruses, preferably SARS-CoV-2.

Furthermore, according to the invention, it can also behave in such a way that the composition, in particular the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, inhibits and/or reduces or prevents the proliferation and/or replication of the corona viruses, preferably SARS-CoV-2.

The present invention, both according to the first aspect of the present invention and according to all other aspects of the present invention, is thus associated with a multitude of advantages and special features which make the therapy concept according to the invention unique and special, in particular highly efficient.

A further subject matter of the present invention - according to a second aspect of the present invention - is the use according to the invention of a composition, in particular a pharmaceutical composition, for producing a medicament or drug for the prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity, wherein the composition contains octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, as antiviral active ingredient.

According to the present aspect, the present invention also relates to the use of a composition, in particular pharmaceutical composition, for the prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity, wherein the composition contains octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, as antiviral active ingredient.

For further details on this aspect of the invention, reference can be made to the statements on the other aspects of the invention, which statements equally apply to the present aspect of the invention.

Likewise, the present invention - according to a third aspect of the present invention - relates to octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, for use in the prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity.

For further details on this aspect of the invention, reference can be made to the statements on the other aspects of the invention, which statements equally apply to the present aspect of the invention.

Yet another subject matter of the present invention - according to a fourth aspect of the present invention - is the use according to the invention of octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, for producing a medicament and/or drug for prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity.

In this context, the present invention according to the present aspect also relates to the use of octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, for the prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity.

For further details on this aspect of the invention, reference can be made to the statements on the other aspects of the invention, which statements equally apply to the present aspect of the invention.

Furthermore, as regards the above-mentioned aspects of the invention according to the third aspect and fourth aspect of the present invention, the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, can be used or administered in a composition as previously defined.

The present invention also describes a method for the prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19,
wherein in the method a patient suffering from a viral disease, in particular a (viral) disease caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, is administered a pharmaceutically and/or therapeutically effective amount, in particular a pharmaceutically and/or therapeutically antivirally effective amount, of octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride.

For further details of the method described here, reference can be made to the statements on the aspects of the invention, which statements equally apply to the method described here.

• So kann es insbesondere vorgesehen sein, dass das Octenidin und/oder dessen Salze und/oder Ester in Form eines Hydrochloridsalzes, vorzugsweise Octenidindihydrochlorid, eingesetzt bzw. verwendet wird. Zudem kann das Octenidin und/oder dessen Salze und/oder Ester, vorzugsweise Octenidindihydrochlorid, in pharmazeutisch und/oder therapeutisch wirksamen, insbesondere in pharmazeutisch und/oder therapeutisch antiviral wirksamen Mengen, vorliegt und/oder verwendet werden.

As regards the aforementioned aspects of the present invention according to the third and fourth aspects, the following may also be provided in this regard:

• In particular, it can be provided that the octenidine and/or its salts and/or esters are employed or used in the form of a hydrochloride salt, preferably octenidine dihydrochloride. In addition, the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, can be present and/or used in pharmaceutically and/or therapeutically effective amounts, in particular in pharmaceutically and/or therapeutically antivirally effective amounts.

With regard to the third and fourth aspects of the present invention, it can equally be provided that the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, is employed and/or used together with at least one local anesthetic. The local anesthetic can be a local anesthetic based on an organic acid ester or acid amide, preferably acid amide. In particular, the local anesthetic can be selected from the group of local anesthetics of the ester type and local anesthetics of the amide type, preferably local anesthetics of the amide type.

In particular, the local anesthetic can be selected from the group of benzocaine, procaine, tetracaine, lidocaine, etidocaine, prilocaine, mepivacaine, bupivacaine and S-ropivacin and their salts and esters as well as their combinations and mixtures, in particular lidocaine and its salts and esters, preferably lidocaine hydrochloride.

According to the invention, with regard to the aforementioned aspects, the local anesthetic can be selected from the group of lidocaine (2-diethylamino-N-(2,6-dimethylphenyl)acetamide) and its salts and esters, preferably lidocaine hydrochloride. The local anesthetic can thus in particular be lidocaine and/or its salts and/or esters, preferably lidocaine hydrochloride.

With regard to the aforementioned aspects, it can be provided that the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, is employed and/or used together with at least one anti-inflammatory agent, in particular benzydamine and/or its salts and/or esters, preferably benzydamine hydrochloride.

Furthermore, according to the aforementioned aspects, the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, can be employed or used together with at least one non-steroidal anti-inflammatory drug (NSAID active ingredient), in particular selected from the group of flurbiprofen, ibuprofen, dexibuprofen, naproxen, ketoprofen, dexketoprofen, tiaprofenic acid, diclofenac and acetylsalicylic acid and their salts and esters as well as their combinations and mixtures, in particular flurbiprofen and its salts and esters, preferably flurbiprofen.

In particular, the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, can be employed and/or used together with flurbiprofen and/or its salts and/or esters, preferably flurbiprofen.

According to the third and fourth aspects of the present invention, it can also generally be provided that the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, are treated with at least one acidifying agent, in particular in the form of an organic acid or their salts or esters, preferably tartaric acid and/or citric acid, preferably tartaric acid, is employed and/or used.

In addition, the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, can be employed and/or used with at least one anise oil, in particular star anise oil.

Furthermore, the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, can be employed and/or used with at least one essential oil, in particular peppermint oil.

In addition, the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, can be employed and/or used with at least one coffee extract and/or tea extract, in particular coffee extract.

According to the third and fourth aspects of the present invention, the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, can be employed and/or used with propylene glycol.

Furthermore, the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, can be employed and/or used with at least one mucilaginous drug and/or its extract. The mucilaginous drug or its extract can be selected from the group of Iceland moss (Lichen islandicus), marshmallow (Althaea officinalis L.), ribwort plantain (Plantago lanceolata L.), mallow (Malva sylvestris L. and M. neglecta WALLR. and others), fenugreek (Trigonella foenum-graecum L.), salep and quince (Cydonia oblonga MILL.) and combinations and mixtures thereof, preferably Iceland moss (Lichen islandicus) and/or marshmallow (Althaea officinalis L.).

With regard to the third and fourth aspects of the present invention, it can also be provided that the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, are not employed and/or used together with and/or in the absence of phenoxyethanol (2-phenoxyethanol).

In addition, it can be provided that the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, are not employed and/or used together with and/or in the absence of n-propanol (propan-1-ol) and/or not together with isopropanol, in particular not together with a primary alcohol.

Furthermore, it can also be provided for the third and fourth aspects of the present invention that the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, is administered with a daily dose in the range of 0.15 mg/diem to 120 mg/diem, in particular in the range of 0.15 mg/diem to 120 mg/diem, preferably in the range of 0.3 mg/diem to 100 mg/diem, preferably in the range of 1.5 mg/diem to 60 mg/diem, particularly preferably in the range of 2.25 mg/diem to 120 mg/diem, more preferably in the range of 2.5 mg/diem to 40 mg/diem.

In particular, the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, can be prepared for administration of a daily dose in the range of 0.15 mg/diem to 120 mg/diem, in particular in the range of 0.15 mg/diem to 120 mg/diem, preferably in the range of 0.3 mg/diem to 100 mg/diem, preferably in the range of 1.5 mg/diem to 60 mg/diem, particularly preferably in the range of 2.25 mg/diem to 120 mg/diem, further preferably in the range of 2.5 mg/diem to 40 mg/diem.

Further embodiments, modifications and variations as well as advantages of the present invention will be readily apparent and achievable by a person skilled in the art upon reading the description without departing from the scope of the present invention.

The following embodiments serve only to illustrate the present invention, but without intending to limit the present invention thereto.

EXAMPLES OF IMPLEMENTATION:

1. Production examples:

Production of lozenges based on hard caramel that can be used according to the invention

• Der Zucker bzw. die Zuckerersatzstoffe/Zuckeraustauschstoffe werden in Wasser gelöst und anschließend bei Temperaturen zwischen 120 und 140 °C gekocht und vakuumiert. Dieser heißen Masse werden der Wirkstoff (Octenidindihydrochlorid) sowie gegebenenfalls weitere Wirk- und/oder Inhaltsstoffe, wie zuvor genannt, in fester oder flüssiger Form zudosiert. Nach kontrolliertem Abkühlen auf Temperaturen unterhalb von 75 °C werden die Hartkaramellen in der gewünschten Form geprägt und nachfolgend verpackt.

Various lozenges based on hard caramel that can be used according to the invention are produced. For the sugar-containing variant, e.g. sucrose and/or glucose syrup can be used, while for the sugar-free variant, sugar substitutes, in particular sugar alcohols, such as maltitol (maltitol) or isomalt or isomaltitol (Palatinit ^® ), can be used as the lozenge base or hard caramel base (matrix), whereby both the sugar-containing and the sugar-free variant may have additional active ingredients and/or ingredients (e.g. local anesthetics, mucilaginous drugs or their extracts, processing aids, aromas and aroma substances, flavorings, sweeteners and sweeteners, acidifiers, stabilizers, antiseptics, colorants, etc.) added. The corresponding active ingredients and ingredients are incorporated into the matrix. The lozenges or hard caramels are produced as follows:

• The sugar or sugar substitutes are dissolved in water and then boiled at temperatures between 120 and 140 °C and vacuum packed. The active ingredient (octenidine dihydrochloride) and any other active ingredients and/or ingredients, as previously mentioned, are added to this hot mass in solid or liquid form. After controlled cooling to temperatures below 75 °C, the hard candies are embossed in the desired shape and then packaged.

In this way, different recipes for lozenges that can be used according to the invention are produced with variable amounts of ingredients: Recipe 1: Lozenges, sugar-free (isomalt) Octenidine dihydrochloride: 0.05 - 2.0 wt.% Isomalt: 93.0 - 99.95 wt.% Acidifiers, colours, sweeteners and flavourings: 0 - 5.0 wt.% Total: 1,000 - 4,000 mg Recipe 2: Lozenge, sugar-free (maltitol) Octenidine dihydrochloride: 0.05 - 2.0 wt.% Maltitol: 93.0 - 99.95 wt.% Acidifiers, colours, sweeteners and flavourings: 0 - 5.0 wt.% Total: 1,000 - 4,000 mg Recipe 3: Lozenges, sugar-free (maltitol/isomalt) Octenidine dihydrochloride: 0.05 - 2.0 wt.% Maltitol/Isomalt 1 : 0.10 - 4: 93.0 - 99.95 wt.% (dry matter) Acidifiers, colours, sweeteners and flavourings: 0 - 5.0 wt.% Total: 1,000 - 4,000 mg Recipe 4: Lozenges, containing sugar (sucrose/glucose syrup) Octenidine dihydrochloride: 0.05 - 2.0 wt.% Sucrose/glucose syrup 1 : 0.5 - 4: 93.0 - 99.95 wt.% (dry matter) Acidifiers, colours, sweeteners and flavourings: 0 - 5.0 wt.% Total: 1,000 - 4,000 mg

The following recipe for lozenges that can be used according to the invention is prepared in a corresponding manner: Recipe 5: Lozenges, sugar-free (Isomalt) Octenidine dihydrochloride: 0.05 - 2.0 wt% Isomalt (dry substance): 93.0 - 99.95 wt.% Acidifiers, colours, flavouring: 0 - 1.5 wt.% Tartaric acid: 0 - 2.0 wt.% Star anise oil: 0 - 1.0 wt.% Peppermint oil: 0 - 0.5 wt.% Total: 1,000 - 4,000 mg

2. Efficacy studies

(i) Example 1:

The antiviral efficacy against SARS-CoV-2 of an octenidine dihydrochloride composition usable according to the invention is investigated in comparison to placebo in patients with existing SARS-CoV-2 infection.

For this purpose, a composition containing octenidine dihydrochloride based on the above-described formulation 1 is used, namely as a solid dosage form in the form of a lozenge in the form of a hard caramel (hereinafter also referred to as “octenidine dihydrochloride lozenge”), wherein a respective dosage unit in the form of the lozenge has an octenidine dihydrochloride content of 2.6 mg and an isomalt content of 2.57 g (corresponding to about 6 kcal or about 26 kJ).

In the corresponding placebo composition, which is also available as a solid dosage form in the form of a lozenge shaped like a hard caramel (hereinafter also referred to as “placebo lozenge”), the active ingredient octenidine dihydrochloride is replaced by an appropriate amount of isomalt.

SARS-CoV-2 is detected in the respective patients using a corresponding PCR test (polymerase chain reaction), using patient samples based on pharyngeal swabs. The PCR test is used to determine the so-called Ct value (cycle threshold), with the CT value being based on the required number of measurement cycles carried out to detect SARS-CoV-2.

A small Ct value therefore means a high viral load, since relatively few measurement cycles have to be carried out to detect the virus. A high Ct value means a low viral load, since relatively many measurement cycles have to be carried out to detect the virus. A negative result (i.e. no detection of SARS-CoV-2) is given in this case with a Ct value of 38.

First, an initial PCR test is carried out on the patients before administration of the respective lozenge and the corresponding Ct value is determined (listed under “Ct0” in Tables 1 and 2 below).

The patients then receive either an octenidine dihydrochloride lozenge (“octenidine dihydrochloride group”) or a placebo lozenge (“placebo group”), with one lozenge being administered per patient. The duration of the lozenge is 15 minutes.

In order to avoid or exclude sucking or dilution effects, the subsequent second PCR test is only carried out 15 minutes after the end of sucking the administered composition (i.e. 30 minutes after sucking has begun) and the corresponding Ct value is determined (indicated under “Ct1” in Tables 1 and 2 below).

The following Table 1 shows the corresponding results obtained for the octenidine dihydrochloride group: Patient / Octenidine dihydrochloride lozenge Ct0 Ct1 O1 30.87 33.04 O2 17.77 21.37 O3 28.77 30.65 O4 37.06 negative O5 34.16 36.04 O6 27.31 negative O7 17.83 19.40 O8 26.74 34.09 O9 22.65 29.75 O10 21.58 28.85 O11 34.46 35.16 O12 21.64 22,50 O13 32.03 33.88 O14 29.65 31.35 O15 28.30 30.14 O16 27.16 29.19 O17 21.86 28.79 O18 21.46 29.54 O19 23.89 30.19 O20 24.77 29.78

In addition, Table 2 below shows the results obtained for the placebo group: Patient / Placebo lozenge Ct0 Ct1 P1 35.69 34.17 P2 25.16 25.11 P3 19,45 20.17

The results shown in Tables 1 and 2 show that there is a clear antiviral effect with regard to SARS-CoV2 when octenidine dihydrochloride lozenges that can be used according to the invention are administered. For example, a clear increase in the Ct value determined in the PCR tests can be observed for the patients treated with the octenidine dihydrochloride lozenge compared to the placebo group, and this after just one administration of the composition. The Ct1 values show the presence of a significantly reduced viral load after administration of the octenidine dihydrochloride lozenge and also in comparison to the placebo group.

The above investigations thus demonstrate the antiviral effect with respect to the corona virus SARS-CoV2 of the composition based on the octenidine dihydrochloride lozenge that can be used according to the invention.

(ii) Example 2:

In addition, the antiviral efficacy of a composition that can be used according to the invention in the form of the octenidine dihydrochloride lozenge described in Example 1 is being investigated on other patients. The patients have a positive PCR test for SARS-CoV2 before administration of the lozenges (indicated under “Ct0” in Table 3 below).

The patients receive a total of three octenidine dihydrochloride lozenges in a defined time sequence. Each tablet is sucked for 15 minutes, with a PCR test being carried out every 15 minutes. The PCR test after administration of the first octenidine dihydrochloride lozenge is therefore carried out 30 minutes after administration (listed under “Ct1” in Table 3 below).

The second octenidine dihydrochloride lozenge is administered 2.5 hours after the administration of the first lozenge, with the corresponding PCR test being carried out 3 hours after the administration of the first lozenge and 30 minutes after the administration of the second lozenge (indicated under ‘Ct2’ in Table 3 below).

In addition, the third octenidine dihydrochloride lozenge is administered 5.5 hours after administration of the first lozenge, and the corresponding PCR test is also performed 30 minutes after administration of the third lozenge and thus 6 hours after administration of the first lozenge (indicated under ‘Ct3’ in Table 3 below).

The following Table 3 shows the results obtained in this regard: Patient / Octenidine dihydrochloride lozenge Ct0 Ct1 Ct2 Ct3 Oct1 21.58 22.39 28.46 30.15 Oct2 26.35 34.43 negative negative Oct3 24.18 29.68 31.49 34.72 Oct4 27,90 31.72 31.10 34.03

The placebo lozenges described in Example 1 are administered to another patient in an analogous manner.

The following Table 4 shows the results obtained: Patient / Placebo lozenge Ct0 Ct1 Ct2 Ct3 Pla1 24.08 23,24 24.10 23.86

The results show that over time, with the consecutive administration of several lozenges using octenidine dihydrochloride as the active substance, there is a significant and sustained increase in the respective Ct value, accompanied by a lower viral load, even compared to placebo.

Thus, the above investigations also demonstrate the antiviral effect of octenidine dihydrochloride discovered according to the invention in the context of its topical application.

(iii) Example 3:

In addition, for patients with positive SARS-CoV2 results, the viral load is determined based on swabs from the mouth or throat. The results obtained are shown in the single figure.

In this context, the patients are treated with a composition which can be used according to the invention in the form of the octenidine dihydrochloride lozenges described in Example 1.

The graphic representation according to the single figure shows the state or value of the viral load ("VL") before treatment with the composition ("ZvB") and after treatment ("ZnB"). The determination of the viral load refers to a respective sample which is taken 30 minutes after administration of an octenidine dihydrochloride lozenge, whereby the sucking period is 15 minutes, so that any sucking or dilution effects are avoided or excluded.

The single figure shows the overall significant reduction in viral load after administration of the octenidine dihydrochloride lozenge.

Overall, the applicant's above investigations show that the active ingredient octenidine or its salts or esters, in particular octenidine dihydrochloride, is capable of reducing or weakening the viral load in the prophylactic or therapeutic treatment of viral diseases caused by SARS-CoV2, in particular COVID-19, due to the surprisingly discovered antiviral effect when applied topically in the mouth or throat. This antiviral effect of octenidine or octenidine dihydrochloride is completely unexpected.

Overall, octenidine or its salts and/or esters, in particular octenidine dihydrochloride, is therefore, on the basis of the surprisingly discovered findings of the applicant, efficiently suitable for use in the prophylactic or therapeutic topical treatment of viral diseases caused by corona viruses, in particular SARS-CoV2, in particular COVID-19.

QUOTES INCLUDED IN THE DESCRIPTION

This list of documents listed by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions.

Cited non-patent literature

• E. Mutschler et al., “Mutschler Drug Effects - Textbook of Pharmacology and Toxicology”, 8th edition, Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart, 2001, pages 267 [0070]
• Römpp Chemistry Encyclopedia, 10th edition, Volume 3, Georg Thieme Verlag, Stuttgart/New York, 1997, pages 2442 [0070]
• Lidocaine Hydrochloride, European Pharmacopoeia (Ph. Eur.), 9th edition (January 2017). In addition, with regard to lidocaine, reference can be made to European Pharmacopoeia 8.0, European Directorate for the Quality of Medicines and Healthcare, pages 2620/2621 [0079]
• Lidocaine hydrochloride on European Pharmacopoeia 8.0, European Directorate for the Quality of Medicines and Healthcare, pages 2620/2621, keyword: "Lidocaine Hydrochloride" [0079]
• RÖMPP Lexicon of Natural Substances, first edition, Georg Thieme Verlag, Stuttgart/New York, 1997, page 609 [0091]
• RÖMPP Lexicon of Natural Substances, first edition, Georg Thieme Verlag, Stuttgart/New York, 1997, pages 478 and 479 [0094]
• H. Wagner “Pharmaceutical Biology - Drugs and their Ingredients”, Gustav Fischer Verlag, Stuttgart/New York, 1985, especially pages 280 ff [0104]
• Römpp Chemistry Encyclopedia, 10th edition, Volume 6, Georg Thieme Verlag, Stuttgart/New York, 1999, pages 5096 to 5100 [0148]

Claims (66)

Composition, in particular pharmaceutical composition, for use in the prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity, wherein the composition contains octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, as antiviral active ingredient. Composition for use according to Claim 1 , wherein the composition contains the octenidine and/or its salts and/or esters in the form of a hydrochloride salt, preferably octenidine dihydrochloride; and/or wherein the octenidine and/or its salts and/or esters is an octenidine hydrochloride salt, preferably octenidine dihydrochloride; and/or wherein the composition contains octenidine dihydrochloride as an antiviral active ingredient. Composition for use according to Claim 1 or 2 , wherein the composition contains the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, in pharmaceutically and/or therapeutically effective, in particular in pharmaceutically and/or therapeutically antivirally effective amounts. Composition for use according to one of the preceding claims, wherein the composition contains the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, in a (relative) amount in the range of 0.001 wt.% to 10 wt.%, in particular in the range of 0.005 wt.% to 7.5 wt.%, preferably in the range of 0.01 wt.% to 5 wt.%, preferably in the range of 0.02 wt.% to 4 wt.%, particularly preferably in the range of 0.03 wt.% to 2 wt.%, more preferably in the range of 0.05 wt.% to 1 wt.%, based on the composition. A composition for use according to any one of the preceding claims, wherein the composition contains at least one local anesthetic. Composition for use according to Claim 5 , wherein the local anesthetic is a local anesthetic based on an organic acid ester or acid amide, preferably acid amide, in particular wherein the local anesthetic is selected from the group of local anesthetics of the ester type and local anesthetics of the amide type and combinations and mixtures thereof, preferably local anesthetics of the amide type. Composition for use according to Claim 5 or 6 , wherein the local anesthetic is selected from the group of benzocaine, procaine, tetracaine, lidocaine, etidocaine, prilocaine, mepivacaine, bupivacaine and S-ropivacin and their salts and esters as well as their combinations and mixtures, in particular lidocaine and its salts and esters, preferably lidocaine hydrochloride. Composition for use according to any of the Claims 5 until 7 , wherein the local anesthetic is selected from the group of lidocaine (2-diethylamino-N-(2,6-dimethylphenyl)acetamide) and its salts and esters, preferably lidocaine hydrochloride. Composition for use according to one of the preceding claims, wherein the composition contains, in particular as a local anesthetic, lidocaine (2-diethylamino-N-(2,6-dimethylphenyl)acetamide) and/or its salts and/or esters, preferably lidocaine hydrochloride. Composition for use according to any of the Claims 5 until 9 , wherein the composition contains the local anesthetic, in particular lidocaine and/or its salts and/or esters, preferably lidocaine hydrochloride, in pharmaceutically and/or therapeutically effective, in particular in pharmaceutically and/or therapeutically local anesthetically effective amounts. Composition for use according to any of the Claims 5 until 10 , wherein the composition contains the local anesthetic, in particular lidocaine and/or its salts and/or esters, preferably lidocaine hydrochloride, in a (relative) amount in the range of 0.01 wt.% to 5 wt.%, in particular in the range of 0.05 wt.% to 4 wt.%, preferably in the range of 0.1 wt.% to 2.5 wt.%, preferably in the range of 0.2 wt.% to 0.6 wt.%, based on the composition. Composition for use according to one of the preceding claims, wherein the composition contains at least one anti-inflammatory agent, in particular benzydamine and/or its salts and/or esters, preferably benzydamine hydrochloride. Composition for use according to Claim 12 , wherein the composition contains the anti-inflammatory agent, in particular benzydamine and/or its salts and/or esters, preferably benzydamine hydrochloride, in pharmaceutically and/or therapeutically effective, in particular in pharmaceutically and/or therapeutically anti-inflammatory effective amounts. Composition for use according to Claim 12 or 13 , wherein the composition contains the anti-inflammatory agent, in particular benzydamine and/or its salts and/or esters, preferably benzydamine hydrochloride, in a (relative) amount in the range of 0.001 wt.% to 10 wt.%, in particular in the range of 0.005 wt.% to 7.5 wt.%, preferably in the range of 0.01 wt.% to 5 wt.%, preferably in the range of 0.02 wt.% to 4 wt.%, particularly preferably in the range of 0.03 wt.% to 2 wt.%, further preferably in the range of 0.05 wt.% to 1 wt.%, based on the composition. Composition for use according to one of the preceding claims, wherein the composition contains at least one non-steroidal anti-inflammatory drug (NSAID active ingredient), in particular wherein the non-steroidal anti-inflammatory drug (NSAID active ingredient) is selected from the group of flurbiprofen, ibuprofen, dexibuprofen, naproxen, ketoprofen, dexketoprofen, tiaprofenic acid, diclofenac and acetylsalicylic acid and their salts and esters and their combinations and mixtures, in particular flurbiprofen and its salts and esters, preferably flurbiprofen; and/or wherein the composition contains flurbiprofen and/or its salts and/or esters, preferably flurbiprofen. Composition for use according to Claim 15 , wherein the composition contains the non-steroidal anti-inflammatory drug (NSAID active ingredient), in particular flurbiprofen and/or its salts and/or esters, preferably flurbiprofen, in pharmaceutically and/or therapeutically effective, in particular in pharmaceutically and/or therapeutically non-steroidal anti-inflammatory effective amounts. Composition for use according to Claim 15 or 16 , wherein the composition contains the non-steroidal anti-inflammatory drug (NSAID active ingredient), in particular flurbiprofen and/or its salts and/or esters, preferably flurbiprofen, in a (relative) amount in the range of 0.001 wt.% to 10 wt.%, in particular in the range of 0.005 wt.% to 7.5 wt.%, preferably in the range of 0.01 wt.% to 5 wt.%, preferably in the range of 0.02 wt.% to 4 wt.%, particularly preferably in the range of 0.03 wt.% to 2 wt.%, further preferably in the range of 0.05 wt.% to 1 wt.%, based on the composition. Composition for use according to one of the preceding claims, wherein the composition contains at least one acidifying agent, in particular in the form of an organic acid and/or its salts and/or esters, preferably tartaric acid and/or citric acid, preferably tartaric acid; in particular in a (relative) amount in the range from 0.01% by weight to 10% by weight, in particular in the range from 0.1% by weight to 5% by weight, preferably in the range from 0.2% by weight to 1% by weight, based on the composition. Composition for use according to one of the preceding claims, wherein the composition contains at least one anise oil, in particular star anise oil; in particular in a (relative) amount in the range of 0.005% to 5% by weight, in particular in the range of 0.05% to 2% by weight, preferably in the range of 0.1% to 0.75% by weight, based on the composition. Composition for use according to one of the preceding claims, wherein the composition contains at least one essential oil, in particular peppermint oil; in particular in a (relative) amount in the range of 0.001 wt.% to 1 wt.%, in particular in Range from 0.005 wt% to 0.5 wt%, preferably in the range from 0.01 wt% to 0.1 wt%, based on the composition. Composition for use according to one of the preceding claims, wherein the composition contains at least one coffee extract and/or tea extract, in particular coffee extract; in particular in a (relative) amount in the range of 0.001% by weight to 10% by weight, in particular in the range of 0.01% by weight to 5% by weight, preferably in the range of 0.1% by weight to 1% by weight, based on the composition. Composition for use according to any one of the preceding claims, wherein the composition contains polypropylene glycol; in particular in a (relative) amount in the range of 0.001 wt.% to 5 wt.%, in particular in the range of 0.01 wt.% to 1 wt.%, preferably in the range of 0.1 wt.% to 0.5 wt.%, based on the composition. Composition for use according to one of the preceding claims, wherein the composition contains at least one mucilaginous drug and/or its extract; in particular in a (relative) amount in the range of 0.01% to 20% by weight, in particular in the range of 0.1% to 15% by weight, preferably in the range of 1% to 10% by weight, based on the composition; and/or in particular wherein the mucilaginous drug or its extract is selected from the group of Iceland moss (Lichen islandicus), marshmallow (Althaea officinalis L.), ribwort plantain (Plantago lanceolata L.), mallow (Malva sylvestris L. and M. neglecta WALLR. and others), fenugreek (Trigonella foenum-graecum L.), salep and quince (Cydonia oblonga MILL.) and combinations and mixtures thereof, preferably Iceland moss (Lichen islandicus) and/or marshmallow (Althaea officinalis L.); and/or in particular wherein the mucilaginous drug is used and/or is present in the form of the drug, in particular in the form of crushed or powdered plant parts or plant components; and/or in particular wherein the mucilaginous drug is used and/or is present in the form of an extract, in particular in the form of a dry extract. Composition for use according to one of the preceding claims, wherein the composition contains at least one excipient (carrier), preferably a pharmacologically and/or physiologically acceptable excipient (carrier); and/or wherein the composition contains the active ingredients and/or ingredients together with at least one excipient (carrier), preferably a pharmacologically and/or physiologically acceptable excipient (carrier). Composition for use according to one of the preceding claims, wherein the composition contains at least one further active ingredient and/or ingredient, in particular pharmaceutical additive and/or excipient, in particular selected from the group of processing aids, stabilizers, emulsifiers, antioxidants, preservatives, humectants, sweeteners and sweeteners, pH adjusters, pH buffer substances, thickeners, flavorings, antiseptics, colorants, buffers, fragrances, scents, extenders, binders, wetting agents and/or preservatives and combinations and mixtures thereof; in particular in a (relative) amount in the range from 0.01% by weight to 15% by weight, in particular in the range from 0.1% by weight to 10% by weight, preferably in the range from 0.5% by weight to 5% by weight, based on the composition. Composition for use according to any of the Claims 1 until 25 , wherein the composition contains at least substantially no phenoxyethanol (2-phenoxyethanol); and/or wherein the composition is at least substantially free of phenoxyethanol (2-phenoxyethanol); and/or wherein the composition is in the absence of phenoxyethanol (2-phenoxyethanol). Composition for use according to any of the Claims 1 until 25 , wherein the composition contains phenoxyethanol (2-phenoxyethanol), in particular in a (relative) amount in the range of 0.1 wt.% to 10 wt.%, in particular in the range of 0.5 wt.% to 5 wt.%, preferably in the range of 0.75 wt.% to 3 wt.%, based on the composition. Composition for use according to one of the preceding claims, wherein the composition contains at least substantially no n-propanol (propan-1-ol) and/or at least substantially no isopropanol, in particular at least substantially no primary alcohol; and/or wherein the composition is at least substantially free of n-propanol (propan-1-ol) and/or at least substantially free of isopropanol, in particular at least substantially free of a primary alcohol; and/or wherein the composition is present in the absence of n-propanol (propan-1-ol) and/or in the absence of isopropanol, in particular in the absence of a primary alcohol. Composition for use according to one of the preceding claims, wherein the composition contains the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, in an (absolute) amount and/or dose in the range of 0.05 mg to 15 mg, in particular in the range of 0.1 mg to 12.5 mg, preferably in the range of 0.2 mg to 10 mg, more preferably in the range of 0.3 mg to 7.5 mg, particularly preferably in the range of 0.5 mg to 5 mg, based on a dosage unit of the composition. Composition for use according to one of the preceding claims, wherein the composition contains the local anesthetic, in particular lidocaine and/or its salts and/or esters, preferably lidocaine hydrochloride, in an (absolute) amount and/or dose in the range of 0.1 mg to 50 mg, in particular in the range of 1 mg to 20 mg, preferably in the range of 3 mg to 15 mg, preferably in the range of 4 mg to 10 mg, based on a dosage unit of the composition. Composition for use according to one of the preceding claims, wherein the composition contains the anti-inflammatory agent, in particular benzydamine and/or its salts and/or esters, preferably benzydamine hydrochloride, in an (absolute) amount and/or dose in the range of 0.1 mg to 50 mg, in particular in the range of 0.5 mg to 20 mg, preferably in the range of 1 mg to 15 mg, preferably in the range of 2 mg to 10 mg, based on a dosage unit of the composition. Composition for use according to one of the preceding claims, wherein the composition contains the non-steroidal anti-inflammatory drug (NSAID active ingredient), in particular flurbiprofen and/or its salts and/or esters, preferably flurbiprofen, in an (absolute) amount and/or dose in the range of 0.1 mg to 50 mg, in particular in the range of 0.5 mg to 20 mg, preferably in the range of 1 mg to 15 mg, preferably in the range of 2 mg to 10 mg, based on a dosage unit of the composition. Composition for use according to one of the preceding claims, wherein the composition contains the acidifying agent, in particular in the form of an organic acid and/or its salts and/or esters, preferably tartaric acid and/or citric acid, preferably tartaric acid, in an (absolute) amount and/or dose in the range from 0.5 mg to 100 mg, in particular in the range from 1 mg to 50 mg, preferably in the range from 2 mg to 20 mg, based on a dosage unit of the composition; and/or wherein the composition contains the anise oil, in particular star anise oil, in an (absolute) amount and/or dose in the range from 0.2 mg to 80 mg, in particular in the range from 0.5 mg to 40 mg, preferably in the range from 0.75 mg to 15 mg, based on a dosage unit of the composition; and/or wherein the composition contains the essential oil, in particular peppermint oil, in an (absolute) amount and/or dose in the range from 0.01 mg to 5 mg, in particular in the range from 0.05 mg to 3 mg, preferably in the range from 0.1 mg to 1 mg, based on a dosage unit of the composition; and/or wherein the composition contains the coffee extract and/or tea extract, in particular coffee extract, in an (absolute) amount and/or dose in the range from 0.05 mg to 100 mg, in particular in the range from 0.5 mg to 50 mg, preferably in the range from 1 mg to 20 mg, based on a dosage unit of the composition; and/or wherein the composition contains the propylene glycol in an (absolute) amount and/or dose in the range of 0.05 mg to 50 mg, in particular in the range of 0.5 mg to 20 mg, preferably in the range of 1 mg to 10 mg, based on a dosage unit of the composition; and/or wherein the composition contains the mucilaginous drug and/or its extract in an (absolute) amount and/or dose in the range of 0.5 mg to 200 mg, in particular in the range of 1 mg to 100 mg, preferably in the range of 5 mg to 50 mg, based on a dosage unit of the composition. Composition for use according to any of the Claims 29 until 33 , wherein the (absolute) amount and/or dose is the (single) amount and/or (single) dose administered with a single application (single application) of the composition and/or the (single) amount and/or (single) dose administered with a single application (single application) of a prepared dosage form of the composition; and/or wherein the dosage unit is a single application (single application) of the composition and/or a single application (single application) of a prepared dosage form of the composition. Composition for use according to any one of the preceding claims, wherein the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, is administered at a daily dose in the range of 0.15 mg/diem to 120 mg/diem, in particular in the range of 0.15 mg/diem to 120 mg/diem, preferably in the range of 0.3 mg/diem to 100 mg/diem, preferably in the range of 1.5 mg/diem to 60 mg/diem, particularly preferably in the range of 2.25 mg/diem to 120 mg/diem, further preferably in the range of 2.5 mg/diem to 40 mg/diem; and/or wherein the composition is prepared for the administration of octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, in a daily dose in the range of 0.15 mg/diem to 120 mg/diem, in particular in the range of 0.15 mg/diem to 120 mg/diem, preferably in the range of 0.3 mg/diem to 100 mg/diem, preferably in the range of 1.5 mg/diem to 60 mg/diem, particularly preferably in the range of 2.25 mg/diem to 120 mg/diem, more preferably in the range of 2.5 mg/diem to 40 mg/diem. Composition for use according to one of the preceding claims, wherein the composition is present and/or designed as a solid dosage form or as a liquid dosage form, in particular as a solid dosage form; in particular wherein the composition is present and/or designed as a solid dosage form in the form of a tablet, a dragee, a pill, a lozenge or the like, in particular in the form of a lozenge, preferably hard caramel, and/or in particular wherein the composition is present and/or designed as a tablet, dragee, pill, lozenge or the like, in particular a lozenge, preferably hard caramel; or in particular, wherein the composition is present and/or designed as a liquid dosage form in the form of a fluid, a mouthwash, a mouth rinse, a juice, a gargle solution, a spray, in particular a mouth and/or throat spray or nasal spray, or the like and/or in particular, wherein the composition is present and/or designed as a fluid, mouthwash, mouth rinse, juice, gargle solution, spray, in particular a mouth and/or throat spray or nasal spray, or the like. Composition for use according to one of the preceding claims, wherein the composition is present and/or designed as a solid dosage form; and/or wherein the composition is present and/or designed as a solid dosage form in the form of a tablet, a dragee, a pill, a lozenge or the like, in particular in the form of a lozenge, preferably hard caramel, and/or wherein the composition is present and/or designed as a tablet, dragee, pill, lozenge or the like, in particular a lozenge, preferably hard caramel; and/or wherein the solid dosage form, in particular the tablet, the dragee, the pill or the lozenge, in particular a lozenge, preferably hard caramel, has a total weight in the range from 0.5 g to 7 g, in particular in the range from 1 g to 6 g, preferably in the range from 2 g to 5 g. Composition for use according to one of the preceding claims, wherein the composition, in particular the solid dosage form, is a lozenge, in particular in the form of a hard caramel; and/or wherein the composition, in particular the solid dosage form, is based on a lozenge and/or is present and/or designed as a lozenge, in particular hard caramel), in particular such that the composition, in particular the solid dosage form, releases a therapeutically effective amount of active ingredients and/or ingredients, in particular octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, when sucked, when the composition, in particular the solid dosage form, is administered and sucked in the mouth and throat of a patient. Composition for use according to one of the preceding claims, wherein the composition, in particular the solid dosage form, contains at least one sugar and/or at least one sugar substitute, in particular as an excipient (carrier), preferably a pharmacologically and/or physiologically acceptable excipient (carrier); and/or in particular wherein the sugar is selected from the group of sucrose, glucose, in particular dextrose, and fructose; and/or in particular wherein the sugar substitute is selected from sugar alcohols, preferably from the group of mannitol, xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructooligosaccharides, glucans, polyglucose and combinations and mixtures thereof, particularly preferably isomalt and/or mannitol, very particularly preferably isomalt. Composition for use according to one of the preceding claims, wherein the composition, in particular the solid dosage form, contains the active ingredients and/or ingredients in a solid matrix and/or mass, in particular in a matrix and/or mass based on sugars and/or sugar substitutes, in particular as in Claim 39 defined; and/or wherein the composition, in particular the solid dosage form, comprises the sugar and/or the sugar substitute in a (relative) amount in the range from 50% by weight to 99.95% by weight, in particular in the range from 70% by weight to 99.5% by weight, preferably in the range from 80% by weight to 99.25% by weight, preferably in the range from 90% by weight to 99% by weight, based on the composition, in particular the solid dosage form. Composition for use according to one of the preceding claims, wherein the composition, in particular the solid dosage form, has a residual moisture (residual moisture content) of at most 10% by weight, in particular at most 5% by weight, preferably at most 3% by weight, based on the composition, in particular the solid dosage form; and/or wherein the composition, in particular the solid dosage form, has a residual moisture (residual moisture content) in the range from 0.1% by weight to 10% by weight, in particular in the range from 0.5% by weight to 5% by weight, preferably in the range from 1% by weight to 3% by weight, based on the composition, in particular the solid dosage form. Composition, in particular pharmaceutical composition, for use in the prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity, in particular composition for use according to one of the preceding claims, wherein the composition contains octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, as the antiviral active ingredient, wherein the pharmaceutical composition is present and/or designed as a solid dosage form in the form of a lozenge, in particular based on hard caramel and/or as hard caramel, the lozenge having a total weight in the range of 0.5 g to 7 g, in particular in the range from 1 g to 6 g, preferably in the range from 2 g to 5 g, containing per lozenge: - Octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, in an (absolute) amount and/or dose in the range from 0.05 mg to 15 mg, in particular in the range from 0.1 mg to 12.5 mg, preferably in the range from 0.5 mg to 10 mg, preferably in the range from 0.75 mg to 7.5 mg, particularly preferably in the range from 1 mg to 5 mg; - optionally at least one further active ingredient and/or ingredient, in particular pharmaceutical additive and/or excipient, in particular selected from the group of processing aids, stabilizers, emulsifiers, antioxidants, preservatives, humectants, sweeteners and sweeteners, pH adjusters, pH buffer substances, thickeners, flavorings, antiseptics, colorants, buffers, fragrances, scents, extenders, binders, wetting agents and/or preservatives and combinations and mixtures thereof, in amounts in the range from 0.1 mg to 500 mg, in particular in the range from 0.5 mg to 250 mg, preferably in the range from 1 mg to 100 mg; - at least one sugar and/or at least one sugar substitute, in particular as an excipient (carrier), preferably a pharmacologically and/or physiologically acceptable excipient (carrier); in particular wherein the sugar is selected from the group of sucrose, glucose, in particular dextrose, and fructose and/or in particular wherein the sugar substitute is selected from sugar alcohols, preferably from the group of mannitol, xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructooligosaccharides, glucans, polyglucose and combinations and mixtures thereof, particularly preferably isomalt and/or mannitol, very particularly preferably isomalt; and/or in particular in amounts to provide and/or maintain the total weight of the lozenge. Composition, in particular pharmaceutical composition, for use in the prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity, in particular composition for use according to one of the preceding claims, wherein the composition contains octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, as the antiviral active ingredient, wherein the pharmaceutical composition is present and/or designed as a solid dosage form in the form of a lozenge, in particular based on hard caramel and/or as hard caramel, wherein the lozenge has a total weight in the range of 0.5 g to 7 g, in particular in the range of 1 g to 6 g, preferably in the range of 2 g to 5 g, containing per lozenge: - octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, in an (absolute) amount and/or dose in the range of 0.05 mg to 15 mg, in particular in the range of 0.1 mg to 12.5 mg, preferably in the range of 0.5 mg to 10 mg, preferably in the range of 0.75 mg to 7.5 mg, particularly preferably in the range of 1 mg to 5 mg; - at least one local anesthetic, in particular lidocaine, preferably lidocaine hydrochloride, in an (absolute) amount and/or dose in the range of 0.1 mg to 50 mg, in particular in the range of 1 mg to 20 mg, preferably in the range of 3 mg to 15 mg, preferably in the range of 4 mg to 10 mg; - optionally at least one further active ingredient and/or ingredient, in particular pharmaceutical additive and/or excipient, in particular selected from the group of processing aids, stabilizers, emulsifiers, antioxidants, preservatives, humectants, sweeteners and sweeteners, pH adjusters, pH buffer substances, thickeners, flavorings, antiseptics, colorants, buffers, fragrances, scents, extenders, binders, wetting agents and/or preservatives and combinations and mixtures thereof, in amounts in the range from 0.1 mg to 500 mg, in particular in the range from 0.5 mg to 250 mg, preferably in the range from 1 mg to 100 mg; - at least one sugar and/or at least one sugar substitute, in particular as an excipient (carrier), preferably a pharmacologically and/or physiologically acceptable excipient (carrier); in particular wherein the sugar is selected from the group of sucrose, glucose, in particular dextrose, and fructose and/or in particular wherein the sugar substitute is selected from sugar alcohols, preferably from the group of mannitol, xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructooligosaccharides, glucans, polyglucose and combinations and mixtures thereof, particularly preferably isomalt and/or mannitol, very particularly preferably isomalt; and/or in particular in amounts to provide and/or maintain the total weight of the lozenge. Composition, in particular pharmaceutical composition, for use in the prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity, in particular composition for use according to one of the preceding claims, wherein the composition is present and/or designed as a solid dosage form in the form of a lozenge, in particular based on hard caramel and/or as hard caramel, wherein the lozenge has a total weight in the range of 0.5 g to 7 g, in particular in the range of 1 g to 6 g, preferably in the range of 2 g to 5 g, containing per lozenge: - octenidine and/or its Salts and/or esters, preferably octenidine dihydrochloride, in an (absolute) amount and/or dose in the range from 0.05 mg to 15 mg, in particular in the range from 0.1 mg to 12.5 mg, preferably in the range from 0.5 mg to 10 mg, preferably in the range from 0.75 mg to 7.5 mg, particularly preferably in the range from 1 mg to 5 mg; - optionally at least one local anesthetic, in particular lidocaine, preferably lidocaine hydrochloride, in an (absolute) amount and/or dose in the range from 0.1 mg to 50 mg, in particular in the range from 1 mg to 20 mg, preferably in the range from 3 mg to 15 mg, preferably in the range from 4 mg to 10 mg; - optionally at least one further active ingredient and/or ingredient, in particular pharmaceutical additive and/or excipient, in particular selected from the group of processing aids, stabilizers, emulsifiers, antioxidants, preservatives, humectants, sweeteners and sweetening agents, pH adjusters, pH buffer substances, thickeners, flavorings, antiseptics, colorants, buffers, fragrances, scents, extenders, binding agents, wetting agents and/or preservatives and combinations thereof and Mixtures, in amounts in the range from 0.1 mg to 500 mg, in particular in the range from 0.5 mg to 250 mg, preferably in the range from 1 mg to 100 mg; - at least one sugar and/or at least one sugar substitute, in particular as an excipient (carrier), preferably a pharmacologically and/or physiologically acceptable excipient (carrier); in particular wherein the sugar is selected from the group of sucrose, glucose, in particular dextrose, and fructose; and/or in particular wherein the sugar substitute is selected from sugar alcohols, preferably from the group of mannitol, xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructooligosaccharides, glucans, polyglucose and combinations and mixtures thereof, particularly preferably isomalt and/or mannitol, very particularly preferably isomalt; and/or in particular in amounts to provide and/or maintain the total weight of the lozenge, wherein the composition or lozenge contains at least substantially no phenoxyethanol (2-phenoxyethanol) and/or wherein the lozenge is at least substantially free of phenoxyethanol (2-phenoxyethanol) and/or wherein the composition or lozenge is present in the absence of phenoxyethanol (2-phenoxyethanol). Composition, in particular pharmaceutical composition, for use in the prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity, in particular composition for use according to one of the preceding claims, wherein the composition is present and/or designed as a solid dosage form in the form of a lozenge, in particular based on hard caramel and/or as hard caramel, wherein the lozenge has a total weight in the range of 0.5 g to 7 g, in particular in the range of 1 g to 6 g, preferably in the range of 2 g to 5 g, containing per lozenge: - octenidine and/or its Salts and/or esters, preferably octenidine dihydrochloride, in an (absolute) amount and/or dose in the range from 0.05 mg to 15 mg, in particular in the range from 0.1 mg to 12.5 mg, preferably in the range from 0.5 mg to 10 mg, preferably in the range from 0.75 mg to 7.5 mg, particularly preferably in the range from 1 mg to 5 mg; - optionally at least one local anesthetic, in particular lidocaine, preferably lidocaine hydrochloride, in an (absolute) amount and/or dose in the range from 0.1 mg to 50 mg, in particular in the range from 1 mg to 20 mg, preferably in the range from 3 mg to 15 mg, preferably in the range from 4 mg to 10 mg; - optionally at least one acidifier, in particular in the form of an organic acid or its salts or esters, preferably tartaric acid and/or citric acid, preferably tartaric acid, in an (absolute) amount and/or dose in the range from 0.5 mg to 100 mg, in particular in the range from 1 mg to 50 mg, preferably in the range from 2 mg to 20 mg; - optionally at least one anise oil, in particular star anise oil, in an (absolute) amount and/or dose in the range from 0.2 mg to 80 mg, in particular in the range from 0.5 mg to 40 mg, preferably in the range from 0.75 mg to 15 mg; - optionally at least one essential oil, in particular peppermint oil, in an (absolute) amount and/or dose in the range from 0.01 mg to 5 mg, in particular in the range from 0.05 mg to 3 mg, preferably in the range from 0.1 mg to 1 mg; - optionally at least one coffee extract and/or tea extract, in particular coffee extract, in an (absolute) amount and/or dose in the range from 0.05 mg to 100 mg, in particular in the range from 0.5 mg to 50 mg, preferably in the range from 1 mg to 20 mg; - optionally propylene glycol in an (absolute) amount and/or dose in the range from 0.05 mg to 50 mg, in particular in the range from 0.5 mg to 20 mg, preferably in the range from 1 mg to 10 mg; - optionally at least one mucilaginous drug and/or its extract in an (absolute) amount and/or dose in the range from 0.5 mg to 200 mg, in particular in the range from 1 mg to 100 mg, preferably in the range from 5 mg to 50 mg; - optionally at least one further active ingredient and/or ingredient, in particular pharmaceutical additive and/or excipient, in particular selected from the group of processing aids, stabilizers, emulsifiers, antioxidants, preservatives, humectants, sweeteners and sweeteners, pH adjusters, pH buffer substances, thickeners, flavorings, antiseptics, colorants, buffers, fragrances, scents, extenders, binders, wetting agents and/or preservatives and combinations and mixtures thereof, in an (absolute) amount and/or dose in the range from 0.1 mg to 500 mg, in particular in the range from 0.5 mg to 250 mg, preferably in the range from 1 mg to 100 mg; - at least one sugar and/or at least one sugar substitute, in particular as an excipient (Carrier), preferably pharmacologically and/or physiologically acceptable excipient (carrier); in particular wherein the sugar is selected from the group of sucrose, glucose, in particular dextrose, and fructose and/or in particular wherein the sugar substitute is selected from sugar alcohols, preferably from the group of mannitol, xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructooligosaccharides, glucans, polyglucose and combinations and mixtures thereof, particularly preferably isomalt and/or mannitol and combinations and mixtures thereof, very particularly preferably isomalt; and/or in particular in amounts to provide and/or maintain the total weight of the lozenge, in particular wherein the composition or lozenge contains at least substantially no phenoxyethanol (2-phenoxyethanol) and/or in particular wherein the lozenge is at least substantially free of phenoxyethanol (2-phenoxyethanol) and/or in particular wherein the composition or lozenge is present in the absence of phenoxyethanol (2-phenoxyethanol). Composition, in particular pharmaceutical composition, for use in the prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity, in particular composition for use according to one of the preceding claims, wherein the composition is present and/or designed as a solid dosage form in the form of a lozenge, in particular based on hard caramel and/or as hard caramel, wherein the lozenge has a total weight in the range of 0.5 g to 7 g, in particular in the range of 1 g to 6 g, preferably in the range of 2 g to 5 g, containing per lozenge: - octenidine and/or its Salts and/or esters, preferably octenidine dihydrochloride, in an (absolute) amount and/or dose in the range from 0.05 mg to 15 mg, in particular in the range from 0.1 mg to 12.5 mg, preferably in the range from 0.5 mg to 10 mg, preferably in the range from 0.75 mg to 7.5 mg, particularly preferably in the range from 1 mg to 5 mg; - optionally at least one local anesthetic, in particular lidocaine, preferably lidocaine hydrochloride, in an (absolute) amount and/or dose in the range from 0.1 mg to 50 mg, in particular in the range from 1 mg to 20 mg, preferably in the range from 3 mg to 15 mg, preferably in the range from 4 mg to 10 mg; - optionally at least one anti-inflammatory drug, in particular benzydamine and/or its salts and/or esters, preferably benzydamine hydrochloride, in an (absolute) amount and/or dose in the range from 0.1 mg to 50 mg, in particular in the range from 0.5 mg to 20 mg, preferably in the range from 1 mg to 15 mg, preferably in the range from 2 mg to 10 mg, - optionally at least one non-steroidal anti-inflammatory drug (NSAID active ingredient), in particular flurbiprofen and/or its salts and/or esters, preferably flurbiprofen, in an (absolute) amount and/or dose in the range from 0.1 mg to 50 mg, in particular in the range from 0.5 mg to 20 mg, preferably in the range from 1 mg to 15 mg, preferably in the range from 2 mg to 10 mg; - optionally at least one acidifier, in particular in the form of an organic acid or its salts or esters, preferably tartaric acid and/or citric acid, preferably tartaric acid, in an (absolute) amount and/or dose in the range from 0.5 mg to 100 mg, in particular in the range from 1 mg to 50 mg, preferably in the range from 2 mg to 20 mg; - optionally at least one anise oil, in particular star anise oil, in an (absolute) amount and/or dose in the range from 0.2 mg to 80 mg, in particular in the range from 0.5 mg to 40 mg, preferably in the range from 0.75 mg to 15 mg; - optionally at least one essential oil, in particular peppermint oil, in an (absolute) amount and/or dose in the range from 0.01 mg to 5 mg, in particular in the range from 0.05 mg to 3 mg, preferably in the range from 0.1 mg to 1 mg; - optionally at least one coffee extract and/or tea extract, in particular coffee extract, in an (absolute) amount and/or dose in the range from 0.05 mg to 100 mg, in particular in the range from 0.5 mg to 50 mg, preferably in the range from 1 mg to 20 mg; - optionally propylene glycol in an (absolute) amount and/or dose in the range from 0.05 mg to 50 mg, in particular in the range from 0.5 mg to 20 mg, preferably in the range from 1 mg to 10 mg; - optionally at least one mucilaginous drug and/or its extract in an (absolute) amount and/or dose in the range from 0.5 mg to 200 mg, in particular in the range from 1 mg to 100 mg, preferably in the range from 5 mg to 50 mg; - optionally at least one further active ingredient and/or ingredient, in particular pharmaceutical additive and/or excipient, in particular selected from the group of processing aids, stabilizers sifiers, emulsifiers, antioxidants, preservatives, humectants, sweeteners and sweetening agents, pH adjusters, pH buffer substances, thickeners, flavourings, antiseptics, colourings, buffers, fragrances, scents, extenders, binders, wetting agents and/or preservatives and combinations and mixtures thereof, in an (absolute) amount and/or dose in the range from 0.1 mg to 500 mg, in particular in the range from 0.5 mg to 250 mg, preferably in the range from 1 mg to 100 mg; - at least one sugar and/or at least one sugar substitute, in particular as an excipient (carrier), preferably a pharmacologically and/or physiologically acceptable excipient (carrier); in particular wherein the sugar is selected from the group of sucrose, glucose, in particular dextrose, and fructose and/or in particular wherein the sugar substitute is selected from sugar alcohols, preferably from the group of mannitol, xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructooligosaccharides, glucans, polyglucose and combinations and mixtures thereof, particularly preferably isomalt and/or mannitol and combinations and mixtures thereof, very particularly preferably isomalt; and/or in particular in amounts to provide and/or maintain the total weight of the lozenge, in particular wherein the composition or lozenge contains at least substantially no phenoxyethanol (2-phenoxyethanol) and/or in particular wherein the lozenge is at least substantially free of phenoxyethanol (2-phenoxyethanol) and/or in particular wherein the composition or lozenge is present in the absence of phenoxyethanol (2-phenoxyethanol). Composition for use according to any of the Claims 1 until 36 , wherein the composition is present and/or designed as a liquid dosage form; and/or wherein the composition is present and/or designed as a liquid dosage form in the form of a fluid, a mouthwash, a mouth rinse, a juice, a gargle solution, a spray, in particular a mouth and/or throat spray or nasal spray, or the like, and/or in particular wherein the composition is present and/or designed as a fluid, mouthwash, mouth rinse, juice, gargle solution, spray, in particular a mouth and/or throat spray or nasal spray, or the like. Composition for use according to Claim 47 , wherein the composition, in particular the liquid dosage form, is aqueous, alcoholic or aqueous-alcoholic based; and/or wherein the composition, in particular the liquid dosage form, contains the active ingredients and/or ingredients together with at least one excipient (carrier), preferably pharmacologically and/or physiologically acceptable excipient (carrier), in particular wherein the excipient (carrier) is selected from the group of solvents, solubilizers, emulsifiers and the like, in particular wherein the carrier is selected from the group of water, ethanol, isopropanol, ethyl carbonate, ethyl acetate, benzyl alcohol, benzyl benzoate, propylene glycol, 1,3-butyl glycol and combinations and mixtures thereof; and/or wherein the composition, in particular the liquid dosage form, comprises at least one sugar and/or sugar substitute, in particular wherein the at least one sugar is selected from the group of sucrose, glucose, in particular dextrose, and fructose and/or in particular wherein the at least one sugar substitute is selected from sugar alcohols, preferably from the group of mannitol, xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructooligosaccharides, glucans, polyglucose, particularly preferably maltitol syrup; and/or wherein the composition, in particular the liquid dosage form, contains water, in particular in an amount of at least 10 wt.%, in particular at least 20 wt.%, preferably at least 30 wt.%, based on the composition, in particular the liquid dosage form, and/or in particular in an amount in the range of 10 wt.% to 98 wt.%, in particular in the range of 20 wt.% to 95 wt.%, preferably in the range of 30 wt.% to 90 wt.%, based on the composition, in particular the liquid dosage form. Composition for use according to one of the preceding claims, wherein the composition and/or the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, is used as a co-therapeutic agent and/or as a co-medication in the context of a basic COVID-19 therapy and/or wherein the composition and/or the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, is used as a combination therapeutic agent for a basic COVID-19 therapy and/or existing COVID-19 therapy. Composition for use according to any one of the preceding claims, wherein the composition and/or the octenidine and/or its salts and/or esters, preferably Octenidine dihydrochloride, is used for exposure prophylaxis, in particular post-exposure prophylaxis and/or pre-exposure prophylaxis, against viruses, in particular against corona viruses, preferably SARS-CoV-2; and/or wherein the composition and/or the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, is used for infection prophylaxis against viruses, in particular against corona viruses, preferably SARS-CoV-2; and/or wherein the composition and/or the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, is used to reduce the viral load, in particular the viral load of corona viruses, preferably SARS-CoV-2, preferably to reduce the viral load in the mouth, throat and/or nasal cavity; and/or wherein the composition and/or the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, is used in the presymptomatic stage and/or postsymptomatic stage, in particular in the presymptomatic stage, of (viral) diseases caused in particular by viruses, in particular corona viruses, preferably SARS-CoV-2, preferably COVID-19; and/or wherein the composition and/or the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, is used in asymptomatic courses of (viral) diseases caused by viruses, in particular corona viruses, preferably SARS-CoV-2, preferably COVID-19; and/or wherein the composition and/or the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, is used in symptomatic courses of (viral) diseases caused by viruses, in particular corona viruses, preferably SARS-CoV-2, preferably COVID-19. Composition for use according to one of the preceding claims, wherein the composition, in particular the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, inactivates and/or kills the viruses, in particular the corona viruses, preferably SARS-CoV-2; and/or wherein the composition, in particular the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, inhibits and/or reduces and/or prevents the proliferation and/or replication of the viruses, in particular the corona viruses, preferably SARS-CoV-2. Use of a composition, in particular pharmaceutical composition, for producing a medicament or drug for prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity, wherein the composition contains octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, as antiviral active ingredient. Use of a composition, in particular pharmaceutical composition, for the prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity, wherein the composition contains octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, as antiviral active ingredient. Use according to Claim 52 or 53 , each characterized by one or more of the features of the Claims 1 until 51 . Octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, for use in the prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity. Use of octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, for producing a medicament and/or drug for prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity. Use of octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, for the prophylactic and/or therapeutic topical (local) treatment, in particular prophylactic and/or therapeutic antiviral topical treatment, of viral diseases, in particular of (viral) diseases caused by corona viruses, preferably SARS-CoV-2, preferably COVID-19, in particular for topical application in the mouth, throat and/or nasal cavity and/or for topical application to the mucous membranes of the mouth, throat and/or nasal cavity. Octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, for use in Claim 55 and/or use of octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, according to Claim 56 or 57 , wherein the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, in a composition according to one of the Claims 1 until 51 is used and/or administered. Octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, for use in Claim 55 and/or use of octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, according to Claim 56 or 57 or after Claim 58 , wherein the octenidine and/or its salts and/or esters are present and/or used in the form of a hydrochloride salt, preferably octenidine dihydrochloride; and/or wherein the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, are present and/or used in pharmaceutically and/or therapeutically effective, in particular in pharmaceutically and/or therapeutically antivirally effective amounts. Octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, for use in Claim 55 and/or use of octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, according to Claim 56 or 57 or after Claim 58 or 59 , wherein the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, is employed and/or used together with at least one local anesthetic; in particular wherein the local anesthetic is a local anesthetic based on an organic acid ester or acid amide, preferably acid amide, and/or in particular wherein the local anesthetic is selected from the group of local anesthetics of the ester type and local anesthetics of the amide type, preferably local anesthetics of the amide type; and/or in particular wherein the local anesthetic is selected from the group of benzocaine, procaine, tetracaine, lidocaine, etidocaine, prilocaine, mepivacaine, bupivacaine and S-ropivacin and their salts and esters and their combinations and mixtures, in particular lidocaine and its pharmaceutically acceptable salts and esters, preferably lidocaine hydrochloride, and/or in particular wherein the local anesthetic is selected from the group of lidocaine (2-diethylamino-N-(2,6-dimethylphenyl)acetamide) and its salts and esters, preferably lidocaine hydrochloride and/or wherein the local anesthetic is lidocaine and/or its salts and/or esters, preferably lidocaine hydrochloride. Octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, for use in Claim 55 and/or use of octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, according to Claim 56 or 57 or according to one of the Claims 58 until 60 , wherein the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, is employed and/or used together with at least one anti-inflammatory agent, in particular benzydamine and/or its salts and/or esters, preferably benzydamine hydrochloride. Octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, for use in Claim 55 and/or use of octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, according to Claim 56 or 57 or according to one of the Claims 58 until 61 , wherein the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, together sam with at least one non-steroidal anti-inflammatory drug (NSAID active ingredient), in particular selected from the group of flurbiprofen, ibuprofen, dexibuprofen, naproxen, ketoprofen, dexketoprofen, tiaprofenic acid, diclofenac and acetylsalicylic acid and their salts and esters and their combinations and mixtures, in particular flurbiprofen and its salts and esters, preferably flurbiprofen; and/or wherein the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, is employed and/or used together with flurbiprofen and/or its salts and/or esters, preferably flurbiprofen. Octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, for use in Claim 55 and/or use of octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, according to Claim 56 or 57 or according to one of the Claims 58 until 62 , wherein the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, is employed and/or used with at least one acidifying agent, in particular in the form of an organic acid or its salts or esters, preferably tartaric acid and/or citric acid, preferably tartaric acid; and/or wherein the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, is employed and/or used with at least one anise oil, in particular star anise oil; and/or wherein the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, is employed and/or used with at least one essential oil, in particular peppermint oil; and/or wherein the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, is employed and/or used with at least one coffee extract and/or tea extract, in particular coffee extract; and/or wherein the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, are employed and/or used with propylene glycol; and/or wherein the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, are employed and/or used with at least one mucilaginous drug and/or its extract, in particular wherein the mucilaginous drug or its extract is selected from the group of Iceland moss (Lichen islandicus), marshmallow (Althaea officinalis L.), ribwort plantain (Plantago lanceolata L.), mallow (Malva sylvestris L. and M. neglecta WALLR. and others), fenugreek (Trigonella foenum-graecum L.), salep and quince (Cydonia oblonga MILL.) and combinations and mixtures thereof, preferably Iceland moss (Lichen islandicus) and/or marshmallow (Althaea officinalis L.). Octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, for use in Claim 55 and/or use of octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, according to Claim 56 or 57 or according to one of the Claims 58 until 63 , wherein the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, are not employed and/or used together with and/or in the absence of phenoxyethanol (2-phenoxyethanol); and/or wherein the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, are not employed and/or used together with and/or in the absence of n-propanol (propan-1-ol) and/or not together with isopropanol, in particular not together with a primary alcohol. Octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, for use in Claim 55 and/or use of octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, according to Claim 56 or 57 or according to one of the Claims 58 until 64 , wherein the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, is administered at a daily dose in the range of 0.15 mg/diem to 120 mg/diem, in particular in the range of 0.15 mg/diem to 120 mg/diem, preferably in the range of 0.3 mg/diem to 100 mg/diem, preferably in the range of 1.5 mg/diem to 60 mg/diem, particularly preferably in the range of 2.25 mg/diem to 120 mg/diem, further preferably in the range of 2.5 mg/diem to 40 mg/diem; and/or wherein the octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, is prepared for administration of a daily dose in the range of 0.15 mg/diem to 120 mg/diem, in particular in the range of 0.15 mg/diem to 120 mg/diem, preferably in the range of 0.3 mg/diem to 100 mg/diem, preferably in the range of 1.5 mg/diem to 60 mg/diem, particularly preferably in the range of 2.25 mg/diem to 120 mg/diem, further preferably in the range of 2.5 mg/diem to 40 mg/diem. Octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, for use in Claim 55 and/or use of octenidine and/or its salts and/or esters, preferably octenidine dihydrochloride, according to Claim 56 or 57 or according to one of the Claims 58 until 65 , each characterized by one or more of the features of the Claims 1 until 51 .

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