Composition for inflammatory diseases of the mouth and throat

Abstract

Composition, in particular pharmaceutical composition, in the form of a fixed dosage (solid dosage form) for sucking and / or chewing, preferably for sucking, in particular lozenge, preferably for use in the prophylactic and / or therapeutic topical (local) treatment of inflammatory diseases of the mouth and throat, wherein the composition contains an effective, in particular pharmaceutically and / or therapeutically effective, amount of an active ingredient preferably suitable and / or effective for the topical (local) treatment of inflammatory diseases of the mouth and throat, in particular with antiseptic and / or antimicrobial properties, preferably with antibacterial and / or antiviral and / or antifungal properties, wherein the active ingredient is incorporated and / or embedded in a solid matrix, wherein the composition, in particular the solid dosage form and / or the matrix, releases the active ingredient upon topical (local) application and / or use, preferably by sucking and / or chewing, preferably by sucking, in the oral and pharyngeal cavity; wherein the active ingredient is octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride; and wherein the composition, in particular the solid dosage form and / or the matrix, furthermore and / or additionally contains at least one further ingredient (a) and / or (b), in particular (a) and (b), wherein the at least one further ingredient (a) and / or (b) is selected from the group of (a) Flavor modulators, in particular selected from the group of the following components (i), (ii) and / or (iii): (i) Bitter (taste) masking agents, in particular selected from the group consisting of bitter taste receptor antagonists, preferably 4-(2,2,3-trimethylcyclopentyl)butanoic acid, and saponins, preferably glycyrrhizic acid (glycyrrhizin) and its salts or esters and / or glycyrrhetinic acid (glycyrrhetin) and its salts or esters, complexing agents, in particular cyclodextrins, and combinations or mixtures thereof, (ii) Bitter substances, in particular coffee extract and / or tea extract and / or their respective bitter substances, preferably coffee extract and / or its bitter substances, (iii) preferably natural or nature-identical (aroma) oils and / or essential oils, in particular with antiseptic and / or antimicrobial properties, preferably with antibacterial, antifungal and / or antiviral properties, in particular selected from the group of anise oils, in particular star anise oil, peppermint oil, eucalyptus oil, lavender oil, tea tree oil, chamomile oil, clove oil, rosemary oil, caraway oil, cinnamon oil, sage oil and fennel oil, as well as combinations or mixtures thereof; in particular wherein the ingredient (a) and / or the flavor modulator comprises a combination of at least two different components (i), (ii) and / or (iii), preferably a combination of components (i), (ii) and (iii); (b) Acidulants, in particular saliva-stimulating and / or flavor-enhancing acidulants, preferably acidulants authorized under pharmaceutical and / or food law and / or acidulants authorized as pharmaceutical additives and / or food additives, in particular selected from the group of tartaric acid and its salts, in particular sodium tartrate, sodium potassium tartrate (Rochelle salt) and calcium tartrate, citric acid and its salts, metatartaric acid, fumaric acid, ascorbic acid, phosphoric acid and its salts, stannous chloride, in particular tin(II) chloride, malic acid, lactic acid, adipic acid, succinic acid and other pharmaceutically compatible and / or physiologically acceptable organic acids and their salts, as well as their combinations or mixtures.

Description

[0001] 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 inflammatory diseases of the mouth and throat, as well as to the field of organoleptics or gustatory optimization or taste adjustment of compositions intended for oral administration, in particular pharmaceutical compositions.

[0002] The present invention relates in particular to a composition, especially a pharmaceutical composition, in the form of a fixed dosage (solid dosage form) for sucking or chewing, preferably for sucking, which is suitable or intended for use in the prophylactic or therapeutic topical (local) treatment of inflammatory diseases of the oral cavity or pharynx. According to the invention, the active ingredient used is octenidine, in particular in the form of a pharmaceutically compatible or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible or physiologically acceptable salt, most preferably octenidine dihydrochloride.

[0003] The present invention also relates to a composition, in particular a pharmaceutical composition, for use in the prophylactic or therapeutic topical (local) treatment of inflammatory diseases of the mouth or throat. The present invention also relates to the use of a composition, in particular a pharmaceutical composition, (for the manufacture of a drug or medicament) for the prophylactic or therapeutic topical (local) treatment of inflammatory diseases of the mouth and throat.

[0004] Furthermore, a method for the prophylactic or therapeutic topical (local) treatment of inflammatory diseases of the mouth or throat is also described.

[0005] The present invention also relates to the use of special ingredients (a) and / or (b), in particular ingredients (a) and (b), to improve and / or adjust the organoleptic properties, in particular the taste, preferably to reduce and / or mask the bitter taste, of a composition, in particular a pharmaceutical composition, in the form of a fixed dosage (solid dosage form) for sucking and / or chewing, in particular for sucking, as it can be used for the prophylactic or therapeutic topical (local) treatment of inflammatory diseases of the mouth and throat.

[0006] Furthermore, the present invention also relates to the use of at least one ingredient (a) and / or (b), in particular (a) and (b), to reduce and / or mask the bitter taste of octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride, preferably in a (common) composition.

[0007] Inflammatory diseases of the mouth and throat, i.e., inflammation in the oral cavity and / or the throat / pharynx (also referred to as mouth and / or throat inflammation), often occur as a secondary symptom of colds, flu-like infections, and influenza, but also as independent illnesses. Inflammatory diseases of the mouth and / or throat are often accompanied by unpleasant or distressing pain symptoms for the affected patient, which can further worsen their condition.

[0008] In general, mouth and throat inflammations can be caused by viruses, such as rhinoviruses, influenza viruses, parainfluenza viruses, coronaviruses, tonsillitis viruses such as adenoviruses and herpesviruses, bacterial pathogens such as bacteria of the genera Streptococcus, Staphylococcus, Pseudomonas, Escherichia, Theophilus, and the like, as well as by fungi. In particular, such inflammations can be exacerbated or even caused by factors such as inadequate oral and dental hygiene, vitamin deficiencies, iron deficiency, excessive smoking, alcohol abuse, side effects of medication, or similar conditions. For example, a weakened immune system can predispose to a disease-causing infection of the mouth and throat with the viruses, bacteria, or fungi in question. Furthermore, systemic infections or diseases can also cause or lead to inflammation of the mouth and throat.

[0009] An inflammatory disease of the mouth or throat can also be caused by several types of pathogens of the aforementioned kind, for example, in that an additional or subsequent bacterial (secondary) infection develops as a result of a viral (primary) infection, which can be promoted, for example, by pre-existing tissue damage.

[0010] Non-restrictive examples of inflammatory diseases of the mouth / pharynx include inflammations of the oral cavity, such as gingivitis, stomatitis, periodontitis, inflammation of the pharyngeal mucosa (pharyngitis), inflammation of the tonsils (tonsillitis), inflammation of the larynx (laryngitis), as well as oral mucosal lesions and throat inflammations, especially angina or the like.

[0011] Inflammatory diseases of the mouth and throat are very common and, due to the unpleasant pain symptoms, place a burden on the patient, especially since the diseases are often combined with or occur together with other symptoms, such as fever, cough, headache, a blocked nose or the like, e.g. in the case of colds, flu-like infections or influenza.

[0012] Therefore, there is also a great need for the provision of appropriate treatment or therapy concepts that are effective against inflammatory diseases of the mouth or throat, or against the pathogens or agents that cause these diseases, or that lead to a reduction in the pain symptoms associated with the diseases.

[0013] The treatment of inflammatory diseases of the mouth and throat generally involves topical (local) therapy and, if necessary, additional systemic therapy, particularly in more severe cases, depending on the severity of the condition. While antibiotics are often administered systemically in more severe cases, antiseptics and anti-inflammatory agents (such as antiphlogistics, anti-inflammatory drugs, local antibiotics, etc.) are frequently used as supportive therapy and, in milder cases, may be the sole treatment for topical, symptomatic relief. These agents can be administered orally, for example, in the form of throat rinses, sprays, or lozenges.

[0014] In this context, the active ingredient cetylpyridinium chloride (CPC) (1-hexadecylpyridinium chloride) is regularly used as an active ingredient for the topical treatment of inflammatory processes of the mouth and throat. This is a quaternary ammonium compound with bactericidal and fungicidal properties, which is used, among other things, in lozenges. A disadvantage of this active ingredient is that, at high doses and with excessive consumption, gastrointestinal disturbances, shortness of breath, and increased methemoglobin formation can sometimes occur, especially in children.

[0015] Furthermore, the active ingredient hexetidine (1,3-bis(2-ethylhexyl)-hexahydro-5-methyl-5-pyridinamine) is also used as a topical antiseptic or disinfectant for the mucous membranes of the mouth, throat, and pharynx. It can be applied, for example, as a spray or in the form of mouthwash or gargle solutions. With prolonged use and high doses, gastrointestinal discomfort and taste disturbances can occur.

[0016] The application method of sprays or rinses and gargles is also generally disadvantageous in that precise dosage is not easily achieved. Rinses and gargles are also not suitable for use everywhere and at all times. Furthermore, solutions have the disadvantage of a relatively limited shelf life of the active ingredient.

[0017] Furthermore, active ingredients of natural origin are used, such as so-called mucilaginous drugs or their extracts, like Iceland moss (Lichen islandicus). However, such preparations do not always offer the desired therapeutic success.

[0018] For the topical treatment of inflammatory diseases of the mouth and throat, orally administered preparations containing the active ingredient octenidine, particularly in the form of octenidine dihydrochloride, are used. Octenidine and octenidine dihydrochloride are antimicrobial agents from the dipyridine chemical group, and generally exhibit a broad spectrum of activity.

[0019] However, a disadvantage is that octenidine or octenidine dihydrochloride, and thus the compositions containing this active ingredient that are often considered unpleasant or unappetizing, cause a bitter taste when administered topically or orally, so that the organoleptic or gustatory properties in this regard are insufficient or not optimal.

[0020] The active ingredient itself was patented as early as 1977 (see DE 27 08 331 C2). With regard to fixed dosage forms using octenidine or octenidine dihydrochloride as the active ingredient, which can be used for the topical (local) treatment of inflammatory diseases of the mouth and throat, the potential for improving the organoleptic properties, particularly with regard to the bitter taste of octenidine or octenidine dihydrochloride, has not yet been fully recognized and exploited.

[0021] The bitter taste associated with octenidine or octenidine dihydrochloride when applied topically (locally) or administered orally, especially in the mouth or oral cavity, can lead to lower acceptance of products containing this active ingredient, particularly in patients with sensitive tastes.

[0022] In general, the human tongue is the primary organ for taste perception, or gustatory sensory perception. Taste papillae are located on the tongue, and these can differ in their morphology and taste perception. The taste papillae of the tongue generally contain taste buds. At their upper end, taste buds have a depression called a pore, which is generally filled with saliva. Substances present or dissolved in this fluid can be perceived as taste, or gustatory, via corresponding receptors on sensory cells.

[0023] Overall, the known tastes as perceived by humans are of great importance, since taste perception also influences positive evaluations of vital substances and negative evaluations of toxic substances. For example, most people find a bitter taste particularly unpleasant and negative.

[0024] The human tongue possesses specialized bitter taste receptors, particularly concentrated at the back of the tongue, allowing bitter-tasting substances to be perceived via a dedicated receptor system (resulting in a high intensity and spontaneity of the taste perception associated with bitter substances). While not solely reliant on this mechanism, bitter substances, when ingested orally, activate these bitter taste receptors, accompanied by the corresponding taste perception.

[0025] In particular, the perception of bitter tastes generally occurs via G-protein-coupled physiological mechanisms or G-protein-coupled receptors. Since this type of sensory perception is relatively time-consuming and long-lasting, the perception of bitter tastes is also prolonged, often accompanied by a bitter aftertaste (which further increases the general aversion to bitter tastes).

[0026] Bitter-tasting formulations can be perceived as unpleasant when applied topically (locally) or orally, which can lead to premature discontinuation of use if patient acceptance is low, sometimes accompanied by incomplete or suboptimal drug release or administration. This, in turn, can lead to reduced efficacy or insufficient therapeutic success, which can then result in a longer duration and greater disease severity.

[0027] In particular, an undesirably bitter taste is often perceived as organoleptically or gustatorily incompatible and sometimes even as unappetizing and repulsive. While this is not intended as a definitive explanation, it may also have evolutionary biological reasons related to the development of a protective function. For example, numerous poisonous plants and toxins taste bitter, and an aversion to bitterness prevents their ingestion. Bitter-tasting substances (bitter compounds) occur naturally in plants, where they generally serve as protection against herbivores by making the plant less palatable. The negative association or connotation of a bitter taste is particularly linked to protection against the ingestion of or intoxication from unwanted or toxic (plant) substances, such as toxic alkaloids.Therefore, a negatively connoted (bitter) taste also serves a warning or protective function.

[0028] An aversion to bitter-tasting substances is particularly pronounced in children. Although this aversion can decrease with age, it often remains the case that even adults perceive a pronounced bitter taste as unpleasant or negative.

[0029] The negative taste association or connotation is particularly disadvantageous with regard to the oral intake or administration of such compositions which contain active ingredients with a bitter (inherent) taste, but which, however, have, for example, health-promoting effects or therapeutic efficacy, as this can impair their acceptance and consequently their use or intake.

[0030] Due to the generally negative association of a bitter taste, the topical or oral administration of drugs or compounds containing bitter-tasting active ingredients, such as octenidine or octenidine dihydrochloride, is often not optimal or is made more difficult, for example also with regard to children and adolescents, who often have an even stronger aversion to bitter-tasting substances or active ingredients.

[0031] The above statements demonstrate that the taste or gustatory properties and sensory perception of taste of corresponding compositions are of great importance with regard to acceptance and thus also to application properties.

[0032] The compositions known in the prior art, including those based on octenidine or octenidine dihydrochloride, do not always fully meet the organoleptic or taste requirements, particularly due to the excessive bitterness often inherent in such compositions. In particular, the prior art lacks comprehensive concepts for the sustainable modification or improvement of the taste of such compositions.

[0033] Furthermore, the prior art does not include any advanced concepts for increasing the efficacy of octenidine- or octenidine dihydrochloride-containing compositions while simultaneously improving their taste, particularly with regard to diseases of the mouth or throat. The prior art focuses primarily on the primary efficacy properties based on the single substance. Further improvement or enhancement of the efficacy properties while simultaneously improving organoleptic properties or (bitter) taste has not been described or considered in the prior art to date.

[0034] In summary, with regard to the state of the art, compositions based on octenidine or octenidine dihydrochloride do not always have optimal taste or organoleptic properties when administered topically (locally) or orally, due to the bitter taste underlying octenidine or octenidine dihydrochloride.

[0035] In particular, there is a great need in the prior art for the provision of new compositions based on octenidine or octenidine dihydrochloride as an active ingredient for topical (local) or oral administration, especially for the purpose of the topical (local) treatment of inflammatory diseases of the mouth or throat, with improved taste properties or with reduced bitter taste of the underlying composition, and this with equally high efficacy against the underlying diseases.

[0036] Against this background, an object of the present invention is to provide a composition based on octenidine or octenidine dihydrochloride for topical (local) or oral application in the mouth or throat in the treatment of inflammatory diseases of the mouth and throat, whereby the disadvantages of the prior art described above are to be largely avoided or at least mitigated.

[0037] The present invention is based in particular on the objective of providing a composition containing octenidine or octenidine dihydrochloride for topical (local) or oral administration in the mouth or throat, specifically for the topical (local) treatment of inflammatory diseases of the mouth or throat. The composition provided within the scope of the present invention is intended to have an improved taste or organoleptic properties, particularly with regard to a reduction or improvement of the bitter taste associated with the use of the active ingredient octenidine or octenidine dihydrochloride. In particular, the composition provided according to the invention is intended to have improved (bitter) taste properties.

[0038] A further object of the present invention is to provide a composition based on octenidine or octenidine dihydrochloride as an active ingredient, suitable for use in the prophylactic or therapeutic topical (local) treatment of inflammatory diseases of the mouth or throat. The composition provided according to the invention should exhibit improved organoleptic and taste properties, as well as high or improved efficacy when administered topically (locally) or orally with regard to the underlying inflammatory diseases of the mouth or throat. In this context, a uniform and time-defined or long-lasting release of the active ingredient upon administration of the composition should also be ensured.

[0039] In this context, a further objective of the present invention is to provide a composition containing octenidine or octenidine dihydrochloride, which, in addition to high efficacy against the inflammatory diseases of the mouth or throat in question, should also be easy to administer or apply, have good tolerability with few side effects, and generally be highly accepted.

[0040] An object of the present invention is also to provide, in addition to the taste and organoleptic optimization, a targeted optimization or increase in the effectiveness of octenidine or octenidine dihydrochloride with regard to the underlying inflammatory diseases of the mouth and throat, in view of the composition provided according to the invention with octenidine or octenidine dihydrochloride as the underlying active ingredient.

[0041] In a completely unexpected manner, the applicant has now discovered that the aforementioned problems can be solved by providing or formulating a specific composition, in particular a pharmaceutical composition, in the form of a fixed dose for lozenging, especially a lozenge, preferably for use in the prophylactic or therapeutic topical (local) treatment of inflammatory diseases of the mouth or throat, wherein the composition contains an effective amount of an active ingredient, preferably suitable or effective for the topical (local) treatment of inflammatory diseases of the mouth or throat, with antiseptic or antimicrobial properties, namely based on octenidine or, in a particularly preferred manner, octenidine dihydrochloride, wherein the active ingredient is incorporated or embedded in a solid matrix and, upon topical (local) application, is released or absorbed.The composition is released in a defined manner in the oral cavity and / or pharynx. As detailed below, the composition according to the invention contains at least one further ingredient (a) and / or (b), in particular (a) and (b), whereby a targeted improvement or optimization of the taste can be achieved with high efficacy, especially with regard to the bitter taste of the active ingredient octenidine or octenidine dihydrochloride. The present invention aims at a topical (local) application of the composition, particularly in the oral cavity and pharynx, based on a fixed dosage (fixed dosage form) for sucking, in particular in the form of a lozenge.

[0042] 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 a pharmaceutical composition, in the form of a fixed dosage (solid dosage form) for sucking or chewing, preferably for sucking, in particular a lozenge, preferably for use in the prophylactic or therapeutic topical (local) treatment of inflammatory diseases of the mouth or throat, according to claim 1; advantageous further developments and embodiments of this aspect of the invention are the subject of the respective dependent claims and the related subsidiary claims.

[0043] A further subject matter of the present invention – according to a second aspect of the present invention – is the composition according to the invention for use in the prophylactic or therapeutic topical (local) treatment of diseases of the oral cavity or pharynx, as described in the independent claim relating to this composition. Advantageous further developments and embodiments of this aspect of the invention are the subject of the corresponding dependent claim.

[0044] Likewise, according to a third aspect of the present invention, the use of the composition according to the invention, in particular the pharmaceutical composition (for the manufacture of a medicament or drug), for the prophylactic or therapeutic topical (local) treatment of inflammatory diseases of the oral cavity or pharynx, as described in the independent claim relating to this use. Advantageous further developments and embodiments of this aspect of the invention are the subject of the corresponding dependent claim.

[0045] A further object of the present invention – according to a fourth aspect of the present invention – is the use according to the invention of specific ingredients (a) and / or (b), in particular (a) and (b), to improve and / or adjust the organoleptic properties, especially the taste, preferably to reduce and / or mask the bitter taste, of a composition which comprises as an active ingredient octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible or physiologically acceptable salt, particularly preferably octenidine dihydrochloride, according to the independent claim in this respect. Advantageous further developments and embodiments of this aspect of the invention are the subject of the dependent claim in this respect.

[0046] Also described is a method for the prophylactic or therapeutic topical (local) treatment of inflammatory diseases of the mouth or throat.

[0047] It goes without saying that any embodiments, designs, advantages and the like, which are listed below for the purpose of avoiding repetition only with regard to one aspect of the invention, naturally also apply to the other aspects of the invention without the need for separate mention.

[0048] Furthermore, it goes without saying that the following specifications of values, numbers and ranges are not to be understood as limiting; it is self-evident to the person skilled in the art that deviations from the specified range or specifications are possible in individual cases or depending on the application, without leaving the scope of the present invention.

[0049] Furthermore, it should be noted that for all relative or percentage-based quantity specifications mentioned below, especially those related to weight, these specifications must be selected or combined by a person skilled in the art in such a way that the total always results in 100% or 100% by weight, possibly including further components, ingredients, additives, or constituents, particularly as defined below. This is self-evident to a person skilled in the art.

[0050] Furthermore, it should be noted that all values ​​or parameters mentioned below, or the like, can generally be determined using standardized or explicitly specified determination methods, or using determination methods that are generally familiar to those skilled in the field.

[0051] Furthermore, for the purposes of describing the present invention, the features of the present invention cited in connection with specific embodiments, configurations, advantages, examples, or the like are also considered disclosed in combination. Thus, higher-order combinations of individual or multiple features cited for specific embodiments, configurations, application examples, or the like are also considered disclosed.

[0052] In particular, with regard to the features characterizing the invention, all possible combinations of these features shall be deemed disclosed, with embodiments of comparable or corresponding preference of the various features in their combination being preferred (e.g. quantities or quantity ranges of the relevant active ingredients and components of the same preference or the like).

[0053] It is particularly important to note that for the quantities listed below relating to the various active ingredients or components of the composition according to the invention, especially relative or absolute quantities of the same preference or level of preference, the respective combinations relating to the various active ingredients or components with the corresponding preference or level of preference are also disclosed. Likewise, all other combinations (i.e., combinations based on different preferences or levels of preference) are also disclosed.

[0054] 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 a pharmaceutical composition, in the form of a fixed dosage (solid dosage form) for sucking and / or chewing, preferably for sucking, in particular a lozenge, preferably for use in the prophylactic and / or therapeutic topical (local) treatment of inflammatory diseases of the mouth and throat. wherein the composition contains an effective, in particular pharmaceutically and / or therapeutically effective, amount of an active ingredient preferably suitable and / or effective for the topical (local) treatment of inflammatory diseases of the mouth and throat, in particular with antiseptic and / or antimicrobial properties, preferably with antibacterial and / or antiviral and / or antifungal properties, wherein the active ingredient is incorporated and / or embedded in a solid matrix, wherein the composition, in particular the fixed dosage (solid dosage form) and / or the matrix, releases the active ingredient upon topical (local) application and / or use, preferably by sucking and / or chewing, preferably by sucking, in the oral and pharyngeal cavity; wherein the active ingredient is octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride; and wherein the composition, in particular the fixed dosage (solid dosage form) and / or the matrix, furthermore and / or additionally contains at least one further ingredient (a) and / or (b), in particular (a) and (b), wherein the at least one further ingredient (a) and / or (b) is selected from the group of (a) Flavor modulators, in particular selected from the group of the following components (i), (ii) and / or (iii): (i) Bitter (taste) masking agents, in particular selected from the group consisting of bitter taste receptor antagonists, preferably 4-(2,2,3-trimethylcyclopentyl)butanoic acid, and saponins, preferably glycyrrhizic acid (glycyrrhizin) and its salts or esters and / or glycyrrhetinic acid (glycyrrhetin) and its salts or esters, complexing agents, in particular cyclodextrins, and combinations or mixtures thereof, (ii) Bitter substances, in particular coffee extract and / or tea extract and / or their respective bitter substances, preferably coffee extract and / or its bitter substances, (iii) preferably natural or nature-identical (aroma) oils and / or essential oils, in particular with antiseptic and / or antimicrobial properties, preferably with antibacterial, antifungal and / or antiviral properties, in particular selected from the group of anise oils, in particular star anise oil, peppermint oil, eucalyptus oil, lavender oil, tea tree oil, chamomile oil, clove oil, rosemary oil, caraway oil, cinnamon oil, sage oil and fennel oil, as well as combinations or mixtures thereof; in particular wherein the ingredient (a) and / or the flavor modulator comprises a combination of at least two different components (i), (ii) and / or (iii), preferably a combination of components (i), (ii) and (iii); (b) Acidulants, in particular saliva-stimulating and / or flavor-enhancing acidulants, preferably acidulants authorized under pharmaceutical and / or food law and / or acidulants authorized as pharmaceutical additives and / or food additives, in particular selected from the group of tartaric acid and its salts, in particular sodium tartrate, sodium potassium tartrate (Rochelle salt) and calcium tartrate, citric acid and its salts, metatartaric acid, fumaric acid, ascorbic acid, phosphoric acid and its salts, stannous chloride, in particular tin(II) chloride, malic acid, lactic acid, adipic acid, succinic acid and other pharmaceutically compatible and / or physiologically acceptable organic acids and their salts, as well as their combinations or mixtures.

[0055] With regard to the present invention, the applicant has discovered, quite unexpectedly, that based on the targeted and purposeful measures implemented according to the invention, the organoleptic properties and / or taste of the composition according to the invention, in particular the pharmaceutical composition as defined herein, which contains as an active ingredient bitter-tasting octenidine, especially in the form of a pharmaceutically compatible or physiologically tolerable salt, most preferably octenidine dihydrochloride, can be improved, specifically adjusted, and tailored. According to the invention, it has been possible to specifically reduce or mask the bitter taste of the underlying composition associated with octenidine or octenidine dihydrochloride.

[0056] The composition according to the invention thus exhibits overall improved or positive organoleptic properties and an improved taste. As a result of the targeted taste improvement, the composition according to the invention also exhibits improved product properties. In particular, the organoleptic and taste compatibility of the octenidine-containing or octenidine dihydrochloride-containing composition according to the invention is increased. This also leads to increased acceptance and improved application behavior, and thus to an overall excellent acceptance of the composition according to the invention.

[0057] In particular, the administration or sucking of the composition, which is available as a fixed dosage (fixed dosage form), is perceived as more pleasant and soothing in the mouth according to the invention. This also leads to more consistent and sustained application of the composition in the underlying inflammatory diseases of the mouth and throat, thus increasing its efficacy, resulting in a reduced duration and less severe illness.

[0058] Due to the measures according to the invention, the bitter (inherent) taste of octenidine or octenidine dihydrochloride as the underlying active ingredient is effectively counteracted in the composition according to the invention, so that overall an organoleptic or taste optimization is achieved for the composition according to the invention.

[0059] On this basis, the application properties of the composition according to the invention are also improved insofar as the sucking behavior of the composition, which is available as a solid dosage (solid dosage form), is improved overall, and therefore the active ingredient is released optimally at the site of action over a defined or longer period of time.

[0060] This also leads to a high or even further improved effectiveness of the composition according to the invention.

[0061] The present invention is based on the use of specific additional ingredients (a) and / or (b), as defined herein, which allow the flavor properties of the composition to be specifically adjusted, improved, and tailored. According to the invention, specific ingredients (a) in the form of flavor modulators, on the one hand, and / or specific ingredients (b) in the form of acidulants, on the other, can be used. With regard to ingredient (a) and flavor modulators, specific components can be used, namely (i) bitter (flavor) masking agents, (ii) bitter substances, and (iii) preferably natural or nature-identical (flavor) oils or essential oils.

[0062] By selectively choosing and combining the respective ingredients or components, the organoleptic properties and / or taste of the composition can be adjusted, thereby counteracting the bitter (inherent) taste of octenidine or octenidine dihydrochloride. The ingredients used according to the invention, particularly in combination, (a) especially those based on components (i), (ii) and / or (iii), and (b) work together to reduce or mask the bitter taste, particularly beyond the sum of the individual effects of the substances and thus synergistically. Therefore, the invention also provides a highly effective and efficient technical solution for the targeted reduction or masking of the bitter taste associated with octenidine or octenidine dihydrochloride.

[0063] According to the invention, in this context, the bitter taste of octenidine or octenidine dihydrochloride is counteracted directly, so to speak, by means of the use of special taste modulators or acidifying agents. In particular, the bitter taste is also counteracted on an organoleptic-sensory level.

[0064] The composition according to the invention thus exhibits improved taste and gustatory properties, particularly with regard to a further masking of the generally unpleasant bitter taste of octenidine or octenidine dihydrochloride in the composition. This sustainably improves application acceptance and overall acceptance of the composition according to the invention. In particular, the composition according to the invention offers an optimized taste, especially as a result of the targeted use and combination of specific ingredients, as defined herein.

[0065] The composition according to the invention also exhibits high efficacy against the underlying inflammatory diseases of the mouth and throat. The composition according to the invention is particularly suitable for temporary, stand-alone, supportive, or co-therapeutic treatment of inflammations of the mouth and throat, especially since the composition according to the invention has antiseptic and antimicrobial properties and also has anti-inflammatory and anti-inflammatory effects, thus also achieving efficient pain relief.

[0066] According to the invention, an improvement or enhancement of the active properties of octenidine or octenidine dihydrochloride is also provided, also in combination with an improvement of the organoleptic properties, in particular the taste, of the composition according to the invention.

[0067] According to the invention, a composition in the form of a fixed dosage for sucking or chewing, in particular sucking, based on octenidine or octenidine dihydrochloride is provided, which is highly effective and is organoleptically and / or taste-optimized, in particular with regard to the bitter taste underlying the octenidine or octenidine dihydrochloride.

[0068] The improvement in taste or gustatory effect is also of great importance insofar as the composition according to the invention, as a solid dosage form for sucking or chewing, in particular when applied topically (locally) or orally in the mouth and throat, releases the active ingredient over a longer period of time, especially when sucking or chewing the composition (which in turn is associated with an improved or defined release and effect of octenidine or octenidine dihydrochloride at the site of action in the mouth or throat).

[0069] The term “composition” or “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, homeopathic remedies, foodstuffs and food supplements, etc.

[0070] Furthermore, the term "oral and pharyngeal cavity," as used according to the invention, is to be understood broadly. In particular, the term encompasses the oral cavity as well as the throat / pharyngeal cavity with the associated biological structures and tissues. The oral cavity specifically includes the oral cavity itself, and the throat / pharyngeal cavity encompasses the throat and pharyngeal region, in particular the nasopharynx, oropharynx, and laryngopharynx, as well as, more broadly, the neck region and especially the upper neck region.

[0071] The term “topical (i.e., local) treatment”, as used according to the invention, is to be understood very broadly overall and includes in particular both prophylactic topical treatment, especially for disinfection purposes with regard to the mouth and throat, and therapeutic or curative topical treatment, especially in the case of the acute inflammatory stage of the present diseases of the mouth and throat.

[0072] The terms "salt" and "ester", as used here with regard to the active ingredients or components, refer in particular to the respective pharmaceutically compatible or physiologically compatible or harmless salts or esters of the active ingredients or components listed.

[0073] The following should also be noted regarding ingredients (a) and (b): Regarding the (a)(i) bitter taste masking agent, which is, for example, 4-(2,2,3-trimethylcyclopentyl)butanoic acid, it can—without limiting ourselves to or relying on this theory—particularly achieve a reduced sensory perception or taste sensation of the bitter taste of octenidine or octenidine dihydrochloride. In particular, the bitter taste masking agent can act as a bitter taste receptor antagonist. This can reduce the influence of, or interaction with, the corresponding bitter taste receptors, especially on the tongue, particularly with respect to the bitter-tasting octenidine or octenidine dihydrochloride. Therefore, based on the composition according to the invention, the sensitivity to bitter tastes is reduced and the bitter taste is perceived less intensely.

[0074] According to the invention, the (a)(i) bitter taste masking agent can be a bitter taste receptor antagonist. This can generally be a substance or compound that eliminates or reduces the bitter taste effect of octenidine or octenidine dihydrochloride, or has the opposite effect. This can be achieved, in particular, by influencing the bitter taste receptors accordingly, thereby reducing the perception of bitterness, for example, by decreasing the binding or interaction of octenidine or octenidine dihydrochloride to the corresponding bitter taste receptors. The bitter taste masking agent, in particular the bitter taste receptor antagonist, can, without limitation, be a competitive antagonist, a non-competitive antagonist, and / or a functional antagonist.

[0075] Furthermore, within the scope of the present invention, it is particularly such that the (a)(ii) bittering agent, in particular coffee extract or tea extract and / or the bittering agents relating thereto, can be used to further adjust or improve the taste, in particular also in addition to or intensify the taste-modulating effect of the (a)(i) bitter (taste) masking agent. For example, dry extracts or aqueous extracts can be used.

[0076] In particular, the (a)(ii) bitter substance may be such that it has an independent, but less pronounced, or more pleasant or positively associated or positively connoted (bitter) taste.

[0077] Without relying on or limiting ourselves to this theory, the bitter substance can be designed in such a way that, upon application of the composition, it binds to or interacts with corresponding bitter taste receptors, particularly those that are not deactivated by the (a)(i) bitter taste masking agent. On this basis, the (a)(ii) bitter substance can produce an independent taste, which, for example, is less bitter, so that the taste of the composition according to the invention is also perceived as more pleasant for this reason. In particular, this can reduce or prevent the binding or interaction of octenidine or octenidine dihydrochloride to such receptors, thus also reducing the perception of the bitter taste caused by octenidine or octenidine dihydrochloride.

[0078] Furthermore, within the scope of the present invention, it can be such that the (a)(ii) bittering agent provides the composition according to the invention with a (less unpleasantly perceived) basic bitter taste, which can be particularly positive with regard to compliance or acceptance in application, as a bitter basic taste is also associated with a high efficacy of the composition.

[0079] By further using a (a)(iii) preferably natural or nature-identical (aroma) oil or essential oil, the composition according to the invention can be equipped with a further flavor component which likewise enables a positive flavor development or modulation, also in the sense of a "fresh" and "invigorating" taste. In this respect, too, a supplement or further support of the flavor-modulating effect of components (a)(i) and (a)(ii) can be achieved.

[0080] According to a preferred embodiment of the invention, the (aroma) oil or essential oil can also be equipped with antiseptic or antimicrobial, preferably antibacterial, antifungal and / or antiviral properties. This can also result in a further enhancement of the antiseptic or antimicrobial properties of octenidine or octenidine dihydrochloride in the composition according to the invention.

[0081] As previously stated, the composition according to the invention comprises, with respect to ingredient (a), a combination of at least two different components (i), (ii) or (iii), preferably a combination of components (i), (ii) and (iii). This ensures a further optimization of the taste properties of the composition according to the invention, also with regard to reducing or masking the bitter taste caused by octenidine or octenidine dihydrochloride.

[0082] By further using ingredient (b), the organoleptic properties, in particular the taste, of the composition according to the invention can be further improved or specifically adjusted, especially in combination with the aforementioned components of ingredient (a).

[0083] The use of (b) acidifying agent in the composition according to the invention leads to a complementary or further improvement or modulation of the taste. In particular, the use of (b) acidifying agent can enhance the aroma. Thus, the organoleptic, and especially the taste, properties of the composition according to the invention can be further improved or adjusted by using (b) acidifying agent.

[0084] When the composition is used or administered, especially with regard to the fixed dosage (fixed 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 and distribution of the active ingredient in the mouth or throat.

[0085] Furthermore, the release and distribution of the other ingredients, especially the aforementioned ingredient (a), are also improved, which likewise has a positive effect on the taste of the composition. In particular, the pH value of the composition can be adjusted by using the acidifying agent. Specifically, the pH value of saliva can also be influenced when the composition is administered. In particular, a reduction in the corresponding pH value may occur. This can also improve the efficacy, especially with regard to the antiseptic and antimicrobial properties of the active ingredient or the composition. In addition, the (storage) stability of the composition is increased.

[0086] The organoleptic properties of the composition according to the invention can be further improved or adjusted by using an acidifying agent. When the composition is used or administered in a fixed dosage form, such as a lozenge, the acidifying agent can also specifically induce or increase saliva flow or production, thereby stimulating, positively influencing, and homogenizing the release of the active ingredient.

[0087] According to the invention, it is particularly intended that the composition is prepared and used for topical (i.e., synonymously: local) application to the mucous membranes of the mouth and throat. This also results in high efficacy with regard to the underlying inflammatory diseases of the mouth and throat.

[0088] According to the invention, it is also advantageous with regard to adjusting or improving the olfactory properties, in particular the taste, and / or with regard to providing high efficacy against the inflammatory diseases of the mouth or throat in question, if the composition according to the invention contains ingredient (a) (flavor modulator) on the one hand and ingredient (b) (acidifying agent) on the other. In particular, the composition can contain ingredient (a) (flavor modulator) and ingredient (b) (acidifying agent) in combination. In this context, the composition can contain a combination of ingredient (a) (flavor modulator) and ingredient (b) (acidifying agent).

[0089] According to the invention, it is also advantageous if the composition, in particular the ingredient (a) (taste modulator), contains the component (i) (bitter receptor antagonist) and the component (ii) (bitter substance). In particular, the ingredient (a) (taste modulator) can contain or consist of a combination of the component (i) (bitter receptor antagonist) and the component (ii) (bitter substance).

[0090] Furthermore, it may be specifically provided that the composition contains ingredient (a) (flavor modulator) on the one hand and ingredient (b) (acidifying agent) on the other, and that the composition, in particular ingredient (a) (flavor modulator), contains component (i) (bitter receptor antagonist) and component (ii) (bitter substance). In this respect as well, ingredient (a) (flavor modulator) may thus contain or consist of a combination of component (i) (bitter receptor antagonist) and component (ii) (bitter substance).

[0091] In particular, the composition may also include, in particular, ingredient (a) (flavor modulator), component (i) (bitter receptor antagonist), component (ii) (bitter substance), and component (iii) (flavor oil). In particular, ingredient (a) (flavor modulator) may contain or consist of a combination of component (i) (bitter receptor antagonist), component (ii) (bitter substance), and component (iii) (flavor oil).

[0092] Furthermore, according to the invention, it is particularly advantageous with regard to a further improved adjustment or specification of the organoleptic properties, especially the taste, of the composition according to the invention if the composition contains the ingredient (a) (flavor modulator) on the one hand and the ingredient (b) (acidifying agent) on the other hand, and if the composition, in particular the ingredient (a) (flavor modulator), contains the component (i) (bitter receptor antagonist), the component (ii) (bitter substance), and the component (iii) (flavor oil). In this context, the ingredient (a) (flavor modulator) can also contain or consist of a combination of the component (i) (bitter receptor antagonist), the component (ii) (bitter substance), and the component (iii) (flavor oil).

[0093] According to the invention, it may be provided that component (iii) ((aroma) oil) is selected from the group consisting of anise oil, in particular star anise oil, peppermint oil, tea tree oil, chamomile oil, clove oil and cinnamon oil, and combinations or mixtures thereof; preferably from the group consisting of anise oil, in particular star anise oil, and peppermint oil, and combinations or mixtures thereof; more preferably from the group consisting of anise oil, in particular star anise oil, and peppermint oil; and most preferably a combination of star anise oil and peppermint oil. In particular, component (iii) ((aroma) oil) may comprise or consist of a combination of star anise oil and peppermint oil.

[0094] A combination of star anise oil and peppermint oil allows for the creation of highly desirable organoleptic and flavor properties. In particular, the combined use of star anise oil and peppermint oil can further enhance the effectiveness of the composition.

[0095] Star anise oil can generally be obtained from true star anise, botanically Illicium verum, particularly by extraction from the ripe fruits of the plant. The main component of star anise oil is trans-anethole, especially in a quantity of 80% to 90% by weight, based on the essential oil. Star anise oil may also contain foeniculin, limonene, and / or cineole. For further details on star anise oil, please refer to RÖMPP Lexikon Naturstoffe (Lexicon of Natural Products), first edition, Georg Thieme Verlag, Stuttgart / New York, 1997, page 609, entry: "Star Anise," and the literature cited therein, the entire contents of which are hereby incorporated by reference.

[0096] Anise oil, especially star anise oil, can be used to further adjust the flavor of the mixture. Furthermore, anise oil and star anise oil also possess expectorant, antispasmodic, and, in particular, antiseptic and antimicrobial properties.

[0097] According to one embodiment of the invention, it is particularly possible that nature-identical or synthetic or natural anise oil, in particular star anise oil, is used. In a preferred embodiment, nature-identical star anise oil can thus be used. In particular, component (iii) (aroma) oil can comprise the anise oil, in particular star anise oil, in the form of or as nature-identical anise oil, in particular star anise oil. A combination of nature-identical star anise oil and peppermint oil is further preferred with regard to component (iii) (aroma) oil. The use of nature-identical anise oil, in particular star anise oil, has the advantage that it has particularly well-defined properties or a defined composition, especially with regard to low or high levels of oxidation.The lack of estragole content in anise oil, especially star anise oil.

[0098] According to the invention, as mentioned above, natural anise oil or star anise oil can also be used. If such an oil has a high estragole content, appropriate treatment processes can be applied to reduce the estragole content, in particular stripping, chromatography, distillation, adsorption, or the like.

[0099] Peppermint oil can be obtained, in particular, from the aerial parts of peppermint, botanically Mentha piperita, especially from the leaves. Peppermint oil used according to the invention can contain, in particular, menthol, preferably in amounts of 25% to 45% by weight, menthone, preferably in amounts of 20% to 30% by weight, and / or menthyl acetate, preferably in amounts of 2% to 10% by weight, each based on the essential oil.

[0100] For further details on the peppermint oil that can be used according to the invention, reference can also be made to RÖMPP Lexikon Naturstoffe, first edition, Georg Thieme Verlag, Stuttgart / New York, 1997, pages 478 and 479, keyword: “peppermint oil” and the literature referenced therein, the entire content of which is hereby included by reference.

[0101] By using (a)(iii) the (aroma) oil or essential oil, in particular anise oil, preferably star anise oil, and / or peppermint oil, the flavor of the composition according to the invention can be further adjusted, and the efficacy of the composition according to the invention can be specifically enhanced or tailored with regard to the underlying diseases. Peppermint oil also exhibits antiseptic or antimicrobial and, moreover, antifungal activity, which is a further advantage with regard to the underlying topical application, for example, with regard to secondary infections or the like.

[0102] As regards the composition according to the invention, the further ingredient (b) (acidifying agent) may in particular be selected from the group consisting of tartaric acid and its salts, especially sodium tartrate, sodium potassium tartrate (Rochelle salt) and calcium tartrate, citric acid and its salts, and metatartaric acid, as well as combinations or mixtures thereof; preferably from the group consisting of tartaric acid and its salts, especially sodium tartrate, sodium potassium tartrate (Rochelle salt) and calcium tartrate, citric acid and its salts, as well as combinations or mixtures thereof; preferably tartaric acid and citric acid, as well as combinations or mixtures thereof; particularly preferably tartaric acid. According to the invention, it may in particular be provided that the further ingredient (b) (acidifying agent) contains tartaric acid or is formed from it.

[0103] Furthermore, the following combinations of ingredients (a), in particular based on the relevant components (i), (iii) and (iii), as well as (b) are also preferred: According to the invention, it may in particular be provided that (a)(i) the bitter (taste) masking agent comprises or consists of a bitter taste receptor antagonist, in particular 4-(2,2,3-trimethylcyclopentyl)butanoic acid. In this context, it may also be provided that (a)(ii) the bitter substance comprises or consists of coffee extract and / or its bitter substances.

[0104] In this context, according to the invention, the ingredient (a) and / or the flavor modulator comprises or consists of a combination of components (i), (ii) and (iii). This allows the flavor masking or modulation with respect to the bitter taste associated with octenidine or octenidine dihydrochloride to be further optimized.

[0105] Furthermore, according to one embodiment of the invention, it is particularly provided that (b) the acidifying agent comprises or consists of tartaric acid and / or citric acid, preferably tartaric acid. This allows the taste to be further adjusted in a special way.

[0106] Furthermore, the aforementioned acidifying agents can further induce or increase saliva flow or saliva production.

[0107] As regards the composition according to the invention, the relative or absolute amounts of the respective active ingredients or components used are also of great importance, particularly with regard to providing defined organoleptic properties or a defined taste and optimized effectiveness as well as defined application properties of the composition according to the invention.

[0108] With regard to the following information on absolute quantities or doses, it is particularly important to note that the respective absolute quantity is the weight-based (single) quantity or (single) dose administered with a single application (single application) in the form of the composition (e.g. as a lozenge or the like) and / or the weight-based (single) quantity or (single) dose administered with a single application (single application) of a prepared dosage or dosage form of the composition (e.g. as a lozenge or the like).

[0109] In particular, the composition may contain the ingredient (a) (flavor modulator) in a (relative) (total) amount in the range of 0.005 wt.% to 10 wt.%, in particular in the range of 0.01 wt.% to 8 wt.%, preferably in the range of 0.05 wt.% to 6 wt.%, preferably in the range of 0.1 wt.% to 5 wt.%, most preferably in the range of 0.2 wt.% to 3 wt.%, based on the composition.

[0110] According to the invention, it can also be provided that the composition contains the ingredient (a) (flavor modulator) in an (absolute) (total) amount in the range of 0.1 mg to 250 mg, in particular in the range of 0.5 mg to 200 mg, preferably in the range of 1 mg to 150 mg, preferably in the range of 2 mg to 100 mg, and particularly preferably in the range of 5 mg to 50 mg.

[0111] Furthermore, the composition (a)(i) may contain the bitterness masking agent in a (relative) amount in the range of 0.002 wt.% to 2 wt.%, in particular in the range of 0.004 wt.% to 1 wt.%, preferably in the range of 0.02 wt.% to 0.75 wt.%, preferably in the range of 0.03 wt.% to 0.6 wt.%, most preferably in the range of 0.01 wt.% to 0.45 wt.%, based on the composition.

[0112] In particular, the composition (a)(i) may contain the bitterness masking agent in an (absolute) amount in the range of 0.05 mg to 50 mg, particularly in the range of 0.1 mg to 25 mg, preferably in the range of 0.5 mg to 20 mg, preferably in the range of 0.75 mg to 15 mg, and most preferably in the range of 1 mg to 10 mg.

[0113] According to the invention, it is particularly provided that (a)(i) the bitter (taste) masking agent comprises or consists of 4-(2,2,3-trimethylcyclopentyl)butanoic acid.

[0114] In particular, the composition may contain 4-(2,2,3-trimethylcyclopentyl)butanoic acid in a (relative) amount in the range of 0.002 wt.% to 1 wt.%, particularly in the range of 0.004 wt.% to 0.6 wt.%, preferably in the range of 0.01 wt.% to 0.4 wt.%, based on the composition.

[0115] Furthermore, the composition may contain 4-(2,2,3-trimethylcyclopentyl)butanoic acid in an (absolute) amount in the range of 0.05 mg to 25 mg, in particular in the range of 0.1 mg to 15 mg, preferably in the range of 0.2 mg to 8 mg.

[0116] 4-(2,2,3-Trimethylcyclopentyl)butanoic acid is a particularly effective bitter taste receptor antagonist, thus efficiently reducing the undesirable bitter taste.

[0117] Glycyrrhizic acid (glycyrrhizin) or its salts or esters and / or glycyrrhetinic acid (glycyrrhetin) or its salts or esters can also be used as (a)(i) bitter taste maskers. These are equally effective bitter taste maskers or bitter taste receptor antagonists, and the aforementioned substances also exhibit antibacterial and anti-inflammatory properties, as well as expectorant properties in cases of cough.

[0118] Enoxonol, for example, can be used as a bitter-tasting masking agent. It is specifically the aglycone or metabolite of glycyrrhizic acid (glycyrrhizin). Enoxonol is particularly effective against (irritating) coughs, which, in addition to reducing the bitter taste, is a further advantage with regard to the underlying diseases of the mouth and throat. Furthermore, enoxonol exhibits antibacterial and anti-inflammatory properties.

[0119] Furthermore, the composition (a)(ii) may contain the bitter substance in a (relative) amount in the range of 0.001 wt.% to 5 wt.%, in particular in the range of 0.002 wt.% to 3 wt.%, preferably in the range of 0.003 wt.% to 2 wt.%, preferably in the range of 0.004 wt.% to 1.5 wt.%, and most preferably in the range of 0.02 wt.% to 0.75 wt.%.

[0120] In particular, the composition (a)(ii) may contain the bitter substance in an (absolute) amount in the range of 0.01 mg to 100 mg, particularly in the range of 0.05 mg to 75 mg, preferably in the range of 0.075 mg to 50 mg, preferably in the range of 0.1 mg to 30 mg, and most preferably in the range of 0.5 mg to 20 mg.

[0121] According to one embodiment of the invention, (a)(ii) the bitter substance comprises or consists of coffee extract and / or its bitter substances.

[0122] In particular, the composition may contain the coffee extract and / or its bitter substances in a (relative) amount in the range of 0.001 wt.% to 10 wt.%, particularly in the range of 0.01 wt.% to 5 wt.%, preferably in the range of 0.1 wt.% to 1 wt.%, based on the composition.

[0123] Furthermore, the composition may contain coffee extract and / or its bitter substances in an (absolute) amount 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.

[0124] In particular, the composition (a)(iii) may contain the (aroma) oil and / or essential oil in a (relative) amount in the range of 0.005 wt.% to 5 wt.%, in particular in the range of 0.01 wt.% to 3.5 wt.%, preferably in the range of 0.02 wt.% to 2 wt.%, preferably in the range of 0.03 wt.% to 1.5 wt.%, most preferably in the range of 0.01 wt.% to 0.75 wt.%, based on the composition.

[0125] Furthermore, the composition (a)(iii) may contain the (aroma) oil and / or essential oil in an (absolute) amount in the range of 0.2 mg to 100 mg, in particular in the range of 0.3 mg to 80 mg, preferably in the range of 0.5 mg to 50 mg, preferably in the range of 0.75 mg to 30 mg, particularly preferably in the range of 1 mg to 20 mg.

[0126] According to the invention, it may in particular be provided that (a)(iii) the (aroma) oil and / or essential oil contains or consists of anise oil, preferably star anise oil, and / or peppermint oil, preferably anise oil, preferably star anise oil, and peppermint oil.

[0127] In this context, the composition may contain anise oil, in particular star anise oil, in a (relative) 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.

[0128] Furthermore, the composition may contain anise oil, in particular star anise oil, in an (absolute) amount 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.

[0129] In particular, the composition may contain peppermint oil in a (relative) amount in the range of 0.001 wt.% to 1 wt.%, especially in the range of 0.005 wt.% to 0.5 wt.%, preferably in the range of 0.01 wt.% to 0.1 wt.%, based on the composition.

[0130] Furthermore, the composition may contain peppermint oil in an (absolute) amount 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.

[0131] According to the invention, it is particularly provided that the anise oil, especially star anise oil, is at least substantially free of estragole and / or contains at least substantially no estragole (see above).

[0132] In this context, it is preferred according to the invention that the anise oil, in particular star anise oil, has an estragole content of less than 1,000 ppm, in particular less than 100 ppm, preferably less than 10 ppm, preferably less than 5 ppm, based on the anise oil, in particular star anise oil.

[0133] In particular, according to the invention, the composition may be provided that it is at least substantially free of estragole or contains at least substantially no estragole. In this context, it is particularly provided according to the invention that the composition has an estragole content of less than 500 ppm, in particular less than 50 ppm, preferably less than 5 ppm, preferably less than 1 ppm, based on the composition.

[0134] According to a preferred embodiment of the invention, an anise oil, in particular star anise oil, with a low estragole content or at least substantially free of estragole is used for the composition according to the invention. In particular, the composition according to the invention as such has a low estragole content or is at least substantially free of estragole. This further improves the tolerability and compatibility of the composition according to the invention and avoids or reduces undesirable side effects associated with estragole.

[0135] Estragole is a phenylpropanoid, specifically an allylphenol, belonging to a group of plant constituents or secondary metabolites, making it a natural component of many plants. However, under certain circumstances, estragole can be carcinogenic or mutagenic. The Committee on Herbal Medicinal Products (HMPC), a scientifically based panel of the European Medicines Agency that develops monographs for herbal medicinal products, has not derived a generally applicable limit value from its toxicological assessment, which also considered estragole intake via food. However, it has emphasized that the intake of estragole from (herbal) medicinal products should generally be kept as low as possible.The maximum recommended intake is 0.05 mg estragole per day for adults and 1 µg per kg body weight for children.

[0136] The present invention therefore also focuses on a technical solution whereby the estragole content of the composition according to the invention is further reduced or whereby the composition is essentially free of estragole, as previously stated.

[0137] In other words, according to the invention, it can be such that the anise oil is a nature-identical anise oil or that the star anise oil is a nature-identical star anise oil.

[0138] To further mask bitterness, additional measures can be taken or ingredients incorporated—in combination with or as a supplement to the aforementioned measures—especially individually or in targeted combinations. For example, sweeteners and sweetening agents, such as cyclamates like sodium cyclamate or stevia, can be used to mask the unwanted bitter taste. Certain flavorings, particularly fruit flavorings, can also be used to mask the unwanted bitter taste or increase palatability (e.g., fruit flavorings of blackcurrant, lemon, orange, etc., for example, in the form of lemon or orange oil). Certain substances that form complexes with bitter substances can also mask their taste. Furthermore, lipophilic substances, such as certain fats or oils, can also be used to mask the unwanted bitter taste.to positively alter the taste perception. Furthermore, hydrocolloids, such as gelatin or xanthan gum, or certain polymers, such as polyvinylpyrrolidone (PVP), can be used to block or mask the bitter taste. Similarly, zinc salts, especially zinc gluconate, can also be used to mask bitterness. Granulation with certain granulating agents, such as silicates (e.g., magnesium trisilicate), can also be used to mask bitterness.

[0139] Furthermore, the composition may contain the ingredient (b) (acidifying agent) in a (relative) (total) amount in the range of 0.01 wt.% to 8 wt.%, in particular in the range of 0.02 wt.% to 6 wt.%, preferably in the range of 0.05 wt.% to 6 wt.%, preferably in the range of 0.03 wt.% to 4 wt.%, most preferably in the range of 0.1 wt.% to 1 wt.%, based on the composition.

[0140] In particular, the composition may contain the ingredient (b) (acidifying agent) in an (absolute) (total) amount in the range of 0.25 mg to 150 mg, particularly in the range of 0.5 mg to 100 mg, preferably in the range of 0.75 mg to 75 mg, preferably in the range of 1 mg to 60 mg, and most preferably in the range of 2 mg to 30 mg.

[0141] According to the invention, it may in particular be provided that (b) the acidifying agent comprises or consists of tartaric acid and / or citric acid, preferably tartaric acid.

[0142] In this context, the composition may contain tartaric acid and / or citric acid, preferably tartaric acid, in a (relative) amount in the range of 0.01 wt.% to 10 wt.%, in particular in the range of 0.1 wt.% to 5 wt.%, preferably in the range of 0.2 wt.% to 1 wt.%, based on the composition.

[0143] In particular, the composition may contain tartaric acid and / or citric acid, preferably tartaric acid, in an (absolute) amount in the range of 0.2 mg to 80 mg, particularly in the range of 0.5 mg to 60 mg, preferably in the range of 0.75 mg to 25 mg.

[0144] According to the invention, it may further be provided in particular that the composition contains the octenidine, in particular its pharmaceutically compatible and / or physiologically compatible salt, in the form of a hydrochloride salt, particularly preferably octenidine dihydrochloride.

[0145] In particular, the octenidine, especially its pharmaceutically compatible and / or physiologically acceptable salt, may be an octenidine hydrochloride salt, most preferably octenidine dihydrochloride.

[0146] In particular, the composition may contain octenidine dihydrochloride as the active ingredient. According to the invention, it is particularly provided that the active ingredient is octenidine dihydrochloride. Specifically, the octenidine, or the active ingredient octenidine, is present in the form of octenidine dihydrochloride.

[0147] The active ingredient octenidine (CAS No.: 71251-02-0) or octenidine dihydrochloride (CAS No.: 70775-75-6) used according to the invention belongs to the group of quaternary ammonium compounds or to the chemical group of bipyridines. Octenidine or octenidine dihydrochloride has two cation-active 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.

[0148] For further details on octenidine or its pharmaceutically compatible and / or physiologically acceptable salts or esters, preferably salts, preferably hydrochloride salts, particularly preferably octenidine dihydrochloride, reference can be made, for example, to Römpp Chemielexikon, 10th edition, volume 4, 1998, Georg-Thieme-Verlag, Stuttgart / New York, page 2986, entry: “Octenidine dihydrochloride”, whereby the entire disclosure content, including the literature mentioned therein, is hereby fully included by reference.

[0149] According to a preferred embodiment of the invention, the composition according to the invention can contain the octenidine, in particular its pharmaceutically compatible and / or physiologically acceptable salt, in the form of a hydrochloride salt, particularly preferably octenidine dihydrochloride. According to a preferred embodiment of the invention, the octenidine, in particular its pharmaceutically compatible and / or physiologically acceptable salt, is an octenidine hydrochloride salt, particularly preferably octenidine dihydrochloride.

[0150] In a particularly preferred embodiment, the composition according to the invention contains octenidine dihydrochloride or octenidine in the form of octenidine dihydrochloride as an antiseptic and / or antimicrobial active ingredient. The use of octenidine dihydrochloride is associated with a particularly high efficacy and a defined spectrum of activity of the composition according to the invention.

[0151] According to the invention, it is particularly the case that the composition according to the invention contains the octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically compatible salt or ester, especially preferably octenidine dihydrochloride, in pharmaceutically and / or therapeutically effective amounts, in particular in pharmaceutically and / or therapeutically antiseptic and / or antimicrobial effective amounts.

[0152] According to the invention, it is therefore particularly provided that the composition contains the octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably hydrochloride salt, particularly preferably octenidine dihydrochloride, in effective, in particular pharmaceutically and / or therapeutically effective, amounts.

[0153] In this regard, the composition may contain octenidine, in particular in the form of a salt or ester, most preferably octenidine dihydrochloride, in a (relative) amount in the range of 0.001 wt.% to 10 wt.%, particularly in the range of 0.005 wt.% to 7.5 wt.%, preferably in the range of 0.01 wt.% to 5 wt.%, more preferably in the range of 0.02 wt.% to 4 wt.%, more preferably in the range of 0.03 wt.% to 2 wt.%, and more preferably in the range of 0.05 wt.% to 1 wt.%, based on the composition.

[0154] In particular, the composition may contain octenidine, especially in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, particularly preferably octenidine dihydrochloride, in an (absolute) amount in the range of 0.05 mg to 25 mg, particularly in the range of 0.1 mg to 20 mg, preferably in the range of 0.2 mg to 15 mg, preferably in the range of 0.3 mg to 10 mg, particularly preferably in the range of 0.5 mg to 8 mg.

[0155] According to the invention, the composition can include further active ingredients or components, whereby the active properties and / or the organoleptic properties of the composition can be further specified or adjusted.

[0156] In particular, the composition may contain at least one local anesthetic.

[0157] This allows the effectiveness of the composition according to the invention to be further increased or tailored. For example, the local anesthetic can be used to specifically treat local pain symptoms associated with the inflammatory disease, particularly in the mouth or throat. This also protects the affected tissue, for example, by reducing throat clearing or normalizing swallowing behavior, and supports the action of octenidine or octenidine dihydrochloride.

[0158] Regarding the local anesthetic that can be used according to the invention, in principle all local anesthetics suitable for topical application can be used. For further details on local anesthetics, reference can be made, for example, to E. Mutschler et al., "Mutschler Arzneimittelwirkungen - Lehrbuch der Pharmakologie und Toxikologie" [Mutschler Drug Effects - Textbook of Pharmacology and Toxicology], 8th edition, Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart, 2001, pages 267 ff., and Römpp Chemielexikon [Römpp Chemistry Lexicon], 10th edition, Volume 3, Georg Thieme Verlag, Stuttgart / New York, 1997, page 2442, entry: "Lokalanästhetika" [Local Anesthetics], as well as the literature referenced therein. In general, local anesthetics reversibly and locally inhibit the excitability of the pain-transmitting sensory end organs and the conductivity of the sensory nerve fibers. As a result, the sensation of pain is temporarily eliminated without impairing consciousness.The effect of local anesthetics on sensory nerve endings is not specific; however, the various excitable structures have different sensitivities. The fact that motor functions do not fail at the dosages typically used for local anesthetics is primarily due to the fact that motor nerve fibers have a larger diameter than sensory nerve fibers, which are important for pain transmission.

[0159] According to the invention, the local anesthetic can be a local anesthetic based on an organic acid ester or acid amide, preferably an acid amide, in particular wherein the local anesthetic is selected from the group of ester-type local anesthetics and amide-type local anesthetics as well as their combinations and mixtures, preferably amide-type local anesthetics.

[0160] Furthermore, the local anesthetic may be selected from the group consisting of benzocaine, procaine, tetracaine, lidocaine, etidocaine, prilocaine, mepivacaine, bupivacaine and S-ropivacine and their salts and esters, as well as their combinations and mixtures, in particular lidocaine and its pharmaceutically compatible and / or physiologically acceptable salts and esters, preferably lidocaine hydrochloride.

[0161] In particular, according to the invention, the local anesthetic can be selected from the group consisting of lidocaine (2-diethylamino-N-(2,6-dimethylphenyl)acetamide) and its pharmaceutically compatible and / or physiologically compatible salts and esters, preferably lidocaine hydrochloride.

[0162] In particular, the composition may contain lidocaine (2-diethylamino-N-(2,6-dimethylphenyl)acetamide) and / or its pharmaceutically compatible and / or physiologically acceptable salts and / or esters, preferably lidocaine hydrochloride, especially as a local anesthetic.

[0163] Lidocaine is a local anesthetic of the amide type, specifically of the aminoamide type, which exhibits good local efficacy combined with a rapid onset of action and good tolerability. Lidocaine reversibly blocks voltage-gated sodium channels in the cell membranes of nerve cells. Specifically, lidocaine inhibits the influx of sodium ions through voltage-gated sodium channels into nerve cells, leading to reduced excitability of nerve fibers because the increase in sodium permeability required for the generation of an action potential is diminished. This reduces the perception of pain.

[0164] In particular, the local anesthetic can be selected from the group consisting of lidocaine and its pharmaceutically compatible and / or physiologically compatible salts and esters. According to a preferred embodiment of the invention, the local anesthetic is used in the form of lidocaine hydrochloride. Compared to lidocaine, lidocaine hydrochloride exhibits a particularly high water solubility. This further improves the release of the active ingredient upon contact with liquid or saliva—without relying on or limiting ourselves to this theory—which also leads to improved efficacy. It should also be noted that—again, without relying on or limiting ourselves to this theory—the inflamed tissue present in the diseases of the mouth and throat, particularly as a result of local lactic acidosis, has a lower pH value compared to normal or non-inflamed tissue.Lidocaine hydrochloride also exhibits good penetration properties for this reason, since the protonated form is already present.

[0165] According to the invention, the composition can contain the local anesthetic, in particular lidocaine and / or its pharmaceutically compatible and / or physiologically compatible salts and / or esters, preferably lidocaine hydrochloride, in pharmaceutically and / or therapeutically effective amounts, in particular in pharmaceutically and / or therapeutically effective local anesthetic amounts.

[0166] In particular, the composition may contain the local anesthetic, especially lidocaine and / or its pharmaceutically compatible and / or physiologically compatible 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.

[0167] In particular, the composition may contain the local anesthetic, especially lidocaine and / or its pharmaceutically compatible and / or physiologically compatible salts and / or esters, preferably lidocaine hydrochloride, in an (absolute) amount in the range of 0.1 mg to 50 mg, especially 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.

[0168] For further information on lidocaine, reference can be made, for example, to RÖMPP Chemielexikon, 10th edition, Volume 3, 1997, Georg Thieme-Verlag, Stuttgart / New York, entry: "Lidocaine," as well as to the literature referenced therein, the entire content of which is hereby fully included by reference. Reference can also be made to the information in Lidocaine Hydrochloride, European Pharmacopoeia (Ph. Eur.), 9th edition (January 2017). Furthermore, with regard to lidocaine, reference can be made to the information in European Pharmacopoeia 8.0, European Directorate for the Quality of Medicines and Healthcare, pages 2620 / 2621, entry: "Lidocaine." Furthermore, with regard to lidocaine hydrochloride, reference can be made to European Pharmacopoeia 8.0, European Directorate for the Quality of Medicines and Healthcare, pages 2620 / 2621, keyword: “Lidocaine Hydrochloride”.

[0169] Benzocaine can be used as a local anesthetic in the composition according to the invention. The applicant has surprisingly discovered that, within the context of the composition according to the invention, benzocaine, together with octenidine or octenidine dihydrochloride, exhibits a high efficacy. Without wishing to commit to or limit oneself to a specific theory, the particularly good effect of benzocaine, a neutral non-ionizable primary amine, can possibly be attributed to the fact that the blockage of nerve impulse conduction caused by benzocaine is based on the fact that the normal membrane structure is disintegrated by the "incorporation" of benzocaine into the lipid phase, thereby indirectly leading to a blockage of the sodium channel; that is, this mechanism of action differs from that of other local anesthetics of the classical type.This different mechanism of action is important insofar as inflamed tissue has a lower pH value compared to normal tissue as a result of local lactic acidosis, but this does not negatively affect the penetration of benzocaine, thus counteracting a loss of efficacy.

[0170] The composition according to the invention may also include the following active ingredients: Furthermore, according to the invention, the composition may contain at least one anti-inflammatory agent, in particular benzydamine and / or its pharmaceutically compatible and / or physiologically compatible salts and / or esters, preferably benzydamine hydrochloride.

[0171] In this regard, the composition may contain the anti-inflammatory agent, in particular benzydamine and / or its pharmaceutically compatible and / or physiologically acceptable salts and / or esters, preferably benzydamine hydrochloride, in pharmaceutically and / or therapeutically effective amounts, in particular in pharmaceutically and / or therapeutically anti-inflammatory amounts.

[0172] In particular, the composition may contain the anti-inflammatory agent, especially benzydamine and / or its pharmaceutically compatible and / or physiologically acceptable salts and / or esters, preferably benzydamine hydrochloride, in a (relative) amount in the range of 0.001 wt.% to 10 wt.%, particularly 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.

[0173] Furthermore, the composition may contain the anti-inflammatory agent, in particular benzydamine and / or its pharmaceutically compatible and / or physiologically acceptable salts and / or esters, preferably benzydamine hydrochloride, in an (absolute) amount 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.

[0174] Benzydamine is a benzylated indazole derivative belonging to the class of anti-inflammatory drugs. It exhibits anti-inflammatory, analgesic, and mildly antimicrobial properties. When used in conjunction with the other active ingredients, the composition according to the invention can effectively treat pain and irritation in the mouth and throat, particularly in the context of symptomatic relief. Furthermore, the symptoms associated with inflammatory diseases or infections can be alleviated, especially since benzydamine also has antipyretic properties.

[0175] Furthermore, the composition may also contain at least one non-steroidal anti-inflammatory drug (NSAID), in particular wherein the non-steroidal anti-inflammatory drug (NSAID) is selected from the group consisting 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; and / or wherein the composition contains flurbiprofen and / or its pharmaceutically compatible and / or physiologically acceptable salts and / or esters, preferably flurbiprofen.

[0176] In this regard, the composition may contain the non-steroidal anti-inflammatory drug (NSAID active ingredient), in particular flurbiprofen and / or its pharmaceutically compatible and / or physiologically acceptable salts and / or esters, preferably flurbiprofen, in pharmaceutically and / or therapeutically effective amounts, in particular in pharmaceutically and / or therapeutically effective non-steroidal anti-inflammatory amounts.

[0177] In this context, the composition may contain the non-steroidal anti-inflammatory drug (NSAID active ingredient), in particular flurbiprofen and / or its pharmaceutically compatible and / or physiologically acceptable 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.

[0178] Furthermore, the composition may contain the non-steroidal anti-inflammatory drug (NSAID active ingredient), in particular flurbiprofen and / or its pharmaceutically compatible and / or physiologically acceptable salts and / or esters, preferably flurbiprofen, in an (absolute) amount 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.

[0179] Flurbiprofen, which is preferably used as a non-steroidal anti-inflammatory drug (NSAID) within the scope of the present invention, is generally classified as belonging to the group of phenylalkanoic acid derivatives of NSAIDs. Flurbiprofen is attributed with anti-inflammatory, analgesic, and decongestant properties. In particular, it can be used for targeted local treatment of sore throats and pain in the mouth and throat, equally in combination with the other active ingredients of the composition according to the invention.

[0180] Furthermore, according to the invention, the composition may contain at least one mucilage drug and / or its extract.

[0181] In this context, the composition may contain the mucilage drug or its extract in a (relative) amount in the range of 0.001 wt.% to 20 wt.%, in particular in the range of 0.01 wt.% to 15 wt.%, preferably in the range of 0.05 wt.% to 10 wt.%, based on the composition.

[0182] Furthermore, the composition may contain the mucilage drug or its extract in an (absolute) amount in the range of 0.25 mg to 200 mg, in particular in the range of 0.5 mg to 100 mg, preferably in the range of 0.75 mg to 50 mg.

[0183] In this regard, the mucilage drug or its extract may 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.) as well as their combinations and mixtures, preferably Iceland moss (Lichen islandicus) and / or marshmallow (Althaea officinalis L.).

[0184] Furthermore, the mucilage drug can be used or present in the form of the drug itself, particularly in the form of crushed or powdered plant parts or components. It can also be used or present in the form of an extract, particularly a dry extract.

[0185] Regarding the mucilage drug optionally used according to the invention, it can be added to the composition in the form of the drug itself, particularly in the form of crushed or powdered plant parts or components. Furthermore, the mucilage drug can be used in the form of an extract, particularly a dry extract, which is available, for example, from an aqueous, alcoholic, or aqueous-alcoholic extract of the drug. Using an extract of a mucilage drug offers the advantage over using the drug itself that high concentrations of the mucilage drug can be used, thus enabling a particularly good effect.

[0186] Mucilaginous drugs and their extracts have a particularly soothing and protective effect. They also reduce the urge to cough (antitussives). Furthermore, mucilaginous drugs can exhibit independent antimicrobial and antibacterial activity. They also possess film-forming properties, allowing an antimicrobial and antibacterial protective film to form in the mouth and throat. This film-forming property can also lead to the embedding of the active ingredient octenidine or octenidine dihydrochloride within the film in the mouth and throat, thus prolonging its contact time.

[0187] The respective mucilaginous drugs and their extracts are known to experts. For further details on mucilaginous drugs and their preparations, effects, and applications, reference can be made to H. Wagner, "Pharmaceutical Biology - Drugs and their Constituents," Gustav Fischer Verlag, Stuttgart / New York, 1985, especially pages 280 ff.

[0188] According to the invention, it can also be provided that the composition contains propylene glycol.

[0189] In particular, the composition may contain propylene glycol in a (relative) amount in the range of 0.001 wt.% to 5 wt.%, especially 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.

[0190] Furthermore, the composition may contain propylene glycol in an (absolute) amount 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 10 mg.

[0191] Propylene glycol can further optimize the underlying matrix of the composition, particularly with regard to the incorporation of the active ingredients. Furthermore, propylene glycol itself can exhibit antimicrobial activity, which supports the efficacy of the composition according to the invention in treating inflammatory diseases of the mouth and throat.

[0192] Furthermore, the composition may contain at least one rheology and / or consistency and / or wetting modifier and / or soft consistency enhancer, in particular wherein the rheology and / or wetting modifier and / or soft consistency enhancer is selected from the group of mucilages; carrageenans, preferably lota-carrageenan; in particular acidic glycosaminoglycans, preferably hyaluronic acid and its pharmaceutically compatible and / or physiologically acceptable salts, preferably sodium hyaluronate; poloxamers; polysorbates; xanthan gums; gelling agents, in particular organic gelling agents and natural or synthetic gelling agents; thixotropic consistency and / or rheology additives, in particular silicic acids; polyalkylene glycols, preferably polyethylene glycol and polypropylene glycol, preferably polypropylene glycol; gum arabic; locust bean gum; galactomannans; guar gum; guarans; polysaccharides; agar agar;Gum arabic, gelatin and pectins, as well as combinations and mixtures thereof;

[0193] In this regard, the composition may contain the rheology, consistency, or wetting modifier and / or the soft consistency former in a (relative) amount in the range of 0.1 wt.% to 20 wt.%, in particular in the range of 0.5 wt.% to 10 wt.%, preferably in the range of 1 wt.% to 5 wt.%, based on the composition.

[0194] In particular, the composition may contain the rheology, consistency, or wetting modifier and / or the soft consistency former in an (absolute) amount in the range of 1 mg to 1,000 mg, particularly in the range of 3 mg to 500 mg, preferably in the range of 5 mg to 250 mg.

[0195] The rheology and / or consistency and / or wetting modifier or the soft consistency enhancer, when administered to the mouth and throat, can also lead to an increased mucoadhesive effect and thus to a longer contact time between the composition and the active ingredient with the underlying tissue or mucous membranes. This is accompanied by a prolonged exposure time of the active substances as well. In this context, for example, hyaluronic acid, in particular sodium hyaluronate, or polypropylene glycol, or a mucilage can be used. In particular, this can also counteract the sensation of a dry mouth or throat. In particular, an antimicrobial or antibacterial (protective) film or barrier can also be generated on the oral or pharyngeal mucosa using the aforementioned substances.

[0196] Furthermore, the galenic properties of the composition according to the invention can be specifically designed or tailored based on the rheology and / or consistency and / or wetting modifying agent or soft consistency former. For example, with regard to the formation of the composition as a soft caramel, soft consistency formers in the form of gum arabic, guar gum, agar-agar, gelatin or the like can be used.

[0197] The composition according to the invention may also contain at least one further active ingredient and / or component, in particular a 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 buffers, thickeners, flavorings, antiseptics, colorings, buffers, odorants, fragrances, extenders, binders, wetting agents and / or preservatives as well as their combinations and mixtures.

[0198] In this regard, the composition may contain the further active ingredient or component in a (relative) amount in the range of 0.01 wt.% to 15 wt.%, particularly in the range of 0.1 wt.% to 10 wt.%, preferably in the range of 0.5 wt.% to 5 wt.%, based on the composition.

[0199] In particular, the composition may contain the further active ingredient in an (absolute) amount in the range of 0.1 mg to 500 mg, especially in the range of 1 mg to 250 mg, preferably in the range of 5 mg to 100 mg.

[0200] According to one embodiment of the invention, the composition can also be such that it contains at least substantially no phenoxyethanol (2-phenoxyethanol) or that the composition is at least substantially free of phenoxyethanol (2-phenoxyethanol); and / or wherein the composition is present in the absence of phenoxyethanol (2-phenoxyethanol). This is because the applicant has surprisingly found that the use of octenidine, or in the form of its salts or esters, particularly preferably octenidine dihydrochloride, is associated with excellent antiseptic and antimicrobial (including antiviral) activity. This allows for a further optimized spectrum of activity with minimal side effects.

[0201] However, it is also possible in principle for the composition to contain phenoxyethanol (2-phenoxyethanol).

[0202] In this regard, the composition may contain phenoxyethanol (2-phenoxyethanol) 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.

[0203] Furthermore, the composition may contain phenoxyethanol (2-phenoxyethanol) in an (absolute) amount in the range of 1 mg to 200 mg, in particular in the range of 5 mg to 100 mg, preferably in the range of 7.5 mg to 60 mg.

[0204] Furthermore, according to the invention, it is particularly provided that the composition contains at least substantially no n-propanol (propan-1-ol) and / or at least substantially no isopropanol and / or at least substantially no ethanol, and in particular at least substantially no primary alcohol. In particular, it is provided according to the invention that the composition is at least substantially free of n-propanol (propan-1-ol) and / or at least substantially free of isopropanol and / or at least substantially free of ethanol, and in particular at least substantially free of a primary alcohol. Specifically, the composition is present in the absence of n-propanol (propan-1-ol) and / or in the absence of isopropanol, and in particular in the absence of a primary alcohol. This also improves the tolerability of the composition according to the invention.

[0205] As regards the composition according to the invention, it is in particular present as a solid dosage or is designed as a solid dosage form. The information concerning the solid state of the composition according to the invention generally refers to the composition as it is formed (in an air environment) at room temperature (20°C) and ambient pressure (1013.25 hPa).

[0206] In particular, the composition according to the invention can be in the form of a fixed dosage (fixed dosage form) in the form of a tablet, a dragee, a pill, a lozenge, a granule, a chewable tablet, a chewing gum, a melt-in-the-mouth tablet, a film-coated tablet, a lozenge or the like, especially in the form of a lozenge, preferably hard caramel or soft caramel, preferably hard caramel.

[0207] In particular, the composition, especially fixed dosage (fixed dosage form), may be in the form of a tablet, coated tablet, pill, lozenge, granules, chewable tablet, chewing gum, orodispersible tablet, film-coated tablet, lozenge or the like, especially lozenge, preferably hard caramel or soft caramel, preferably hard caramel.

[0208] According to the invention, it is particularly provided that the composition releases the active ingredient or ingredients upon topical or oral application, especially in the mouth and throat, which can occur, for example, by dissolving the composition, as is the case in particular with a lozenge or the like.

[0209] In particular, the composition, especially the fixed dosage form, preferably the tablet, the dragee, the pill, the lozenge, the granules, the chewing gum, the orodispersible tablet, the film-coated tablet or the lozenge, especially lozenge, preferably hard caramel or soft caramel, preferably hard caramel, may have a total weight in the range of 0.5 g to 7 g, especially in the range of 1 g to 6 g, preferably in the range of 2 g to 5 g.

[0210] According to the invention, it can be provided in particular that the composition, especially the fixed dosage (solid dosage form), is a lozenge, preferably in the form of a hard caramel or soft caramel, preferably hard caramel.

[0211] Furthermore, the composition, in particular the fixed dosage (fixed dosage form), can be based on lozenges or be in the form of a lozenge, preferably hard or soft caramel, preferably hard caramel, in particular such that the composition, in particular the fixed dosage (fixed dosage form), releases a therapeutically effective amount of active ingredients and / or components, preferably octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride, when sucked and / or chewed, preferably when the composition, in particular the fixed dosage (fixed dosage form), is administered and / or sucked and / or chewed in the mouth and throat of a patient.

[0212] According to the invention, the composition can further contain at least one excipient (carrier), preferably a pharmacologically and / or physiologically harmless excipient (carrier). This allows the composition according to the invention to be further adjusted or tailored with regard to its formulation.

[0213] In particular, the composition, especially the fixed dosage form, can contain at least one sugar and / or at least one sugar substitute, particularly as a matrix (matrix former) and / or as an excipient (carrier), preferably pharmacologically and / or physiologically harmless excipients (carriers). This allows the composition according to the invention to be further adjusted or tailored with regard to its formulation, especially concerning the formation of the matrix underlying the fixed dosage form. Based on this, the drug release or drug availability can also be specifically adjusted or controlled.

[0214] Sugars of all kinds and / or sugar substitutes of all kinds are particularly suitable as a matrix or mass for the storage of the active ingredients and other substances.

[0215] In particular, the sugar may be selected from the group consisting of sucrose, glucose, especially dextrose, and fructose.

[0216] Furthermore, 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 their combinations and mixtures, particularly preferably isomalt and / or mannitol, most preferably isomalt.

[0217] Preferably, the composition, in particular the fixed dosage (solid dosage form), may comprise the active ingredients and / or other ingredients in a solid matrix, in particular in a matrix based on sugars and / or sugar substitutes, especially as defined above.

[0218] In general, the composition according to the invention, in particular the solid dosage form, contains the active ingredients and / or other ingredients in a solid matrix or mass. The active ingredients and / or other ingredients are thus incorporated or embedded in a matrix, so that they are effectively protected and, in particular, homogeneously distributed.

[0219] According to the invention, it is therefore particularly provided that the composition, in particular the fixed dosage (solid dosage form), comprises the active ingredients and / or components 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 defined above.

[0220] In particular, the composition, especially the fixed dosage (solid dosage form), may contain or incorporate or embed all active ingredients, especially octenidine, particularly in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride, and the ingredients (a), in particular ingredients (a)(i), (a)(ii) and (a)(iii), and (b) and optionally all other active ingredients and / or ingredients in the solid matrix.

[0221] According to the invention, the composition, in particular the fixed dosage (solid dosage form), can contain 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 based on the fixed dosage (solid dosage form).

[0222] In particular, the sugars and / or sugar substitutes form the matrix and / or the solid mass of the composition present as a solid dosage (solid dosage form). Thus, the amount of matrix mass (i.e., sugars and / or sugar substitutes) can generally be in the range of 50 wt.% to 99.95 wt.%, particularly in the range of 70 wt.% to 99.5 wt.%, preferably in the range of 80 wt.% to 99.25 wt.%, and more preferably in the range of 90 wt.% to 99 wt.%, based on the composition, and especially based on the solid dosage (solid dosage form).

[0223] Furthermore, the composition, in particular the fixed dosage (fixed dosage form), may contain the sugar and / or the sugar substitute in an (absolute) amount in the range of 250 mg to 6,950 mg, in particular in the range of 500 mg to 5,950 mg, preferably in the range of 1,000 mg to 4,950 mg.

[0224] In particular, the composition, especially the fixed dosage (solid dosage form), may contain sugar in a (relative) amount in the range of 50 wt.% to 99.95 wt.%, especially in the range of 70 wt.% to 99.5 wt.%, preferably in the range of 80 wt.% to 99.25 wt.%, more preferably in the range of 90 wt.% to 99 wt.%, based on the composition, especially based on the fixed dosage (solid dosage form), and / or wherein the composition, especially the fixed dosage (solid dosage form), contains the sugar substitute in a (relative) amount in the range of 50 wt.% to 99.95 wt.%, especially in the range of 70 wt.% to 99.5 wt.%, more preferably in the range of 80 wt.% to 99.25 wt.%, more preferably in the range of 90 wt.% to 99 wt.%, based on the composition, especially based on the fixed dosage (solid dosage form).

[0225] According to the invention, the composition, in particular the fixed dosage (solid dosage form), can also contain at least one sugar substitute, in particular as a matrix (matrix former) and / or as an excipient (carrier), preferably pharmacologically and / or physiologically harmless excipients (carriers).

[0226] In this context, the sugar substitute should 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 their combinations and mixtures, particularly preferably isomalt and / or mannitol, most preferably isomalt. Based on this, reduced-calorie, tooth-friendly, or non-cariogenic compositions can be provided.

[0227] While sugar and sweeteners are collectively referred to as sweeteners, sugar substitutes—unlike the intensely flavored sweeteners—are used technologically like sucrose, meaning they possess a "body" and a physiological energy value ("nutritive sugar substitutes"). Their sweetness is roughly equivalent to that of sucrose. The physiological advantage of sugar substitutes compared to sucrose lies in their insulin-independent metabolism (advantageous, for example, for diabetics) and their partially reduced cariogenic effect. For some sugar substitutes (e.g., xylitol), an anti-cariogenic effect has been described.

[0228] The term "sugar alcohol" is the group name for polyhydroxy compounds formed from monosaccharides by the reduction of the carbonyl group. These compounds are not sugars, yet they taste sweet and can therefore be used as sugar substitutes. These generally crystalline, water-soluble polyols are classified according to the number of hydroxyl groups they contain, such as tetrites, pentites, hexites, etc. Naturally occurring sugar alcohols include glycerol, threitol, erythritol, adonite (ribitol), arabite (formerly lyxite), xylitol, dulcite (galactite), mannitol, and sorbitol (glucite).

[0229] For further details on the terms "sugar", "sugar substitutes" and "sugar alcohols", reference can be made, for example, to Römpp ChemieLexikon, 10th edition, volume 6, Georg Thieme Verlag, Stuttgart / New York, 1999, pages 5096 to 5100, keywords: "sugar", "sugar alcohols" and "sugar substitutes".

[0230] In particular, the composition, especially the fixed dosage (solid dosage form) and / or the matrix, may be at least substantially free of sucrose.

[0231] Furthermore, the composition, in particular the fixed dosage (fixed dosage form) and / or the matrix, can be at least substantially free of disaccharides.

[0232] According to the invention, the composition, in particular the fixed dosage (fixed dosage form) and / or the matrix, can be at least substantially free of sugar(s).

[0233] In this context, the composition, in particular the fixed dosage (fixed dosage form) and / or the matrix, can be at least essentially sugar-free.

[0234] According to the invention, the composition, in particular the fixed dosage (solid dosage form) and / or the matrix, may contain sucrose in amounts of at most 1 wt.%, in particular in amounts of at most 0.5 wt.%, preferably in amounts of at most 0.1 wt.%, particularly preferably in amounts of at most 0.01 wt.%, based on the composition, in particular based on the fixed dosage (solid dosage form) and / or the matrix.

[0235] In particular, the composition, especially the fixed dosage (solid dosage form) and / or the matrix, may contain disaccharide(s) in amounts of at most 1 wt.%, in particular in amounts of at most 0.5 wt.%, preferably in amounts of at most 0.1 wt.%, particularly preferably in amounts of at most 0.01 wt.%, based on the composition, in particular based on the fixed dosage (solid dosage form) and / or the matrix.

[0236] Furthermore, the composition, in particular the fixed dosage (solid dosage form) and / or the matrix, may contain sugar in amounts of at most 1 wt.%, in particular in amounts of at most 0.5 wt.%, preferably in amounts of at most 0.1 wt.%, particularly preferably in amounts of at most 0.01 wt.%, based on the composition, in particular based on the fixed dosage (solid dosage form) and / or the matrix.

[0237] According to the invention, it can also be provided that the composition, in particular the solid dosage (solid dosage form), has 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 based on the solid dosage (solid dosage form).

[0238] In particular, the composition, especially the solid dosage (solid dosage form), may have a residual moisture content in the range of 0.1 wt.% to 10 wt.%, particularly in the range of 0.5 wt.% to 5 wt.%, preferably in the range of 1 wt.% to 3 wt.%, based on the composition, particularly based on the solid dosage (solid dosage form).

[0239] In conjunction 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 a solid dosage or solid dosage form. Furthermore, the (storage) stability is increased.

[0240] The applicant has found that the active ingredient octenidine and / or its salts or esters or octenidine dihydrochloride, in the form of a solid pharmaceutical preparation, preferably for lozenging, particularly in the form of a lozenge, exhibits optimal efficacy with regard to the prophylactic or therapeutic topical treatment of the underlying inflammatory diseases of the mouth and throat. Without limiting itself to or relying on this theory, the concept according to the invention, in which the composition is provided as a solid dosage or in a solid dosage form, particularly in the form of a lozenge, is associated with an optimized release behavior of the active ingredient, both with regard to the time-related release quantity or rate and the duration of action, so that the efficacy is also improved accordingly.

[0241] Solid dosage forms, particularly for lozenges, with the incorporation of active ingredients and / or other substances into a solid matrix or mass, offer several advantages in this context: Firstly, this allows for more precise dosing of the active ingredients and other substances, resulting in improved dosage accuracy. Secondly, it improves the ease of application and administration, meaning that patients can take the medication virtually anywhere (e.g., while traveling, outdoors, etc.) since no special preparations need to be mixed. Furthermore, solid dosage forms offer the advantage that the active ingredients in solid preparations are generally stable over time. Finally, solid dosage forms ensure a defined residence time in the mouth and throat, thus enabling efficient and controlled therapy.Finally, the fixed dosage or fixed dosage form, in particular through the incorporation of the active ingredients into the matrix, enables an improved combination with other active ingredients and a uniform, homogeneous distribution across the matrix, which also benefits a uniform release.

[0242] The pharmaceutical potential of octenidine or octenidine dihydrochloride with regard to the topical treatment of inflammatory diseases of the mouth and throat is thus fully realized in the composition according to the invention with its fixed dosage or fixed dosage form for lozenges, while simultaneously optimizing its organoleptic and gustatory properties. This insight originates with the applicant. It was the applicant who first formulated the active ingredient octenidine or octenidine dihydrochloride in the form of a solid galenic preparation, preferably for lozenges, particularly in the form of a lozenge, also with a view to specifically masking the unpleasant bitter taste. In this way, the potential of octenidine, and in particular octenidine dihydrochloride, with regard to its antibacterial and antiviral properties, is fully realized.The antifungal effect is optimally utilized with improved acceptance and compatibility of the composition, making it ideal for the topical treatment of inflammatory diseases of the mouth and throat.

[0243] The fixed dosage or fixed dosage form of the composition according to the invention, particularly for lozenges, also results in improved incorporation of ingredient (a) (flavor modulator) or ingredient (b) (acidifying agent). In particular, this allows for a uniform release of ingredients (a) and / or (b) in the mouth or throat upon topical or oral administration, thus ensuring optimal masking of the bitter taste associated with octenidine or octenidine dihydrochloride. Therefore, the invention also provides an optimal improvement in the organoleptic properties and / or taste of the composition according to the invention.

[0244] According to the invention, the inflammatory diseases of the mouth and throat can be selected from sore throats, hoarseness, catarrh, colds, viral and / or bacterial infections, tonsillitis, in particular angina, gingivitis, pharyngitis, stomatitis, periodontitis, tonsillitis, laryngitis, oral mucosa lesions such as aphthous ulcers, or the like.

[0245] The term “inflammatory diseases of the mouth and throat” as used in the invention is to be understood in a particularly broad sense within the scope of the present invention and includes in particular all inflammatory diseases that can occur in the area of ​​the oral cavity, the throat and the neck.

[0246] For further details on the aforementioned diseases, reference can be made, for example, to Roche-Lexikon Medizin, 3rd edition, 1993, Urban & Schwarzenberg, Munich / Vienna / Baltimore, as well as to Pschyrembel, medizinisches Wörterbuch, 257th edition, 1993, Nikol Verlagsgesellschaft mbH, Hamburg.

[0247] Furthermore, with regard to the composition according to the invention, the octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly 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.

[0248] The composition according to the invention, in particular the pharmaceutical composition, is ideally suited for the prophylactic and curative topical treatment of inflammatory diseases of the mouth and throat, especially also for the purpose of disinfecting the mouth and throat, for example in cases of sore throat, hoarseness, catarrh, colds, viral infections, tonsillitis, inflammation of the mouth and throat, and gums. Within its indications, the pharmaceutical composition according to the invention is effective against typical bacteria, such as Staphylococcus aureus, Escherichia coli, Streptococcus pyogenes, Pseudomonas aeruginosa, Streptococcus pneumoniae, Streptococcus mutans, Streptococcus sanguis, and Haemophilus influenzae, as well as against typical tonsillitis viruses, such as adenoviruses and herpesviruses, and in particular also against coronaviruses, such as SARS-CoV-2.In particular, the composition according to the invention also has an antifungal effect.

[0249] The composition according to the invention can be produced in a manner known per se. For further details, reference can also be made to the following exemplary embodiments.

[0250] In the production of lozenges, for example those based on hard caramels, the following procedure can be used: first, the active ingredients and other components – possibly after grinding – are weighed out and then mixed into the previously heated base substance based on sugars or sugar substitutes (e.g., isomalt), followed by forming lozenges and subsequent cooling. Such manufacturing processes are well known to those skilled in the art.

[0251] The production of hard candies can typically be carried out as follows: In the production of lozenges according to the invention, particularly in the form of hard candies, the sugar or sugar substitutes are first dissolved in water, then heated to temperatures (e.g., between 120 and 140 °C), and finally vacuum-sealed. The active ingredients, i.e., octenidine or octenidine dihydrochloride, as well as ingredients (a) and (b), and optionally further ingredients, such as local anesthetic, mucilaginous drugs or their extracts, colorings, flavorings, 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 approximately 75 °C), the hard candies can be embossed in the desired shape. The shapes can be, for example, round, oval, oblong, polygonal, etc., 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 collectively in bags or pouches.

[0252] According to the present aspect, the present invention also relates to the following compositions, which are likewise available in the form of a fixed dosage (solid dosage form) for sucking or chewing, preferably for sucking, in particular in the form of a lozenge: According to the present aspect, the invention also relates to the composition according to the invention, in particular a pharmaceutical composition, in the form of a fixed dosage (solid dosage form) for sucking and / or chewing, preferably for sucking, in particular a lozenge, preferably for use in the prophylactic and / or therapeutic topical treatment of inflammatory diseases of the mouth and throat, in particular as a composition as defined above, wherein the composition contains an effective, in particular pharmaceutically and / or therapeutically effective, amount of an active ingredient preferably suitable and / or effective for the topical treatment of inflammatory diseases of the mouth and throat, in particular with antiseptic and / or antimicrobial properties, preferably with antibacterial and / or antiviral and / or antifungal properties. wherein the active ingredient is incorporated and / or embedded in a solid matrix, wherein the composition, in particular the fixed dosage (solid dosage form) and / or the matrix, releases the active ingredient upon topical application and / or use, preferably by sucking and / or chewing, preferably by sucking, in the oral and pharyngeal cavity; wherein the active ingredient is octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride; and wherein the composition, in particular the fixed dosage (solid dosage form) and / or the matrix, furthermore and / or additionally contains at least one further ingredient (a) and / or (b), in particular (a) and (b), wherein the at least one further ingredient (a) and / or (b) is selected from the group of (a) Flavor modulators, in particular selected from the group of the following components (i), (ii) and / or (iii): (i) Bitter (taste) masking agents, in particular selected from the group consisting of bitter taste receptor antagonists, preferably 4-(2,2,3-trimethylcyclopentyl)butanoic acid, and saponins, preferably glycyrrhizic acid (glycyrrhizin) and its salts or esters and / or glycyrrhetinic acid (glycyrrhetin) and its salts or esters, complexing agents, in particular cyclodextrins, and combinations or mixtures thereof, (ii) Bitter substances, in particular coffee extract and / or tea extract and / or their respective bitter substances, preferably coffee extract and / or its bitter substances, (iii) preferably natural or nature-identical (aroma) oils and / or essential oils, in particular with antiseptic and / or antimicrobial properties, preferably with antibacterial, antifungal and / or antiviral properties, in particular selected from the group of anise oils, in particular star anise oil, peppermint oil, eucalyptus oil, lavender oil, tea tree oil, chamomile oil, clove oil, rosemary oil, caraway oil, cinnamon oil, sage oil and fennel oil, as well as combinations or mixtures thereof; in particular wherein the ingredient (a) and / or the flavor modulator comprises a combination of at least two different components (i), (ii) and / or (iii), preferably a combination of components (i), (ii) and (iii); (b) Acidulants, in particular saliva-stimulating and / or flavor-enhancing acidulants, preferably acidulants authorized under pharmaceutical and / or food law and / or acidulants authorized as pharmaceutical additives and / or as food additives, in particular selected from the group of tartaric acid and its salts, in particular sodium tartrate, sodium potassium tartrate (Rochelle salt) and calcium tartrate, citric acid and its salts, metatartaric acid, fumaric acid, ascorbic acid, phosphoric acid and its salts, stannous chloride, in particular tin(II) chloride, malic acid, lactic acid, adipic acid, succinic acid and other pharmaceutically compatible and / or physiologically acceptable organic acids and their salts, as well as their combinations or mixtures; wherein the composition is in the form of a lozenge, in particular on a hard caramel base or as a hard caramel or on a soft caramel base or as a soft caramel, preferably on a hard caramel base or as a 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, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride, in an (absolute) amount in the range of 0.05 mg to 25 mg, in particular in the range of 0.1 mg to 20 mg, preferably in the range of 0.2 mg to 15 mg, preferably in the range of 0.3 mg to 10 mg, particularly preferably in the range of 0.5 mg to 8 mg; - Ingredient (a) (flavor modulator) in an (absolute) (total) amount in the range of 0.1 mg to 250 mg, in particular in the range of 0.5 mg to 200 mg, preferably in the range of 1 mg to 150 mg, preferably in the range of 2 mg to 100 mg, particularly preferably in the range of 5 mg to 50 mg; - Ingredient (b) (acidifying agent) in an (absolute) (total) amount in the range of 0.25 mg to 150 mg, in particular in the range of 0.5 mg to 100 mg, preferably in the range of 0.75 mg to 75 mg, preferably in the range of 1 mg to 60 mg, particularly preferably in the range of 2 mg to 30 mg; - optionally at least one rheology and / or wetting modifier and / or soft consistency agent, in particular wherein the rheology and / or wetting modifier and / or soft consistency agent is selected from the group consisting of mucilages, carrageenans, preferably iota-carrageenan, in particular acidic glycosaminoglycans, preferably hyaluronic acid and its pharmaceutically compatible and / or physiologically acceptable salts, preferably sodium hyaluronate, poloxamers, xanthan gums, gelling agents, polyalkylene glycols, preferably polyethylene glycol and polypropylene glycol, preferably polypropylene glycol, gum arabic, locust bean gum, galactomannans, guar gum, guarans, polysaccharides, agar-agar, gum arabic, gelatin and pectins, as well as their combinations and mixtures, in an (absolute) amount in the range of 1 mg to 1,000 mg, particularly in the range of 3 mg to 500 mg, preferably in the range of 5 mg to 250 mg; - optionally at least one further active ingredient and / or component, in particular a 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 buffers, thickeners, flavorings, antiseptics, colorings, buffers, odorants, fragrances, extenders, binders, wetting agents and / or preservatives as well as their combinations and mixtures, in an (absolute) quantity in the range of 0.1 mg to 500 mg, in particular in the range of 0.5 mg to 250 mg, preferably in the range of 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 harmless excipient (carrier); in particular wherein the sugar is selected from the group consisting 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 consisting of mannitol, xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructooligosaccharides, glucans, polyglucose and their combinations and mixtures, particularly preferably isomalt and / or mannitol, most preferably isomalt; and / or in particular in quantities to provide and / or maintain the total weight of the lozenge.

[0253] Furthermore, according to the present aspect, the present invention also relates to the composition according to the invention, in particular a pharmaceutical composition, in the form of a fixed dosage (solid dosage form) for sucking and / or chewing, preferably for sucking, in particular a lozenge, preferably for use in the prophylactic and / or therapeutic topical treatment of inflammatory diseases of the mouth and throat, in particular as a previously defined composition, wherein the composition contains an effective, in particular pharmaceutically and / or therapeutically effective, amount of an active ingredient preferably suitable and / or effective for the topical treatment of inflammatory diseases of the mouth and throat, in particular with antiseptic and / or antimicrobial properties, preferably with antibacterial and / or antiviral and / or antifungal properties, wherein the active ingredient is incorporated and / or embedded in a solid matrix, wherein the composition, in particular the fixed dosage (solid dosage form) and / or the matrix, releases the active ingredient upon topical application and / or use, preferably by sucking and / or chewing, preferably by sucking, in the oral and pharyngeal cavity; wherein the active ingredient is octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride; and wherein the composition, in particular the fixed dosage (solid dosage form) and / or the matrix, furthermore and / or additionally contains at least one further ingredient (a) and / or (b), in particular (a) and (b), wherein the at least one further ingredient (a) and / or (b) is selected from the group of (a) Flavor modulators, in particular selected from the group of the following components (i), (ii) and / or (iii): (i) Bitter (taste) masking agents, in particular selected from the group consisting of bitter taste receptor antagonists, preferably 4-(2,2,3-trimethylcyclopentyl)butanoic acid, and saponins, preferably glycyrrhizic acid (glycyrrhizin) and its salts or esters and / or glycyrrhetinic acid (glycyrrhetin) and its salts or esters, complexing agents, in particular cyclodextrins, and combinations or mixtures thereof, (ii) Bitter substances, in particular coffee extract and / or tea extract and / or their respective bitter substances, preferably coffee extract and / or its bitter substances, (iii) preferably natural or nature-identical (aroma) oils and / or essential oils, in particular with antiseptic and / or antimicrobial properties, preferably with antibacterial, antifungal and / or antiviral properties, in particular selected from the group of anise oils, in particular star anise oil, peppermint oil, eucalyptus oil, lavender oil, tea tree oil, chamomile oil, clove oil, rosemary oil, caraway oil, cinnamon oil, sage oil and fennel oil, as well as combinations or mixtures thereof; wherein the ingredient (a) and / or the flavor modulator comprises a combination of components (i), (ii) and (iii); (b) Acidulants, in particular saliva-stimulating and / or flavor-enhancing acidulants, preferably acidulants authorized under pharmaceutical and / or food law and / or acidulants authorized as pharmaceutical additives and / or as food additives, in particular selected from the group of tartaric acid and its salts, in particular sodium tartrate, sodium potassium tartrate (Rochelle salt) and calcium tartrate, citric acid and its salts, metatartaric acid, fumaric acid, ascorbic acid, phosphoric acid and its salts, stannous chloride, in particular tin(II) chloride, malic acid, lactic acid, adipic acid, succinic acid and other pharmaceutically compatible and / or physiologically acceptable organic acids and their salts, as well as their combinations or mixtures; wherein the composition is in the form of a lozenge, in particular on a hard caramel base or as a hard caramel or on a soft caramel base or as a soft caramel, preferably on a hard caramel base or as a 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, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride, in an (absolute) amount in the range of 0.05 mg to 25 mg, in particular in the range of 0.1 mg to 20 mg, preferably in the range of 0.2 mg to 15 mg, preferably in the range of 0.3 mg to 10 mg, particularly preferably in the range of 0.5 mg to 8 mg; - Ingredient (a)(i) (bitter taste masking agent) in an (absolute) amount in the range of 0.05 mg to 50 mg, in particular in the range of 0.1 mg to 25 mg, preferably in the range of 0.5 mg to 20 mg, preferably in the range of 0.75 mg to 15 mg, particularly preferably in the range of 1 mg to 10 mg; - Ingredient (a)(ii) (bitter substance) in an (absolute) amount in the range of 0.01 mg to 100 mg, in particular in the range of 0.05 mg to 75 mg, preferably in the range of 0.075 mg to 50 mg, preferably in the range of 0.1 mg to 30 mg, particularly preferably in the range of 0.5 mg to 20 mg; - Ingredient (a)(iii) ((Aroma) oil and / or essential oil) in an (absolute) amount in the range of 0.2 mg to 100 mg, in particular in the range of 0.3 mg to 80 mg, preferably in the range of 0.5 mg to 50 mg, preferably in the range of 0.75 mg to 30 mg, particularly preferably in the range of 1 mg to 20 mg; - Ingredient (b) (acidifying agent) in an (absolute) (total) amount in the range of 0.25 mg to 150 mg, in particular in the range of 0.5 mg to 100 mg, preferably in the range of 0.75 mg to 75 mg, preferably in the range of 1 mg to 60 mg, particularly preferably in the range of 2 mg to 30 mg; - optionally at least one rheology and / or wetting modifier and / or soft consistency agent, in particular wherein the rheology and / or wetting modifier and / or the soft consistency agent is selected from the group consisting of mucilages, carrageenans, preferably lota-carrageenan, in particular acidic glycosaminoglycans, preferably hyaluronic acid and its pharmaceutically compatible and / or physiologically acceptable salts, preferably sodium hyaluronate, poloxamers, xanthan gums, gelling agents, polyalkylene glycols, preferably polyethylene glycol and polypropylene glycol, preferably polypropylene glycol, gum arabic, locust bean gum, galactomannans, guar gum, guarans, polysaccharides, agar-agar, gum arabic, gelatin and pectins, as well as their combinations and mixtures, in an (absolute) amount in the range of 1 mg to 1,000 mg, particularly in the range of 3 mg to 500 mg, preferably in the range of 5 mg to 250 mg; - optionally at least one further active ingredient and / or component, in particular a 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 buffers, thickeners, flavorings, antiseptics, colorings, buffers, odorants, fragrances, extenders, binders, wetting agents and / or preservatives as well as their combinations and mixtures, in an (absolute) quantity in the range of 0.1 mg to 500 mg, in particular in the range of 0.5 mg to 250 mg, preferably in the range of 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 harmless excipient (carrier); in particular wherein the sugar is selected from the group consisting 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 consisting of mannitol, xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructooligosaccharides, glucans, polyglucose and their combinations and mixtures, particularly preferably isomalt and / or mannitol, most preferably isomalt; and / or in particular in quantities to provide and / or maintain the total weight of the lozenge.

[0254] According to the present aspect, the present invention also relates to the composition according to the invention, in particular a pharmaceutical composition, in the form of a fixed dosage (solid dosage form) for sucking and / or chewing, preferably for sucking, in particular a lozenge, preferably for use in the prophylactic and / or therapeutic topical treatment of inflammatory diseases of the mouth and throat, in particular a composition as defined above. wherein the composition contains an effective, in particular pharmaceutically and / or therapeutically effective, amount of an active ingredient preferably suitable and / or effective for the topical treatment of inflammatory diseases of the mouth and throat, in particular with antiseptic and / or antimicrobial properties, preferably with antibacterial and / or antiviral and / or antifungal properties, wherein the active ingredient is incorporated and / or embedded in a solid matrix, wherein the composition, in particular the fixed dosage (solid dosage form) and / or the matrix, releases the active ingredient upon topical application and / or use, preferably by sucking and / or chewing, preferably by sucking, in the oral and pharyngeal cavity; wherein the active ingredient is octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride; and wherein the composition, in particular the fixed dosage (solid dosage form) and / or the matrix, furthermore and / or additionally contains at least one further ingredient (a) and / or (b), in particular (a) and (b), wherein the at least one further ingredient (a) and / or (b) is selected from the group of (a) Flavor modulators, in particular selected from the group of the following components (i), (ii) and / or (iii): (i) bitter (taste) masking agents, in particular 4-(2,2,3-trimethylcyclopentyl)butanoic acid, (ii) Bitter substances, in particular coffee extract and / or tea extract and / or their respective bitter substances, preferably coffee extract and / or its bitter substances, (iii) preferably natural or nature-identical (aroma) oils and / or essential oils, in particular anise oil, in particular star anise oil, and / or peppermint oil, preferably anise oil, in particular star anise oil, and peppermint oil; wherein the anise oil, in particular star anise oil, is at least substantially free of estragole and / or contains at least substantially no estragole, in particular wherein the anise oil, in particular star anise oil, has an estragole content of less than 1,000 ppm, in particular less than 100 ppm, preferably less than 10 ppm, preferably less than 5 ppm, and / or wherein the composition has an estragole content of less than 500 ppm, in particular less than 50 ppm, preferably less than 5 ppm, preferably less than 1 ppm, based on the anise oil, in particular star anise oil; and / or wherein the composition is at least substantially free of estragole and / or contains at least substantially no estragole, in particular wherein the composition has an estragole content of less than 500 ppm, in particular less than 50 ppm, preferably less than 5 ppm, preferably less than 1 ppm, based on the composition; wherein the ingredient (a) and / or the flavor modulator comprises a combination of components (i), (ii) and (iii); (b) Acidulants, in particular saliva-stimulating and / or flavor-enhancing acidulants, preferably acidulants authorized under pharmaceutical and / or food law and / or acidulants authorized as pharmaceutical additives and / or as food additives, in particular selected from the group consisting of tartaric acid and its salts, in particular sodium tartrate, sodium potassium tartrate (Rochelle salt) and calcium tartrate, citric acid and its salts, metatartaric acid, fumaric acid, ascorbic acid, phosphoric acid and its salts, stannous chloride, in particular tin(II) chloride, malic acid, lactic acid, adipic acid, succinic acid and other pharmaceutically compatible and / or physiologically acceptable organic acids and their salts, as well as their combinations or mixtures, preferably tartaric acid and / or citric acid, particularly preferably tartaric acid; wherein the composition is in the form of a lozenge, in particular on a hard caramel base or as a hard caramel or on a soft caramel base or as a soft caramel, preferably on a hard caramel base or as a 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, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride, in an (absolute) amount in the range of 0.05 mg to 25 mg, in particular in the range of 0.1 mg to 20 mg, preferably in the range of 0.2 mg to 15 mg, preferably in the range of 0.3 mg to 10 mg, particularly preferably in the range of 0.5 mg to 8 mg; - Ingredient (a)(i) (bitter taste masking agent) in an (absolute) amount in the range of 0.05 mg to 50 mg, in particular in the range of 0.1 mg to 25 mg, preferably in the range of 0.5 mg to 20 mg, preferably in the range of 0.75 mg to 15 mg, particularly preferably in the range of 1 mg to 10 mg; - Ingredient (a)(ii) (bitter substance) in an (absolute) amount in the range of 0.01 mg to 100 mg, in particular in the range of 0.05 mg to 75 mg, preferably in the range of 0.075 mg to 50 mg, preferably in the range of 0.1 mg to 30 mg, particularly preferably in the range of 0.5 mg to 20 mg; - Ingredient (a)(iii) ((Aroma) oil and / or essential oil) in an (absolute) amount in the range of 0.2 mg to 100 mg, in particular in the range of 0.3 mg to 80 mg, preferably in the range of 0.5 mg to 50 mg, preferably in the range of 0.75 mg to 30 mg, particularly preferably in the range of 1 mg to 20 mg; - Ingredient (b) (acidifying agent) in an (absolute) (total) amount in the range of 0.25 mg to 150 mg, in particular in the range of 0.5 mg to 100 mg, preferably in the range of 0.75 mg to 75 mg, preferably in the range of 1 mg to 60 mg, particularly preferably in the range of 2 mg to 30 mg; - optionally at least one rheology and / or wetting modifier and / or soft consistency enhancer, in particular wherein the rheology and / or wetting modifier and / or the soft consistency enhancer is selected from the group consisting of mucilages, carrageenans, preferably iota-carrageenan, in particular acidic glycosaminoglycans, preferably hyaluronic acid and its pharmaceutically compatible and / or physiologically acceptable salts, preferably sodium hyaluronate, poloxamers, xanthan gums, gelling agents, polyalkylene glycols, preferably polyethylene glycol and polypropylene glycol, preferably polypropylene glycol, gum arabic, locust bean gum, galactomannans, guar gum, guarans, polysaccharides, agar-agar, gum arabic, gelatin and pectins, as well as their combinations and mixtures, in an (absolute) amount in the range of 1 mg to 1,000 mg, particularly in the range of 3 mg to 500 mg, preferably in the range of 5 mg to 250 mg; - optionally at least one further active ingredient and / or component, in particular a 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 buffers, thickeners, flavorings, antiseptics, colorings, buffers, odorants, fragrances, extenders, binders, wetting agents and / or preservatives as well as their combinations and mixtures, in an (absolute) quantity in the range of 0.1 mg to 500 mg, in particular in the range of 0.5 mg to 250 mg, preferably in the range of 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 harmless excipient (carrier); in particular wherein the sugar is selected from the group consisting 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 consisting of mannitol, xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructooligosaccharides, glucans, polyglucose and their combinations and mixtures, particularly preferably isomalt and / or mannitol, most preferably isomalt; and / or in particular in quantities to provide and / or maintain the total weight of the lozenge.

[0255] 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.

[0256] For further details on this aspect of the invention, reference can be made to the explanations of the other aspects of the invention, these explanations applying equally to the present aspect of the invention.

[0257] A further object of the present invention - according to a second aspect of the present invention - is also the pharmaceutical composition, as described herein, for use in the prophylactic and / or therapeutic topical treatment of inflammatory diseases of the mouth and throat.

[0258] For further details on this aspect of the invention, reference can be made to the explanations of the other aspects of the invention, these explanations applying equally to the present aspect of the invention.

[0259] A further object of the present invention - according to a third aspect of the present invention - is the use according to the invention of a composition, in particular a pharmaceutical composition, as described above, for the prophylactic and / or therapeutic topical treatment of inflammatory diseases of the mouth and throat.

[0260] In this context, the present invention also relates to the use of a composition, in particular a pharmaceutical composition, as described herein, for the manufacture of a medicinal product or drug for the prophylactic and / or therapeutic topical treatment of inflammatory diseases of the mouth and throat.

[0261] Also described within the scope of the present invention is a method for the prophylactic and / or therapeutic topical treatment of inflammatory diseases of the mouth and throat, wherein the method comprises a process step in which a composition, in particular a pharmaceutical composition, in the form of a fixed dose for sucking and / or chewing, preferably for sucking, in particular a lozenge, as described herein, is administered to a patient suffering from an inflammatory disease of the mouth and throat, in particular topically, preferably in effective, in particular pharmaceutically and / or therapeutically effective, amounts.

[0262] For further details of the described method, reference can be made to the explanations of the other aspects of the invention, these explanations applying equally to the present aspect of the invention.

[0263] A further object of the present invention – according to a fourth aspect of the present invention – is the use according to the invention of at least one ingredient (a) and / or (b), in particular (a) and (b), to improve and / or adjust the organoleptic properties, in particular the taste, preferably to reduce and / or mask the bitter taste, of a composition, in particular a pharmaceutical composition, in the form of a fixed dosage (solid dosage form) for sucking and / or chewing, preferably for sucking, in particular a lozenge, preferably for use in the prophylactic and / or therapeutic topical treatment of inflammatory diseases of the oral cavity and pharynx, in particular a composition as defined above. wherein at least one further ingredient (a) and / or (b) is selected from the group of (a) Flavor modulators, in particular selected from the group of the following components (i), (ii) and / or (iii): (i) Bitter (taste) masking agents, in particular selected from the group consisting of bitter taste receptor antagonists, preferably 4-(2,2,3-trimethylcyclopentyl)butanoic acid, and saponins, preferably glycyrrhizic acid (glycyrrhizin) and its salts or esters and / or glycyrrhetinic acid (glycyrrhetin) and its salts or esters, complexing agents, in particular cyclodextrins, and combinations or mixtures thereof, (ii) Bitter substances, in particular coffee extract and / or tea extract and / or their respective bitter substances, preferably coffee extract and / or its bitter substances, (iii) preferably natural or nature-identical (aroma) oils and / or essential oils, in particular with antiseptic and / or antimicrobial properties, preferably with antibacterial, antifungal and / or antiviral properties, in particular selected from the group of anise oils, in particular star anise oil, peppermint oil, eucalyptus oil, lavender oil, tea tree oil, chamomile oil, clove oil, rosemary oil, caraway oil, cinnamon oil, sage oil and fennel oil, as well as combinations or mixtures thereof; in particular wherein the ingredient (a) and / or the flavor modulator comprises a combination of at least two different components (i), (ii) and / or (iii), preferably a combination of components (i), (ii) and (iii); (b) Acidulants, in particular saliva-stimulating and / or flavor-enhancing acidulants, preferably acidulants authorized under pharmaceutical and / or food law and / or acidulants authorized as pharmaceutical additives and / or as food additives, in particular selected from the group of tartaric acid and its salts, in particular sodium tartrate, sodium potassium tartrate (Rochelle salt) and calcium tartrate, citric acid and its salts, metatartaric acid, fumaric acid, ascorbic acid, phosphoric acid and its salts, stannous chloride, in particular tin(II) chloride, malic acid, lactic acid, adipic acid, succinic acid and other pharmaceutically compatible and / or physiologically acceptable organic acids and their salts, as well as their combinations or mixtures; wherein the composition contains an effective, in particular pharmaceutically and / or therapeutically effective, amount of an active ingredient preferably suitable and / or effective for the topical treatment of inflammatory diseases of the mouth and throat, in particular with antiseptic and / or antimicrobial properties, preferably with antibacterial and / or antiviral and / or antifungal properties, wherein the active ingredient is incorporated and / or embedded in a solid matrix, wherein the composition, in particular the fixed dosage (solid dosage form) and / or the matrix, releases the active ingredient upon topical application and / or use, preferably by sucking and / or chewing, preferably by sucking, in the oral and pharyngeal cavity; wherein the active ingredient is octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride; in particular wherein the composition, in particular the fixed dosage (solid dosage form) and / or the matrix, contains at least one further ingredient (a) and / or (b), in particular (a) and (b), and / or wherein the at least one further ingredient (a) and / or (b), in particular (a) and (b), is added to the composition and / or incorporated into the composition, in particular the fixed dosage (solid dosage form) and / or the matrix; and / or in particular wherein the organoleptic properties to be improved and / or adjusted, in particular taste, preferably the bitter taste to be reduced and / or masked, are specified and / or formed by octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride.

[0264] In this context, the present invention relates in particular to the use of at least one ingredient (a) and / or (b), in particular (a) and (b), for reducing and / or masking the bitter taste of octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride, preferably in a (common) composition, in particular a pharmaceutical composition, in particular for sucking and / or chewing, preferably for sucking, preferably a composition as defined above, preferably a composition as defined here. wherein at least one further ingredient (a) and / or (b) is selected from the group of (a) Flavor modulators, in particular selected from the group of the following components (i), (ii) and / or (iii): (i) Bitter (taste) masking agents, in particular selected from the group consisting of bitter taste receptor antagonists, preferably 4-(2,2,3-trimethylcyclopentyl)butanoic acid, and saponins, preferably glycyrrhizic acid (glycyrrhizin) and its salts or esters and / or glycyrrhetinic acid (glycyrrhetin) and its salts or esters, complexing agents, in particular cyclodextrins, and combinations or mixtures thereof, (ii) Bitter substances, in particular coffee extract and / or tea extract and / or their respective bitter substances, preferably coffee extract and / or its bitter substances, (iii) preferably natural or nature-identical (aroma) oils and / or essential oils, in particular with antiseptic and / or antimicrobial properties, preferably with antibacterial, antifungal and / or antiviral properties, in particular selected from the group of anise oils, in particular star anise oil, peppermint oil, eucalyptus oil, lavender oil, tea tree oil, chamomile oil, clove oil, rosemary oil, caraway oil, cinnamon oil, sage oil and fennel oil, as well as combinations or mixtures thereof; in particular wherein the ingredient (a) and / or the flavor modulator comprises a combination of at least two different components (i), (ii) and / or (iii), preferably a combination of components (i), (ii) and (iii); (b) Acidulants, in particular saliva-stimulating and / or flavor-enhancing acidulants, preferably acidulants authorized under pharmaceutical and / or food law and / or acidulants authorized as pharmaceutical additives and / or food additives, in particular selected from the group of tartaric acid and its salts, in particular sodium tartrate, sodium potassium tartrate (Rochelle salt) and calcium tartrate, citric acid and its salts, metatartaric acid, fumaric acid, ascorbic acid, phosphoric acid and its salts, stannous chloride, in particular tin(II) chloride, malic acid, lactic acid, adipic acid, succinic acid and other pharmaceutically compatible and / or physiologically acceptable organic acids and their salts, as well as their combinations or mixtures.

[0265] As regards the aforementioned uses according to the fifth aspect described herein, these may be medical or non-medical uses within the scope of the invention.

[0266] For further details on this aspect of the invention, reference can be made to the explanations of the other aspects of the invention, these explanations applying equally to the present aspect of the invention.

[0267] Further embodiments, modifications and variations as well as advantages of the present invention are readily apparent and achievable for the person skilled in the art when reading the description, without leaving the scope of the present invention.

[0268] The following embodiments serve only to illustrate the present invention, but without limiting the present invention to them. EXAMPLES OF EXECUTION: A. Production of the compositions

[0269] The following describes the production of compositions according to the invention in the form of lozenges, which are designed as hard caramels and are also sugar-free or based on sugar substitutes: A sugar substitute is used as the base (matrix) for the lozenges or hard candies. The lozenges and hard candies are manufactured as follows: The sugar substitute (here: isomalt) is dissolved in water and then boiled at temperatures between 120 and 140 °C and vacuum-sealed. The active ingredient (here: octenidine dihydrochloride) and the other ingredients, as listed below, are added to this hot mixture in solid or liquid form and homogeneously incorporated. After cooling to temperatures below 75 °C, the hard candies are embossed in the desired shape and then packaged.

[0270] Other ingredients used include: - Bitter (taste) masking agent (hereinafter referred to as “component (a) (i)”; here: 4-(2,2,3-trimethylcyclopentyl)butanoic acid); - Bitter substance (hereinafter referred to as “component (a) (ii)”; here: coffee extract); - first natural or nature-identical oil (hereinafter referred to as “component (a) (iii)-1”; here: star anise oil); - second natural or nature-identical oil (hereinafter referred to as “component (a) (iii)-2”; here: peppermint oil); - Acidifying agent (hereinafter referred to as ‘component (b)’; here: tartaric acid); - Sweetener (here: sucralose).

[0271] In the present formulations, the first natural or nature-identical oil (“component (a) (iii)-1”) is a nature-identical star anise oil with an estragole content of less than 5 ppm, based on the star anise oil.

[0272] In principle, other active ingredients and / or components, such as local anesthetics, mucilaginous drugs or their extracts, processing aids, flavorings and flavorings, flavorings, sweeteners and sweeteners, acidulants, stabilizers, antiseptics, colorings, etc., can optionally be added.

[0273] In the following formulations, the respective active ingredients or components must be selected or combined with regard to the specified (relative) quantities in such a way that the total results in 100% by weight. The relative quantities refer to the respective (total) composition as the relevant reference point.

[0274] Based on this, various formulations of lozenges usable according to the invention with variable amounts of ingredients are provided: Composition 1: Lozenge, sugar-free: Active ingredient: 0.05 - 2.0 wt.% Sugar substitute: 93.0 - 99.95 wt.% Component (a) (i) and component (a) (ii): 0.1 - 1.0 wt.% Component (a) (iii)-1: 0.05 - 1.0 wt.% Component (a) (iii)-2: 0.01 - 0.1 wt.% Component (b): 0.2 - 1 wt.% Sweetener: 0.01 - 0.1 wt.% Sum: 1,000 - 4,000 mg

[0275] Composition 1 thus comprises the active ingredient and component (b) in combination with components (a) (i), (a) (ii) and (a) (iii)-1 as well as (a) (iii)-2. Composition 2: Lozenge, sugar-free: Active ingredient: 0.05 - 2.0 wt.% Sugar substitute: 93.0 - 99.95 wt.% Component (a) (i) and component (a) (ii): 0.1 - 1.0 wt.% Component (a) (iii)-1: 0 wt.% Component (a) (iii)-2: 0 wt.% Component (b): 0.2 - 1 wt.% Sweetener: 0.01 - 0.1 wt.% Sum: 1,000 - 4,000 mg

[0276] Composition 2 thus comprises the active ingredient and component (b) in combination with components (a) (i) and (a) (ii). Composition 3: Lozenge, sugar-free: Active ingredient: 0.05 - 2.0 wt.% Sugar substitute: 93.0 - 99.95 wt.% Component (a) (i) and component (a) (ii): 0 wt.% Component (a) (iii)-1: 0.05 - 1.0 wt.% Component (a) (iii)-2: 0.01 - 0.1 wt.% Component (b): 0.2 - 1 wt.% Sweetener: 0.01 - 0.1 wt.% Sum: 1,000 - 4,000 mg

[0277] Composition 3 thus comprises the active ingredient and component (b) in combination with components (a) (iii)-1 and (a) (iii)-2. Composition 4: Lozenge, sugar-free: Active ingredient: 0.05 - 2.0 wt.% Sugar substitute: 93.0 - 99.95 wt.% Component (a) (i) and component (a) (ii): 0.1 - 1.0 wt.% Component (a) (iii)-1: 0 wt.% Component (a) (iii)-2: 0 wt.% Component (b): 0 wt.% Sweetener: 0.01 - 0.1 wt.% Sum: 1,000 - 4,000 mg

[0278] Composition 4 thus comprises the active ingredient in combination with components (a) (i) and (a) (ii).

[0279] Based on the above explanations, a reference or comparison composition is also provided according to the following formula: Composition 5: Sugar-free lozenge (reference or comparison) Active ingredient: 0.1 wt.% Sugar substitute: 99.9 wt.% Sum: 1,000 - 4,000 mg B. Properties of the compositions

[0280] The present compositions are characterized with regard to their organoleptic properties, in particular with regard to the masking of the bitter taste associated with octenidine or octenidine dihydrochloride, as well as their antimicrobial properties.

[0281] The characterization of the properties shown below is based on the ratings “+++” (very good), “++” (good), “+” (satisfactory), “o” (sufficient) and “-” (insufficient), as can be seen from the following explanations. 1. Taste characteristics

[0282] The respective compositions are characterized with regard to their organoleptic properties using a so-called electronic tongue (also known as an e-tongue or e-tongue) with respect to bitterness and its masking. The electronic tongue allows for an assessment of the effectiveness in masking bitterness. The electronic tongue determines taste characteristics based on special taste sensors capable of detecting sour, salty, umami, astringent, and bitter tastes. Specifically, the electronic tongue is a multi-sensor system employing mathematical methods for signal processing and analysis.The taste receptors can detect different types of taste, namely an initial taste, which corresponds to the first taste in the mouth, and an aftertaste, which corresponds to the lingering taste that remains even after swallowing. The compounds are examined in dissolved form, using lozenges weighing 2,600 mg.

[0283] Based on the electronic tongue, the compositions according to the invention can be characterized with regard to their taste properties. For this purpose, corresponding solutions of the compositions according to the invention are used for further investigation by means of the electronic tongue.

[0284] The following table shows the relevant properties of the respective compositions with regard to masking the bitter taste. composition Bitter taste masking 1 +++ 2 ++ 3 ◯ 4 + 5 -

[0285] The table above shows that the composition according to the invention, with the specific combination of components (a) (i) bitterness masking agent, (a) (ii) bitter substance, (a) (iii)-1 natural or nature-identical oil in the form of star anise oil, (a) (iii)-2 second natural or nature-identical oil in the form of peppermint oil, and component (b) in the form of the acidifying agent, exhibits the best taste properties or provides very good masking of the bitter taste. Composition 2 according to the invention has good taste properties overall, while composition 3 according to the invention has sufficient properties in this respect. With composition 4 according to the invention, satisfactory taste properties are achieved. In contrast, the reference or comparison composition 5, which is based solely on the active ingredient octenidine, exhibitsOctenidine dihydrochloride-based products have the worst or inadequate taste properties.

[0286] The results thus demonstrate the efficiency and effectiveness of the concept according to the invention with regard to the targeted masking of the bitter taste associated with octenidine or octenidine dihydrochloride. In this respect, the invention provides a significant improvement in taste and / or organoleptic properties. 2. Antimicrobial properties

[0287] The present compositions are characterized with regard to their antimicrobial, in particular antibacterial and antiviral, properties.

[0288] The determination of antibacterial properties is based on quantitative suspension tests to determine antibacterial and bactericidal activity in accordance with DIN EN 1040. The test organisms used are Staphylococcus aureus, Escherichia coli, Streptococcus pyogenes, Pseudomonas aeruginosa, Streptococcus pneumoniae, Streptococcus mutans, Streptococcus sanguis, and Haemophilus influenzae. For sample preparation, 2,600 mg lozenges are dissolved in 10 ml of artificial saliva at 37°C. The exposure time is 15 min ± 10 sec at a test temperature of 20°C ± 1°C, the surface method is used for the counting method, and the incubation time is 48 hours at 37°C ± 1°C.

[0289] The antimicrobial properties of the compositions are characterized by averages across all microbes tested. The following table shows the antibacterial properties of each composition. composition antibacterial effect 1 +++ 2 + 3 ++ 4 ◯ 5 ◯

[0290] The table above shows that composition 1 according to the invention exhibits very good antibacterial activity. Composition 2 according to the invention exhibits satisfactory antibacterial properties. Composition 3 according to the invention exhibits good properties in this regard. Composition 4 according to the invention and the reference or comparison composition 5 each show sufficient properties in this respect.

[0291] Furthermore, the antiviral properties of the compositions are determined in a suspension test (here, against coronaviruses). The compositions exhibit antiviral efficacy.

[0292] The above statements demonstrate the overall improvement in organoleptic properties associated with the present invention, or the reduction of the bitter taste associated with octenidine or octenidine dihydrochloride, while simultaneously providing efficacy against corresponding pathogens or germs. QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] DE 27 08 331 C2

[0020] Cited non-patent literature

[0000] RÖMPP Lexicon of Natural Products, first edition, Georg Thieme Verlag, Stuttgart / New York, 1997, page 609, entry: “Star anise

[0095] RÖMPP Lexicon of Natural Substances, first edition, Georg Thieme Verlag, Stuttgart / New York, 1997, pages 478 and 479, entry: “Peppermint oil

[0100] Römpp Chemistry Lexicon, 10th edition, Volume 4, 1998, Georg-Thieme-Verlag, Stuttgart / New York, page 2986

[0148] E. Mutschler et al., “Mutschler Drug Effects - Textbook of Pharmacology and Toxicology”, 8th edition, Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart, 2001, pages 267 ff

[0158] Römpp Chemistry Lexicon, 10th edition, Volume 3, Georg Thieme Verlag, Stuttgart / New York, 1997, pages 2442

[0158] RÖMPP Chemistry Lexicon, 10th edition, Volume 3, 1997, Georg Thieme-Verlag, Stuttgart / New York, entry: “Lidocaine

[0168] Lidocaine Hydrochloride, European Pharmacopoeia (Ph. Eur.), 9th edition (January 2017

[0168] Referring to lidocaine, see the statements in European Pharmacopoeia 8.0, European Directorate for the Quality of Medicines and Healthcare, pages 2620 / 2621

[0168] Lidocaine hydrochloride on European Pharmacopoeia 8.0, European Directorate for the Quality of Medicines and Healthcare, pages 2620 / 2621

[0168] H. Wagner “Pharmaceutical Biology - Drugs and their Ingredients”, Gustav Fischer Verlag, Stuttgart / New York, 1985, especially pages 280 ff

[0187] Römpp Chemistry Lexicon, 10th edition, Volume 6, Georg Thieme Verlag, Stuttgart / New York, 1999, pages 5096 to 5100

[0229] Roche Lexicon of Medicine, 3rd edition, 1993, Urban & Schwarzenberg, Munich / Vienna / Baltimore

[0246] Pschyrembel, medical dictionary, 257th edition, 1993, Nikol Verlagsgesellschaft mbH, Hamburg

[0246]

Claims

[1] Composition, in particular pharmaceutical composition, in the form of a fixed dosage (solid dosage form) for sucking and / or chewing, preferably for sucking, in particular lozenge, preferably for use in the prophylactic and / or therapeutic topical (local) treatment of inflammatory diseases of the mouth and throat, wherein the composition contains an effective, in particular pharmaceutically and / or therapeutically effective, amount of an active ingredient preferably suitable and / or effective for the topical (local) treatment of inflammatory diseases of the mouth and throat, in particular with antiseptic and / or antimicrobial properties, preferably with antibacterial and / or antiviral and / or antifungal properties, wherein the active ingredient is incorporated and / or embedded in a solid matrix, wherein the composition, in particular the solid dosage form and / or the matrix, releases the active ingredient upon topical (local) application and / or use, preferably by sucking and / or chewing, preferably by sucking, in the oral and pharyngeal cavity; wherein the active ingredient is octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride; and wherein the composition, in particular the solid dosage form and / or the matrix, furthermore and / or additionally contains at least one further ingredient (a) and / or (b), in particular (a) and (b), wherein the at least one further ingredient (a) and / or (b) is selected from the group of (a) Flavor modulators, in particular selected from the group of the following components (i), (ii) and / or (iii): (i) Bitter (taste) masking agents, in particular selected from the group consisting of bitter taste receptor antagonists, preferably 4-(2,2,3-trimethylcyclopentyl)butanoic acid, and saponins, preferably glycyrrhizic acid (glycyrrhizin) and its salts or esters and / or glycyrrhetinic acid (glycyrrhetin) and its salts or esters, complexing agents, in particular cyclodextrins, and combinations or mixtures thereof, (ii) Bitter substances, in particular coffee extract and / or tea extract and / or their respective bitter substances, preferably coffee extract and / or its bitter substances, (iii) preferably natural or nature-identical (aroma) oils and / or essential oils, in particular with antiseptic and / or antimicrobial properties, preferably with antibacterial, antifungal and / or antiviral properties, in particular selected from the group of anise oils, in particular star anise oil, peppermint oil, eucalyptus oil, lavender oil, tea tree oil, chamomile oil, clove oil, rosemary oil, caraway oil, cinnamon oil, sage oil and fennel oil, as well as combinations or mixtures thereof; in particular wherein the ingredient (a) and / or the flavor modulator comprises a combination of at least two different components (i), (ii) and / or (iii), preferably a combination of components (i), (ii) and (iii); (b) Acidulants, in particular saliva-stimulating and / or flavor-enhancing acidulants, preferably acidulants authorized under pharmaceutical and / or food law and / or acidulants authorized as pharmaceutical additives and / or as food additives, in particular selected from the group of tartaric acid and its salts, in particular sodium tartrate, sodium potassium tartrate (Rochelle salt) and calcium tartrate, citric acid and its salts, metatartaric acid, fumaric acid, ascorbic acid, phosphoric acid and its salts, stannous chloride, in particular tin(II) chloride, malic acid, lactic acid, adipic acid, succinic acid and other pharmaceutically compatible and / or physiologically acceptable organic acids and their salts, as well as their combinations or mixtures. [2] Composition according to claim 1, wherein the composition is prepared and / or used for topical (local) application to the mucous membranes of the mouth and throat. [3] Composition according to claim 1 or 2, wherein the composition contains ingredient (a) (flavor modulator) on the one hand and ingredient (b) (acidifying agent) on the other hand; and / or wherein the composition contains ingredient (a) (flavor modulator) on the one hand and ingredient (b) (acidifying agent) on the other hand in combination; and / or wherein the composition contains a combination of ingredient (a) (flavor modulator) and ingredient (b) (acidifying agent). [4] Composition according to any of the preceding claims, wherein the composition includes, in particular, the ingredient (a) (taste modulator), the component (i) (bitter receptor antagonist) and the component (ii) (bitter substance). [5] Composition according to any one of the preceding claims, wherein the composition contains the ingredient (a) (flavor modulator) on the one hand and the ingredient (b) (acidifying agent) on the other hand and wherein the composition includes, in particular, the ingredient (a) (taste modulator), the component (i) (bitter receptor antagonist) and the component (ii) (bitter substance). [6] Composition according to any of the preceding claims, wherein the composition includes, in particular, the ingredient (a) (flavor modulator), the component (i) (bitter receptor antagonist), the component (ii) (bitter substance), and the component (iii) (flavor oil). [7] Composition according to any one of the preceding claims, wherein the composition contains the ingredient (a) (flavor modulator) on the one hand and the ingredient (b) (acidifying agent) on the other hand and wherein the composition includes, in particular, the ingredient (a) (flavor modulator), the component (i) (bitter receptor antagonist), the component (ii) (bitter substance), and the component (iii) (flavor oil). [8] Composition according to any one of the preceding claims, wherein the component (iii) ((aroma) oil) is selected from the group consisting of anise oil, in particular star anise oil, peppermint oil, tea tree oil, chamomile oil, clove oil and cinnamon oil, and combinations or mixtures thereof; preferably from the group consisting of anise oil, in particular star anise oil, and peppermint oil, and combinations or mixtures thereof; preferably from the group consisting of anise oil, in particular star anise oil, and peppermint oil; particularly preferably a combination of star anise oil and peppermint oil. [9] Composition according to any one of the preceding claims, wherein the further ingredient (b) (acidifying agent) is selected from the group consisting of tartaric acid and its salts, in particular sodium tartrate, sodium potassium tartrate (Rochelle salt) and calcium tartrate, citric acid and its salts and metatartaric acid as well as combinations or mixtures thereof; preferably from the group consisting of tartaric acid and its salts, in particular sodium tartrate, sodium potassium tartrate (Rochelle salt) and calcium tartrate, citric acid and its salts as well as combinations or mixtures thereof; preferably tartaric acid and citric acid as well as combinations or mixtures thereof; particularly preferably tartaric acid. [10] Composition according to any one of the preceding claims, wherein (a)(i) the bitter (taste) masking agent comprises or consists of a bitter taste receptor antagonist, in particular 4-(2,2,3-trimethylcyclopentyl)butanoic acid; and / or where (a)(ii) the bitter substance comprises or consists of coffee extract and / or its bitter substances; in particular wherein the ingredient (a) and / or the flavor modulator comprises or consists of a combination of the components (i), (ii) and (iii). [11] Composition according to any one of the preceding claims, wherein (b) the acidifying agent comprises or consists of tartaric acid and / or citric acid, preferably tartaric acid. [12] Composition according to any one of the preceding claims, wherein the composition contains the ingredient (a) (flavor modulator) in a (relative) (total) amount in the range of 0.005 wt.% to 10 wt.%, in particular in the range of 0.01 wt.% to 8 wt.%, preferably in the range of 0.05 wt.% to 6 wt.%, more preferably in the range of 0.1 wt.% to 5 wt.%, most preferably in the range of 0.2 wt.% to 3 wt.%, based on the composition; and / or wherein the composition contains the ingredient (a) (flavor modulator) in an (absolute) (total) amount in the range of 0.1 mg to 250 mg, in particular in the range of 0.5 mg to 200 mg, preferably in the range of 1 mg to 150 mg, preferably in the range of 2 mg to 100 mg, particularly preferably in the range of 5 mg to 50 mg. [13] Composition according to any one of the preceding claims, wherein the composition (a)(i) contains the bitterness masking agent in a (relative) amount in the range of 0.002 wt.% to 2 wt.%, in particular in the range of 0.004 wt.% to 1 wt.%, preferably in the range of 0.02 wt.% to 0.75 wt.%, more preferably in the range of 0.03 wt.% to 0.6 wt.%, most preferably in the range of 0.01 wt.% to 0.45 wt.%, based on the composition; and / or wherein the composition (a)(i) contains the bitter (taste) masking agent in an (absolute) amount in the range of 0.05 mg to 50 mg, in particular in the range of 0.1 mg to 25 mg, preferably in the range of 0.5 mg to 20 mg, preferably in the range of 0.75 mg to 15 mg, particularly preferably in the range of 1 mg to 10 mg. [14] Composition according to any one of the preceding claims, wherein (a)(i) comprises or consists of the bitter (taste) masking agent 4-(2,2,3-trimethylcyclopentyl)butanoic acid, in particular wherein the composition contains 4-(2,2,3-trimethylcyclopentyl)butanoic acid in a (relative) amount in the range of 0.002 wt.% to 1 wt.%, in particular in the range of 0.004 wt.% to 0.6 wt.%, preferably in the range of 0.01 wt.% to 0.4 wt.%, based on the composition; and / or in particular wherein the composition contains 4-(2,2,3-Trimethylcyclopentyl)butanoic acid in an (absolute) amount in the range of 0.05 mg to 25 mg, in particular in the range of 0.1 mg to 15 mg, preferably in the range of 0.2 mg to 8 mg. [15] Composition according to any one of the preceding claims, wherein the composition (a)(ii) contains the bitter substance in a (relative) amount in the range of 0.001 wt.% to 5 wt.%, in particular in the range of 0.002 wt.% to 3 wt.%, preferably in the range of 0.003 wt.% to 2 wt.%, more preferably in the range of 0.004 wt.% to 1.5 wt.%, most preferably in the range of 0.02 wt.% to 0.75 wt.%; and / or wherein the composition (a)(ii) contains the bitter substance in an (absolute) amount in the range of 0.01 mg to 100 mg, in particular in the range of 0.05 mg to 75 mg, preferably in the range of 0.075 mg to 50 mg, preferably in the range of 0.1 mg to 30 mg, particularly preferably in the range of 0.5 mg to 20 mg. [16] Composition according to any one of the preceding claims, where (a)(ii) the bitter substance comprises or consists of coffee extract and / or its bitter substances, in particular wherein the composition contains the coffee extract and / or its bitter substances in a (relative) amount in the range of 0.001 wt.% to 10 wt.%, in particular in the range of 0.01 wt.% to 5 wt.%, preferably in the range of 0.1 wt.% to 1 wt.%, based on the composition; and / or in particular wherein the composition contains the coffee extract and / or its bitter substances in an (absolute) amount 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. [17] Composition according to any one of the preceding claims, wherein the composition (a)(iii) contains the (aroma) oil and / or essential oil in a (relative) amount in the range of 0.005 wt.% to 5 wt.%, in particular in the range of 0.01 wt.% to 3.5 wt.%, preferably in the range of 0.02 wt.% to 2 wt.%, more preferably in the range of 0.03 wt.% to 1.5 wt.%, most preferably in the range of 0.01 wt.% to 0.75 wt.%, based on the composition; and / or wherein the composition (a)(iii) contains the (aroma) oil and / or essential oil in an (absolute) amount in the range of 0.2 mg to 100 mg, in particular in the range of 0.3 mg to 80 mg, preferably in the range of 0.5 mg to 50 mg, preferably in the range of 0.75 mg to 30 mg, particularly preferably in the range of 1 mg to 20 mg. [18] Composition according to any one of the preceding claims, wherein (a)(iii) the (aroma) oil and / or essential oil contains or consists of anise oil, preferably star anise oil, and / or peppermint oil, preferably anise oil, preferably star anise oil, and peppermint oil, in particular wherein the composition contains anise oil, especially star anise oil, in a (relative) 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; and / or in particular wherein the composition contains anise oil, especially star anise oil, in an (absolute) amount 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; and / or in particular wherein the composition contains peppermint oil in a (relative) amount in the range of 0.001 wt.% to 1 wt.%, in particular in the range of 0.005 wt.% to 0.5 wt.%, preferably in the range of 0.01 wt.% to 0.1 wt.%, based on the composition; and / or in particular wherein the composition contains peppermint oil in an (absolute) amount 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. [19] Composition according to any one of the preceding claims, wherein the anise oil, in particular star anise oil, is at least substantially free of estragole and / or contains at least substantially no estragole; in particular wherein the anise oil, in particular star anise oil, has an estragole content of less than 1,000 ppm, in particular less than 100 ppm, preferably less than 10 ppm, preferably less than 5 ppm, based on the anise oil, in particular star anise oil; and / or where the anise oil is a nature-identical anise oil and / or where the star anise oil is a star anise oil. [20] Composition according to any one of the preceding claims, wherein the composition is at least substantially free of estragole and / or contains at least substantially no estragole; in particular wherein the composition has an estragole content of less than 500 ppm, in particular less than 50 ppm, preferably less than 5 ppm, preferably less than 1 ppm, based on the composition. [21] Composition according to any one of the preceding claims, wherein the composition contains the ingredient (b) (acidifying agent) in a (relative) (total) amount in the range of 0.01 wt.% to 8 wt.%, in particular in the range of 0.02 wt.% to 6 wt.%, preferably in the range of 0.05 wt.% to 6 wt.%, more preferably in the range of 0.03 wt.% to 4 wt.%, most preferably in the range of 0.1 wt.% to 1 wt.%, based on the composition; and / or wherein the composition contains the ingredient (b) (acidifying agent) in an (absolute) (total) amount in the range of 0.25 mg to 150 mg, in particular in the range of 0.5 mg to 100 mg, preferably in the range of 0.75 mg to 75 mg, preferably in the range of 1 mg to 60 mg, particularly preferably in the range of 2 mg to 30 mg. [22] Composition according to any one of the preceding claims, wherein (b) the acidifying agent comprises or consists of tartaric acid and / or citric acid, preferably tartaric acid, in particular wherein the composition contains tartaric acid and / or citric acid, preferably tartaric acid, in a (relative) amount in the range of 0.01 wt.% to 10 wt.%, in particular in the range of 0.1 wt.% to 5 wt.%, preferably in the range of 0.2 wt.% to 1 wt.%, based on the composition; and / or in particular wherein the composition contains tartaric acid and / or citric acid, preferably tartaric acid, in an (absolute) amount in the range of 0.2 mg to 80 mg, in particular in the range of 0.5 mg to 60 mg, preferably in the range of 0.75 mg to 25 mg. [23] Composition according to any one of the preceding claims, wherein the composition contains octenidine, in particular its pharmaceutically compatible and / or physiologically acceptable salt, in the form of a hydrochloride salt, particularly preferably octenidine dihydrochloride; and / or wherein the octenidine, in particular its pharmaceutically compatible and / or physiologically acceptable salt, is an octenidine hydrochloride salt, particularly preferably octenidine dihydrochloride; and / or wherein the composition contains octenidine dihydrochloride as the active ingredient; and / or wherein the active ingredient is octenidine dihydrochloride. [24] Composition according to any of the preceding claims, wherein the composition contains the octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, especially preferably octenidine dihydrochloride, in effective, in particular pharmaceutically and / or therapeutically effective, amounts. [25] Composition according to any one of the preceding claims, wherein the composition contains octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, most 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.%, more preferably in the range of 0.02 wt.% to 4 wt.%, more preferably in the range of 0.03 wt.% to 2 wt.%, and more preferably in the range of 0.05 wt.% to 1 wt.%, based on the composition; and / or wherein the composition contains octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, particularly preferably octenidine dihydrochloride, in an (absolute) amount in the range of 0.05 mg to 25 mg, in particular in the range of 0.1 mg to 20 mg, preferably in the range of 0.2 mg to 15 mg, preferably in the range of 0.3 mg to 10 mg, particularly preferably in the range of 0.5 mg to 8 mg. [26] Composition according to any one of the preceding claims, the composition contains 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 an acid amide, in particular wherein the local anesthetic is selected from the group of ester-type local anesthetics and amide-type local anesthetics as well as their combinations and mixtures, preferably amide-type local anesthetics; and / or in particular wherein the local anesthetic is selected from the group consisting of benzocaine, procaine, tetracaine, lidocaine, etidocaine, prilocaine, mepivacaine, bupivacaine and S-ropivacine and their pharmaceutically compatible and / or physiologically acceptable salts and esters, as well as their combinations and mixtures, in particular lidocaine and its pharmaceutically compatible and / or physiologically 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 pharmaceutically compatible and / or physiologically acceptable salts and esters, preferably lidocaine hydrochloride. [27] Composition according to any of the preceding claims, wherein the composition, in particular as a local anesthetic, contains lidocaine (2-diethylamino-N-(2,6-dimethylphenyl)acetamide) and / or its pharmaceutically compatible and / or physiologically acceptable salts and / or esters, preferably lidocaine hydrochloride. [28] Composition according to claim 26 or 27, wherein the composition contains the local anesthetic, in particular lidocaine and / or its pharmaceutically compatible and / or physiologically acceptable salts and / or esters, preferably lidocaine hydrochloride, in pharmaceutically and / or therapeutically effective amounts, in particular in pharmaceutically and / or therapeutically effective local anesthetic amounts; and / or wherein the composition contains the local anesthetic, in particular lidocaine and / or its pharmaceutically compatible and / or physiologically acceptable 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; and / or wherein the composition contains the local anesthetic, in particular lidocaine and / or its pharmaceutically compatible and / or physiologically acceptable salts and / or esters, preferably lidocaine hydrochloride, in an (absolute) amount 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. [29] Composition according to any one of the preceding claims, wherein the composition contains at least one anti-inflammatory agent, in particular benzydamine and / or its pharmaceutically compatible and / or physiologically acceptable salts and / or esters, preferably benzydamine hydrochloride; in particular wherein the composition contains the anti-inflammatory agent, especially benzydamine and / or its pharmaceutically compatible and / or physiologically acceptable salts and / or esters, preferably benzydamine hydrochloride, in pharmaceutically and / or therapeutically effective amounts, in particular in pharmaceutically and / or therapeutically anti-inflammatory amounts; and / or in particular wherein the composition contains the anti-inflammatory agent, in particular benzydamine and / or its pharmaceutically compatible and / or physiologically acceptable 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.%, more preferably in the range of 0.02 wt.% to 4 wt.%, most 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; and / or in particular wherein the composition contains the anti-inflammatory agent, in particular benzydamine and / or its pharmaceutically compatible and / or physiologically acceptable salts and / or esters, preferably benzydamine hydrochloride, in an (absolute) amount 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. [30] Composition according to any one of the preceding claims, wherein the composition contains at least one non-steroidal anti-inflammatory drug (NSAID), in particular wherein the non-steroidal anti-inflammatory drug (NSAID) is selected from the group consisting of flurbiprofen, ibuprofen, dexibuprofen, naproxen, ketoprofen, dexketoprofen, tiaprofenic acid, diclofenac and acetylsalicylic acid and their pharmaceutically compatible and / or physiologically acceptable salts and esters, as well as their combinations and mixtures, in particular flurbiprofen and its salts and esters, preferably flurbiprofen; and / or wherein the composition contains flurbiprofen and / or its pharmaceutically compatible and / or physiologically acceptable salts and / or esters, preferably flurbiprofen. [31] Composition according to claim 30, wherein the composition contains the non-steroidal anti-inflammatory drug (NSAID active ingredient), in particular flurbiprofen and / or its pharmaceutically compatible and / or physiologically acceptable salts and / or esters, preferably flurbiprofen, in pharmaceutically and / or therapeutically effective amounts, in particular in pharmaceutically and / or therapeutically effective non-steroidal anti-inflammatory amounts; and / or wherein the composition contains the non-steroidal anti-inflammatory drug (NSAID active ingredient), in particular flurbiprofen and / or its pharmaceutically compatible and / or physiologically acceptable 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.%, more preferably in the range of 0.02 wt.% to 4 wt.%, most 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; and / or wherein the composition contains the non-steroidal anti-inflammatory drug (NSAID active ingredient), in particular flurbiprofen and / or its pharmaceutically compatible and / or physiologically acceptable salts and / or esters, preferably flurbiprofen, in an (absolute) amount 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. [32] Composition according to any one of the preceding claims, wherein the composition contains at least one mucilage drug and / or its extract; in particular in a (relative) quantity in the range of 0.001 wt.% to 20 wt.%, especially in the range of 0.01 wt.% to 15 wt.%, preferably in the range of 0.05 wt.% to 10 wt.%, based on the composition; and / or especially in an (absolute) quantity in the range of 0.25 mg to 200 mg, particularly in the range of 0.5 mg to 100 mg, preferably in the range of 0.75 mg to 50 mg; and / or in particular wherein the mucilage drug or its extract is selected from the group consisting 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.) as well as their combinations and mixtures, preferably Iceland moss (Lichen islandicus) and / or marshmallow (Althaea officinalis L.); and / or in particular where the mucilage drug is used and / or is present in the form of the drug, especially in the form of crushed or powdered plant parts or plant components; and / or in particular where the mucilage drug is used and / or is present in the form of an extract, especially in the form of a dry extract. [33] Composition according to any one of the preceding claims, the composition contains propylene glycol; in particular in a (relative) quantity in the range of 0.001 wt.% to 5 wt.%, especially 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; and / or especially in an (absolute) quantity in the range of 0.05 mg to 100 mg, particularly in the range of 0.5 mg to 50 mg, preferably in the range of 1 mg to 10 mg. [34] Composition according to any one of the preceding claims, wherein the composition contains at least one rheology and / or consistency and / or wetting modifier and / or soft consistency enhancer, in particular wherein the rheology and / or wetting modifier and / or soft consistency enhancer is selected from the group consisting of mucilages; carrageenans, preferably lota-carrageenan; in particular acidic glycosaminoglycans, preferably hyaluronic acid and its pharmaceutically compatible and / or physiologically acceptable salts, preferably sodium hyaluronate; poloxamers; polysorbates; xanthan gums; gelling agents, in particular organic gelling agents and natural or synthetic gelling agents; thixotropic consistency and / or rheology additives, in particular silicic acids; polyalkylene glycols, preferably polyethylene glycol and polypropylene glycol, preferably polypropylene glycol; gum arabic; locust bean gum; galactomannans; guar gum; guarans; polysaccharides; agar agar; gum arabic;Gelatin; and pectins; as well as their combinations and mixtures; in particular in a (relative) quantity in the range of 0.1 wt.% to 20 wt.%, especially in the range of 0.5 wt.% to 10 wt.%, preferably in the range of 1 wt.% to 5 wt.%, based on the composition; and / or especially in an (absolute) quantity in the range of 1 mg to 1,000 mg, particularly in the range of 3 mg to 500 mg, preferably in the range of 5 mg to 250 mg. [35] Composition according to any one of the preceding claims, wherein the composition contains at least one further active ingredient and / or component, in particular a 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 buffers, thickeners, flavorings, antiseptics, colorings, buffers, odorants, fragrances, extenders, binders, wetting agents and / or preservatives as well as their combinations and mixtures; in particular in a (relative) quantity in the range of 0.01 wt.% to 15 wt.%, especially in the range of 0.1 wt.% to 10 wt.%, preferably in the range of 0.5 wt.% to 5 wt.%, based on the composition; and / or especially in an (absolute) quantity in the range of 0.1 mg to 500 mg, particularly in the range of 1 mg to 250 mg, preferably in the range of 5 mg to 100 mg. [36] Composition according to any one of claims 1 to 35, 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). [37] Composition according to any one of claims 1 to 35, wherein the composition contains phenoxyethanol (2-phenoxyethanol), in particular in a (relative) amount in the range of 0.1 wt.% to 10 wt.%, particularly 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; and / or especially in an (absolute) quantity in the range of 1 mg to 200 mg, particularly in the range of 5 mg to 100 mg, preferably in the range of 7.5 mg to 60 mg. [38] Composition according to any 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 and / or at least substantially no ethanol, 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 and / or at least substantially free of ethanol, in particular at least substantially free of a primary alcohol; and / or wherein the composition is 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. [39] Composition according to any one of the preceding claims, wherein the composition is in the form of a fixed dosage (solid dosage form) and / or is designed as such; and / or wherein the composition is in the form of a tablet, coated tablet, pill, lozenge, granules, chewable tablet, chewing gum, orodispersible tablet, film-coated tablet, lozenge or the like, in particular in the form of a lozenge, preferably hard or soft caramel, preferably hard caramel, and / or wherein the composition, in particular the fixed dosage (fixed dosage form), is in the form of a tablet, coated tablet, pill, lozenge, granules, chewable tablet, chewing gum, orodispersible tablet, film-coated tablet, lozenge or the like, in particular lozenge, preferably hard caramel or soft caramel, preferably hard caramel; and / or wherein the composition, in particular the fixed dosage (fixed dosage form), preferably the tablet, the dragee, the pill, the lozenge, the granules, the chewing gum, the orodispersible tablet, the film-coated tablet or the lozenge, in particular lozenge, preferably hard caramel or soft caramel, preferably hard caramel, 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. [40] Composition according to any one of the preceding claims, wherein the composition, in particular the fixed dosage (solid dosage form), is a lozenge, preferably in the form of a hard or soft caramel, preferably hard caramel; and / or wherein the composition, in particular the fixed dosage (fixed dosage form), is formed on a lozenge basis and / or is in the form of a lozenge, preferably hard or soft caramel, preferably hard caramel, and / or is designed in such a way that the composition, in particular the fixed dosage (fixed dosage form), releases a therapeutically effective amount of active ingredients and / or components, preferably octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride, when sucked and / or chewed, preferably when the composition, in particular the fixed dosage (fixed dosage form), is administered and / or sucked and / or chewed in the mouth and throat of a patient. [41] Composition according to any one of the preceding claims, wherein the composition, in particular the fixed dosage form, contains at least one excipient (carrier), preferably a pharmacologically and / or physiologically harmless excipient (carrier); and / or wherein the composition, in particular the fixed dosage (solid dosage form), contains at least one sugar and / or at least one sugar substitute, in particular as a matrix (matrix former) and / or as an excipient (carrier), preferably pharmacologically and / or physiologically harmless excipient (carrier); in particular wherein the sugar is selected from the group consisting of sucrose, glucose, especially dextrose, and fructose; and / or in particular wherein the sugar substitute is selected from the group of sugar alcohols, preferably from the group of mannitol, xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructooligosaccharides, glucans, polyglucose and their combinations and mixtures, particularly preferably isomalt and / or mannitol, most particularly preferably isomalt. [42] Composition according to any one of the preceding claims, wherein the composition, in particular the fixed dosage (solid dosage form), comprises the active ingredients and / or other ingredients in a solid matrix, in particular in a matrix based on sugars and / or sugar substitutes, in particular as defined in claim 41; and / or wherein the composition, in particular the fixed dosage (fixed dosage form), contains or incorporates or has embedded all active ingredients, in particular the octenidine, especially in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride, and the ingredients (a), in particular the ingredients (a)(i), (a)(ii) and / or (a)(iii), preferably (a)(i), (a)(ii) and (a)(iii), and (b) and optionally all other active ingredients and / or ingredients in the solid matrix. [43] Composition according to claim 41 or 42, wherein the composition, in particular the fixed dosage (solid dosage form), comprises 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 based on the fixed dosage (solid dosage form); and / or wherein the composition, in particular the fixed dosage (solid dosage form), comprises the sugar and / or the sugar substitute in an (absolute) amount in the range of 250 mg to 6,950 mg, in particular in the range of 500 mg to 5,950 mg, preferably in the range of 1,000 mg to 4,950 mg; and / or wherein the composition, in particular the fixed dosage (solid dosage form), comprises the sugar 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 based on the fixed dosage (solid dosage form), and / or wherein the composition, in particular the fixed dosage (solid dosage form), comprises 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 based on the fixed dosage (solid dosage form). [44] Composition according to any one of the preceding claims, wherein the composition, in particular the fixed dosage (solid dosage form), contains at least one sugar substitute, in particular as a matrix (matrix former) and / or as an excipient (carrier), preferably pharmacologically and / or physiologically harmless excipient (carrier); in particular wherein the sugar substitute is selected from sugar alcohols, preferably from the group consisting of mannitol, xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructooligosaccharides, glucans, polyglucose and their combinations and mixtures, particularly preferably isomalt and / or mannitol, most particularly preferably isomalt. [45] Composition according to any of the preceding claims, wherein the composition, in particular the solid dosage (solid dosage form) and / or the matrix, is at least substantially free of sucrose. [46] Composition according to any one of the preceding claims, wherein the composition, in particular the fixed dosage (solid dosage form) and / or the matrix, is at least substantially free of disaccharides; and / or wherein the composition, in particular the fixed dosage (solid dosage form) and / or the matrix, is at least substantially free of sugar(s); and / or wherein the composition, in particular the fixed dosage (fixed dosage form) and / or the matrix, is at least essentially sugar-free. [47] Composition according to any one of the preceding claims, wherein the composition, in particular the solid dosage form and / or the matrix, contains sucrose in amounts of at most 1 wt.%, in particular in amounts of at most 0.5 wt.%, preferably in amounts of at most 0.1 wt.%, particularly preferably in amounts of at most 0.01 wt.%, based on the composition, in particular based on the solid dosage form and / or the matrix; and / or wherein the composition, in particular the solid dosage form and / or the matrix, contains disaccharide(s) in amounts of at most 1 wt.%, in particular in amounts of at most 0.5 wt.%, preferably in amounts of at most 0.1 wt.%, particularly preferably in amounts of at most 0.01 wt.%, based on the composition, in particular based on the solid dosage form and / or the matrix; and / or wherein the composition, in particular the fixed dosage (fixed dosage form) and / or the matrix, contains sugar in amounts of at most 1 wt.%, in particular in amounts of at most 0.5 wt.%, preferably in amounts of at most 0.1 wt.%, particularly preferably in amounts of at most 0.01 wt.%, based on the composition, in particular based on the fixed dosage (fixed dosage form) and / or the matrix. [48] ​​Composition according to any one of the preceding claims, wherein the composition, in particular the solid dosage form, has a 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 based on the solid dosage form; and / or wherein the composition, in particular the solid dosage form, has a residual moisture content 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 1 wt.% to 3 wt.%, based on the composition, in particular based on the solid dosage form. [49] Composition according to any one of the preceding claims, the inflammatory diseases of the mouth and throat are selected from sore throats, hoarseness, catarrh, colds, viral and / or bacterial infections, tonsillitis, especially angina, gingivitis, pharyngitis, stomatitis, periodontitis, tonsillitis, laryngitis, oral mucosa lesions such as aphthous ulcers, or the like. [50] Composition according to any of the preceding claims, wherein the octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly 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. [51] Composition according to any of the preceding claims, wherein the composition is prepared for the administration of octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly 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. [52] Composition, in particular pharmaceutical composition, in the form of a fixed dosage (solid dosage form) for sucking and / or chewing, preferably for sucking, in particular lozenge, preferably for use in the prophylactic and / or therapeutic topical (local) treatment of inflammatory diseases of the mouth and throat, in particular composition according to any one of the preceding claims, wherein the composition contains an effective, in particular pharmaceutically and / or therapeutically effective, amount of an active ingredient preferably suitable and / or effective for the topical (local) treatment of inflammatory diseases of the mouth and throat, in particular with antiseptic and / or antimicrobial properties, preferably with antibacterial and / or antiviral and / or antifungal properties, wherein the active ingredient is incorporated and / or embedded in a solid matrix, wherein the composition, in particular the fixed dosage (solid dosage form) and / or the matrix, releases the active ingredient upon topical (local) application and / or use, preferably by sucking and / or chewing, preferably by sucking, in the oral and pharyngeal cavity; wherein the active ingredient is octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride; and wherein the composition, in particular the fixed dosage (fixed dosage form) and / or the matrix, furthermore and / or additionally contains at least one further ingredient (a) and / or (b), in particular (a) and (b), wherein the at least one further ingredient (a) and / or (b) is selected from the group of (a) Flavor modulators, in particular selected from the group of the following components (i), (ii) and / or (iii): (i) Bitter (taste) masking agents, in particular selected from the group consisting of bitter taste receptor antagonists, preferably 4-(2,2,3-trimethylcyclopentyl)butanoic acid, and saponins, preferably glycyrrhizic acid (glycyrrhizin) and its salts or esters and / or glycyrrhetinic acid (glycyrrhetin) and its salts or esters, complexing agents, in particular cyclodextrins, and combinations or mixtures thereof, (ii) Bitter substances, in particular coffee extract and / or tea extract and / or their respective bitter substances, preferably coffee extract and / or its bitter substances, (iii) preferably natural or nature-identical (aroma) oils and / or essential oils, in particular with antiseptic and / or antimicrobial properties, preferably with antibacterial, antifungal and / or antiviral properties, in particular selected from the group of anise oils, in particular star anise oil, peppermint oil, eucalyptus oil, lavender oil, tea tree oil, chamomile oil, clove oil, rosemary oil, caraway oil, cinnamon oil, sage oil and fennel oil, as well as combinations or mixtures thereof; in particular wherein the ingredient (a) and / or the flavor modulator comprises a combination of at least two different components (i), (ii) and / or (iii), preferably a combination of components (i), (ii) and (iii); (b) Acidulants, in particular saliva-stimulating and / or flavor-enhancing acidulants, preferably acidulants authorized under pharmaceutical and / or food law and / or acidulants authorized as pharmaceutical additives and / or as food additives, in particular selected from the group of tartaric acid and its salts, in particular sodium tartrate, sodium potassium tartrate (Rochelle salt) and calcium tartrate, citric acid and its salts, metatartaric acid, fumaric acid, ascorbic acid, phosphoric acid and its salts, stannous chloride, in particular tin(II) chloride, malic acid, lactic acid, adipic acid, succinic acid and other pharmaceutically compatible and / or physiologically acceptable organic acids and their salts, as well as their combinations or mixtures; wherein the composition is in the form of a lozenge, in particular on a hard caramel base or as a hard caramel or on a soft caramel base or as a soft caramel, preferably on a hard caramel base or as a 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, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride, in an (absolute) amount in the range of 0.05 mg to 25 mg, in particular in the range of 0.1 mg to 20 mg, preferably in the range of 0.2 mg to 15 mg, preferably in the range of 0.3 mg to 10 mg, particularly preferably in the range of 0.5 mg to 8 mg; - Ingredient (a) (flavor modulator) in an (absolute) (total) amount in the range of 0.1 mg to 250 mg, in particular in the range of 0.5 mg to 200 mg, preferably in the range of 1 mg to 150 mg, preferably in the range of 2 mg to 100 mg, particularly preferably in the range of 5 mg to 50 mg; - Ingredient (b) (acidifying agent) in an (absolute) (total) amount in the range of 0.25 mg to 150 mg, in particular in the range of 0.5 mg to 100 mg, preferably in the range of 0.75 mg to 75 mg, preferably in the range of 1 mg to 60 mg, particularly preferably in the range of 2 mg to 30 mg; - optionally at least one rheology and / or wetting modifier and / or soft consistency agent, in particular wherein the rheology and / or wetting modifier and / or the soft consistency agent is selected from the group consisting of mucilages, carrageenans, preferably lota-carrageenan, in particular acidic glycosaminoglycans, preferably hyaluronic acid and its pharmaceutically compatible and / or physiologically acceptable salts, preferably sodium hyaluronate, poloxamers, xanthan gums, gelling agents, polyalkylene glycols, preferably polyethylene glycol and polypropylene glycol, preferably polypropylene glycol, gum arabic, locust bean gum, galactomannans, guar gum, guarans, polysaccharides, agar-agar, gum arabic, gelatin and pectins, as well as their combinations and mixtures, in an (absolute) amount in the range of 1 mg to 1,000 mg, particularly in the range of 3 mg to 500 mg, preferably in the range of 5 mg to 250 mg; - optionally at least one further active ingredient and / or component, in particular a 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 buffers, thickeners, flavorings, antiseptics, colorings, buffers, odorants, fragrances, extenders, binders, wetting agents and / or preservatives as well as their combinations and mixtures, in an (absolute) quantity in the range of 0.1 mg to 500 mg, in particular in the range of 0.5 mg to 250 mg, preferably in the range of 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 harmless excipient (carrier); in particular wherein the sugar is selected from the group consisting 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 consisting of mannitol, xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructooligosaccharides, glucans, polyglucose and their combinations and mixtures, particularly preferably isomalt and / or mannitol, most preferably isomalt; and / or in particular in quantities to provide and / or maintain the total weight of the lozenge. [53] Composition, in particular pharmaceutical composition, in the form of a fixed dosage (solid dosage form) for sucking and / or chewing, preferably for sucking, in particular lozenge, preferably for use in the prophylactic and / or therapeutic topical (local) treatment of inflammatory diseases of the mouth and throat, in particular composition according to any one of the preceding claims, wherein the composition contains an effective, in particular pharmaceutically and / or therapeutically effective, amount of an active ingredient preferably suitable and / or effective for the topical (local) treatment of inflammatory diseases of the mouth and throat, in particular with antiseptic and / or antimicrobial properties, preferably with antibacterial and / or antiviral and / or antifungal properties, wherein the active ingredient is incorporated and / or embedded in a solid matrix, wherein the composition, in particular the fixed dosage (solid dosage form) and / or the matrix, releases the active ingredient upon topical (local) application and / or use, preferably by sucking and / or chewing, preferably by sucking, in the oral and pharyngeal cavity; wherein the active ingredient is octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride; and wherein the composition, in particular the fixed dosage (fixed dosage form) and / or the matrix, furthermore and / or additionally contains at least one further ingredient (a) and / or (b), in particular (a) and (b), wherein the at least one further ingredient (a) and / or (b) is selected from the group of (a) Flavor modulators, in particular selected from the group of the following components (i), (ii) and / or (iii): (i) Bitter (taste) masking agents, in particular selected from the group consisting of bitter taste receptor antagonists, preferably 4-(2,2,3-trimethylcyclopentyl)butanoic acid, and saponins, preferably glycyrrhizic acid (glycyrrhizin) and its salts or esters and / or glycyrrhetinic acid (glycyrrhetin) and its salts or esters, complexing agents, in particular cyclodextrins, and combinations or mixtures thereof, (ii) Bitter substances, in particular coffee extract and / or tea extract and / or their respective bitter substances, preferably coffee extract and / or its bitter substances, (iii) preferably natural or nature-identical (aroma) oils and / or essential oils, in particular with antiseptic and / or antimicrobial properties, preferably with antibacterial, antifungal and / or antiviral properties, in particular selected from the group of anise oils, in particular star anise oil, peppermint oil, eucalyptus oil, lavender oil, tea tree oil, chamomile oil, clove oil, rosemary oil, caraway oil, cinnamon oil, sage oil and fennel oil, as well as combinations or mixtures thereof; wherein the ingredient (a) and / or the flavor modulator comprises a combination of components (i), (ii) and (iii); (b) Acidulants, in particular saliva-stimulating and / or flavor-enhancing acidulants, preferably acidulants authorized under pharmaceutical and / or food law and / or acidulants authorized as pharmaceutical additives and / or as food additives, in particular selected from the group of tartaric acid and its salts, in particular sodium tartrate, sodium potassium tartrate (Rochelle salt) and calcium tartrate, citric acid and its salts, metatartaric acid, fumaric acid, ascorbic acid, phosphoric acid and its salts, stannous chloride, in particular tin(II) chloride, malic acid, lactic acid, adipic acid, succinic acid and other pharmaceutically compatible and / or physiologically acceptable organic acids and their salts, as well as their combinations or mixtures; wherein the composition is in the form of a lozenge, in particular on a hard caramel base or as a hard caramel or on a soft caramel base or as a soft caramel, preferably on a hard caramel base or as a 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, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride, in an (absolute) amount in the range of 0.05 mg to 25 mg, in particular in the range of 0.1 mg to 20 mg, preferably in the range of 0.2 mg to 15 mg, preferably in the range of 0.3 mg to 10 mg, particularly preferably in the range of 0.5 mg to 8 mg; - Ingredient (a)(i) (bitter taste masking agent) in an (absolute) amount in the range of 0.05 mg to 50 mg, in particular in the range of 0.1 mg to 25 mg, preferably in the range of 0.5 mg to 20 mg, preferably in the range of 0.75 mg to 15 mg, particularly preferably in the range of 1 mg to 10 mg; - Ingredient (a)(ii) (bitter substance) in an (absolute) amount in the range of 0.01 mg to 100 mg, in particular in the range of 0.05 mg to 75 mg, preferably in the range of 0.075 mg to 50 mg, preferably in the range of 0.1 mg to 30 mg, particularly preferably in the range of 0.5 mg to 20 mg; - Ingredient (a)(iii) ((Aroma) oil and / or essential oil) in an (absolute) amount in the range of 0.2 mg to 100 mg, in particular in the range of 0.3 mg to 80 mg, preferably in the range of 0.5 mg to 50 mg, preferably in the range of 0.75 mg to 30 mg, particularly preferably in the range of 1 mg to 20 mg; - Ingredient (b) (acidifying agent) in an (absolute) (total) amount in the range of 0.25 mg to 150 mg, in particular in the range of 0.5 mg to 100 mg, preferably in the range of 0.75 mg to 75 mg, preferably in the range of 1 mg to 60 mg, particularly preferably in the range of 2 mg to 30 mg; - optionally at least one rheology and / or wetting modifier and / or soft consistency agent, in particular wherein the rheology and / or wetting modifier and / or the soft consistency agent is selected from the group consisting of mucilages, carrageenans, preferably lota-carrageenan, in particular acidic glycosaminoglycans, preferably hyaluronic acid and its pharmaceutically compatible and / or physiologically acceptable salts, preferably sodium hyaluronate, poloxamers, xanthan gums, gelling agents, polyalkylene glycols, preferably polyethylene glycol and polypropylene glycol, preferably polypropylene glycol, gum arabic, locust bean gum, galactomannans, guar gum, guarans, polysaccharides, agar-agar, gum arabic, gelatin and pectins, as well as their combinations and mixtures, in an (absolute) amount in the range of 1 mg to 1,000 mg, particularly in the range of 3 mg to 500 mg, preferably in the range of 5 mg to 250 mg; - optionally at least one further active ingredient and / or component, in particular a 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 buffers, thickeners, flavorings, antiseptics, colorings, buffers, odorants, fragrances, extenders, binders, wetting agents and / or preservatives as well as their combinations and mixtures, in an (absolute) quantity in the range of 0.1 mg to 500 mg, in particular in the range of 0.5 mg to 250 mg, preferably in the range of 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 harmless excipient (carrier); in particular wherein the sugar is selected from the group consisting 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 consisting of mannitol, xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructooligosaccharides, glucans, polyglucose and their combinations and mixtures, particularly preferably isomalt and / or mannitol, most preferably isomalt; and / or in particular in quantities to provide and / or maintain the total weight of the lozenge. [54] Composition, in particular pharmaceutical composition, in the form of a fixed dosage (solid dosage form) for sucking and / or chewing, preferably for sucking, in particular lozenge, preferably for use in the prophylactic and / or therapeutic topical (local) treatment of inflammatory diseases of the mouth and throat, in particular composition according to any one of the preceding claims, wherein the composition contains an effective, in particular pharmaceutically and / or therapeutically effective, amount of an active ingredient preferably suitable and / or effective for the topical (local) treatment of inflammatory diseases of the mouth and throat, in particular with antiseptic and / or antimicrobial properties, preferably with antibacterial and / or antiviral and / or antifungal properties, wherein the active ingredient is incorporated and / or embedded in a solid matrix, wherein the composition, in particular the fixed dosage (solid dosage form) and / or the matrix, releases the active ingredient upon topical (local) application and / or use, preferably by sucking and / or chewing, preferably by sucking, in the oral and pharyngeal cavity; wherein the active ingredient is octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride; and wherein the composition, in particular the fixed dosage (fixed dosage form) and / or the matrix, furthermore and / or additionally contains at least one further ingredient (a) and / or (b), in particular (a) and (b), wherein the at least one further ingredient (a) and / or (b) is selected from the group of (a) Flavor modulators, in particular selected from the group of the following components (i), (ii) and / or (iii): (i) bitter (taste) masking agents, in particular 4-(2,2,3-tri-methylcyclopentyl)butanoic acid, (ii) Bitter substances, in particular coffee extract and / or tea extract and / or their respective bitter substances, preferably coffee extract and / or its bitter substances, (iii) preferably natural or nature-identical (aroma) oils and / or essential oils, in particular anise oil, in particular star anise oil, and / or peppermint oil, preferably anise oil, in particular star anise oil, and peppermint oil; wherein the anise oil, in particular star anise oil, is at least substantially free of estragole and / or contains at least substantially no estragole, in particular wherein the anise oil, in particular star anise oil, has an estragole content of less than 1,000 ppm, in particular less than 100 ppm, preferably less than 10 ppm, preferably less than 5 ppm, and / or wherein the composition has an estragole content of less than 500 ppm, in particular less than 50 ppm, preferably less than 5 ppm, preferably less than 1 ppm; and / or wherein the composition is at least substantially free of estragole and / or contains at least substantially no estragole, in particular wherein the composition has an estragole content of less than 500 ppm, in particular less than 50 ppm, preferably less than 5 ppm, preferably less than 1 ppm, based on the composition; wherein the ingredient (a) and / or the flavor modulator comprises a combination of components (i), (ii) and (iii); (b) Acidulants, in particular saliva-stimulating and / or flavor-enhancing acidulants, preferably acidulants authorized under pharmaceutical and / or food law and / or acidulants authorized as pharmaceutical additives and / or food additives, in particular selected from the group consisting of tartaric acid and its salts, in particular sodium tartrate, sodium potassium tartrate (Rochelle salt) and calcium tartrate, citric acid and its salts, metatartaric acid, fumaric acid, ascorbic acid, phosphoric acid and its salts, stannous chloride, in particular tin(II) chloride, malic acid, lactic acid, adipic acid, succinic acid and other pharmaceutically compatible and / or physiologically acceptable organic acids and their salts, as well as their combinations or mixtures; preferably tartaric acid and / or citric acid, particularly preferably tartaric acid; wherein the composition is in the form of a lozenge, in particular on a hard caramel base or as a hard caramel or on a soft caramel base or as a soft caramel, preferably on a hard caramel base or as a 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, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride, in an (absolute) amount in the range of 0.05 mg to 25 mg, in particular in the range of 0.1 mg to 20 mg, preferably in the range of 0.2 mg to 15 mg, preferably in the range of 0.3 mg to 10 mg, particularly preferably in the range of 0.5 mg to 8 mg; - Ingredient (a)(i) (bitter taste masking agent) in an (absolute) amount in the range of 0.05 mg to 50 mg, in particular in the range of 0.1 mg to 25 mg, preferably in the range of 0.5 mg to 20 mg, preferably in the range of 0.75 mg to 15 mg, particularly preferably in the range of 1 mg to 10 mg; - Ingredient (a)(ii) (bitter substance) in an (absolute) amount in the range of 0.01 mg to 100 mg, in particular in the range of 0.05 mg to 75 mg, preferably in the range of 0.075 mg to 50 mg, preferably in the range of 0.1 mg to 30 mg, particularly preferably in the range of 0.5 mg to 20 mg; - Ingredient (a)(iii) ((Aroma) oil and / or essential oil) in an (absolute) amount in the range of 0.2 mg to 100 mg, in particular in the range of 0.3 mg to 80 mg, preferably in the range of 0.5 mg to 50 mg, preferably in the range of 0.75 mg to 30 mg, particularly preferably in the range of 1 mg to 20 mg; - Ingredient (b) (acidifying agent) in an (absolute) (total) amount in the range of 0.25 mg to 150 mg, in particular in the range of 0.5 mg to 100 mg, preferably in the range of 0.75 mg to 75 mg, preferably in the range of 1 mg to 60 mg, particularly preferably in the range of 2 mg to 30 mg; - optionally at least one rheology and / or wetting modifier and / or soft consistency agent, in particular wherein the rheology and / or wetting modifier and / or the soft consistency agent is selected from the group consisting of mucilages, carrageenans, preferably lota-carrageenan, in particular acidic glycosaminoglycans, preferably hyaluronic acid and its pharmaceutically compatible and / or physiologically acceptable salts, preferably sodium hyaluronate, poloxamers, xanthan gums, gelling agents, polyalkylene glycols, preferably polyethylene glycol and polypropylene glycol, preferably polypropylene glycol, gum arabic, locust bean gum, galactomannans, guar gum, guarans, polysaccharides, agar-agar, gum arabic, gelatin and pectins, as well as their combinations and mixtures, in an (absolute) amount in the range of 1 mg to 1,000 mg, particularly in the range of 3 mg to 500 mg, preferably in the range of 5 mg to 250 mg; - optionally at least one further active ingredient and / or component, in particular a 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 buffers, thickeners, flavorings, antiseptics, colorings, buffers, odorants, fragrances, extenders, binders, wetting agents and / or preservatives as well as their combinations and mixtures, in an (absolute) quantity in the range of 0.1 mg to 500 mg, in particular in the range of 0.5 mg to 250 mg, preferably in the range of 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 harmless excipient (carrier); in particular wherein the sugar is selected from the group consisting 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 consisting of mannitol, xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructooligosaccharides, glucans, polyglucose and their combinations and mixtures, particularly preferably isomalt and / or mannitol, most preferably isomalt; and / or in particular in quantities to provide and / or maintain the total weight of the lozenge. [55] Composition, in particular pharmaceutical composition, according to any of the preceding claims for use in the prophylactic and / or therapeutic topical (local) treatment of inflammatory diseases of the mouth and throat. [56] Use of a composition, in particular a pharmaceutical composition, according to any of the preceding claims for the prophylactic and / or therapeutic topical (local) treatment of inflammatory diseases of the mouth and throat. [57] Use of a composition, in particular a pharmaceutical composition, according to any of the preceding claims for the manufacture of a drug or medicament for the prophylactic and / or therapeutic topical (local) treatment of inflammatory diseases of the mouth and throat. [58] Use of at least one ingredient (a) and / or (b), in particular (a) and (b), to improve and / or adjust the organoleptic properties, in particular the taste, preferably to reduce and / or mask the bitter taste, of a composition, in particular a pharmaceutical composition, in the form of a fixed dosage (solid dosage form) for sucking and / or chewing, preferably for sucking, in particular a lozenge, preferably for use in the prophylactic and / or therapeutic topical (local) treatment of inflammatory diseases of the mouth and throat, in particular a composition as defined above, wherein at least one further ingredient (a) and / or (b) is selected from the group of (a) Flavor modulators, in particular selected from the group of the following components (i), (ii) and / or (iii): (i) Bitter (taste) masking agents, in particular selected from the group consisting of bitter taste receptor antagonists, preferably 4-(2,2,3-trimethylcyclopentyl)butanoic acid, and saponins, preferably glycyrrhizic acid (glycyrrhizin) and its salts or esters and / or glycyrrhetinic acid (glycyrrhetin) and its salts or esters, complexing agents, in particular cyclodextrins, and combinations or mixtures thereof, (ii) Bitter substances, in particular coffee extract and / or tea extract and / or their respective bitter substances, preferably coffee extract and / or its bitter substances, (iii) preferably natural or nature-identical (aroma) oils and / or essential oils, in particular with antiseptic and / or antimicrobial properties, preferably with antibacterial, antifungal and / or antiviral properties, in particular selected from the group of anise oils, in particular star anise oil, peppermint oil, eucalyptus oil, lavender oil, tea tree oil, chamomile oil, clove oil, rosemary oil, caraway oil, cinnamon oil, sage oil and fennel oil, as well as combinations or mixtures thereof; in particular wherein the ingredient (a) and / or the flavor modulator comprises a combination of at least two different components (i), (ii) and / or (iii), preferably a combination of components (i), (ii) and (iii); (b) Acidulants, in particular saliva-stimulating and / or flavor-enhancing acidulants, preferably acidulants authorized under pharmaceutical and / or food law and / or acidulants authorized as pharmaceutical additives and / or as food additives, in particular selected from the group of tartaric acid and its salts, in particular sodium tartrate, sodium potassium tartrate (Rochelle salt) and calcium tartrate, citric acid and its salts, metatartaric acid, fumaric acid, ascorbic acid, phosphoric acid and its salts, stannous chloride, in particular tin(II) chloride, malic acid, lactic acid, adipic acid, succinic acid and other pharmaceutically compatible and / or physiologically acceptable organic acids and their salts, as well as their combinations or mixtures; wherein the composition contains an effective, in particular pharmaceutically and / or therapeutically effective, amount of an active ingredient preferably suitable and / or effective for the topical (local) treatment of inflammatory diseases of the mouth and throat, in particular with antiseptic and / or antimicrobial properties, preferably with antibacterial and / or antiviral and / or antifungal properties, wherein the active ingredient is incorporated and / or embedded in a solid matrix, wherein the composition, in particular the fixed dosage (solid dosage form) and / or the matrix, releases the active ingredient upon topical (local) application and / or use, preferably by sucking and / or chewing, preferably by sucking, in the oral and pharyngeal cavity; wherein the active ingredient is octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride; in particular wherein the composition, in particular the fixed dosage form and / or the matrix, contains at least one further ingredient (a) and / or (b), in particular (a) and (b), and / or wherein the at least one further ingredient (a) and / or (b), in particular (a) and (b), is added to the composition and / or incorporated into the composition, in particular the fixed dosage form and / or the matrix; and / or in particular wherein the organoleptic properties to be improved and / or adjusted, in particular taste, preferably the bitter taste to be reduced and / or masked, are specified and / or formed by octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride. [59] Use of at least one ingredient (a) and / or (b), in particular (a) and (b), for reducing and / or masking the bitter taste of octenidine, in particular in the form of a pharmaceutically compatible and / or physiologically acceptable salt or ester, preferably in the form of a pharmaceutically compatible and / or physiologically acceptable salt, particularly preferably octenidine dihydrochloride, preferably in a (common) composition, in particular a pharmaceutical composition, in particular for sucking and / or chewing, preferably for sucking, preferably a composition as defined above, preferably use according to claim 58, wherein at least one further ingredient (a) and / or (b) is selected from the group of (a) Flavor modulators, in particular selected from the group of the following components (i), (ii) and / or (iii): (i) Bitter (taste) masking agents, in particular selected from the group consisting of bitter taste receptor antagonists, preferably 4-(2,2,3-trimethylcyclopentyl)butanoic acid, and saponins, preferably glycyrrhizic acid (glycyrrhizin) and its salts or esters and / or glycyrrhetinic acid (glycyrrhetin) and its salts or esters, complexing agents, in particular cyclodextrins, and combinations or mixtures thereof, (ii) Bitter substances, in particular coffee extract and / or tea extract and / or their respective bitter substances, preferably coffee extract and / or its bitter substances, (iii) preferably natural or nature-identical (aroma) oils and / or essential oils, in particular with antiseptic and / or antimicrobial properties, preferably with antibacterial, antifungal and / or antiviral properties, in particular selected from the group of anise oils, in particular star anise oil, peppermint oil, eucalyptus oil, lavender oil, tea tree oil, chamomile oil, clove oil, rosemary oil, caraway oil, cinnamon oil, sage oil and fennel oil, as well as combinations or mixtures thereof; in particular wherein the ingredient (a) and / or the flavor modulator comprises a combination of at least two different components (i), (ii) and / or (iii), preferably a combination of components (i), (ii) and (iii); (b) Acidulants, in particular saliva-stimulating and / or flavor-enhancing acidulants, preferably acidulants authorized under pharmaceutical and / or food law and / or acidulants authorized as pharmaceutical additives and / or as food additives, in particular selected from the group of tartaric acid and its salts, in particular sodium tartrate, sodium potassium tartrate (Rochelle salt) and calcium tartrate, citric acid and its salts, metatartaric acid, fumaric acid, ascorbic acid, phosphoric acid and its salts, stannous chloride, in particular tin(II) chloride, malic acid, lactic acid, adipic acid, succinic acid and other pharmaceutically compatible and / or physiologically acceptable organic acids and their salts, as well as their combinations or mixtures. [60] Composition for use according to claim 55, use according to claim 56, use according to claim 57 and use according to claim 58 or 59, eachcharacterized by one or more of the features of claims 1 to 54.