DE202005018338U1 - Pharmaceutical composition, in lozenge form, useful e.g. for treating dry cough, hoarseness and inflammatory diseases of mouth and throat, comprises Lichen islandicus and/or Mentha piperita, carrier, diluents, additives and sweeteners - Google Patents

Abstract

A pharmaceutical composition (A), in a solid dosage form (preferably lozenge) as cough agent and/or for the topical treatment of inflammatory diseases of the mouth and throat, comprising a combination of Lichen islandicus(I) (Iceland moss) and/or its extract and Mentha piperita(II) (peppermint) and/or its extract (preferably in the form of peppermint oil (Menthae piperitae aetheroleum)), is new. An independent claim is also included for a lozenge, for treating cough and hoarseness, comprising (A). ACTIVITY : Antitussive; Antiinflammatory; Antianginal; Antibacterial; Antimicrobial; Antiasthmatic; Antiulcer; Laxative; Antidiarrheic. MECHANISM OF ACTION : None given.

Description

The The present invention relates to a pharmaceutical composition in the form of a solid dosage form, especially lozenge-based, which is a combination of Icelandic Moss (Lichen islandicus) and / or its extract together with peppermint (Mentha piperita) and / or their extract, in particular in the form of peppermint oil (Menthae piperitae aetheroleum).

The aforementioned pharmaceutical invention Composition or combination of Icelandic moss (Lichen islandicus) or its extract together with Mentha piperita (peppermint) and / or their extract, especially in the form of peppermint oil (Menthae piperitae aetheroleum), is particularly suitable as a soothing Cough medicine, especially for coughing or coughing and hoarseness, as well as for the treatment of inflammatory Oral and pharyngeal diseases.

Especially In respiratory infections, external stimuli, like bad or dry respiratory air, the already attacked throat and pharynx dry out. Cough irritation and hoarseness are the episode. Here come in general so-called cough medicine Use, generally between cough-suppressing or cough-inhibiting Cough medicine, so-called antitussives, on the one hand and cough-forming or expectorant Cough medicine, so-called expectorants, on the other hand distinguished becomes. While Antitussives (eg morphine derivatives, such as codeine and its natural and synthetic derivatives such as dihydrocodeine, hydrocodone, etc.) via a Inhibition of the reflexibility of the cough center in the Medulla oblongata act and thus dampen the cough center, so to speak inhibit the cough reflex, strengthen and / or accelerate the expectorants (eg ammonium chloride, Potassium iodate, essential oils, etc.) on the other hand physiological expectoration, whereby either the secretolytic or the secretomotor effect predominates. The aforementioned Some substances have serious side effects: antitussives based on morphine derivatives In addition to her cough-inhibiting effect also analgesic and / or respiratory depressive act and also be addictive to varying degrees. Also some of the above expectorants have serious side effects: For example, the use of ammonium chloride as an expectorant poses the danger metabolic acidosis, and the use of the expectorant Potassium iodate can trigger iodism.

inflammatory Oral and pharyngeal disorders, d. H. inflammation in the area of the oral cavity and the throat / throat, often occur as a concomitant from colds and influenza-like infections, but also as independent diseases. Not restrictive examples for such inflammatory Sore throat diseases are throat infections, especially angina, inflammation of the larynx (laryngitis), inflammations the pharyngeal mucosa (pharyngitis) and inflammation of the tonsils (tonsillitis). Also inflammations in the area of the oral cavity, such as Stomatitis, gingivitis, oral mucosal lesions and The like are to be mentioned in this context. For more details to the aforementioned diseases, for example, on Roche lexicon Medicine, 3rd edition, 1993, Urban & Schwarzenberg, Munich / Vienna / Baltimore, as well as on Pschyrembel, Medical Dictionary, 257th edition, 1993, Nikol Verlagsgesellschaft mbH, Hamburg. The term "inflammatory Oral and pharyngeal diseases "is therefore very far to understand and includes all inflammatory Diseases that occur in the mouth, throat and throat can.

The treatment of inflammatory diseases of the oral and pharyngeal space is - depending on the severity of the disease - generally by topical and possibly additional systemic therapy in more serious cases. While antibacterials are administered systemically in more severe cases, antiseptics and anti-inflammatory substances (such as anti-inflammatory drugs, anti-inflammatory agents, local antibiotics, etc.) may be used as adjunctive and, in some cases, alone for topical, symptomatic treatment Form of pharyngeal rinses, sprays or lozenges can be administered. As an active ingredient for the topical treatment of inflammatory processes of the mouth and throat has in particular 1-Hexadecylpyridiniumchlorid (international free name: "cetylpyridinium" (CPC)) proven this is a quaternary ammonium compound with bactericidal and fungicidal action, which inter alia in Lozenges is used. A disadvantage of this active ingredient is the fact that at high dosage and excessive consumption gastrointestinal complaints, respiratory distress and increased methaemoglobin formation, especially in children, can occur. Furthermore, as a topical antiseptic or disinfectant for the oral, throat and throat mucosa and 1,3-bis (2-ethylhexyl) -hexahydro-5-methyl-5-pyridinamine (international free name: "Hexetidine") has been proven, which can be applied, for example, as a spray or in the form of rinsing or gargling solutions; for prolonged use and high dosage It can also cause gastrointestinal discomfort and in addition to taste irritation. Furthermore, active ingredients of natural origin are used. However, such preparations do not always offer the desired therapeutic success.

Of the The present invention is therefore based on the object, a pharmaceutical To provide a composition which is a cough medicine, in particular for coughing or coughing or hoarseness, as well as for efficient topical treatment of inflammatory Diseases of the oropharynx (ie of inflammatory Diseases of the cervical area and the oral cavity) is suitable and in particular the previously described disadvantages of the prior art, at least largely avoids or at least mitigates.

The Applicant has now surprisingly found out that the previously described problem can be solved by having a pharmaceutical preparation in the form of a fixed dosage based from Icelandic Moss (Lichen islandicus) and / or its extract together with peppermint (Mentha piperita) and / or their extract, in particular in the form of peppermint oil (Menthae piperitae aetheroleum), formulated. Such a pharmaceutical Composition is particularly suitable for the preparation of lozenges, in particular on hard caramel base, which is used as cough medicine, in particular for coughing, irritating cough and / or hoarseness, but also for inflammatory Diseases of the oropharynx reach topical application can.

The previously described problem is due to a pharmaceutical composition in the form of a solid dosage, preferably lozenge-based, according to claim 1 solved. Further, advantageous embodiments of the pharmaceutical composition according to the present invention are the subject of the dependent claims.

• (a) Isländisches Moos (Lichen islandicus) und/oder dessen Extrakt; sowie
• (b) Pfefferminze (Mentha piperita) und/oder deren Extrakt, insbesondere in Form von Pfefferminzöl (Menthae piperitae aetheroleum), enthält.

The present invention thus relates to a pharmaceutical composition in the form of a solid dosage, preferably lozenge-based, in particular for use as a cough suppressant and / or for the topical treatment of inflammatory diseases of the oropharynx, wherein the pharmaceutical composition in combination and in each case in pharmaceutically active amounts

• (a) Icelandic moss (Lichen islandicus) and / or its extract; such as
• (b) peppermint (Mentha piperita) and / or its extract, in particular in the form of peppermint oil (Menthae piperitae aetheroleum).

The The aforementioned combination is particularly suitable for temporary sole use or supporting Treatment for coughing and hoarseness and inflammation of the oropharynx, because the combination is anti-inflammatory or inflammation-reducing acts. By using of course based active ingredients based on Icelandic moss or its extract and peppermint or their extract are those with synthetic Active ingredients occurring side effects effectively prevented.

Of the Term "pharmaceutical Composition "or" pharmaceutical combination "- in the context of the present Invention mostly synonymous used - is very far to understand and includes every kind of possible pharmaceutical composition or combination, in particular Medicines or pharmaceuticals as such, but also medical devices, homeopathic Funds etc.

The Pharmaceutical preparation according to the present invention can used for the treatment of various diseases, in particular for the treatment of cough and coughing, especially in dry Irritating cough, about it in addition, with mucous membrane irritation and mucosal lesions in the Mouth and throat, dehydration of the mucous membranes in the area of the oropharynx, especially as a result of infections Hoarseness as well as bronchial catharsis and bronchial asthma. For example the pharmaceutical preparation according to the present invention is suitable Invention as a soothing cough suppressant

In addition, the pharmaceutical composition according to the invention can be used for example in irritated mucosa with sore throat or sore throat in dry mucous membrane or in dry throat mucosa with sore throat. In addition, the inventive pharmaceutical composition or combination for sore throat with simultaneous mucosal protection can be used. By the combination according to the invention an efficient effect is achieved: The mucous membrane is sufficiently wetted, so that a feeling of dryness and a spread of bacteria is counteracted. Thus, the pharmaceutical composition or Combination actively counteracts dry mouth and combats both the inflammation. Thus, the pharmaceutical composition according to the invention is suitable, for example, for the supportive or sole treatment in mucous membrane irritation and / or sore throat. In this way, sore throat can be effectively combated: The wetting of the dried up oral mucosa also makes it difficult to penetrate further pathogens. The regeneration of the inflammatory altered oral mucosa can heal in the surface-anesthetized areas. Thus, an anti-inflammatory effect comes into play.

in the Frame of the combination according to the invention or pharmaceutical preparation, the mucus drug Icelandic act Moss on the one hand and peppermint on the other in particular in conjunction with the other constituents, since that Icelandic Moss, but also the peppermint, contains wetting substances, which the attacked mucous membranes of the oropharynx and moisten it, so to speak, the mucous in this way against disturbing external stimuli protect the natural protective function of the mucous membranes in the mouth. and pharynx is supported. The pharmaceutical preparation according to the present invention acts as if it were an "inner glove" in the mouth cavity or in the mouth / throat area.

by virtue of ensures their relatively long residence in the mouth and throat the preparation according to the invention Furthermore for the natural Stimulation of salivation, which in turn leads to moistening dried out mucous membranes leads. This will be manifold confounders, which lead to mucosal irritations, eliminated, and there is a soothing moistening of the mouth and pharyngeal mucosa.

The Pharmaceutical according to the invention Preparation does not only soothe and moisturize, but about that also bactericidal and antimicrobial. That's why she's for the before especially suitable for these indications.

As previously described the pharmaceutical invention Preparation due to the presence of the mucus drug Icelandic Moss mucilages, which provide physical coverage of the mucosa surrendered and over this barrier gives the underlying cells the opportunity give, to regenerate. This mucosal barrier has no Compound chemical type with the cells, but relies only on a physical effect. Therefore, the pharmaceutical according to the invention Preparation particularly well tolerated, especially for Children or for Pregnant and breastfeeding persons. Due to the fact that the application the pharmaceutical of the invention Preparation is associated with no side effects, is the Pharmaceutical according to the invention Preparation especially for the treatment of the aforementioned patient or groups of people suitable.

As described above, is used by the ingredients of the invention Combination of Icelandic Moss on the one hand and peppermint on the other hand a protective layer formed on the mucosa of the oropharynx, causing irritation from the mucous membranes be kept away and the emergence of cough is inhibited. In this way, the pharmaceutical preparation according to the invention is suitable not only for prophylactic and / or therapeutic treatment mucosal irritation and mucosal lesions in the mouth and throat and dehydration of the mucous membranes in the mouth and Throat area, but especially of cough and coughing, especially from dry irritated cough. The inventive pharmaceutical Preparation can in particular for the relief of cough irritation in colds the respiratory tract to combat this annoying coughing stimulus be used without the natural and meaningful cough reflex is suppressed. Furthermore the pharmaceutical according to the invention is suitable Composition also for prophylactic and / or therapeutic Treatment of hoarseness, bronchial catharsis and bronchial asthma in the last two cases especially for supporting Application or therapy.

By the use of course based active ingredients based on the synergistic combination of the mucus drug Iceland Moss on the one hand and the peppermint on the other will be with the Synthetic agents occurring side effects effectively prevented.

A special feature of the present invention must therefore be seen in the synergistic combination of lichen islandicus (Icelandic moss) and / or its extract on the one hand and Mentha piperita (peppermint) and / or its extract, in particular in the form of peppermint oil (Menthae piperitae aetheroleum), on the other hand , Because - as the Applicant has found - acts such a combination of the two aforementioned drugs in a synergistic way, ie beyond the effect of the individual drugs continuously.

The Applicant has surprisingly found out that the inventive combination of Lichen islandicus (Icelandic Moss) and / or its extract on the one hand and Mentha piperita (peppermint) on the other and / or their extract, in particular in the form of peppermint oil (Menthae piperitae aetheroleum), on the other hand, the inflammation-induced irritation of Mouth and throat mucosa significantly reduces and coughing and Hoarseness relieves, and indeed over the effect of the individual substances. This indicates a synergistic effect with respect to the combination according to the invention out.

The both drugs Icelandic Moss on the one hand and peppermint on the other or their extracts are the skilled person as such suffice are known, but are not yet considered in their combination been drawn: slime drugs are because of their anti-inflammatory Properties externally for the treatment of boils, ulcers, glandular swelling and inflammation of the pharynx, internally also as Laxans, Antidiarrhoikum and used for the treatment of gastric and intestinal inflammation. Schleime are heteropolysaccharides with molecular weights of about 50,000 to 2,000,000 by extraction with hot or cold water the drug can be won. The high viscosity solutions are in contrast to the gums are not sticky. A distinction is made between acid and neutral slimes. Depending on their sugar composition, they can be glucomannans or mannans, in galactomannans, xylans or rhamnogalacturonans organize. After its localization in the plant one can get vacuolar mucus and distinguish membrane mucus. As a prototype for one Acid phlegm may be considered the mucus of the marshmallow root become. He contains L-rhamnose, D-galactose, D-galacturonic acid and D-glucuronic acid in the molar relationship of about 3: 2: 3: 3. The simplest built part of the polysaccharide consists of repeating undecasaccharide subunits. For further Details of slime drugs and their preparations, effects and application can be referred to H. Wagner "Pharmaceutical Biology - Drugs and their ingredients ", Gustav Fischer Verlag Stuttgart / New York, 1985, especially pages 280 ff.

The Slime drug Icelandic Moss is the German name for Lichen islandicus or Cetraria islandica (Parmeliaceae), a lichen - contrary the German name no moss - that from northern countries, such as from Iceland, Norway and Sweden. Iceland Moss in the true sense consists of the dried thallus of Cetraria islandica and its preparations. The drug contains under other mucilages and bitter substances and bitter tasting lichen acids. Out solve the powdered lichen about 60 wt .-% when cooking with highly dilute sodium bicarbonate solution, and on cooling the solution a jelly is created. The extract consists of a polysaccharide mixture of Lichenin and isolichenin, a series of bitter tasting lichen acids (fumarprotocetrar, Protocetraric and cetraric acid) as well as protolichesteric acid, which converts in the workup in Lichesterinsäure, and usnic acid as antibiotic lichen dye. As a mucus drug possesses Iceland Moss soothing properties, it also acts antimicrobial. The bittern content justified its application in the case of loss of appetite. For example, Icelandic moss becomes in catarrh and diarrhea, as bitter tonic, externally in poorly healing Wounds, cosmetic preparations, in hair fixatives, in addition to biscuit flour and the like, in loss of appetite and irritation of the mucous membranes in the mouth and Throat area applied. An oral and throat disinfectant based from Icelandic Moss has a soothing effect on dry irritated cough. The cold macerate and other bitter-tasting preparations of the drug become Elimination of sub- or antacidity used. As dosage forms are depending on the field of application the crushed drug for infusions as well as other galenic preparations or the crushed drug preferably for Cold macerate and other bitter-tasting preparations for oral use applied. For For more details about Icelandic moss, for example Reference may be made to the following references: Römpp Chemie-Lexikon, 9th edition, Volume 3, Georg Thieme Verlag, Stuttgart / New York, 1990, pages 2055/2056, Keyword: "Icelandic Moss "; HagerROM 2001, Springer Verlag, Heidelberg, keywords: "Cetraria", "Cetraria ericetorum OPIZ "," Cetraria islandica (L.) ACHARIUS "and" Lichen islandicus (Icelandic Moss) "monograph" Lichen islandicus (Icelandic Moos) ", Federal Gazette No. 43 of March 2, 1989; H. Wagner, "Pharmaceutical Biology - drugs and their ingredients ", Gustav Fischer Verlag, Stuttgart / New York, 1985, page 281, keyword: "Cetrariae Lichen (= Lichen islandicus - Icelandic Moss)".

What the Icelandic As far as moss is concerned, it can be used according to the invention in the form of the drug, in particular in Form of crushed or powdered parts of plants or plant constituents, added to the pharmaceutical composition or combination be.

Furthermore, there is the possibility that the Icelandic moss is added in the form of an extract, in particular in the form of a dry extract. Such a dry extract is advantageously based an aqueous, alcoholic or aqueous-alcoholic extract, preferably based on an aqueous extract, obtainable (for example by customary methods, for example removal of the water and / or alcohol in vacuo, if appropriate with heating, lyophilization etc.). The drug / extract ratio can vary within wide ranges. If the Icelandic moss is added in the form of an extract, in particular a drug / extract ratio in the range of 0.4: 1 to 15: 1, in particular in the range of 1: 1 to 10: 1, preferably in the range of 5: 1 to 8: 1, used.

The Use of an extract of Lichen islandicus offers over the Use of the drug as such has the distinct advantage that high concentrations at Lichen islandicus are used, so that a particularly good therapeutic Effect is achieved. Particularly outstanding therapeutic results are obtained when lichen islandicus as an extract, preferably as a dry extract, with a drug / extract ratio of at least 1: 1 or more is added.

What the amount of Icelandic Moss and / or its extract in the pharmaceutical composition As far as combination is concerned, the quantity can be within wide ranges vary. In general, the amount of lichen islandicus and / or its extract in the range of 0.01 to 10 wt .-%, in particular 0.1 to 5 wt .-%, preferably 0.5 to 3 wt .-%, most preferably 1.5 to 2.5 wt .-%, based on the pharmaceutical composition or combination, d. H. based on the solid dosage form. Yet It may be advantageous or necessary, depending on the application be deviated from the abovementioned quantities.

The Peppermint (Mentha piperita) is a cross between different Mint species. It was first described botanically at the end of the 17th century. Century. Of the peppermint in turn are over 100 varieties and varieties known. For example, one differentiates between dark and and bright green Varieties, with z. B. the dark green Type "Mitcham" still today as special good quality applies. The name "Mentha" derives from the Greek word "Minthe" from that of mythology after a nymph is the one from the goddess of the underworld fragrant plant has been transformed. The word component "piperita" is derived from Latin word "piper" (= pepper) from and on expresses that the Peppermint was also valued as a spice because of the intense taste. The use of peppermint and its essential oil are primarily based on the traditional application. Investigations have shown that the Ingredients of peppermint, especially the menthol, on the stomach / intestinal tract antispasmodic, have cholagogue and antiseptic effects. menthol-containing Rubbings or inhalations provided by the cooling Effect on a cold a feeling Facilitated nasal breathing without, however, acting directly decongestant. Furthermore, there are indications that preparations from the essential oil in external Application to help with tension headaches. That in the peppermint leaves containing essential oil is related on its composition strongly on the level of development of the leaves from the harvest. The main ingredients are besides Menthol also Menthone and menthyl acetate. Furthermore, the plant contains tannins, Phenolic acids and flavonoids. Overall, the peppermint comes to the inside Use in indigestion, flatulence, gall bladder problems and Irritable bowel syndrome. externally Peppermint is used because of its antiseptic effect in oral mucosal inflammation and beyond for colds and runny nose, where they feel mediates better nasal breathing, as well as muscle and nerve pain as well as tension headache.

What As far as peppermint (Mentha piperita) is concerned, it is included in the framework the pharmaceutical composition, in particular in the form of peppermint oil (Menthae piperitae aetheroleum).

What the amount of peppermint and / or its extract, preferably peppermint oil, in the As regards pharmaceutical composition or combination, see above can this be alike vary widely. In general, the amount is Mentha piperita (peppermint) and / or its extract, preferably peppermint oil (Menthae piperitae aetheroleum), in the range of 0.001 to 5% by weight, in particular from 0.01 to 1% by weight, preferably from 0.01 to 0.5% by weight, particularly preferably 0.01 to 0.3 wt .-%, based on the pharmaceutical Composition. Nevertheless, it may be application-related or case-by-case may be advantageous or necessary, from the aforementioned Variations deviate.

In general, the pharmaceutical composition according to the invention contains Icelandic moss on the one hand and peppermint on the other hand in a weight ratio of Lichen islandicus (Icelandic moss) and / or its extract on the one hand to Mentha piperita (peppermint) and / or its extract, in particular in the form of peppermint oil (Menthae piperitae aetheroleum On the other hand, especially in a weight ratio of the dry extract of lichen islandicus (Icelandic moss) to peppermint oil (Menthae piperitae aetheroleum), in the range of 1000: 1 to 1: 1, especially 500: 1 to 25: 1, preferably 250: 1 to 50: 1, more preferably 150: 1 to 75: 1. In a very particularly preferred embodiment, this weight ratio is approximately 100: 1.

Next the aforementioned active ingredients and ingredients - lichen islandicus or its Extract on the one hand and Mentha piperita or its extract on the other hand - can Pharmaceutical according to the invention Composition also usual pharmaceutical Carrier-, Contain additives and / or auxiliaries. Such substances can, for example from the group of processing aids, flavorings, flavorings, sweeteners and sweeteners, acidifiers, Stabilizers, preservatives, fragrances, fillers, Extenders, wetting agents, binders, buffers, dyes and colorants, Antiseptics and mixtures thereof may be selected, the aforementioned Substances preferably used in pharmaceutically customary concentrations become.

According to one particularly preferred embodiment contains the pharmaceutical invention Composition beside Icelandic Moss or its extract and peppermint or their extract also flavors, especially natural Flavors, preferably of the cough herb type. In general, the pharmaceutical according to the invention contains Composition of such flavors in amounts of 0.01 to 5 wt .-%, in particular 0.1 to 3 wt .-%, preferably 0.2 to 2 wt .-%, especially preferably 0.5 to 1.5 wt .-%, based on the pharmaceutical composition.

Furthermore can according to a preferred according to the invention embodiment the pharmaceutical composition of the present invention Furthermore at least one acidulant or stabilizer, preferably tartaric acid, in particular in amounts of from 0.01 to 5% by weight, in particular from 0.1 to 3% by weight, preferably 0.2 to 1 wt .-%, particularly preferably 0.3 to 0.8 wt .-%, based on the pharmaceutical composition.

Next the aforementioned active ingredients and / or ingredients may be the pharmaceutical composition according to the invention Furthermore contain at least one other pharmacologically active substance.

in the general contains the pharmaceutical invention Composition of the active ingredients and / or ingredients in a solid Matrix or mass. The active ingredients and / or ingredients are therefore in incorporated into a matrix so that it is effective protected and are distributed homogeneously.

The solid dosage form and the incorporation of the active ingredients and / or ingredients in a solid matrix or mass offers a number of advantages: On the one hand, the active ingredients and ingredients are better in this way dose, d. H. it is achieved an improved dosing accuracy. On the other hand, this makes the application or revenue option possible improved, d. H. the revenue opportunity for the Patients are virtually everywhere given (eg traveling, outdoors etc.), because no special Forms of preparation must be mixed. In addition, the solid delivers Dosage form the decisive advantage that the active ingredients in solid Preparations are generally more stable in storage. Furthermore granted the solid dosage form a defined residence time or residence time in the mouth and throat and thus an efficient therapy. After all allows the solid dosage form, in particular by the incorporation of Active ingredients and ingredients in the matrix, an improved combination with other active ingredients and their uniform, homogeneous distribution over the Matrix.

When Matrix or mass for the incorporation of the active ingredients and ingredients are particularly suitable Sugar of all kinds and / or sugar substitutes of all kinds. Examples suitable for the invention Sugars are, for example, sucrose, glucose, in particular dextrose, and fructose. According to the invention suitable Sugar substitutes are especially selected from sugar alcohols. According to the invention preferred Sugar substitutes are selected from the group of mannitol, Xylitol, sorbitol, isomalt, maltitol syrup, lactitol, leucrose, fructo-oligosaccharides, Glucans and / or polyglucose.

While sugar and sweeteners together as a sweetener be designated, are - in Contrary to the intensively tasting sweeteners - sugar substitutes technological such as sucrose, d. H. they have a "body" and a physiological calorific value ("nutritive sugar substitutes"). The sweetness corresponds within wide limits, about that of sucrose. The physiological advantage the sugar substitutes compared to sucrose is in the insulinunhabhängigen Metabolization (beneficial eg for diabetics) and in the Part reduced cariogenic effect. For some sugar substitutes (eg xylitol) an anticariogenic effect is described.

The term "sugar alcohol" is the group name for those derived from monosaccharides by Redukti on the carbonyl group resulting polyhydroxy compounds that are not sugars, but nevertheless sweet taste and therefore may optionally find use as sugar substitutes. A distinction is made in these generally crystalline, water-soluble polyols according to the number of hydroxyl groups contained in the molecule so-called Tetrite, Pentite, Hexite etc. Naturally occurring sugar alcohols are, for. As glycerol, threitol and erythritol, adonite (ribitol), arabitol (formerly: lyxite) and xylitol, dulcitol (galactitol), mannitol and sorbitol (glucitol).

For more advanced For example, details of the terms "sugar", "sugar substitutes" and "sugar alcohols" may be used be referred to Römpp Chemie-Lexikon, 10th edition, volume 6, Georg Thieme Verlag, Stuttgart / New York, 1999, pages 5096 to 5100, keywords: "sugar", "sugar alcohols" and "sugar substitutes".

The Amount of matrix or solid, in particular of sugars and / or Sugar substitutes, can vary widely. The Amount of matrix mass (i.e., sugars and / or sugar substitutes) is generally in the range of 80 to 99.5 wt .-%, in particular 85 to 99 wt .-%, preferably 90 to 99 wt .-%, particularly preferably 95 to 99 wt .-%, based on the pharmaceutical composition. Yet may be required by application or case or be advantageous to deviate from the aforementioned amounts.

In accordance with the invention particularly preferred embodiment are used as the matrix or solid mass sugar substitutes, especially sugar alcohols, preferably isomalt (Isomaltit or Palatinit ^® M), ie the Lutschta bletten are preferably formulated without sugar. This has the advantage that they are also suitable for diabetics. Preferably, a lozenge corresponds to less than 1 BE, in particular less than 0.5 BE, preferably less than 0.3 BE, most preferably less than 0.2 BE.

According to one particularly preferred embodiment is the pharmaceutical composition of the invention or the solid according to the invention Dosage form as a lozenge, especially in the form of a hard caramel, in front. If the inventive solid Formed dosage form on lozenge base, this leads to that the solid dosage form when sucked a therapeutically effective amount of Active ingredients and / or ingredients releases when the solid dosage form In the mouth and throat of a patient administered and sucked becomes.

at the preferred embodiment of the pharmaceutical composition according to the invention in the form of a lozenge, especially on a hard caramel base, The weight of the lozenge may vary widely; in general the total weight of the lozenge 1 to 5 g, preferably 2 to 3 g, more preferably 2.4 to 2.8 g, most preferably about 2.6 g. It contains the lozenge is generally 10 to 300 mg, especially 20 to 100 mg, preferably 40 to 60 mg, more preferably about 50 mg, lichen islandicus and / or its extract, 0.1 to 100 mg, in particular 0.2 to 10 mg, preferably 0.3 to 0.6 mg, especially preferably about 0.5 mg, Mentha piperita (peppermint) and / or their Extract, in particular in the form of peppermint oil (Menthae piperitae aetheroleum), and 1.9 to 4.9 g, in particular: 2 to 3 g, particularly preferably about 2.5 g, sugar and / or sugar substitutes and beyond optionally as optional ingredients 0.1 to 100 mg, in particular 5 to 50 mg, preferably 20 to 30 mg, more preferably about 26 mg, flavors, especially natural Flavorings, preferably of the cough herb type, and optionally 0.1 to 100 mg, in particular 5 to 50 mg, preferably 10 to 20 mg, more preferably about 15 mg, acidulant or stabilizer, preferably tartaric acid.

• – etwa 50 mg Lichen islandicus, vorzugsweise dessen Extrakt,
• – etwa 0,5 mg Mentha piperita (Pfefferminze), vorzugsweise Pfefferminzöl (Menthae piperitae aetheroleum),
• – etwa 2,5 g Zucker und/oder Zuckeraustauschstoffe,
• – gegebenenfalls etwa 26 mg Aromen, insbesondere natürliche Aromen, vorzugsweise vom Typ Hustenkräuter,
• – gegebenenfalls etwa 15 mg Säuerungsmittel bzw. Stabilisator, vorzugsweise Weinsäure,

enthält.According to a particularly preferred embodiment according to the invention, the composition of the invention is in the form of a lozenge on hard caramel base, wherein the lozenge has a total weight of about 2.6 g and lozenge each

• - about 50 mg lichen islandicus, preferably its extract,
• - about 0,5 mg Mentha piperita (peppermint), preferably peppermint oil (Menthae piperitae aetheroleum),
• - about 2,5 g of sugar and / or sugar substitutes,
• - where appropriate, about 26 mg of aromas, in particular natural aromas, preferably cough-herb type,
• - if appropriate, about 15 mg acidulant or stabilizer, preferably tartaric acid,

contains.

As previously stated can the lozenge of the invention about that also contain other active ingredients and / or ingredients. In this regard can to the above statements be referred.

The Preparation of the pharmaceutical according to the invention Composition is carried out in a conventional manner. For more advanced Details may be made to the following embodiment. In the production of lozenges on hard caramel base For example, it is possible to proceed in such a way that first the Active substances and ingredients - if appropriate after crushing - weighed and then into the basic substance based on sugars or sugar substitutes are mixed, followed by heating of the ground substance, shaping of lozenges and subsequent cooling. Such manufacturing process are well known to the skilled person as such, so that is not closer to this needs to be received.

As previously described, the pharmaceutical preparation according to the present invention in particular for prophylactic and / or therapeutic treatment of cough and cough, in particular dry irritated cough; Mucosal irritations and mucosal lesions in the Mouth and throat; Dehydration of the mucous membranes in the area the mouth and throat area; Hoarseness; Bronchial catharsis and bronchial asthma. Furthermore, the pharmaceutical described above is suitable Composition according to the present invention, in particular for Use for purposes of topical treatment of inflammatory Oral and pharyngeal diseases. For more details with respect to the use according to the invention can on the above statements to get expelled.

Further Configurations, modifications and variations as well as advantages of present invention are for the person skilled in the art readily discernible when reading the description and realizable without him the scope of the present invention leaves.

The following embodiment is merely illustrative of the present invention, without However, to limit the invention thereto.

embodiment

Preparation of a pharmaceutical according to the invention Composition in the form of lozenges (hard caramel base) based on an extract of lichen islandicus in combination with peppermint oil (Menthae piperitae aetheroleum)

A pharmaceutical composition according to the invention in the form of hard-caramel-based lozenges is produced. It is (Palatinit ^® 953 M or isomalt E) or (= matrix) used a sugar-free form with a sugar substitute based on isomaltitol as lozenges based hard caramel base. In the matrix then the appropriate active ingredients and ingredients are incorporated. The preparation of lozenges or hard caramels is done in a conventional manner.

• – Isländisches Moos (Lichen islandicus) (Trockenextrakt),
• – Pfefferminzöl (Menthae piperitae aetheroleum),
• – natürliche Aromen vom Typ Hustenkräuter und
• – Weinsäure (Säuerungsmittel/Stabilisator)

über eine separate Dosiereinheit zugegeben.The starting materials are weighed according to this recipe, and (here: Palatinit ^® M) individually into the matrix / hard caramel base blended. The addition of water can be omitted. The mixing process takes place in the weighing station with the corresponding approved calibrated weights. The raw materials are heated and processed via the production rail and divided into small quantities. At this level then starting materials or intermediates, namely

• - Icelandic moss (Lichen islandicus) (dry extract),
• - peppermint oil (Menthae piperitae aetheroleum),
• - Natural flavors of the type cough herbs and
• - tartaric acid (acidifier / stabilizer)

added via a separate dosing unit.

It Re-mixing and mixing the entire batch. The amount is stored in an interim storage and on the Dosing or dosing returned. There are the lozenges manufactured in their appropriate size and while of the process. The finished tablets are added immediately forwarded to the blister station and packed with free packaging. The following Palletizing takes place at the end of the blister process. The products are coming into the quarantine and are from quality control checked on the appropriate active ingredients and the weight and after the appropriate tests Approved.

In this way, sugar-free lozenges ("hard caramels") are prepared with the following composition per lozenge: Palatinit ^® M (isomalt E 953) 2,508,500 mg Lichen islandicus (dry extract) 50,000 mg natural flavors ("Typhustenkräuter") 26,000 mg peppermint oil 0.500 mg tartaric acid 15,000 mg Total: 2,600,000 mg

example

Twenty Patients with dry and irritated cough and hoarseness due to colds, associated with irritation of the mucous membranes in the mouth and throat, were described with those in the previous preparation example Treated lozenges, each with a total daily dose from 5 to 10 lozenges - distributed over the Day - administered has been.

at a week long Application of lozenges according to the invention could have irritating cough and hoarseness, as well as mucous membrane irritations in the mouth / throat completely be treated.

The Investigations prove the good effect of the composition according to the invention. The inventive pharmaceutical Preparation leads in the treatment of dry irritated cough and hoarseness, accompanying with irritation of the mucous membranes of the oropharynx, to an impressive improvement of the associated symptoms. This is a decisive advantage of the combination according to the invention.

Without To commit oneself to a certain theory is possible the effect may be by explaining that the Ingredients, especially of Icelandic moss and peppermint oil, the attacked mucous wrap, they are so against disturbing external stimuli Shield and help to maintain the natural protective function of the mucous membranes in the mouth and throat supported becomes. Due to their long residence time in the mouth, the lozenges provide for the Stimulation of salivation. As a result, they better eliminate the diverse confounders, which lead to mucosal irritations, and serve for soothing moistening of the oral and pharyngeal mucosa.

Claims (21)

Pharmaceutical composition in the form of a solid dosage, preferably on lozenge base, in particular as a cough medicine and / or for topical treatment of inflammatory Oral and pharyngeal diseases, containing a combination of Lichen islandicus (Icelandic Moss) and / or its extract on the one hand and Mentha piperita (peppermint) on the other and / or their extract, in particular in the form of peppermint oil (Menthae piperitae aetheroleum), on the other hand. Pharmaceutical composition according to claim 1, being lichen islandicus in the form of the drug, especially in the form crushed or powdered parts of plants or plant parts, is added. Pharmaceutical composition according to claim 1, wherein lichen islandicus in the form of an extract, in particular a Dry extract, is added, in particular the extract starting from an aqueous, alcoholic or aqueous-alcoholic Extract, preferably an aqueous extract, is available. Pharmaceutical composition according to one or more of the preceding claims, wherein lichen islandicus in the form of an extract, preferably one Dry extract, with a drug / extract ratio in the range of 0.4: 1 to 15: 1, in particular in the range of 1: 1 to 10: 1, preferably in the range of 5: 1 to 8: 1. Pharmaceutical composition according to one or more of the preceding claims, containing lichen islandicus and / or its extract in quantities of 0.01 to 10 wt .-%, in particular 0.1 to 5 wt .-%, preferably 0.5 to 3 wt .-%, particularly preferably 1.5 to 2.5 wt .-%, based on the pharmaceutical composition. Pharmaceutical composition according to one or more of the preceding claims, mentha piperita (peppermint) in the form of peppermint oil (Menthae piperitae aetheroleum). Pharmaceutical composition according to one or more of the preceding claims, containing Mentha piperita (peppermint) and / or its extract, preferably peppermint oil (Menthae piperitae aetheroleum), in amounts of 0.001 to 5 wt .-%, in particular from 0.01 to 1% by weight, preferably 0.01 to 0.5 wt .-%, particularly preferably 0.01 to 0.3 Wt .-%, based on the pharmaceutical composition. Pharmaceutical composition according to one or more of the preceding claims, the weight ratio of Lichen islandicus (Icelandic Moss) and / or its extract on the one hand to Mentha piperita (peppermint) and / or their extract, in particular in the form of peppermint oil (Menthae piperitae aetheroleum), on the other hand, especially the weight ratio of Dry extract of Lichen islandicus (Icelandic moss) to peppermint oil (Menthae piperitae aetheroleum), ranging from 1000: 1 to 1: 1, in particular 500: 1 to 25: 1, preferably 250: 1 to 50: 1, more preferably 150: 1 to 75: 1, and most preferably about 100: 1 amounts to. Pharmaceutical composition according to one or more of the preceding claims, also containing conventional pharmaceutical Carrier-, Additives and / or auxiliaries, in particular from the group of processing aids, Flavorings, Flavorings, Sweeteners and Sweeteners, acidifiers, Stabilizers, preservatives, fragrances, fillers, Extenders, wetting agents, binders, buffering agents, dyes and colorants, Antiseptics and mixtures thereof, preferably in pharmaceutically usual Concentrations. Pharmaceutical composition according to one or several of the preceding claims, containing as well Flavors, especially natural Flavorings, preferably of the cough herb type, in particular in quantities from 0.01 to 5 wt .-%, in particular 0.1 to 3 wt .-%, preferably 0.2 to 2 wt .-%, particularly preferably 0.5 to 1.5 wt .-%, based on the pharmaceutical composition. Pharmaceutical composition according to one or several of the preceding claims, containing as well at least one) acidifying agent or stabilizer, preferably tartaric acid, in particular in amounts from 0.01 to 5 wt .-%, in particular 0.1 to 3 wt .-%, preferably 0.2 to 1 wt .-%, particularly preferably 0.3 to 0.8 wt .-%, based on the pharmaceutical composition. Pharmaceutical composition according to one or several of the preceding claims, containing as well contain at least one other pharmacologically active substance. Pharmaceutical composition according to one or several of the preceding claims, containing the active ingredients and / or ingredients in a solid matrix and / or mass. Pharmaceutical composition according to one or several of the preceding claims, containing the active ingredients and / or ingredients in a matrix and / or Composition based on sugars and / or sugar substitutes. Pharmaceutical composition according to claim 14, the sugars being selected are from the group of sucrose, glucose, in particular dextrose, and fructose and / or wherein the sugar substitutes are selected from sugar alcohols and / or from the group of mannitol, xylitol, sorbitol, Isomalt, maltitol syrup, lactitol, leucrose, fructo-oligosaccharides, Glucans and / or polyglucose. Pharmaceutical composition according to claim 14 or 15, containing sugars and / or sugar substitutes in quantities from 80 to 99.5% by weight, in particular from 85 to 99% by weight, preferably from 90 to 99% by weight, especially preferably 95 to 99 wt .-%, based on the pharmaceutical composition. Pharmaceutical composition according to one or several of the preceding claims, wherein the solid dosage form is a lozenge, in particular in the form of a hard caramel, and / or wherein the solid dosage form is formed on a lozenge base, so that the solid dosage form a therapeutically effective amount of the active ingredients and / or ingredients when sucking liberated when the solid dosage form in the mouth and throat of a Patients are administered and sucked. Pharmaceutical composition according to one or more of the preceding claims, in particular for the topical treatment of coughing or irritating cough and hoarseness and / or for topical Treatment of inflammatory diseases of the oropharynx, on lozenge-based, wherein the solid dosage form is a combination of lichen islandicus (Icelandic moss) and / or its extract on the one hand and Mentha piperita (peppermint) and / or its extract, in particular in the form of peppermint oil ( Menthae piperitae aetheroleum), on the other hand. Pharmaceutical composition according to one or several of the preceding claims, wherein the pharmaceutical composition is in the form of a lozenge, especially on hard caramel base, is present, wherein the lozenge a total weight of 1 to 5 g, preferably 2 to 3 g, more preferably Containing from 2.4 to 2.8 g, most preferably about 2.6 g each lozenge: - 10 to 300 mg, in particular 20 to 100 mg, preferably 40 to 60 mg, more preferably about 50 mg, lichen islandicus and / or its Extract, - 0.1 to 100 mg, in particular 0.2 to 10 mg, preferably 0.3 to 0.6 mg, more preferably about 0.5 mg, Mentha piperita (peppermint) and / or their extract, in particular in the form of peppermint oil (Menthae piperitae aetheroleum) - 1.9 to 4.9 g, especially 2 to 3 g, more preferably about 2.5 g, sugars and / or sugar substitutes, - optionally 0.1 to 100 mg, especially 5 to 50 mg, preferably 20 to 30 mg, especially preferably about 26 mg, flavors, especially natural flavors, preferably of the type cough herbs, - possibly 0.1 to 100 mg, especially 5 to 50 mg, preferably 10 to 20 mg, more preferably about 15 mg, acidulant or stabilizer, preferably tartaric acid. Pharmaceutical composition according to one or several of the preceding claims, wherein the pharmaceutical composition is in the form of a lozenge is present on hard caramel base, wherein the lozenge is a total weight of about 2.6 g, containing per lozenge: - about 50 mg lichen islandicus, preferably its extract, - about 0.5 Mentha piperita (peppermint), preferably peppermint oil (Menthae piperitae aetheroleum), - approximately 2.5 g of sugar and / or sugar substitutes, - possibly about 26 mg of aromas, especially natural aromas, preferably of the type cough herbs, - possibly about 15 mg of acidulant or stabilizer, preferably tartaric acid. Lozenges for the treatment of coughing and Hoarseness, having a pharmaceutical composition according to one or more of the preceding claims.