BE1026420B1 - Composition, in particular composition in the form of an oral solution, comprising an extract of thyme as active substance - Google Patents

Abstract

The present invention relates to a composition, in particular to a composition in the form of an oral solution, comprising a thyme extract as active substance, said composition further comprising glycerol as a co-solvent.

Description

Composition, in particular composition in the form of an oral solution, comprising an extract of thyme as active substance

The present invention relates to a composition, in particular to a composition in the form of an oral solution, comprising an extract of thyme as active substance.

Known since Antiquity, thyme, Thymus vulgaris L., has various properties necessary for the resolution of respiratory diseases.

The phenols (including thymol, linalol, geraniol and carvacrol) contained in the essential oil, naturally present in the plant, give it antiseptic and antifungal properties essential for the elimination of pathogens (bacteria, viruses and mycoses).

On the other hand, thyme has expectorant properties allowing the evacuation of mucus through the respiratory tract in case of bronchitis.

Its anti-inflammatory properties attributed to the presence of rosmarinic acid help relieve the pain caused by a sore throat.

In addition, the antispasmodic and spasmolytic properties inherent in the presence of flavonoids, allow to act on the smooth muscles of the respiratory tract and to fight against cough.

The EMA recognizes thyme as an expectorant, against coughs and colds as a traditional use. While the WHO recognizes the effectiveness of thyme against coughs during colds or bronchitis and in gargling against laryngitis.

Conventionally, thyme is consumed in the form of herbal tea or infusion, in the form of essential oils but also in the form of syrup, the latter form being particularly used in order to calm sore throats and fatty coughs.

Oral solutions and in particular syrups based on thyme extract as active substance are known. These syrups consist

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BE2018 / 5464 generally in an aqueous solution comprising an extract of thyme and a large proportion of sucrose.

Unfortunately, even if such oral solutions prove to be effective in combating or at least in soothing sore throats and fatty coughs, a precipitate forms in the containers (bottles). Indeed, during the conservation of current oral solutions, certain components of the thyme extract agglomerate and give rise to the formation of a precipitate at the bottom of the containers.

As a result, current oral solutions do not remain homogeneous over time, they do not remain clear and their stability over time is reduced.

To solve these problems, the invention provides, according to the invention, a composition, in particular a composition in the form of an oral solution, comprising an extract of thyme as active substance, said composition further comprising glycerol as co- solvent.

In the context of the present invention, it has been demonstrated that the presence of glycerol as co-solvent makes it possible to eliminate the problem of formation of a precipitate so that the composition remains homogeneous, clear and stable at over time. This advantageously makes it possible to have a composition which retains its properties over time even after opening the container.

Preferably, the composition according to the invention comprises said thyme extract in the form of a liquid extract. In particular, according to the invention, this hydroalcoholic extract can be obtained from the leaves and flowers of Thymus vulgaris L. using a mixture of ethanol (20-24% v / v) and water as solvent for extraction. This hydroalcoholic extraction can be carried out with a water-alcohol mixture on a shred of leaves and flowers of Thymus vulgaris L. previously dried or not.

According to the invention, said thyme extract in the form of a liquid extract is a hydroalcoholic extract or a hydroglycerine extract.

Preferably, following this extraction, a step of filtering the extract obtained is carried out and, optionally, a step of at least partial evaporation of the solvent.

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Advantageously, the composition according to the invention also comprises at least one viscosifying agent.

Preferably, according to the invention, said at least one viscosifying agent is chosen from the group consisting of carbohydrates, polyols and their mixtures. For example, within the meaning of the present invention, said at least one viscosifying agent may be sucrose as carbohydrate or maltitol syrup as polyol or a mixture of these two substances. When a composition according to the invention comprises one or more viscosifying agent (s), it is in the form of a syrup or at least in a viscous form close to the form of a syrup.

Preferably, the composition according to the invention comprises said at least one viscosifying agent in an amount of 20 to 70% by weight relative to the total weight of the composition, preferably in an amount of 50 to 60% by weight relative to the total weight of the composition.

Advantageously, the composition according to the invention also comprises an additional co-solvent, for example ethanol.

Advantageously, the composition according to the invention comprises said thyme extract in an amount of 4 to 20% by weight relative to the total weight of the composition, preferably in an amount of 15% by weight relative to the total weight of the composition. Such a percentage by weight of said thyme extract has been determined to be adequate for a composition according to the invention, in particular for a composition according to the invention in the form of an oral solution, to be effective in combating or less to soothe sore throat and oily cough.

Advantageously, the composition according to the invention comprises said additional co-solvent, for example ethanol, in an amount of 2 to 10% by weight relative to the total weight of the composition, preferably in an amount of 4 to 8% by weight. weight relative to the total weight of the composition.

Preferably, the composition according to the invention comprises said glycerol in an amount of 5 to 40% by weight relative to the total weight of the composition, preferably in an amount of 15% by weight relative to the total weight of the composition. In the context of the present invention, such a percentage by weight of glycerol as a co-solvent has been determined to be

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BE2018 / 5464 suitable so that a precipitate does not form and so that the composition remains clear, homogeneous and stable.

Preferably, the composition according to the invention is used as an expectorant in the treatment of cough.

The present invention also relates to the use of a composition according to the invention for combating or at least for soothing sore throats and fatty coughs.

Examples

1. Comparative test 1

Table 1 below shows a composition according to the invention in the form of an oral solution comprising an extract of thyme and glycerol in solution in purified water (composition A) and a composition not comprising glycerol but only a thyme extract in solution in purified water (composition B).

Table 1: compositions (% m / v)

Composition A Composition B Fluid extract (1: 1) of thyme * 15 15 Glycerol 15 0 Purified water 70 85

* Thymus vulgaris L. / extraction solvent: water-ethanol (20-24% v / v)

These compositions A and B were compared in order to determine the formation or not of a precipitate and their clear character or not over time. To this end, compositions A and B were formulated and packaged in glass bottles at room temperature. One week after this conditioning, it was visually determined whether a precipitate had formed or not and whether the composition was still clear or not.

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The results obtained are presented in Table 2 below.

Table 2

Presence of a precipitate Clear composition Composition A no Yes Composition B Yes no

As can be seen, it appears, for composition A, that the presence of glycerol as a co-solvent makes it possible to eliminate the problem of formation of a precipitate, this in contrast to composition B not comprising glycerol as a co-solvent. This is particularly advantageous when a composition according to the invention, in particular when a composition according to the invention in the form of an oral solution, retains its properties over time while remaining clear and homogeneous.

2. Comparative test 2

Table 3 below shows a composition according to the invention in the form of an oral solution comprising an extract of thyme, sucrose, glycerol and ethanol in solution in purified water (composition C) and a composition comprising neither glycerol nor ethanol but only an extract of thyme and sucrose in solution in purified water (composition D).

Table 3

Composition C Composition D Fluid extract (1: 1) of thyme * 15 15 Sucrose 53 53 Glycerol 15 0 Ethanol 7 0 Purified water 10 32

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BE2018 / 5464 * Thymus vulgaris L. / extraction solvent: water-ethanol (20-24% v / v)

These compositions C and D were compared in order to determine the formation or not of a precipitate and their limpid character or not over time. To this end, compositions C and D were formulated and packaged in glass bottles at room temperature. One week after this conditioning, it was visually determined whether a precipitate had formed or not and whether the composition was still clear or not.

The results obtained are presented in Table 4 below.

Table 4

Presence of a precipitate Clear composition Composition C no Yes Composition D Yes no

As can be seen, it appears, for composition C, that the presence of glycerol and ethanol as co-solvents makes it possible to eliminate the problem of formation of a precipitate, this in contrast to composition D does not comprising neither glycerol nor ethanol as co-solvents. This is particularly advantageous when a composition according to the invention, in particular when a composition according to the invention in the form of an oral solution, retains its properties over time while remaining clear and homogeneous.

The present invention has been described in relation to specific embodiments, which have a purely illustrative value and should not be considered as limiting. In general, it will be obvious to a person skilled in the art that the present invention is not limited to the examples illustrated and / or described above.

The use of the verbs "to understand", "to include", "to include", or any other variant, as well as their conjugations, cannot in any way exclude the presence of elements other than those mentioned.

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The use of the indefinite article "a", "an", or of the definite article "the", "the" or "the", to introduce an element does not exclude the presence of a plurality of these elements.

Claims (11)

claims 1. Composition, in particular composition in the form of an oral solution, comprising an extract of thyme as active substance, said composition being characterized in that it also comprises glycerol as co-solvent. 2. Composition, in particular composition in the form of an oral solution, according to claim 1, characterized in that it comprises said thyme extract in the form of a liquid extract. 3. Composition, in particular composition in the form of an oral solution, according to claim 1 or 2, characterized in that it further comprises at least one viscosifying agent. 4. Composition, in particular composition in the form of an oral solution, according to claim 3, characterized in that said at least one viscosifying agent is chosen from the group consisting of carbohydrates, polyols and their mixtures. 5. Composition, in particular composition in the form of an oral solution, according to claim 3 or 4, characterized in that it comprises said at least one viscosifying agent in an amount of 20 to 70% by weight relative to the total weight of the composition, preferably in an amount of 50 to 60% by weight relative to the total weight of the composition. 6. Composition, in particular composition in the form of an oral solution, according to any one of the preceding claims, characterized in that it also comprises an additional co-solvent, for example ethanol. 7. Composition, in particular composition in the form of an oral solution, according to any one of the preceding claims, characterized in that it comprises said thyme extract in an amount of 4 to 20% by weight per 2018/5464 BE2018 / 5464 relative to the total weight of the composition, preferably at a rate of 15% by weight relative to the total weight of the composition. 8. Composition, in particular composition in the form of an oral solution, according to claim 6, characterized in that it comprises said additional co-solvent, for example ethanol, in a proportion of 2 to 10% by weight relative to the total weight of the composition, preferably at a rate of 4 to 8% by weight relative to the total weight of the composition. 9. Composition, in particular composition in the form of an oral solution, according to any one of the preceding claims, characterized in that it comprises said glycerol in an amount of 5 to 40% by weight relative to the total weight of the composition , preferably at a rate of 15% by weight relative to the total weight of the composition. 10. Composition, in particular composition in the form of an oral solution, according to any one of claims 1 to 9, for use as an expectorant in the treatment of cough. 11. Use of a composition, in particular of a composition in the form of an oral solution, according to any one of claims 1 to 9, for combating or at least for soothing sore throats. PATENT COOPERATION TREATY INTERNATIONAL-TYPE RESEARCH REPORT DRAWN UP UNDER ARTICLE XI.23., §10 OF THE CODE OF BELGIAN ECONOMIC LAW IDENTIFICATION OF THE INTERNATIONAL APPLICATION REFERENCE OF THE DEPOSITOR OR REPRESENTATIVE T806BE prio Belgian national application n ° 201805464 Date of filing 03-07-2018 Priority date claimed Submitter (Name) TILMAN SA Date of the request for an international type search 28-07-2018 Number assigned by the international search administration to the request for an international search SN71720 I. CLASSIFICATION OF THE SUBJECT OF THE REQUEST (in the case of several symbols of the classification, indicate them all) According to the International Patent Classification (IPC) or both according to the national classification and the IPC A61P11 / 14; A61K47 / 10; A61K36 / 53; A61P11 / 04 II. RESEARCH AREAS Minimum documentation consulted Classification system Classification symbols CPI A61P; A61K Documentation consulted other than the minimum documentation insofar as these documents form a large part of the fields consulted III. | JlL HAS BEEN ESTIMATED THAT SOME CLAIMS CANNOT BE SEARCHED (Comments on additional sheet) IV. I [ABSENCE OF UNITY OF THE INVENTION AND / OR FINDING RELATING TO THE SCOPE OF THE RESEARCH (Comments on the additional sheet)