| JPH07233046 | EXTERNAL PREPARATION |
| JPH0458871 | AGING PREVENTING FOOD |
| JPS6056156 | [Title of the Invention] alpha ‐Toko fellow roux 13-cis ‐vitamin A acid ester |
TARANTINO GERMANO (IT)
| WO2010089046A1 | 2010-08-12 |
BEN-ERIK VAN WYK, MICHAEL WINK: "Medicinal Plants of the World", 1 January 2004, TIMBER PRESS, Portland, Oregon, USA, ISBN: 0-88192-602-7, article "Commiphora myrrha", pages: 111, XP002689227
| CLAIMS 1. A pharmaceutical composition or a medical device or a food supplement comprising a myrrh extract in soya oil, a vegetable oil and at least one antioxidant for use in the treatment of otitis. 2. The composition for use according to claim 1 , wherein said vegetable oil is selected from the group comprising or alternatively consisting of olive oil, sunflower oil, corn oil or soya oil. 3. The composition for use according to claims 1 or 2, wherein said vegetable oil is olive oil. 4. The composition for use according to one of the preceding claims, wherein said at least one antioxidant is selected from the group comprising or alternatively consisting of vitamins with an antioxidant activity selected among vitamin E; tocopherols, preferably DL-alpha-tocopherol; tocotrienols or mixtures thereof, and a rosemary extract, preferably a rosemary hydroglyceric extract. 5. The composition for use according to one of the preceding claims, wherein said composition is in liquid or suspension or emulsion form and comprises or alternatively consists of a myrrh extract in soya oil, an olive oil and DL-alpha-tocopherol. 6. The composition for use according to any one of the preceding claims, wherein said composition comprises or alternatively consists of: a. said myrrh extract in soya oil is present in an amount of 5 to 25% by weight, with respect to the total weight of the composition; preferably, in an amount of 10 to 15% by weight, with respect to the total weight of the composition, b. said vegetable oil, preferably olive oil, is present in an amount of 95 to 75% by weight, with respect to the total weight of the composition; preferably, in an amount of 90 to 85% by weight, with respect to the total weight of the composition, and c. said at least one antioxidant, preferably DL-alpha-tocopherol, is present in an amount of 0.1 to 2% by weight, with respect to the total weight of the composition; preferably, in an amount of 0.2 to 0.8% by weight, with respect to the total weight of the composition. |
The present invention relates to a pharmaceutical composition or a medical device or a food supplement comprising a myrrh extract, preferably a myrrh oil extract or a myrrh hydroglyceric extract, for otological use or for oral use or for topical use, preferably for treating pediatric patients. In particular, the present invention relates to a myrrh extract, preferably a myrrh oil extract or a myrrh hydroglyceric extract, for relieving and/or preventing irritative states of pharynx (nasopharynx, oropharynx, laryngopharynx and hypopharynx), throat (pharyngitis and tonsillitis) and/or ear (otitis), which might be caused by infections (treatment of oropharynx infections) or by colds and/or allergies.
Myrrh is an aromatic gum resin extracted from a tree or bush of the genus Commiphora, of the family of Burseraceae, it can also be found in powder form. There are about fifty species of Commiphora, distributed on the shores of the Red Sea, in Senegal, in Madagascar and in India. The species which is most used for producing myrrh is Commiphora yrrha (spread in Somalia, Ethiopia, Sudan, Arab peninsula). At the end of summer the shrub covers with flowers and on the stem appear a series of nodules bleeding myrrh as yellow droplets which are harvested once dried in the air. Myrrh is used today as extract or essential oil, the latter being obtained by distillation. Myrrh has an analgesic activity.
A task of the present invention is to be able to provide a composition based on a myrrh extract having a high anti-inflammatory, analgesic and antiseptic activity, a high emollient power and a remarkable barrier protective effect.
Another task of the present invention is to be able to provide a composition based on a myrrh extract which can relieve and/or prevent irritative states of pharynx (nasopharynx, oropharynx, laryngopharynx and hypopharynx), throat (pharyngitis and tonsillitis) and/or ear (otitis), which might be caused by infections (treatment of oropharynx infections) or by colds and/or allergies.
An aim of the present invention is to provide a pharmaceutical composition, a medical device or a food supplement comprising a myrrh extract, preferably a myrrh oil extract or a myrrh hydroglyceric extract, for otological use or for oral use or for topical use, which have a higher therapeutic activity than products on the market.
Another aim of the present invention is to provide a pharmaceutical composition, a medical device or a food supplement comprising a myrrh extract, preferably a myrrh oil extract or a myrrh hydroglyceric extract, for otological use or for oral use or for topical use; said pharmaceutical composition or said medical device or said food supplement being easily administered for treating patients, e.g. pediatric patients.
Still another aim of the present invention is to provide a pharmaceutical composition, a medical device or a food supplement comprising a myrrh extract, preferably a myrrh oil extract or a myrrh hydroglyceric extract, for otological use or for oral use or for topical use; said pharmaceutical composition or said medical device or said food supplement being able to create a protective film for ensuring a barrier effect. These and other aims, which shall be manifest from the following detailed description, have been achieved by the Applicant who has prepared a pharmaceutical composition, a medical device or a food supplement (in short the compositions of the present invention) comprising a myrrh extract, as described below.
An object of the present invention is a pharmaceutical composition, a medical device or a food supplement (in short the compositions of the present invention) for use in the preventive or curative treatment of irritative states of pharynx (nasopharynx, oropharynx, laryngopharynx and hypopharynx), throat (pharyngitis and tonsillitis) and/or ear (otitis), which might be caused by infections (treatment of oropharynx infections) or by colds and/or allergies, as claimed in the appended claims.
In the framework of the present description the expression "the compositions of the present invention" refers to a "pharmaceutical composition or a medical device or a food supplement".
Preferred embodiments of the present invention will appear from the following description, without any intent to limit the scope thereof.
The Applicant has prepared a pharmaceutical composition, a medical device and a food supplement (the compositions of the present invention) for use in the preventive and/or curative treatment of irritative states of pharynx, throat and/or ear comprising or alternatively consisting of a myrrh extract, a vegetable oil and at least one antioxidant. Said compositions of the present invention are for use in the treatment of otitis and pharyngitis.
Said myrrh extract is selected from the group comprising or alternatively consisting of a myrrh aqueous extract, a myrrh alcoholic extract, a myrrh hydroglyceric extract or a myrrh oil extract.
In one embodiment, said extract is a myrrh oil extract or a myrrh hydroglyceric extract.
Advantageously, said myrrh oil extract is a myrrh extract in soya bean oil.
The compositions of the present invention comprise said myrrh extract in a concentration of 5 to 50% of myrrh extract, with respect to the total weight of the extract; still more preferably, said extract has a concentration of 10 to 20% of myrrh extract, with respect to the total weight of the extract.
The compositions of the present invention further comprise an oil or an oil mixture. Oils are vegetable oils. In one embodiment, said oil is selected from the group comprising or alternatively consisting of olive oil, sunflower oil, corn oil or soya oil. Advantageously, the vegetable oil is olive oil.
The compositions of the present invention further comprise one or more substances having an antioxidant activity or a suspension comprising one or more substances having an antioxidant activity. The substances are selected from the group comprising or alternatively consisting of vitamins with an antioxidant activity. In one embodiment, the substance with antioxidant activity is selected from the group comprising or alternatively consisting of vitamin E, tocopherols, preferably DL-alpha-tocopherol, tocotrienols or mixtures thereof and rosemary extracts.
The antioxidant can be in the form of an oily suspension containing a concentrate of tocotrienols and/or tocopherols alone or in combination with squalene and/or carotenoids and/or phytosterols and/or coenzyme Q10; said suspension contains an amount of compounds ranging from 0.1 to 10% by weight. The rosemary extract is a rosemary hydroglyceric extract.
The compositions of the present invention, for use as medicament in the treatment of ear diseases and inflammations, comprise said myrrh extract in an amount of 5 to 25% by weight, with respect to the total weight of the composition; preferably in an amount of 10 to 15% by weight, with respect to the total weight of the composition; said oil in an amount of 95 to 75% by weight, with respect to the total weight of the composition; preferably in an amount of 90 to 85% by weight, with respect to the total weight of the composition; and said antioxidant in an amount of 0.1 to 2% by weight, with respect to the total weight of the composition; preferably in an amount of 0.1 to 0.8% by weight, with respect to the total weight of the composition.
The compositions of the present invention for use as medicament in the treatment of ear diseases and inflammations, in the form of ear drops, comprise olive oil, preferably in an amount of 75 to 90% by weight, with respect to the weight of the composition, a myrrh extract in oil, preferably an extract in soya oil, in a concentration ranging from 10 to 20% by weight, with respect to the weight of the composition, and DL- alpha-tocopherol or a suspension of tocopherols and tocotrienols, preferably in an amount of 0.1 to 3% by weight, with respect to the weight of the composition.
In one embodiment, 100 grams of composition comprise 14.5 grams of a myrrh extract in oil, 0.60 grams of a composition of tocopherols and tocotrienols (trade name Tocomin® by Carotech®), and 74.90 of olive oil.
In another embodiment, 100 grams of composition comprise 80 grams of olive oil, 15 grams of a myrrh extract in oil, and 5 grams of rosemary oil extract.
In still another embodiment, 100 grams of composition in the form of ear drops comprise 10 to 20 grams of a myrrh extract in soya oil, preferably 12 to 16 grams, 90 to 80 grams of a vegetable oil such as olive oil, preferably 88 to 84 grams. Said 100 grams of composition in the form of drops are added with DL-alpha- tocopherol in an amount of 0.10 grams to 0.30 grams, preferably 0.15 to 0.20 grams, to obtain the final composition. This composition is applied in an amount of 2 to 3 drops in each ear 1 to 2 times per day. Preferably the daily dose (6 drops/ear) comprises 24 mg of myrrh extract in oil and 0.4 mg of DL-alpha- tocopherol. The compositions of the present invention, for use as medicament, further comprise an emulsifier selected from the group comprising xanthan gum, carboxymethylcellulose and polysorbate.
In one embodiment, 100 grams of composition comprise 15 grams of a myrrh extract in oil, preferably a myrrh extract in soya oil; 0.5 grams of rosemary dry extract and the rest consists of glycerin, water, soya lecithin, polysorbate 80.
The compositions of the present invention are for topical use, e.g. in the form of cream; or for otological use, e.g. in the form of ear drops; or for oral use, e.g. in the form of solution, syrup, mouth wash, spray solution.
The compositions of the present invention can be in the form of an aqueous suspension comprising an emulsifier selected among xanthan gum, carboxymethylcellulose and/or polysorbate. Once applied, this composition can form on the application surface a patina or a film or a sort of solid coating thanks to the presence of carboxymethylcellulose. The composition thus performs a soothing action and creates a highly effective barrier effect.
The compositions of the present invention can be in the form an oral spray solution.
In one embodiment, the oral spray solution can contain 10 to 20% by weight of a myrrh hydroglyceric extract E:D=10:1 (extract:drug), preferably 12 to 16% by weight; 10 to 16% by weight of fructose, preferably 12 to 14%; 50 to 70% by weight of water, preferably 55 to 65%; 10 to 18% by weight of glycerol or vegetable glycerin, preferably 12 to 15%.
In one embodiment, 100 grams of an oral spray solution can contain 10 to 30 grams of a myrrh hydroglyceric extract E:D=10:1 (extract:drug), preferably 15 grams. Said solution can contain water, myrrh hydroglyceric extract, fructose, glycerol or vegetable glycerin, citric acid, preservatives and sweeteners. All the compositions of the present invention are useful for relieving, preventing and/or treating irritative states of pharynx (nasopharynx, oropharynx, laryngopharynx and hypopharynx), throat (pharyngitis and tonsillitis) and/or ear (otitis), which might be caused by infections (treatment of oropharynx infections) or by colds and/or allergies. The oily composition of the present invention containing a myrrh oil extract enables a longer persistence of drops in the ear, thus allowing the composition to perform its action effectively. At the same time, oily substances can perform a coadjutant action in the prevention and removal of wax plugs, if any. The oily composition of the present invention is apt for use in the symptomatic treatment of otitis in pediatric patients. 2 to 3 drops are administered 1 to 2 times per day for a treatment period of 5 to 7 days. The oily composition of the present invention is already effective in the symptomatic treatment of otitis within 48 hours from the first treatment consisting in the administration of 2 to 3 drops 1 to 2 times per day. In one preferred embodiment, the composition for ear use is in liquid or suspension or emulsion form and comprises or alternatively consists of a myrrh extract in soya oil, an olive oil and DL-alpha-tocopherol.
Experimental part
The composition of the present invention containing a myrrh oil extract was tested for the symptomatic treatment of otitis in pediatric patients.
The composition in the form of ear drops contains (for 100 grams of composition): - 14.5 grams of a myrrh extract in soya oil,
- 85.5 grams of a vegetable oil such as olive oil.
Said 100 grams of composition in the form of drops were added with 0.25 grams of DL-alpha-tocopherol to obtain a final composition (tested composition) of 100.25 grams.
No. of patients Complaint Treatment Results
2 drops TID for 5 days, Pain and inflammation
2 (age: 3-5 years) Otitis media-externa association with disappeared 48 hours antibiotic after first administration
2 drops TID for 5 days,
Pain disappeared on
2 (age: 2-7 years) Otitis media-externa no association with
second day antibiotic
2 drops TID for 5 days, Pain and inflammation
4 (age: 9 months-
Otitis media-externa no association with disappeared 48 hours 2 years)
antibiotic after first administration No. of patients Complaint Treatment Results
Pain and inflammation
2 (age: 7-9 months) Otitis media-externa 2 drops TID, for 5 days disappeared 48 hours after first administration
2 to 3 drops BID for 5 Pain disappeared at the
3 (age: 3-6 years) Catarrhal otitis days; no association end of first day. Full with antibiotic recovery on fifth day
Pain disappeared
2 to 3 drops BID for 5
between first and
1 (age: 3-6 years) Acute catarrhal otitis days; association with
second day. Full antibiotic
recovery on fifth day
Pain reduction after few
4 Otitis media 2 to 3 drops
minutes
Some preferred embodiments PEn of the present invention are as follows:
1. A pharmaceutical composition or a medical device or a food supplement comprising a myrrh extract, a vegetable oil and at least one antioxidant for use in the preventive and/or curative treatment of irritative states of pharynx, throat and/or ear, which might be caused by infections or colds and/or allergies.
2. The composition for use according to PE1 , for the treatment of pharyngitis and otitis.
3. The composition for use according to PE1 or PE2, wherein said myrrh extract is selected from the group consisting of a myrrh hydroglyceric extract or a myrrh oil extract; preferably said myrrh oil extract is a myrrh extract in soya oil.
4. The composition for use according to any one of PE1-PE3, wherein:
- said oil is selected from the group consisting of olive oil, sunflower oil, corn oil or soya oil; and
- said at least one antioxidant is selected from the group consisting of vitamins with an antioxidant activity, preferably vitamin E; tocopherols, preferably DL-alpha-tocopherol; tocotrienols or mixtures thereof, and a rosemary extract, preferably a rosemary hydroglyceric extract.
5. The composition for use according PE4, wherein said at least one antioxidant is an oily suspension containing a concentrate of tocotrienols and tocopherols alone or in combination with squalene and/or carotenoids and/or phytosterols and/or coenzyme Q10; said suspension has an extract concentration of 20 to 50%.
6. The composition for use according to one of the PEs above, wherein said extract has a concentration of 5 to 50% of myrrh extract, with respect to the total weight of the extract; still more preferably said extract has a concentration of 10 to 20% of myrrh extract, with respect to the total weight of the extract.
7. The composition for use according to any one of the PEs above, wherein:
a. said myrrh extract is present in an amount of 5 to 25% by weight, with respect to the total weight of the composition; preferably, in an amount of 10 to 15% by weight, with respect to the total weight of the composition,
b. said oil is present in an amount of 95 to 75% by weight, with respect to the total weight of the composition; preferably, in an amount of 90 to 85% by weight, with respect to the total weight of the composition, and
c. said at least one antioxidant is present in an amount of 0.1 to 2% by weight, with respect to the total weight of the composition; preferably, in an amount of 0.2 to 0.8% by weight, with respect to the total weight of the composition.
8. The composition for use according to any one of the PEs above, wherein said composition comprises olive oil, preferably in an amount of 75 to 90% by weight, with respect to the weight of the composition, a myrrh extract in oil, preferably in a concentration of 10 to 20% by weight, with respect to the weight of the composition, and DL-aipha-tocopherol or a suspension of tocopherols and tocotrienols, preferably in an amount of 0.1 to 3% by weight, with respect to the weight of the composition.
9. The composition for use according to any one of the PEs above, wherein said composition further comprises an emulsifier selected from the group comprising xanthan gum, carboxymethylcellulose, polysorbate. 10. The composition for use according to one of the PEs above, wherein said composition is for topical, otological or oral use, preferably in the form of drops or spray solution.