ITRM20100436A1 - NEW SUBSTANCES FOR USE IN THE TREATMENT OF THE DROP OF LIBIDO FEMININO. - Google Patents

Description

"New substances for use in the treatment of decreased female libido"

DESCRIPTION

The present invention refers to plant products belonging to the Origanum Majorana species for use in the treatment of the decrease in female libido. The present invention also relates to pharmaceutical mixtures and compositions which comprise said product for use in the treatment of decreased female libido.

STATE OF THE PRIOR ART

Recent studies have shown that nearly a third of adult women have lost interest in sex life. The decline in female libido, recognized and medically defined as hypoactive sexual desire disorder (HSDD), results from the combination of several physical and mental factors.

Hypoactive sexual desire disorder is the lack of persistent and / or recurring sexual desire and desire for sexual activity and causes distress and stress in the patient who suffers from it or problems in her relationships.

Currently, despite the seriousness and the spread of the problem, there are no treatments capable of restoring female sexual desire by determining a standard frequency of sexual intercourse or behaviors that can be defined as normal.

It is known in the state of the art that the plant of Origanum Majorana (Marjoram) has, like other plants belonging to the Lamiaceae (or Labiatae) family, digestive, carminative and antispasmodic properties; it also has antineuralgic, diuretic and expectorant properties.

It is also known that the essence of marjoram in high doses has amazing properties with darkening of the intellectual and muscular faculties. The food use of this plant as an aromatic agent is also well known.

SUMMARY OF THE INVENTION

The inventor has surprisingly discovered that by treating a group of women with an evident hypoactive sexual desire disorder (hereinafter referred to more simply as a decrease in female libido) with an elaborate obtained from the plant belonging to the Origanum Majorana species (commonly also known with the name of Marjoram), the patients showed, regardless of age and the possible cause that determined the decrease in libido, a significant increase in sexual desire.

The object of the present invention is therefore an elaborate of a plant belonging to the Origanum Majorana species for use in the treatment of the decline in female libido.

A second object of the present invention is a pharmaceutical composition comprising said elaborate and one or more excipients and / or carriers and / or diluents for use in the treatment of decreased female libido.

A third object of the invention is a blend of herbal extracts comprising said elaborate for use in the treatment of decreased female libido.

The present invention provides a new, simple, inexpensive and side-effect-free treatment for a very widespread and widespread problem such as the drop in female libido.

The advantages, characteristics and methods of use of the present invention will become evident from the following detailed description of some embodiments, presented by way of non-limiting example.

DETAILED DESCRIPTION OF THE INVENTION

The present invention refers to a plant product belonging to the Origanum Majorana species for use in the treatment of the decrease in female libido.

The Origanum Majorana (or marjoram) is a species of the genus Origanum, native to Europe and the central and southern regions of Asia and is a species commonly used in food as an aromatic plant whose essential oil consists from terpenes, bitter principles, mucilage and natural substances.

For the preparation of said product, both the entire plant belonging to said species and one or more parts of it, such as the root, bark, leaf, fruit, seed or flower, both in dried and fresh form, are used as raw material. . The procedures for drying the plants or parts thereof are known to those skilled in the art and need no further description here.

The product can be prepared for example in the form of dry extract, soft, lyophilized, granulated, powder.

In one embodiment, said extract can be obtained in liquid form using a suitable solvent or mixture of solvents selected from the group comprising ethanol, water, distilled water, esters, ethers, polyols or a hydroalcoholic mixture, for example 80, 75 , 70, 60% alcohol in water. The hydroalcoholic extract, possibly concentrated, is normally indicated as mother tincture.

In a specific embodiment, said extract is obtained using the vegetable material comprising the marjoram plant or parts thereof in a weight ratio with respect to a hydroalcoholic extraction mixture of about 1:10. The maceration and extraction times can vary from 7 to 20 days, and the process is preferably carried out at room temperature.

The liquid extracts obtained as previously described or according to other methods known to those skilled in the art can be filtered to separate the liquid extract from the residual plant material and suitably concentrated or brought in the form of dry, soft, lyophilisate or powder extract.

For example, dry plant extracts can be prepared by total evaporation of the solvent at temperatures below 50 ° C, so as not to alter the active ingredients.

In one embodiment, said product is a mother tincture of marjoram prepared according to the procedure reported in the pharmacopoeia.

The product of the present invention is used for the treatment of decreased female libido or hypoactive sexual desire disorder, also associated with other pathologies. In fact, this disorder often occurs in association with other pathologies such as, for example, menopausal disorders, depression or as a side effect of taking certain drugs as contraceptives.

The dosage of the product administered to the patient may vary according to age and general conditions, the nature and severity of the situation. Furthermore, it is evident that the effective quantity may be lowered or increased if necessary according to the responses of the patient being treated and / or according to the evaluation of the doctor who prescribes the extract of the present invention.

In a specific embodiment, the elaborate, preferably in the form of mother tincture, is used at a dosage of between 20 and 60 drops per day, preferably 40. The treatment time is at least one week and can last, for example, for 1, 3, 5, 6 or 7 months.

The subject of the present invention is also a mixture of herbal extracts for use in the treatment of the decrease in female libido comprising a marjoram extract and preferably at least one plant extract selected from the group formed by Tribulus terrestris, Lepidium mwyenei, Muira Puama, Marjoram , Damiana.

The mixtures can be prepared either by mixing the different extracts obtained separately, or by carrying out the extraction process on a mixture of plant material obtained from different plants.

Also subject of the present invention are pharmaceutical compositions comprising a marjoram elaborate as previously described and one or more excipients and / or carriers and / or diluents for use in the treatment of the decline in female libido.

The pharmaceutical compositions according to the present invention can be formulated in various forms for oral or topical use such as for example solution, suspension, emulsion, syrup, powder, granules, capsule, tablet, dragee, gel, cream, ointment which may depend on the route of administration. choice. According to a specific embodiment of the invention, the pharmaceutical composition in a form suitable for oral administration can include formulations such as capsules, tablets, dragees, granules. In these solid forms the marjoram extract in solid form can be mixed with one or more inert, pharmaceutically acceptable excipients. These excipients can be selected from those normally known in the state of the art and include, but are not limited to: a) carriers, such as sodium citrate and calcium phosphate, b) fillers such as starch, lactose, microcrystalline cellulose, sucrose, glucose, mannitol and colloidal silica, c) humectants, such as glycerol, d) disintegrating agents, such as alginates, calcium carbonate, starches, starch derivatives, cellulose and polyvinylpyrrolidone, silicates and sodium carbonate e) binders such as carboxymethylcellulose, alginates, gelatin, polyvinylpyrrolidone, sucrose, polymeric derivatives of cellulose, starch derivatives f) retardants such as paraffin, cellulose polymers, esters of fatty acids g) accelerators of absorption, such as quaternary ammonium compounds, h ) wetting agents and surfactants such as cetyl alcohol and glycerol monostearate, i) adsorbents, such as benthic clays and kaolin, k) lubricants such as talc, calcium stearate or, magnesium stearate, polyethylene glycol, sodium lauryl sulfate, sodium stearyl fumarate j) glidants such as talc, colloidal silica.

If the selected compositions constitute the filling of gelatin capsules, the excipients include, but are not limited to them, compounds of the type: lactose, high molecular weight polyethylene glycol and the like.

Solid dosage forms can be coated with enteric, gastric or other coatings well known in the state of the art. They may contain opacifying agents and may be of the type to allow the release of the active ingredients only or preferably in a certain tract of the intestine, possibly in a delayed manner. Substances which may permit such delayed use include, but are not limited to, polymers and waxes.

Liquid forms suitable for oral administration are emulsions, solutions, prepared or extemporaneous suspensions, syrups and elixirs. Excipients suitable for the formulations according to the present invention in liquid forms for oral use include, but are not limited to, diluents commonly used in the art, such as water or other solvents, solubilizing and emulsifying agents selected from ethyl alcohol, polyalcohols, propylene glycol , glycerol, polyethylene glycol and sorbitan esters. These formulations may also contain sweeteners and flavorings selected from those well known in the state of the art.

Said compositions can also contain preservatives of the antibacterial or antifungal type, selected, but not exclusively, from: paraben, chlorbutanol, phenol, sorbic acid and the like. It may also be helpful to include an isotonic agent, for example, a sugar, sodium chloride or the like. Furthermore, delayed absorption pharmaceutical forms can be obtained with agents such as, for example, aluminum monostearate and gelatin.

The suspensions, in addition to the marjoram extract, may contain suspending agents such as, for example, isostearic alcohols, ethoxylates, polyethylene sorbitol and sorbitan esters, microcrystalline cellulose, aluminum hydroxide, bentonite, alginates and cellulose derivatives in general or the like. The right fluidity can be maintained with coating material such as lecithin, with the maintenance of the right particle size in the dispersions or with the use of surfactants.

Typically compositions, for oral use in solid form, can contain a quantity of marjoram extract in all its forms described above, comprised between 5 and 500 mg per dosage unit, preferably between 10-100 mg.

In the present description, the term dosage unit refers to the unitary formulation for a single administration, for example a tablet, a capsule, etc.

The compositions in the form of emulsions can be O / W (Oil / Water) or W / O or W / O / W and O / W / O, preferably micro or nanoemulsions, but they can also be dispersions or colloidal solutions. Microemulsions can be proposed as gels, creams or even in the form of foams. All known surfactants such as silicone, glucosidic and phospholipidic ones can be used for the preparation of the emulsions.

The effect of increasing female sexual desire following the administration of a marjoram plant extract as described above is also useful in those women who do not suffer from a pathology of decreased libido, but who still want to increase sexual desire .

Therefore, a further object of the present invention is the use of a marjoram preparation as described above to increase female sexual desire and the use of said preparation in food supplements.

There are no particular limitations in the realization of the supplement comprising the elaborate of this description, for illustrative and non-limiting purposes, the supplement described here can be made in the form of candies, jellies, drinks (suspensions or emulsions) or in the form of more complex, nutraceutical foods. A non-limiting example of such nutraceuticals could be represented, for example, by liquid beverages such as smoothies, juices, soft drinks or foods such as gums, biscuits, granules, chocolate bars, crackers and rusks, etc. The extract can also be introduced at the most suitable moment of preparation, in liquid or dried form, in liquid or solid foods, as the technician of the sector for the realization of food supplements will be able to define in a simple way and without the use of inventive activity. The food supplement may also contain other ingredients such as a combination of vitamins, salts and other substances aimed at integrating the diet.

The invention is described below in detail in the following examples which are purely for illustrative purposes without limiting the scope of protection conferred.

EXAMPLES

Example 1. Method for preparing the mother tincture of marjoram.

Alcoholic extraction is carried out by maceration of the raw material in a hydroalcoholic solution (ratio of ethanol / water 60:40) for a period of ten days; the quantity of the plant referred to the dry residue is such as to obtain the final mother tincture in a ratio of 1:10. After ten days of maceration at room temperature, the supernatant is separated and filtered, while the solid residue is squeezed and the juice filtered. The liquid fractions are then joined and, after 48 hours of rest, filtered again.

The alcoholic strength of the vegetable mother tincture is about 65 ° / - 5 °. The liquid is stored in closed containers, preferably not made of plastic, in a cool and dark place.

Example 2. Testing of the mother tincture as obtained in example 1 The mother tincture of Origanum Majorana as obtained in example 1 was administered in the measure of 20 drops 2 times a day for 2 months to 13 women aged between 34 and 59 years old who had manifested an evident decrease in libido, obtaining a stimulation and an increase in sexual desire in 10 of them. The results of the trial are summarized in Table 1 below: Table 1.

Patient Age Sexual desire 1 52 +++ 2 44 ++ 3 48 +++ 4 35 ++ 5 34 +++ 6 40 ++ 7 43 +++ 8 55 --9 59 ++ 10 49 +++ 11 38 ++ 12 47 --13 51 +++

Claims (14)

CLAIMS 1. A plant product belonging to the Origanum Majorana species for use in the treatment of decreased female libido. 2. Process according to claim 1, wherein the raw material used for the preparation of said elaborate comprises the whole plant or one or more parts thereof selected from root, bark, leaf, fruit, seed or flower. Process according to claim 1 or 2, wherein said raw material is in dried and / or fresh form. Process according to any one of claims 1 to 3 in the form of liquid, dry, powder, granulated or lyophilized extract. 5. Process according to claim 4 in the form of a liquid extract obtainable with a solvent or a mixture of extraction solvents selected from the group comprising ethanol, water, distilled water, esters, ethers, polyols or their mixture. Process according to any one of claims 1 to 5 in the form of mother tincture. 7. Process according to claim 6 wherein said mother tincture is administered with a dosage regimen comprised between 20 and 60 drops per day for a period of at least 7 days. 8. Pharmaceutical composition comprising a preparation according to any one of claims 1 to 7 and one or more excipients and / or carriers and / or diluents for use in the treatment of decreased female libido. 9. Pharmaceutical composition for oral or topical use in a form chosen from the group of solution, suspension, emulsion, syrup, powder, granulated capsule, tablet, pill, tablet, gel, cream, ointment. 10. Vegetable blend comprising an elaborate according to any one of claims 1 to 7. 11. Mixture according to the preceding claim comprising at least one plant extract selected from the group formed by Tribulus terrestris, Lepidium mwyenei, Muira Puama, Marjoram, Damiana. Method for preparing a pharmaceutical composition comprising a mixing step of a product according to any one of claims 1 to 7 and one or more excipients and / or carriers and / or diluents. 13. Use of an elaborate plant belonging to the Origanum Majorana species to increase female libido. 14. Use of a preparation according to the preceding claim in a food supplement.