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Title:
COMPOSITION COMPRISING GINSENG, MORINGA AND RUTIN AND THE USE THEREOF IN THE TREATMENT OF MALE SEXUAL DYSFUNCTIONS
Document Type and Number:
WIPO Patent Application WO/2020/100052
Kind Code:
A4
Abstract:
The present invention regards a composition based on Panax (ginseng) extract, Moringa extract and rutin, the innovative formulation thereof as a pharmaceutical or nutraceutical composition and the use thereof for the treatment of male sexual dysfunctions, in particular, the treatment of erectile dysfunction and damage of the endothelial microcirculation of the male genital organ.

Inventors:
CASTORINA SEBASTIANO MAURIZIO (IT)
VANELLI ARIANNA (IT)
TADDEI ALESSANDRO (IT)
MURZILLI STEFANIA (IT)
Application Number:
PCT/IB2019/059738
Publication Date:
July 02, 2020
Filing Date:
November 13, 2019
Export Citation:
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Assignee:
NUTRILINEA S R L (IT)
International Classes:
A61K36/258; A61K31/7048; A61K36/18; A61P15/10
Attorney, Agent or Firm:
HOFFMANN EITLE S.R.L. et al. (IT)
Download PDF:
Claims:
AMENDED CLAIMS

received by the International Bureau on 1 1.05.2020

CLAIMS

1. A composition for use in a method for the preventive and/or curative treatment of a male sexual dysfunction in a subject in the need thereof, wherein the composition comprises

(i) a mixture comprising, or alternatively, consisting of:

(I) an extract from at least one plant of the Panax genus comprising ginsenosides, wherein said at least one plant of the Panax genus belongs to a species selected from among the group comprising or, alternatively, consisting of Panax ginseng Meyer, Panax notoginseng Chen., Panax pseudoginseng Wall., Panax guinguefolium L. and mixtures thereof;

(II) an extract from at least one plant of the Moringa genus comprising saponins, wherein said at least one plant of the Moringa genus belongs to the species selected from among the group comprising or, alternatively, consisting of Moringa oleifera Lam, Moringa peregrina Fiore and the mixtures thereof; and

(III) rutin; and, optionally,

(ii) at least one food grade or pharmaceutical additive and/or excipient.

2. The composition for use according to claim 1 , wherein said male sexual dysfunction is selected from an erectile dysfunction and a microcirculatory endothelial dysfunction of the male genital organ.

3. The composition for use according to claim 1 or 2, wherein said composition is for use as a vasodilator

4. The composition for use according to claim 1 or 2, wherein said composition is for use as a stimulant of testosterone hormone.

5. The composition for use according to any one of claims 1 to 4, wherein said composition is for use as an adjuvant to a drug for the treatment of the erectile dysfunction.

6. The composition for use according to claim 5, said drug for the treatment of the erectile dysfunction is an inhibitor of phosphodiesterase-5 (PDE-5).

7. The composition for use according to any one of claims 1 to 6, wherein said composition comprises (i) a mixture comprising, or alternatively, consisting of:

(I) an extract from at least one plant of the Panax genus comprising ginsenosides at a by weight % comprised in a range from 1 % to 30% with respect to the total weight of said extract (I), wherein said at least one plant of the Panax genus belongs to a species selected from among the group comprising or, alternatively, consisting of Panax ginseng Meyer, Panax notoginseng Chen., Panax pseudoginseng Wall., Panax guinguefolium L. and the mixtures thereof;

(II) an extract from at least one plant of the Moringa genus comprising saponins at a by weight % comprised in the range from 10% to 50% with respect to the total weight of said extract (I), wherein said at least one plant of the Moringa genus belongs to the species selected from among the group comprising or, alternatively, consisting of Moringa oieifera Lam, Moringa peregrina Fiore and the mixtures thereof;

(III) rutin; and, optionally,

(ii) at least one food grade or pharmaceutical additive and/or excipient.

8. The composition for use according to any one of claims 1 to 7, wherein said composition comprises

(i) a mixture comprising, or alternatively, consisting of:

(I) an extract from a plant of the Panax ginseng Meyer species comprising ginsenosides;

(II) an extract from a plant of the Moringa oieifera Lam species comprising saponins; and

(III) rutin; and, optionally,

(ii) at least one food grade or pharmaceutical additive and/or excipient.

9. A composition for use according to any one of the preceding claims, wherein the composition is in a formulation for oral use in a solid form, wherein said formulation comprises:

- a first layer comprising or, alternatively, consisting of said (I) extract from at least one plant of the Panax genus comprising ginsenosides formulated according to a first immediate release formulation;

- a second layer comprising or, alternatively, consisting of said (II) extract from a plant of the Moringa genus comprising saponins formulated according to a second delayed release formulation; and/or

- a third layer comprising or, alternatively, consisting of (III) rutin formulated according to a third intermediate release formulation.

10. A composition for use according to claim 9, wherein the composition comprises:

- the first layer comprising or, alternatively, consisting of said (I) extract Panax ginseng Meyer comprising ginsenosides formulated according to said first immediate release formulation, preferably said (I) extract is a dry extract of Panax ginseng Meyer roots;

- the second layer comprising or, alternatively, consisting of said (II) extract Moringa oieifera Lam comprising saponins formulated according to said second delayed release formulation, preferably said (II) extract is a dry extract of Moringa oieifera Lam seeds; and - the third layer comprising or, alternatively, consisting of (III) rutin formulated according to said third intermediate release formulation.

11. A composition comprising

(i) a mixture comprising, or alternatively, consisting of:

(I) an extract from a plant of the Panax ginseng Meyer species comprising ginsenosides;

(II) an extract from a plant of the Moringa oleifera Lam species comprising saponins; and

(III) rutin; and, optionally,

(ii) at least one food grade or pharmaceutical additive and/or excipient.

12. The composition according to claim 11, wherein said composition comprises

(i) a mixture comprising, or alternatively, consisting of:

(I) an extract from a plant of the Panax ginseng Meyer species comprising ginsenosides at a by weight % comprised in a range from 1% to 30% with respect to the total weight of said extract (I), preferably from 5% to 15%, more preferably 10%;

(II) an extract from a plant of the Moringa oleifera Lam species comprising saponins at a by weight % comprised in a range from 10% to 50% with respect to the total weight of said extract

(II), preferably from 15% to 25%, more preferably 20%;

and

(III) rutin; and, optionally,

(ii) at least one food grade or pharmaceutical additive and/or excipient.

13. The composition according to claim 11 or 12, wherein said composition comprises:

- ginsenoside from said (I) extract from Panax ginseng Meyer at an amount comprised between 5 mg and 100 mg, preferably between 25 mg and 75 mg;

- saponins from said (II) extract from a plant of the Moringa oleifera Lam species at an amount comprised between 5 mg and 80 mg, preferably between 25 mg and 55 mg; and

- rutin at an amount comprised between 5 mg and 100 mg, preferably between 25 mg and 75 mg.

14. The composition according to any one of claims 11 to 13, wherein the composition is in a formulation for oral use in a solid form comprising:

- a first layer comprising or, alternatively, consisting of said (I) extract from Panax ginseng Meyer comprising ginsenosides formulated according to a first immediate release formulation, preferably said (I) extract is a dry extract of Panax ginseng Meyer roots; - a second layer comprising or, alternatively, consisting of said (II) extract from Moringa oleifera Lam comprising saponins formulated according to a second delayed release formulation, preferably said (II) extract is a dry extract of Moringa oleifera Lam seeds; and

- a third layer comprising or, alternatively, consisting of (III) rutin formulated according to a third intermediate release formulation.

15. Non-therapeutic use of the composition according to any one of claims 11 to 14, wherein said use is for a non-therapeutic treatment of a low or lack of male sexual drive or libido.