WO2024100574A1 - Composition à base de plantes pour la gestion d'une dysfonction sexuelle - Google Patents

Composition à base de plantes pour la gestion d'une dysfonction sexuelle Download PDF

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Publication number
WO2024100574A1
WO2024100574A1 PCT/IB2023/061275 IB2023061275W WO2024100574A1 WO 2024100574 A1 WO2024100574 A1 WO 2024100574A1 IB 2023061275 W IB2023061275 W IB 2023061275W WO 2024100574 A1 WO2024100574 A1 WO 2024100574A1
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component
herbal composition
mixture
polyherbal
amino acids
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English (en)
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Swati Vishal Jajodia
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4525—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with oxygen as a ring hetero atom
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/87—Vitaceae or Ampelidaceae (Vine or Grape family), e.g. wine grapes, muscadine or peppervine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds

Definitions

  • the present invention relates to a herbal composition for management of sexual dysfunction. More particularly, the present invention relates to a herbal composition for management of libido in both men and women, wherein the composition has no or minimal side effects.
  • BACKGROUND OF THE INVENTION Sexual dysfunction is characterized by disturbances in sexual desire and in the psychophysiological changes associated with the sexual response cycle (American Psychiatric Association, 1994). One of the common sexual dysfunctions is linked to low libido which is prevalent in both men and women.
  • the libido is a sexual drive-in individual that can be determined and influenced by several factors, such as social, psychological, and hormonal factors.
  • the etiology of the disorder is multifactorial and in men is mainly attributed to psychogenic, organic (neurogenic, hormonal, arterial, cavernosal or drug-induced), or mixed psychogenic and organic.
  • the etiology in female is linked to vasculogenic, neurogenic, hormonal, or psychogenic factors.
  • plant-derived and herbal medications still is a promising alternative for both men and women seeking to improve their sex life. The reason for the same can be linked to reduced side effects. Nevertheless, the efficacy of most herbal agents in treating sexual problems remains uncertain. Aung et al; (H.H. AUNG et al. / The American Journal of Chinese Medicine, Vol.32, No.
  • the article discloses alternative therapies for male and female sexual dysfunction.
  • the article discloses the use of herbal medicines like Yohimbine, Ginkgo biloba, Tribulus terrestris/Protodioscin, Ginseng, and Damiana for treating male sexual dysfuntion.
  • a nutritional supplement containing ginseng (30% ginseng extract), ginkgo (24% flavone glycosides and 6% terpene lactones), damiana leaf, L-Arginine, along with vitamins A, B6, B12, biotin, folate, niacin, pantothenic acid, riboflavin, thiamin, antioxidant vitamins (C and E), calcium, iron, and zinc, for enhancement of female sexual function.
  • Elizabeth Westand Michael Krychman discloses the most popular and currently used aphrodisiac products marketed in the United States. Research has demonstrated that the risks of yohimbine, Spanish fly, mad honey, and Bufo toad outweigh any benefit, and these products should be avoided. Other products, such as Maca, Tribulus, Ginkgo, and ginseng, have limited.
  • the document further discloses “ArginMax”, which is a combination supplement containing an array of vitamins marketed toward women (A, B-complex, C, E), zinc, as well as L- Arginine, Korean ginseng, Ginkgo, and Damiana leaf. The proposed mechanism of action is through enhancement of the NO pathway.
  • L-Arginine is a precursor of NO, which causes central to smooth muscle relaxation, vascular dilatation, and vaginal wall engorgement.
  • WO2020/115274 discloses compositions comprising L-Arginine and L-Citrulline in specific ratios and the use thereof for improving the sexual function in a sexually healthy human subject on demand.
  • WO2021/030698 discloses a topical composition for improving the sensitivity of the skin and improving blood flow to the skin comprising sweet almond oil, cinnamon bark oil, coriander seed oil, L-Arginine, and L-Citrulline in an oil-in-water emulsion.
  • the existing treatments for the above disorder are either having side effects or very less data available on the efficacy of such herbal formulations is known.
  • the main object of the present invention is to provide a composition for management of sexual dysfunction.
  • Another object of the present invention is to provide a composition for management of libido in both men and women.
  • Yet another object of the present invention is to provide a herbal composition having no or minimal side effects.
  • SUMMARY OF THE INVENTION The present invention relates to a herbal composition for management of libido in both men and women in a short time period without any side effects.
  • the present invention provides a herbal composition for the management of libido, comprising of a component A, a component B and an excipient.
  • the component A is a combination of amino acids including L-Citrulline and L-Arginine in a ratio of 0.5:1, 1:1 or 1:3.
  • the component B is a combination of polyherbal mixture including Fenugreek (Trigonella foenum graecum), Tribulus terrestris, grape seed extract and piperine (95%) in a ratio ranging from 0.05 to 1.
  • a method of preparing a herbal composition comprising the steps of weighing and drying a predefined amount of the amino acids of component A and a predefined amount of the polyherbal mixture of component B.
  • the amino acids of component A and polyherbal mixture of component B are dried and mixed for 55 minutes to form a mixture followed by addition of microcrystalline cellulose and polysorbate 80 in the mixture for 20 minutes followed by mixing talc for 5 more minutes to form another mixture that is then dried and mixed with the mixture obtained above to form a herbal composition.
  • the predefined amount of the amino acids of component A is in a range of 150 mg – 300 mg and the predefined amount of the polyherbal mixture is in a range of 380 mg – 460 mg.
  • Figure 1 is a flow chart depicting the process of preparing the herbal composition, according to an embodiment of the present invention.
  • Figure 2 is a graphical representation showing comparative dissolution data in 90 ml water with respect to % release profile of the drug, according to the present invention.
  • Figure 3 is a graphical representation showing comparative dissolution data in 900 ml water for capsules with respect to % release profile of the drug, according to the present invention.
  • Figure 4 is a graphical representation showing comparative dissolution data in 900 ml water for capsule composition with respect to % release profile of the drug, according to the present invention.
  • DETAILED DESCRIPTION OF THE INVENTION The present invention now will be described hereinafter with reference to the detailed description, in which some, but not all embodiments of the invention are indicated. Indeed, the invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Like numbers refer to like elements throughout. The present invention is described fully herein with non-limiting embodiments and exemplary experimentation.
  • the present invention relates to a herbal composition for management of libido in both men and women with no or minimal side effects as well as in a short time interval.
  • the present invention provides a herbal composition for management of libido, comprising of: a component A; a component B; and an excipient; wherein, the component A is a combination of amino acids including L- Citrulline and L-Arginine in a ratio of 0.5:1, 1:1 or 1:3; the component B is a polyherbal mixture including Fenugreek (Trigonella foenum graecum), Tribulus terrestris, grape seed extract, and piperine (95%) in a ratio ranging from 0.05 to 1.
  • Fenugreek Trigonella foenum graecum
  • Tribulus terrestris Tribulus terrestris
  • grape seed extract and piperine (95%) in a ratio ranging from 0.05 to 1.
  • the amino acids of component A includes 17.05% of L-Citrulline and 17.05% of L-Arginine.
  • the polyherbal mixture of component B includes 22.72% of Fenugreek (Trigonella foenum graecum); 17.05% of Tribulus terrestris; 11.36% of grape seed extract; and 1.14% of piperine (95%).
  • the excipient is a pharmaceutically acceptable ingredient, which is selected from microcrystalline cellulose or methyl cellulose, polysorbate 80, sodium lauryl sulphate, talc, silica or magnesium stearate, and is essentially a mixture of 48 mg of microcrystalline cellulose, 2 mg of talc and 2 mg of magnesium stearate.
  • the amino acids of component A includes 75 mg of L-citrulline and 75 mg of L-Arginine
  • the polyherbal mixture of component B includes 100 mg of Fenugreek (Trigonella foenum graecum); 75 mg og Tribulus terrestris; 50 mg of grape seed extract; and 5 mg of piperine (95%).
  • the herbal composition is in the form of a tablet, a capsule, a sachet, oral capsules, granules, a paste, a pill, a syrup or liquid.
  • the libido is managed in a period ranging from 30 days to 90 days.
  • the herbal composition helps in managing libido in a single dosage form of the amino acids of component A and the polyherbal mixture of component B in a range of 150 mg – 230 mg, while in a double dosage form, the libido is managed by the amino acids of component A and the polyherbal mixture of component B in a range of 300 mg – 460 mg and the herbal composition possess minimal side effects.
  • a method of preparing a herbal composition comprising the steps of: a) weighing and drying a predefined amount of the amino acids of the component A and a predefined amount of the polyherbal mixture of the component B; b) drying and mixing the amino acids of the component A and the polyherbal mixture of the component B of step (a) for 55 minutes to form a mixture; c) adding microcrystalline cellulose and polysorbate 80 in the mixture obtained in step (b) for 20 minutes followed by mixing talc for 5 more minutes to form another mixture; and d) drying and mixing the another mixture obtained in step (c) with the mixture obtained in step (b) to form a herbal composition; wherein, the predefined amount of the amino acids is 150 mg; and the predefined amount of the polyherbal mixture is 380 mg.
  • Fenugreek (Trigonella foenum graecum) is native to southern Europe and the Mediterranean region, fenugreek is cultivated in central and southeastern Europe, western Asia, India, and northern Africa. Tribulus terrestris is an annual plant in the caltrop family (Zygophyllaceae) widely distributed around the world. It is native to warm temperate and tropical regions in southern Eurasia and Africa. The grape seed is native to Asia and it is well-known from pre-history. The part of the grape seed that was used in the present invention was seed that was procured from the Konark Herbals & Healthcare Pvt. Ltd. Piperine is found in Black Pepper, which is native to the Malabar Coast of India and is one of the earliest spices known.
  • EXAMPLE 1 Ingredients of Herbal Composition
  • the ingredients of herbal composition comprising of component A having 75 mg (17.05%) of L-Citrulline and 75 mg (17.05%) of L-Arginine and component B having 100 mg (22.72%) of Fenugreek (Trigonella foenum graecum), 75 mg (17.05%) of Tibulus terrestris, 50 mg (11.36%) of grape seed extract, 5 mg (1.14%) of Piperine (95%). Further, the excipients include 48 mg (10.9%) of microcrystalline cellulose, 2 mg (0.45%) of talc and 10 mg (2.28%) of polysorbate 80 (Table 1). Table 1: Ingredients of Herbal Composition S. No.
  • FIG. 2 shows a graphical representation depicting the comparative dissolution data in 90 ml water with respect to % release profile of the drug.
  • EXAMPLE 2 Clinical Study An open label clinical trial was conducted for testing efficacy in 90 patients suffering from Libido and copulatory performance. The inclusion criteria includes ability and acceptance to provide written consent, fluent in English, patients with history of Libido and copulatory performance issues. The patients include men or women between 18-75 years. On the other hand, there were some exclusions such as patients who had undergone major surgery, suffering from trauma, illness or are immobile for 3 or more days within the past month, women who are pregnant, and the patients with a positive test for drugs of abuse at the screening or evaluation visit were not allowed to participate in the trial.
  • the trial was conducted by giving the test molecule (TM) orally in the form of capsules to each patient.
  • the objective was to determine the efficacy of capsule in Libido and copulatory performance and to evaluate the safety of the TM capsules in patients with Libido and copulatory performance.
  • the dosage was given only one time and the trial was conducted for 3 months (Table 2).
  • the endpoint result of this clinical trial was seen to be positive having improvement in libido and copulatory performance in patients.
  • Table 2 Study Details An open label, trial for efficacy product in patients Ti l Phase of development Pilot phase Test Molecule (TM) o n n d le for 3 or more days within the past month. 2.
  • excipients include 48 mg (13.18%) of microcrystalline cellulose and 2 mg (0.45%) of talc (Table 4).
  • Table 4 Capsules Quantity ge Component B 3 Fenugreek (Trigonella foenum graecum) 100 22.72
  • Figure 3 shows a graphical representation of comparative dissolution data in 900 ml water for capsules with respect to % release profile of the drug.
  • the capsule composition includes component A having 75 mg (17.05%) of L-Citrulline and 75 mg (17.05%) of L-Arginine and component B having 100 mg (22.72%) of Fenugreek (Trigonella foenum graecum), 75 mg (17.05%) of Tribulus terrestris, 50 mg (11.36%) of grape seed extract, 5 mg (1.14%) of Piperine (95%). Further, the excipients include 48 mg (12.73%) of microcrystalline cellulose, 2 mg (0.45%) of talc and 2 mg (0.45%) of magnesium stearate (Table 5).

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Bioinformatics & Cheminformatics (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention concerne une composition à base de plantes pour la gestion de la libido à la fois chez l'homme et chez la femme, ladite composition n'ayant pas ou peu d'effets secondaires. Plus particulièrement, la présente invention concerne une composition à base de plantes comprenant le composant A et le composant B. Le composant A est une combinaison d'acides aminés L-Arginine et L-Citrulline dans un rapport défini. Le composant B selon la présente invention est un mélange à base de polyherbes de fenugrec (Trigonella foenum graecum), Tribulus terrestris, un extrait de pépins de raisin et de la pipérine (95 %) dans des pourcentages en poids définis pour la gestion de faible libido chez les hommes et les femmes.
PCT/IB2023/061275 2022-11-08 2023-11-08 Composition à base de plantes pour la gestion d'une dysfonction sexuelle Ceased WO2024100574A1 (fr)

Applications Claiming Priority (2)

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IN202221045315 2022-11-08
IN202221045315 2022-11-08

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IN2005MN00702A (fr) * 2003-03-17 2005-09-30 Samsung Electronics Co Ltd
WO2019003163A2 (fr) * 2017-06-28 2019-01-03 Buzzelet Development And Technologies Ltd. Produit cannabinoïde enrichi en terpène bon pour la santé des femmes
EP3890718A1 (fr) * 2018-12-07 2021-10-13 Inxo A/S Compositions pour améliorer la fonction sexuelle

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IN2005MN00702A (fr) * 2003-03-17 2005-09-30 Samsung Electronics Co Ltd
WO2019003163A2 (fr) * 2017-06-28 2019-01-03 Buzzelet Development And Technologies Ltd. Produit cannabinoïde enrichi en terpène bon pour la santé des femmes
EP3890718A1 (fr) * 2018-12-07 2021-10-13 Inxo A/S Compositions pour améliorer la fonction sexuelle

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