ITMI20080589A1 - HYDROXYSEROSOL FORMULATIONS ONLY FOR THE PREVENTIVE AND CURATIVE TREATMENT OF DAMAGES PRODUCED BY THE OXIDATIVE EFFECTS ON THE DNA IN POST-MENOPAUSAL SITUATIONS - Google Patents

HYDROXYSEROSOL FORMULATIONS ONLY FOR THE PREVENTIVE AND CURATIVE TREATMENT OF DAMAGES PRODUCED BY THE OXIDATIVE EFFECTS ON THE DNA IN POST-MENOPAUSAL SITUATIONS Download PDF

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Publication number
ITMI20080589A1
ITMI20080589A1 IT000589A ITMI20080589A ITMI20080589A1 IT MI20080589 A1 ITMI20080589 A1 IT MI20080589A1 IT 000589 A IT000589 A IT 000589A IT MI20080589 A ITMI20080589 A IT MI20080589A IT MI20080589 A1 ITMI20080589 A1 IT MI20080589A1
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IT
Italy
Prior art keywords
extract
formulations
post
menopausal
dna
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IT000589A
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Italian (it)
Inventor
Felicia Cisale
Gianluca Fasiello
Alessandro Merendino
Azzurra Villanova
Luciano Villanova
Luigi Villanova
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Lachifarma Srl
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Priority to IT000589A priority Critical patent/ITMI20080589A1/en
Priority to PCT/EP2009/002416 priority patent/WO2009121600A2/en
Publication of ITMI20080589A1 publication Critical patent/ITMI20080589A1/en

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    • 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
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05—Phenols
    • 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
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/592—9,10-Secoergostane derivatives, e.g. ergocalciferol, i.e. vitamin D2
    • 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
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • 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)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232—Angelica
    • 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)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/537—Salvia (sage)
    • 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)
    • A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/894—Dioscoreaceae (Yam family)
    • A61K36/8945—Dioscorea, e.g. yam, Chinese yam or water yam
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Description

Descrizione del brevetto per invenzione industriale avente per titolo: Description of the patent for industrial invention entitled:

“FORMULAZIONI DI IDROSSITIROSOLO PER IL TRATTAMENTO PREVENTIVO E CURATIVO DEI DANNI PRODOTTI DAGLI EFFETTI OSSIDATIVI SUL DNA NELLE SITUAZIONI POST-MENOPAUSALI” "FORMULATIONS OF HYDROXYTROSOL FOR THE PREVENTIVE AND CURATIVE TREATMENT OF THE DAMAGES PRODUCED BY THE OXIDATIVE EFFECTS ON DNA IN POST-MENOPAUSAL SITUATIONS"

La presente invenzione riguarda composizioni di idrossitirosolo (HT) e di altri biofenoli utili contro i danni prodotti dagli effetti ossidativi sul DNA nelle situazioni post-menopausali. The present invention relates to compositions of hydroxytyrosol (HT) and other biophenols useful against the damage produced by the oxidative effects on DNA in post-menopausal situations.

Stato della tecnica State of the art

Un procedimento per la preparazione di HT a elevata purezza e adatto all’uso come ingrediente da utilizzare in campo farmaceutico, alimentare e cosmetico è descritto in EP 1623960 a nome della Richiedente. A process for the preparation of high purity HT and suitable for use as an ingredient to be used in the pharmaceutical, food and cosmetic fields is described in EP 1623960 in the name of the Applicant.

EP 1623960 descrive inoltre formulazioni di HT per applicazioni in campo farmaceutico, alimentare e cosmetico. EP 1623960 also describes HT formulations for applications in the pharmaceutical, food and cosmetic fields.

Molti riferimenti scientifici si riferiscono alle attività benefiche dell’idrossitirosolo e di altri biofenoli. Many scientific references refer to the beneficial activities of hydroxytyrosol and other biophenols.

In particolare, Simonetta Salvini et al.- Daily consumption of a high-phenol extra-virgin olive oil reduces oxidative DNA damage in postmenopausal women - British Journal of Nutrition (2006), 95, 742-751] descrivono gli effetti benefici di una dieta ricca in olio extra-vergine di olivo ad alto contenuto in HT nel controllo della sindrome post-menopausale. In particular, Simonetta Salvini et al. - Daily consumption of a high-phenol extra-virgin olive oil reduces oxidative DNA damage in postmenopausal women - British Journal of Nutrition (2006), 95, 742-751] describe the beneficial effects of a diet rich in extra-virgin olive oil with a high content of HT in the control of post-menopausal syndrome.

Descrizione dell’invenzione Description of the invention

Si è ora trovato che l’associazione di idrossitirosolo con almeno uno dei seguenti componenti: It has now been found that the association of hydroxytyrosol with at least one of the following components:

- estratto di Angelica sinensis; - Angelica sinensis extract;

- estratto di Salvia officinalis; - Salvia officinalis extract;

- estratto di Passiflora; - Passionflower extract;

- estratto di Olea europea; - European Olea extract;

- estratto di Dioscorea; - Dioscorea extract;

- ioni Calcio, Magnesio; - Calcium, Magnesium ions;

- Vitamina D; - Vitamin D;

- uno o più composti biofenolici e/o carotenoidi, - one or more biophenolic compounds and / or carotenoids,

è particolarmente efficace nel trattamento e nella prevenzione degli stress ossidativi, in particolare a carico del DNA cellulare, responsabili della sindrome post-menopausale. it is particularly effective in the treatment and prevention of oxidative stress, in particular on the cellular DNA, responsible for post-menopausal syndrome.

L’invenzione ha pertanto come oggetto formulazioni farmaceutiche o dietetiche contenenti come principi attivi detta associazione. The invention therefore has as its object pharmaceutical or dietary formulations containing said association as active ingredients.

L’invenzione riguarda inoltre l’uso della associazione per la preparazione di composizioni per il trattamento della sindrome post-menopausale. The invention also relates to the use of the association for the preparation of compositions for the treatment of post-menopausal syndrome.

Con il termine di “biofenolo” si intende un composto fenolico di origine vegetale ad attività antiossidante: esempi di tali composti comprendono acido gallico, acido caffeico, tirosolo, catechina, epicatechina, epigallocatechina, quercetina, resveratrolo, acido ellagico. The term "biophenol" refers to a phenolic compound of plant origin with antioxidant activity: examples of such compounds include gallic acid, caffeic acid, tyrosol, catechin, epicatechin, epigallocatechin, quercetin, resveratrol, ellagic acid.

Esempi di carotenoidi comprendono luteina, licopene, zeaxantina, tocoferoli. Examples of carotenoids include lutein, lycopene, zeaxanthin, tocopherols.

Sono preferite in particolare formulazioni comprendenti idrossitirosolo associato a: Particularly preferred are formulations comprising hydroxytyrosol associated with:

- estratti di Olea europea; - extracts of Olea europea;

- estratti di Dioscorea, Angelica sinensis, Salvia officinalis; - extracts of Dioscorea, Angelica sinensis, Salvia officinalis;

Passiflora; Passionflower;

- acido caffeico, acido gallico, luteina, tirosolo; - caffeic acid, gallic acid, lutein, tyrosol;

- ioni calcio, Magnesio e Vitamina D utili come preventivi dell’osteoporosi per lo stabile mantenimento della densità e solidità ossea. - Calcium, Magnesium and Vitamin D ions useful as osteoporosis preventives for the stable maintenance of bone density and solidity.

L’estratto di Angelica sinensis è utile contro le vampate di calore, mentre l’estratto di Salvia officinalis ha una azione tonica, stimolante generale, astringente e riduce la sudorazione specialmente notturna. Angelica sinensis extract is useful against hot flashes, while Salvia officinalis extract has a tonic, general stimulating, astringent action and reduces sweating, especially at night.

L’estratto di Passiflora ha invece un’attività sedativa, senza effetti depressivi, utile nelle fasi di insonnia di origine nervosa, irrequietezza, ansia, nei crampi e nei dolori intestinali. Passionflower extract, on the other hand, has a sedative effect, without depressive effects, useful in the phases of insomnia of nervous origin, restlessness, anxiety, cramps and intestinal pain.

Le associazioni dell’invenzione risultano particolarmente efficaci in quanto possono controllare efficacemente e in modo sinergico sintomi e cause della sindrome post-menopausale. The combinations of the invention are particularly effective as they can effectively and synergistically control symptoms and causes of post-menopausal syndrome.

Le formulazioni dell’invenzione sono preferibilmente in forma di compresse o analoghe forme orali solide, vantaggiose dal punto di vista della comodità di assunzione, stabilità (fino a tre anni o più) e possibilità di veicolare elevate quantità di idrossitirosolo, in misura di gran lunga maggiore a quella assumibile con la dieta, considerando che il contenuto di idrossitirosolo nell’olio di oliva varia a seconda del cultivar, delle condizioni pedo-climatiche, del momento di frangitura e della tecnica di frangitura, etc. ed è comunque tale da non permettere dosaggi sufficientemente elevati. The formulations of the invention are preferably in the form of tablets or similar solid oral forms, advantageous from the point of view of ease of intake, stability (up to three years or more) and the possibility of conveying high quantities of hydroxytyrosol, to a far greater extent. higher than that assumed with the diet, considering that the hydroxytyrosol content in olive oil varies according to the cultivar, the pedo-climatic conditions, the moment of pressing and the pressing technique, etc. and it is in any case such as not to allow sufficiently high dosages.

Il contenuto di idrossitirosolo nelle formulazioni dell’invenzione potrà variare da 0,1 a 10 mg per dose unitaria, mentre i dosaggi degli altri componenti potranno variare entro ampi limiti, in analogia con quanto noto per prodotti a base degli stessi ingredienti attivi. In linea di massima, il contenuto di ogni singolo componente potrà essere compreso nell’intervallo del ± 50% dei valori riportati nei seguenti Esempi che illustrano l’invenzione in maggior dettaglio. The content of hydroxytyrosol in the formulations of the invention may vary from 0.1 to 10 mg per unit dose, while the dosages of the other components may vary within wide limits, in analogy with what is known for products based on the same active ingredients. In principle, the content of each individual component may be within the range of ± 50% of the values shown in the following Examples that illustrate the invention in greater detail.

ESEMPIO 1 EXAMPLE 1

Compressa a base di HT HT based tablet

ESEMPIO 2 EXAMPLE 2

Compressa a base di HT Olea europaea E.S. Tablet based on HT Olea europaea E.S.

ESEMPIO 3 EXAMPLE 3

Compressa a base di HT Olea europaea E.S. Acido caffeico Tablet based on HT Olea europaea E.S. Caffeic acid

ESEMPIO 4 EXAMPLE 4

Compressa a base di HT Olea europaea E.S. Acido caffeico Estratti di Passiflora, Angelica, Salvia e Dioscorea Tablet based on HT Olea europaea E.S. Caffeic acid Extracts of Passionflower, Angelica, Sage and Dioscorea

Claims (7)

RIVENDICAZIONI 1. Formulazioni farmaceutiche o dietetiche comprendenti idrossitirosolo e almeno uno dei seguenti componenti: - estratto di Angelica sinensis; - estratto di Salvia officinalis; - estratto di Passiflora; - estratto di Olea europea; - estratto di Dioscorea; - ioni Calcio, Magnesio; - Vitamina D; - uno o più composti biofenolici e/o carotenoidi. CLAIMS 1. Pharmaceutical or dietary formulations comprising hydroxytyrosol and at least one of the following components: - Angelica sinensis extract; - Salvia officinalis extract; - Passionflower extract; - European Olea extract; - Dioscorea extract; - Calcium, Magnesium ions; - Vitamin D; - one or more biophenolic and / or carotenoid compounds. 2. Formulazioni secondo la rivendicazione 1 contenenti estratti di Olea europea. 2. Formulations according to claim 1 containing extracts of Olea europea. 3. Formulazioni secondo la rivendicazione 1 o 2 in cui i biofenoli e/o i carotenoidi sono scelti fra scelti fra acido caffeico, acido gallico, tirosolo. 3. Formulations according to claim 1 or 2 wherein the biophenols and / or carotenoids are selected from among selected from caffeic acid, gallic acid, tyrosol. 4. Formulazioni secondo una delle rivendicazioni da 1 a 3 comprendenti estratti di Dioscorea, Angelica sinensis, Salvia officinalis Passiflora. 4. Formulations according to one of claims 1 to 3 comprising extracts of Dioscorea, Angelica sinensis, Salvia officinalis Passiflora. 5. Formulazioni secondo una delle rivendicazioni da 1 a 4 comprendenti ioni Calcio, ioni Magnesio e Vitamina D. 5. Formulations according to one of claims 1 to 4 comprising Calcium ions, Magnesium ions and Vitamin D. 6. Formulazioni secondo una delle rivendicazioni da 1 a 5 in forma di compresse. 6. Formulations according to one of claims 1 to 5 in the form of tablets. 7. Uso di una associazione di idrossitirosolo con almeno uno dei seguenti componenti: - estratto di Angelica sinensis; - estratto di Salvia officinalis; - estratto di Passiflora; - estratto di Olea europea; - estratto di Dioscorea; - ioni Calcio, Magnesio; - Vitamina D; - uno o più composti biofenolici e/o carotenoidi; per la preparazione di composizioni per il trattamento della sindrome post-menopausale.7. Use of a combination of hydroxytyrosol with at least one of the following components: - Angelica sinensis extract; - Salvia officinalis extract; - Passionflower extract; - European Olea extract; - Dioscorea extract; - Calcium, Magnesium ions; - Vitamin D; - one or more biophenolic and / or carotenoid compounds; for the preparation of compositions for the treatment of postmenopausal syndrome.
IT000589A 2008-04-04 2008-04-04 HYDROXYSEROSOL FORMULATIONS ONLY FOR THE PREVENTIVE AND CURATIVE TREATMENT OF DAMAGES PRODUCED BY THE OXIDATIVE EFFECTS ON THE DNA IN POST-MENOPAUSAL SITUATIONS ITMI20080589A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
IT000589A ITMI20080589A1 (en) 2008-04-04 2008-04-04 HYDROXYSEROSOL FORMULATIONS ONLY FOR THE PREVENTIVE AND CURATIVE TREATMENT OF DAMAGES PRODUCED BY THE OXIDATIVE EFFECTS ON THE DNA IN POST-MENOPAUSAL SITUATIONS
PCT/EP2009/002416 WO2009121600A2 (en) 2008-04-04 2009-04-02 Hydroxytyrosol formulations for the treatment and prevention of dna oxidative damages in post-menopausal conditions

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IT000589A ITMI20080589A1 (en) 2008-04-04 2008-04-04 HYDROXYSEROSOL FORMULATIONS ONLY FOR THE PREVENTIVE AND CURATIVE TREATMENT OF DAMAGES PRODUCED BY THE OXIDATIVE EFFECTS ON THE DNA IN POST-MENOPAUSAL SITUATIONS

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Publication number Priority date Publication date Assignee Title
US10675290B2 (en) * 2013-04-05 2020-06-09 Societe Des Produits Nestle S.A. Compositions for use in stimulating bone growth
CN103599239B (en) * 2013-11-01 2015-05-06 于明儒 Traditional Chinese medicine ointment for treating osteoporosis
IT201900000343A1 (en) * 2019-01-10 2020-07-10 Herbal E Antioxidant Derivatives S R L Ed In Forma Abbreviata H&Ad S R L COMPOSITIONS FOR THE TREATMENT OF MENOPAUSE, OSTEOPENIA AND OSTEOPOROSIS, METABOLIC AND VASCULAR DISORDERS RELATED TO CLIMATER
EP3968973A1 (en) * 2019-05-13 2022-03-23 Société des Produits Nestlé S.A. Compositions and methods using a combination of calcium and at least one of oleuropein or metabolite thereof
EP4216735A1 (en) * 2020-09-24 2023-08-02 Mars Incorporated Food compositions and applications thereof

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EP1718273A2 (en) * 2003-12-30 2006-11-08 Med Care S.r.l. Compositions comprising vitamins and/or derivatives thereof stabilised with olea europea extract and/or ionene polymers
ITMI20041627A1 (en) * 2004-08-06 2004-11-06 Lachifarma S R L Lab Chimi Co PROCESS FOR THE RECOVERY OF THYROSOL HYDROXYTYROSOL AND OTHER PHENOLIC COMPONENTS FROM VEGETATION WATERS AND METHOD OF CATALYTIC OXIDATION OF THYROXIS TO HYDROXYSIROSOL
EP2040696B1 (en) * 2006-07-14 2017-01-25 DSM IP Assets B.V. Compositions and use thereof for the treatment, co-treatment or prevention of inflammatory disorders

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WO2009121600A2 (en) 2009-10-08

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