WO2007039124A2 - Compositions comprising colostrum and hyaluronic acid for the treatment of vaginal dryness - Google Patents

Compositions comprising colostrum and hyaluronic acid for the treatment of vaginal dryness Download PDF

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Publication number
WO2007039124A2
WO2007039124A2 PCT/EP2006/009183 EP2006009183W WO2007039124A2 WO 2007039124 A2 WO2007039124 A2 WO 2007039124A2 EP 2006009183 W EP2006009183 W EP 2006009183W WO 2007039124 A2 WO2007039124 A2 WO 2007039124A2
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WO
WIPO (PCT)
Prior art keywords
compositions
vaginal
colostrum
hyaluronic acid
treatment
Prior art date
Application number
PCT/EP2006/009183
Other languages
French (fr)
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WO2007039124A3 (en
Inventor
Rosa Maria Gobbi
Original Assignee
You Biomedical Research S.R.L
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by You Biomedical Research S.R.L filed Critical You Biomedical Research S.R.L
Priority to EP06805796A priority Critical patent/EP1940517A2/en
Publication of WO2007039124A2 publication Critical patent/WO2007039124A2/en
Publication of WO2007039124A3 publication Critical patent/WO2007039124A3/en

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Classifications

    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/728—Hyaluronic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/20—Milk; Whey; Colostrum
    • 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
    • A61K36/13—Coniferophyta (gymnosperms)
    • A61K36/14—Cupressaceae (Cypress family), e.g. juniper or cypress
    • 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
    • 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
    • A61K36/534—Mentha (mint)
    • 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)
    • A61K36/75—Rutaceae (Rue family)
    • A61K36/752—Citrus, e.g. lime, orange or lemon
    • 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)
    • A61K36/886—Aloeaceae (Aloe family), e.g. aloe vera
    • 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)
    • A61K36/889—Arecaceae, Palmae or Palmaceae (Palm family), e.g. date or coconut palm or palmetto
    • 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
    • A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • 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
    • A61P15/12—Drugs for genital or sexual disorders; Contraceptives for climacteric disorders

Definitions

  • the present invention relates to vaginal compositions comprising colostrum and hyaluronic acid, useful for the treatment of vaginal dryness in menopause.
  • Vaginal dryness is one of the consequences of the decrease in estrogen levels in menopause.
  • the fall in circulating estrogen level involves in fact the thinning of the vaginal walls, with reduction of elasticity and decrease in the natural secretion and lubrication, which makes sexual intercourse difficult and painful.
  • Vaginal dryness is usually treated with the replacement therapy comprising estrogens, which however involves well known side effects (slight increase in the number of breast tumours, slight increase in stroke cases, risk of "stimulation" of endometrious with possible “hyperplasia”, increase in the risk of thrombotic phenomena).
  • vaginal topical compositions comprising colostrum exert a beneficial action on vaginal epithelium, increasing its elasticity and promoting mucosal secretion.
  • the present invention relates to fluid compositions in the form of vaginal creams, gel, solutions, ovules, suppositories, capsules or washes containing colostrum and hyaluronic acid, useful for the treatment of vaginal dryness in menopause.
  • the present invention also relates to the use of colostrum and hyaluronic acid for the treatment of vaginal dryness associated to postmenopausal syndrome.
  • colostrum can derive from any mammal, preferably of equine, bovine, ovine origin, and it will be present in the compositions of the invention in percentages ranging from 5 to 0%.
  • hyaluronic acid will be present in the compositions of the invention in percentages ranging from 0.1 to 2%.
  • the compositions of the present invention will also contain soy isoflavones. Soy isoflavones are phytoestrogens that have been used for a long time in replacement therapy.
  • soy isoflavones can be selected from genistein, daidzein, glycitein and their glycosides genistin, daidzin and glycitin, and they will be present in percentages ranging preferably from 0.01 to 5% by weight.
  • compositions of the present invention will also contain vegetable extracts from plants which exert a complementary or anyway useful activity for the purposes of the invention, for example estrogenic, anti-inflammatory, antifungal, antibacterial, re-epithelizing, hydrating, decongesting, microcirculation-improving, protective, antioxidant, refreshing activities and the like.
  • Examples of said plants are coconut palm ⁇ Elaeis guineensis), aloe ⁇ Aloe barbadensis), cypress (Cupressus saffirvirens), maca (Lepidium meyeni ⁇ ), minth ⁇ Mentha piperita), thyme ⁇ Thymus vulgaris), vervain ⁇ Lippia citriodora), oreganon ⁇ Origanum vulgare), and plants of the Citrus genus.
  • compositions of the present invention proved to exert a synergetic activity: in fact they exert a surprisingly higher action than that obtained from the sum of the activity of the single active components.
  • compositions of the present invention will be formulated in the form of vaginal gel, creams, solutions, ovules, suppositories, capsules and washes, using techniques and conventional excipients well-known in the pharmaceutical technique, such as diluents, disintegrants, moisturizers and lubricants.
  • a preferred formulation is that in cream.

Abstract

The present invention relates to vaginal compositions containing colostrum and hyaluronic acid, more particularly fluid compositions in the form of vaginal creams, gel, solutions, ovules, suppositories, capsules or washes, useful for the treatment of vaginal dryness in menopause.

Description

COMPOSITIONS COMPRISING COLOSTRUM AND HYALURONIC ACID FOR THE TREATMENT OF VAGINAL DRYNESS
Summary of the invention
The present invention relates to vaginal compositions comprising colostrum and hyaluronic acid, useful for the treatment of vaginal dryness in menopause. Technical background
Vaginal dryness is one of the consequences of the decrease in estrogen levels in menopause. The fall in circulating estrogen level involves in fact the thinning of the vaginal walls, with reduction of elasticity and decrease in the natural secretion and lubrication, which makes sexual intercourse difficult and painful. Vaginal dryness is usually treated with the replacement therapy comprising estrogens, which however involves well known side effects (slight increase in the number of breast tumours, slight increase in stroke cases, risk of "stimulation" of endometrious with possible "hyperplasia", increase in the risk of thrombotic phenomena). It has now been found that vaginal topical compositions comprising colostrum exert a beneficial action on vaginal epithelium, increasing its elasticity and promoting mucosal secretion.
Disclosure of the invention
Therefore, the present invention relates to fluid compositions in the form of vaginal creams, gel, solutions, ovules, suppositories, capsules or washes containing colostrum and hyaluronic acid, useful for the treatment of vaginal dryness in menopause.
The present invention also relates to the use of colostrum and hyaluronic acid for the treatment of vaginal dryness associated to postmenopausal syndrome. According to the present invention, colostrum can derive from any mammal, preferably of equine, bovine, ovine origin, and it will be present in the compositions of the invention in percentages ranging from 5 to 0%. According to the present invention, hyaluronic acid will be present in the compositions of the invention in percentages ranging from 0.1 to 2%. According to a preferred aspect of the present invention, the compositions of the present invention will also contain soy isoflavones. Soy isoflavones are phytoestrogens that have been used for a long time in replacement therapy. It is in fact known that Asian women, thanks to a diet rich in phytoestrogens, have markedly fewer postmenopausal symptoms than Western women. According to the present invention, soy isoflavones can be selected from genistein, daidzein, glycitein and their glycosides genistin, daidzin and glycitin, and they will be present in percentages ranging preferably from 0.01 to 5% by weight.
According to a preferred aspect, the compositions of the present invention will also contain vegetable extracts from plants which exert a complementary or anyway useful activity for the purposes of the invention, for example estrogenic, anti-inflammatory, antifungal, antibacterial, re-epithelizing, hydrating, decongesting, microcirculation-improving, protective, antioxidant, refreshing activities and the like. Examples of said plants are coconut palm {Elaeis guineensis), aloe {Aloe barbadensis), cypress (Cupressus semprevirens), maca (Lepidium meyeniϊ), minth {Mentha piperita), thyme {Thymus vulgaris), vervain {Lippia citriodora), oreganon {Origanum vulgare), and plants of the Citrus genus.
The compositions of the present invention proved to exert a synergetic activity: in fact they exert a surprisingly higher action than that obtained from the sum of the activity of the single active components.
The compositions of the present invention will be formulated in the form of vaginal gel, creams, solutions, ovules, suppositories, capsules and washes, using techniques and conventional excipients well-known in the pharmaceutical technique, such as diluents, disintegrants, moisturizers and lubricants. According to the present invention, a preferred formulation is that in cream.
An example of formulation according to the invention is reported below:
Example - Vaginal cream
Figure imgf000004_0001

Claims

1. Vaginal compositions containing colostrum and hyaluronic acid for the treatment of vaginal dryness in menopause.
2. Compositions as claimed in claim 1, in which colostrum derives from any mammal, preferably of equine, bovine, ovine origin.
3. Compositions as claimed in claim 1 e 2, containing colostrum in percentages ranging from 5 to 30%.
4. Compositions as claimed in claim 1 e 2, containing hyaluronic acid in percentages ranging from 0.1 to 2%.
5. Compositions according to the above claims, further containing soy isoflavones.
6. Compositions according to the above claims, further containing vegetable extracts from plants selected from the group consisting of Elaeis guineensis, Aloe barbadensis, Cupressus semprevirens, Mentha piperita, Thymus vulgaris, Lippia citriodora, Origanum vulgare, and plants of the Citrus genus.
7. Compositions as claimed in any one of the above claims, in the form of vaginal creams, gel, solutions, ovules, suppositories, capsules or washes.
8. Compositions as claimed in claim 6, in the form of creams.
9. The use of colostrum for the preparation of compositions vaginal for the treatment of vaginal dryness in menopause.
PCT/EP2006/009183 2005-09-23 2006-09-21 Compositions comprising colostrum and hyaluronic acid for the treatment of vaginal dryness WO2007039124A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP06805796A EP1940517A2 (en) 2005-09-23 2006-09-21 Compositions comprising colostrum and hyaluronic acid for the treatment of vaginal dryness

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT001777A ITMI20051777A1 (en) 2005-09-23 2005-09-23 COLOSSUS-BASED COMPOSITIONS FOR VAGINAL DRYING TREATMENT
ITMI2005A001777 2005-09-23

Publications (2)

Publication Number Publication Date
WO2007039124A2 true WO2007039124A2 (en) 2007-04-12
WO2007039124A3 WO2007039124A3 (en) 2007-06-28

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IT (1) ITMI20051777A1 (en)
WO (1) WO2007039124A2 (en)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010028652A1 (en) 2008-09-12 2010-03-18 Nanoko A/S Colostrum composition
ITMI20091628A1 (en) * 2009-09-24 2011-03-25 You Biomedical Res Srl COMPOSITIONS FOR THE TREATMENT OF VAGINAL DRYNESS AND RECURRENT VAGINAL INFECTIONS
CN102239922A (en) * 2010-05-13 2011-11-16 江苏星驰生物科技有限公司 Colostrum formula powder
ITRM20100419A1 (en) * 2010-07-28 2012-01-29 Galsor S R L PHARMACEUTICAL COMPOSITION BASED ON ONE OR MORE FRACTIONS OF HYALURONIC ACID OR ITS SALTS ASSOCIATED WITH AN INHIBITOR OF IALURONIDASI AND ITS USES IN MEDICAL FIELD.
ITMI20102260A1 (en) * 2010-12-09 2012-06-10 Bionest Ltd MULTIPURPOSE GEL AGAINST THE VAGINAL DRYNESS WITH A DIRECT AND DELAYED EFFECT
ITMI20112438A1 (en) * 2011-12-30 2013-07-01 Bionest Ltd INJECTABLE FORMULATIONS OF CYTOKINES, GROWTH FACTORS, CHEMOTACTIC FACTORS, STAMINAL STIMULATION FATORS AND RNA FOR DERMA REGENERATION
WO2019213473A1 (en) * 2018-05-04 2019-11-07 The Procter & Gamble Company Compositions and methods for treating vaginal dryness

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WO2004089278A2 (en) * 2003-04-09 2004-10-21 Dolhay Klinika Egészségügyi Kft. Sexual hygienic composition

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US6251436B1 (en) * 1995-09-29 2001-06-26 L.A.M. Pharmaceutical Corporation Drug preparations for treating sexual dysfunction
EP1444984A1 (en) * 2003-02-06 2004-08-11 B.S.D. BIO SCIENCE DEVELOPMENT SNC Di OMINI C. & ZUCCARI G. Topical pharmaceutical compositions containing natural active constituents suitable for the prevention and treatment of mucosal inflammation processes
WO2004089278A2 (en) * 2003-04-09 2004-10-21 Dolhay Klinika Egészségügyi Kft. Sexual hygienic composition

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Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010028652A1 (en) 2008-09-12 2010-03-18 Nanoko A/S Colostrum composition
US8637075B2 (en) 2008-09-12 2014-01-28 Pharma Gp Aps Colostrum composition
ITMI20091628A1 (en) * 2009-09-24 2011-03-25 You Biomedical Res Srl COMPOSITIONS FOR THE TREATMENT OF VAGINAL DRYNESS AND RECURRENT VAGINAL INFECTIONS
CN102239922A (en) * 2010-05-13 2011-11-16 江苏星驰生物科技有限公司 Colostrum formula powder
ITRM20100419A1 (en) * 2010-07-28 2012-01-29 Galsor S R L PHARMACEUTICAL COMPOSITION BASED ON ONE OR MORE FRACTIONS OF HYALURONIC ACID OR ITS SALTS ASSOCIATED WITH AN INHIBITOR OF IALURONIDASI AND ITS USES IN MEDICAL FIELD.
JP2013544858A (en) * 2010-12-09 2013-12-19 ツァンボン ソシエタ ペル アチオニ Versatile gel for vaginal dryness with direct and delayed effects
CN103338778A (en) * 2010-12-09 2013-10-02 赞邦股份公司 Multipurpose gel for vaginal dryness with direct and delayed effect
WO2012076409A1 (en) * 2010-12-09 2012-06-14 Zambon S.P.A. Multipurpose gel for vaginal dryness with direct and delayed effect
ITMI20102260A1 (en) * 2010-12-09 2012-06-10 Bionest Ltd MULTIPURPOSE GEL AGAINST THE VAGINAL DRYNESS WITH A DIRECT AND DELAYED EFFECT
US9248151B2 (en) 2010-12-09 2016-02-02 Zambon S.P.A. Multipurpose gel for vaginal dryness with direct and delayed effect
AU2011340757B2 (en) * 2010-12-09 2016-10-27 Zambon S.P.A. Multipurpose gel for vaginal dryness with direct and delayed effect
EA026198B1 (en) * 2010-12-09 2017-03-31 Замбон С.П.А. Multipurpose gel for vaginal dryness with direct and delayed effect
ITMI20112438A1 (en) * 2011-12-30 2013-07-01 Bionest Ltd INJECTABLE FORMULATIONS OF CYTOKINES, GROWTH FACTORS, CHEMOTACTIC FACTORS, STAMINAL STIMULATION FATORS AND RNA FOR DERMA REGENERATION
WO2019213473A1 (en) * 2018-05-04 2019-11-07 The Procter & Gamble Company Compositions and methods for treating vaginal dryness
CN112088010A (en) * 2018-05-04 2020-12-15 宝洁公司 Compositions and methods for treating vaginal dryness
US11633452B2 (en) 2018-05-04 2023-04-25 The Procter & Gamble Company Compositions and methods for treating vaginal dryness

Also Published As

Publication number Publication date
WO2007039124A3 (en) 2007-06-28
EP1940517A2 (en) 2008-07-09
ITMI20051777A1 (en) 2007-03-24

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