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Title:
COMPOSITIONS COMPRISING COLOSTRUM AND HYALURONIC ACID FOR THE TREATMENT OF VAGINAL DRYNESS
Document Type and Number:
WIPO Patent Application WO/2007/039124
Kind Code:
A3
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.

Inventors:
GOBBI ROSA MARIA (CH)
Application Number:
PCT/EP2006/009183
Publication Date:
June 28, 2007
Filing Date:
September 21, 2006
Export Citation:
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Assignee:
BIONEST LTD (IE)
GOBBI ROSA MARIA (CH)
International Classes:
A61P15/02; A61K31/728; A61K35/20; A61P15/12
Domestic Patent References:
WO2004089278A22004-10-21
Foreign References:
US6251436B12001-06-26
EP1444984A12004-08-11
Other References:
"ORLANE", PROMT, 1991, XP002403656
DATABASE WPI Week 200211, Derwent World Patents Index; AN 2002-075790, XP002430223
"Cryosplin: wound healing remedy", EPODOC, 2004, XP002401523
BECLERE C ET AL: "[Colostrum sterols in the treatment of post-menopausal disorders.]", SEMAINE MÉDICALE PROFESSIONELLE ET MÉDICO-SOCIALE 14 OCT 1957, vol. 33, no. 37, 14 October 1957 (1957-10-14), pages 1430 - 1433, XP001249074
DATABASE WPI Week 198419, Derwent World Patents Index; AN 1984-116620, XP002430224
Attorney, Agent or Firm:
MINOJA, Fabrizio et al. (Via Plinio 63, Milano, IT)
Download PDF:
Claims:

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.

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