NATURAL COMPOSITION FOR USE IN GYNAECOLOGY

• US 20200129547A1
• Filed: 04/04/2018
• Published: 04/30/2020
• Est. Priority Date: 04/05/2017
• Status: Active Grant

• Current Assignee: Organicare LLC
• Original Assignee: Organicare LLC
• Inventors: Papa, Franco, Colognato, Renato
• Granted Patent: US 11,369,632 B2
• Time in Patent Office: Days
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 33/40 Peroxides
• CPC Class Codes: A61K 36/28 Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
• CPC Class Codes: A61K 36/53 Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
• CPC Class Codes: A61K 36/537 Salvia (sage)
• CPC Class Codes: A61K 36/54 Lauraceae (Laurel family), e.g. cinnamon or sassafras
• CPC Class Codes: A61K 36/61 Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
• CPC Class Codes: A61K 36/63 Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
• CPC Class Codes: A61K 36/68 Plantaginaceae (Plantain Family)
• CPC Class Codes: A61K 36/88 Liliopsida (monocotyledons)
• CPC Class Codes: A61K 36/886 Aloeaceae (Aloe family), e.g. aloe vera
• CPC Class Codes: A61K 36/8962 Allium, e.g. garden onion, leek, garlic or chives
• CPC Class Codes: A61K 36/9066 Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
• CPC Class Codes: A61K 36/9068 Zingiber, e.g. garden ginger
• CPC Class Codes: A61K 47/44 Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61P 15/02 for disorders of the vagina
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/10 Antimycotics

Abstract

The present invention relates to a composition based on components of natural origin, in particular ozonized olive oil “ and liquid vegetable extracts, for the topical treatment of vaginosis and/or vulvovaginitis of bacterial and/or fungal origin.

Claims

1. An ozonized olive oil, comprising a peroxide value of 50-350 mEq 0₂/Kg comprising at least one liquid vegetable extract selected from among Allium spp., Aloe spp., Calendula officinalis, Cinnamomum spp., Curcuma spp., Lavender spp., Melaleuca spp., Plantago, Salvia officinalis, Salvia miltiorrhiza, Thymus spp., Zingiber spp. and mixtures thereof.

2. The ozonized olive oil of claim 1, further comprising 0.5-10.0% by weight of at least one liquid vegetable extract selected from among Allium spp., Aloe spp., Calendula officinalis, Cinnamomum spp., Curcuma spp., Lavender spp., Melaleuca spp., Plantago, Salvia officinalis, Salvia miltiorrhiza, Thymus spp., Zingiber spp. and mixtures thereof.

3. The ozonized olive oil of claim 1, wherein the at least one liquid vegetable extract comprises at least one essential oil selected from among Allium spp., Aloe spp., Calendula officinalis, Cinnamomum spp., Curcuma spp., Lavender spp., Melaleuca spp., Plantago, Salvia officinalis, Salvia miltiorrhiza, Thymus spp., Zingiber spp. and mixtures thereof.

4. The ozonized olive oil of claim 1, further comprising 0.5-2.5% by weight of liquid vegetable extract of lavender.

5. The ozonized olive oil of claim 1, further comprising 1.0-3.0% by weight or 1.2-2.5% by weight, of a mixture of liquid vegetable extracts comprising essential oils, of Lavender spp., Calendula officinalis and/or Melaleuca spp.

6. The ozonized olive oil of claim 1, wherein said oil has a peroxide value of 100-350 mEq O₂/Kg, 150-350 mEq O₂/Kg, or 250-350 mEq O₂/Kg.

7. The ozonized olive oil of claim 1, wherein the ozonized olive oil is configurable for gynaecological use in the topical treatment of bacterial and/or fungal vaginosis and/or vulvovaginitis.

8. The ozonized olive oil claim 7, wherein the ozonized olive oil id configurable for the topical treatment of vulvovaginitis caused by at least one pathogen selected from among fungi belonging to the genus Candida and Gardenerella vaginalis.

9. The ozonized olive oil of claim 7, wherein said use comprises applying inside the vagina a pharmacologically effective amount, preferably 1-20 ml/die or 3-10 ml/die, of said ozonized olive oil.

10. The ozonized olive oil claim 7, wherein said use comprises applying inside the vaginal cavity said ozonized olive oil for at least 3 days, for 3-6 days, every other day for at least 2 or for at least 3 administrations.

11. The ozonized olive oil of claim 7, wherein said use comprises applying inside the vaginal cavity said ozonized olive oil for a period of at least 10 days;

or for 10-20 days with 72-hour intervals between one application and the other.

12. The ozonized olive oil of claim 1, wherein the ozonized olive oil is a component of a pharmaceutical composition comprising the ozonized olive oil and at least one pharmacologically acceptable excipient.

13. The ozonized olive oil of claim 1, wherein the ozonized olive oil is a component of a medical device.

14. The ozonized olive oil of claim 1, wherein the ozonized olive oil is a component of a pharmaceutical composition or a medical device, and wherein said composition or said device is in the form of an ointment, cream, gel, foam, emulsion, or solution.

15. A pharmaceutical composition for gynaecological use, comprising:

an ozonized olive oil comprising a peroxide value of 50 -350 mEq 0₂/Kg comprising at least one liquid vegetable extract selected from among Allium spp., Aloe spp., Calendula officinalis, Cinnamomum spp., Curcuma spp., Lavender spp., Melaleuca spp., Plantago, Salvia officinalis, Salvia miltiorrhiza, Thymus spp., Zingiber spp. and mixtures thereof, wherein the pharmaceutical composition is for use in the topical treatment of bacterial and/or fungal vaginosis and/or vulvovaginitis, wherein the vulvovaginitis is caused by at least one pathogen selected from among fungi belonging to the genus Candida and Gardenerella vaginalis.

16. The ozonized olive oil of claim 1, wherein the at least one liquid vegetable extract comprises at least one essential oil comprising lavender essential oil.

17. The ozonized olive oil of claim 1, further comprising 0.5-2.5% by weight of liquid vegetable extract of lavender essential oil.

18. The ozonized olive oil of claim 7, wherein the ozonized olive oil is configurable for the topical treatment of vulvovaginitis caused by at least one pathogen selected from among Candida albicans, Candida glabrata and Gardenerella vaginalis.

19. A method for topical treatment of bacterial and/or fungal vaginosis and/or vulvovaginitis, comprising:

topically applying an ozonized olive oil to a subject, wherein the ozonized olive oil comprising a peroxide value of 50-350 mEq 0₂/Kg comprising at least one liquid vegetable extract selected from among Allium spp., Aloe spp., Calendula officinalis, Cinnamomum spp., Curcuma spp., Lavender spp., Melaleuca spp., Plantago, Salvia officinalis, Salvia miltiorrhiza, Thymus spp., Zingiber spp. and mixtures thereof; and

treating bacterial and/or fungal vaginosis and/or vulvovaginitis, wherein the vulvovaginitis is caused by at least one pathogen selected from among fungi belonging to the genus Candida and Gardenerella vaginalis.

20. The method of claim 19, further comprising the topical treatment of vulvovaginitis caused by at least one pathogen selected from among Candida albicans, Candida glabrata, and Gardenerella vaginalis.