Classifications

• • 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
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• • 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
  • A61K36/06—Fungi, e.g. yeasts
  • A61K36/062—Ascomycota
  • A61K36/064—Saccharomycetales, e.g. baker's yeast
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
  • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
  • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
  • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
  • A61K8/37—Esters of carboxylic acids
  • A61K8/375—Esters of carboxylic acids the alcohol moiety containing more than one hydroxy group
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
  • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
  • A61K8/9728—Fungi, e.g. yeasts
• • 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
  • A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
• • 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
  • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
  • A61P31/10—Antimycotics
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
  • A61Q19/00—Preparations for care of the skin
  • A61Q19/005—Preparations for sensitive skin

Definitions

• the present invention relates to a composition useful for the preparation of an egg, as well as a medical device, a drug, or a cosmetic product comprising it.
• Vulvovaginal infections are low genital infections affecting the vulva and / or vagina. They are manifested by irritation, itching, pain and abnormal vaginal discharge. These infections are very common. This is indeed the most common cause of medical consultation in women.
• Vulvovaginal infections are mainly of bacterial or mycotic origin, with parasitic infections, mainly Trichomonas, accounting for only about 10% of these infections.
• Vulvovaginal bacterial infections account for about 50 to 60% of all infections of the vulva and vagina. The most common infections in these infections are Gardnerella vaginalis, Gardnerella mobiluncus, Chlamydia trachomatis, Mycoplasma hominis, Peptostreptococcus species and Ureaplasma urealyticum.
• Mycotic vulvovaginal infections are mainly candidiasis.
• Bacterial and parasitic infections are mainly treated with antibiotics / antiparasitic agents of the nitroimidazole family, such as metronidazole, whereas mycotic infections are usually treated with antifungal agents of the imidazole family, such as econazole, miconazole or fluconazole.
• the present invention stems from the unexpected finding by the inventors that it was possible to formulate eggs from a mixture of lyophilized Saccharomyces boulardii yeast cells and wax and that these eggs were able to release cells.
• live S. vagardii yeast in the vaginal mucosa which helps to fight against vulvovaginal infections, including the secretion of capric acid.
• antibiotic treatments for vulvovaginal infections usually result in depletion of the protective vaginal flora, which promotes recurrence and re-infection.
• the use of ovules according to the invention in the context of antibiotic therapy therefore limits the risk of recurrence or reinfection that would be related to an imbalance of the saprophytic flora.
• the present invention relates to a composition
• a composition comprising, or consisting of, a mixture of yeast Saccharomyces boulardii cells and a wax.
• the present invention also relates to a medical device, a medicament or a cosmetic product comprising, or consisting of, a composition as defined above.
• the invention relates to the medical device or the medicament as defined above, for its use as an ovum, for its use in the prevention or treatment of vulvovaginal infections or for its use in the rebalancing of the vaginal flora, especially after treatment with a local or systemic anti-infective, and / or to help consolidate the healing after taking a local vaginal anti-infective treatment, and / or to prevent recurrences vaginal infections.
• the present invention also relates to the use of a composition as defined above for the preparation of an egg, a medicament or a medical device intended for the prevention or treatment of vulvovaginal infections, or intended for the rebalancing of the vaginal flora, in particular after treatment with a local or systemic anti-infective, and / or to help to consolidate healing after taking local vaginal anti-infective therapy, and / or preventing recurrence of vaginal infections.
• the present invention also relates to the cosmetic use of a composition as defined above or a cosmetic product as defined above for the intimate hygiene or personal hygiene of an individual.
• the present invention also relates to a method for preventing or treating a vulvovaginal infection in an individual, as well as a method for rebalancing the vaginal flora, especially after treatment with a local or systemic anti-infective, and / or to help consolidate healing after taking a local vaginal anti-infective treatment, and / or to prevent recurrence of vaginal infections in an individual, in which the individual is administered a composition as defined above , in particular in a prophylactically or therapeutically effective amount.
• the present invention also relates to a method of intimate hygiene or personal hygiene of an individual, wherein the individual is administered a composition as defined above or a cosmetic product as defined above, in particular in a cosmetically effective amount.
• the present invention also relates to a process for obtaining a composition as defined above, comprising the following steps:
• the wax is maintained in the liquid state at a temperature below 42 ° C. and Saccharomyces boulardii yeast cells are added with stirring;
• the mixture is allowed to cool with stirring while maintaining it liquid until a temperature of less than 36 ° C .;
• the mixture is poured into a mold
• the mixture is demolded after solidification.
• the term “comprising” means “including”, “containing” or “encompassing”, that is to say that when an object “includes” one or more elements, other elements that those mentioned can also be included in the object.
• the expression “consisting of” means “consisting of”, that is, when an object "consists of In one or more elements, the object can not include other elements than those mentioned.
• Saccharomyces boulardii is a yeast well known to those skilled in the art. It is especially described in Hennequin et al. (2001) J. Clin. Microbiol. 39: 551-559. As used herein, the nomenclatures "Saccharomyces boulardii” and “Saccharomyces cerevisiae var boulardii” (abbreviated S. cerevisiae var boulardii) are considered equivalent.
• yeast Saccharomyces boulardii cells according to the invention are obtained from pharmaceutical products of Bioflor® brand, Bioflora®, Codex®, Econorm®, Enflor®, Enterol®, Florastor®, Floratil®, Florestor®, Inteflora ®, Perenterol®, Perenteryl®, Precosa®, Reflor®, Ultra-Levura® or Ultra-Levure®.
• the yeast Saccharomyces boulardii cells according to the invention can also be identical to the deposit made with the American Type Culture Collection (ATCC, USA) under the reference 7401 2, from the National Collection of Culture and Microorganisms (CNCM, Pasteur Institute, France) under the reference 1-745 or from the Centraalbureau voor Schimmelcultures (CBS, The Netherlands) under the reference Hansen CBS 5926.
• ATCC American Type Culture Collection
• CCM National Collection of Culture and Microorganisms
• CBS Centraalbureau voor Schimmelcultures
• yeast Saccharomyces boulardii cells according to the invention are mixed with the wax in powder form, in particular freeze-dried form.
• the viability or vitality of yeast Saccharomyces boulardii cells derived from lyophilizates is greater than that obtainable with other methods of preserving yeast cells, such as drying, for example.
• lyophilization is a preservation process in which live Saccharomyces boulardii yeast cells are frozen and are then sublimated with the frozen water they contain to yield a lyophilisate in the form of a dry yeast powder preferably containing less than 2% water and more preferably less than 1% water.
• lyophilized Saccharomyces boulardii yeast cells are obtained from concentrated cells.
• Many freeze-drying methods well known to those skilled in the art can be used to produce lyophilized Saccharomyces boulardii yeast cells according to the invention.
• Saccharomyces boulardii yeast cells according to the invention are lyophilized using the following lyophilization process:
• yeast Saccharomyces boulardii cells are cultured in a liquid culture medium until the cells reach a stationary phase; the yeast cells Saccharomyces boulardii are concentrated and the concentrate is frozen, optionally in the presence of a cryoprotectant, such as lactose;
• the concentrate is lyophilized.
• the lyophilized Saccharomyces boulardii yeast cells are in the form of a powder.
• Saccharomyces boulardii is the only probiotic included in the mixture, the composition, the drug, the medical device or the cosmetic product according to the invention.
• no other probiotic such as bacteria of the genus Lactobacillus, in particular L. rhamnosus, L. fermentum, L. crispatus, L. jensinii or L. gasseri, of the genus Enterococcus, in particular Enterococcus faecium, or yeasts of the genus Saccharomyces genus, especially S. cerevisiae, is present in the mixture, the composition, the drug, the medical device or the cosmetic product.
• a "probiotic” refers to a living (or revivable) microorganism, such as a bacterium or yeast, which when administered in an adequate amount, provides a beneficial effect on the health of the individual to whom it is administered.
• the mixture according to the invention comprises from 1.5 ⁇ 10 9 to 2.5 ⁇ 10 10 , in particular from 2 ⁇ 10 9 to 2 ⁇ 10 10 , Colony Forming Units (CFU) of Saccharomyces yeast cells. boulardii.
• CFU Colony Forming Units
• the mixture according to the invention comprises, or consists of, 15 to 35% (w / w) of yeast Saccharomyces boulardii cells in powder form, in particular lyophilized form.
• Wax 15 to 35% (w / w) of yeast Saccharomyces boulardii cells in powder form, in particular lyophilized form.
• the term "wax” refers to a composition based on one or more esters of an alcohol, especially glycerol, and fatty acids, which is solid at room temperature (18-23 ° C. ).
• the wax according to the invention is based on "hard fat", within the meaning of the European Pharmacopoeia (Ph.Eur.), Namely a mixture of triglycerides, diglycerides and monoglycerides, which can in particular be obtained either by the esterification of glycerol by fatty acids of natural origin, or by transesterification of natural fats.
• the fatty acids according to the invention are saturated or unsaturated, preferably saturated.
• the fatty acids according to the invention preferably comprise at least 8 carbon atoms (C8) or at least 12 carbon atoms (Cl 2).
• the fatty acids according to the invention comprise at most 18 carbon atoms (Cl 8).
• the wax according to the invention comprises or is based on triglycerides, especially saturated.
• the invention comprises or is based on saturated C8-C18 or C12-C18 triglycerides.
• the wax according to the invention may comprise additives, such as at least one lubricant or at least one emulsifier, in particular selected from the group consisting of glycerol monoricinoleate, a polyethylene glycol monocetyl ether, in particular the Ceteth-20, polyethylene glycol monostearic ether, especially Steareth-20, and lecithin.
• additives such as at least one lubricant or at least one emulsifier, in particular selected from the group consisting of glycerol monoricinoleate, a polyethylene glycol monocetyl ether, in particular the Ceteth-20, polyethylene glycol monostearic ether, especially Steareth-20, and lecithin.
• the wax according to the invention has a melting point of greater than 32 ° C. Also preferably, the wax according to the invention has a melting point below 37 ° C. More preferably, the wax of the invention has a melting point of greater than 32 ° C and less than 37 ° C.
• the melting point is preferably measured under normal pressure.
• a normal pressure is a pressure of 1 bar.
• the wax according to the invention is selected from the group consisting of SUPPOCIRE® NA PASTILLES (Gattefossé), OVUCIRE® 3460 PASTILLES (Gattefossé) and SUPPOCIRE® AML PASTILLES (Gattefossé).
• the wax according to the invention has a relative humidity of 20% to 35% before mixing.
• the mixture according to the invention has a melting point greater than 32 ° C. Also preferably, the mixture according to the invention has a melting point less than 37 ° C. More preferably, the mixture according to the invention has a melting point of greater than 32 ° C and less than 37 ° C.
• the melting point is preferably measured under normal pressure.
• a normal pressure is a pressure of 1 bar.
• the mixture according to the invention has a liquefaction time of less than 10 min. in water at 37 ° C.
• the mixture according to the invention has a breaking strength greater than 5.4 kg at a temperature of 23 ° C.
• the mixture according to the invention comprises, or consists of, 15 to 35% (w / w) of yeast Saccharomyces boulordii cells in powder form, in particular lyophilized, and from 65 to 85% (w / w). ) of wax according to the invention. More preferably, the mixture according to the invention comprises, or consists of, 30% (m / m) of yeast Saccharomyces boulardii cells in powder form, in particular freeze-dried form, and 70% (m / m) of wax according to US Pat. invention.
• the composition, in particular pharmaceutical, according to the invention, the medical device according to the invention, the drug according to the invention or the cosmetic product according to the invention comprises, or consists of, mixing into a unit mass of 1 g at 5 g, especially about or exactly 2 g.
• the pharmaceutical composition according to the invention, the medical device according to the invention, the medicament according to the invention or the cosmetic product according to the invention comprises a unit mass of 0.15 g to 1, 75 g, in particular from 0.3 to 0.7 g, of yeast Saccharomyces boulardii cells in powder form, in particular lyophilized form. More preferably, the pharmaceutical composition according to the invention, the medical device according to the invention, the medicinal product according to the invention or the cosmetic product according to the invention, comprises a unit mass of 0.6 g, yeast Saccharomyces boulardii in powder form, especially lyophilized. applications
• the composition according to the invention may be a pharmaceutical composition.
• the pharmaceutical composition may comprise one or more pharmaceutically acceptable excipients or carriers in addition to the mixture.
• the vulvovaginal infections according to the invention are infections of the vulva and / or the vagina.
• the vulvovaginal infections according to the invention may be infections:
• Gardnerella vaginalis Gardnerella mobiluncus, Chlamydia trachomatis, Mycoplasma hominis, Peptostreptococcus species
• Trichomonas including Trichomonas.
• the anti-infectives according to the invention may in particular be:
• antibiotics especially from the family of nitroimidazoles, such as metodinazole;
• antifungals in particular from the family of imidazoles, such as econazole, miconazole or fluconazole; or
• antiparasitic agents in particular from the family of nitroimidazoles, such as metodinazole;
• rebalancing of vaginal flora refers to the restoration of normal or healthy vaginal flora, particularly in terms of the diversity and amount of vaginal microorganisms.
• composition according to the invention may be a cosmetic composition.
• the cosmetic composition may comprise one or more cosmetically acceptable excipients or vehicles in addition to the mixture.
• the cosmetic product according to the invention may comprise one or more cosmetically acceptable excipients or vehicles in addition to the composition according to the invention.
• the intimate hygiene or the private toilet designates the toilet of the vulva and / or the vagina.
• the pharmaceutical composition according to the invention, the medical device according to the invention, the drug according to the invention or the cosmetic product according to the invention is administered by the vaginal route, in particular in the form of an egg.
• ovum is considered equivalent to “vaginal ovum” or “gynecological ovum”.
• the individual according to the invention is a mammal, more preferably a human, in particular a female.
• Example 1 a mammal, more preferably a human, in particular a female.
• SUPPOCIRE® containing an egg / suppository at low
• AML PASTILLES phospholipid hydroxyl number (6 mg
• the yeast used is Saccharomyces boulardii in freeze-dried powder form (Ultra-Levure®, Biocodex, Lot 7316).
• the suppository mass is heated to 55 ° C until complete fusion.
• the mixture is poured into a 2 g ruler mold (the ideal egg casting temperature was determined from a thermo-rheogram of the mixture made with a Rheomat apparatus 1 1 5 (LabMakelaar Benelux BV)).
• the eggs are cooled to room temperature for 4 minutes.
• This method determines the temperature at which the egg becomes sufficiently liquid to slip into a U - shaped capillary tube (1.5 mm ID). This method is a simple and reliable way to compare egg melting points. This melting point must be below 37 ° C. Three eggs are tested per lot.
• This method determines the breaking strength of eggs.
• the value defined corresponds to the mass needed to generate their overwriting.
• the egg is positioned on a jaw and connected to a rod on which are added successively weights. The force exerted on the egg is increased until the egg is crushed. Eggs must be able to withstand a weight of at least 1800-2000 g. Five eggs are tested per lot.

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• Gynecology & Obstetrics (AREA)
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• 2016
  • 2016-04-27 FR FR1670198A patent/FR3050641B1/fr active Active
• 2017
  • 2017-04-27 KR KR1020187034309A patent/KR20190016949A/ko not_active IP Right Cessation
  • 2017-04-27 WO PCT/EP2017/060123 patent/WO2017186877A1/fr active Application Filing
  • 2017-04-27 MX MX2018013194A patent/MX2018013194A/es unknown
  • 2017-04-27 EP EP17725173.3A patent/EP3448403A1/de active Pending
  • 2017-04-27 RU RU2018141418A patent/RU2018141418A/ru not_active Application Discontinuation
  • 2017-04-27 US US16/173,536 patent/US20190142745A1/en not_active Abandoned
  • 2017-04-27 CA CA3022447A patent/CA3022447A1/fr active Pending
  • 2017-04-27 CN CN201780031646.8A patent/CN109195615A/zh active Pending

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