WO2015087213A1 - Food supplement - Google Patents

Food supplement Download PDF

Info

Publication number
WO2015087213A1
WO2015087213A1 PCT/IB2014/066591 IB2014066591W WO2015087213A1 WO 2015087213 A1 WO2015087213 A1 WO 2015087213A1 IB 2014066591 W IB2014066591 W IB 2014066591W WO 2015087213 A1 WO2015087213 A1 WO 2015087213A1
Authority
WO
WIPO (PCT)
Prior art keywords
weight
food supplement
supplement according
sodium
infections
Prior art date
Application number
PCT/IB2014/066591
Other languages
French (fr)
Inventor
Ettore DE ANGELIS
Original Assignee
De Angelis Ettore
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.)
Filing date
Publication date
Application filed by De Angelis Ettore filed Critical De Angelis Ettore
Priority to EP14830594.9A priority Critical patent/EP3079504A1/en
Publication of WO2015087213A1 publication Critical patent/WO2015087213A1/en

Links

Classifications

    • 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)
    • A61K36/74—Rubiaceae (Madder family)
    • A61K36/746—Morinda
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/175—Amino acids
    • 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
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
    • A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
    • 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
    • A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • the present invention discloses a food supplement, comprising: D-mannose, Morinda citrifolia freeze-dried juice and N-Acetylcysteine (NAC) . It is a further aspect of the present invention the use of said supplement in the prevention and treatment of infections and inflammations of the urinary-gynecologic system.
  • vaginal flora that is found in healthy women hinders the colonization of the vagina by hostile germs. This major defensive function is ascribed to the ability of the bacterial vaginal flora to occupy the possible seats of adhesion of the other microorganisms, to synthetize hydrogen peroxide, having a direct and indirect bactericidal action, to acidify the vaginal environment (pH 4-4.5) .
  • an "abnormal vaginal flora" establishes, to which specific vaginoses are associated, due to Candida or Trichomonas, bacterial vaginoses, characterized by an excessive growth of commensal germs, such as Gardnerella vaginalis, Micoplasma hominis, and a number of species of anaerobes, such as Mobiluncus peptostreptococcus, Bacteroides, Eubacterium species, all of which have a sessile growth, and/or aerobic vaginites, based on a decrease in the physiological vaginal flora, followed by an increase in the aerobic bacteria of mainly intestinal origin (mostly Escherichia coli, Staphilococcus pyogenes, Pseudomonas, Proteus less frequently) .
  • Biofilms are structured communities of bacterial cells, often of different, also fungal, species, embedded in a self- produced polymeric matrix and adhering to an inert or living surface. Recent studies examined the composition and the spatial arrangement of the microbial component associated to the vaginal epithelium, coming to the conclusion that the pathogen agents associated to cystites, bacterial vaginoses, aerobi vaginites, and Candida have a trend to form biofilms.
  • the above-described diseases are dealt with, without achieving decisive results, with a mix of antibiotic therapies, debilitating for the immune system, coming over time to completely compromise the balance of the vaginal bacterial flora, leaving the organism completely without defenses, exposing it to any bacterial attacks, and to the chronicization of the same diseases. Furthermore, the antibiotic therapies generate mutating antibiotic-resistant bacterial strains, giving rise to a vicious cycle, which increasingly worsens the organism that is subjected to such treatments.
  • Italy has been signalled by European Union for antibiotic over-prescription, particularly when managing urinary system infections.
  • composition formulates so as to be able to be administered orally with a high compliance of the patient, able to prevent and treat biofilm-sustained acute and chronic vaginal infections.
  • the present invention discloses a food supplement comprising D-mannose, Morinda citrifolia, N- Acetylcysteine (NAC) .
  • said supplement also comprises an acidity adjusting agent.
  • the preferably freeze-dried juice of said Morinda citrifolia is present.
  • the supplement is formulated in a conventional manner by using one or more pharmaceutically acceptable carriers, including acceptable excipients and vehicles that promote the processing of the active compounds.
  • the supplement can be formulated by combining the active compounds with pharmaceutically acceptable carriers well known in the art.
  • Such carriers allow the supplement of the present invention being formulated as a tablet, pill, powder, granule, lozenge, capsule, liquid, gel, syrup, slurry, suspension and the like, for the oral ingestion by a subject who in need thereof.
  • the capsule, tablet, powder, liquid are preferred, the liquid being particularly useful.
  • Preparations for oral use can be obtained by mixing one or more excipients with the composition of the present invention, optionally grinding the resulting mixture and processing the mixture of granules, after adding suitable auxiliaries, if desired, to obtain tablets or cores for lozenges.
  • Suitable excipients can be fillers, such as sugars, including fructose, lactose, sucrose, mannitol and sorbitol; and cellulose-based substances such as, for example, corn starch, wheat starch, rice starch, potato starch, gelatin, tragacanth gum, methylcellulose, hydroxypropyl methylcellulose, sodium carboxymethylcellulose and/or polyvinylpyrrolidone (PVP) .
  • disintegrating agents such as cross- linked polyvinylpyrrolidone, agar, or alginic acid or a salt thereof, such as sodium alginate, lubricants such as magnesium stearate and carriers such as binders can be added thereto.
  • Oral formulations can include hard gelatin capsules, as well as sealed capsules made of soft gelatin and a plasticizer, such as glycerol or sorbitol.
  • the hard capsules can contain the composition of the present invention in admixture with fillers such as lactose, binders such as starches, and/or lubricants such as talc or magnesium stearate.
  • the active compounds can be dissolved or dispersed in suitable solvents, such as fat acid, liquid paraffin, or liquid polyethylene glycols. Furthermore, stabilizers can be added thereto.
  • compositions for the use claimed herein comprise compositions in which the active components are contained in an efficient amount to achieve the aim thereof. More specifically, an efficient amount means an amount of the composition that is efficient in preventing, alleviating, or improving the symptoms of the disease.
  • the supplement of the present invention comprises:
  • NAC N-Acetylcysteine from 0.1 to 6% weight/weight
  • D-mannose, Morinda citrifolia freeze-dried juice, NAC are present in a weight ratio equal to 5 / 3 / 1.
  • said supplement comprises:
  • D-mannose from 1.5 to 15%, or 2 - 12%, or 3 - 10%, or 4 - 8%, or 4.5 - 7% or about 5% weight/weight;
  • Morinda citrifolia freeze-dried juice from 0.5 8%, 1 - 6%, 2 - 4% or about 3% weight/weight
  • NAC from 0.25 to 5%, or 0.5 - 4%, or 0.75 - 3%, or about 1% weight/weight ;
  • said supplement comprises:
  • N-Acetylcysteine about 1% weight/weight .
  • said supplement also comprises an acidity adjusting agent selected from the group consisting in: sodium maleates, potassium maleate, calcium maleates, sodium adipate, potassium adipate, sodium fumarate, potassium fumarate, calcium fumarate, 1, 4-heptonolactone, niacin, nicotinamide, triammonium citrate, ammonium iron citrate, sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, ammonium carbonate, ammonium bicarbonate, magnesium carbonate, magnesium bicarbonate, sodium glycerophosphate, calcium glycerophosphate.
  • said acidity adjusting agent is sodium bicarbonate.
  • said components are diluted in purified water.
  • said liquid formulation is sweetened with the addition of a natural or synthetic sweetener selected from the group consisting in: molasses, concentrated apple juice, concentrated grapes juice, stevioside, honey, rice syrup, maple, sorghum, agaves juice, sucrose, fructose, glucose, sorbitol, xylitol, mannitol, glycine, lactose, monellin, erythritol, acesulfame K, aspartame, saccharine, sucralose, maltitol, isomalt, cyclamate, neohesperidin dihydrochalcone, naringin dihydrochalcone .
  • said sweetener is fructose.
  • the supplement of the present invention administered orally, surprisingly showed to be efficient in the prevention and treatment of urinary-gynecologic irritations and infections.
  • the supplement of the present invention showed to be efficient in protecting and restoring the physiological vaginal flora.
  • the supplement of the present invention surprisingly showed to be able to block the adhesion of the bacterial cells onto the epithelial vaginal surface, to prevent the microbial growth, inhibit the spreading of the pathogens and disintegrating the polysaccharide matrices already formed of the biofilm. Therefore, the supplement of the present invention is useful in the treatment and prevention of relapses of the specific vaginoses, the bacterial vaginoses, and the aerobic vaginites.
  • the use of the supplement of the present invention showed to be capable of preventing and eliminating the microbial co-aggregation, hindering the exchange of intercellular information, preventing the formation of the polymeric matrix biofilm produced by structured communities of bacterial and/or fungal cells (often of different species), of acting on the so-called persisting cells, contrasting the intracellular bacterial communities IBCs and the corresponding quiescent intracellular reserves, insensitive to antibiotics and the normal immune response.
  • the supplement of the present invention by preventing and eliminating the microbial co-aggregation, prevents the biofilm formation or results in a disintegration.
  • the bacteria remaining without the protection provided by the biofilm, in the presence of the composition of the present invention lose their adhesive ability, whereby they will be eliminated by the urine.
  • persisting cells are meant those cells that survive the antimicrobial treatments that kill most of the genetically identical cells. In fact, said cells have entered a state of extremely slow physiological growth, which makes them insensitive (refractory or tolerant) to the action of antimicrobial drugs. When these persisting microbial cells are not eliminated by the immune system, they compose a reservoir from which a relapse of the infection will develop, thus triggering a persisting inoculation cycle.
  • the use of the supplement of the present invention showed to be also capable of stopping the persisting inoculation cycle, causing new colonization sites in the body, and gives rise to the so-called antibiotic- resistant poly-microbial infections, all of which have a sessile growth and with a trend to chronicization .
  • the supplement of the present invention hinders the aggression by Candida Albicans, Escherichia Coli, and other bacteria.
  • Morinda citrifolia D- mannose, and NAC makes efficient and unique this formulation for the treatment and prevention of the relapses of all types of vaginites, ascending cystites, for the prevention of the sexually-transmitted diseases and the obstetrical complications.
  • the supplement of the present invention allows dealing with urinary system diseases resulting from microbial, poly-microbial, and/or fungal infections, with a trend to chronicization, without using antibiotics, preserving the functionality, health, efficiency and balance of the urinary-gynecologic system on the whole.

Abstract

The present invention discloses a food supplement comprising: D-mannose, Morinda citrifolia freeze-dried juice, and N-Acetylcysteine (NAC). A further aspect of the present invention is the use of said supplement in the prevention and treatment of infections and inflammations of the urinary-gynecologic system.

Description

FOOD SUPPLEMENT
Description
The present invention discloses a food supplement, comprising: D-mannose, Morinda citrifolia freeze-dried juice and N-Acetylcysteine (NAC) . It is a further aspect of the present invention the use of said supplement in the prevention and treatment of infections and inflammations of the urinary-gynecologic system.
Background of the art
The vaginal flora that is found in healthy women hinders the colonization of the vagina by hostile germs. This major defensive function is ascribed to the ability of the bacterial vaginal flora to occupy the possible seats of adhesion of the other microorganisms, to synthetize hydrogen peroxide, having a direct and indirect bactericidal action, to acidify the vaginal environment (pH 4-4.5) .
When lacks or alterations in the physiology of the vaginal flora are found, an "abnormal vaginal flora" establishes, to which specific vaginoses are associated, due to Candida or Trichomonas, bacterial vaginoses, characterized by an excessive growth of commensal germs, such as Gardnerella vaginalis, Micoplasma hominis, and a number of species of anaerobes, such as Mobiluncus peptostreptococcus, Bacteroides, Eubacterium species, all of which have a sessile growth, and/or aerobic vaginites, based on a decrease in the physiological vaginal flora, followed by an increase in the aerobic bacteria of mainly intestinal origin (mostly Escherichia coli, Staphilococcus pyogenes, Pseudomonas, Proteus less frequently) .
Recent studies pointed out that that aerobic vaginitis, together with bacterial vaginosis, account for about 70% of all vaginitis, and furthermore, that these two pathological forms may co-exist.
According to a study performed by the Atlanta Centers for Disease Control and Prevention (CDC) , up to 80% of bacterial infections that are found in the western countries are to be ascribed to biofilms. Biofilms are structured communities of bacterial cells, often of different, also fungal, species, embedded in a self- produced polymeric matrix and adhering to an inert or living surface. Recent studies examined the composition and the spatial arrangement of the microbial component associated to the vaginal epithelium, coming to the conclusion that the pathogen agents associated to cystites, bacterial vaginoses, aerobi vaginites, and Candida have a trend to form biofilms. This massive role of the biofilms in vaginal diseases underlies the absent or incomplete response to antibiotics and antifungals, and the high presence of morbid recidivating urinary- gynecologic forms that are antibiotic-resistant and with a trend to chronicization observed. The presence of biofilms is followed by a slower and more reduced penetration of antibiotics; a higher conjugation frequency between bacteria, which promotes the exchange of plasmids containing genes coding for multiple antibiotic resistances; the onset of antibiotic-resistant bacterial phenotypes, due to the lack of oxygen and nutrients in the areas farthest from the biofilm surface; an antagonist activity of microbial catabolites which, by interacting with the antibiotic molecules, neutralize their activity. Furthermore, the release of single bacteria and aggregates (mono- and multi-species) from a mature biofilm acts as a persisting inoculum, promoting new colonization sites in the body, and giving rise to the so-called antibiotic- resistant poly-microbial infections with a sessile growth and a trend to chronicization . In fact, the reports of mixed infections on poly-microbial biofilms, which are composed of both aerobic and anaerobic bacterial species, and of fungal species, which create considerable therapeutic problems are increasing.
Generally, the above-described diseases are dealt with, without achieving decisive results, with a mix of antibiotic therapies, debilitating for the immune system, coming over time to completely compromise the balance of the vaginal bacterial flora, leaving the organism completely without defenses, exposing it to any bacterial attacks, and to the chronicization of the same diseases. Furthermore, the antibiotic therapies generate mutating antibiotic-resistant bacterial strains, giving rise to a vicious cycle, which increasingly worsens the organism that is subjected to such treatments.
Particularly, Italy has been signalled by European Union for antibiotic over-prescription, particularly when managing urinary system infections.
In order to overcome the problems illustrated above, the need is strongly felt for a composition formulates so as to be able to be administered orally with a high compliance of the patient, able to prevent and treat biofilm-sustained acute and chronic vaginal infections. Description of the invention
The present invention discloses a food supplement comprising D-mannose, Morinda citrifolia, N- Acetylcysteine (NAC) .
In a further embodiment, said supplement also comprises an acidity adjusting agent.
In a preferred embodiment, the preferably freeze-dried juice of said Morinda citrifolia is present.
The supplement is formulated in a conventional manner by using one or more pharmaceutically acceptable carriers, including acceptable excipients and vehicles that promote the processing of the active compounds.
The supplement can be formulated by combining the active compounds with pharmaceutically acceptable carriers well known in the art. Such carriers allow the supplement of the present invention being formulated as a tablet, pill, powder, granule, lozenge, capsule, liquid, gel, syrup, slurry, suspension and the like, for the oral ingestion by a subject who in need thereof. The capsule, tablet, powder, liquid are preferred, the liquid being particularly useful. Preparations for oral use can be obtained by mixing one or more excipients with the composition of the present invention, optionally grinding the resulting mixture and processing the mixture of granules, after adding suitable auxiliaries, if desired, to obtain tablets or cores for lozenges. Suitable excipients can be fillers, such as sugars, including fructose, lactose, sucrose, mannitol and sorbitol; and cellulose-based substances such as, for example, corn starch, wheat starch, rice starch, potato starch, gelatin, tragacanth gum, methylcellulose, hydroxypropyl methylcellulose, sodium carboxymethylcellulose and/or polyvinylpyrrolidone (PVP) . If desired, disintegrating agents, such as cross- linked polyvinylpyrrolidone, agar, or alginic acid or a salt thereof, such as sodium alginate, lubricants such as magnesium stearate and carriers such as binders can be added thereto.
Oral formulations can include hard gelatin capsules, as well as sealed capsules made of soft gelatin and a plasticizer, such as glycerol or sorbitol. The hard capsules can contain the composition of the present invention in admixture with fillers such as lactose, binders such as starches, and/or lubricants such as talc or magnesium stearate. In the soft capsules, the active compounds can be dissolved or dispersed in suitable solvents, such as fat acid, liquid paraffin, or liquid polyethylene glycols. Furthermore, stabilizers can be added thereto.
The use of said supplement and of formulations containing it for the prevention and treatment of urinary-gynecologic inflammations and infections is also claimed .
Suitable compositions for the use claimed herein comprise compositions in which the active components are contained in an efficient amount to achieve the aim thereof. More specifically, an efficient amount means an amount of the composition that is efficient in preventing, alleviating, or improving the symptoms of the disease.
In an embodiment, the supplement of the present invention comprises:
D-mannose from 1 to 20% weight/weight
Morinda citrifolia freeze-dried juice from 0.1 to
10% weight/weight
N-Acetylcysteine (NAC) from 0.1 to 6% weight/weight Preferably, D-mannose, Morinda citrifolia freeze-dried juice, NAC are present in a weight ratio equal to 5 / 3 / 1. More preferably, said supplement comprises:
D-mannose from 1.5 to 15%, or 2 - 12%, or 3 - 10%, or 4 - 8%, or 4.5 - 7% or about 5% weight/weight; Morinda citrifolia freeze-dried juice from 0.5 8%, 1 - 6%, 2 - 4% or about 3% weight/weight
NACfrom 0.25 to 5%, or 0.5 - 4%, or 0.75 - 3%, or about 1% weight/weight ;
In a preferred embodiment, said supplement comprises:
D-mannose about 5% weight/weight;
Morinda citrifolia freeze-dried juice about 3% weight/weight ;
N-Acetylcysteine about 1% weight/weight .
In a further embodiment, said supplement also comprises an acidity adjusting agent selected from the group consisting in: sodium maleates, potassium maleate, calcium maleates, sodium adipate, potassium adipate, sodium fumarate, potassium fumarate, calcium fumarate, 1, 4-heptonolactone, niacin, nicotinamide, triammonium citrate, ammonium iron citrate, sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, ammonium carbonate, ammonium bicarbonate, magnesium carbonate, magnesium bicarbonate, sodium glycerophosphate, calcium glycerophosphate. Preferably, said acidity adjusting agent is sodium bicarbonate. Where the supplement of the present invention is formulated in a liquid formulation to be administered orally, said components are diluted in purified water. Preferably, said liquid formulation is sweetened with the addition of a natural or synthetic sweetener selected from the group consisting in: molasses, concentrated apple juice, concentrated grapes juice, stevioside, honey, rice syrup, maple, sorghum, agaves juice, sucrose, fructose, glucose, sorbitol, xylitol, mannitol, glycine, lactose, monellin, erythritol, acesulfame K, aspartame, saccharine, sucralose, maltitol, isomalt, cyclamate, neohesperidin dihydrochalcone, naringin dihydrochalcone . Preferably, said sweetener is fructose.
The supplement of the present invention, administered orally, surprisingly showed to be efficient in the prevention and treatment of urinary-gynecologic irritations and infections.
The supplement of the present invention showed to be efficient in protecting and restoring the physiological vaginal flora.
The supplement of the present invention surprisingly showed to be able to block the adhesion of the bacterial cells onto the epithelial vaginal surface, to prevent the microbial growth, inhibit the spreading of the pathogens and disintegrating the polysaccharide matrices already formed of the biofilm. Therefore, the supplement of the present invention is useful in the treatment and prevention of relapses of the specific vaginoses, the bacterial vaginoses, and the aerobic vaginites.
Particularly, the use of the supplement of the present invention showed to be capable of preventing and eliminating the microbial co-aggregation, hindering the exchange of intercellular information, preventing the formation of the polymeric matrix biofilm produced by structured communities of bacterial and/or fungal cells (often of different species), of acting on the so-called persisting cells, contrasting the intracellular bacterial communities IBCs and the corresponding quiescent intracellular reserves, insensitive to antibiotics and the normal immune response.
The supplement of the present invention, by preventing and eliminating the microbial co-aggregation, prevents the biofilm formation or results in a disintegration. The bacteria, remaining without the protection provided by the biofilm, in the presence of the composition of the present invention lose their adhesive ability, whereby they will be eliminated by the urine.
By the term "persisting cells" is meant those cells that survive the antimicrobial treatments that kill most of the genetically identical cells. In fact, said cells have entered a state of extremely slow physiological growth, which makes them insensitive (refractory or tolerant) to the action of antimicrobial drugs. When these persisting microbial cells are not eliminated by the immune system, they compose a reservoir from which a relapse of the infection will develop, thus triggering a persisting inoculation cycle.
The use of the supplement of the present invention showed to be also capable of stopping the persisting inoculation cycle, causing new colonization sites in the body, and gives rise to the so-called antibiotic- resistant poly-microbial infections, all of which have a sessile growth and with a trend to chronicization .
The supplement of the present invention hinders the aggression by Candida Albicans, Escherichia Coli, and other bacteria.
The surprising results obtained by the use of the supplement of the present invention are made possible by a synergy that is generated between D-mannose, Morinda citrifolia, and NA'C, and the response which they promote in contact with the colonizing pathogenic organisms.
Particularly, the association of Morinda citrifolia, D- mannose, and NAC makes efficient and unique this formulation for the treatment and prevention of the relapses of all types of vaginites, ascending cystites, for the prevention of the sexually-transmitted diseases and the obstetrical complications.
The supplement of the present invention allows dealing with urinary system diseases resulting from microbial, poly-microbial, and/or fungal infections, with a trend to chronicization, without using antibiotics, preserving the functionality, health, efficiency and balance of the urinary-gynecologic system on the whole.

Claims

1. A food supplement, comprising:
D-mannose from 1 to 20% weight/weight
Morinda citrifolia freeze-dried juice from 0.1 to 10% weight/weight
N-Acetylcysteine (NAC) from 0.1 to 6% weight/weight.
2. The food supplement according to claim 1, comprising: D-mannose from 1.5 to 15%, or 2 - 12%, or 3 - 10%, or 4 - 8%, or 4.5 - 7%, or about 5% weight/weight;
Morinda citrifolia freeze-dried juice from 0.5 - 8%, 1 - 6%, 2 - 4%, or about 3% weight/weight
NAC from 0.25 to 5%, or 0.5 - 4%, or 0.75 - 3%, or about 1% weight/weight.
3. The food supplement according to claim 1 or 2, comprising:
D-mannose about 5% weight/weight;
Morinda citrifolia freeze-dried juice about 3% weight/weight ;
N-Acetylcysteine about 1% weight/weight .
4. The food supplement according to one of the claims from 1 or 3, where D-mannose, Morinda citrifolia freeze- dried juice, and NAC are present in a weight ratio equal to 5/ 3 / 1, respectively.
5. The food supplement according to one of the claims 1 to 4, also comprising an acidity adjusting agent, preferably selected from the group consisting in: sodium maleates, potassium maleate, calcium maleates, sodium adipate, potassium adipate, sodium fumarate, potassium fumarate, calcium fumarate, 1, 4-heptonolactone, niacin, nicotinamide, triammonium citrate, ammonium iron citrate, sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, ammonium carbonate, ammonium bicarbonate, magnesium carbonate, magnesium bicarbonate, sodium glycerophosphate, calcium glycerophosphate .
6. A formulation in the form of a tablet, pill, powder, granule, lozenge, capsule, liquid, gel, syrup, slurry, or suspension, comprising the supplement according to one of the claims 1 to 5, and pharmaceutically acceptable excipients.
7. The use of the food supplement according to one of the claims 1 to 5 for the prevention and treatment of urinary-gynecologic irritations and infections.
8. The use of the food supplement according to claim 7, where said infections are microbial, poly-microbial, and/or fungal infections.
9. The use of the food supplement according to claim 7, where said infections are vaginites, ascending cystites, sexually-transmitted diseases, obstetrical complications .
10. The use of the food supplement according to one of the claims 7 to 9, where said infections have persisting cells .
PCT/IB2014/066591 2013-12-13 2014-12-04 Food supplement WO2015087213A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP14830594.9A EP3079504A1 (en) 2013-12-13 2014-12-04 Food supplement

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT002087A ITMI20132087A1 (en) 2013-12-13 2013-12-13 DIETARY SUPPLEMENT
ITMI2013A002087 2013-12-13

Publications (1)

Publication Number Publication Date
WO2015087213A1 true WO2015087213A1 (en) 2015-06-18

Family

ID=50115989

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2014/066591 WO2015087213A1 (en) 2013-12-13 2014-12-04 Food supplement

Country Status (3)

Country Link
EP (1) EP3079504A1 (en)
IT (1) ITMI20132087A1 (en)
WO (1) WO2015087213A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115634205A (en) * 2022-11-18 2023-01-24 湖南九典制药股份有限公司 Acetylcysteine granules and preparation method thereof

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060073156A1 (en) * 2002-09-04 2006-04-06 Zambon Group S.P.A. Fosfomycin and n-acetylcysteine for the treatment of biofilms caused by escheric ia coli and other pathogens of the urinary tract
US20060159788A1 (en) * 2002-11-14 2006-07-20 Brett West Method and formulation for treating Candidiasis using Morinda citrifolia
US20110064706A1 (en) * 2008-01-11 2011-03-17 U.S. Nutraceuticals, Llc D/B/A Valensa International Method of preventing, controlling and ameliorating urinary tract infections and supporting digestive health by using a synergistic cranberry derivative, a d-mannose composition and a proprietary probiotic blend

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060073156A1 (en) * 2002-09-04 2006-04-06 Zambon Group S.P.A. Fosfomycin and n-acetylcysteine for the treatment of biofilms caused by escheric ia coli and other pathogens of the urinary tract
US20060159788A1 (en) * 2002-11-14 2006-07-20 Brett West Method and formulation for treating Candidiasis using Morinda citrifolia
US20110064706A1 (en) * 2008-01-11 2011-03-17 U.S. Nutraceuticals, Llc D/B/A Valensa International Method of preventing, controlling and ameliorating urinary tract infections and supporting digestive health by using a synergistic cranberry derivative, a d-mannose composition and a proprietary probiotic blend

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
ANONYMOUS: "Ausilium Lavanda", INTERNET CITATION, 22 March 2012 (2012-03-22), pages 1 - 2, XP002720395, Retrieved from the Internet <URL:http://web.archive.org/web/20120322111244/http://www.deakos.com/prodotto.php?tid=53> [retrieved on 20140217] *
CESARE MARIA NAVA ET AL: "Trattamento e prevenzione delle recidive delle vaginiti", M.D. MEDICINAE DOCTOR, 15 June 2013 (2013-06-15), pages 26 - 29, XP055102517, Retrieved from the Internet <URL:http://www.passonieditore.it/md/08/Esperienze.pdf> [retrieved on 20140217] *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115634205A (en) * 2022-11-18 2023-01-24 湖南九典制药股份有限公司 Acetylcysteine granules and preparation method thereof

Also Published As

Publication number Publication date
EP3079504A1 (en) 2016-10-19
ITMI20132087A1 (en) 2015-06-14

Similar Documents

Publication Publication Date Title
ES2676168T3 (en) Procedures to treat gastrointestinal diseases
EP2070530B1 (en) Treatment of diseases associated with the use of antibiotics
CA2590995A1 (en) Composition for prophylaxis or treatment of urinary system infection and method thereof
US20130046019A1 (en) Methods of Treatment Using 3-Bromopyruvate and Other Selective Inhibitors of ATP Production
KR102227117B1 (en) Use of 2,3,5-Substituted Thiophene Compound for Prevention, Improvement or Treatment of Breast Cancer
US20140154317A1 (en) Pharmaceutical Composition for Treatment of Helicobacter Pylori Associated Diseases
WO2015087213A1 (en) Food supplement
EP2329819B1 (en) Pharmaceutical composition for use in treating sexually transmitted infections
CN1438032A (en) Compound preparation for dissolving staphyloase and preparation method
CN101669959A (en) Medical composite for treating livestock and poultry intestinal canal diseases and preparation method and application thereof
CN105106147A (en) Pemirolast potassium tablet and production technology thereof
CN101756924B (en) Sustained-release tablets of faropenem sodium
US7811609B2 (en) Use of metal compounds to treat gastrointestinal infections
CN103153304A (en) Compositions for treating helicobacter pylori infection
US20150157653A1 (en) Prevention of Clostridium Difficile Infection in High Risk Patients
CN102526100B (en) Pharmaceutical composition containing lappaconitine and iodine
US20170071887A1 (en) Method for applying metformin and sodium butyrate in k-ras mutation cancer treatment
Ruanguan et al. Antibiotic therapy for typhoid fever
KR102038866B1 (en) Use of PPARδ Agonists as Antibiotics, Therapeutics for Treatment of Burns, Wounds and Diabetic Ulcers
CN1310645C (en) Bacteriostasis antiinflammation pain-stopping pharmaceutical composition and application thereof
US20230022880A1 (en) Antimicrobial Composition
CN105878263A (en) Medicine composition containing malic acid clebopride malate and application thereof
CN1290549C (en) Composite medicine for treating throat diseases
CN1582938A (en) Vaginal effervescent tablets of ofloxacin
CN116898862A (en) Antibacterial composition, antibacterial drug and application

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 14830594

Country of ref document: EP

Kind code of ref document: A1

REEP Request for entry into the european phase

Ref document number: 2014830594

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: 2014830594

Country of ref document: EP

NENP Non-entry into the national phase

Ref country code: DE