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WO2008018111A2 - Composition contenant de la canneberge (vaccinium macrocarpon) et de la lactoferrine pour la prévention et le traitement d'infections urinaires - Google Patents

Composition contenant de la canneberge (vaccinium macrocarpon) et de la lactoferrine pour la prévention et le traitement d'infections urinaires Download PDF

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Publication number
WO2008018111A2
WO2008018111A2 PCT/IT2007/000578 IT2007000578W WO2008018111A2 WO 2008018111 A2 WO2008018111 A2 WO 2008018111A2 IT 2007000578 W IT2007000578 W IT 2007000578W WO 2008018111 A2 WO2008018111 A2 WO 2008018111A2
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WO
WIPO (PCT)
Prior art keywords
cranberry
lactoferrin
composition
treatment
prevention
Prior art date
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Ceased
Application number
PCT/IT2007/000578
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English (en)
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WO2008018111A3 (fr
Inventor
Giulia Falcone
Enrico Boldrini
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Opocrin SpA
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Opocrin SpA
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Filing date
Publication date
Application filed by Opocrin SpA filed Critical Opocrin SpA
Publication of WO2008018111A2 publication Critical patent/WO2008018111A2/fr
Publication of WO2008018111A3 publication Critical patent/WO2008018111A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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)
    • A61K36/45—Ericaceae or Vacciniaceae (Heath or Blueberry family), e.g. blueberry, cranberry or bilberry
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/40—Transferrins, e.g. lactoferrins, ovotransferrins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system

Definitions

  • the present invention concerns a composition containing cranberry
  • the invention concerns a pharmaceutical or nutraceutical composition for oral administration indicated for the prevention and treatment of urinary tract infections, particularly in women, both in the fertile period and during menopause, in which the known antimicrobial activity of cranberry is enhanced by synergic interaction with another active ingredient of natural origin - lactoferrin.
  • urinary tract infections are characterised by the presence of bacteria in urine, in association with an inflammatory reaction in the host.
  • the bacteria responsible for urinary tract infections are mainly gram- negative, and particularly Escherichia coli, which is the dominant uropathogen (from 75% to 95% of the cases).
  • Escherichia coli which is the dominant uropathogen (from 75% to 95% of the cases).
  • Staphylococcus sapro- phyticus Much less frequent is Staphylococcus sapro- phyticus (from 5% to 20% of the cases); other enterobacteria such as Kleb- siella and Proteus can only occasionally cause UTI (Susan A. Mehnert-Kay, Diagnosis and Management of Urinary Tract Infections, Am. Fam. Physician, 2005, 72:451-6, 458).
  • E. coli normally has type 1 fimbriae and P fimbriae, macromolecules of protein origin enabling the bacteria to adhere to the uroepithelial cells.
  • UTI affect over 40% of women of fertile age at least once. This category of women are actually the ones most at risk of contracting this type of pathology. UTI in women can be classified as: acute uncomplicated cystitis, recurrent cystitis, uncomplicated acute pyelonephritis and complicated UTI. Urinary tract infections are also possible in men, but with much less incidence. Moreover, in both men and women, there may occur cystitis correlated to catheter and asymptomatic bacteriuria, which is particularly found in the elderly (Bosisio, V. et al., A prospective, descriptive study on the practice and management of urinary tract infections by general practitioners in Italy: clinical pathways (Part II), Arch. Ital. Urol. Androl., 2003, 75, 2).
  • cystitis was based on urinoculture, considered positive in the case of isolation with a count above 100,000 colonies/ml.
  • years of clinical practice and literature reviews have con- firmed that acute cystitis may even arise with lower bacterial counts.
  • the treatment for acute cystitis envisages the use of trimethoprimsul- famethoxazol as a first choice drug for three days, except in cases of allergy and in cases of patients affected by germs with a known in-vitro resistance due to recent antibiotic treatment, or resident in geographic areas with a drug- resistance above 10-20%.
  • the alternative is fluoroquinolones for three days (Susan A. Mehnert-Kay, ibidem; V. Bosisio, et al., ibidem).
  • antibiotic treatment with fluoroquinolones is not recommended, however, as a first choice therapy in uncomplicated acute UTI, in order to preserve its effectiveness for complicated infections.
  • Cystitis can lead to persistent infections even after adequate antibiotic treatment (recurrent infections) or to a new onset of infection after microbio- logically documented eradication (re-infections).
  • Repeated infections caused by the same etiological agent are, by definition, complicated infections, and call for diagnostic examinations and more aggressive treatment plans.
  • fluoroquinolones are particularly recommended in the treatment of complicated cystitis even if, in recent years, they have seen widespread use also in acute cystitis due to a problem of bacterial resistance. In this regard, it has been reported (Karlowsky et al., Susceptibility of antimicrobial-resistant urinary Escherichia coli isolates to fluoroquinolones and nitrofurantoin, Clin. Infect.
  • the cranberry or red berry (Vaccinium macrocarpon) is a bright red coloured berry of North American origin that grows exclusively in certain areas of the American continent, and particularly in the cool temperate regions of the USA (Massachusetts, New Jersey, Oregon, Washington, Wisconsin), and in some areas of Canada and Chile. It differs from the bilberry (Vaccinium myrtil- lus), which is more common in Europe and has smaller bluish berries, with a qualitative and quantitative content of active ingredients and biological properties that are partly different.
  • the cranberry is grown on a large scale in the aforesaid regions of North America, in sandy soil rich in water, and is harvested between May and October. Only 12% of the harvest is eaten as fresh fruit while the rest is sent to the food processing industry, where it is used in the form of juice for bever- ages and dried fruit for various processes as well as in the herbal field and in food supplements and nutraceutical preparations, where it is used in the form of syrups, concentrated juices, capsules of extract, tablets and powders.
  • cranberry juice has a very acidic and astringent taste (pH « 2,5) which many people do not find very agreeable. That is why, when used as a nutraceutical product, it is often employed in a cranberry "cocktail" consisting of at least 25% juice, sweetener, water and vitamin C.
  • Cranberry (Vaccinium macrocarpon) has been used as a urinary antiseptic for at least 200 years since even the native populations of North Amer- ica knew its activity in preventing and treating infections and inflammations, particularly of the urinary tract. It has been used as a traditional treatment for UTI before the introduction of antibiotics, and continues to be widely used as a product for self-medication for this purpose.
  • cranberry administration for the treatment of urinary tract infections may carry out a valid co-adjuvant function in antibiotic chemoprophylaxis and could, in any case, be particularly significant in treating patients affected by recurrent UTI or those for whom prolonged antibiotic treatment is not recommended or possible.
  • lactoferrin is a multifunctional immunoregulatory glycoprotein of the transferrin family of proteins. It has a molecular weight of about 80 kDa and is normally found in the colostrum and milk of mammals (and particularly in human and bovine milk) and, to a lesser extent, in saliva, tears, bile, blood and gastric and genital mucosa secretions.
  • Native lactoferrin is a glycosylated protein molecule having two main lobes each bonding with an atom of ferric ion (Fe 3+ ) in the presence of sodium bicarbonate. It is through this chelating activity of iron that lactoferrin performs its antibacterial (bacteriostatic) function, such as during breast-feeding, by reducing the availability of iron necessary for the growth and reproduction of pathogenic microorganisms.
  • lactoferrin The bacteriostatic and bactericide properties of lactoferrin were demonstrated in vitro for a number of pathogenic micro-organisms, both gram- positive and gram-negative ones, and have been used in order to prepare antibacterial compositions recommended for various specific infective pathologies.
  • European patent application EP-A-0753308 proposes the topical use of lactoferrin in the treatment of acute or recurrent infections caused by Streptococcus pyogenes, Staphylo- coccus aureus or other gram+ intracellular pathogenic bacteria, with particular reference, but not exclusive, to the prevention and treatment of infections of the oropharyngeal tract.
  • lactoferrin administered in a topical preparation onto the affected area - exerts an anti- invasive action on the pathogenic micro-organisms, preventing their adher- ence to the walls of the host cells and their penetration inside.
  • the proposed composition which may also be associated with antibiotics, is preferably administered in the form of drops, chewing gum or powder for dermatological application.
  • lactoferrin A more specific therapeutic indication for urinary and intestinal tract infections is described for lactoferrin in the international patent application WO 98/06425 (Holdingsbolaget Vid Goteborgs Universitet AB), which proposes lactoferrin-based pharmaceutical compositions for oral administration in general for the prevention and treatment of infections, inflammations and even tumours, and specifically for the prevention and treatment of UTI and colitis.
  • lactoferrin-based pharmaceutical compositions for oral administration in general for the prevention and treatment of infections, inflammations and even tumours, and specifically for the prevention and treatment of UTI and colitis.
  • possible associations with other active ingredients are not taken into consideration.
  • lactoferrin and its antibacterial activity have been widely studied is that of infections by Helicobacter pylori, which affect the gastro-enteric tract and which are responsible, amongst other things, for gastric ulcer.
  • lactoferrin was proposed in pharmaceutical compositions - possibly containing other active ingredients as one or more antibiotics - for the preven- tion and treatment of H. pylori infections.
  • the present invention specifically provides a composition for the prevention and treatment of urinary tract infections that contains therapeu- tically effective quantities of cranberry (Vaccinium macrocarpon) and lactoferrin, in combination, in a physiologically acceptable vehicle.
  • cranberry Vaccinium macrocarpon
  • lactoferrin lactoferrin
  • the proposed composition includes the following active components in the following proportions:
  • each dosage unit of the proposed composition in- eludes the following active components in the following proportions:
  • composition according to the pre- sent invention consists of oral dosage units in which each dosage unit includes the following active components in the following proportions:
  • These dosage units can take the form of tablets, chewable tablets, soft or hard capsules, granules for drinkable solutions or drops for oral solutions, and are preferably made up of chewable tablets.
  • the recommended dosage is one unit, 1 to 4 times a day.
  • the recommended dosage is 1 or 2 tablets per day.
  • the pharmaceutical or nutraceutical preparations according to the present invention can contain additives normally used in the pharmaceutical art such as sweeteners, flavourings, colorants, coatings and preservatives, inert diluents such as calcium carbonate, sodium carbonate, lactose and talc, binding agents such as starch, gelatine and polyvinylpyrrolidone, suspending agents such as methylcellulose or hydroxyethylcellulose, and imbibing agents such as lecithin, polyoxyethylene stearate and polyoxymethylene sorbitan monooleate, reducing agents such as ascorbic acid and its salts, as well as other suitable pharmaceutical excipients.
  • additives normally used in the pharmaceutical art such as sweeteners, flavourings, colorants, coatings and preservatives, inert diluents such as calcium carbonate, sodium carbonate, lactose and talc, binding agents such as starch, gelatine and polyvinylpyrrolidone, suspending agents such as
  • the present invention concerns the use of a combination of cranberry (Vaccinium macrocarpon) and lactoferrin for the production of a preparation for the prevention and treatment of urinary tract infections.
  • the composition which is specially designed for oral administration, comprises - as already noted - the following active compo- nents in the following proportions:
  • Each dosage unit of the proposed composition for use in the treatment of UTIs - that can be presented in any one of the aforesaid pharmaceutical forms - preferably includes the following active components in the following proportions: preferred
  • the cranberry and lactoferrin composition proposed according to the present invention is recommended for the prevention and treatment of acute and recurrent infections of the urinary tract, and even more specifically is recommended for the prevention of recurrent cystitis, since it can be taken for long periods and without the contraindications typical of anti- biotic chemoprophylaxis.
  • the preparations of natural origin proposed according to the present invention can also be used as co-adjuvants in connection with a suitable antibiotic therapy.
  • mice were used as the experimental animal model.
  • the cranberry and lactoferrin-based products used were, respectively, "100% Cranberry Powder” by NutriCran ® Bio-100 of Wareham, MA, USA, and bovine lactoferrin "Lactoferrin High Grade, standard granulometry” by Biopole SA of Les Isnes, Belgium.
  • Bacteria - Strains of E. coli clinically isolated from patients with significant bacteriuria, were used.
  • the bacteria were prepared for the adherence trial by means of centrifugation, washing in phosphate-buffered saline (PBS, pH 7.2) and suspension in a final concentration of 10 9 cells/ml.
  • PBS phosphate-buffered saline
  • Epithelial cells The uroepithelial cells were obtained from the uri- nary sediment of women who did not have a medical record of UTI. The cells were collected via centrifugation and re-suspended in PBS buffer at a final concentration of 10 5 cells/ml.
  • mice Four groups of twenty mice each were used (each group consisting of 10 males and 10 females), and divided as follows: - 20 mice receiving a diet consisting of feed added with just cranberry (20% of total weight of the feed).
  • mice receiving a diet consisting of feed added with just lactoferrin (10% of the total weight of the feed).
  • mice were 20 mice, used as controls, receiving a normal diet (with no cranberry and lactoferrin added).
  • mice urine was collected in order to assess bacterial adherence to the uroepithelial cells.
  • Bacterial adherence trial Bacterial adherence was evaluated according to the technique described by Parsons and Schmidt (Parsons, C. L., Schmidt, J. D., In vitro bacterial adherence to vaginal cells of normal and cystitis-prone women, J. Urol., 1980, 123(2): 184-7).
  • the urine of the mice treated with the tested substances was preventively incubated with E. coli (10 9 bacte- ria) for 10 min. at 37 0 C.
  • the E. co// treated in this way and 10 5 epithelial cells in PBS were mixed and incubated at 37 0 C for 30 minutes.
  • the mixture was then filtered.
  • the epithelial cells and bacteria adhering to them present on the filter were coloured with methylene blue and examined under a microscope. Adherence was evaluated as the average number of bacteria per epithelial cell (in a sample of 50 cells).
  • the cranberry-lactoferrin combination according to the present invention significantly inhibits bacterial adherence as early as the second day of treatment, and presents values above 80% inhibition after four days.
  • the percentages of inhibition, both on the second and fourth day of treatment, are considerably higher than the values ob- tained with the sole use of either cranberry or lactoferrin.
  • the combination is appreciably better as regards therapeutic efficacy - even better than what was expected by adding together the effectiveness of the two active ingredients.

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Abstract

La présente invention concerne une composition pour la prévention et le traitement d'infections urinaires contenant, en combinaison, des quantités thérapeutiquement efficaces de canneberge (Vacciniυm macrocarpon)et de la lactoferrine, pour l'administration orale, dans laquelle l'action antimicrobienne connue de la canneberge est améliorée par une interaction synergique avec la lactoferrine. L'invention concerne également l'utilisation de canneberge et de lactoferrine, en combinaison, pour la production d'une composition pour la prévention et le traitement d'infections urinaires, notamment indiquée en tant que substitut naturel à une thérapie antibiotique, ou en tant que co-adjuvant dans ladite thérapie, en particulier dans la prévention d'infections urinaires récurrentes.
PCT/IT2007/000578 2006-08-09 2007-08-08 Composition contenant de la canneberge (vaccinium macrocarpon) et de la lactoferrine pour la prévention et le traitement d'infections urinaires Ceased WO2008018111A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT000435A ITRM20060435A1 (it) 2006-08-09 2006-08-09 Composizione a base di mirtillo rosso vaccinium mcrocarpon e lattoferrina per la prevenzione e il trattamento delle infezioni del tratto urinario
ITRM2006A000435 2006-08-09

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WO2008018111A2 true WO2008018111A2 (fr) 2008-02-14
WO2008018111A3 WO2008018111A3 (fr) 2008-03-20

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PCT/IT2007/000578 Ceased WO2008018111A2 (fr) 2006-08-09 2007-08-08 Composition contenant de la canneberge (vaccinium macrocarpon) et de la lactoferrine pour la prévention et le traitement d'infections urinaires

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WO (1) WO2008018111A2 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010078660A1 (fr) * 2009-01-12 2010-07-15 The Royal Institution For The Advancement Of Learning/Mcgill University Utilisation de proanthocyanidines en tant qu'agent anti-apoptotique et agent antiadhésion bactérienne
FR2959938A1 (fr) * 2010-05-12 2011-11-18 Gunter Haesaerts Sonde urinaire comportant des proanthocyanidines et son mode d'utilisation
JP2018537998A (ja) * 2015-12-23 2018-12-27 オーシャン スプレー クランベリーズ インコーポレイテッド フルーツチューサプリメント
GR1009632B (el) * 2018-07-09 2019-10-25 Ιουλια Κλεωνος Τσετη Διατροφικο συμπληρωμα για την απο του στοματος χορηγηση συνδυασμου λακτοφερινης, ξυλογλυκανης, προανθοκυανιδινων και σιμεθικονης, χρησιμων για την προληψη λοιμωξεων του γαστρεντερικου και ουροποιητικου συστηματος
CN111712237A (zh) * 2017-12-20 2020-09-25 外科和医用视网膜中心 蓝莓提取物作为用于保持人体角膜前膜健康的辅助剂的口服施用制剂

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1278137B1 (it) * 1995-07-12 1997-11-17 Piera Valenti Utilizzo della lattoferrina per la terapia topica delle infezioni acute o recidivanti causate da "streptococcus pyogenes" o da altri
US6159447A (en) * 1997-10-16 2000-12-12 Pharmacal Biotechnologies, Llc Compositions for controlling bacterial colonization
US6231866B1 (en) * 1998-04-30 2001-05-15 Douglas G. Mann Infused vegetable, fruit, herb, and/or seed fiber product and dietary supplements containing same
EP1068871A1 (fr) * 1999-07-07 2001-01-17 Jean-Paul Perraudin Nouvelles méthodes et médicament pour le traitement des infections émanant d'un biofilm microbiel
US7785640B2 (en) * 2004-01-16 2010-08-31 Amerilab Technologies, Inc. Effervescent composition including cranberry extract
US7956031B2 (en) * 2005-05-31 2011-06-07 Naidu Lp Metallo-lactoferrin-coenzyme compositions for trigger and release of bioenergy

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010078660A1 (fr) * 2009-01-12 2010-07-15 The Royal Institution For The Advancement Of Learning/Mcgill University Utilisation de proanthocyanidines en tant qu'agent anti-apoptotique et agent antiadhésion bactérienne
FR2959938A1 (fr) * 2010-05-12 2011-11-18 Gunter Haesaerts Sonde urinaire comportant des proanthocyanidines et son mode d'utilisation
JP2018537998A (ja) * 2015-12-23 2018-12-27 オーシャン スプレー クランベリーズ インコーポレイテッド フルーツチューサプリメント
CN111712237A (zh) * 2017-12-20 2020-09-25 外科和医用视网膜中心 蓝莓提取物作为用于保持人体角膜前膜健康的辅助剂的口服施用制剂
US11937625B2 (en) * 2017-12-20 2024-03-26 Centro De Retina Medica Y Quirurgica, S.C. Oral administration formulation of blueberry extract as a coadjuvant for preserving the health of human precorneal film
GR1009632B (el) * 2018-07-09 2019-10-25 Ιουλια Κλεωνος Τσετη Διατροφικο συμπληρωμα για την απο του στοματος χορηγηση συνδυασμου λακτοφερινης, ξυλογλυκανης, προανθοκυανιδινων και σιμεθικονης, χρησιμων για την προληψη λοιμωξεων του γαστρεντερικου και ουροποιητικου συστηματος

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ITRM20060435A1 (it) 2008-02-10

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