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WO2018122762A1 - Préparation orale comprenant une préparation probiotique de lactobacillus helveticus - Google Patents

Préparation orale comprenant une préparation probiotique de lactobacillus helveticus Download PDF

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Publication number
WO2018122762A1
WO2018122762A1 PCT/IB2017/058460 IB2017058460W WO2018122762A1 WO 2018122762 A1 WO2018122762 A1 WO 2018122762A1 IB 2017058460 W IB2017058460 W IB 2017058460W WO 2018122762 A1 WO2018122762 A1 WO 2018122762A1
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WO
WIPO (PCT)
Prior art keywords
weight
pharmaceutical preparation
preparation according
oral
amount
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/IB2017/058460
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English (en)
Inventor
Cristiano Umberto RUMIO
Francesco Palladini
Davide NENZIONI
Domenico MANISCALCO
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Metis Healthcare Srl
Original Assignee
Metis Healthcare Srl
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 Metis Healthcare Srl filed Critical Metis Healthcare Srl
Publication of WO2018122762A1 publication Critical patent/WO2018122762A1/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
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • 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)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • 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)
    • A61K36/61—Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
    • 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)
    • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/736—Prunus, e.g. plum, cherry, peach, apricot or almond
    • 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
    • A61P31/04—Antibacterial agents

Definitions

  • the present invention find application in the medical field, in particular, in the treatment of oral cavity diseases.
  • Such a part of the body is certainly easier to be reached as compared to the intestines and offers the possibility of a direct therapeutic treatment.
  • the oral cavity and the pharynx are characterized by the absence of an abundant mucosal layer and by a lower microbial competition than the intestines, which factors partially prevent the activity of the probiotics at the l intestinal level.
  • lymphatic structures such as the tonsils of the Waldeyer' s lymphatic ring, allow a very intimate contact of the drug, thus favoring its activity.
  • micro-organisms which are characterized by the capacity of antagonizing S. pyogenes and by the modulating properties on the immune responses both in the epithelial cells and in the cells of the lymphatic system; they are in particular Streptococcus salivarius and Lactobacillus helveticus .
  • SlpA S-layer surface protein
  • micro ⁇ organisms described above must be formulated in a suitable pharmaceutical preparation.
  • the inventors of the present patent application have developed pharmaceutical formulations, whose components are capable of exerting a particularly favorable synergistic action for treating oral cavity diseases.
  • the present invention relates to pharmaceutical preparations comprising probiotic micro-organisms.
  • the invention describes the use of such pharmaceutical preparations for preventing and/or treating diseases of the oral cavity, nasal cavities, pharyngeal and laryngeal tracts, and middle ear.
  • the present invention describes a method of preventing and/or treating diseases of the oral cavity, nasal cavities, pharyngeal and laryngeal tracts, and middle ear, comprising the administration of the described pharmaceutical preparations .
  • the present invention relates to a pharmaceutical preparation comprising a preparation of the probiotic micro-organism Lactobacillus helveticus .
  • Lactobacillus helveticus MIMLh5 was isolated from a Grana Padano cheese whey-graft.
  • Lactobacillus helveticus is Lactobacillus helveticus MIMLh5.
  • Lactobacillus helveticus is the micro-organism deposited with the Leibniz-Lnstitut DSMZ-Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH ( InhoffenstraBe 7B, 38124 Braunschweig - GERMANY) on February 7, 2017 with number DSM 32422.
  • Streptococcus salivarius was isolated from the pharyngeal mucosal of a healthy subject.
  • Streptococcus salivarius is the micro-organism deposited with the Leibniz-Institut DSMZ-Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH ( InhoffenstraBe 7B, 38124 Braunschweig - GERMANY) on February 7, 2017 with number DSM 32423.
  • the described preparation comprises Lactobacillus helveticus in combination with Streptococcus salivarius .
  • each probiotic preparation of the micro-organism that is of Lactobacillus helveticus and/or Streptococcus salivarius, may be in active or inactive form.
  • micro-organism is active, i.e. live, or was inactivated by suitable methods, such as tyndallization, for example.
  • the probiotic micro-organism preparation of the invention is a tyndallized preparation.
  • the probiotic component is for example present in the preparation of the invention in an amount of about 0.6-1% (weight/total weight of the pharmaceutical preparation) .
  • such a component represents about 0.8-0.9% (weight/weight) of the pharmaceutical preparation .
  • the preparation of the invention may further comprise hyaluronic acid.
  • a pharmaceutically acceptable salt thereof may be used, such as the sodium salt or potassium salt thereof, or a mixture of the two salts.
  • the hyaluronic acid is hyaluronic acid of low molecular weight .
  • the molecular weight of the hyaluronic acid used is of about 0.2-1 x 10 6 Da and even more preferably of about 0.4-0.8 x 10 6 Da.
  • the hyaluronic acid component is present in the preparation of the invention in an amount of about 0.01- 20% (weight/weight) , according to the type of pharmaceutical formulation.
  • the hyaluronic acid may be preferably present in an amount of about 0.01-1% (weight/weight), preferably of about 0.1-0.4% (weight/weight), and more preferably of about 0.2% (weight/weight) .
  • the preparations of the invention comprise water, preferably demineralized water.
  • the described preparation comprises further pharmacologically active components capable of increasing or modulating the activity of the preparation itself.
  • Such components may comprise for example one or more polysaccharides having inhibitory activity towards the adhesion of S. pyogenes to the oropharyngeal mucosa.
  • the described preparation may further comprise a preparation of the S-layer surface protein (SlpA) of Lactobacillus helveticus .
  • SlpA S-layer surface protein
  • one or more medicinal plant extracts may be included, selected from the group comprising: an extract of Echinacea (for example, Echinace Angustifolia) , Eucalyptus globulus Labill, Prunus armeniaca L. Garcinia kola Heckel, Garcinia kola Heckel, Sisymbrium officinale Scop. (Syn. Erysimum officinale L. ) .
  • Echinacea for example, Echinace Angustifolia
  • Eucalyptus globulus Labill Prunus armeniaca L.
  • Garcinia kola Heckel Garcinia kola Heckel
  • Sisymbrium officinale Scop. Syn. Erysimum officinale L.
  • the described formulations comprise an extract of: Echinace Angustifolia and/or Syn. Erysimum officinale L.
  • each of such extracts is included, independently of one another, in an amount of about 0.01-5% (weight/weight) and preferably of about 1% (weight/weight) in the described preparations .
  • the pharmaceutical preparation is an oral spray.
  • the preparation may include one or more components adapted to obtain an oral spray formulation.
  • the preparation may comprise one or more of the components selected from: preservatives, antioxidants, chelating agents, buffers (for example sodium bicarbonate) , viscosity regulators, stabilizers, dispersers, sweeteners, flavorings, film-forming agents, etc. adapted to obtain an oral spray preparation.
  • preservatives for example, antioxidants, chelating agents, buffers (for example sodium bicarbonate) , viscosity regulators, stabilizers, dispersers, sweeteners, flavorings, film-forming agents, etc.
  • preservatives the following are contemplated: ethyl alcohol, glycerin, propylenglycol , sorbic acid and sorbates, sodium benzoate, etc.
  • the preparation comprises a combination of preservatives comprising: sodium benzoate and potassium sorbate.
  • each of the sodium benzoate and potassium sorbate may be present in amounts of about 0.05%-0.2% (weight/weight) and preferably in amounts of about 0.1% (weight/weight) .
  • the described preparation comprises Epsileen® (Siveele, Netherlands), an ⁇ -polylysine homopolypeptide produced via bacterial fermentation and having antimicrobial and antibacterial activity against molds, yeasts, Gram-positive and Gram- negative bacteria.
  • Epsileen® may be included in an amount of about 0.05% (weight/weight) .
  • a further antimicrobial (preservative) which may be used is Biosecur®.
  • Such a preservative may be present in an amount of about 0.3% (weight/weight) .
  • antioxidants the following are contemplated: ascorbic acid and esters thereof, hydrosulfites and bisulfites, butylated hydroxyanisole (BHA) , tocopherols, lecithin, etc.
  • EDTA ethylenediaminetetraacetic acid
  • citric acid and tartaric acid etc.
  • sweeteners the following are contemplated: glucose, fructose, xylitol, sorbitol, sucrose, sucralose or other artificial sweeteners (saccharin, acesulfame K, etc. ) ,
  • the sweeteners may be present in an amount of about 0.04-0.1% (weight/weight ) and preferably of about 0.06-0.08% (weight/weight) .
  • the pharmaceutical preparation preferably does not comprise one or more of the following as an ingredient: glucose, fructose, sucrose, fructooligosaccharides (FOS) .
  • the flavorings comprise one or more of the flavoring compounds allowed for pharmaceutical preparations, in particular for oral use.
  • flavoring of mint for this purpose, the following may be used: flavoring of mint, orange, strawberry and other generally appreciated flavorings.
  • the described pharmaceutical spray preparation is a preparation for children.
  • liquid preparations for oral use comprise solutions, such as mouthwashes or oral washes, syrups or suspensions, in suitable aqueous or hydroalcoholic solutions .
  • excipients such as for example: suspending agents, such as sorbitol syrup, cellulose derivatives or hydrogenated fats; emulsifiers, such as for example: lecithin or acacia, other non-aqueous carriers, such as for example: almond oil, ester oils, ethyl alcohol or fractioned vegetable oils; preservatives, such as for example: methyl- or propyl-p-hydroxybenzoate or sorbic acid; antibacterial agents.
  • suspending agents such as sorbitol syrup, cellulose derivatives or hydrogenated fats
  • emulsifiers such as for example: lecithin or acacia
  • other non-aqueous carriers such as for example: almond oil, ester oils, ethyl alcohol or fractioned vegetable oils
  • preservatives such as for example: methyl- or propyl-p-hydroxybenzoate or sorbic acid
  • antibacterial agents such as for example: sorbitol syrup, cellulose derivatives or hydrogenated fat
  • a liquid preparation for example for an oral spray, according to the present invention, is a preparation having the following composition:
  • the preservatives may comprise potassium sorbate and sodium benzoate, each in an amount of about 0.1% (w/w) .
  • the present invention further describes solid pharmaceutical preparations for oral use, represented for example by lozenges, tablets, (hard or soft) capsules, granules or dragees, prepared according to methods known in the field and by using suitable and pharmaceutically acceptable excipients.
  • binding agents may be included, such as for example: pregelatinized cornstarch, polyvinylpyrrolidone, hydroxypropyl methylcellulose, hydroxypropyl cellulose, additives, such as for example: lactose, sorbitol, microcrystalline cellulose, calcium hydrogen phosphate; lubricants, such as for example: magnesium stearate, talc, silica; disintegrants , such as for example: potato starch or sodium starch glycolate; preservative agents, such as for example: sodium lauryl sulfate; stabilizers, such as for example: hydrophilic fumed silica; pH modifying agents, such as for example sodium bicarbonate.
  • additives such as for example: lactose, sorbitol, microcrystalline cellulose, calcium hydrogen phosphate
  • lubricants such as for example: magnesium stearate, talc, silica
  • disintegrants such as for example: potato starch or sodium starch glycolate
  • preservative agents such as
  • sweeteners and flavors may be included as described above for liquid preparations.
  • a solid pharmaceutical preparation for example represented by a tablet, comprises hyaluronic acid or a salt thereof.
  • a component may be preferably included in an amount of about 8-12% (weight/weight) and more preferably of about 10% (weight/weight) .
  • a solid preparation for example a tablet, according to the present invention, is a preparation having the following composition:
  • Echinace Angustifolia Extract or the same preparation was obtained with the addition of Echinace Angustifolia Extract and/or Syn. Erysimum officinale L in an amount of about 1% (w/w) each .
  • the preservatives may comprise potassium sorbate and sodium benzoate, each in an amount of about 0.1% (w/w) .
  • a further pharmaceutical form which may be prepared according to the present invention is represented by toothpastes .
  • suitable excipients will be selected from: additives; binders, such as for example: carrageenan or derivatives thereof, xanthan gum, carboxymethylcellulose, carbopol; additives, such as for example: bentonite, magnesium aluminum silicate, microcrystalline cellulose, silica, sodium alginate; abrasive agents; humectants, such as for example: sorbitol, glycerol; surfactants; antibacterial agents; binding agents, such as for example: carboxymethyl cellulose alkali salts, hydroxymethyl cellulose, hydroxyethyl carboxymethyl cellulose, synthetic and natural gums, polyvinylpyrrolidone, starch, and others; preservatives, such as for example: sodium benzoate; antibacterial agents, such as for example: zinc citrate dihydrate, antibacterial agents, such as for example: triclosan; desensitizing agents; anti-tartar agents; sodium bicarbonate; antibacterial activity enhancers, such as for example: enzyme
  • the invention describes the use of the pharmaceutical preparation for preventing and/or treating diseases of the oral cavity, nasal cavities, pharyngeal and laryngeal tracts, and middle ear .
  • diseases refers to inflammatory and infectious pathologies.
  • pathologies are bacterial by nature .
  • streptococci are streptococci, group A beta- haemolytic streptococci, in more detail Streptococcus pyogenes, and group C r G and F Streptococci .
  • the described preparation is used in treating oropharyngeal cavity infections in children, and especially in children aged 5-12 years.
  • the present invention describes a method for preventing and/or treating diseases of the oral and pharyngeal cavity comprising the administration of an effective amount of one of the described pharmaceutical preparations.
  • Such a method comprises in particular the administration of the preparation of the invention several times a day.
  • this may be applied 2-3 times a day.
  • the amount of the administered probiotic preparation preferably comprises about 10 10 micro-organisms (for each of the administered strain) .
  • the described method is applied for preventing and/or treating oropharyngeal cavity infections in children, and especially in children aged 5-12 years.
  • the formulation indicated above may be modified adding the extract of:
  • the preparation provides a very valid alternative to the use of drugs traditionally used for treating oropharyngeal cavity diseases, among which in primis non-steroidal anti-inflammatory drugs.
  • inactive micro-organisms further increases the safety of the pharmaceutical product, especially if it should be administered to patients of pediatric age.
  • inactive micro-organisms reduces or even eliminates stability problems of the formulation, with important technological advantages; moreover, the shelf-life of the product is usefully prolonged.
  • the preventive and/or therapeutic effect was noted, produced by the combination of the probiotic preparation with hyaluronic acid, which effect goes well beyond the properties of the single components.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • Botany (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

La présente invention concerne une préparation pharmaceutique comprenant des probiotiques pour le traitement de maladies de la cavité buccale.
PCT/IB2017/058460 2016-12-28 2017-12-28 Préparation orale comprenant une préparation probiotique de lactobacillus helveticus Ceased WO2018122762A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102016000131819 2016-12-28
IT102016000131819A IT201600131819A1 (it) 2016-12-28 2016-12-28 Preparazione per spray orale

Publications (1)

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WO2018122762A1 true WO2018122762A1 (fr) 2018-07-05

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PCT/IB2017/058460 Ceased WO2018122762A1 (fr) 2016-12-28 2017-12-28 Préparation orale comprenant une préparation probiotique de lactobacillus helveticus

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IT (1) IT201600131819A1 (fr)
WO (1) WO2018122762A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025132965A1 (fr) * 2023-12-21 2025-06-26 Reichardt Elisabeth Formulations et dispositifs comprenant des bactéries productrices de lantibiotiques

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003055906A1 (fr) * 2001-12-28 2003-07-10 Nederlandse Organisatie Voor Toegepast-Natuurwetenschappelijk Onderzoek Tno Proteines a couche de surface bacterienne modifiees
WO2010081126A2 (fr) * 2009-01-12 2010-07-15 Wyeth Llc Compositions comprenant des composants probiotiques et prébiotiques et des sels minéraux, ainsi que de la lactoferrine
EP2452571A1 (fr) * 2010-11-15 2012-05-16 Nestec S.A. Analyse de compositions nutritionnelles complémentaires pour nourrissons et jeunes enfants
US20140065218A1 (en) * 2011-05-16 2014-03-06 Organobalance Medical Ag Novel lactic acid bacteria and compositions containing them against bacterial colds
US9138451B2 (en) * 2008-10-31 2015-09-22 Bionorica Se Plant extract hydrolysates and antibacterial product containing the same
WO2015162570A1 (fr) * 2014-04-23 2015-10-29 Sofar Spa Composition topique destinée à être utilisée dans le traitement d'une maladie inflammatoire de l'intestin
WO2016064643A1 (fr) * 2014-10-24 2016-04-28 University Of Florida Research Foundation, Incorporated Protéine a de couche superficielle (slpa) de lactobacillus acidophilus utilisée comme agent thérapeutique pour le traitement de maladies inflammatoires

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003055906A1 (fr) * 2001-12-28 2003-07-10 Nederlandse Organisatie Voor Toegepast-Natuurwetenschappelijk Onderzoek Tno Proteines a couche de surface bacterienne modifiees
US9138451B2 (en) * 2008-10-31 2015-09-22 Bionorica Se Plant extract hydrolysates and antibacterial product containing the same
WO2010081126A2 (fr) * 2009-01-12 2010-07-15 Wyeth Llc Compositions comprenant des composants probiotiques et prébiotiques et des sels minéraux, ainsi que de la lactoferrine
EP2452571A1 (fr) * 2010-11-15 2012-05-16 Nestec S.A. Analyse de compositions nutritionnelles complémentaires pour nourrissons et jeunes enfants
US20140065218A1 (en) * 2011-05-16 2014-03-06 Organobalance Medical Ag Novel lactic acid bacteria and compositions containing them against bacterial colds
WO2015162570A1 (fr) * 2014-04-23 2015-10-29 Sofar Spa Composition topique destinée à être utilisée dans le traitement d'une maladie inflammatoire de l'intestin
WO2016064643A1 (fr) * 2014-10-24 2016-04-28 University Of Florida Research Foundation, Incorporated Protéine a de couche superficielle (slpa) de lactobacillus acidophilus utilisée comme agent thérapeutique pour le traitement de maladies inflammatoires

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
TAVERNITI VALENTINA ET AL: "In Vitro Functional and Immunomodulatory Properties of the Lactobacillus helveticus MIMLh5-Streptococcus salivarius ST3 Association That Are Relevant to the Development of a Pharyngeal Probiotic Product", APPLIED AND ENVIRONMENTAL MICROBIOLOGY,, vol. 78, no. 12, 1 June 2012 (2012-06-01), pages 4209 - 4216, XP009162457, ISSN: 0099-2240, DOI: 10.1128/AEM.00325-12 *
VALENTINA TAVERNITI ET AL: "Health-Promoting Properties of Lactobacillus helveticus", FRONTIERS IN MICROBIOLOGY, vol. 3, 1 January 2012 (2012-01-01), XP055307602, DOI: 10.3389/fmicb.2012.00392 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025132965A1 (fr) * 2023-12-21 2025-06-26 Reichardt Elisabeth Formulations et dispositifs comprenant des bactéries productrices de lantibiotiques

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