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WO1997016198A1 - Formulation a effet probiotique - Google Patents

Formulation a effet probiotique Download PDF

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Publication number
WO1997016198A1
WO1997016198A1 PCT/AT1996/000214 AT9600214W WO9716198A1 WO 1997016198 A1 WO1997016198 A1 WO 1997016198A1 AT 9600214 W AT9600214 W AT 9600214W WO 9716198 A1 WO9716198 A1 WO 9716198A1
Authority
WO
WIPO (PCT)
Prior art keywords
microorganisms
lactobacillus
drying
stabilized
probiologically
Prior art date
Application number
PCT/AT1996/000214
Other languages
German (de)
English (en)
Inventor
Helmut Viernstein
Diether Polheim
Svend Laulund
Original Assignee
Chr. Hansen Biosystems A/S
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 Chr. Hansen Biosystems A/S filed Critical Chr. Hansen Biosystems A/S
Priority to AU72657/96A priority Critical patent/AU7265796A/en
Publication of WO1997016198A1 publication Critical patent/WO1997016198A1/fr

Links

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
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/065—Microorganisms
    • 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
    • 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
    • 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
    • A61K35/745—Bifidobacteria

Definitions

  • the invention relates to probiotic compositions.
  • lactic acid bacteria encompasses a category of microorganisms which, due to their human-specific and food-technological properties, has become the focus of scientific interest in recent years.
  • probiotics as a growth promoter originally limited to the area of animal feed refers to living microorganisms which, as a food additive, favorably influence the balance of the digestive organisms.
  • probiotics are generally relevant for a wide range of predominantly lactic acid-containing preparations, substrates, food and feed, and are used both in human and veterinary medicine and in animal nutrition.
  • Taxonomically the spectrum of lactic acid bacteria currently essentially includes the genera Lactobacillus, Streptococcus, Lactococcus, Leuconostoc, Enterococcus, Bifidobacterium, Carnobacterium and Sporolactobacillus (Bergey's Manual of Systematic Bacteriology, IX. Ed.). Some of these representatives (Lactobacillus, Bifidobacterium and Enterococcus) are considered natural and useful intestinal dwellers of humans (and also of animals) and occur there - depending on the intestinal segment, age and eating habits - in different numbers of germs. In general, the effects of lactic acid bacteria are divided into four main effects:
  • Antimicrobial e.g. growth inhibition of pathogenic germs
  • Living microorganisms are difficult to stabilize, which is why they are usually in dried form in preparations; the representation can be carried out by different drying processes, e.g. lyophilization, spray drying, etc.
  • the object of the present invention is therefore to provide a probiotically effective formulation which has a high degree of gastric juice resistance, is easy to process as a food additive and can also be produced on a large scale in a reproducible manner.
  • a probiotic formulation comprising microorganisms stabilized by drying and enteric matrix components which formulation is present in dry granulated form.
  • the prerequisites for the effectiveness of bacteria are created by producing formulations which are made from viable microorganisms which have been preserved by drying and from matrix components which are both indispensable for the preparation of the formulations and also ensure a high degree of gastric juice resistance , consist. It is only because of the embedding of microorganisms in suitable enteric matrix components that it is possible that a sufficiently high number of desired surviving microorganisms can get into the intestine.
  • the manufacturing process according to the invention sets up a granulation of powder masses dry way, whereby the processing process itself causes only a slight reduction in the number of survival germs.
  • Particularly preferred gastric juice-resistant matrix components are alginates (eg sodium alginate), cellulose or their derivatives (eg hydroxypropylmethyl cellulose (HPMC), HPMC acetate succinate, HPMC phthalate, methacrylic acid derivatives, shellac, galactomannans and mixtures of these components. These substances are found in pharmaceuticals - and / or the food industry has already been tried and tested, is considered harmless and also shows excellent properties with regard to the microorganisms stabilized by drying.
  • Particularly advantageous examples of HPMC or HPMC derivatives include HPMC-50SH 4000, HPMCP-HP 55 (according to US - Pharmacopeia XXIII, NF18, No. 2910 and No. 200731), and HPMC acetate succinate LF (HPMC-AS-LF) (Shin-Etsu, Japan).
  • Lactic acid bacteria preferably from the genera Streptococcus, Lactobacillus, Enterococcus and Bifidobacterium, but also Enterobacteriaceae, preferably the genera Enterobacter and Escherichia, are used as microorganisms in the formulations according to the invention, the genes or species Lactobacillus delbschreibii subsp. bulgaricus, lactobacil Ius acidophilus, Lactobacillus casei subsp. casei, Lactobacillus helveticus, Lactobacillus lactis, Lactobacillus salivarius, Lac tobacillus plantarum, Streptococcus salivarius subsp.
  • thermophilus Enterococcus faecium, Bifidobacterium bifidum, Bifidobacterium infantis, Bifidobacterium longum, etc., physiological Escherichia coli and mixtures of these microorganisms are particularly preferred.
  • the formulation according to the invention advantageously comprises technically necessary auxiliaries, e.g. pharmaceutical carriers and / or formulation auxiliaries, such as tableting agents, consistency-increasing agents, stabilizers, food additives, etc.
  • auxiliaries e.g. pharmaceutical carriers and / or formulation auxiliaries, such as tableting agents, consistency-increasing agents, stabilizers, food additives, etc.
  • the probiotic formulation according to the invention generally comprises
  • Formulations which have 30 to 70, in particular 30 to 55% by weight, of stabilized microorganisms are particularly preferred.
  • Formulations which are particularly preferred according to the invention are those which comprise microorganisms of the species Enterococcus faecium and / or Lactobacillus acidophilus stabilized by drying, and sodium alginate and / or hydroxypropylmethyl cellulose or one of its derivatives and magnesium stearate.
  • the present invention relates to the use of the probiotically active formulations according to the invention as additives for foods and for the manufacture of medicaments, in particular for the manufacture of preparations for the treatment of disorders of the intestinal flora.
  • Another aspect of the present invention is a method for producing probiotic formulations, which comprises the following steps:
  • the microorganisms are mixed with the corresponding gastric juice-resistant matrix components and, if appropriate, with further auxiliary components, in particular those necessary for compacting (cube mixer, ERWEKA company) and with an eccentric press (type EK 0, KORSCH company) to give compressed products with a diameter of 10 mm pressed.
  • the pressing pressure applied is 15 kN.
  • the compacts obtained are subsequently processed into granules using a dry granulating device (device type TG 2 / S, company ERWEKA) and this is then classified using a sieve tower (company RETSCH).
  • Granules with particle diameters of 2.0 to 4.0 mm are Further examinations, such as the determination of initial germ counts, survival germ counts, etc., are supplied.
  • the lyophilisate can already adhere to the glass wall when the dilution bottles are loaded, as a result of which the bacteria partially survive in the dry film under a moist protective layer.
  • the dilution bottle must therefore be subjected to an even shaking motion right from the start to prevent the lyophilisate from settling on the bottom.
  • the components for a first compacting process are mixed and compressed.
  • the compressed products are then granulated into granules A as an intermediate product.
  • the granulate A is compressed again with other necessary components (e.g. with the same parts by weight of HMPC acetate succinate granulate) and granulated to an end product (granulate B).
  • This manufacturing technology optimizes the embedding of the microorganisms in the stabilizing matrix by means of several process steps which can be carried out easily.
  • the powder mixture prepared in accordance with the mixing ratio given above was granulated dry, the granules subsequently mixed 1: 1 with HPMC-AS-LF granules of the same average grain size and subjected to the dry granulation process again.
  • the cultural live germ count determination was for the starting lyophilisate, the starting granules and for the preparations after incubation in 0.1 N HCl ("survival germ count"). Detection was carried out by plating on Rogosa agar (medium: anaerobically for 72 h at 37 0 C; Lit .: Mitsuoka, Zbl.Bakt.I. Orig, 210 (1969), 32-51.); the survival germ numbers were determined in the same way.
  • Formulation recipe 49.5 g L. acidophilus lyophilisate
  • Formulation recipe 20 g L.acidophilus lyophilisate
  • Granules Granules Mixed granules-granules

Landscapes

  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Nutrition Science (AREA)
  • Engineering & Computer Science (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne une formulation à effet probiotique, comportant des micro-organismes stabilisés par séchage et des composants de matrice résistants au suc gastrique. Cette formulation se présente sous la forme de granulés secs. L'invention concerne également son utilisation.
PCT/AT1996/000214 1995-11-02 1996-11-04 Formulation a effet probiotique WO1997016198A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU72657/96A AU7265796A (en) 1995-11-02 1996-11-04 Probiotically acting formulation

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ATA1810/95 1995-11-02
AT0181095A AT405235B (de) 1995-11-02 1995-11-02 Probiotisch wirksame formulierung

Publications (1)

Publication Number Publication Date
WO1997016198A1 true WO1997016198A1 (fr) 1997-05-09

Family

ID=3521473

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/AT1996/000214 WO1997016198A1 (fr) 1995-11-02 1996-11-04 Formulation a effet probiotique

Country Status (3)

Country Link
AT (1) AT405235B (fr)
AU (1) AU7265796A (fr)
WO (1) WO1997016198A1 (fr)

Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997035596A1 (fr) * 1996-03-25 1997-10-02 Abbott Laboratories Methode et formule pour la prevention de la diarrhee
WO2000007571A3 (fr) * 1998-08-06 2000-05-11 Helmut Viernstein Formulations renfermant des micro-organismes a effet probiotique
WO2002005829A3 (fr) * 2000-07-17 2002-05-02 Hansens Lab Procede permettant de reduire les changements dans la flore gastro-intestinale nuisibles du point de vue ecologique intervenus chez des patients suivant un traitement medicamenteux
WO2005060937A1 (fr) * 2003-12-23 2005-07-07 Chr. Hansen A/S Tablettes comprimees comprenant des micro-organismes probiotiques viables
WO2006122965A1 (fr) 2005-05-18 2006-11-23 Dsm Ip Assets B.V. Compositions pour applications enteriques de micro-organismes
EP2194125A2 (fr) 2005-05-11 2010-06-09 Chr. Hansen A/S Souches de bactéries lactiques sensitives aux antibiotiques
US7785635B1 (en) 2003-12-19 2010-08-31 The Procter & Gamble Company Methods of use of probiotic lactobacilli for companion animals
WO2010103201A1 (fr) * 2009-03-10 2010-09-16 Lesaffre Et Compagnie Granulé probiotique stable et son procédé de préparation
US7906112B2 (en) 2003-12-19 2011-03-15 The Procter & Gamble Company Canine probiotic Lactobacilli
US7998473B2 (en) 2003-12-19 2011-08-16 The Procter & Gamble Company Methods of treatment or prevention of gastrointestinal disorders using canine probiotic bifidobacterium
US8034601B2 (en) 2005-05-31 2011-10-11 The Procter & Gamble Company Feline probiotic bifidobacteria
US8563522B2 (en) 1997-07-08 2013-10-22 The Iams Company Method of maintaining and/or attenuating a decline in quality of life
US8809035B2 (en) 2003-12-19 2014-08-19 The Iams Company Canine probiotic Bifidobacterium
US8877178B2 (en) 2003-12-19 2014-11-04 The Iams Company Methods of use of probiotic bifidobacteria for companion animals
US9192177B2 (en) 2005-05-31 2015-11-24 The Iams Company Feline probiotic Lactobacilli
US9415083B2 (en) 2004-05-10 2016-08-16 Mars, Incorporated Method for decreasing inflammation and stress in a mammal
US9771199B2 (en) 2008-07-07 2017-09-26 Mars, Incorporated Probiotic supplement, process for making, and packaging
US10104903B2 (en) 2009-07-31 2018-10-23 Mars, Incorporated Animal food and its appearance
CN110891432A (zh) * 2017-07-31 2020-03-17 三菱商事生命科学株式会社 吞咽困难者用增粘组合物

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6466124A (en) * 1987-09-04 1989-03-13 Freunt Ind Co Ltd Granule containing intestinal useful bacterium and production thereof
WO1989005849A1 (fr) * 1987-12-23 1989-06-29 Chr. Hansen's Laboratorium A/S Bacteries d'acide lactique destinees a etre utilisees dans des produits lactes fermentes et dans des preparations veterinaires
EP0627173A1 (fr) * 1993-05-31 1994-12-07 GIULIANI S.p.A. Préparation pour utilisation diététique ou comme complément alimentaire avec libération ciblée dans le colon
WO1995034292A2 (fr) * 1994-06-14 1995-12-21 Recordati S.A. Chemical And Pharmaceutical Company Composes stabilises et biologiquement actifs contenus dans des microgranules enrobees pouvant etre mises en suspension dans des liquides alimentaires

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US4839281A (en) * 1985-04-17 1989-06-13 New England Medical Center Hospitals, Inc. Lactobacillus strains and methods of selection
SE465206B (sv) * 1989-12-22 1991-08-12 Eva Grahn Farmaceutisk beredning foer bekaempning av patogena tarmbakterier
EP0471904A1 (fr) * 1990-05-09 1992-02-26 Milpak, Inc. Composition instantanée à base de yaourt
DE4119306C2 (de) * 1991-06-12 1996-05-30 Wheli Inter Ag Organische Rohstoffe, Zwischen- und Endprodukte für die Ernährung und zur Verwendung für technische Zwecke, die Vitalstoffe enthalten
IT1254210B (it) * 1992-02-10 1995-09-14 Simone Claudio De Composizioni dietetiche e/o farmaceutiche a base di batteri lattici liofilizzati, loro preparazione e impiego

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6466124A (en) * 1987-09-04 1989-03-13 Freunt Ind Co Ltd Granule containing intestinal useful bacterium and production thereof
WO1989005849A1 (fr) * 1987-12-23 1989-06-29 Chr. Hansen's Laboratorium A/S Bacteries d'acide lactique destinees a etre utilisees dans des produits lactes fermentes et dans des preparations veterinaires
EP0627173A1 (fr) * 1993-05-31 1994-12-07 GIULIANI S.p.A. Préparation pour utilisation diététique ou comme complément alimentaire avec libération ciblée dans le colon
WO1995034292A2 (fr) * 1994-06-14 1995-12-21 Recordati S.A. Chemical And Pharmaceutical Company Composes stabilises et biologiquement actifs contenus dans des microgranules enrobees pouvant etre mises en suspension dans des liquides alimentaires

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DATABASE WPI Section Ch Week 8916, Derwent World Patents Index; Class A96, AN 89-119459, XP002025911 *

Cited By (36)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997035596A1 (fr) * 1996-03-25 1997-10-02 Abbott Laboratories Methode et formule pour la prevention de la diarrhee
US5902578A (en) * 1996-03-25 1999-05-11 Abbott Laboratories Method and formula for the prevention of diarrhea
US8563522B2 (en) 1997-07-08 2013-10-22 The Iams Company Method of maintaining and/or attenuating a decline in quality of life
WO2000007571A3 (fr) * 1998-08-06 2000-05-11 Helmut Viernstein Formulations renfermant des micro-organismes a effet probiotique
WO2002005829A3 (fr) * 2000-07-17 2002-05-02 Hansens Lab Procede permettant de reduire les changements dans la flore gastro-intestinale nuisibles du point de vue ecologique intervenus chez des patients suivant un traitement medicamenteux
US8840880B2 (en) 2003-12-19 2014-09-23 The Iams Company Canine probiotic bifidobacteria globosum
US9821015B2 (en) 2003-12-19 2017-11-21 Mars, Incorporated Methods of use of probiotic bifidobacteria for companion animals
US7785635B1 (en) 2003-12-19 2010-08-31 The Procter & Gamble Company Methods of use of probiotic lactobacilli for companion animals
US9580680B2 (en) 2003-12-19 2017-02-28 Mars, Incorporated Canine probiotic bifidobacterium pseudolongum
US8900568B2 (en) 2003-12-19 2014-12-02 The Iams Company Method of treating diarrhea in a canine
US8900569B2 (en) 2003-12-19 2014-12-02 The Iams Company Method of treating diarrhea in a canine
US7906112B2 (en) 2003-12-19 2011-03-15 The Procter & Gamble Company Canine probiotic Lactobacilli
US7998473B2 (en) 2003-12-19 2011-08-16 The Procter & Gamble Company Methods of treatment or prevention of gastrointestinal disorders using canine probiotic bifidobacterium
US8894991B2 (en) 2003-12-19 2014-11-25 The Iams Company Canine probiotic Lactobacilli
US8877178B2 (en) 2003-12-19 2014-11-04 The Iams Company Methods of use of probiotic bifidobacteria for companion animals
US8809035B2 (en) 2003-12-19 2014-08-19 The Iams Company Canine probiotic Bifidobacterium
US8802158B2 (en) 2003-12-19 2014-08-12 The Iams Company Methods of use of probiotic Lactobacilli for companion animals
WO2005060937A1 (fr) * 2003-12-23 2005-07-07 Chr. Hansen A/S Tablettes comprimees comprenant des micro-organismes probiotiques viables
US9415083B2 (en) 2004-05-10 2016-08-16 Mars, Incorporated Method for decreasing inflammation and stress in a mammal
US8021883B2 (en) 2005-05-11 2011-09-20 Chr. Hansen A/S Antibiotic-sensitive lactic acid bacteria strains
US8440450B2 (en) 2005-05-11 2013-05-14 Chr. Hansen A/S Antibiotic-sensitive lactic acid bacteria strains
EP2264164A1 (fr) 2005-05-11 2010-12-22 Chr. Hansen A/S Souches de bactéries lactiques sensitives aux antibiotiques
EP2194125A2 (fr) 2005-05-11 2010-06-09 Chr. Hansen A/S Souches de bactéries lactiques sensitives aux antibiotiques
US8697126B2 (en) 2005-05-18 2014-04-15 Dsm Ip Assets B.V. Compositions for enternal application of microorganisms
WO2006122965A1 (fr) 2005-05-18 2006-11-23 Dsm Ip Assets B.V. Compositions pour applications enteriques de micro-organismes
US8034601B2 (en) 2005-05-31 2011-10-11 The Procter & Gamble Company Feline probiotic bifidobacteria
US9192177B2 (en) 2005-05-31 2015-11-24 The Iams Company Feline probiotic Lactobacilli
US9404162B2 (en) 2005-05-31 2016-08-02 Mars, Incorporated Feline probiotic bifidobacteria and methods
US9427000B2 (en) 2005-05-31 2016-08-30 Mars, Incorporated Feline probiotic lactobacilli composition and methods
US9771199B2 (en) 2008-07-07 2017-09-26 Mars, Incorporated Probiotic supplement, process for making, and packaging
US10709156B2 (en) 2008-07-07 2020-07-14 Mars, Incorporated Pet supplement and methods of making
FR2942939A1 (fr) * 2009-03-10 2010-09-17 Lesaffre & Cie Levure probiotique stable a la granulation,compositions probiotiques la comprenant,leur procede de preparation et leurs utilisations
RU2523199C2 (ru) * 2009-03-10 2014-07-20 Лезафр Э Компани Стабильные пробиотические гранулы и способ их получения
WO2010103201A1 (fr) * 2009-03-10 2010-09-16 Lesaffre Et Compagnie Granulé probiotique stable et son procédé de préparation
US10104903B2 (en) 2009-07-31 2018-10-23 Mars, Incorporated Animal food and its appearance
CN110891432A (zh) * 2017-07-31 2020-03-17 三菱商事生命科学株式会社 吞咽困难者用增粘组合物

Also Published As

Publication number Publication date
AT405235B (de) 1999-06-25
ATA181095A (de) 1998-11-15
AU7265796A (en) 1997-05-22

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