WO2009004409A1 - Préparation contenant des microorganismes - Google Patents

Préparation contenant des microorganismes Download PDF

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Publication number
WO2009004409A1
WO2009004409A1 PCT/IB2007/052998 IB2007052998W WO2009004409A1 WO 2009004409 A1 WO2009004409 A1 WO 2009004409A1 IB 2007052998 W IB2007052998 W IB 2007052998W WO 2009004409 A1 WO2009004409 A1 WO 2009004409A1
Authority
WO
WIPO (PCT)
Prior art keywords
parts
aqueous composition
organisms
micro
pressure
Prior art date
Application number
PCT/IB2007/052998
Other languages
English (en)
Inventor
Cosmo Mezzina
Giovanni Scapagnini
Original Assignee
Sirc - Natural & Dietetic Foods S.R.L.
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 Sirc - Natural & Dietetic Foods S.R.L. filed Critical Sirc - Natural & Dietetic Foods S.R.L.
Publication of WO2009004409A1 publication Critical patent/WO2009004409A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • 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
    • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/065—Microorganisms
    • 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
    • A23L33/135—Bacteria or derivatives thereof, e.g. probiotics
    • 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
    • A23L33/16—Inorganic salts, minerals or trace elements
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
    • A23P20/00—Coating of foodstuffs; Coatings therefor; Making laminated, multi-layered, stuffed or hollow foodstuffs
    • A23P20/10—Coating with edible coatings, e.g. with oils or fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/288—Compounds of unknown constitution, e.g. material from plants or animals

Definitions

  • This invention relates to a preparation that contains live micro-organisms.
  • a preparation for oral use such as a coated tablet, with a coating layer that contains live micro-organisms. It also relates to said coating film, as well as a method of producing said film.
  • These preparations are useful in the pharmaceutical and diet supplement fields.
  • Pharmaceutical formulations that convey live micro-organisms, specifically lactic bacteria, to the intestine are already known.
  • Said useful constituent may be an active constituent, which can be absorbed as such or after metabolisation, or a substrate suitable for the micro-organisms, which they use on reaching the intestine, or both.
  • the micro-organisms and said constituent are physically separate, so there is no interaction between them.
  • a great advantage of the preparation according to the present invention is therefore that it reduces the number of administrations of the preparations, because the micro-organisms and at least one constituent useful for their use and/or an active constituent can be administered in a single preparation. Two or three combined effects are thus obtained from a single preparation.
  • Another advantage of the preparation according to the present invention is that as a result of said composition it is possible to include a substrate available to the micro-organisms in the same preparation; said substrate is useful to optimise the functionality of the bacteria when the preparation reaches the intestine.
  • a further advantage is the total separation of the micro-organisms from the active constituent. Such interaction is undesirable because it could cause deterioration of the active constituent due to the action of the micro-organisms or the death of the micro-organisms due to the active constituent, with a consequent reduction, in practice, at least of their quantity in the preparation. Said separation consequently offers a wider choice of type of micro-organism and type of active constituent, because the choice is not limited to a combination of substances that do not interact undesirably with one another.
  • a further advantage is the possibility, if necessary, of formulating the preparation so as to obtain differentiated release over time of the micro-organisms and the active constituent contained in the substrate.
  • the film dissolves first, releasing the micro-organisms, then the slow-release tablet dissolves, releasing the active constituent.
  • This invention therefore relates not only to a coating film which comprises said micro-organisms, but also to the aqueous composition from which said coating film is produced by means of a specific process.
  • Said aqueous composition (C) comprises the following constituents (parts by weight): a) 100 parts of live micro-organisms, b) 5.4 to 6.1 parts of organic material comprising selenium, c) 130 to 160 parts of natural or semisynthetic elastomeric membranes, and d) natural organic acids; said composition having a weight ratio between the water and the natural or semisynthetic membrane that ranges between 1.5:1 and 2.5:1 , a pH that ranges between 4 and 6.5, and a viscosity equal to or less than 10,000 centipoise (cP).
  • Micro-organisms that typically tolerate an acid pH in the said range include lactic bacteria, for example.
  • the most common species of said bacteria are Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus lactis, Lactobacillus bulgaricus, Streptococcus thermophilus and Bifidobacterium bifidum.
  • the preferred micro-organisms are Bifidobacterium bifidum.
  • the organic compounds comprising selenium are preferably chosen from among selenium yeasts and organic salts, in particular salts deriving from aminoacids, such as selenium aspartate. Said natural organic acids include tartaric acid, malic acid and citric acid.
  • the acids can be added as such or in the form of complex natural solutions, e.g. in the form of citrus fruit juice.
  • the preferred citrus fruit juice is one which naturally has a fairly acid pH, such as lemon or lime juice.
  • the quantity of citrus fruit juice is approximately 5.4 to 6.1 parts by weight to 100 parts by weight of microorganisms.
  • an acidity corrector can be added to the composition.
  • Said acidity corrector consists of the organic acids previously mentioned, such as tartaric acid, malic acid and citric acid.
  • the aqueous composition according to the invention preferably has a pH ranging between 5 and 6.5 when it contains micro-organisms of the species Bifidobacterium bifidum.
  • the preferred examples are shellac gum, glycerin and gum arabic.
  • Said aqueous composition preferably also contains an emulsifier, such as polysorbate.
  • the aqueous composition according to the invention can also contain any other constituent that one skilled in the art may consider suitable, such as talc and silicon dioxide.
  • the water in the aqueous composition according to the invention is preferably demineralised water.
  • a preferred example of the following aqueous composition comprises (parts by weight): a) 100 parts of micro-organisms, b) 5.4 to 6.1 parts of selenium yeast, c) 5.4 to 6.1 parts of citrus fruit juice, d) 135 to 150 parts of shellac gum, e) 11.9 to 13.2 parts of talc, f) 5.4 to 6.1 parts of tartaric acid, and g) 3.9 to 4.4 parts of polysorbate.
  • the weight ratio between the water and the microorganisms ranges between 2.5:1 and 3.2:1.
  • the constituents to be added are dissolved in water.
  • the constituent with the lowest dissolution or solubilisation rate is preferably added to the water first, followed in succession by the other constituents in increasing order of dissolution/solubilisation rate.
  • constituent (a) which consists of the micro-organisms, is added last.
  • the aqueous composition is stirred at a speed of approximately 900 rpm during the addition of the constituents.
  • Said preparation is, preferably, performed at ambient temperature, that is to say a temperature ranging approximately 20 to 25°C. Ordinary known mixers are used to prepare said aqueous composition.
  • the aqueous composition thus prepared is then used in to coat formulations for oral use, namely tablets, pills and capsules.
  • aqueous composition prefferably prepared immediately before use in the oral formulation coating process.
  • This invention also relates to the process of coating a formulation for oral use, which comprises the following successive stages: 1 ) heating of the material to be coated, which is contained in receptacle (R) of an appliance for coating formulations, at a temperature below the temperature at which the micro-organisms present in coating composition (C) die;
  • the nebulisation pressure of said coating composition (C) being between 0.2 and 0.9 bar, and preferably approximately 0.45 bar.
  • the pressure difference between the pressure of composition (C) and the pressure of receptacle (R) is preferably greater than 1.5 bars but less than 2.5 bars.
  • the material to be coated is heated, for example, by means of a gaseous fluid which is inert towards the material to be coated; said gas could be air, for example.
  • the temperature at which the material to be coated is heated typically ranges between 55° and 75°C, and preferably between 60° and 70 0 C.
  • the apparatus used for coating the formulation typically has a rotation speed during the operations involved in the process according to the present invention which ranges between 3 and 7 rpm, and preferably between 3 and 5 rpm. If the formulation to be coated with the film according to the invention is a tablet, the apparatus used to perform said operation is generally a coating pan.
  • a receptacle (R) of an appliance for coating the formulations is filled with the material to be coated, and said material is heated to a temperature of 39-41 0 C by an airstream with an input temperature of 59-61 0 C.
  • the pressure in receptacle (R) is then reduced to -2 bars and the aqueous coating composition (C) in spray form is introduced into receptacle (R), the nebulisation pressure being approximately 2.5 bars.
  • the water present in composition (C) evaporates almost instantly, and the material to be coated is immediately covered with a coating film containing the micro-organisms, which are still alive.
  • This invention also relates to said preparations for oral use coated with the film according to the present invention; said preparations include, as mentioned, either an active constituent or a substrate useful to the micro-organisms or both.
  • an active constituent or a substrate useful to the micro-organisms or both.
  • the following non-limiting example is given for the purpose of illustration only.
  • composition (C) thus obtained has a pH of 5.4 and a viscosity of 7,200 cP.
  • Tablet coating process Introduce approximately 150 kg of tablets to be coated into a rotary coating pan.
  • composition (C) originating from said mixer onto the tablets.
  • the pressure of composition (C) exiting from the spray nozzles is 0.45 bar.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Veterinary Medicine (AREA)
  • Nutrition Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Mycology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Microbiology (AREA)
  • Zoology (AREA)
  • Botany (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne un film de revêtement obtenu à partir d'une composition aqueuse comprenant (parties en poids) : 100 parties de microorganismes vivants, 5,4-6,1 parties de matériau organique comprenant du sélénium, 130-160 parties de membranes élastomères naturelles ou semi-synthétiques, et des acides organiques naturels, ladite composition ayant un rapport massique entre l'eau et la membrane naturelle ou semi-synthétique qui se situe dans la plage entre 1,5/1 et 2,5/1, un pH qui se situe dans la plage entre 4 et 6,5, et une viscosité égale ou inférieure à 10.000 centipoises. L'invention concerne un procédé pour obtenir ledit film de revêtement, comprenant le chauffage du matériau devant être revêtu, qui est contenu dans le réceptacle d'un appareil pour enrober des comprimés, à une température au-dessous de la température à laquelle les microorganismes présents dans la composition aqueuse meurent ; la réduction de pression dans ledit réceptacle à une pression dans le réceptacle qui se situe dans la plage entre -1 et -2 bar, et la pulvérisation de ladite composition aqueuse sur le matériau devant être revêtu, la pression de nébulisation de ladite composition étant de 0,2 à 0,9 bar.
PCT/IB2007/052998 2007-06-29 2007-07-30 Préparation contenant des microorganismes WO2009004409A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IBPCT/IB2007/052538 2007-06-29
IB2007052538 2007-06-29

Publications (1)

Publication Number Publication Date
WO2009004409A1 true WO2009004409A1 (fr) 2009-01-08

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2007/052998 WO2009004409A1 (fr) 2007-06-29 2007-07-30 Préparation contenant des microorganismes

Country Status (1)

Country Link
WO (1) WO2009004409A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL2007037C2 (en) * 2011-07-04 2013-01-07 Csk Food Enrichment Bv Cheese coating compositions having biopreservative properties.

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001321094A (ja) * 2000-05-12 2001-11-20 Kenji Tokunaga 乳酸菌を含むローヤルゼリー錠剤の製造方法
WO2002039834A1 (fr) * 2000-11-14 2002-05-23 Societe Des Produits Nestle S.A. Composition nutritionnelle destinee a une maladie immunitaire
EP1222919A2 (fr) * 2001-01-09 2002-07-17 Pharmachem Laboratories, Inc. Compositions comprenant un matrix de glycoprotéines et méthode pour leur fabrication
EP1579771A1 (fr) * 2002-11-29 2005-09-28 Freund Corporation Matiere d'enrobage de gomme laque a base d'eau, procede de production correspondant, aliment enrobe obtenu avec ladite matiere d'enrobage, procede de production associe, medicament enrobe, son procede de production, composition de gla age pour collation huileuse, procede de gla age et collation huil

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001321094A (ja) * 2000-05-12 2001-11-20 Kenji Tokunaga 乳酸菌を含むローヤルゼリー錠剤の製造方法
WO2002039834A1 (fr) * 2000-11-14 2002-05-23 Societe Des Produits Nestle S.A. Composition nutritionnelle destinee a une maladie immunitaire
EP1222919A2 (fr) * 2001-01-09 2002-07-17 Pharmachem Laboratories, Inc. Compositions comprenant un matrix de glycoprotéines et méthode pour leur fabrication
EP1579771A1 (fr) * 2002-11-29 2005-09-28 Freund Corporation Matiere d'enrobage de gomme laque a base d'eau, procede de production correspondant, aliment enrobe obtenu avec ladite matiere d'enrobage, procede de production associe, medicament enrobe, son procede de production, composition de gla age pour collation huileuse, procede de gla age et collation huil

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL2007037C2 (en) * 2011-07-04 2013-01-07 Csk Food Enrichment Bv Cheese coating compositions having biopreservative properties.
EP2543246A1 (fr) 2011-07-04 2013-01-09 CSK Food Enrichment B.V. Compositions de revêtement de fromage ayant des propriétés biopréservatives

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