WO2023197052A1 - Procédé d'obtention de lait humain en poudre pour la conservation des immunoglobulines, lait humain en poudre, kit contenant du lait humain en poudre, utilisation du kit et du lait humain en poudre - Google Patents

Procédé d'obtention de lait humain en poudre pour la conservation des immunoglobulines, lait humain en poudre, kit contenant du lait humain en poudre, utilisation du kit et du lait humain en poudre Download PDF

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Publication number
WO2023197052A1
WO2023197052A1 PCT/BR2023/050103 BR2023050103W WO2023197052A1 WO 2023197052 A1 WO2023197052 A1 WO 2023197052A1 BR 2023050103 W BR2023050103 W BR 2023050103W WO 2023197052 A1 WO2023197052 A1 WO 2023197052A1
Authority
WO
WIPO (PCT)
Prior art keywords
human milk
milk
fact
freeze
sachets
Prior art date
Application number
PCT/BR2023/050103
Other languages
English (en)
Portuguese (pt)
Inventor
Emily Fernanda Freire Folco
Maira BILLI
Original Assignee
Eurofarma Laboratórios S.A.
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 Eurofarma Laboratórios S.A. filed Critical Eurofarma Laboratórios S.A.
Publication of WO2023197052A1 publication Critical patent/WO2023197052A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23C—DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; MAKING THEREOF
    • A23C1/00—Concentration, evaporation or drying
    • A23C1/06—Concentration by freezing out the water
    • A23C1/08—Freeze-drying
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23C—DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; MAKING THEREOF
    • A23C9/00—Milk preparations; Milk powder or milk powder preparations
    • A23C9/15—Reconstituted or recombined milk products containing neither non-milk fat nor non-milk proteins
    • A23C9/1508—Dissolving or reconstituting milk powder; Reconstitution of milk concentrate with water; Standardisation of fat content of milk
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23C—DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; MAKING THEREOF
    • A23C9/00—Milk preparations; Milk powder or milk powder preparations
    • A23C9/16—Agglomerating or granulating milk powder; Making instant milk powder; Products obtained thereby
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23C—DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; MAKING THEREOF
    • A23C9/00—Milk preparations; Milk powder or milk powder preparations
    • A23C9/18—Milk in dried and compressed or semi-solid form
    • 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
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/20—Milk; Whey; Colostrum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism

Definitions

  • the present invention presents as a fifth object the use of human milk powder for the production of reconstituted human milk and a kit containing human milk powder, useful for the manufacture of a food formula that protects against infections, diarrhea and allergies and promotes healthy growth, weight gain and possible reduction in hospitalization time for premature babies.
  • the fractionation step must occur with previously pasteurized milk, and can be carried out with the aid of a graduated, volumetric, automatic pipette, scale or other measuring instruments for standardization and precision of the filling volume.
  • the aluminum sachets are composed of polypropylene, polyethylene and other additives, free from Bisphenol A, also known as BPA.
  • BPA can contaminate food, which can pose some health risks, such as hormonal changes and even embryo malformations, in the case of pregnant women. Studies on this component and its risks are still discussed.
  • some countries, including Brazil have chosen to ban the import and manufacture of baby bottles containing Bisphenol A, considering the greater exposure and susceptibility of individuals using this product. For this reason, packaging for processing and storing freeze-dried human milk must be free of this component.
  • the aluminum sachet maintains the smell, flavor and original color of the material, and is also an important protective barrier against oxidation, humidity and light.
  • This material is chemically inert and stable, being resistant to low and high temperatures, that is, the material performs well and, for example, does not become brittle at low temperatures.
  • the freezing stage must take place at low temperatures, below -30 °C, preferably between -80 °C and -30 °C.
  • the freezing time may vary according to the volume to be frozen, material and format of the packaging used, number of samples inside the container/support and temperature used during the process.
  • said sachets have a parabola bottom. This bottom prevents loss of content accumulated in the corners of the packaging.
  • Figure 5 shows the comparison of the concentration of IgA, IgM and IgG and retention percentage for frozen milk and freeze-dried milk samples. According to the results presented in this figure, it can be said that the process described in the invention is capable of preserving the immunoglobulins present in milk with retention rates greater than 84% and preferably greater than 90%.
  • EXAMPLE 4 Assessment of the physicochemical and microbiological characteristics of freeze-dried human milk.
  • the microbial count was carried out using the plate counting method, transferring 1 ml of the 1:10 preparation to 2 Petri dishes. 15-20ml of Tryptic Soy Agar (TSA) medium was added, melted and maintained at 45-50°C, in 2 Petri dishes. The plates were homogenized carefully using “8” movements and the media was allowed to solidify. To count total aerobic microorganisms, the TSA plates (inverted) were incubated in an oven at 30-35 °C for 3 to 5 days. The plates were read, the arithmetic mean was calculated and multiplied by the dilution factor obtained. The value obtained is the number of CFU per ml_ of the product.
  • TSA Tryptic Soy Agar

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  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Virology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Dairy Products (AREA)

Abstract

La présente invention concerne un procédé d'obtention de lait humain en poudre lyophilisé pour la conservation des immunoglobulines et le kit pour la reconstitution de la matière lyophilisée à fractionnement facile.
PCT/BR2023/050103 2022-04-13 2023-03-28 Procédé d'obtention de lait humain en poudre pour la conservation des immunoglobulines, lait humain en poudre, kit contenant du lait humain en poudre, utilisation du kit et du lait humain en poudre WO2023197052A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
BR102022007104-7A BR102022007104A2 (pt) 2022-04-13 2022-04-13 Processo de obtenção de leite humano em pó para preservação das imunoglobulinas, leite humano em pó kit contendo leite humano em pó, uso do kit e uso do leite humano em pó
BR1020220071047 2022-04-13

Publications (1)

Publication Number Publication Date
WO2023197052A1 true WO2023197052A1 (fr) 2023-10-19

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/BR2023/050103 WO2023197052A1 (fr) 2022-04-13 2023-03-28 Procédé d'obtention de lait humain en poudre pour la conservation des immunoglobulines, lait humain en poudre, kit contenant du lait humain en poudre, utilisation du kit et du lait humain en poudre

Country Status (2)

Country Link
BR (1) BR102022007104A2 (fr)
WO (1) WO2023197052A1 (fr)

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013048313A1 (fr) * 2011-09-26 2013-04-04 Swedish Orphan Biovitrum Ab (Publ) Formulations améliorées de lipase stimulée par les sels biliaires humaine recombinée
CN110075054A (zh) * 2019-06-06 2019-08-02 山东天源人乳库科技发展有限公司 一种来源于人乳的人源性生长因子修复制剂及其制备方法
US20200205430A1 (en) * 2018-12-31 2020-07-02 Madeline Owens Freeze-drying, storing, rehydrating and feeding using breast milk
WO2020168439A1 (fr) * 2019-02-22 2020-08-27 Aquero Canada Ltd. Compositions lactées enrichies et leurs procédés de préparation
WO2020178733A1 (fr) * 2019-03-04 2020-09-10 Warszawski Uniwersytet Medyczny Procédé de conservation du lait humain et lait humain conservé à l'aide de ce procédé
JP2020158587A (ja) * 2019-03-26 2020-10-01 森永乳業株式会社 ラクトフェリン及びゲル化剤を含む組成物
WO2021003575A1 (fr) * 2019-07-09 2021-01-14 Aquero Canada Ltd. Compositions, procédés de production, stérilisation et utilisations bénéfiques pour la santé de lait lyophilisé
CN112655769A (zh) * 2020-12-21 2021-04-16 山东天源人乳库科技发展有限公司 一种人乳闪释片剂及其制备方法
CN113767983A (zh) * 2021-09-10 2021-12-10 河北省生殖医院 一种含有婴儿籍益生菌的人乳冻干粉组合物及制备方法和应用

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013048313A1 (fr) * 2011-09-26 2013-04-04 Swedish Orphan Biovitrum Ab (Publ) Formulations améliorées de lipase stimulée par les sels biliaires humaine recombinée
US20200205430A1 (en) * 2018-12-31 2020-07-02 Madeline Owens Freeze-drying, storing, rehydrating and feeding using breast milk
WO2020168439A1 (fr) * 2019-02-22 2020-08-27 Aquero Canada Ltd. Compositions lactées enrichies et leurs procédés de préparation
WO2020178733A1 (fr) * 2019-03-04 2020-09-10 Warszawski Uniwersytet Medyczny Procédé de conservation du lait humain et lait humain conservé à l'aide de ce procédé
JP2020158587A (ja) * 2019-03-26 2020-10-01 森永乳業株式会社 ラクトフェリン及びゲル化剤を含む組成物
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WO2021003575A1 (fr) * 2019-07-09 2021-01-14 Aquero Canada Ltd. Compositions, procédés de production, stérilisation et utilisations bénéfiques pour la santé de lait lyophilisé
CN112655769A (zh) * 2020-12-21 2021-04-16 山东天源人乳库科技发展有限公司 一种人乳闪释片剂及其制备方法
CN113767983A (zh) * 2021-09-10 2021-12-10 河北省生殖医院 一种含有婴儿籍益生菌的人乳冻干粉组合物及制备方法和应用

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CASTRO ALBARRAN JORGE, NAVARRO HERNANDEZ ROSA ELENA, SOLIS PACHECO JOSUE, SALAZAR QUIÑONES ITZA CARMINA, MACIAS LOPEZ GRISELDA, BA: "Impacto de la pasteurización/liofi lización en el contenido disponible de inmunoglobulinas en leche humana madura. Estudio de aplicación en bancos de leche humana en hospitales - Impact of pasteurization/freeze-drying on available immunoglobulin content of the mature human milk. Use in human milk ba", NUTRICIPN HOSPITALARIA, JARPYO EDITORES, MADRID., ES, vol. 34, no. 4, ES , pages 899 - 906, XP093098926, ISSN: 0212-1611, DOI: 10.20960/nh.627 *
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