CL2012001399A1 - Method to manufacture adjuvant for vaccine (oil / water emulsion with squalene, polysorbate 80 and sorbitan trioleate), which comprises (i) forming the first emulsion in a homogenizer from one container to another to form a second emulsion, (ii) and microfluidizing the first emulsion to form second emulsion. - Google Patents

Method to manufacture adjuvant for vaccine (oil / water emulsion with squalene, polysorbate 80 and sorbitan trioleate), which comprises (i) forming the first emulsion in a homogenizer from one container to another to form a second emulsion, (ii) and microfluidizing the first emulsion to form second emulsion.

Info

Publication number
CL2012001399A1
CL2012001399A1 CL2012001399A CL2012001399A CL2012001399A1 CL 2012001399 A1 CL2012001399 A1 CL 2012001399A1 CL 2012001399 A CL2012001399 A CL 2012001399A CL 2012001399 A CL2012001399 A CL 2012001399A CL 2012001399 A1 CL2012001399 A1 CL 2012001399A1
Authority
CL
Chile
Prior art keywords
emulsion
container
homogenizer
components
adjuvant
Prior art date
Application number
CL2012001399A
Other languages
Spanish (es)
Inventor
Harald Rueckl
Hanno Scheffczik
Barbara Santry
Original Assignee
Novartis Ag
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=62623433&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CL2012001399(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from DE102009056883A external-priority patent/DE102009056883B4/en
Application filed by Novartis Ag filed Critical Novartis Ag
Publication of CL2012001399A1 publication Critical patent/CL2012001399A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/01—Hydrocarbons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/164—Amides, e.g. hydroxamic acids of a carboxylic acid with an aminoalcohol, e.g. ceramides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55555—Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55566—Emulsions, e.g. Freund's adjuvant, MF59
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies

Abstract

La solicitud 201201399 describe a un método para la fabricación de un adyuvante para vacunas que es una emulsión de aceite en agua porque el adyuvante comprende escualeno, polisorbato 80 y trioleato de sorbitán, y porque el método comprende las etapas de: (i) formar una primera emulsión, que tiene un primer tamaño promedio de gotita de aceite usando un homogeneizador, en donde la primera emulsión se forma por circulación que comprende: (a) una circulación de tipo I que transfiere los componentes de la primera emulsión entre un primer contenedor y un homogeneizador, seguido por: (b) una circulación de tipo II que transfiere los componentes de la primera emulsión entre el primer contenedor hacia un segundo contenedor, a través del mismo homogeneizador, en donde todos los componentes de la emulsión desde el primer contenedor se hacen pasar a través del homogeneizador hacia el segundo contenedor, y luego, todos los componentes de la emulsión del segundo contenedor se hacen pasar a través del homogeneizador de vuelta hacia el primer contenedor; (ii) microfluidizar la primera emulsión para formar una segunda emulsión, circulando los componentes de la segunda emulsión a través de un equipo de microfluidización varias veces, en donde la circulación comprende transferir los componentes de la segunda emulsión desde un primer contenedor de emulsión a través del equipo de microfluidización hacia un segundo contenedor de emulsión, y luego a través del mismo equipo de microfluidización.The application 201201399 describes a method for the manufacture of a vaccine adjuvant which is an oil-in-water emulsion because the adjuvant comprises squalene, polysorbate 80 and sorbitan trioleate, and because the method comprises the steps of: (i) forming a first emulsion, having a first average oil droplet size using a homogenizer, wherein the first emulsion is formed by circulation comprising: (a) a type I circulation that transfers the components of the first emulsion between a first container and a homogenizer, followed by: (b) a type II circulation that transfers the components of the first emulsion between the first container to a second container, through the same homogenizer, where all the components of the emulsion from the first container are are passed through the homogenizer into the second container, and then all components of the emulsion from the second container are passed through d the homogenizer back to the first container; (ii) microfluidizing the first emulsion to form a second emulsion by circulating the components of the second emulsion through microfluidization equipment several times, wherein the circulation comprises transferring the components of the second emulsion from a first emulsion container through from microfluidization equipment into a second emulsion container, and then through the same microfluidization equipment.

CL2012001399A 2009-12-03 2012-05-30 Method to manufacture adjuvant for vaccine (oil / water emulsion with squalene, polysorbate 80 and sorbitan trioleate), which comprises (i) forming the first emulsion in a homogenizer from one container to another to form a second emulsion, (ii) and microfluidizing the first emulsion to form second emulsion. CL2012001399A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US28351809P 2009-12-03 2009-12-03
DE102009056883A DE102009056883B4 (en) 2009-12-03 2009-12-03 Vaccine adjuvants and improved methods of making the same

Publications (1)

Publication Number Publication Date
CL2012001399A1 true CL2012001399A1 (en) 2013-03-08

Family

ID=62623433

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2012001399A CL2012001399A1 (en) 2009-12-03 2012-05-30 Method to manufacture adjuvant for vaccine (oil / water emulsion with squalene, polysorbate 80 and sorbitan trioleate), which comprises (i) forming the first emulsion in a homogenizer from one container to another to form a second emulsion, (ii) and microfluidizing the first emulsion to form second emulsion.

Country Status (2)

Country Link
US (1) USRE46906E1 (en)
CL (1) CL2012001399A1 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EA024770B1 (en) * 2009-12-03 2016-10-31 Новартис Аг Method for manufacture of a vaccine adjuvant

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