AU2018337493B2 - Preparation of solid dosage forms comprising antibodies by solution/suspension layering - Google Patents

Preparation of solid dosage forms comprising antibodies by solution/suspension layering Download PDF

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Publication number
AU2018337493B2
AU2018337493B2 AU2018337493A AU2018337493A AU2018337493B2 AU 2018337493 B2 AU2018337493 B2 AU 2018337493B2 AU 2018337493 A AU2018337493 A AU 2018337493A AU 2018337493 A AU2018337493 A AU 2018337493A AU 2018337493 B2 AU2018337493 B2 AU 2018337493B2
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AU
Australia
Prior art keywords
antibody
solid dosage
sustained release
dosage form
kda
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AU2018337493A
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English (en)
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AU2018337493A1 (en
Inventor
Roberto BRAVO
Carmen GOETZ
Felipe VARUM
Laetitia VON ROCHOW
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Tillotts Pharma AG
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Tillotts Pharma AG
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Application filed by Tillotts Pharma AG filed Critical Tillotts Pharma AG
Publication of AU2018337493A1 publication Critical patent/AU2018337493A1/en
Priority to AU2024219328A priority Critical patent/AU2024219328A1/en
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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Mycology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Microbiology (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2018337493A 2017-09-20 2018-09-11 Preparation of solid dosage forms comprising antibodies by solution/suspension layering Active AU2018337493B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2024219328A AU2024219328A1 (en) 2017-09-20 2024-09-03 Preparation of solid dosage forms comprising antibodies by solution/suspension layering

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP17192260.2 2017-09-20
EP17192260.2A EP3459528B1 (en) 2017-09-20 2017-09-20 Preparation of solid dosage forms comprising antibodies by solution/suspension layering
PCT/EP2018/074520 WO2019057562A1 (en) 2017-09-20 2018-09-11 PREPARATION OF SOLID GALENIC SHAPES COMPRISING ANTIBODIES BY SOLUTION / SUSPENSION STRATIFICATION

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2024219328A Division AU2024219328A1 (en) 2017-09-20 2024-09-03 Preparation of solid dosage forms comprising antibodies by solution/suspension layering

Publications (2)

Publication Number Publication Date
AU2018337493A1 AU2018337493A1 (en) 2020-03-19
AU2018337493B2 true AU2018337493B2 (en) 2024-09-12

Family

ID=59923358

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AU2018337493A Active AU2018337493B2 (en) 2017-09-20 2018-09-11 Preparation of solid dosage forms comprising antibodies by solution/suspension layering
AU2024219328A Pending AU2024219328A1 (en) 2017-09-20 2024-09-03 Preparation of solid dosage forms comprising antibodies by solution/suspension layering

Family Applications After (1)

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AU2024219328A Pending AU2024219328A1 (en) 2017-09-20 2024-09-03 Preparation of solid dosage forms comprising antibodies by solution/suspension layering

Country Status (27)

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US (2) US11826470B2 (enExample)
EP (2) EP3459528B1 (enExample)
JP (2) JP7204743B2 (enExample)
KR (2) KR20240137117A (enExample)
CN (1) CN111093635A (enExample)
AR (1) AR112901A1 (enExample)
AU (2) AU2018337493B2 (enExample)
BR (1) BR112020005460A8 (enExample)
CA (1) CA3075862A1 (enExample)
CL (1) CL2020000735A1 (enExample)
CO (1) CO2020003070A2 (enExample)
CR (2) CR20200130A (enExample)
EA (1) EA202090640A8 (enExample)
ES (1) ES2938609T3 (enExample)
GE (2) GEP20227351B (enExample)
IL (2) IL272933B2 (enExample)
JO (1) JOP20200064A1 (enExample)
MA (1) MA50157A (enExample)
MX (1) MX2020003032A (enExample)
MY (1) MY209948A (enExample)
PH (1) PH12020500353A1 (enExample)
SA (1) SA520411573B1 (enExample)
SG (1) SG11202002203YA (enExample)
TW (1) TWI802592B (enExample)
UA (1) UA129148C2 (enExample)
WO (1) WO2019057562A1 (enExample)
ZA (2) ZA202001752B (enExample)

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ES2938609T3 (es) * 2017-09-20 2023-04-13 Tillotts Pharma Ag Preparación de formas farmacéuticas sólidas que comprenden anticuerpos mediante estratificación de solución/suspensión
CN112107694B (zh) * 2020-10-30 2022-07-22 黄山中皇制药有限公司 一种喜炎平干混悬剂
CN112263564B (zh) * 2020-10-30 2022-07-19 黄山中皇制药有限公司 一种喜炎平干混悬剂的制备方法
CN116236463A (zh) * 2023-02-16 2023-06-09 山东省药学科学院 右酮洛芬缓释微丸胶囊及其制备方法
CN120981225A (zh) 2023-03-28 2025-11-18 蒂洛特斯制药股份有限公司 用于在下部胃肠道中缓释的包含抗体的固体口服剂型

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TW201914578A (zh) 2019-04-16
BR112020005460A2 (pt) 2020-09-24
IL318231A (en) 2025-03-01
GEP20227351B (en) 2022-02-10
CA3075862A1 (en) 2019-03-28
PH12020500353A1 (en) 2021-01-25
IL272933A (en) 2020-04-30
MY209948A (en) 2025-08-14
EA202090640A8 (ru) 2021-12-28
MA50157A (fr) 2020-07-29
EP3684339A1 (en) 2020-07-29
EA202090640A1 (ru) 2020-06-15
JP2023036901A (ja) 2023-03-14
EP3459528A1 (en) 2019-03-27
KR20200055711A (ko) 2020-05-21
AU2018337493A1 (en) 2020-03-19
CN111093635A (zh) 2020-05-01
BR112020005460A8 (pt) 2022-12-27
EP3459528B1 (en) 2022-11-23
MX2020003032A (es) 2020-07-22
TWI802592B (zh) 2023-05-21
SG11202002203YA (en) 2020-04-29
IL272933B2 (en) 2025-06-01
CO2020003070A2 (es) 2020-04-13
CR20200130A (es) 2020-08-06
UA129148C2 (uk) 2025-01-29
CL2020000735A1 (es) 2020-10-23
US11826470B2 (en) 2023-11-28
JP2020534290A (ja) 2020-11-26
AU2024219328A1 (en) 2024-09-19
ES2938609T3 (es) 2023-04-13
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