TWI802592B - 包括抗體的固體劑型之藉由溶液/懸浮液分層之製備 - Google Patents

包括抗體的固體劑型之藉由溶液/懸浮液分層之製備 Download PDF

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TWI802592B
TWI802592B TW107132680A TW107132680A TWI802592B TW I802592 B TWI802592 B TW I802592B TW 107132680 A TW107132680 A TW 107132680A TW 107132680 A TW107132680 A TW 107132680A TW I802592 B TWI802592 B TW I802592B
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weight
antibody
solid dosage
coating liquid
functional fragment
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TW107132680A
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Chinese (zh)
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TW201914578A (zh
Inventor
維倫 菲力普 約瑟 奧利維拉
羅喬 蕾蒂夏 凡
卡門 高茲
岡薩勒斯 羅伯特 卡洛斯 布拉沃
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瑞士商迪洛特醫藥有限公司
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], 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

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  • 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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (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)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (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)
TW107132680A 2017-09-20 2018-09-17 包括抗體的固體劑型之藉由溶液/懸浮液分層之製備 TWI802592B (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP17192260.2A EP3459528B1 (en) 2017-09-20 2017-09-20 Preparation of solid dosage forms comprising antibodies by solution/suspension layering
EP17192260.2 2017-09-20

Publications (2)

Publication Number Publication Date
TW201914578A TW201914578A (zh) 2019-04-16
TWI802592B true TWI802592B (zh) 2023-05-21

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TW107132680A TWI802592B (zh) 2017-09-20 2018-09-17 包括抗體的固體劑型之藉由溶液/懸浮液分層之製備

Country Status (26)

Country Link
US (2) US11826470B2 (https=)
EP (2) EP3459528B1 (https=)
JP (2) JP7204743B2 (https=)
KR (2) KR20240137117A (https=)
CN (1) CN111093635A (https=)
AR (1) AR112901A1 (https=)
AU (2) AU2018337493B2 (https=)
CA (1) CA3075862A1 (https=)
CL (1) CL2020000735A1 (https=)
CO (1) CO2020003070A2 (https=)
CR (2) CR20210203A (https=)
EA (1) EA202090640A8 (https=)
ES (1) ES2938609T3 (https=)
GE (4) GEAP202115318A (https=)
IL (2) IL272933B2 (https=)
JO (2) JOP20200064B1 (https=)
MA (1) MA50157A (https=)
MX (1) MX2020003032A (https=)
MY (1) MY209948A (https=)
PH (1) PH12020500353A1 (https=)
SA (1) SA520411573B1 (https=)
SG (1) SG11202002203YA (https=)
TW (1) TWI802592B (https=)
UA (1) UA129148C2 (https=)
WO (1) WO2019057562A1 (https=)
ZA (2) ZA202001752B (https=)

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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
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
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
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
AU2024241638A1 (en) 2023-03-28 2025-10-09 Tillotts Pharma Ag Solid oral dosage form comprising antibodies for sustained release in the lower gastrointestinal tract

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AU2018337493B2 (en) 2024-09-12
CR20210203A (es) 2022-03-21
GEAP202215611A (en) 2022-12-12
SG11202002203YA (en) 2020-04-29
US20210030682A1 (en) 2021-02-04
JOP20200064A1 (ar) 2020-03-17
CL2020000735A1 (es) 2020-10-23
ZA202001752B (en) 2025-04-30
BR112020005460A2 (pt) 2020-09-24
GEP20227351B (en) 2022-02-10
BR112020005460A8 (pt) 2022-12-27
CR20200130A (es) 2020-08-06
IL272933A (en) 2020-04-30
JOP20240141A1 (ar) 2024-06-24
ES2938609T3 (es) 2023-04-13
WO2019057562A1 (en) 2019-03-28
JOP20200064B1 (ar) 2024-12-22
ZA202210822B (en) 2024-10-30
KR20240137117A (ko) 2024-09-19
IL272933B2 (en) 2025-06-01
EP3459528A1 (en) 2019-03-27
PH12020500353A1 (en) 2021-01-25
US20240099980A1 (en) 2024-03-28
AU2018337493A1 (en) 2020-03-19
MX2020003032A (es) 2020-07-22
EA202090640A8 (ru) 2021-12-28
AU2024219328A1 (en) 2024-09-19
KR20200055711A (ko) 2020-05-21
CN111093635A (zh) 2020-05-01
JP7204743B2 (ja) 2023-01-16
MY209948A (en) 2025-08-14
GEP20237504B (en) 2023-04-25
CA3075862A1 (en) 2019-03-28
IL272933B1 (en) 2025-02-01
IL318231A (en) 2025-03-01
EP3684339A1 (en) 2020-07-29
US11826470B2 (en) 2023-11-28
JP2020534290A (ja) 2020-11-26
AU2024219328B2 (en) 2026-03-26
CO2020003070A2 (es) 2020-04-13
SA520411573B1 (ar) 2023-12-19
UA129148C2 (uk) 2025-01-29
AR112901A1 (es) 2019-12-26
JP2023036901A (ja) 2023-03-14
MA50157A (fr) 2020-07-29
TW201914578A (zh) 2019-04-16
EP3459528B1 (en) 2022-11-23
EA202090640A1 (ru) 2020-06-15
GEAP202115318A (en) 2021-09-10

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