IL272933B2 - Preparation of solid dosage forms comprising antibodies by solution/ suspension layering - Google Patents

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

Info

Publication number
IL272933B2
IL272933B2 IL272933A IL27293320A IL272933B2 IL 272933 B2 IL272933 B2 IL 272933B2 IL 272933 A IL272933 A IL 272933A IL 27293320 A IL27293320 A IL 27293320A IL 272933 B2 IL272933 B2 IL 272933B2
Authority
IL
Israel
Prior art keywords
coating liquid
dosage form
solid dosage
antibody
active agent
Prior art date
Application number
IL272933A
Other languages
English (en)
Hebrew (he)
Other versions
IL272933A (en
IL272933B1 (en
Inventor
Felipe Varum
Rochow Laetitia Von
Carmen Goetz
Roberto Bravo
Original Assignee
Tillotts Pharma Ag
Felipe Varum
Rochow Laetitia Von
Carmen Goetz
Roberto Bravo
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=59923358&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=IL272933(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Tillotts Pharma Ag, Felipe Varum, Rochow Laetitia Von, Carmen Goetz, Roberto Bravo filed Critical Tillotts Pharma Ag
Publication of IL272933A publication Critical patent/IL272933A/en
Publication of IL272933B1 publication Critical patent/IL272933B1/en
Publication of IL272933B2 publication Critical patent/IL272933B2/en

Links

Classifications

    • 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

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)
  • 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)
IL272933A 2017-09-20 2018-09-11 Preparation of solid dosage forms comprising antibodies by solution/ suspension layering IL272933B2 (en)

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
PCT/EP2018/074520 WO2019057562A1 (en) 2017-09-20 2018-09-11 PREPARATION OF SOLID GALENIC SHAPES COMPRISING ANTIBODIES BY SOLUTION / SUSPENSION STRATIFICATION

Publications (3)

Publication Number Publication Date
IL272933A IL272933A (en) 2020-04-30
IL272933B1 IL272933B1 (en) 2025-02-01
IL272933B2 true IL272933B2 (en) 2025-06-01

Family

ID=59923358

Family Applications (2)

Application Number Title Priority Date Filing Date
IL272933A IL272933B2 (en) 2017-09-20 2018-09-11 Preparation of solid dosage forms comprising antibodies by solution/ suspension layering
IL318231A IL318231A (en) 2017-09-20 2018-09-11 Preparation of solid tablets containing antibodies by solution/suspension layering

Family Applications After (1)

Application Number Title Priority Date Filing Date
IL318231A IL318231A (en) 2017-09-20 2018-09-11 Preparation of solid tablets containing antibodies by solution/suspension layering

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=)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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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WO1999045903A1 (en) * 1998-03-10 1999-09-16 Immucell Corporation Colonic delivery of protein or peptide compositions
EP2777695A1 (en) * 2006-02-09 2014-09-17 Alba Therapeutics Corporation Formulations for a tight junction effector
WO2012130872A1 (en) * 2011-03-28 2012-10-04 Ablynx Nv Method for producing solid formulations comprising immunoglobulin single variable domains

Also Published As

Publication number Publication date
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
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
TWI802592B (zh) 2023-05-21
EA202090640A1 (ru) 2020-06-15
GEAP202115318A (en) 2021-09-10

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