JP2024543125A - バイオ医薬品化合物を含む医薬組成物 - Google Patents

バイオ医薬品化合物を含む医薬組成物 Download PDF

Info

Publication number
JP2024543125A
JP2024543125A JP2024530529A JP2024530529A JP2024543125A JP 2024543125 A JP2024543125 A JP 2024543125A JP 2024530529 A JP2024530529 A JP 2024530529A JP 2024530529 A JP2024530529 A JP 2024530529A JP 2024543125 A JP2024543125 A JP 2024543125A
Authority
JP
Japan
Prior art keywords
composition
compositions
vaccines
vaccine
powder
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
JP2024530529A
Other languages
English (en)
Japanese (ja)
Other versions
JPWO2023094818A5 (https=
JP2024543125A5 (https=
Inventor
セヴマルケル,ヨーナス
レン,ローベルト
Original Assignee
オレクソ・アクチエボラゲット
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
Priority claimed from GBGB2117005.5A external-priority patent/GB202117005D0/en
Priority claimed from GBGB2208144.2A external-priority patent/GB202208144D0/en
Priority claimed from GBGB2213306.0A external-priority patent/GB202213306D0/en
Application filed by オレクソ・アクチエボラゲット filed Critical オレクソ・アクチエボラゲット
Publication of JP2024543125A publication Critical patent/JP2024543125A/ja
Publication of JPWO2023094818A5 publication Critical patent/JPWO2023094818A5/ja
Publication of JP2024543125A5 publication Critical patent/JP2024543125A5/ja
Pending legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/162Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from virus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/47Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0043Nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/02Sprayers or atomisers specially adapted for therapeutic purposes operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A61M15/0043Non-destructive separation of the package, e.g. peeling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/0061Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using pre-packed dosages having an insert inside
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/08Inhaling devices inserted into the nose
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y302/00Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/01023Beta-galactosidase (3.2.1.23), i.e. exo-(1-->4)-beta-D-galactanase
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/06Solids
    • A61M2202/064Powder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/07General characteristics of the apparatus having air pumping means
    • A61M2205/071General characteristics of the apparatus having air pumping means hand operated
    • A61M2205/073Syringe, piston type

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Immunology (AREA)
  • Pulmonology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Otolaryngology (AREA)
  • Biophysics (AREA)
  • Virology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Medicinal Preparation (AREA)
  • Fire-Extinguishing By Fire Departments, And Fire-Extinguishing Equipment And Control Thereof (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
JP2024530529A 2021-11-25 2022-11-25 バイオ医薬品化合物を含む医薬組成物 Pending JP2024543125A (ja)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
GBGB2117005.5A GB202117005D0 (en) 2021-11-25 2021-11-25 New pharmaceutical composition
GB2117005.5 2021-11-25
GB2208144.2 2022-06-01
GBGB2208144.2A GB202208144D0 (en) 2022-06-01 2022-06-01 New pharmaceutical composition
GB2213306.0 2022-09-12
GBGB2213306.0A GB202213306D0 (en) 2022-09-12 2022-09-12 New pharmaceutical composition
PCT/GB2022/052985 WO2023094818A1 (en) 2021-11-25 2022-11-25 Pharmaceutical composition comprising biopharmaceutical drug compounds

Publications (3)

Publication Number Publication Date
JP2024543125A true JP2024543125A (ja) 2024-11-19
JPWO2023094818A5 JPWO2023094818A5 (https=) 2025-12-02
JP2024543125A5 JP2024543125A5 (https=) 2025-12-02

Family

ID=84367624

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2024530529A Pending JP2024543125A (ja) 2021-11-25 2022-11-25 バイオ医薬品化合物を含む医薬組成物

Country Status (11)

Country Link
US (1) US20240408212A1 (https=)
EP (1) EP4436551A1 (https=)
JP (1) JP2024543125A (https=)
KR (1) KR20240111761A (https=)
AR (1) AR127783A1 (https=)
AU (1) AU2022398370A1 (https=)
CA (1) CA3239053A1 (https=)
IL (1) IL313015A (https=)
MX (1) MX2024006130A (https=)
TW (1) TW202329916A (https=)
WO (1) WO2023094818A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12414916B2 (en) 2021-06-10 2025-09-16 Belhaven BioPharma Inc. Dry powder formulations of epinephrine and associated methods
US20260108686A1 (en) 2024-10-21 2026-04-23 Belhaven BioPharma Inc. Compositions, devices, and methods for intranasal delivery of dry powder epinephrine

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19518810A1 (de) 1995-05-26 1996-11-28 Bayer Ag Nasal-Applikator
DE69913113T2 (de) 1998-03-10 2004-08-26 Valois S.A.S. Behälter, verfahren zur befüllung dieses behälter und abgabevorrichtung für das im behälter enthaltene pulver
FR2817847B1 (fr) 2000-12-08 2003-03-28 Tebro Dispositif de distribution de produit fluide ou pulverulent
LU90825B1 (en) 2001-09-06 2003-03-07 Iee Sarl Method for the determination of one or more parameters of a seat passenger
AU2003272959A1 (en) 2003-10-09 2005-04-27 Bioactis Limited Powdery medicine dispensing device for nasal cavity
EP1834651A1 (en) * 2006-03-15 2007-09-19 Universiteit Gent Compositions and methods for veterinary vaccination
WO2009090189A1 (en) * 2008-01-15 2009-07-23 Abbott Gmbh & Co.Kg Powdered protein compositions and methods of making same
EP2266563A1 (en) 2009-06-11 2010-12-29 Charité-Universitätsmedizin Berlin (Charité) Use of opioid receptor antagonists for acute treatment of paraphilic arousal states
GB2472327B (en) 2009-07-31 2013-03-13 Shin Nippon Biomedical Lab Ltd Intranasal granisetron and nasal applicator
JP5623355B2 (ja) 2010-07-30 2014-11-12 オートリブ ディベロップメント エービー カーテンエアバッグ
WO2014004400A2 (en) 2012-06-28 2014-01-03 The Governt. Of The Usa As Represented By The Secretary Of The Department Of Health & Human Services Nasal dry powder delivery system for vaccines and other treatment agents
FR3007992B1 (fr) 2013-07-05 2018-01-26 Aptar France Sas Dispositif de distribution de produit fluide ou pulverulent.
RU2720808C2 (ru) * 2013-09-03 2020-05-13 Джорджия Тек Рисёч Корпорейшн Термостабильные препараты вакцин и микроиглы
CN104489669A (zh) * 2014-12-12 2015-04-08 深圳先进技术研究院 一种植物酵素益生菌粉及其制备方法
US11331270B2 (en) 2017-08-20 2022-05-17 Nasus Pharma Ltd. Dry powder compositions for intranasal delivery
EP3698773A1 (en) * 2019-02-21 2020-08-26 Università degli Studi di Parma Composition and manufacturing of powders containing nanoadjuvants for mucosal vaccination
US10653690B1 (en) * 2019-07-09 2020-05-19 Orexo Ab Pharmaceutical composition for nasal delivery
FR3098420B1 (fr) 2019-07-10 2021-07-09 Aptar France Sas Dispositif de distribution nasale de poudre
RS63725B1 (sr) * 2020-05-18 2022-12-30 Orexo Ab Nova farmaceutska kompozicija za davanje leka
FR3121047B1 (fr) 2021-03-29 2023-07-14 Aptar France Sas Dispositif de distribution nasale de poudre

Also Published As

Publication number Publication date
IL313015A (en) 2024-07-01
EP4436551A1 (en) 2024-10-02
MX2024006130A (es) 2024-06-04
WO2023094818A1 (en) 2023-06-01
US20240408212A1 (en) 2024-12-12
TW202329916A (zh) 2023-08-01
CA3239053A1 (en) 2023-06-01
AU2022398370A1 (en) 2024-05-30
AR127783A1 (es) 2024-02-28
KR20240111761A (ko) 2024-07-17

Similar Documents

Publication Publication Date Title
AU2002366267B2 (en) Pharmaceutical compositions in particulate form
US11364293B2 (en) Compositions and methods for making and using thermostable immunogenic formulations with increased compatibility of use as vaccines against one or more pathogens
CN108472247B (zh) 缓释环孢菌素负载微粒
US20240408212A1 (en) Pharmaceutical composition comprising biopharmaceutical drug compounds
JP2004532277A (ja) 噴霧凍結乾燥組成物
CA2456830A1 (en) Calcium phosphate particles as mucosal adjuvants
Madani et al. An overview on dosage forms and formulation strategies for vaccines and antibodies oral delivery
Biswas et al. Understanding mucosal physiology and rationale of formulation design for improved mucosal immunity
US20040213745A1 (en) Powder formulations of rSEB for improved vaccination
CN111712233A (zh) 粉末制剂、药筒及装置
KR100796220B1 (ko) 미립자 전달 시스템 및 사용 방법
CN118973556A (zh) 包含生物制药药物化合物的药物组合物
Conti et al. Controlled delivery of biotechnological products
WO2003032945A1 (en) Binary composition for 'prime-boost' release of active ingredients like vaccines
WO2021138495A1 (en) Particles for multi-dose delivery
McDonough et al. Nasal delivery of micro-and nano-encapsulated drugs
US20260000621A1 (en) Compositions and methods of use for stabilizing and delivery of atomic layer deposition coating of agent-containing lipid-emulsion formulations
CN103200933A (zh) 作为疫苗载体的多孔可降解聚电解质微球
US20260014251A1 (en) Compositions, methods, and uses for polynucleotide formulations for drying and prolonged storage
Ruseska et al. Protamine–a review on an oligonucleotide-binding peptide applied in nanopharmaceuticals including vaccines
WO2026006624A1 (en) Stabilized and atomic layer deposition (ald)-coated lipid assembly-free polynucleotide-containing microparticles and uses thereof
CN118555964A (zh) 癌症治疗组合物及其用途
CN119343135A (zh) 包封方法和颗粒
WO2004052341A1 (en) Adjuvant compositions containing a sugar in crystalline form and aminoalkyl glucosaminide-4-phosphate
JP2003527413A (ja) 粘膜表面へ投与するための医薬組成物

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20251121

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20251121