JP7401471B2 - 凍結乾燥形態の医薬組成物 - Google Patents

凍結乾燥形態の医薬組成物 Download PDF

Info

Publication number
JP7401471B2
JP7401471B2 JP2020571767A JP2020571767A JP7401471B2 JP 7401471 B2 JP7401471 B2 JP 7401471B2 JP 2020571767 A JP2020571767 A JP 2020571767A JP 2020571767 A JP2020571767 A JP 2020571767A JP 7401471 B2 JP7401471 B2 JP 7401471B2
Authority
JP
Japan
Prior art keywords
group
pharmaceutical composition
dispersion
lyophilized
weight
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.)
Active
Application number
JP2020571767A
Other languages
English (en)
Japanese (ja)
Other versions
JP2021528450A (ja
JPWO2020002353A5 (https=
JP2021528450A5 (https=
Inventor
オリファー デンク,
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Breath Therapeutics GmbH
Original Assignee
Breath Therapeutics GmbH
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
Application filed by Breath Therapeutics GmbH filed Critical Breath Therapeutics GmbH
Publication of JP2021528450A publication Critical patent/JP2021528450A/ja
Publication of JPWO2020002353A5 publication Critical patent/JPWO2020002353A5/ja
Publication of JP2021528450A5 publication Critical patent/JP2021528450A5/ja
Application granted granted Critical
Publication of JP7401471B2 publication Critical patent/JP7401471B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/127Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7016Disaccharides, e.g. lactose, lactulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • A61K38/13Cyclosporins
    • 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
    • A61K47/24Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • 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
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
    • 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
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Pulmonology (AREA)
  • Otolaryngology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
JP2020571767A 2018-06-27 2019-06-25 凍結乾燥形態の医薬組成物 Active JP7401471B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP18180177 2018-06-27
EP18180177.0 2018-06-27
PCT/EP2019/066875 WO2020002353A1 (en) 2018-06-27 2019-06-25 Pharmaceutical compositions in lyophilized form

Publications (4)

Publication Number Publication Date
JP2021528450A JP2021528450A (ja) 2021-10-21
JPWO2020002353A5 JPWO2020002353A5 (https=) 2022-06-28
JP2021528450A5 JP2021528450A5 (https=) 2022-06-28
JP7401471B2 true JP7401471B2 (ja) 2023-12-19

Family

ID=62814888

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2020571767A Active JP7401471B2 (ja) 2018-06-27 2019-06-25 凍結乾燥形態の医薬組成物

Country Status (11)

Country Link
US (2) US20210244664A1 (https=)
EP (1) EP3813788A1 (https=)
JP (1) JP7401471B2 (https=)
CN (1) CN113038930A (https=)
AU (1) AU2019295027B2 (https=)
BR (1) BR112020026629A2 (https=)
CO (1) CO2021000223A2 (https=)
EA (1) EA202092893A1 (https=)
IL (1) IL279760B2 (https=)
MX (1) MX2020013831A (https=)
WO (1) WO2020002353A1 (https=)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025204688A1 (ja) * 2024-03-26 2025-10-02 株式会社ダイセル リン脂質膜保護用液体組成物

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001519776A (ja) 1997-02-20 2001-10-23 アジェンデ・キミケ・リウニテ・アンジェリニ・フランチェスコ・ア・チ・エレ・ア・エフェ・ソシエタ・ペル・アチオニ 非水溶性活性成分封入の凍結乾燥リポソームを含む医薬製剤およびその製造方法
JP2009519250A (ja) 2005-12-08 2009-05-14 ワイス リポソーム組成物
WO2016146645A1 (en) 2015-03-16 2016-09-22 Pari Pharma Gmbh Cyclosporine formulations for use in the prevention or treatment of pulmonary chronic graft rejection

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4857319A (en) * 1985-01-11 1989-08-15 The Regents Of The University Of California Method for preserving liposomes
EP0208764A4 (en) 1985-01-11 1987-10-08 Univ California METHOD FOR PRESERVING LIPOSOMES.
US4963362A (en) 1987-08-07 1990-10-16 Regents Of The University Of Minnesota Freeze-dried liposome mixture containing cyclosporin
DE69211691T2 (de) 1991-04-19 1997-01-16 Nexstar Pharmaceuticals Inc., Boulder, Col. Pharmazeutische formulierung und pharmazeutisches verfahren
WO1996040064A1 (en) 1995-06-07 1996-12-19 Nexstar Pharmaceuticals, Inc. Liposomal cyclosporin formulations as agents for immunosuppression and multiple drug resistant indications
TW497974B (en) * 1996-07-03 2002-08-11 Res Dev Foundation High dose liposomal aerosol formulations
US5958378A (en) * 1996-07-03 1999-09-28 Research Development Foundation High dose liposomal aerosol formulations containing cyclosporin A or budesonide
AU2003237863A1 (en) 2002-05-20 2003-12-12 Research Development Foundation Aerosol drug inhibition of lung metastases
EP1687635A2 (en) * 2003-11-26 2006-08-09 Applera Corporation Ligand-containing micelles and uses thereof
EP1750671B1 (en) * 2004-06-03 2008-10-15 Bracco Research S.A. Liposomal assembly for therapeutic and/or diagnostic use
DE102006051512A1 (de) * 2005-12-06 2007-06-14 Pari GmbH Spezialisten für effektive Inhalation Pharmazeutische Medikamentenzusammensetzungen mit Cyclosporin
EP1797895A1 (en) * 2005-12-16 2007-06-20 Pevion Biotech Ltd. An adjuvant system comprising virosomes and liposomes
US20110070294A1 (en) * 2009-09-23 2011-03-24 Javeri Indu Methods for the Administration of Drugs Using Liposomes
US20140127288A1 (en) * 2011-05-17 2014-05-08 Mitsubishi Gas Chemical Company, Inc. Liposome containing pyrroloquinoline quinone and sugar

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001519776A (ja) 1997-02-20 2001-10-23 アジェンデ・キミケ・リウニテ・アンジェリニ・フランチェスコ・ア・チ・エレ・ア・エフェ・ソシエタ・ペル・アチオニ 非水溶性活性成分封入の凍結乾燥リポソームを含む医薬製剤およびその製造方法
JP2009519250A (ja) 2005-12-08 2009-05-14 ワイス リポソーム組成物
WO2016146645A1 (en) 2015-03-16 2016-09-22 Pari Pharma Gmbh Cyclosporine formulations for use in the prevention or treatment of pulmonary chronic graft rejection

Also Published As

Publication number Publication date
JP2021528450A (ja) 2021-10-21
US20230301914A1 (en) 2023-09-28
AU2019295027B2 (en) 2024-09-19
CO2021000223A2 (es) 2021-01-18
CN113038930A (zh) 2021-06-25
IL279760B2 (en) 2025-10-01
WO2020002353A1 (en) 2020-01-02
CA3104445A1 (en) 2020-01-02
IL279760A (en) 2021-03-01
AU2019295027A1 (en) 2020-12-24
US20210244664A1 (en) 2021-08-12
IL279760B1 (en) 2025-06-01
MX2020013831A (es) 2021-03-25
BR112020026629A2 (pt) 2021-03-23
EP3813788A1 (en) 2021-05-05
EA202092893A1 (ru) 2021-04-19

Similar Documents

Publication Publication Date Title
EP1968538B1 (de) Pharmazeutische zusammensetzungen mit cyclosporin
JP7285930B2 (ja) 肺疾患の治療に使用するための吸入可能な組成物
JP3245955B2 (ja) リポソーム
AU2019253137B2 (en) Cyclosporine formulations for use in the treatment of bronchiolitis obliterans syndrome (bos)
JP7401471B2 (ja) 凍結乾燥形態の医薬組成物
JP7526103B2 (ja) 大環状免疫抑制剤を含む吸入用組成物
CA3104445C (en) Pharmaceutical compositions in lyophilized form
JP7726884B2 (ja) 吸入可能な免疫抑制活性成分を含む分散液の調製のためのプロセス
KR100812764B1 (ko) 구조화된 암포테리신 b 유제
CA3161686C (en) Process for the preparation of dispersions comprising inhalable immunosuppressive active ingredients
EA048772B1 (ru) Фармацевтические композиции в лиофилизированной форме
CN101278913B (zh) 一种peg衍生化磷脂包载前列腺素e1的胶束制剂
EA046086B1 (ru) Способ получения дисперсий, содержащих ингаляционные иммуносупрессивные активные ингредиенты
JP2021528450A5 (https=)
NR et al. TARGETED DRUG DELIVERY IN GASTROESOPHAGEAL REFLUX DISEASE: THE ROLE OF MUCOADHESIVE AND LIPOSOME SYSTEMS
EA044593B1 (ru) Ингаляционные композиции, содержащие макроциклические иммуносупрессанты
EA042761B1 (ru) Способ лечения заболеваний легких и набор

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20220618

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20220618

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20230322

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20230329

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20230615

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20231109

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20231207

R150 Certificate of patent or registration of utility model

Ref document number: 7401471

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150