HRP20230985T1 - Farmaceutske formulacije pegiliranih liposoma i faktora koagulacije krvi - Google Patents

Farmaceutske formulacije pegiliranih liposoma i faktora koagulacije krvi Download PDF

Info

Publication number
HRP20230985T1
HRP20230985T1 HRP20230985TT HRP20230985T HRP20230985T1 HR P20230985 T1 HRP20230985 T1 HR P20230985T1 HR P20230985T T HRP20230985T T HR P20230985TT HR P20230985 T HRP20230985 T HR P20230985T HR P20230985 T1 HRP20230985 T1 HR P20230985T1
Authority
HR
Croatia
Prior art keywords
use according
pharmaceutical preparation
optionally
amphipathic lipid
colloidal particle
Prior art date
Application number
HRP20230985TT
Other languages
English (en)
Inventor
William Henry
Original Assignee
Cantab Biopharmaceuticals Patents Limited
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 Cantab Biopharmaceuticals Patents Limited filed Critical Cantab Biopharmaceuticals Patents Limited
Publication of HRP20230985T1 publication Critical patent/HRP20230985T1/hr

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
    • A61K9/127Liposomes
    • 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
    • A61K9/127Liposomes
    • A61K9/1271Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers
    • 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
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • 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
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • 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
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • A61K38/37Factors VIII
    • 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)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482Serine endopeptidases (3.4.21)
    • A61K38/4833Thrombin (3.4.21.5)
    • 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)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482Serine endopeptidases (3.4.21)
    • A61K38/4846Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
    • 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)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482Serine endopeptidases (3.4.21)
    • A61K38/4866Protein C (3.4.21.69)
    • 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
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/127Liposomes
    • A61K9/1277Processes for preparing; Proliposomes
    • A61K9/1278Post-loading, e.g. by ion or pH gradient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/02Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Hematology (AREA)
  • Dispersion Chemistry (AREA)
  • Dermatology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)

Claims (12)

1. Farmaceutski pripravak za uporabu u liječenju pacijenta koji boluje od hemofilije A koja sadrži faktor krvi VIII i koloidnu česticu, pri čemu koloidna čestica sadrži oko 0.5 do 20 molnih postotaka amfipatskog lipida derivatiziranog sa biokompatibilnim hidrofilnim polimerom, pri čemu je koloidna čestica suštinski neutralna i polimer u suštini ne nosi neto naboj, pri čemu krvni faktor nije inkapsuliran u navedenoj koloidnoj čestici, pri čemu se pripravak primjenjuje subkutano i pri čemu se ponovljena subkutana primjena farmaceutskog pripravka izvodi prije nego što se koncentracija farmaceutske kompozicije u krvi smanjuje do subterapeutskih nivoa.
2. Farmaceutski pripravak za uporabu prema zahtjevu 1, naznačen time što koloidna čestica ima srednji promjer čestice između oko 0.03 do oko 0.4 mikrona (µm); izborno pri čemu koloidna čestica ima srednji promjer čestice od približno 0.1 mikrona (µm).
3. Farmaceutski pripravak za uporabu prema zahtjevu 1 ili zahtjevu 2, naznačen time što navedeni amfipatski lipid je fosfolipid iz prirodnih ili sintetičkih izvora; izborno pri čemu navedeni amfipatski lipid je fosfatidiletanolamin (PE).
4. Farmaceutski pripravak za uporabu prema zahtjevu 1 ili zahtjevu 2, naznačen time što navedeni amfipatski lipid je nenabijeni lipopolimer povezan sa karbamatom; izborno pri čemu navedeni amfipatski lipid je aminopropandiol distearoil (DS).
5. Farmaceutski pripravak za uporabu prema zahtjevu 1, naznačen time što navedene koloidne čestice dalje sadrže drugi amfipatski lipid dobiven bilo iz prirodnih ili sintetičkih izvora; izborno pri čemu navedeni drugi amfipatski lipid je fosfatidilholin.
6. Farmaceutski pripravak za uporabu prema zahtjevu 5, naznačen time što koloidna čestica sadrži palmitoil-oleoil fosfatidil kolin (POPC) i 1,2-distearoil-sn-glicero-3-fosfoetanol-amin (DSPE) u odnosu (POPC:DSPE) od 85 do 99:15 do 1; izborno pri čemu odnos POPC:DSPE je od 90 do 99:10 do 1; izborno pri čemu odnos POPC:DSPE je 97:3.
7. Farmaceutski pripravak za uporabu prema zahtjevu 5, naznačen time što je kolesterol dodan pripravku.
8. Farmaceutski pripravak za uporabu prema bilo kojem od zahtjeva 1 do 7, naznačen time što je navedeni biokompatibilni hidrofilni polimer izabran iz grupe koja se sastoji od polialkiletara, polimliječnih kiselina i poliglikolnih kiselina; izborno pri čemu navedeni biokompatibilni hidrofilni polimer je polietilen glikol.
9. Farmaceutski pripravak za uporabu prema zahtjevu 8, naznačen time što polietilen glikol ima molekulsku težinu između oko 500 do oko 5000 daltona; izborno pri čemu polietilen glikol ima molekulsku težinu od približno 2000 daltona.
10. Farmaceutski pripravak za uporabu prema zahtjevu 8 ili zahtjevu 9, naznačen time što derivatizirani amfipatski lipid je 1,2-distearoil-sn-glicero-3-fosfoetanol-amin-N-[poli-(etilenglikol)]; izborno pri čemu derivatizirani amfipatski lipid je 1,2-distearoil-sn-glicero-3-fosfoetanol-amin-N-[poli-(etilenglikol)-2000] (DSPE-PEG 2000).
11. Farmaceutski pripravak za uporabu prema bilo kojem od zahtjeva 1 do 10, naznačen time što pripravak dodatno sadrži još jedan terapeutski aktivan spoj.
12. Farmaceutski pripravak za uporabu prema bilo kojem od zahtjeva 1 do 11, naznačen time što je navedeni pacijent razvio antitijela na faktor krvi.
HRP20230985TT 2014-10-06 2015-10-06 Farmaceutske formulacije pegiliranih liposoma i faktora koagulacije krvi HRP20230985T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB1417589.7A GB201417589D0 (en) 2014-10-06 2014-10-06 Pharmaceutical Formulations
EP15775444.1A EP3204034B9 (en) 2014-10-06 2015-10-06 Pharmaceutical formulations of pegylated liposomes and blood coagulation factors
PCT/EP2015/073003 WO2016055447A1 (en) 2014-10-06 2015-10-06 Pharmaceutical formulations of pegylated liposomes and blood coagulation factors

Publications (1)

Publication Number Publication Date
HRP20230985T1 true HRP20230985T1 (hr) 2023-12-08

Family

ID=51946871

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20230985TT HRP20230985T1 (hr) 2014-10-06 2015-10-06 Farmaceutske formulacije pegiliranih liposoma i faktora koagulacije krvi

Country Status (15)

Country Link
US (2) US20170304203A1 (hr)
EP (1) EP3204034B9 (hr)
JP (3) JP2017531659A (hr)
AU (1) AU2015330102B2 (hr)
BR (1) BR112017007031A2 (hr)
CA (1) CA2994891C (hr)
ES (1) ES2954134T3 (hr)
GB (1) GB201417589D0 (hr)
HR (1) HRP20230985T1 (hr)
HU (1) HUE063656T2 (hr)
MX (1) MX2017004378A (hr)
PL (1) PL3204034T3 (hr)
RS (1) RS64461B1 (hr)
RU (1) RU2737291C2 (hr)
WO (1) WO2016055447A1 (hr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201417589D0 (en) * 2014-10-06 2014-11-19 Cantab Biopharmaceuticals Patents Ltd Pharmaceutical Formulations
WO2017204896A1 (en) * 2016-05-26 2017-11-30 Becton, Dickinson And Company Methods and devices for liposome preparation by centrifugation

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5013556A (en) 1989-10-20 1991-05-07 Liposome Technology, Inc. Liposomes with enhanced circulation time
US6326353B1 (en) 1993-03-23 2001-12-04 Sequus Pharmaceuticals, Inc. Enhanced circulation effector composition and method
JPH09501169A (ja) 1993-08-06 1997-02-04 オパーバス ホールディング ビー ヴィ 小胞に生体高分子物質を高度に充填する方法
IL113010A (en) * 1994-03-31 1999-10-28 Pharmacia & Upjohn Ab Pharmaceutical formulation comprising factor viii with an activity of at least 500iu/ml and an enhancer for improved subcutaneous intramuscular or intradermal administration
US6156337A (en) * 1994-07-08 2000-12-05 Opperbas Holding B.V. Method for high loading of vesicles with biopolymeric substances
US6310183B1 (en) * 1997-09-10 2001-10-30 Novo Nordisk A/S Coagulation factor VIIa composition
PT1079805E (pt) * 1998-04-27 2005-03-31 Opperbas Holding Bv Composicao farmaceutica compreendendo factor viii e lipossomas neutros
ATE317869T1 (de) 1999-07-14 2006-03-15 Alza Corp Neutrales lipopolymer und liposomale zusammensetzungen daraus
AU2001256148A1 (en) * 2000-05-03 2001-11-12 Novo-Nordisk A/S Subcutaneous administration of coagulation factor vii
US20030232075A1 (en) 2002-05-06 2003-12-18 University Of Minnesota, A Minnesota Corporation Compositions for producing factor Xa
ES2307009T3 (es) * 2003-04-15 2008-11-16 Opperbas Holding B.V. Composicion farmaceutica que contiene proteinas y/o polipeptidos y particulas coloidales.
EP1898939A2 (en) 2005-06-29 2008-03-19 The Research Foundation of State of University Of New York at Buffalo Compositions and methods for less immunogenic pr0tein-lip1d complexes
EP2099475B1 (en) * 2007-01-03 2016-08-24 Novo Nordisk Health Care AG Subcutaneous administration of coagulation factor viia-related polypeptides
WO2009051701A2 (en) 2007-10-15 2009-04-23 Wake Forest University Health Sciences Methods and compositions for printing biologically compatible nanotube composites of autologous tissue
WO2010140061A2 (en) 2009-06-03 2010-12-09 John Charles Mayo Formulations for the treatment of deep tissue pain
DE112010003355T5 (de) 2009-08-21 2012-07-12 Targeted Delivery Technologies Ltd. Veskuläre Formulierungen
GB201007356D0 (en) 2010-04-30 2010-06-16 Leverton Licence Holdings Ltd Conjugated factor VIIa
GB201007357D0 (en) 2010-04-30 2010-06-16 Leverton Licence Holdings Ltd Conjugated factor VIII
AR082803A1 (es) * 2010-09-01 2013-01-09 Portola Pharm Inc Metodos y formulaciones para el tratamiento de la trombosis con betrixaban y un inhibidor de la glicoproteina p
GB2516388A (en) 2012-04-16 2015-01-21 Cantab Biopharmaceuticals Patents Ltd Optimised subcutaneous therapeutic agents
GB201417589D0 (en) * 2014-10-06 2014-11-19 Cantab Biopharmaceuticals Patents Ltd Pharmaceutical Formulations

Also Published As

Publication number Publication date
WO2016055447A1 (en) 2016-04-14
AU2015330102B2 (en) 2021-01-28
CA2994891A1 (en) 2016-04-14
EP3204034C0 (en) 2023-06-07
US20190060235A1 (en) 2019-02-28
PL3204034T3 (pl) 2023-11-06
JP2017531659A (ja) 2017-10-26
RU2017115831A (ru) 2018-11-14
CA2994891C (en) 2023-04-04
MX2017004378A (es) 2018-02-09
JP2020183446A (ja) 2020-11-12
RU2737291C2 (ru) 2020-11-26
US20170304203A1 (en) 2017-10-26
ES2954134T3 (es) 2023-11-20
AU2015330102A1 (en) 2017-05-25
US11484499B2 (en) 2022-11-01
EP3204034A1 (en) 2017-08-16
JP2023002687A (ja) 2023-01-10
BR112017007031A2 (pt) 2018-01-30
RU2017115831A3 (hr) 2019-05-06
EP3204034B9 (en) 2023-10-04
EP3204034B1 (en) 2023-06-07
RS64461B1 (sr) 2023-09-29
GB201417589D0 (en) 2014-11-19
HUE063656T2 (hu) 2024-01-28

Similar Documents

Publication Publication Date Title
Pei et al. Drug delivery to macrophages: challenges and opportunities
Ferreira et al. pH-sensitive liposomes for drug delivery in cancer treatment
JP6751424B2 (ja) ダイズホスファチジルセリンで作られたコクリエート
JP6535281B2 (ja) 関節炎の処置方法
JP2018184470A5 (hr)
US20170281541A1 (en) Liposome-based mucus-penetrating particles for mucosal delivery
CN108024960A (zh) 含有阴离子药物的药物组合物及其制备方法
US20170072033A1 (en) Liposomal compositions for mucosal delivery
JP2017052790A (ja) sPLA2加水分解性リポソームを含む医薬組成物
US20080026049A1 (en) Liposomal compositions for parenteral delivery of agents
AU2015352688A1 (en) Pharmaceutical composition, preparation and uses thereof
AU2015206628A1 (en) Liposome compositions encapsulating modified cyclodextrin complexes and uses thereof
Camilo et al. Lipid vesicles: Applications, principal components and methods used in their formulations. A review
HRP20230985T1 (hr) Farmaceutske formulacije pegiliranih liposoma i faktora koagulacije krvi
Mozafari et al. An overview of liposome-derived nanocarrier technologies
Li et al. Colistin-entrapped liposomes driven by the electrostatic interaction: mechanism of drug loading and in vivo characterization
JP2018535952A5 (hr)
CA2595485A1 (en) Liposomal compositions for parenteral delivery of statins
CN113041345B (zh) 一种纳米类毒素疫苗及其用途
JP7463306B2 (ja) 関節内ステロイドの合併症を軽減する方法
JP2017531659A5 (hr)
EP3017823B1 (en) Lipid nanoparticle of polymyxin
CN104248768B (zh) 靶向中枢神经系统的纳米药物载体
WO2003022250A2 (en) Unilamellar vesicles stabilized with short chain hydrophilic polymers
TW202220668A (zh) 用於疼痛控制之關節內皮質類固醇的藥學組成物