HRP20220896T1 - Liofilizirana farmaceutska formulacija i njena upotreba - Google Patents

Liofilizirana farmaceutska formulacija i njena upotreba Download PDF

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Publication number
HRP20220896T1
HRP20220896T1 HRP20220896TT HRP20220896T HRP20220896T1 HR P20220896 T1 HRP20220896 T1 HR P20220896T1 HR P20220896T T HRP20220896T T HR P20220896TT HR P20220896 T HRP20220896 T HR P20220896T HR P20220896 T1 HRP20220896 T1 HR P20220896T1
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HR
Croatia
Prior art keywords
formulation
dihydrate
formulation according
pharmaceutical composition
polysorbate
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HRP20220896TT
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English (en)
Inventor
Markku Jalkanen
Mikael Maksimow
Ilse Piippo
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Faron Pharmaceuticals Oy
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Publication of HRP20220896T1 publication Critical patent/HRP20220896T1/hr

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    • 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
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/21Interferons [IFN]
    • A61K38/215IFN-beta
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/186Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • 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
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K9/0019Injectable 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
    • A61K9/08Solutions
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/18Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/52Cytokines; Lymphokines; Interferons
    • C07K14/555Interferons [IFN]
    • C07K14/565IFN-beta

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Vascular Medicine (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Rheumatology (AREA)
  • Virology (AREA)
  • Inorganic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Pulmonology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Claims (15)

1. Farmaceutska formulacija u liofiliziranom obliku, koja sadrži interferon beta-1a kao aktivni sastojak u količini od 2.0 - 15 µg u pojedinačnom intravenoznom doznom obliku, disaharide kao sredstvo za punjenje, neionski surfaktant i puferski agens, pri čemu je disaharid izabran između trehaloze dihidrata ili kombinacije trehaloze dihidrata i saharoze, i pri čemu je pH formulacije nakon rekonstitucije 6.0 - 7.5, a interferon beta-1a je rekombinantno proizveden interferon beta-1a sa biološkom aktivnošću od najmanje 150 MIU/mg.
2. Formulacija prema patentnom zahtjevu 1, pri čemu navedena formulacija dalje sadrži antioksidans.
3. Formulacija prema bilo kojem od prethodnih patentnih zahtjeva, pri čemu navedeni disaharid je trehaloza dihidrat.
4. Formulacija prema bilo kojem od prethodnih patentnih zahtjeva, pri čemu navedeni neionski surfaktant je polisorbat ili polietilen glikol (PEG).
5. Formulacija prema bilo kojem od prethodnih patentnih zahtjeva, pri čemu navedena formulacija sadrži dinatrij fosfat dihidrat, natrij dihidrogen fosfat dihidrat, trinatrij citrat dihidrat ili njihovu kombinaciju kao pufersko sredstvo.
6. Formulacija prema bilo kojem od prethodnih patentnih zahtjeva 2 do 5, pri čemu spomenuti antioksidans je metionin.
7. Formulacija prema bilo kojem od prethodnih patentnih zahtjeva, pri čemu sadržaj preostale vlage spomenute liofilizirane formulacije nije veći od 5 mas%, poželjno u opsegu od 1-5%.
8. Formulacija prema bilo kojem od prethodnih patentnih zahtjeva, pri čemu je formulacija pripremljena iz vodene otopine koji sadrži (i) rekombinantni humani interferon beta-1a kao aktivni sastojak, (ii) trehalozu dihidrat kao sredstvo za punjenje, (iii) polisorbat ili polietilen glikol kao surfaktant, (iv) kombinaciju dinatrij fosfat dihidrata, natrij dihidrogen fosfat dihidrata i trinatrij citrat dihidrata kao puferski agens, i (v) metionin kao antioksidans.
9. Formulacija prema patentnom zahtjevu 8, pri čemu vodena otopina sadrži 0.05 - 0.15 % (m/v) polisorbata ili polietilen glikola, poželjno polisorbat, i 2 - 6 % (m/v) trehaloza dihidrata.
10. Vodena farmaceutska kompozicija dobivena rekonstituiranjem liofilizirane formulacije prema bilo kojem od prethodnih patentnih zahtjeva 1 do 9.
11. Vodena farmaceutska kompozicija prema patentnom zahtjevu 10 za intravenoznu administraciju.
12. Uređaj za isporuku koji sadrži vodenu farmaceutsku kompoziciju prema patentnom zahtjevu 10.
13. Prethodno napunjena šprica koji sadrži vodenu farmaceutsku kompoziciju prema patentnom zahtjevu 10.
14. Uređaj za isporuku prema patentnom zahtjevu 12 ili prethodno napunjena šprica prema patentnom zahtjevu 13, pri čemu je unutrašnja površina uređaja za isporuku ili prethodno napunjenog šprica silikonizirana.
15. Liofilizirana formulacija iz bilo kojeg od patentnih zahtjeva 1 do 9 ili vodena farmaceutska kompozicija iz patentnog zahtjeva 10 za upotrebu u prevenciji i/ili liječenju bolesti ili poremećaja odabranih od - vaskularno-endotelne bolesti, - vaskularnog propuštanja kod akutnog respiratornog distresnog sindroma (ARDS) ili sindroma sustavnog upalnog odgovora (SIRS), - ishemijsko-reperfuzijske ozlijede u vaskularnoj ili kardiokirurgiji i transplantacije organa, - ishemijskog predkondicioniranja prije ozbiljnog vaskularnog ili kardiokirurškog zahvata i transplantacije organa, - akutnog pankreatitisa ili akutne ozlijede bubrega, - višestrukog zatajenja organa (MOF), - virusnih infekcija, i - bakterijske uplate pluća i sepse.
HRP20220896TT 2016-02-29 2017-02-28 Liofilizirana farmaceutska formulacija i njena upotreba HRP20220896T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FI20165153A FI126979B (en) 2016-02-29 2016-02-29 Lyophilized pharmaceutical formulation and use thereof
EP17711246.3A EP3423042B1 (en) 2016-02-29 2017-02-28 A lyophilised pharmaceutical formulation and its use
PCT/FI2017/050128 WO2017149199A1 (en) 2016-02-29 2017-02-28 A lyophilised pharmaceutical formulation and its use

Publications (1)

Publication Number Publication Date
HRP20220896T1 true HRP20220896T1 (hr) 2022-10-14

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HRP20220896TT HRP20220896T1 (hr) 2016-02-29 2017-02-28 Liofilizirana farmaceutska formulacija i njena upotreba

Country Status (20)

Country Link
US (1) US10293030B2 (hr)
EP (1) EP3423042B1 (hr)
JP (1) JP6869255B2 (hr)
KR (1) KR20180114018A (hr)
CN (2) CN107921001A (hr)
AU (1) AU2017225236B2 (hr)
BR (1) BR112018016545B1 (hr)
CA (1) CA3011609C (hr)
DK (1) DK3423042T3 (hr)
ES (1) ES2922481T3 (hr)
FI (1) FI126979B (hr)
HK (1) HK1250147A1 (hr)
HR (1) HRP20220896T1 (hr)
HU (1) HUE059550T2 (hr)
LT (1) LT3423042T (hr)
PL (1) PL3423042T3 (hr)
PT (1) PT3423042T (hr)
RS (1) RS63429B1 (hr)
SI (1) SI3423042T1 (hr)
WO (1) WO2017149199A1 (hr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BRPI1015938A2 (pt) * 2009-06-25 2016-09-27 Revance Therapeutics Inc formulações da toxina botulínica livre de albumina
EP3395356B1 (en) * 2011-02-18 2021-05-19 Stemdr Inc. Composition containing inducer of sirt1 expression for preventing or treating sepsis or septic shock
UY38238A (es) * 2018-05-25 2019-12-31 Genzyme Corp Composiciones farmacéuticas para el tratamiento de la deficiencia de esfingomielinasa ácida

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0150067A3 (en) 1984-01-23 1986-12-30 Takeda Chemical Industries, Ltd. Stable composition of gamma-interferon
CA1294215C (en) 1986-10-27 1992-01-14 Ze'ev Shaked Pharmaceutical compositions of recombinant beta-interferon and formulation processes
US5556771A (en) 1995-02-10 1996-09-17 Gen-Probe Incorporated Stabilized compositions of reverse transcriptase and RNA polymerase for nucleic acid amplification
JP4293497B2 (ja) 1997-09-23 2009-07-08 レントシュレール ビオテクノロジー ゲー・エム・ベー・ハー インターフェロン−β液状組成物
US6887462B2 (en) * 2001-04-09 2005-05-03 Chiron Corporation HSA-free formulations of interferon-beta
CN101664545A (zh) 2002-07-17 2010-03-10 比奥根艾迪克Ma公司 使用干扰素-β治疗肾衰竭
US7534423B2 (en) 2003-03-28 2009-05-19 Faron Pharmaceuticals Oy Method for inducing an elevated level of adenosine in an individual
AR044302A1 (es) 2003-05-13 2005-09-07 Ares Trading Sa Formulaciones con proteinas liquidas estabilizadas en recipientes farmaceuticos
CA2526099C (en) * 2003-06-20 2013-02-05 Ares Trading Sa Freeze-dried fsh / lh formulations
JP4971160B2 (ja) * 2004-08-12 2012-07-11 シェーリング コーポレイション 安定するpeg化インターフェロン処方物
US20120269770A1 (en) * 2010-11-22 2012-10-25 Mark Brader Stable Preserved Compositions of Interferon-Beta

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Publication number Publication date
LT3423042T (lt) 2022-08-10
BR112018016545B1 (pt) 2023-10-10
US20170246254A1 (en) 2017-08-31
FI20165153A (fi) 2017-08-30
EP3423042B1 (en) 2022-04-27
JP6869255B2 (ja) 2021-05-12
KR20180114018A (ko) 2018-10-17
US10293030B2 (en) 2019-05-21
CN115364060A (zh) 2022-11-22
RS63429B1 (sr) 2022-08-31
SI3423042T1 (sl) 2022-10-28
AU2017225236A1 (en) 2018-08-02
AU2017225236B2 (en) 2022-03-31
WO2017149199A1 (en) 2017-09-08
CN107921001A (zh) 2018-04-17
ES2922481T3 (es) 2022-09-15
CA3011609A1 (en) 2017-09-08
BR112018016545A2 (pt) 2018-12-26
PT3423042T (pt) 2022-07-25
FI126979B (en) 2017-09-15
HK1250147A1 (zh) 2018-11-30
DK3423042T3 (da) 2022-07-18
PL3423042T3 (pl) 2022-09-19
JP2019513123A (ja) 2019-05-23
HUE059550T2 (hu) 2022-11-28
EP3423042A1 (en) 2019-01-09
CA3011609C (en) 2023-10-10

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