HRP20120483T1 - Formulacije peg interferona beta - Google Patents

Formulacije peg interferona beta Download PDF

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Publication number
HRP20120483T1
HRP20120483T1 HRP20120483AT HRP20120483T HRP20120483T1 HR P20120483 T1 HRP20120483 T1 HR P20120483T1 HR P20120483A T HRP20120483A T HR P20120483AT HR P20120483 T HRP20120483 T HR P20120483T HR P20120483 T1 HRP20120483 T1 HR P20120483T1
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Croatia
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preparation according
concentration
present
peg
preparation
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HRP20120483AT
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English (en)
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Alessandra@Del@Rio
Joel@Richard
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Merck@Serono@SA
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    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/21—Interferons [IFN]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/21—Interferons [IFN]
    • A61K38/215—IFN-beta
    • 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
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/52—Cytokines; Lymphokines; Interferons
    • C07K14/555—Interferons [IFN]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/52—Cytokines; Lymphokines; Interferons
    • C07K14/555—Interferons [IFN]
    • C07K14/565—IFN-beta
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
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  • Gastroenterology & Hepatology (AREA)
  • Organic Chemistry (AREA)
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  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
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  • Toxicology (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biomedical Technology (AREA)
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  • Neurosurgery (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Tekući farmaceutski pripravak koji sadrži pegilirani interferon PEGIFN pomoćnu tvar poliol poloksamer kao surfaktant i natrijev acetat kao pufer naznačen time da pH farmaceutskog pripravka je ± Patent sadrži još patentnih zahtjeva

Claims (21)

1. Tekući farmaceutski pripravak koji sadrži pegilirani interferon-β (PEGIFN-β), pomoćnu tvar poliol, poloksamer 188 kao surfaktant i natrijev acetat kao pufer naznačen time da pH farmaceutskog pripravka je 4.2 ± 0.2.
2. Pripravak prema zahtjevu 1 naznačen time da navedena pomoćna tvar poliol je manitol.
3. Pripravak prema zahtjevu 1 ili 2, naznačen time da navedeni PEG-IFN-β je prisutan u koncentraciji od 0.01 mg/ml do 0.1 mg/ml.
4. Pripravak prema zahtjevu 3, naznačen time da navedeni PEG-I FN- β je prisutan u koncentraciji od 0.044 mg/ml, 0.055 mg/ml ili 0.110 mg/ml.
5. Pripravak prema bilo kojem od prethodnih zahtjeva, naznačen time da PEG-IFN-β sadrži ravni ili razgranati PEG, a poželjno razgranati PEG.
6. Pripravak prema zahtjevu 5, naznačen time da PEG ima molekularnu težinu od najmanje 20 kDa, poželjno barem 40 kDa, još poželjnije 40 kDa.
7. Pripravak prema zahtjevu 1 ili 2, naznačen time da navedena pomoćna tvar poliol je prisutna u koncentraciji od 30 mg/ml do 50 mg/ml.
8. Pripravak prema zahtjevu 1 ili 2, naznačen time da navedena pomoćna tvar poliol je prisutna u koncentraciji od 40 mg/ml do 50 mg/ml.
9. Pripravak prema zahtjevu 1 ili 2, naznačen time da navedena pomoćna tvar poliol je prisutna u koncentraciji od 45 mg/ml.
10. Pripravak prema zahtjevu 1 ili 2, naznačen time da navedeni poloksamer 188 je prisutan u koncentraciji od 0.1 mg/ml do 1 mg/ml.
11. Pripravak prema zahtjevu 1 ili 2, naznačen time da navedeni poloksamer 188 je prisutan u koncentraciji od 0.4 mg/ml do 0.7 mg/ml.
12. Pripravak prema zahtjevu 1 ili 2, naznačen time da navedeni poloksamer 188 je prisutan u koncentraciji od 0.5 mg/ml.
13. Pripravak prema zahtjevu 1 ili 2, naznačen time da navedeni natrijev acetat kao pufer je prisutan u koncentraciji od 5 mM do 500 mM.
14. Pripravak prema zahtjevu 13, naznačen time da navedeni natrijev acetat kao pufer je prisutan u koncentraciji od 10 mM.
15. Pripravak prema bilo kojem od prethodnih zahtjeva, naznačen time da navedeni pripravak je vodena otopina.
16. Pripravak prema bilo kojem od prethodnih zahtjeva, naznačen time da navedeni pripravak nadalje sadrži metionin.
17. Pripravak prema zahtjevu 16, naznačen time da je metionin prisutan u koncentraciji da 0.10 do 0.50 mg/ml, poželjno 0.20 do 0.40 mg/ml, još poželjnije 0.12 ili 0.25 mg/ml.
18. Postupak za dobivanje tekućeg farmaceutskog pripravka prema bilo kojem od zahtjeva 1-17, naznačen time da navedeni postupak sadrži dodavanje proračunate količine pomoćne tvari poliola i poloksamera 188 u pufersku otopinu natrijevog acetata i zatim se dodaje PEG-IFN-beta.
19. Hermetički začepljen spremnik u sterilnim uvjetima i prikladan za pohranjivanje prije uporabe, naznačen time da sadrži tekuću farmaceutsku formulaciju prema bilo kojem od zahtjeva od 1 do 17.
20. Spremnik prema zahtjevu 19, naznačen time navedeni spremnik je prethodno napunjena štrcaljka ili bočica za auto-injektorski uređaj.
21. Kit sa farmaceutskim pripravkom, naznačen time da kit sadrži spremnik ispunjen sa farmaceutskim pripravkom prema bilo kojem od zahtjeva 1 do 17.
HRP20120483AT 2007-12-20 2012-06-08 Formulacije peg interferona beta HRP20120483T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP07150258 2007-12-20
US1025808P 2008-01-07 2008-01-07
PCT/EP2008/067876 WO2009080699A2 (en) 2007-12-20 2008-12-18 Peg-interferon-beta formulations

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HRP20120483T1 true HRP20120483T1 (hr) 2012-07-31

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US (1) US9138403B2 (hr)
EP (1) EP2234645B1 (hr)
JP (2) JP5563475B2 (hr)
KR (1) KR20100099298A (hr)
CN (1) CN101878043A (hr)
AT (1) ATE555812T1 (hr)
AU (1) AU2008340058A1 (hr)
BR (1) BRPI0821029A2 (hr)
CY (1) CY1112820T1 (hr)
DK (1) DK2234645T3 (hr)
EA (1) EA201070773A1 (hr)
ES (1) ES2387236T3 (hr)
HR (1) HRP20120483T1 (hr)
IL (1) IL206441A0 (hr)
PL (1) PL2234645T3 (hr)
PT (1) PT2234645E (hr)
RS (1) RS52417B (hr)
SI (1) SI2234645T1 (hr)
WO (1) WO2009080699A2 (hr)
ZA (1) ZA201001908B (hr)

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US7731948B2 (en) 2004-06-01 2010-06-08 Ares Trading S.A. Stabilized interferon liquid 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
SI2234645T1 (sl) * 2007-12-20 2012-07-31 Merck Serono Sa Formulacije peg interferon beta

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WO2009080699A3 (en) 2009-11-26
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KR20100099298A (ko) 2010-09-10
BRPI0821029A2 (pt) 2015-06-16
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US20100239529A1 (en) 2010-09-23
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