HRP20090434T1 - Sastavi kontroliranog otpuštanja za interferon koji se temelji na pegt/pbt blok kopolimerima - Google Patents

Sastavi kontroliranog otpuštanja za interferon koji se temelji na pegt/pbt blok kopolimerima Download PDF

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Publication number
HRP20090434T1
HRP20090434T1 HR20090434T HRP20090434T HRP20090434T1 HR P20090434 T1 HRP20090434 T1 HR P20090434T1 HR 20090434 T HR20090434 T HR 20090434T HR P20090434 T HRP20090434 T HR P20090434T HR P20090434 T1 HRP20090434 T1 HR P20090434T1
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Croatia
Prior art keywords
block copolymers
composition
pegt
poly
controlled release
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HR20090434T
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English (en)
Inventor
Chantal Bechet Anne
Van Dijkhuizen-Radersma Riemke
Stigter Martin
Mattijs Bezemer Jeroen
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Biolex Therapeutics
Octoplus Polyactive Sciences B.V.
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Application filed by Biolex Therapeutics, Octoplus Polyactive Sciences B.V. filed Critical Biolex Therapeutics
Publication of HRP20090434T1 publication Critical patent/HRP20090434T1/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]
    • A61K38/212IFN-alpha
    • 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
    • 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]
    • 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
    • A61K47/34Macromolecular 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
    • 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
    • A61K9/0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • 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
    • 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
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647Polyesters, e.g. poly(lactide-co-glycolide)
    • 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
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • 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
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    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • A61P31/18Antivirals for RNA viruses for HIV
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    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Postupak pripreme mikrodijelova, naznačen time, da isti sadrže jedan ili više aktivnih spojeva odabranih iz grupe interferona i jednog ili više biorazgradivih blok kopolimera stvorenih od poli(etilenglikol) tereftalata (PEGT) i poli(butilen tereftalata) (PBT), koji se sastoje od sljedećih koraka: (a) priprema emulzije koja se sastoji od (aa) vodene unutarnje faze koja sadrži jedan ili više aktivnih spojeva, i (ab) organske vanjske faze koja sadrži jedan ili više biorazgradivih blok kopolimera i bar jedno organsko otapalo; (b) ukrućivanje jednog ili više biorazgradivih blok kopolimera u mikrodijelove otklanjanjem barem dijela organskog otapala iz emulzije pripremljene u koraku (a); (c) prikupljanje i sušenje mikrodijelova oblikovanih u koraku (b) pri čemu korak (b) se provodi emulzifikacijom emulzije pripremljene u koraku (a) i povezane vodene faze da bi se dobila w/o/w-dvostruka emulzija, pri čemu povezana vodena faza sadrži osmotski agens, pri čemu je osmolalnost povezane vodene faze viša od one vodene unutarnje faze. Patent sadrži još 4 patentna zahtjeva.

Claims (5)

1. Postupak pripreme mikrodijelova, naznačen time, da isti sadrže jedan ili više aktivnih spojeva odabranih iz grupe interferona i jednog ili više biorazgradivih blok kopolimera stvorenih od poli(etilenglikol) tereftalata (PEGT) i poli(butilen tereftalata) (PBT), koji se sastoje od sljedećih koraka: (a) priprema emulzije koja se sastoji od (aa) vodene unutarnje faze koja sadrži jedan ili više aktivnih spojeva, i (ab) organske vanjske faze koja sadrži jedan ili više biorazgradivih blok kopolimera i bar jedno organsko otapalo; (b) ukrućivanje jednog ili više biorazgradivih blok kopolimera u mikrodijelove otklanjanjem barem dijela organskog otapala iz emulzije pripremljene u koraku (a); (c) prikupljanje i sušenje mikrodijelova oblikovanih u koraku (b) pri čemu korak (b) se provodi emulzifikacijom emulzije pripremljene u koraku (a) i povezane vodene faze da bi se dobila w/o/w-dvostruka emulzija, pri čemu povezana vodena faza sadrži osmotski agens, pri čemu je osmolalnost povezane vodene faze viša od one vodene unutarnje faze.
2. Postupak prema zahtjevu 1, naznačen time, da je osmotski agens sol.
3. Postupak prema zahtjevu 2, naznačen time, da je sol natrij klorid.
4. Postupak prema zahtjevu 3, naznačen time, da je natrij klorid prisutan u razini od oko 3 do oko 6 wt.%.
5. Postupak prema bilo kojem od ranijih zahtjeva, naznačen time, da je interferon izabran iz grupe alfa-interferona.
HR20090434T 2005-01-07 2009-08-11 Sastavi kontroliranog otpuštanja za interferon koji se temelji na pegt/pbt blok kopolimerima HRP20090434T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP05075043A EP1679065A1 (en) 2005-01-07 2005-01-07 Controlled release compositions for interferon based on PEGT/PBT block copolymers
PCT/NL2006/000006 WO2006085747A1 (en) 2005-01-07 2006-01-06 Controlled release compositions for interferon based on pegt/pbt block copolymers

Publications (1)

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HRP20090434T1 true HRP20090434T1 (hr) 2009-09-30

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HR20090434T HRP20090434T1 (hr) 2005-01-07 2009-08-11 Sastavi kontroliranog otpuštanja za interferon koji se temelji na pegt/pbt blok kopolimerima

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Country Link
US (3) US7736674B2 (hr)
EP (4) EP1679065A1 (hr)
JP (2) JP2008526837A (hr)
KR (2) KR101354521B1 (hr)
CN (2) CN101137349B (hr)
AT (1) ATE431134T1 (hr)
AU (2) AU2006213168B2 (hr)
BR (1) BRPI0606514A2 (hr)
CA (1) CA2594434A1 (hr)
CY (1) CY1109297T1 (hr)
DE (1) DE602006006797D1 (hr)
DK (1) DK1843749T3 (hr)
ES (1) ES2327267T3 (hr)
HK (1) HK1152644A1 (hr)
HR (1) HRP20090434T1 (hr)
IL (2) IL184431A (hr)
MX (1) MX2007008293A (hr)
PL (1) PL1843749T3 (hr)
PT (1) PT1843749E (hr)
RS (1) RS51129B (hr)
RU (2) RU2409348C2 (hr)
SG (1) SG158856A1 (hr)
SI (1) SI1843749T1 (hr)
WO (1) WO2006085747A1 (hr)

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BRPI0606514A2 (pt) 2010-01-19
RU2007130090A (ru) 2009-02-20
EP1886668B1 (en) 2012-11-14
ATE431134T1 (de) 2009-05-15
DK1843749T3 (da) 2009-09-07
JP4887542B2 (ja) 2012-02-29
CA2594434A1 (en) 2006-08-17
AU2006213168A1 (en) 2006-08-17
EP2266535B1 (en) 2013-03-06
HK1152644A1 (en) 2012-03-09
KR101354521B1 (ko) 2014-01-22
WO2006085747A1 (en) 2006-08-17
RU2409348C2 (ru) 2011-01-20
US20100074868A1 (en) 2010-03-25
SI1843749T1 (sl) 2009-10-31
PL1843749T3 (pl) 2009-10-30
EP2266535A3 (en) 2011-06-15
KR20070118225A (ko) 2007-12-14
US8163307B2 (en) 2012-04-24
ES2327267T3 (es) 2009-10-27
DE602006006797D1 (de) 2009-06-25
EP1679065A1 (en) 2006-07-12
EP1843749B1 (en) 2009-05-13
CN101137349B (zh) 2013-01-02
IL208175A0 (en) 2010-12-30
IL184431A (en) 2012-03-29
AU2010224413B2 (en) 2012-03-22
PT1843749E (pt) 2009-08-17
JP2008526837A (ja) 2008-07-24
CN101791396A (zh) 2010-08-04
SG158856A1 (en) 2010-02-26
CY1109297T1 (el) 2014-07-02
JP2011016836A (ja) 2011-01-27
RU2010138739A (ru) 2012-03-27
MX2007008293A (es) 2007-12-07
US7867518B2 (en) 2011-01-11
CN101137349A (zh) 2008-03-05
RS51129B (sr) 2010-10-31
US20090226532A1 (en) 2009-09-10
AU2006213168B2 (en) 2011-09-15
US7736674B2 (en) 2010-06-15
AU2010224413A1 (en) 2010-10-14
EP1886668A1 (en) 2008-02-13
KR20100109983A (ko) 2010-10-11
US20080008733A1 (en) 2008-01-10
EP1843749A1 (en) 2007-10-17
IL184431A0 (en) 2007-10-31
EP2266535A2 (en) 2010-12-29

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