HRP20140590T1 - Tekuä†i oblik g-csf konjugata - Google Patents
Tekuä†i oblik g-csf konjugata Download PDFInfo
- Publication number
- HRP20140590T1 HRP20140590T1 HRP20140590AT HRP20140590T HRP20140590T1 HR P20140590 T1 HRP20140590 T1 HR P20140590T1 HR P20140590A T HRP20140590A T HR P20140590AT HR P20140590 T HRP20140590 T HR P20140590T HR P20140590 T1 HRP20140590 T1 HR P20140590T1
- Authority
- HR
- Croatia
- Prior art keywords
- aqueous preparation
- active substance
- aqueous
- polysorbate
- range
- Prior art date
Links
- 239000012669 liquid formulation Substances 0.000 title 1
- 239000004094 surface-active agent Substances 0.000 claims 6
- 238000000034 method Methods 0.000 claims 3
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims 2
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 2
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 2
- 229930195725 Mannitol Natural products 0.000 claims 2
- 229920001213 Polysorbate 20 Polymers 0.000 claims 2
- AYFVYJQAPQTCCC-UHFFFAOYSA-N Threonine Natural products CC(O)C(N)C(O)=O AYFVYJQAPQTCCC-UHFFFAOYSA-N 0.000 claims 2
- 239000004473 Threonine Substances 0.000 claims 2
- 239000013543 active substance Substances 0.000 claims 2
- 239000000594 mannitol Substances 0.000 claims 2
- 235000010355 mannitol Nutrition 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 2
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 2
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 2
- 229940068977 polysorbate 20 Drugs 0.000 claims 2
- 229920000053 polysorbate 80 Polymers 0.000 claims 2
- 229940068968 polysorbate 80 Drugs 0.000 claims 2
- 230000002265 prevention Effects 0.000 claims 2
- 229910052708 sodium Inorganic materials 0.000 claims 2
- 239000011734 sodium Substances 0.000 claims 2
- 239000000600 sorbitol Substances 0.000 claims 2
- 239000008181 tonicity modifier Substances 0.000 claims 2
- 102000004269 Granulocyte Colony-Stimulating Factor Human genes 0.000 claims 1
- 108010017080 Granulocyte Colony-Stimulating Factor Proteins 0.000 claims 1
- 208000012902 Nervous system disease Diseases 0.000 claims 1
- 208000025966 Neurological disease Diseases 0.000 claims 1
- 239000003708 ampul Substances 0.000 claims 1
- 238000010322 bone marrow transplantation Methods 0.000 claims 1
- 238000001802 infusion Methods 0.000 claims 1
- 238000002347 injection Methods 0.000 claims 1
- 239000007924 injection Substances 0.000 claims 1
- 229930182817 methionine Natural products 0.000 claims 1
- 125000001360 methionine group Chemical group N[C@@H](CCSC)C(=O)* 0.000 claims 1
- 208000004235 neutropenia Diseases 0.000 claims 1
- 210000000130 stem cell Anatomy 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
Classifications
-
- 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
- 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
- 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
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/06—Antianaemics
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K17/00—Carrier-bound or immobilised peptides; Preparation thereof
- C07K17/02—Peptides being immobilised on, or in, an organic carrier
- C07K17/08—Peptides being immobilised on, or in, an organic carrier the carrier being a synthetic polymer
Claims (11)
1. Vodeni pripravak koji sadrži polimer-G-CSF konjugat kao djelatnu tvar sa sljedećom formulom:
[image]
gdje je AA treonin 133, ili treonin 134 ako je prisutan N-terminalni metionin, od G-CSF, i gdje je f cijeli broj izabran između 1 do 2500, polisorbat 20 i/ili polisorbat 80 kao površinski aktivnu tvar (surfaktant), sorbitol i/ili manitol kao modifikatore toničnosti, acetat kao pufer i natrij, bez drugih pomoćnih tvari, pri čemu pripravak ima pH u rasponu od 4.5 do 5.5.
2. Vodeni pripravak prema zahtjevu 1, gdje je površinski aktivna tvar (surfaktant) prisutna u koncentraciji od 0.0001% (w/v) - 0.05% (w/v).
3. Vodeni pripravak prema zahtjevu 1 ili 2, gdje je pH u rasponu od 4.7 do 5.3.
4. Vodeni pripravak prema bilo kojem od prethodnih zahtjeva, gdje je pH u rasponu od 4.9 do 5.1.
5. Vodeni pripravak prema bilo kojem od prethodnih zahtjeva, gdje je polimer-G-CSF konjugat prisutan u koncentraciji od 1 - 20 mg/ml, poželjno 8-12 mg/ml.
6. Farmaceutski spremnik koji sadrži vodeni pripravak prema bilo kojem od prethodnih zahtjeva.
7. Farmaceutski spremnik prema zahtjevu 6, gdje je spremnik štrcaljka, bočica, boca za infuziju, ampula, karpula, štrcaljka sa zaštitom igle ili karpula unutar injekcijske brizgalice (pen).
8. Postupak pripreme vodenog pripravka prema bilo kojem od zahtjeva 1 do 5, gdje je polimer-G-CSF konjugat kao djelatna tvar oblikovan u vodeni pripravak čiji je pH u rasponu od 4.5 do 5.5 i koji sadrži polisorbat 20 i/ili polisorbat 80 kao površinski aktivnu tvar (surfaktant), sorbitol i/ili manitol kao modifikatore toničnosti, acetat kao pufer i natrij.
9. Postupak pripreme vodenog pripravka prema zahtjevu 8, gdje je vodeni pripravak razrijeđen 1:2 do 1:8.
10. Vodeni pripravak prema bilo kojem od zahtjeva 1 do 5 za uporabu u liječenju ili prevenciji neutropenije, u liječenju ili prevenciji neuroloških poremećaja, u vezi s transplantacijom koštane srži, ili za mobilizaciju matičnih stanica.
11. Vodeni pripravak koji se može dobiti postupkom prema zahtjevu 9, za pedijatrijsku uporabu.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP07115047 | 2007-08-27 | ||
PCT/EP2008/061232 WO2009027437A1 (en) | 2007-08-27 | 2008-08-27 | Liquid formulation of g-csf conjugate |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20140590T1 true HRP20140590T1 (hr) | 2014-08-15 |
Family
ID=39862881
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20140590AT HRP20140590T1 (hr) | 2007-08-27 | 2014-06-24 | Tekuä†i oblik g-csf konjugata |
Country Status (24)
Country | Link |
---|---|
US (1) | US8546328B2 (hr) |
EP (2) | EP2197919B1 (hr) |
JP (2) | JP5570988B2 (hr) |
KR (1) | KR20100052501A (hr) |
CN (2) | CN101827864A (hr) |
AU (1) | AU2008292186B9 (hr) |
BR (1) | BRPI0815975B8 (hr) |
CA (1) | CA2696594C (hr) |
CY (1) | CY1115908T1 (hr) |
DE (1) | DE202008017456U1 (hr) |
DK (1) | DK2197919T3 (hr) |
EA (1) | EA020069B1 (hr) |
ES (1) | ES2476915T3 (hr) |
HR (1) | HRP20140590T1 (hr) |
IL (1) | IL204190A (hr) |
MX (1) | MX2010002448A (hr) |
NZ (1) | NZ583276A (hr) |
PL (1) | PL2197919T3 (hr) |
PT (1) | PT2197919E (hr) |
RS (1) | RS53404B (hr) |
SI (1) | SI2197919T1 (hr) |
UA (1) | UA98001C2 (hr) |
WO (1) | WO2009027437A1 (hr) |
ZA (1) | ZA201000798B (hr) |
Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
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RU2519031C1 (ru) * | 2010-01-19 | 2014-06-10 | Ханми Сайенс Ко., Лтд. | Жидкие препаративные формы для длительно действующего конъюгата g-csf |
CN102892780B (zh) | 2010-03-17 | 2015-07-29 | 通益制药有限公司 | 获得生物活性的重组人g-csf的方法 |
EP2384759A1 (en) | 2010-05-06 | 2011-11-09 | Suomen Punainen Risti Veripalvelu | Sulphated hyaluronic acid in combination with G-CSF for use in mobilising blood stem cells |
TWI751154B (zh) * | 2016-04-18 | 2022-01-01 | 大陸商江蘇恆瑞醫藥股份有限公司 | 一種重組人粒細胞集落刺激因子的製備方法 |
IT201700108526A1 (it) * | 2017-09-28 | 2019-03-28 | Alfasigma Spa | Composizioni orali per il trattamento del refluso gastroesofageo. |
US20210121529A1 (en) * | 2018-05-04 | 2021-04-29 | Ilkogen Ilaç Sanayi Ve Ticaret A.S. | Stable hybrid fc fusion g-csf formulation |
CN114224853B (zh) * | 2022-01-04 | 2022-09-23 | 山东新时代药业有限公司 | 聚乙二醇化重组人粒细胞刺激因子注射用冻干制剂 |
WO2024037633A2 (en) * | 2022-08-19 | 2024-02-22 | Evive Biotechnology (Shanghai) Ltd | Formulations comprising g-csf and uses thereof |
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ITMI20061624A1 (it) | 2006-08-11 | 2008-02-12 | Bioker Srl | Mono-coniugati sito-specifici di g-csf |
BRPI0809670A8 (pt) | 2007-04-03 | 2018-12-18 | Biogenerix Ag | métodos para aumentar a produção de célula tronco, para aumentar o número de granulócitos em um indivíduo, para prevenir, tratar e aliviar a mielossupressão que resulta de uma terapia contra o câncer, para tratar uma condição em um indivíduo, para tratar neutropenia e trombocitopenia em um mamífero, para expandir células tronco hematopoiéticas em cultura, para aumentar a hematopoiese em um indivíduo, para aumentar o número de célulars progenitoras hematopoiéticas em um indivíduo, e para fornecer enxerto estável da medula óssea, e, forma de dosagem oral. |
US8207112B2 (en) * | 2007-08-29 | 2012-06-26 | Biogenerix Ag | Liquid formulation of G-CSF conjugate |
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2008
- 2008-08-27 EP EP08787525.8A patent/EP2197919B1/en active Active
- 2008-08-27 EP EP12194213.0A patent/EP2578235A3/en not_active Withdrawn
- 2008-08-27 CN CN200880104971A patent/CN101827864A/zh active Pending
- 2008-08-27 CN CN201510065114.9A patent/CN104689333B/zh not_active Expired - Fee Related
- 2008-08-27 UA UAA201003493A patent/UA98001C2/uk unknown
- 2008-08-27 KR KR1020107004576A patent/KR20100052501A/ko not_active Application Discontinuation
- 2008-08-27 SI SI200831235T patent/SI2197919T1/sl unknown
- 2008-08-27 ES ES08787525.8T patent/ES2476915T3/es active Active
- 2008-08-27 NZ NZ583276A patent/NZ583276A/en not_active IP Right Cessation
- 2008-08-27 WO PCT/EP2008/061232 patent/WO2009027437A1/en active Application Filing
- 2008-08-27 JP JP2010522361A patent/JP5570988B2/ja not_active Expired - Fee Related
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- 2008-08-27 EA EA201070315A patent/EA020069B1/ru not_active IP Right Cessation
- 2008-08-27 US US12/675,749 patent/US8546328B2/en active Active
- 2008-08-27 BR BRPI0815975A patent/BRPI0815975B8/pt not_active IP Right Cessation
- 2008-08-27 PL PL08787525T patent/PL2197919T3/pl unknown
- 2008-08-27 AU AU2008292186A patent/AU2008292186B9/en active Active
- 2008-08-27 MX MX2010002448A patent/MX2010002448A/es unknown
- 2008-08-27 DE DE202008017456U patent/DE202008017456U1/de not_active Expired - Lifetime
- 2008-08-27 DK DK08787525.8T patent/DK2197919T3/da active
- 2008-08-27 PT PT87875258T patent/PT2197919E/pt unknown
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2010
- 2010-02-03 ZA ZA201000798A patent/ZA201000798B/xx unknown
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2013
- 2013-11-05 JP JP2013229688A patent/JP5836351B2/ja not_active Expired - Fee Related
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