HRP20241131T1 - Visokokoncentrirane formulacije inhibitornih antitijela masp-2 niske viskoznosti, pribori i metode - Google Patents
Visokokoncentrirane formulacije inhibitornih antitijela masp-2 niske viskoznosti, pribori i metode Download PDFInfo
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- HRP20241131T1 HRP20241131T1 HRP20241131TT HRP20241131T HRP20241131T1 HR P20241131 T1 HRP20241131 T1 HR P20241131T1 HR P20241131T T HRP20241131T T HR P20241131TT HR P20241131 T HRP20241131 T HR P20241131T HR P20241131 T1 HRP20241131 T1 HR P20241131T1
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- 239000000203 mixture Substances 0.000 title claims 29
- 101710117460 Mannan-binding lectin serine protease 2 Proteins 0.000 title claims 3
- 102100026046 Mannan-binding lectin serine protease 2 Human genes 0.000 title claims 3
- 239000003112 inhibitor Substances 0.000 title 1
- 238000009472 formulation Methods 0.000 claims 28
- 239000008194 pharmaceutical composition Substances 0.000 claims 13
- 150000001413 amino acids Chemical group 0.000 claims 6
- KWTQSFXGGICVPE-WCCKRBBISA-N Arginine hydrochloride Chemical compound Cl.OC(=O)[C@@H](N)CCCN=C(N)N KWTQSFXGGICVPE-WCCKRBBISA-N 0.000 claims 5
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 5
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 5
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 5
- 229920000053 polysorbate 80 Polymers 0.000 claims 5
- 229940068968 polysorbate 80 Drugs 0.000 claims 5
- 239000001509 sodium citrate Substances 0.000 claims 5
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims 5
- 239000000243 solution Substances 0.000 claims 5
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 claims 4
- 239000012634 fragment Substances 0.000 claims 4
- 239000004475 Arginine Substances 0.000 claims 3
- 229960003121 arginine Drugs 0.000 claims 3
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims 3
- 235000009697 arginine Nutrition 0.000 claims 3
- 239000003795 chemical substances by application Substances 0.000 claims 3
- 238000002347 injection Methods 0.000 claims 3
- 239000007924 injection Substances 0.000 claims 3
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims 2
- 101001056015 Homo sapiens Mannan-binding lectin serine protease 2 Proteins 0.000 claims 2
- 229940024606 amino acid Drugs 0.000 claims 2
- 235000001014 amino acid Nutrition 0.000 claims 2
- 239000007853 buffer solution Substances 0.000 claims 2
- 239000001110 calcium chloride Substances 0.000 claims 2
- 229910001628 calcium chloride Inorganic materials 0.000 claims 2
- 235000011148 calcium chloride Nutrition 0.000 claims 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 2
- 102000054960 human MASP2 Human genes 0.000 claims 2
- 229910001629 magnesium chloride Inorganic materials 0.000 claims 2
- 238000007911 parenteral administration Methods 0.000 claims 2
- 238000007920 subcutaneous administration Methods 0.000 claims 2
- 239000004094 surface-active agent Substances 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 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 1
- 241000282412 Homo Species 0.000 claims 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims 1
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 1
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims 1
- 229930006000 Sucrose Natural products 0.000 claims 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 1
- 239000000654 additive Substances 0.000 claims 1
- 230000000996 additive effect Effects 0.000 claims 1
- 239000007864 aqueous solution Substances 0.000 claims 1
- 229940090047 auto-injector Drugs 0.000 claims 1
- 239000000872 buffer Substances 0.000 claims 1
- 239000006172 buffering agent Substances 0.000 claims 1
- 125000002091 cationic group Chemical group 0.000 claims 1
- -1 citrate Chemical compound 0.000 claims 1
- 230000000295 complement effect Effects 0.000 claims 1
- 230000001419 dependent effect Effects 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 208000035475 disorder Diseases 0.000 claims 1
- 239000002552 dosage form Substances 0.000 claims 1
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 1
- 230000035772 mutation Effects 0.000 claims 1
- 239000002736 nonionic surfactant Substances 0.000 claims 1
- 229940090048 pen injector Drugs 0.000 claims 1
- 229920001983 poloxamer Polymers 0.000 claims 1
- 229960000502 poloxamer Drugs 0.000 claims 1
- 229920000136 polysorbate Polymers 0.000 claims 1
- 229950008882 polysorbate Drugs 0.000 claims 1
- 229940071643 prefilled syringe Drugs 0.000 claims 1
- 238000005086 pumping Methods 0.000 claims 1
- 239000000600 sorbitol Substances 0.000 claims 1
- 239000005720 sucrose Substances 0.000 claims 1
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- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
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Claims (17)
1. Farmaceutska formulacija stabilna kada se čuva na temperaturi između 2°C i 8°C najmanje šest mjeseci i koja ima viskoznost između 2 i 50 mPa-s (centipoza (cP)) mjereno pri 25°C s brzinom smicanja u rasponu od 100 000 do 250 000 l/s prikladnom za parenteralnu primjenu u ispitanika sisavaca, koja obuhvaća:
(a) vodenu otopinu koja sadrži puferski sustav s pH vrijednošću od 5.0 do 7.0, naznačenu time što puferski sustav sadrži najmanje jedno pufersko sredstvo odabrano iz skupine koja se sastoji od citrata ili histidina;
(b) monoklonsko antitijelo ili njegov fragment koji se specifično veže na humani MASP-2 i sadrži (i) varijabilnu regiju teškog lanca koja sadrži aminokiselinsku sekvencu navedenu u SEQ ID NO:2 i (ii) varijabilnu regiju lakog lanca koja sadrži aminokiselinsku sekvencu navedenu u SEQ ID NO: 3, i koje je antitijelo ili njegov fragment u koncentraciji od 50 mg/mL do 250 mg/mL; i
(c) sredstvo koje modificira toničnost u dovoljnoj količini da formulacija bude hipertonična.
2. Farmaceutska formulacija prema zahtjevu 1, naznačena time što se primjenjuje najmanje jedno ili više od sljedećeg:
(a) pri čemu je koncentracija antitijela u formulaciji od 100 mg/mL do 225 mg/mL, ili od 150 mg/mL do 200 mg/mL, ili od 175 mg/mL do 195 mg/mL;
(b) pri čemu je viskoznost formulacije od 2 mPa-s (cP) do 40 mPa-s (cP), ili od 2 mPa-s (cP) do 30 mPa-s (cP), ili od 2 mPa-s (cP) do 25 mPa-s (cP), ili od 2 mPa-s (cP) do 20 mPa-s (cP), ili od 2 mPa-s (cP) do 18 mPa-s (cP);
(c) pri čemu je viskoznost manja od oko 25 mPa-s (cP), primjerice manja od oko 20 mPa-s (cP), ili manja od oko 18 mPa-s (cP);
(d) pri čemu je koncentracija protutijela 185 mg/ml;
(e) pri čemu je formulacija stabilna ako se čuva između 2°C i 8°C najmanje 12 mjeseci;
(f) pri čemu sila klizanja formulacije injekcijom iznosi 25 Newtona ili manje kada se injektira kroz iglu promjera 27GA 31.75 mm (1,25") na sobnoj temperaturi; ili
(g) pri čemu sila klizanja formulacije injekcijom iznosi 20 Newtona ili manje kada se injektira kroz iglu promjera 25GA 25.4 mm (1") na sobnoj temperaturi; ili
3. Farmaceutska formulacija tvrdnje 1, naznačena time što je najmanje jedno pufersko sredstvo citrat, kao što je natrijev citrat, kao što je citrat, u kojem je citrat prisutan u otopini u koncentraciji od 10 mM do 50 mM.
4. Farmaceutska formulacija prema zahtjevu 1, naznačena time što je sredstvo za modificiranje toničnosti aminokiselina s pozitivno nabijenim bočnim lancem odabrana iz skupine koju čine:
(a) pri čemu je aminokiselina s pozitivno nabijenim bočnim lancem prisutna u formulaciji u koncentraciji od 150 mM do 300 mM;
(b) pri čemu je pozitivno nabijeni bočni lanac arginin ili L-arginin-HCl, i
(c) pri čemu je arginin prisutan u otopini na hipertoničkoj razini od 200 mM do 300 mM.
5. Farmaceutska formulacija prema zahtjevu 3, naznačena time što otopina sadrži oko 20 mM citrata i ima pH od oko 5.5 do 6.5, izborno gdje otopina dalje sadrži arginin u koncentraciji od oko 200 mM.
6. Farmaceutska formulacija prema zahtjevu 1, naznačena time što otopina dalje sadrži surfaktant u koncentraciji od 0.001% (w/v) i 0.1% (w/v), izborno gdje je surfaktant neionski surfaktant kao što je polisorbat ili poloksamer, npr. polisorbat 80.
7. Farmaceutska formulacija prema zahtjevu 1, naznačena time što se primjenjuje najmanje jedno ili više od sljedećeg:
(a) pri čemu formulacija ne uključuje saharozu ili sorbitol;
(b) pri čemu formulacija ne uključuje CaCl2;
(c) pri čemu formulacija ne uključuje MgCl2;
(d) ako formulacija ne uključuje CaCl2 i ako formulacija ne uključuje MgCl2; ili
(e) u kojoj formulacija ne uključuje dvovalentni kationski aditiv.
8. Farmaceutska formulacija tvrdnje 1, naznačena time što se formulacija odabire iz skupine koja se sastoji od:
(i) formulacije koja sadrži
(a) polisorbat 80 u koncentraciji od 0.01 do 0.08% w/v;
(b) L-arginin HCl u koncentraciji od 150 mM do 200 mM;
(c) natrijev citrat u koncentraciji od 10 mM do 50 mM; i
(d) 150 mg/mL do 200 mg/mL antitijela; i
(ii) formulacije koja sadrži
(a) polisorbat 80 u koncentraciji od oko 0.01 w/v;
(b) L-arginin HCl u koncentraciji od oko 200 mM;
(c) natrijev citrat u koncentraciji od oko 20 mM; i
(d) 175 mg/mL do 195 mg/mL antitijela.
9. Farmaceutska formulacija prema zahtjevu 1, formulacija koja se u biti sastoji od:
(a) polisorbat 80 u koncentraciji od 0.01 do 0.08% w/v;
(b) L-arginin HCl u koncentraciji od 150 mM do 200 mM;
(c) natrijev citrat u koncentraciji od 10 mM do 50 mM; i
(d) monoklonsko antitijelo ili njegov fragment koji se specifično veže na humani MASP-2 u koncentraciji od 150 mg/mL do 200 mg/mL, pri čemu navedeno antitijelo ili njegov fragment sadrži (i) varijabilnu regiju teškog lanca koja sadrži aminokiselinsku sekvencu navedenu u SEQ ID NO:2 i (ii) varijabilnu regiju lakog lanca koja sadrži aminokiselinsku sekvencu navedenu u SEQ ID NO: 3.
10. Zatvoreni spremnik koji sadrži formulaciju prema zahtjevu 1 ili 9.
11. Uređaj za supkutanu primjenu koji sadrži formulaciju prema zahtjevu 1 ili 9.
12. Komplet koji sadrži unaprijed napunjeni spremnik koji sadrži farmaceutsku formulaciju koja sadrži MASP-2 antitijelo prema zahtjevu 1 ili 9 i upute za uporabu formulacije, primjerice gdje je unaprijed napunjeni spremnik odabran iz skupine koju čine: štrcaljka, pen injektor, zapečaćena bočica, auto-injektor i uređaj za pumpanje, izborno pri čemu komplet nadalje sadrži najmanje jedan injekcijski uređaj prikladan za davanje formulacije u zapečaćenoj bočici ljudskom subjektu.
13. Farmaceutski jedinični oblik doziranja prikladan za parenteralnu primjenu ljudima, naznačen time što sadrži formulaciju prema zahtjevu 1 ili 9 u prikladnom spremniku.
14. Formulacija prema zahtjevu 1 ili 9 za uporabu u liječenju subjekta koji pati od bolesti ili poremećaja povezane s komplementom ovisne o MASP-2, izborno gdje je formulacija prikladna za supkutanu primjenu, izborno gdje je formulacija sadržana u unaprijed napunjenoj štrcaljki.
15. Farmaceutska formulacija prema zahtjevu 1, naznačena time što formulacija sadrži od 0.001% w/v do 0.05% w/v polisorbata 80, oko 20 mM natrijevog citrata i oko 200 mM L-arginin HCl, pri čemu je koncentracija antitijela u formulacija je od 175 mg/mL do 195 mg/mL, i gdje je viskoznost manja od 25 mPa-s (cP).
16. Farmaceutska formulacija prema zahtjevu 1, naznačena time što je formulacija sterilna.
17. Farmaceutska formulacija prema zahtjevu 1, naznačena time što je monoklonsko antitijelo monoklonsko antitijelo pune dužine, izborno gdje je antitijelo ljudsko IgG4 antitijelo pune dužine, kao što je ljudsko IgG4 antitijelo koje sadrži mutaciju u zglobnoj regiji.
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| EP17847485.4A EP3506886B1 (en) | 2016-08-31 | 2017-08-30 | Highly concentrated low viscosity masp-2 inhibitory antibody formulations, kits, and methods |
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| JOP20190068A1 (ar) * | 2016-10-13 | 2019-04-01 | Omeros Corp | طرق لتقليل البول البروتيني في خاضع بشري يعاني من الاعتلال الكلوي a الناتج عن الجلوبيولين المناعي |
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