DK3148510T3 - Væskeformig farmaceutisk sammensætning - Google Patents
Væskeformig farmaceutisk sammensætning Download PDFInfo
- Publication number
- DK3148510T3 DK3148510T3 DK15724974.9T DK15724974T DK3148510T3 DK 3148510 T3 DK3148510 T3 DK 3148510T3 DK 15724974 T DK15724974 T DK 15724974T DK 3148510 T3 DK3148510 T3 DK 3148510T3
- Authority
- DK
- Denmark
- Prior art keywords
- suitably
- histidine
- pharmaceutical composition
- liquid pharmaceutical
- adalimumab
- Prior art date
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- Microbiology (AREA)
- Orthopedic Medicine & Surgery (AREA)
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- Inorganic Chemistry (AREA)
- Transplantation (AREA)
- Diabetes (AREA)
- Pain & Pain Management (AREA)
- Ophthalmology & Optometry (AREA)
- Medicinal Preparation (AREA)
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Claims (14)
1. Vandig farmaceutisk sammensætning, der omfatter: (a) adalimumab; (b) histidinbuffermiddel (eller histidinbuffersystem); (c) sukkerstabilisator valgt fra gruppen, der indbefatter trehalose, saccharose, sorbitol, maltose, lactose, xylitol, arabitol, erythritol, lactitol, maltitol, inositol; og (d) 0,05 mg/ml til 2 mg/ml overfladeaktivt stof valgt blandt polysorbat 20 og polysorbat 80; hvor sammensætningen: • har et pH på mellem 5,0 og 6,7; • enten er fri for andre aminosyrer end histidin eller omfatter en eller flere andre aminosyrer end histidin ved en (samlet) koncentration på højst 0,1 mM; og • enten er fri for phosphatbuffermidler eller omfatter et phosphatbuffersystem ved en koncentration på højst 0,1 mM.
2. Vandig farmaceutisk sammensætning ifølge et hvilket som helst af ovennævnte krav, hvor sammensætningen omfatter adalimumab ved en koncentration på 25 mg/ml til 75 mg/ml.
3. Vandig farmaceutisk sammensætning ifølge et hvilket som helst af ovennævnte krav, hvor sammensætningen omfatter histidinbuffermidlet (eller histidinbuffersystemet) ved en koncentration på 2 til 50 mM.
4. Vandig farmaceutisk sammensætning ifølge et hvilket som helst af ovennævnte krav, hvor sammensætningen omfatter sukkerstabilisatoren ved en koncentration på 50 til 400 mM.
5. Vandig farmaceutisk sammensætning ifølge et hvilket som helst af ovennævnte krav, hvor sammensætningen omfatter det overfladeaktive stof ved en koncentration på 0,9 til 1,5 mg/ml.
6. Vandig farmaceutisk sammensætning ifølge et hvilket som helst af ovennævnte krav, hvor sukkerstabilisatoren er en sukkeralkohol valgt fra gruppen, der består af sorbitol, xylitol, arabitol, erythritol, lactitol, maltitol og inositol.
7. Vandig farmaceutisk sammensætning ifølge et hvilket som helst af ovennævnte krav, hvor sukkerstabilisatoren er sorbitol.
8. Vandig farmaceutisk sammensætning ifølge et hvilket som helst af ovennævnte krav, hvor det overfladeaktive stof er polysorbat 20.
9. Vandig farmaceutisk sammensætning ifølge et hvilket som helst af ovennævnte krav, hvor sammensætningen yderligere omfatter en citratbuffer.
10. Vandig farmaceutisk sammensætning ifølge et hvilket som helst af ovennævnte krav, hvor natriumchlorid er til stede ved en koncentration på mellem 25 og 100 mM. hvis sammensætningen omfatter natriumchlorid som et eventuelt tonicitetsmiddel.
11. Vandig farmaceutisk sammensætning ifølge et hvilket som helst af ovennævnte krav, hvor sammensætningen omfatter: (a) 45 til 55 mg/ml adalimumab; (b) 2 til 50 mM histidinbuffermiddel (eller histidinbuffersystem); (c) 50 til 300 mM sorbitol; og (d) 0,05 til 2 mg/ml polysorbat 20; hvor sammensætningen: • enten er fri for andre aminosyrer end histidin eller omfatter en eller flere andre aminosyrer end histidin ved en (samlet) koncentration på højst 0,1 mM; og • enten er fri for phosphatbuffermidler eller omfatter et phosphatbuffersystem ved en koncentration på højst 0,1 mM.
12. Vandig farmaceutisk sammensætning ifølge et hvilket som helst af ovennævnte krav, hvor sammensætningen omfatter: (a) 45 til 55 mg/ml adalimumab; (b) 2 til 50 mM histidinbuffermiddel (eller histidinbuffersystem); (c) 50 til 300 mM sorbitol; og (d) 0,9 til 1,5 mg/ml polysorbat 20; hvor sammensætningen: • har et pH på mellem 5,0 og 6,7; • er fri for andre aminosyrer end histidin; og • er fri for phosphatbuffermidler.
13. Lægemiddeldispenseringsanordning, der omfatter en vandig farmaceutisk sammensætning ifølge et hvilket som helst af ovennævnte krav.
14. Vandig farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 12 til anvendelse til behandling af rheumatoid arthritis, psoriatisk arthritis, ankyloserende spondylitis, Crohns sygdom, ulcerativ colitis, moderat til svær kronisk psoriasis og/eller juvenil idiopatisk arthritis.
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EP14169754.0A EP2946766B1 (en) | 2014-05-23 | 2014-05-23 | Liquid pharmaceutical composition |
PCT/EP2015/060817 WO2015177058A1 (en) | 2014-05-23 | 2015-05-15 | Liquid pharmaceutical composition |
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DKBA201800071U DK201800071Y4 (da) | 2014-05-23 | 2018-09-07 | Væskeformig farmaceutisk sammensætning |
DKBA201800070U DK201800070Y8 (da) | 2014-05-23 | 2018-09-07 | Væskeformig farmaceutisk sammensætning |
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DKBA201800071U DK201800071Y4 (da) | 2014-05-23 | 2018-09-07 | Væskeformig farmaceutisk sammensætning |
DKBA201800070U DK201800070Y8 (da) | 2014-05-23 | 2018-09-07 | Væskeformig farmaceutisk sammensætning |
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US (5) | US10493152B2 (da) |
EP (5) | EP2946766B1 (da) |
JP (3) | JP2017516847A (da) |
CN (2) | CN106659781A (da) |
AU (4) | AU2015263246B2 (da) |
CA (2) | CA3050875A1 (da) |
CY (1) | CY1120488T1 (da) |
DE (1) | DE23189888T1 (da) |
DK (3) | DK3148510T3 (da) |
ES (4) | ES2572919T3 (da) |
HK (1) | HK1257026A1 (da) |
HR (1) | HRP20181226T1 (da) |
HU (1) | HUE040097T2 (da) |
IL (1) | IL249117B1 (da) |
LT (1) | LT3148510T (da) |
PL (1) | PL3148510T3 (da) |
PT (1) | PT3148510T (da) |
RS (1) | RS57772B1 (da) |
SI (1) | SI3148510T1 (da) |
WO (1) | WO2015177058A1 (da) |
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