CY1113904T1 - IGG IMPORTANT STABLE MEDICINAL PREPARATION - Google Patents
IGG IMPORTANT STABLE MEDICINAL PREPARATIONInfo
- Publication number
- CY1113904T1 CY1113904T1 CY20121100699T CY121100699T CY1113904T1 CY 1113904 T1 CY1113904 T1 CY 1113904T1 CY 20121100699 T CY20121100699 T CY 20121100699T CY 121100699 T CY121100699 T CY 121100699T CY 1113904 T1 CY1113904 T1 CY 1113904T1
- Authority
- CY
- Cyprus
- Prior art keywords
- antibody against
- igg
- humanized monoclonal
- monoclonal antibody
- formulation
- Prior art date
Links
Abstract
Η εφεύρεση αυτή κατευθύνεται σε σταθερό φαρμακευτικό σκεύασμα υγρής μορφής, που περιλαμβάνει υψηλή συγκέντρωση, π.χ. 50 mg/ml ή μεγαλύτερη, αντισώματος, σε περίπου 20-60 mΜ ρυθμιστικό διάλυμα ηλεκτρικού ή 30-70 mΜ ρυθμιστικό διάλυμα ιστιδίνης, με pΗ από περίπου pΗ 5.5 έως περίπου pΗ 6.5, περίπου 0,01-0,1 % πολυσορβικό και τροποποιητή τονικότητας, που συμβάλλει στην ισοτονικότητα του σκευάσματος. Το υγρής μορφής σκεύασμα είναι σταθερό σε θερμοκρασία ψύξης (2-8°C) για τουλάχιστον 1 έτος και κατά προτίμηση 2 έτη. Αυτό το υγρής μορφής σκεύασμα είναι κατάλληλο για υποδόρια ένεση. Ως παράδειγμα αυτής της εφεύρεσης χρησιμοποιείται δακλιζουμάμπη, εξανθρωποιημένο μονοκλωνικό αντίσωμα έναντι του υποδοχέα της IL-2, ΗΑΙL-12, εξανθρωποιημένο μονοκλωνικό αντίσωμα έναντι της IL-12 και ΗuΕΡ5C7, εξανθρωποιημένο μονοκλωνικό αντίσωμα έναντι της L σελεκτίνης, και φοντολιζουμάμπη (Flintozumab), εξανθρωποιημένο μονοκλωνικό αντίσωμα έναντι της γ-ιντερφερόνης.This invention is directed to a solid liquid pharmaceutical formulation comprising a high concentration, e.g. 50 mg / ml or greater, antibody, in about 20-60 mM succinate buffer or 30-70 mM histidine buffer, with pH from about pH 5.5 to about pH 6.5, about 0.01-0.1% polysorbate and modifier tonicity, which contributes to the isotonicity of the formulation. The liquid formulation is stable at a cooling temperature (2-8 ° C) for at least 1 year and preferably 2 years. This liquid formulation is suitable for subcutaneous injection. As an example of this invention, daclizumab, a humanized monoclonal antibody against the IL-2 receptor, HAIL-12, a humanized monoclonal antibody against IL-12 and HuEF5C7, a humanized monoclonal antibody against Lectinum and Fluxinab, Fluximab antibody against γ-interferon.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US33750901A | 2001-11-08 | 2001-11-08 | |
| EP02802895A EP1441589B1 (en) | 2001-11-08 | 2002-11-08 | Stable liquid pharmaceutical formulation of igg antibodies |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CY1113904T1 true CY1113904T1 (en) | 2016-07-27 |
Family
ID=58448998
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CY20121100699T CY1113904T1 (en) | 2001-11-08 | 2012-08-03 | IGG IMPORTANT STABLE MEDICINAL PREPARATION |
Country Status (1)
| Country | Link |
|---|---|
| CY (1) | CY1113904T1 (en) |
-
2012
- 2012-08-03 CY CY20121100699T patent/CY1113904T1/en unknown
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