PE20090767A1 - LYOPHILIZED IMMUNOGLOBULIN FORMULATIONS AND METHODS FOR THEIR PREPARATION - Google Patents
LYOPHILIZED IMMUNOGLOBULIN FORMULATIONS AND METHODS FOR THEIR PREPARATIONInfo
- Publication number
- PE20090767A1 PE20090767A1 PE2008001028A PE2008001028A PE20090767A1 PE 20090767 A1 PE20090767 A1 PE 20090767A1 PE 2008001028 A PE2008001028 A PE 2008001028A PE 2008001028 A PE2008001028 A PE 2008001028A PE 20090767 A1 PE20090767 A1 PE 20090767A1
- Authority
- PE
- Peru
- Prior art keywords
- lyophilized
- formulation
- preparation
- methods
- amount
- Prior art date
Links
Landscapes
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
REFERIDO A UNA FORMULACION DE INMUNOGLOBULINAS ESTABLES, LIOFILIZADAS Y DE ALTA CONCENTRACION; ELABORADA LIOFILIZANDO UNA FORMULACIONA ACUOSA QUE COMPRENDE: A) UNA CANTIDAD DE 20 mg/ml A 80mg/ml DE NATALIZUMAB, B) UN BUFER CON UN pH QUE FLUCTUA DE 5,5 A 6,5 C) UNA CANTIDAD DE 20 mg/ml A 80mg/ml DE SACAROSA Y D) POLISORBATO PREFERENTEMENTE POLISORBATO 80, EN UNA CANTIDAD DE 0,02 A 0,08%. EL BUFER ES HISTIDINA CON UNA CONCENTRACION DE 1mM A 12 mM. ADEMAS DICHA FORMULACION COMPRENDE UN AGENTE DE ACUMULACION Y UN MODIFICADOR DE TONICIDAD. ESTA FORMULACION LIOFILIZADA ES RECONSTITUIDA DONDE EL NATALIZUMAB COMPRENDE APROXIMADAMENTE 80 A 160 mg/mlREFERRED TO A FORMULATION OF STABLE IMMUNOGLOBULINS, LYOPHILIZED AND HIGH CONCENTRATION; MADE BY FREEZING AN AQUEOUS FORMULATION THAT INCLUDES: A) AN AMOUNT OF NATALIZUMAB FROM 20 mg / ml TO 80mg / ml, B) A BUFFER WITH A pH THAT FLUCTUES FROM 5.5 TO 6.5 C) AN AMOUNT OF 20 mg / ml AT 80mg / ml OF SACROSE AND D) POLYSORBATE, PREFERENTIALLY POLYSORBATE 80, IN AN AMOUNT OF 0.02 TO 0.08%. THE BUFFER IS HISTIDINE WITH A CONCENTRATION OF 1mM TO 12 mM. IN ADDITION, SUCH FORMULATION INCLUDES AN ACCUMULATION AGENT AND A TONICITY MODIFIER. THIS LYOPHILIZED FORMULATION IS RECONSTITUTED WHERE NATALIZUMAB INCLUDES APPROXIMATELY 80 TO 160 mg / ml
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US92913307P | 2007-06-14 | 2007-06-14 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20090767A1 true PE20090767A1 (en) | 2009-06-24 |
Family
ID=40897430
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2008001028A PE20090767A1 (en) | 2007-06-14 | 2008-06-16 | LYOPHILIZED IMMUNOGLOBULIN FORMULATIONS AND METHODS FOR THEIR PREPARATION |
Country Status (5)
| Country | Link |
|---|---|
| AR (1) | AR067010A1 (en) |
| CL (1) | CL2008001778A1 (en) |
| PE (1) | PE20090767A1 (en) |
| TW (1) | TW200909005A (en) |
| ZA (1) | ZA200909090B (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BR112021015034A2 (en) * | 2019-02-18 | 2021-10-05 | Eli Lilly And Company | THERAPEUTIC ANTIBODY FORMULATION |
-
2008
- 2008-06-13 TW TW97122278A patent/TW200909005A/en unknown
- 2008-06-13 AR ARP080102544 patent/AR067010A1/en unknown
- 2008-06-16 PE PE2008001028A patent/PE20090767A1/en not_active Application Discontinuation
- 2008-06-16 CL CL2008001778A patent/CL2008001778A1/en unknown
-
2009
- 2009-01-01 ZA ZA200909090A patent/ZA200909090B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| ZA200909090B (en) | 2010-08-25 |
| TW200909005A (en) | 2009-03-01 |
| AR067010A1 (en) | 2009-09-30 |
| CL2008001778A1 (en) | 2008-12-19 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FC | Refusal |