FIELD: medicine; pharmaceuticals.
SUBSTANCE: group of inventions relates to pharmacy, particularly to stable aqueous pharmaceutical compositions containing a therapeutic antibody, trehalose and a buffer. Composition comprises a monoclonal antibody, trehalose and a buffer, wherein the weight ratio of said monoclonal antibody and said trehalose in the composition is greater than or equal to 0.49 and less than or equal to 1.47, where the pH of the composition ranges from 5.5 to 7.0, where the composition is stored at −20 °C or −40 °C for at least 6 months and where the monoclonal antibody binds to VEGF. Also disclosed is an article for treating angiogenic disorder in a patient. Group of inventions also relates to methods for reducing aggregation of therapeutic monoclonal antibody.
EFFECT: group of inventions enables to obtain stable aqueous pharmaceutical compositions which show low protein aggregation and low crystallisation of trehalose in prolonged frozen storage.
76 cl, 8 dwg, 3 tbl, 5 ex
| Title | Year | Author | Number |
|---|---|---|---|
| COMPOSITIONS OF ANTIBODIES | 2014 |
|
RU2694055C2 |
| COMPOSITION CONTAINING ANTIBODY | 2010 |
|
RU2609658C2 |
| HIGHLY CONCENTRATED COMPOSITIONS OF MONOCLONAL ANTIBODIES | 2013 |
|
RU2711089C2 |
| COMBINED THERAPY BY AFUCOSYLATED ANTIBODY FOR CD20 WITH ANTIBODY FOR VEGF | 2011 |
|
RU2615459C2 |
| METHOD AND COMPOSITION FOR REDUCTION OF MICROMOLECULE AGGREGATION UNDER PHYSIOLOGICAL CONDITIONS | 2009 |
|
RU2563823C2 |
| COMPOSITIONS AND METHODS, INCLUDING ALKYLGLYCOSIDES, FOR STABILISATION OF PROTEIN-CONTAINING COMPOSITIONS | 2011 |
|
RU2575830C2 |
| ANTI-ANGIOGENESIS THERAPY FOR TREATING PREVIOUSLY TREATED BREAST CANCER | 2010 |
|
RU2576027C2 |
| ANTIBODY PREPARATION | 2008 |
|
RU2476238C2 |
| PURIFICATION OF ANTIBODIES WITH CATION-EXCHANGE CHROMATOGRAPHY | 2008 |
|
RU2498991C2 |
| COMPOSITIONS OF ANTIBODIES | 2005 |
|
RU2426554C2 |
