Stable lyophilized pharmaceutical formulation of IgG antibodies
US8298530B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Aug 12, 2009 |
| Grant date | Oct 30, 2012 |
| Priority date | — |
| Expiry date | Dec 3, 2029 |
Classification
- Technology area (CPC A)Human Necessities
- CPC primaryA61K47/26
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
Abstract
This invention is directed to a stable lyophilized pharmaceutical formulation prepared by lyophilizing an aqueous formulation comprising a high concentration, e.g. 50 mg/ml or more, of an IgG antibody in about 5-25 mM histidine buffer having pH from about 5.5 to about 6.5, about 0.005%-0.03% polysorbate, sucrose, and optionally serine, and/or mannitol. This lyophilized formulation is stable at room temperature for at least 6 months, and preferably 1 year. This lyophilized formulation has a short reconstitution time of less than 2 minutes, and is suitable for parenteral administration such as intravenous, intramuscular, intraperitoneal, or subcutaneous injection. This invention is exemplified by the anti-IL2 receptor antibody.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.