FORMULATION OF HUMAN ANTIBODIES FOR TREATING TNF-ALFA RELATED DISORDERS

• Main Authors: KRAUSE HANS-JUERGEN, BAUST LISA, DICKES MICHAEL
• Format: Patent
• Language: English; Japanese
• Published: 12.11.2015
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

PROBLEM TO BE SOLVED: To provide formulation of human antibodies for treating TNF-α related disorders.SOLUTION: The invention provides a pharmaceutical formulation selected from the group consisting of (a) a liquid aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody in a buffered solution, having a pH of about 4-8 and having a shelf life of at least 18 months; (b) a liquid aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody in a buffered solution, having a pH of about 4-8 and having a shelf life of at least 18 months in a liquid state; (c) a liquid aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody in a buffered solution, having a pH of about 4-8 and maintaining stability after at least three cycles of freeze-and-thawing; and (d) a liquid aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody in a buffered solution, having a pH of about 4-8 and maintaining enhanced stability for at least 12 months at a temperature of 2-8°C. 【課題】ＴＮＦ−α関連疾患の治療用ヒト抗体の製剤。【解決手段】（ａ）緩衝液中に治療有効量の抗体を含み、約４〜８のｐＨと少なくとも１８か月間の保存期間をもつ液体水性医薬製剤；（ｂ）緩衝液中に治療有効量の抗体を含み、約４〜８のｐＨと液体状態で少なくとも１８か月間の保存期間をもつ水性医薬製剤；（ｃ）緩衝液中に治療有効量の抗体を含み、約４〜８のｐＨをもち、製剤の少なくとも３回の凍結／解凍サイクル後に安定性を維持する液体水性医薬製剤；及び（ｄ）緩衝液中に治療有効量の抗体を含み、４〜８のｐＨと２〜８℃の温度で少なくとも１２か月間の高い安定性をもつ液体水性医薬製剤から構成される群から選択される医薬製剤。【選択図】なし