ANTIBODY FORMULATION

• Main Authors: MARY CROMWELL, LIU HONG, YATIN R GOKARN, TIMOTHY J KAMERZELL, MEGAN LI
• Format: Patent
• Language: English; Japanese
• Published: 08.03.2018
• 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: a stable aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody, optionally, not subjected to prior lyophilization; methods for making the formulation; and methods of using the formulation.SOLUTION: An aqueous pharmaceutical formulation comprises a therapeutically effective amount of an antibody, a buffer maintaining the pH in the range from approximately 4.0 to approximately 6.0, and an optional surfactant. In the formulation, the buffer is an arginine acetate buffer with a pH of 4.5-5.5, and the arginine acetate concentration is from approximately 25 mM to approximately 250 mM. In the formulation, the surfactant is polysorbate.SELECTED DRAWING: None 【課題】場合によっては事前に凍結乾燥処理されていない治療的有効量の抗体を含んでなる安定した水性薬学的製剤、該製剤の作成方法及び該製剤の使用方法の提供。【解決手段】治療的有効量の抗体、ｐＨを約４．０から約６．０の範囲に維持するバッファー、及び任意界面活性物質を含んでなる水性薬学的製剤。バッファーが、ｐＨ４．５から５．５のアルギニン酢酸バッファーであり、アルギニン酢酸濃度が約２５ｍＭから約２５０ｍＭである該製剤。界面活性物質がポリソルベートである該製剤。【選択図】なし