SELF-BUFFERING PROTEIN FORMULATIONS

• Main Authors: HERSHENSON SUSAN IRENE, BREMS DAVID N, REMMELE RICHARD LOUIS JR, GOKARN YATIN R, KRAS EVA
• Format: Patent
• Language: English; Japanese
• Published: 14.04.2016
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES

PROBLEM TO BE SOLVED: To provide a self-buffering pharmaceutical protein formulation suitable for veterinary and human medical use.SOLUTION: The invention provides protein formulations comprising protein, particularly pharmaceutically acceptable formulations comprising a pharmaceutical protein that are buffered by the protein itself, that do not require additional buffering agents to maintain a desired pH, and in which the protein is substantially the only buffering agent having the buffer capacity per unit volume of at least approximately 4.0 mM sodium acetate buffer capacity in pure water in the range of pH 5.0 to 4.0 or pH 5.0 to 5.5 under the condition of 21°C, one atmosphere, and equilibrium with ambient atmosphere (i.e., other ingredients, if any, do not act substantially as buffering agents in the formulation). The self-buffering protein formulation does not contain other buffering agents substantially, and stably maintains pH for a long period of time involved in the distribution and storage of pharmaceutical proteins for veterinary and human medical use.SELECTED DRAWING: None 【課題】動物及びヒトに対する医学的使用に好適な自己緩衝医薬タンパク質製剤の提供。【解決手段】タンパク質を含むタンパク質製剤、特に、所望のpHを維持するための追加の緩衝剤を必要とせずにタンパク質自身によって緩衝される医薬タンパク質を含む製薬上許容される製剤、及び前記タンパク質が、ｐＨ、２１℃、一気圧で、大気との平衡状態において、ｐＨ５．０〜４．０又は、ｐＨ５．０〜５．５のｐＨ範囲の純水中の約４．０ｍＭ酢酸Ｎａ緩衝能以上の単位体積当りの緩衝能を有しており、該製剤中でタンパク質が実質的に唯一の緩衝剤である（すなわち他の成分は、存在しているとしても製剤中で緩衝剤としては実質的に作用しない）タンパク質製剤。自己緩衝タンパク質製剤は実質的に他の緩衝剤を含まず、動物及びヒトに対する医学的使用のための医薬タンパク質の流通及び保存に関わる長期間pHを安定的に維持する医薬組成物。【選択図】なし