Stable aqueous injectable pharmaceutical composition for preparing medicaments for treating e.g. allergic reactions including anaphylaxis, hypotension with septic shock or hemorrhagic shock, comprises epinephrine and buffering agent, antioxidant and optionally other excipients e.g. tonicity agent
2023-09-13
专利权人ALEMBIC PHARM LTD (ALEM-C)
申请日期2023-09-13
专利号IN202321061700-A
成果简介NOVELTY - Stable aqueous injectable pharmaceutical composition comprises: 0.05-1.0 mg/ml epinephrine and 0.01-2 mg/ml buffering agent; or 0.1-3 mg/ml antioxidant and optionally other excipients such as a tonicity agent, a chelating agent, a preservative, and/or pH adjusting agent; or 0.05-1.0 mg/ml epinephrine, 0.1-2 mg/ml citric acid, 1-9 mg/ml sodium chloride, hydrochloric acid to adjust the pH, 0.1-3 mg/ml one or more antioxidants, where the antioxidant is selected from sodium bisulfite, sodium metabisulfite; and 0.01-1 mg/m disodium edetate dehydrate, and optionally other excipients, where the pH of the composition is 2.2-5.0, the buffering agent comprises one or more acids selected from citric acid, glutamic acid, malic acid, maleic acid, gluconic acid, benzoic acid, succinic acid, acetic acid, tartaric acid, lactic acid, glutamate, aspartic acid, glycine; and salts of these acids. USE - Stable aqueous injectable pharmaceutical composition for the preparation of medicaments for treating allergic reactions (Type 1), including anaphylaxis, hypotension with septic shock or cardiogenic, hemorrhagic, and traumatic shock, bronchospasm or asthmatic attack, sensitivity reactions, cardiac arrhythmias, Gastrointestinal and renal hemorrhage, superficial bleeding, premature labor, hypoglycemia. No biological data given. ADVANTAGE - The composition has total impurities in the aqueous solution of not more than 3.0 wt.% after storage at 25℃/60% RH for at least 6 months; restricts the distribution of locally administered drugs such as local anesthetics, reduces nasal congestion and/or as performance aid in emergency situations.
IPC 分类号A61K-031/137 ; A61K-047/10 ; A61K-047/12 ; A61K-047/18 ; A61K-047/20 ; A61K-009/00 ; A61K-009/08
国家印度
专业领域医药卫生
语种英语
成果类型专利
文献类型科技成果
条目标识符http://119.78.100.226:8889/handle/3KE4DYBR/20413
专题中国科学院新疆生态与地理研究所
作者单位
ALEMBIC PHARM LTD (ALEM-C)
推荐引用方式
GB/T 7714
GUNJAL R,VANPARIYA K M,DARJI P,et al. Stable aqueous injectable pharmaceutical composition for preparing medicaments for treating e.g. allergic reactions including anaphylaxis, hypotension with septic shock or hemorrhagic shock, comprises epinephrine and buffering agent, antioxidant and optionally other excipients e.g. tonicity agent. IN202321061700-A[P]. 2023.
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