发明申请
WO2016055544A1 COMPOSITION COMPRISING AT LEAST ONE DRY POWDER OBTAINED BY SPRAY DRYING TO INCREASE THE STABILITY OF THE FORMULATION
审中-公开
基本信息:
- 专利标题： COMPOSITION COMPRISING AT LEAST ONE DRY POWDER OBTAINED BY SPRAY DRYING TO INCREASE THE STABILITY OF THE FORMULATION
- 专利标题（中）：组合物包含由喷雾干燥获得的至少一种干粉，以增加配方的稳定性
- 申请号：PCT/EP2015/073188 申请日：2015-10-07
- 公开(公告)号：WO2016055544A1 公开(公告)日：2016-04-14
- 发明人： MAGGI, Loretta , CAPONETTI, Giovanni , BUTTI, Heike , VENEZIANI, Cristina , ZANELLOTTI, Laura
- 申请人： ERATECH S.R.L.
- 申请人地址： Via Lillo del Duca, 10 I-20091 Bresso IT
- 专利权人： ERATECH S.R.L.
- 当前专利权人： ERATECH S.R.L.
- 当前专利权人地址： Via Lillo del Duca, 10 I-20091 Bresso IT
- 代理机构： ZANOLI, Enrico et al.
- 优先权： ITMI2014A001761 20141008
- 主分类号： A61K9/00
- IPC分类号： A61K9/00 ; A61K9/14 ; A61K9/16 ; A61K31/167 ; A61K31/439 ; A61K31/58
摘要：
The present invention relates to inhalation formulations of drugs in the form of dry powder for inhalation administration deliverable as such with an inhaler and provided with high deliverability, respirability and stability. In particular, the invention relates to a pharmaceutical composition for inhalation use in powder form comprising a first powder comprising at least a powder (a1) comprising an active agent or a pharmaceutically acceptable salt thereof, in an amount greater than 1% by weight of the powder, leucine in an amount from 5 to 70% by weight of said powder, a sugar in an amount from 20 to 90%> by weight of the powder; and a second powder comprising a mixture of a first lactose which has an X50 from 35 to 75 μm, with a second lactose which has an X50 from 1.5 to 10 μm, the content of the first and second lactose in the mixture are respectively from 85% to 96% and from 4% to 15%. The ratio by weight between the first powder and the second powder is from 1/5 to 1/100, and the composition has a fine particle fraction (FPF) greater than 60% and a delivered fraction (DF) greater than 85%.
摘要（中）：
本发明涉及用于吸入管理形式的干粉形式的药物吸入制剂，其可与吸入器一起递送并具有高递送性，呼吸性和稳定性。 特别地，本发明涉及一种粉末形式的吸入用药物组合物，其包含至少包含含有活性剂或其药学上可接受的盐的粉末（a1）的第一粉末，其量大于 粉末，亮氨酸的量为所述粉末的5至70重量％，糖为粉末的20至90重量％; 和第二粉末，其包含具有35至75μm的X50的第一乳糖和1.5至10微米的X50的第二乳糖的混合物，混合物中第一和第二乳糖的含量分别为85 至96％及4％至15％。 第一粉末和第二粉末之间的重量比为1/5至1/100，并且组合物具有大于60％的细颗粒分数（FPF）和大于85％的递送部分（DF）。
IPC结构图谱:
| A | 人类生活必需 |
| --A61 | 医学或兽医学；卫生学 |
| ----A61K | 医用、牙科用或梳妆用的配制品 |
| ------A61K9/00 | 以特殊物理形状为特征的医药配制品 |