- 专利标题: NEW PHARMACEUTICAL DEVICE FOR USE IN INTRANASAL ADMINISTRATION
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申请号: US18323115申请日: 2023-05-24
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公开(公告)号: US20230310349A1公开(公告)日: 2023-10-05
- 发明人: Jonas SÄVMARKER , Robert RÖNN
- 申请人: OREXO AB
- 申请人地址: SE Uppsala
- 专利权人: OREXO AB
- 当前专利权人: OREXO AB
- 当前专利权人地址: SE Uppsala
- 优先权: GB 17016.2 2021.11.25
- 主分类号: A61K31/137
- IPC分类号: A61K31/137 ; A61K47/36 ; A61K9/00 ; A61K47/26
摘要:
Disclosed is a needle-free applicator that is suitable for administering a solid, amorphous, mono-particulate powder composition into a body cavity of a human patient, which cavity includes a mucosal surface, wherein the applicator comprises:
(i) an opaque reservoir comprising said powder composition;
(ii) an optional actuating means for generating a force upon actuation of the device by a user; and
(iii)a dispensing means through which, following said actuation, said powder composition may be dispensed,
wherein said powder composition comprises a pharmacologically-effective dosage amount of an adrenergic receptor modulator, or a pharmaceutically-acceptable salt thereof, encapsulated in an amorphous state along with a pharmaceutically-acceptable carrier material; and
which powder composition is less than about 4% chemically degraded after storage for:
(a) at least about 3 months at 40° C. and 75% relative humidity; and/or
(b) at least about 18 months at below about 30° C.; and/or
(c) at least about 18 hours at above about 1 million lux of UV light.
(i) an opaque reservoir comprising said powder composition;
(ii) an optional actuating means for generating a force upon actuation of the device by a user; and
(iii)a dispensing means through which, following said actuation, said powder composition may be dispensed,
wherein said powder composition comprises a pharmacologically-effective dosage amount of an adrenergic receptor modulator, or a pharmaceutically-acceptable salt thereof, encapsulated in an amorphous state along with a pharmaceutically-acceptable carrier material; and
which powder composition is less than about 4% chemically degraded after storage for:
(a) at least about 3 months at 40° C. and 75% relative humidity; and/or
(b) at least about 18 months at below about 30° C.; and/or
(c) at least about 18 hours at above about 1 million lux of UV light.
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