JP2017533212A - 肺送達用ラパマイシン粉末 - Google Patents
肺送達用ラパマイシン粉末 Download PDFInfo
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- JP2017533212A JP2017533212A JP2017522659A JP2017522659A JP2017533212A JP 2017533212 A JP2017533212 A JP 2017533212A JP 2017522659 A JP2017522659 A JP 2017522659A JP 2017522659 A JP2017522659 A JP 2017522659A JP 2017533212 A JP2017533212 A JP 2017533212A
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- Prior art keywords
- rapamycin
- powder
- particles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/436—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
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- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Pulmonology (AREA)
- Otolaryngology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
本出願は、2014年11月7日出願の、米国特許仮出願第62/076,651号の利益を主張する。上記出願の全教示は参照により本明細書に組み込まれる。
コンパートメントに入ったラパマイシンの噴霧乾燥粒子製剤および患者への吸入器を用意するステップであって、前記粉末がラパマイシンの粒子を含むステップと、
患者の呼吸動作により粉末を散布するステップと、
粒子を患者の呼吸器系に送達するステップと、を含む。
から計算できる。
実施例1
1.噴霧溶液の配合
ラパマイシンおよびDPPCを、秤量前に30分間、室温で平衡化させる。水およびエタノールの必要量を秤量し、それぞれ水性および有機相供給容器に移し、両容器中の撹拌子のスイッチを入れる。必要量のラクトース、L−ロイシン、マルトデキストリン、塩化ナトリウム、およびクエン酸ナトリウムを個々に秤量し(必要に応じ)、水性相容器に加え、渦の形成を起こさせずに溶解させる。必要量のDPPC(必要に応じ)、およびラパマイシンを秤量し、有機相容器に加え、溶解させる。
a.マルトデキストリンを含む配合物
乾燥ガス流を流し始めることにより(100kg/時間に設定)、噴霧乾燥を開始する。乾燥ガス入口温度を130℃に設定する。噴霧乾燥機出口温度が80℃に達した後、窒素(噴霧ガス流=20g/分)を使用して、ブランク溶媒(水性流=28mL/分および有機流=42mL/分)を噴霧乾燥機中に霧状に吹くことが可能となるように液体スキッド入口を設定し、システムを冷却させて、55℃の出口温度に安定化させる。
b.マルトデキストリン不含配合物
乾燥ガス流を流し始めることにより(100kg/時間に設定)、噴霧乾燥を開始する。乾燥ガス入口温度を110℃に設定する。噴霧乾燥機出口温度が80℃に達した後、窒素(噴霧ガス流=20g/分)を使用して、ブランク溶媒(水性流=10mL/分および有機流=60mL/分)を噴霧乾燥機中に霧状に吹くことが可能となるように液体スキッド入口を設定し、システムを冷却させて、55℃の出口温度に安定化させる。
生成物フィルターのパルシングを開始し、生成物フィルターパージ流を15scfhに設定する。55℃でシステムを安定化させた後、液体スキッド入口を上記で調製した溶媒の供給に切り替え、供給材料がなくなるまで、プロセスを継続する。供給溶媒がなくなる時点で、液体スキッド入口をブランク溶媒に戻し、溶媒を約10分間噴霧させる。この時点で、生成物フィルターの底部で収集した粉末を15%のRH下で維持されたグローブボックス中の最終収集容器に移す。ブランク溶媒を10分間噴霧後、液体ライン、噴霧ガス、乾燥ガスヒーター、乾燥ガス入口および最終的に排気装置を停止することによりシステムを停止する。
Claims (6)
- 噴霧乾燥ラパマイシン粒子および薬学的に許容可能な賦形剤を含む、患者の気道への肺送達のための医薬組成物。
- 医薬賦形剤が、1種または複数のリン脂質、塩、アミノ酸または糖を含む、請求項1に記載の医薬組成物。
- 粒子が非晶質型のラパマイシンを含む、請求項1に記載の医薬組成物。
- 前記粒子が結晶質型のラパマイシンを含む、請求項1に記載の医薬組成物。
- 前記粒子が結晶質型および非晶質型の両方のラパマイシンを含む、請求項1に記載の医薬組成物。
- 患者の肺系統にラパマイシンを送達する方法であって、
a)コンパートメントに入った請求項1に記載の噴霧乾燥粒子製剤および患者への吸入器を用意するステップであって、前記粉末がラパマイシンの粒子を含むステップと、
b)前記患者の呼吸動作により粉末を散布するステップと、
c)前記粒子を前記患者の呼吸器系に送達するステップと、を含む方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201462076651P | 2014-11-07 | 2014-11-07 | |
US62/076,651 | 2014-11-07 | ||
PCT/US2015/059429 WO2016073836A1 (en) | 2014-11-07 | 2015-11-06 | Rapamycin powders for pulmonary delivery |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2021004679A Division JP7277490B2 (ja) | 2014-11-07 | 2021-01-15 | 肺送達用ラパマイシン粉末 |
Publications (1)
Publication Number | Publication Date |
---|---|
JP2017533212A true JP2017533212A (ja) | 2017-11-09 |
Family
ID=54697649
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2017522659A Pending JP2017533212A (ja) | 2014-11-07 | 2015-11-06 | 肺送達用ラパマイシン粉末 |
JP2021004679A Active JP7277490B2 (ja) | 2014-11-07 | 2021-01-15 | 肺送達用ラパマイシン粉末 |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
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JP2021004679A Active JP7277490B2 (ja) | 2014-11-07 | 2021-01-15 | 肺送達用ラパマイシン粉末 |
Country Status (7)
Country | Link |
---|---|
US (1) | US9387169B2 (ja) |
EP (1) | EP3215121A1 (ja) |
JP (2) | JP2017533212A (ja) |
AU (2) | AU2015342919B2 (ja) |
CA (1) | CA2966637C (ja) |
MA (1) | MA40910A (ja) |
WO (1) | WO2016073836A1 (ja) |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU2014332080B2 (en) | 2013-10-08 | 2020-02-27 | AI Therapeutics, Inc. | Rapamycin for the treatment of lymphangioleiomyomatosis |
MX2016012712A (es) | 2014-04-04 | 2017-03-31 | Lam Therapeutics Inc | Una formulacion de rapamicina inhalable para tratar afecciones relacionadas con la edad. |
BR112017006842A2 (pt) | 2014-10-07 | 2017-12-12 | Lam Therapeutics Inc | formulação de rapamicina inalável para o tratamento de hipertensão pulmonar |
EP3429580A4 (en) * | 2016-03-16 | 2019-11-13 | Buzzelet Development And Technologies Ltd | TERPENANGED CANNABINOID COMPOSITION |
WO2019023181A1 (en) * | 2017-07-24 | 2019-01-31 | University Of Cincinnati | METHODS OF TREATING INFLUENZA-RELATED VIRAL PNEUMONIA |
WO2019084293A1 (en) | 2017-10-25 | 2019-05-02 | Arizona Board Of Regents On Behalf Of The University Of Arizona | COMPOSITIONS AND METHODS FOR ADMINISTERING PHARMACEUTICAL AGENTS |
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2015
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- 2015-11-06 CA CA2966637A patent/CA2966637C/en active Active
- 2015-11-06 US US14/934,491 patent/US9387169B2/en active Active
- 2015-11-06 JP JP2017522659A patent/JP2017533212A/ja active Pending
- 2015-11-06 WO PCT/US2015/059429 patent/WO2016073836A1/en active Application Filing
- 2015-11-06 AU AU2015342919A patent/AU2015342919B2/en active Active
- 2015-11-06 EP EP15798604.3A patent/EP3215121A1/en active Pending
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2020
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- 2021-01-15 JP JP2021004679A patent/JP7277490B2/ja active Active
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Also Published As
Publication number | Publication date |
---|---|
AU2020250195A1 (en) | 2020-11-05 |
AU2015342919A1 (en) | 2017-05-18 |
US9387169B2 (en) | 2016-07-12 |
CA2966637C (en) | 2024-02-13 |
JP2021054870A (ja) | 2021-04-08 |
EP3215121A1 (en) | 2017-09-13 |
WO2016073836A1 (en) | 2016-05-12 |
JP7277490B2 (ja) | 2023-05-19 |
AU2015342919B2 (en) | 2020-07-23 |
MA40910A (fr) | 2017-09-12 |
AU2020250195B2 (en) | 2022-06-02 |
US20160128936A1 (en) | 2016-05-12 |
CA2966637A1 (en) | 2016-05-12 |
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