JP2001507702A - 親水性賦形剤を有する疎水性薬剤の水性懸濁液を噴霧乾燥させる方法およびその方法によって作製された組成物 - Google Patents
親水性賦形剤を有する疎水性薬剤の水性懸濁液を噴霧乾燥させる方法およびその方法によって作製された組成物Info
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- 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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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
- A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
- A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
- A61K31/355—Tocopherols, e.g. vitamin E
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- A—HUMAN NECESSITIES
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- A61K31/557—Eicosanoids, e.g. leukotrienes or prostaglandins
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
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- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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- A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
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- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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- A61K9/1611—Inorganic compounds
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
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- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
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- B01D1/16—Evaporating by spraying
- B01D1/18—Evaporating by spraying to obtain dry solids
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- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J2/00—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
- B01J2/02—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic by dividing the liquid material into drops, e.g. by spraying, and solidifying the drops
- B01J2/04—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic by dividing the liquid material into drops, e.g. by spraying, and solidifying the drops in a gaseous medium
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.乾燥粉末組成物を作製する方法において、 親水性成分の水溶液を作製する段階と、 水溶液に疎水性成分を懸濁して懸濁液を形成する段階と、 懸濁液を噴霧乾燥し、親水性および疎水性成分の混合物を含む粒子を形成する 段階と を含む方法。 2.疎水性成分が、水に対して5mg/ml未満の溶解度を有する請求項1に 記載の方法。 3.親水性成分が1mg/mlから50mg/mlを超える範囲内の濃度を有 し、疎水性成分が10mg/ml未満の濃度に懸濁された請求項2に記載の方法 。 4.疎水性成分が疎水性薬剤を含む請求項1に記載の方法。 5.疎水性薬剤が、ブデソニド、テストステロン、プロゲステロン、エストロ ゲン、フルニソリド、トリアムシノロン、ベクロメタゾン、ベタメタゾン、デキ サメタゾン、フルチカゾン、メチルプレドニゾロン、プレドニゾン、ヒドロコル チゾンからなる群から選択されたステロイドである請求項4に記載の方法。 6.疎水性薬剤が、ペプチド、レチノイド、ビタミンD、ビタミンE、ビタミ ンK、これらビタミンの前駆体および誘導体、プロスタグランジン、ロイコトリ エン、テトラヒドロカンナビノール、肺の界面活性物質である脂質、抗酸化剤、 疎水性抗生物質、または化学療法薬剤を含む請求項4に記載の方法。 7.親水性成分が、疎水性薬剤用の賦形剤を含む請求項1に記載の方法。 8.親水性賦形剤が、ラクトース、クエン酸ナトリウム、マンニトール、ポビ ドン、ペクチン、クエン酸、塩化ナトリウム、およびこれらの混合物からなる群 から選択された材料を含む請求項7に記載の方法。 9.疎水性剤の懸濁液の均質性を高めるために、界面活性剤および/または水 混和性有機溶剤を添加する請求項1に記載の方法。 10.界面活性剤が、レシチン、ポリソルベート、塩化ベンザルコニウム、ソ ルビタンエステル、およびオレイン酸からなる群から選択された材料を含む請求 項9に記載の方法。 11.真空中で疎水性成分を水溶液中に混合し、かつ/または凝集粒子を破壊 するために、噴霧乾燥した粒子をスクリーニングすることをさらに含む請求項1 に記載の方法。 12.乾燥粉末の1回用量を計量する段階と、 1回用量をパッケージに密封する段階と をさらに含む請求項1ないし11のいずれか一項に記載の方法。 13.水溶液に懸濁させる前に、疎水性成分が5μmから20nmの範囲内の 粒径を有する請求項1に記載の方法。 14.粒径が800nmから50nmの範囲内である請求項13に記載の方法 。 15.請求項1ないし14のいずれか一項により作製された乾燥粉末組成物。 16.請求項1ないし14のいずれか一項による乾燥粉末組成物を治療上有効 な量で有する1回用量分容器を含む、乾燥粉末組成物の単位用量。 17.乾燥粉末組成物をエアゾル化する方法であって、 請求項1ないし14のいずれか一項による乾燥粉末組成物のある量を準備する 段階と、 乾燥粉末組成物を流れている気流中に分散させる段階と を含む方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US3483796P | 1996-12-31 | 1996-12-31 | |
US60/034,837 | 1996-12-31 | ||
PCT/US1997/023905 WO1998029098A1 (en) | 1996-12-31 | 1997-12-29 | Processes for spray drying aqueous suspensions of hydrophobic drugs with hydrophilic excipients and compositions prepared by such processes |
Publications (1)
Publication Number | Publication Date |
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JP2001507702A true JP2001507702A (ja) | 2001-06-12 |
Family
ID=21878919
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
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JP53022698A Ceased JP2001507702A (ja) | 1996-12-31 | 1997-12-29 | 親水性賦形剤を有する疎水性薬剤の水性懸濁液を噴霧乾燥させる方法およびその方法によって作製された組成物 |
JP53022398A Pending JP2001507700A (ja) | 1996-12-31 | 1997-12-29 | 疎水性エアゾール薬剤 |
JP53022598A Pending JP2001507701A (ja) | 1996-12-31 | 1997-12-29 | 親水性賦形剤を有する疎水性薬剤の溶液を噴霧乾燥するための方法及びその方法によって作製された組成物 |
Family Applications After (2)
Application Number | Title | Priority Date | Filing Date |
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JP53022398A Pending JP2001507700A (ja) | 1996-12-31 | 1997-12-29 | 疎水性エアゾール薬剤 |
JP53022598A Pending JP2001507701A (ja) | 1996-12-31 | 1997-12-29 | 親水性賦形剤を有する疎水性薬剤の溶液を噴霧乾燥するための方法及びその方法によって作製された組成物 |
Country Status (5)
Country | Link |
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US (6) | US5976574A (ja) |
EP (3) | EP0951300A4 (ja) |
JP (3) | JP2001507702A (ja) |
AU (4) | AU5719798A (ja) |
WO (4) | WO1998029140A1 (ja) |
Cited By (10)
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JP2005501833A (ja) * | 2001-07-30 | 2005-01-20 | ディーエスエム アイピー アセッツ ビー.ブイ. | エピガロカテキンガレートのための組成物 |
JP2006510717A (ja) * | 2002-12-17 | 2006-03-30 | メディミューン・ヴァクシンズ・インコーポレーテッド | 生物活性材料の高圧噴霧乾燥 |
JP2007503380A (ja) * | 2003-08-22 | 2007-02-22 | ベーリンガー インゲルハイム ファルマ ゲゼルシャフト ミット ベシュレンクテル ハフツング ウント コンパニー コマンディトゲゼルシャフト | 含水量を削減した長期安定性に優れた噴霧乾燥非晶質粉末 |
JP2007533694A (ja) * | 2004-04-23 | 2007-11-22 | エラテック エス.アール.エル. | 乾燥粉末医薬組成物、その製造方法、およびその組成物から得られる安定な水性懸濁液 |
WO2008062908A1 (en) * | 2006-11-24 | 2008-05-29 | Canon Kabushiki Kaisha | Method for producing particles and particles |
JP2009542761A (ja) * | 2006-07-13 | 2009-12-03 | ユニリーバー・ナームローゼ・ベンノートシヤープ | 抗寄生虫組成物に関連する改良 |
JP2010028022A (ja) * | 2008-07-24 | 2010-02-04 | Mitsubishi Electric Corp | 添加剤溶解装置 |
JP2010510278A (ja) * | 2006-11-22 | 2010-04-02 | ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング | 新規抗コリン作用薬を含有する安定な粉末製剤 |
WO2014073542A1 (ja) * | 2012-11-07 | 2014-05-15 | 理研ビタミン株式会社 | 粉末状植物ステロール組成物およびその製造方法 |
JP2018162258A (ja) * | 2012-11-09 | 2018-10-18 | サイヴィタス セラピューティックス,インコーポレイテッ | 超低密度肺粉剤 |
Families Citing this family (247)
Publication number | Priority date | Publication date | Assignee | Title |
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US6743777B1 (en) * | 1992-03-19 | 2004-06-01 | Eli Lilly And Company | Cyclic peptide antifungal agents and process for preparation thereof |
US6673335B1 (en) * | 1992-07-08 | 2004-01-06 | Nektar Therapeutics | Compositions and methods for the pulmonary delivery of aerosolized medicaments |
ATE220327T1 (de) * | 1992-09-29 | 2002-07-15 | Inhale Therapeutic Syst | Pulmonale abgabe von aktiven fragmenten des parathormons |
US20030113273A1 (en) * | 1996-06-17 | 2003-06-19 | Patton John S. | Methods and compositions for pulmonary delivery of insulin |
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JP2005501833A (ja) * | 2001-07-30 | 2005-01-20 | ディーエスエム アイピー アセッツ ビー.ブイ. | エピガロカテキンガレートのための組成物 |
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JP2007503380A (ja) * | 2003-08-22 | 2007-02-22 | ベーリンガー インゲルハイム ファルマ ゲゼルシャフト ミット ベシュレンクテル ハフツング ウント コンパニー コマンディトゲゼルシャフト | 含水量を削減した長期安定性に優れた噴霧乾燥非晶質粉末 |
JP2007533694A (ja) * | 2004-04-23 | 2007-11-22 | エラテック エス.アール.エル. | 乾燥粉末医薬組成物、その製造方法、およびその組成物から得られる安定な水性懸濁液 |
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JP2018162258A (ja) * | 2012-11-09 | 2018-10-18 | サイヴィタス セラピューティックス,インコーポレイテッ | 超低密度肺粉剤 |
Also Published As
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JP2001507700A (ja) | 2001-06-12 |
US6077543A (en) | 2000-06-20 |
EP0951300A4 (en) | 2006-07-26 |
US6001336A (en) | 1999-12-14 |
EP0952821A1 (en) | 1999-11-03 |
EP0971698A1 (en) | 2000-01-19 |
US6365190B1 (en) | 2002-04-02 |
US5976574A (en) | 1999-11-02 |
WO1998029096A1 (en) | 1998-07-09 |
AU5806998A (en) | 1998-07-31 |
AU6014098A (en) | 1998-07-31 |
WO1998029141A1 (en) | 1998-07-09 |
AU5719798A (en) | 1998-07-31 |
US5985248A (en) | 1999-11-16 |
EP0952821A4 (en) | 2006-07-26 |
US6572893B2 (en) | 2003-06-03 |
AU5806898A (en) | 1998-07-31 |
WO1998029140A1 (en) | 1998-07-09 |
EP0951300A1 (en) | 1999-10-27 |
WO1998029098A1 (en) | 1998-07-09 |
JP2001507701A (ja) | 2001-06-12 |
EP0971698A4 (en) | 2006-07-26 |
US20020132011A1 (en) | 2002-09-19 |
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