JP2001507701A - 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 - Google Patents
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Info
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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
- A61K31/335—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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/557—Eicosanoids, e.g. leukotrienes or prostaglandins
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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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
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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
- A61K31/56—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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- 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
- A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7012—Compounds having a free or esterified carboxyl group attached, directly or through a carbon chain, to a carbon atom of the saccharide radical, e.g. glucuronic acid, neuraminic acid
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- A—HUMAN NECESSITIES
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- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
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- A—HUMAN NECESSITIES
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- 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
- A61K9/1611—Inorganic compounds
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D1/00—Evaporating
- B01D1/16—Evaporating by spraying
- B01D1/18—Evaporating by spraying to obtain dry solids
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- 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
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
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- Y10S977/773—Nanoparticle, i.e. structure having three dimensions of 100 nm or less
- Y10S977/775—Nanosized powder or flake, e.g. nanosized catalyst
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- Y10S977/904—Specified use of nanostructure for medical, immunological, body treatment, or diagnosis
- Y10S977/926—Topical chemical, e.g. cosmetic or sunscreen
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.乾燥粉末組成物を製造する方法において、 有機溶剤または共溶剤系に親水性成分を少なくとも部分的に溶かす段階と、 同じ有機溶剤または共溶剤系に疎水性成分を少なくとも部分的に溶かして有機 溶液を生成する段階と、 有機溶液を噴霧乾燥し、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.親水性成分が、有機溶剤または共溶剤系に対して少なくともlmg/ml の溶解度を有し、疎水性成分が、有機溶剤または共溶剤系に対して少なくとも0 .0lmg/ml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lmg/mlから100mg/mlの範囲内の濃度を有し、 疎水性成分が0.0lmg/mlから10mg/mlの範囲内の濃度を有する請 求項2に記載の方法。 4.溶剤が、アルコール、ケトン、炭化水素または極性非プロトン溶剤と、そ の混合物および水性溶液を含む請求項1に記載の方法。 5.溶剤が、エタノール:水を重量で80:20から20:80で含む請求項 1に記載の方法。 6.疎水性成分が疎水性薬剤を含む請求項1に記載の方法。 7.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、ベータメタゾンと、 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1に記載の方法。 8.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1に記載の方法。 9.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。 10.親水性賦形剤が、ラクトース、マンニトール、ポビドン、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9に記載 の方法。 11.集塊を破壊するために、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.請求項1ないし11のいずれか一項により製造された乾燥粉末組成物。 14.請求項1ないし11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。 15.乾燥粉末組成物をエアゾル化するための方法であって、 請求項1ないし11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/US1997/023904 WO1998029141A1 (en) | 1996-12-31 | 1997-12-29 | Processes for spray drying solutions of hydrophobic drugs with hydrophilic excipients and compositions prepared by such processes |
Publications (1)
Publication Number | Publication Date |
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JP2001507701A true JP2001507701A (ja) | 2001-06-12 |
Family
ID=21878919
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
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 Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
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 |
Country Status (5)
Country | Link |
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US (6) | US6077543A (ja) |
EP (3) | EP0952821A4 (ja) |
JP (3) | JP2001507702A (ja) |
AU (4) | AU6014098A (ja) |
WO (4) | WO1998029140A1 (ja) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2007513152A (ja) * | 2003-12-03 | 2007-05-24 | マイクロドラッグ アクチェンゲゼルシャフト | 耐湿性容器内のチオトロピウムから構成される医薬製品 |
JP2009518395A (ja) * | 2005-12-09 | 2009-05-07 | テバ ファーマシューティカル インダストリーズ リミティド | 難溶性化合物の水性分散物および溶液ならびにそれらの調製方法 |
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US20030203036A1 (en) | 2000-03-17 | 2003-10-30 | Gordon Marc S. | Systems and processes for spray drying hydrophobic drugs with hydrophilic excipients |
GB9703673D0 (en) * | 1997-02-21 | 1997-04-09 | Bradford Particle Design Ltd | Method and apparatus for the formation of particles |
US20030035778A1 (en) * | 1997-07-14 | 2003-02-20 | Robert Platz | Methods and compositions for the dry powder formulation of interferon |
US7052678B2 (en) | 1997-09-15 | 2006-05-30 | Massachusetts Institute Of Technology | Particles for inhalation having sustained release properties |
US20060165606A1 (en) * | 1997-09-29 | 2006-07-27 | Nektar Therapeutics | Pulmonary delivery particles comprising water insoluble or crystalline active agents |
US6309623B1 (en) * | 1997-09-29 | 2001-10-30 | Inhale Therapeutic Systems, Inc. | Stabilized preparations for use in metered dose inhalers |
US6565885B1 (en) | 1997-09-29 | 2003-05-20 | Inhale Therapeutic Systems, Inc. | Methods of spray drying pharmaceutical compositions |
GB9726916D0 (en) | 1997-12-19 | 1998-02-18 | Danbiosyst Uk | Nasal formulation |
TW581681B (en) * | 1998-02-20 | 2004-04-01 | Nektar Therapeutics | Liquid crystal forms of cyclosporin |
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- 1997-12-29 WO PCT/US1997/023902 patent/WO1998029096A1/en active Application Filing
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Cited By (2)
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JP2007513152A (ja) * | 2003-12-03 | 2007-05-24 | マイクロドラッグ アクチェンゲゼルシャフト | 耐湿性容器内のチオトロピウムから構成される医薬製品 |
JP2009518395A (ja) * | 2005-12-09 | 2009-05-07 | テバ ファーマシューティカル インダストリーズ リミティド | 難溶性化合物の水性分散物および溶液ならびにそれらの調製方法 |
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US6572893B2 (en) | 2003-06-03 |
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JP2001507702A (ja) | 2001-06-12 |
US6001336A (en) | 1999-12-14 |
EP0951300A4 (en) | 2006-07-26 |
WO1998029140A1 (en) | 1998-07-09 |
US6077543A (en) | 2000-06-20 |
WO1998029141A1 (en) | 1998-07-09 |
EP0951300A1 (en) | 1999-10-27 |
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