JPH10510827A - ペプチドおよびタンパク質のエアゾール製剤 - Google Patents
ペプチドおよびタンパク質のエアゾール製剤Info
- Publication number
- JPH10510827A JPH10510827A JP8519730A JP51973096A JPH10510827A JP H10510827 A JPH10510827 A JP H10510827A JP 8519730 A JP8519730 A JP 8519730A JP 51973096 A JP51973096 A JP 51973096A JP H10510827 A JPH10510827 A JP H10510827A
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- Prior art keywords
- aerosol formulation
- formulation according
- medicinal aerosol
- polypeptide
- surfactant
- Prior art date
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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
- A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/28—Insulins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P39/00—General protective or antinoxious agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.(a)HFA噴射剤;(b)噴射剤中に分散し得る薬理学的に活性なポリ ペプチド;および(c)C8−C16脂肪酸またはそれらの塩、胆汁酸塩、リン脂 質またはアルキルサッカリドである界面活性剤(この界面活性剤は気道下部でポ リペプチドの全身吸収を促進するものである) を含有する薬用エアゾール製剤。 2.界面活性剤がC8−C16脂肪酸塩である、請求項1記載の薬用エアゾール 製剤。 3.脂肪酸塩がカプリル酸(C8)、カプリン酸(C10)、ラウリン酸(C12)およ びミリスチン酸(C14)のナトリウム、カリウムおよびリジン塩からなる群から選 択されるものである、請求項2に記載の薬用エアゾール製剤。 4.界面活性剤がトリヒドロキシ胆汁酸塩である、請求項1に記載の薬用エア ゾール製剤。 5.胆汁酸塩がコール酸、グリココール酸およびタウロコール酸からなる群か ら選択されるものである、請求項4に記載の薬用エアゾール製剤。 6.胆汁酸塩がコール酸、グリココール酸およびタウロコール酸のナトリウム およびカリウム塩からなる群から選択されるものである、請求項5に記載の薬用 エアゾール製剤。 7.胆汁酸塩がタウロコール酸ナトリウムである、請求項6に記載の薬用エア ゾール製剤。 8.界面活性剤が一本鎖のリン脂質である、請求項1に記載の薬用エアゾール 製剤。 9.界面活性剤がリゾホスファチジルコリン類、リゾホスファチジルグリセロ ール類、リゾホスファチジルエタノールアミン類、リゾホスファチジルイノシト ール類およびリゾホスファチジルセリン類からなる群から選択されるものである 、請求項8に記載の薬用エアゾール製剤。 10.界面活性剤が二本鎖リン脂質である、請求項1に記載の薬用エアゾール製 剤。 11.界面活性剤がジアシルホスファチジルコリン類、ジアシルホスファチジル グリセロール類、ジアシルホスファチジルエタノールアミン類、ジアシルホスフ ァチジルイノシトール類およびジアシルホスファチジルセリン類からなる群から 選択されるものである、請求項11に記載の薬用エアゾール製剤。 12.界面活性剤をジオクタニルホスファチジルグリセロールおよびジオクタニ ルホスファチジルコリンから選択する、請求項11に記載の薬用エアゾール製剤。 13.界面活性剤がアルキルグリコシド類およびアルキルマルトシド類からなる 群から選択されるものである、請求項1に記載の薬用エアゾール製剤。 14.界面活性剤がデシルグリコシドおよびドデシルマルトシドからなる群から 選択されるものである、請求項13に記載の薬用エアゾール製剤。 15.噴射剤が 1,1,1,2−テトラフルオロエタン(P134a)、1,1,1,2,3,3,3−ヘ プタフルオロプロパン(P227a)または 1,1−ジフルオロエタン(P152a)を含む 、請求項1〜14のいずれかに記載の薬用エアゾール製剤。 16.噴射剤が 1,1,1,2−テトラフルオロエタン(P134a)および 1,1,1,2,3,3, 3−ヘプタフルオロプロパン(P227)を含む、請求項15に記載の薬用エアゾール製 剤。 17.噴射剤が 1,1,1,2−テトラフルオロエタン(P134a)および 1,1,1,2,3,3, 3−ヘプタフルオロプロパン(P227)の密度適合混合物を含む、請求項15または1 6に記載の薬用エアゾール製剤。 18.ポリペプチドの分子量が 40kDまでの、請求項1〜17のいずれかに記載 の薬用エアゾール製剤。 19.ポリペプチドの分子量が 30kDまでの、請求項18に記載の薬用エアゾー ル製剤。 20.ポリペプチドの分子量が 25kDまでの、請求項19に記載の薬用エアゾー ル製剤。 21.ポリペプチドの分子量が 20kDまでの、請求項1〜20のいずれかに記載 の薬用エアゾール製剤。 22.ポリペプチドの分子量が 15kDまでの、請求項1〜21のいずれかに記載 の薬用エアゾール製剤。 23.ポリペプチドの分子量が 10kDまでの、請求項1〜22のいずれかに記載 の薬用エアゾール製剤。 24.ポリペプチドがペプチドホルモンである、請求項1〜23のいずれかに記載 の薬用エアゾール製剤。 25.ポリペプチドがインシュリン、グルカゴン、インシュリンのC−ペプチド 、バソプレッシン、デスモプレッシン、副腎皮質刺激ホルモン(ACTH)、副腎 皮質刺激ホルモン放出ホルモン(CRH)、性腺刺激ホルモン放出ホルモン(Gn RH)、性腺刺激ホルモン放出ホルモンアゴニストおよびアンタゴニスト、性腺 刺激ホルモン(黄体形成ホルモン、またはLHRH)、カルシトニン、副甲状腺ホ ルモン(PTH)、PTH(34)およびPTH(38)のようなPTHの生物活性部分、 成長ホルモン(GH)(例えばヒト成長ホルモン(hGH)、成長ホルモン放出ホル モン(GHRH)、ソマトスタチン、オキシトシン、心房性ナトリウム利尿因子( ANF)、甲状腺刺激ホルモン放出ホルモン(TRH)、デオキシリボヌクレアー ゼ(DNase)、プロラクチン、濾胞刺激ホルモン(FSH)およびそれらの類似 体からなる群から選択されるものである、請求項1〜17のいずれかに記載の薬用 エアゾール製剤。 26.ポリペプチドがインシュリンである、請求項25に記載の薬用エアゾール製 剤。 27.噴射剤および界面活性剤の重量にして 20%までの量のエタノールを含む 、請求項1〜26のいずれかに記載の薬用エアゾール製剤。 28.噴射剤および界面活性剤の重量にして 5%までの量のエタノールを含む、 請求項1〜27のいずれかに記載の薬用エアゾール製剤。 29.補助剤、担体、矯臭剤、緩衝液、抗酸化剤および化学的安定化剤からなる 群から選択された添加剤を含むものである、請求項1〜28のいずれかに記載の薬 用エアゾール製剤。 30.添加剤がラクトース、グルコース、フルクトース、ガラクトース、トレハ ロース、スクロース、マルトース、ラフィノース、マルチトール、メレチトース 、スタキオース、ラクチトール、パラチナイト、デンプン、キシリトール、マン ニトール、ミオイノシトール、それらの水和物、アラニン、グリシンおよびベタ インおよびアルブミンからなる群から選択されるものである、請求項29に記載の 薬用エアゾール製剤。 31.担体がメレチトースである、請求項30に記載の薬用エアゾール製剤。 32.界面活性剤:ポリペプチド比が 1:10〜1:0.2 の範囲で界面活性剤が存在 する、請求項1〜31のいずれかに記載の薬用エアゾール製剤。 33.界面活性剤:ポリペプチド比が 1:4〜1:1 の範囲で界面活性剤が存在する 、請求項32に記載の薬用エアゾール製剤。 34.ポリペプチドが直径 0.01〜10 ミクロンである粒子を含む、請求項1〜33 のいずれかに記載の薬用エアゾール製剤。 35.ポリペプチドが直径 0.1〜6 ミクロンである粒子を含む、請求項34に記載 の薬用エアゾール製剤。 36.ポリペプチドが直径 0.1〜5 ミクロンである粒子を含む、請求項34に記載 の薬用エアゾール製剤。 37.少なくとも 50%のポリペプチドが上記サイズ範囲内の粒子を含む、請求 項34〜36のいずれかに記載の薬用エアゾール製剤。 38.少なくとも 60%のポリペプチドが上記サイズ範囲内の粒子を含む、請求 項34〜36のいずれかに記載の薬用エアゾール製剤。 39.少なくとも 70%のポリペプチドが上記サイズ範囲内の粒子を含む、請求 項34〜36のいずれかに記載の薬用エアゾール製剤。 40.少なくとも 80%のポリペプチドが上記サイズ範囲内の粒子を含む、請求 項34〜36のいずれかに記載の薬用エアゾール製剤。 41.少なくとも 90%のポリペプチドが上記サイズ範囲内の粒子を含む、請求 項34〜36のいずれかに記載の薬用エアゾール製剤。 42.ポリペプチドの濃度が製剤の 0.1mg/ml〜25mg/mlである、請求項1〜41の いずれかに記載の薬用エアゾール製剤。 43.ポリペプチドおよび界面活性剤を水性緩衝液中で混合し;乾燥して固体粉 末とし;所望により固体粉末を微細化し;所望により微細化した粉末、噴射剤お よび所望によりエタノールを低温で容器に加え;混合し;さらに噴射剤および所 望によりエタノールを加える工程を含む、請求項1〜42のいずれかに記載のポリ ペプチドエアゾール製剤の製造方法。 44.治療に使用することを目的とする、請求項1〜42のいずれかに記載のポリ ペプチドエアゾール製剤。 45.気道を経由する疾病処置用の薬剤の製造における、請求項1〜42のいずれ かに記載のポリペプチドエアゾール製剤の使用。 46.請求項1〜42のいずれかに記載のポリペプチドエアゾール製剤の治療有効 量を治療の必要な患者に投与することを含む、上記患者の処置法。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
SE9404467-4 | 1994-12-22 | ||
SE9404467A SE9404467D0 (sv) | 1994-12-22 | 1994-12-22 | Drug formulations |
SE9502453-5 | 1995-07-06 | ||
SE9502453A SE9502453D0 (sv) | 1995-07-06 | 1995-07-06 | Drug formulations |
PCT/SE1995/001540 WO1996019197A1 (en) | 1994-12-22 | 1995-12-19 | Aerosol formulations of peptides and proteins |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2006029669A Division JP2006137776A (ja) | 1994-12-22 | 2006-02-07 | ペプチドおよびタンパク質のエアゾール製剤 |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH10510827A true JPH10510827A (ja) | 1998-10-20 |
JP3862178B2 JP3862178B2 (ja) | 2006-12-27 |
Family
ID=26662195
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP51973096A Expired - Lifetime JP3862178B2 (ja) | 1994-12-22 | 1995-12-19 | ペプチドおよびタンパク質のエアゾール製剤 |
JP2006029669A Pending JP2006137776A (ja) | 1994-12-22 | 2006-02-07 | ペプチドおよびタンパク質のエアゾール製剤 |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2006029669A Pending JP2006137776A (ja) | 1994-12-22 | 2006-02-07 | ペプチドおよびタンパク質のエアゾール製剤 |
Country Status (33)
Country | Link |
---|---|
US (1) | US6524557B1 (ja) |
EP (2) | EP1180365A3 (ja) |
JP (2) | JP3862178B2 (ja) |
KR (1) | KR100428281B1 (ja) |
CN (1) | CN1088581C (ja) |
AR (1) | AR002013A1 (ja) |
AT (1) | ATE217787T1 (ja) |
AU (1) | AU702879B2 (ja) |
BR (1) | BR9510501A (ja) |
CA (1) | CA2206736C (ja) |
CZ (1) | CZ288145B6 (ja) |
DE (1) | DE69526801T2 (ja) |
DK (1) | DK0797431T3 (ja) |
EE (1) | EE03590B1 (ja) |
ES (1) | ES2176355T3 (ja) |
FI (1) | FI119413B (ja) |
HK (1) | HK1003503A1 (ja) |
HU (1) | HU227790B1 (ja) |
IL (1) | IL116458A (ja) |
IS (1) | IS1810B (ja) |
MX (1) | MX9704545A (ja) |
MY (1) | MY120664A (ja) |
NO (1) | NO316105B1 (ja) |
NZ (1) | NZ298167A (ja) |
PL (1) | PL182560B1 (ja) |
PT (1) | PT797431E (ja) |
RU (1) | RU2175866C2 (ja) |
SA (1) | SA95160483B1 (ja) |
SK (1) | SK284346B6 (ja) |
TR (1) | TR199501669A1 (ja) |
TW (1) | TW398978B (ja) |
UA (1) | UA42047C2 (ja) |
WO (1) | WO1996019197A1 (ja) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2004525148A (ja) * | 2001-03-30 | 2004-08-19 | ヤゴテック アーゲー | 医療用エアゾール配合物 |
JP2005536538A (ja) * | 2002-08-23 | 2005-12-02 | シェーリング コーポレイション | 薬学的組成物 |
JP2007161702A (ja) * | 2005-12-15 | 2007-06-28 | Development Center For Biotechnology | 水性吸入用医薬組成物 |
Families Citing this family (89)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6632456B1 (en) * | 1993-06-24 | 2003-10-14 | Astrazeneca Ab | Compositions for inhalation |
US6794357B1 (en) * | 1993-06-24 | 2004-09-21 | Astrazeneca Ab | Compositions for inhalation |
CZ288146B6 (en) * | 1994-12-22 | 2001-05-16 | Astra Ab | Pharmaceutical aerosol preparation, process of its preparation and use |
US5874481A (en) * | 1995-06-07 | 1999-02-23 | Alliance Pharmaceutical Corp. | Fluorochemical solutions for the delivery of lipophilic pharmaceutical agents |
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- 1994-12-19 US US08/624,504 patent/US6524557B1/en not_active Expired - Fee Related
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1995
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Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2004525148A (ja) * | 2001-03-30 | 2004-08-19 | ヤゴテック アーゲー | 医療用エアゾール配合物 |
JP4824267B2 (ja) * | 2001-03-30 | 2011-11-30 | ヤゴテック アーゲー | 医療用エアゾール配合物 |
JP2005536538A (ja) * | 2002-08-23 | 2005-12-02 | シェーリング コーポレイション | 薬学的組成物 |
JP2006312649A (ja) * | 2002-08-23 | 2006-11-16 | Schering Plough Corp | 薬学的組成物 |
JP2007161702A (ja) * | 2005-12-15 | 2007-06-28 | Development Center For Biotechnology | 水性吸入用医薬組成物 |
US8058236B2 (en) | 2005-12-15 | 2011-11-15 | Development Center For Biotechnology | Aqueous inhalation pharmaceutical composition |
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