JPH11501937A - 薬剤用放出制御吹入剤担体 - Google Patents
薬剤用放出制御吹入剤担体Info
- Publication number
- JPH11501937A JPH11501937A JP8530550A JP53055096A JPH11501937A JP H11501937 A JPH11501937 A JP H11501937A JP 8530550 A JP8530550 A JP 8530550A JP 53055096 A JP53055096 A JP 53055096A JP H11501937 A JPH11501937 A JP H11501937A
- Authority
- JP
- Japan
- Prior art keywords
- drug
- gum
- formulation
- particles
- microns
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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- 238000013270 controlled release Methods 0.000 title claims abstract description 42
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- 229920001282 polysaccharide Polymers 0.000 claims abstract description 43
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- 238000000034 method Methods 0.000 claims description 41
- 239000002131 composite material Substances 0.000 claims description 23
- 235000000346 sugar Nutrition 0.000 claims description 22
- 229920001285 xanthan gum Polymers 0.000 claims description 21
- 235000010493 xanthan gum Nutrition 0.000 claims description 20
- 239000000230 xanthan gum Substances 0.000 claims description 20
- 229940082509 xanthan gum Drugs 0.000 claims description 20
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- 239000008187 granular material Substances 0.000 claims description 15
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- 125000002091 cationic group Chemical group 0.000 claims description 6
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims description 5
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- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 1
- JVTAAEKCZFNVCJ-UHFFFAOYSA-M Lactate Chemical compound CC(O)C([O-])=O JVTAAEKCZFNVCJ-UHFFFAOYSA-M 0.000 claims 1
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- 150000001342 alkaline earth metals Chemical class 0.000 claims 1
- 150000001649 bromium compounds Chemical class 0.000 claims 1
- 150000003841 chloride salts Chemical class 0.000 claims 1
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- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 25
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- NDAUXUAQIAJITI-UHFFFAOYSA-N albuterol Chemical compound CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1 NDAUXUAQIAJITI-UHFFFAOYSA-N 0.000 description 11
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- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 7
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 7
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- 210000001331 nose Anatomy 0.000 description 7
- 235000002639 sodium chloride Nutrition 0.000 description 7
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 6
- 239000004480 active ingredient Substances 0.000 description 6
- BNPSSFBOAGDEEL-UHFFFAOYSA-N albuterol sulfate Chemical compound OS(O)(=O)=O.CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1.CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1 BNPSSFBOAGDEEL-UHFFFAOYSA-N 0.000 description 6
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- OMDQUFIYNPYJFM-XKDAHURESA-N (2r,3r,4s,5r,6s)-2-(hydroxymethyl)-6-[[(2r,3s,4r,5s,6r)-4,5,6-trihydroxy-3-[(2s,3s,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxan-2-yl]methoxy]oxane-3,4,5-triol Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O[C@H]2[C@H]([C@@H](O)[C@H](O)[C@@H](CO)O2)O)[C@H](O)[C@H](O)[C@H](O)O1 OMDQUFIYNPYJFM-XKDAHURESA-N 0.000 description 4
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- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 description 3
- GJCOSYZMQJWQCA-UHFFFAOYSA-N 9H-xanthene Chemical class C1=CC=C2CC3=CC=CC=C3OC2=C1 GJCOSYZMQJWQCA-UHFFFAOYSA-N 0.000 description 3
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- JWZZKOKVBUJMES-UHFFFAOYSA-N (+-)-Isoprenaline Chemical compound CC(C)NCC(O)C1=CC=C(O)C(O)=C1 JWZZKOKVBUJMES-UHFFFAOYSA-N 0.000 description 2
- IOVGROKTTNBUGK-SJKOYZFVSA-N (1S,2R)-ritodrine Chemical compound N([C@H](C)[C@@H](O)C=1C=CC(O)=CC=1)CCC1=CC=C(O)C=C1 IOVGROKTTNBUGK-SJKOYZFVSA-N 0.000 description 2
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- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 description 2
- FEWJPZIEWOKRBE-UHFFFAOYSA-M 3-carboxy-2,3-dihydroxypropanoate Chemical compound OC(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-M 0.000 description 2
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
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Classifications
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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
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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
- 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
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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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
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Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.薬剤の凝集複合物の放出制御粒子と、天然物起源の多糖ガムを含んでなる薬 剤学的に許容される担体とを含んでなる、吹入による薬剤送達のための呼吸可能 な粒子ベースの医薬製剤であって、凝集複合物粒子の平均粒子サイズが直径約0 .1〜約125ミクロンである、前記医薬製剤。 2.前記凝集複合物粒子の平均粒子サイズが約0.1〜約10ミクロンである、 請求項1記載の製剤。 3.前記凝集複合物粒子の平均粒子サイズが約1.0〜約355ミクロンである 、請求項1記載の製剤。 4.前記凝集複合物粒子の平均粒子サイズが約10〜約125ミクロンである、 請求項1記載の製剤。 5.前記多糖ガムがホモ多糖ガム、ヘテロ多糖ガム、およびこれらの混合物より なる群のうちの一つからなる、請求項1記載の製剤。 6.前記多糖ガムがデンプンからなる、請求項1記載の製剤。 7.前記ヘテロ多糖ガムがキサンタンガムであり、前記ホモ多糖ガムがローカス トビーンガムである、請求項5記載の製剤。 8.前記多糖ガムが約1:3〜約3:1の比率のヘテロ多糖ガムとホモ多糖ガム とからなる、請求項1記載の製剤。 9.薬物とガムとの比率が約0.5:100〜約1:1である、請求項1記載の 製剤。 10.薬物とガムとの比率が約1:100〜約1:2である、請求項1記載の製 剤。 11.アルカリ金属またはアルカリ土類金属の硫酸塩、塩化物、ホウ酸塩、臭化 物、クエン酸塩、酢酸塩または乳酸塩からなる、約0.1〜約50重量%の陽イ オン性架橋剤をさらに含んでなる、請求項1記載の製剤。 12.前記陽イオン性架橋剤が塩化カリウム及び塩化ナトリウムよりなる群から 選択される、請求項11記載の製剤。 13.前記薬剤学的に許容される担体が、単糖、二糖およびこれらの混合物より なる群から選択される不活性糖希釈剤をさらに含んでなる、請求項1記載の製剤 。 14.前記薬剤学的に許容される担体が、放出制御担体の約0.5〜約3重量% の量の薬剤学的に許容される界面活性剤をさらに含んでなる、請求項1記載の製 剤。 15.前記界面活性剤が、薬剤学的に許容される陰イオン性界面活性剤、陽イオ ン性界面活性剤、両性(両親媒性)界面活性剤、非イオン性界面活性剤、および これらの混合物よりなる群から選択される、請求項14記載の製剤。 16.前記放出制御粒子が一緒に圧縮されて固体塊を形成する、請求項1記載の 製剤。 17.吹入治療法のための放出制御医薬製剤の製造方法であって、 薬剤と天然物起源の多糖ガムとの混合物を同時処理して薬剤とガムとの凝集複 合物を形成し、次に該薬剤とガムとの凝集複合物を粉砕して、約0.1〜約35 5ミクロンの直径を有する粒子を得ることを含んでなる、前記方法。 18.前記ガムと前記薬剤との同時処理の前に前記多糖ガムを粉砕することをさ らに含む、請求項17記載の方法。 19.経口または経鼻吹入治療法により患者を治療する方法であって、 薬剤と天然物起源の多糖ガムとの混合物を同時処理して薬剤とガムとの凝集複 合物を形成し、次に得られた薬剤とガムとの凝集複合物を粉砕して、約0.1〜 約355ミクロンの直径を有する粒子を得、 得られた粒子を適切な吸入器に組み込み、そして 吸入器を用いて、計量された単位投与量の凝集複合物を患者に投与して、気道 または鼻内に吸収される治療上有効量の薬剤を提供する、 ことを含んでなる、前記方法。 20.平均粒子サイズが直径約0.1〜約355ミクロンである、薬剤と天然物 起源の多糖を含んでなる薬剤学的に許容される担体との凝集複合物を含有する、 カプセル、カートリッジブリスターまたはエアゾル容器。 21.気道の上気道での薬剤の放出制御のための経口吹入製剤を提供する方法で あって、 薬剤と天然物起源の多糖ガムとの混合物を顆粒化し、得られた顆粒を乾燥し、 得られた薬剤とガムとの凝集複合物を粉砕して、約0.1〜約355ミクロン の直径を有する粒子を得て、そして 粒子の単位投与量をヒト患者の上気道に送達するのに適した吸入装置に得られ た粒子を組み込む、 ことを含んでなる、前記方法。 22.凝集複合物粒子の平均粒子サイズが、薬剤を気道に送達するために約12 5〜約355ミクロンである、薬剤と天然物起源の多糖ガムを含んでなる薬剤学 的に許容される担体との凝集複合物の放出制御粒子の使用。
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US08/419,635 | 1995-04-07 | ||
US08/419,635 US5612053A (en) | 1995-04-07 | 1995-04-07 | Controlled release insufflation carrier for medicaments |
PCT/US1996/005333 WO1996031198A1 (en) | 1995-04-07 | 1996-04-04 | Controlled release insufflation carrier for medicaments |
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JP2004007204A Division JP2004107360A (ja) | 1995-04-07 | 2004-01-14 | 薬剤用放出制御吹入剤担体 |
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JP53055096A Expired - Fee Related JP3530532B2 (ja) | 1995-04-07 | 1996-04-04 | 薬剤用放出制御吹入剤担体 |
JP2004007204A Pending JP2004107360A (ja) | 1995-04-07 | 2004-01-14 | 薬剤用放出制御吹入剤担体 |
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EP (1) | EP0818991B1 (ja) |
JP (2) | JP3530532B2 (ja) |
KR (1) | KR100274689B1 (ja) |
AT (1) | ATE314840T1 (ja) |
AU (1) | AU712369B2 (ja) |
CA (1) | CA2216828C (ja) |
DE (1) | DE69635706T2 (ja) |
HU (1) | HUP9802828A3 (ja) |
IL (1) | IL117839A (ja) |
MX (1) | MX9707685A (ja) |
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1997
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1999
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2001056581A1 (fr) * | 2000-02-04 | 2001-08-09 | Kissei Pharmaceutical Co., Ltd. | Preparation en poudre pour inhalation et inhalateur de poudre contenant cette preparation |
JP2004513091A (ja) * | 2000-10-03 | 2004-04-30 | ペンウェスト ファーマシューティカルズ カンパニー | 異なる速度の複数の医薬活性成分の送達系 |
JPWO2004075920A1 (ja) * | 2003-02-26 | 2006-06-01 | 大塚製薬株式会社 | 経肺投与用徐放性製剤学的組成物 |
JP2007504277A (ja) * | 2003-05-28 | 2007-03-01 | アベンティス・フアーマ・リミテッド | 安定化された医薬製品 |
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HUP9802828A3 (en) | 1999-11-29 |
TW475903B (en) | 2002-02-11 |
AU5391796A (en) | 1996-10-23 |
KR100274689B1 (ko) | 2001-03-02 |
AU712369B2 (en) | 1999-11-04 |
WO1996031198A1 (en) | 1996-10-10 |
IL117839A (en) | 2002-02-10 |
DE69635706T2 (de) | 2006-08-31 |
NO974404L (no) | 1997-09-23 |
JP2004107360A (ja) | 2004-04-08 |
CA2216828C (en) | 2002-03-26 |
US7172766B2 (en) | 2007-02-06 |
US6387394B1 (en) | 2002-05-14 |
IL117839A0 (en) | 1996-08-04 |
ATE314840T1 (de) | 2006-02-15 |
JP3530532B2 (ja) | 2004-05-24 |
US20020090345A1 (en) | 2002-07-11 |
CA2216828A1 (en) | 1996-10-10 |
MX9707685A (es) | 1998-08-30 |
NO974404D0 (no) | 1997-09-23 |
EP0818991A4 (en) | 1998-08-19 |
DE69635706D1 (de) | 2006-03-30 |
NZ305800A (en) | 1998-08-26 |
HUP9802828A2 (hu) | 1999-07-28 |
NO322442B1 (no) | 2006-10-09 |
US5738865A (en) | 1998-04-14 |
KR19980703685A (ko) | 1998-12-05 |
EP0818991A1 (en) | 1998-01-21 |
US5612053A (en) | 1997-03-18 |
EP0818991B1 (en) | 2006-01-04 |
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