JPH11508250A - ガラス形成性担体に溶解した活性物質からなる組成物及びその製造方法 - Google Patents
ガラス形成性担体に溶解した活性物質からなる組成物及びその製造方法Info
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- JPH11508250A JPH11508250A JP9503789A JP50378997A JPH11508250A JP H11508250 A JPH11508250 A JP H11508250A JP 9503789 A JP9503789 A JP 9503789A JP 50378997 A JP50378997 A JP 50378997A JP H11508250 A JPH11508250 A JP H11508250A
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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
- A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
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- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- 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
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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
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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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
- A61K9/145—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 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
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
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- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dermatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Glass Compositions (AREA)
- Medicinal Preparation (AREA)
- Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
- Processing Of Solid Wastes (AREA)
- Medicines Containing Plant Substances (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Immobilizing And Processing Of Enzymes And Microorganisms (AREA)
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.ガラス形成性担体中に溶解した生物学的活性物質の溶液からなる生物学的活 性組成物であって、ここで前記ガラス形成性担体は可塑剤(B)を含有するガラス 形成性物質(A)からなる前記組成物。 2.ガラス形成性物質(A)単独のガラス転移温度より低い温度で非固体、好まし くは液体又はゼリー状であるため十分の可塑剤(B)を含有する請求項1に記載の 組成物。 3.組成物の指定使用温度で、そして場合により50℃より低い温度、好ましくは 40℃より低い温度、より好ましくは−10℃〜40℃の範囲内そして最も好ましくは 0℃〜40℃の範囲内で非固体、好ましくは液体又はゼリー状の稠度を有する請求 項2に記載の組成物。 4.担体のガラス転移温度(Tg)が生物学的活性物質の著しい分解が回避される 温度で前記生物学的活性物質の溶解を可能にする前記請求項のいずれかの項に記 載の組成物。 5.溶液のガラス転移温度(Tg)が生物学的活性物質の著しい分解なしに安定な 溶液の製造を可能にしそして使用及び/又は貯蔵時安定な溶液を可能にする前記 請求項のいずれかの項に記載の組成物。 6.生物学的活性物質の著しい熱誘発分解が溶液及び/又は担体のガラス転移温 度(Tg)を超える温度まで拡大する温度範囲において回避される前記請求項のい ずれかの項に記載の組成物。 7.生物学的活性物質が生物学的活性化合物、特に水及び脂肪への溶解性が不十 分な化合物である前記請求項のいずれかの項に記載の組成物。 8.生物学的活性物質が抗ウイルス性化合物、抗菌性化合物、抗カビ性化合物、 コルチコステロイド、ビタミン、プロビタミン、ホルモン、抗炎症性化合物、抗 癌剤及び向精神薬化合物から選ばれる請求項1〜7のい ずれかの項に記載の組成物。 9.前記活性物質がグアノシド化合物又はその脂肪酸エステル、好ましくはアシ クロビル、ビダラビン又はイドキスウリジンである請求項8に記載の組成物。 10.前記活性物質がエリスロマイシン、メトロニダゾール、グリセオフルビン及 びイミダゾールから選ばれる請求項8に記載の組成物。 11.前記活性物質がエストラジオールである請求項8に記載の組成物。 12.前記活性物質がピロキシカム、インドメタシン及びクロトリマゾールから選 ばれる請求項8に記載の組成物。 13.前記活性物質がサリチル酸又はその誘導体、好ましくはアセチルサリチル酸 又はアミノサリチル酸、特に4,5−アミノサリチル酸を包含する請求項8に記載 の組成物。 14.前記活性物質がフラボノイド、好ましくはカテキンである請求項8に記載の 組成物。 15.前記活性物質が葉酸拮抗薬、好ましくはメトトレキセートである請求項8に 記載の組成物。 16.前記活性物質がブスルファンである請求項8に記載の組成物。 17.ガラス形成性物質が好ましくは0℃より高いTgを有する単糖及びオリゴ糖、 並びにポリマー及びポリアルキレングリコールから選ばれる前記請求項のいずれ かの項に記載の組成物。 18.ガラス形成性物質がクエン酸を包含する請求項1〜16のいずれかの項に記載 の組成物。 19.可塑剤(B)がアルコール、カーボネート、低分子量ポリマー及び有機酸から 選ばれる前記請求項のいずれかの項に記載の組成物。 20.可塑剤(B)がグリセロール、プロピレングリコール、ジプロピレング リコール、プロピレンカーボネート及び乳酸から選ばれる請求項19に記載の組成 物。 21.さらに皮膚透過促進性物質(C)を含有する前記請求項のいずれかの項に記載 の組成物。 22.皮膚透過促進性物質(C)がオレイン酸、オレイルアルコール、モノオレイン 及びサリチル酸から選ばれる請求項21に記載の組成物。 23.腸管からの生物学的活性物質の取り込みを増加させるため脂肪吸収促進性物 質として作用するモノ、ジ又はトリグリセリドをさらに含有する前記請求項のい ずれかの項に記載の組成物。 24.ガラス形成性物質(A)及び可塑剤(B)の合計重量に基づいてガラス形成性物 質(A)の量が10〜90重量%、好ましくは20〜80重量%、そしてより好ましくは30 〜70重量%の範囲内にあり、そして可塑剤(B)の量が90〜10重量%、好ましくは 80〜20重量%、そしてより好ましくは70〜30重量%の範囲内にある前記請求項の いずれかの項に記載の組成物。 25.ガラス転移温度(Tg)が0℃より低く、好ましくは−10℃より低く、より好 ましくは−20℃より低く、そして最も好ましくは−30℃より低い前記請求項のい ずれかの項に記載の組成物。 26.生物学的活性物質の量がその溶解性限界までである前記請求項のいずれかの 項に記載の組成物。 27.ガラス形成性担体の重量に基づいて10重量%まで、好ましくは0.01〜10重量 %、そしてより好ましくは1〜10重量%の生物学的活性物質を含有する前記請求 項のいずれかの項に記載の組成物。 28.皮膚透過促進性物質(C)の量が担体の重量に基づいて0〜10重量%である前 記請求項のいずれかの項に記載の組成物。 29.実質的に水及び/又は揮発性有機溶媒を含有しない前記請求項のいず れかの項に記載の組成物。 30.生物学的活性物質が治療的又は予防的活性物質である医薬として使用するた めの前記請求項のいずれかの項に記載の生物学的活性組成物。 31.皮膚投与に適合する粘度が付与されている哺乳動物、好ましくは人間への皮 膚適用のための請求項30に記載の組成物。 32.可塑剤(B)を含有するガラス形成性物質(A)からなるガラス形成性担体中の 生物学的活性物質の溶液からなる生物学的活性組成物の製造方法であって、ガラ ス形成性担体を溶融し、そして前記活性物質の著しい分解を防ぐため十分低い温 度で生物学的活性物質を溶融担体中に溶解する段階からなる前記方法。 33.溶融担体を、活性物質をその中に溶解する前、前記活性物質の分解温度より 低い温度に冷却する請求項32に記載の方法。 34.生物学的活性組成物が請求項2〜31のいずれかの項に記載の前記組成物であ る請求項32又は33に記載の方法。 35.溶融担体が非晶質単一相物である請求項32〜34のいずれかの項に記載の方法 。 36.ガラス形成性物質(A)及び可塑剤(B)の混合物を溶融して非晶質物を形成さ せる請求項35に記載の方法。 37.粉末形態の生物学的活性物質を溶融担体に直接添加することにより前記生物 学的活性物質を前記溶融担体に溶解する請求項32〜36のいずれかの項に記載の方 法。 38.最初に生物学的活性物質を可塑剤(B)の一部に溶解するか又は懸濁し、そし てそれによって得られた溶液又は懸濁液を次に非晶質物に添加することにより前 記生物学的活性物質を前記非晶質物に溶解する請求項35〜36のいずれかの項に記 載の方法。 39.最初の溶融操作を90〜170℃、好ましくは105〜160℃の範囲の温度で実行し 、そして次に溶融担体を、生物学的活性物質をその中に溶解する前60〜120℃、 好ましくは80〜110℃の範囲の温度に冷却して下げる請求項32〜38のいずれかの 項に記載の方法。 40.さらに組成物を貯蔵及び/又は使用温度まで冷却して下げる段階を含む請求 項32〜39のいずれかの項に記載の方法。 41.貯蔵及び/又は使用温度が組成物のガラス転移温度(Tg)より高い請求項40 に記載の方法。 42.組成物が−10〜50℃、好ましくは10℃より高い温度そして最も好ましくは人 間又は動物受容体の体温で使用のために指定されそして安定である前記請求項の いずれかの項に記載の組成物又は方法。 43.組成物の貯蔵のために安定な温度が−10〜30℃、好ましくは5〜20℃である 前記請求項のいずれかの項に記載の組成物又は方法。 44.生物学的活性組成物の形成における生物学的活性物質を溶解するためのガラ ス形成性担体の使用であって、ここで前記担体がガラス形成性物質(A)及び可塑 剤(B)からなる前記使用。 45.生物学的活性組成物が請求項2〜31のいずれかの項に記載の前記組成物であ る請求項44に記載の使用。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
SE9502244A SE9502244D0 (sv) | 1995-06-20 | 1995-06-20 | A composition and a process for the preparation thereof |
SE9502244-8 | 1995-06-20 | ||
PCT/SE1996/000806 WO1997000670A1 (en) | 1995-06-20 | 1996-06-19 | A composition comprising an active agent dissolved in a glass-forming carrier and a process for the preparation thereof |
Publications (2)
Publication Number | Publication Date |
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JPH11508250A true JPH11508250A (ja) | 1999-07-21 |
JP4020331B2 JP4020331B2 (ja) | 2007-12-12 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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JP50378997A Expired - Lifetime JP4020331B2 (ja) | 1995-06-20 | 1996-06-19 | ガラス形成性担体に溶解した活性物質からなる組成物及びその製造方法 |
Country Status (15)
Country | Link |
---|---|
US (1) | US6083518A (ja) |
EP (1) | EP0833611B1 (ja) |
JP (1) | JP4020331B2 (ja) |
AT (1) | ATE204466T1 (ja) |
AU (1) | AU695622B2 (ja) |
CA (1) | CA2225286C (ja) |
DE (2) | DE69614689T2 (ja) |
DK (1) | DK0833611T3 (ja) |
ES (1) | ES2118677T3 (ja) |
HK (1) | HK1008774A1 (ja) |
NZ (1) | NZ311208A (ja) |
PT (1) | PT833611E (ja) |
SE (1) | SE9502244D0 (ja) |
WO (1) | WO1997000670A1 (ja) |
ZA (1) | ZA965237B (ja) |
Cited By (4)
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JP2002514587A (ja) * | 1998-05-14 | 2002-05-21 | ビオグラン・アクチエボラーグ | 生物活性組成物 |
JP2002514588A (ja) * | 1998-05-14 | 2002-05-21 | ビオグラン・アクチエボラーグ | 生物活性組成物 |
JP2004359548A (ja) * | 2003-06-02 | 2004-12-24 | Toa Eiyo Ltd | アシクロビル含有水溶液製剤 |
JP2022509479A (ja) * | 2018-10-24 | 2022-01-20 | セラノヴォ・ベー・フェー | 経口医薬製剤のための深共晶溶媒プラットフォーム |
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-
1995
- 1995-06-20 SE SE9502244A patent/SE9502244D0/xx unknown
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1996
- 1996-06-19 DE DE69614689T patent/DE69614689T2/de not_active Expired - Lifetime
- 1996-06-19 US US08/973,902 patent/US6083518A/en not_active Expired - Lifetime
- 1996-06-19 DK DK96921197T patent/DK0833611T3/da active
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- 1996-06-19 AT AT96921197T patent/ATE204466T1/de active
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- 1996-06-19 EP EP96921197A patent/EP0833611B1/en not_active Expired - Lifetime
- 1996-06-19 PT PT96921197T patent/PT833611E/pt unknown
- 1996-06-19 ES ES96921197T patent/ES2118677T3/es not_active Expired - Lifetime
- 1996-06-19 DE DE0833611T patent/DE833611T1/de active Pending
- 1996-06-20 ZA ZA965237A patent/ZA965237B/xx unknown
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1998
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2002514587A (ja) * | 1998-05-14 | 2002-05-21 | ビオグラン・アクチエボラーグ | 生物活性組成物 |
JP2002514588A (ja) * | 1998-05-14 | 2002-05-21 | ビオグラン・アクチエボラーグ | 生物活性組成物 |
JP2004359548A (ja) * | 2003-06-02 | 2004-12-24 | Toa Eiyo Ltd | アシクロビル含有水溶液製剤 |
JP2022509479A (ja) * | 2018-10-24 | 2022-01-20 | セラノヴォ・ベー・フェー | 経口医薬製剤のための深共晶溶媒プラットフォーム |
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ES2118677T1 (es) | 1998-10-01 |
ZA965237B (en) | 1997-01-09 |
AU6247396A (en) | 1997-01-22 |
JP4020331B2 (ja) | 2007-12-12 |
DE69614689T2 (de) | 2002-06-27 |
CA2225286C (en) | 2003-06-10 |
DE833611T1 (de) | 1999-01-07 |
WO1997000670A1 (en) | 1997-01-09 |
EP0833611B1 (en) | 2001-08-22 |
DE69614689D1 (de) | 2001-09-27 |
US6083518A (en) | 2000-07-04 |
SE9502244D0 (sv) | 1995-06-20 |
EP0833611A1 (en) | 1998-04-08 |
DK0833611T3 (da) | 2001-10-08 |
ATE204466T1 (de) | 2001-09-15 |
AU695622B2 (en) | 1998-08-20 |
PT833611E (pt) | 2002-01-30 |
HK1008774A1 (en) | 1999-05-21 |
CA2225286A1 (en) | 1997-01-09 |
ES2118677T3 (es) | 2001-10-16 |
NZ311208A (en) | 1999-03-29 |
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