JP2000507912A - 作用剤の徐放性組成物 - Google Patents
作用剤の徐放性組成物Info
- Publication number
- JP2000507912A JP2000507912A JP9510527A JP51052797A JP2000507912A JP 2000507912 A JP2000507912 A JP 2000507912A JP 9510527 A JP9510527 A JP 9510527A JP 51052797 A JP51052797 A JP 51052797A JP 2000507912 A JP2000507912 A JP 2000507912A
- Authority
- JP
- Japan
- Prior art keywords
- poly
- polymer
- bioactive agent
- solid phase
- release composition
- 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.)
- Withdrawn
Links
Classifications
-
- 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
- A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
-
- 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
- A61K9/1629—Organic macromolecular compounds
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
- A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.a)第1の生体適合性固相材料および生理活性剤を含み、生理活性剤のイン ・ビボの放出を維持するマイクロキャリア、ならびに b)生理活性剤のイン・ビボの放出をさらに維持する第2の生体適合性固相材料 の粒子 を含有してなる、生理活性剤のイン・ビボの徐放性組成物。 2.生理活性剤が第1の固相材料内にカプセル化されている請求項1記載の徐放 性組成物。 3.第1の固相材料が生体適合性ポリマーである請求項2記載の徐放性組成物。 4.生体適合性ポリマーが生分解性ポリマー、非生分解性ポリマー、それらの混 合物およびそれらのコポリマーからなる群より選ばれる請求項3記載の徐放性組 成物。 5.生体適合性ポリマーが生分解性ポリマーである請求項4記載の徐放性組成物 。 6.生体適合性ポリマーが、ポリ(ラクチド)類、ポリ(グリコリド)類、ポリ (ラクチド−コ−グリコリド)類、ポリ(乳酸)類、ポリ(グリコール酸)類、 ポリ(乳酸−コ−グリコール酸)類、ポリカプロラクトン、ポリカーボネート類 、ポリエステルアミド類、ポリ無水物類、ポリ(アミノ酸)類、ポリオルトエス テル類、ポリアセチル類、ポリシアノアクリレート類、ポリエーテルエステル類 、ポリ(ジオキサノン)類、ポリ(アルキレンアルキレート)類、ポリエチレン グリコールとポリオルトエステルのコポリマー類、生分解性ポリウレタン類、そ れらの混合物およびそれらのコポリマーからなる群より選ばれる請求項5記載の 徐放性組成物。 7.生体適合性ポリマーが非生分解性ポリマーである請求項4記載の徐放性組成 物。 8.非生分解性ポリマーが、ポリアクリレート類、エチレンビニルアセテートと 他のアシル置換セルロースアセテートのポリマー類、非分解性ポリウレタン類、 ポリスチレン類、ポリ塩化ビニル、ポリフッ化ビニル、ポリ(ビニルイミダゾー ル)、クロロスルホネート化ポリオレフィン類、ポリエチレンオキシド類、それ らの混合物およびそれらのコポリマーからなる群より選ばれる請求項7記載の徐 放性組成物。 9.第2の固相材料の粒子の少なくとも一部がイン・ビボで一群を形成し、前記 塊がマイクロキャリアの少なくとも一部を含む請求項1記載の徐放性組成物。 10.第2の固相材料が、少なくとも1つの生理活性剤を含む請求項1記載の徐 放性組成物。 11.第2の固相材料が、生体適合性ポリマー、バイオセラミックスおよび脂質 を基礎とする材料からなる群より選ばれる請求項1記載の徐放性組成物。 12.第2の固相材料の粒子が、少なくとも1つの生体適合性ポリマー粒子であ る請求項1記載の徐放性組成物。 13.生体適合性ポリマーが、ポリ(ラクチド)類、ポリ(グリコリド)類、ポ リ(ラクチド−コ−グリコリド)類、ポリ(乳酸)類、ポリ(グリコール酸)類 、ポリ(乳酸−コ−グリコール酸)類、ポリカプロラクトン、ポリカーボネート 類、ポリエステルアミド類、ポリ無水物類、ポリ(アミノ酸)類、ポリオルトエ ステル類、ポリアセチル類、ポリシアノアクリレート類、ポリエーテルエステル 類、ポリ(ジオキサノン)類、ポリ(アルキレンアルキレート)類、ポリエチレ ングリコールとポリオルトエステルのコポリマー類、生分解性ポリウレタン類、 それらの混合物およびそれらのコポリマーからなる群より選ばれる請求項12記 載の徐放性組成物。 14.第2の固相材料の粒子が、少なくとも1つのバイオセラミック粒子である 請求項1記載の徐放性組成物。 15.さらに生理学的に許容され得る賦形剤を含有してなる請求項1記載の徐放 性組成物。 16.a)第1の生体適合性ポリマー内に配置された生理活性剤を含むマイクロ キャリア、および b)第2の生体適合性ポリマーの粒子 を含有してなる、生理活性剤のイン・ビボの徐放性組成物。 17.第1のポリマーと第2のポリマーが同じポリマーである請求項16記載の 徐放性組成物。 18.第1のポリマーが第2のポリマーとは異なるポリマーである請求項16記 載の徐放性組成物。 19.第1のポリマーが、ポリ(ラクチド)類、ポリ(グリコリド)類、ポリ( ラクチド−コ−グリコリド)類、ポリ(乳酸)類、ポリ(グリコール酸)類、ポ リ(乳酸−コ−グリコール酸)類、ポリカプロラクトン、ポリカーボネート類、 ポリエステルアミド類、ポリ無水物類、ポリ(アミノ酸)類、ポリオルトエステ ル類、ポリアセチル類、ポリシアノアクリレート類、ポリエーテルエステル類、 ポリ(ジオキサノン)類、ポリ(アルキレンアルキレート)類、ポリエチレング リコールとポリオルトエステルのコポリマー類、生分解性ポリウレタン類、それ らの混合物およびそれらのコポリマーからなる群より選ばれる請求項16記載の 徐放性組成物。 20.第2のポリマーが、ポリ(ラクチド)類、ポリ(グリコリド)類、ポリ( ラクチド−コ−グリコリド)類、ポリ(乳酸)類、ポリ(グリコール酸)類、ポ リ(乳酸−コ−グリコール酸)類、ポリカプロラクトン、ポリカーボネート類、 ポリエステルアミド類、ポリ無水物類、ポリ(アミノ酸)類、ポリオルトエステ ル類、ポリアセチル類、ポリシアノアクリレート類、ポリエーテルエステル類、 ポリ(ジオキサノン)類、ポリ(アルキレンアルキレート)類、ポリエチレング リコールとポリオルトエステルのコポリマー類、生分解性ポリウレタン類、それ らの混合物およびそれらのコポリマーからなる群より選ばれる請求項16記載の 徐放性組成物。 21.生理活性剤が凝集安定化されている請求項16記載の徐放性組成物。 22.さらに生理学的に許容され得る賦形剤を含有してなる請求項16記載の徐 放性組成物。 23.第1のポリマーが、生理活性剤のイン・ビボの放出を調節するために少な くとも1つの多価金属カチオン成分をさらに含む請求項16記載の徐放性組成物 。 24.第2のポリマーが、生理活性剤のイン・ビボの放出を調節するために少な くとも1つの多価金属カチオン成分をさらに含む請求項16記載の徐放性組成物 。 25.意味をもたない量の有機溶媒を含む請求項16記載の徐放性組成物。 26.イン・ビボの注射後にレシピエントが有機溶媒に関連する副作用を経験し ない請求項25記載の徐放性組成物。 27.a)生分解性ポリマー内に配置された生理活性剤を含むマイクロキャリア 、および b)生分解性ポリマーの粒子 を含有してなる、生理活性剤のイン・ビボの徐放性組成物。 28.生分解性ポリマーがポリ(ラクチド−コ−グリコリド)である請求項27 記載の徐放性組成物。 29.下記工程: a)放出期間を維持する量の固相材料とともに、マイクロキャリアに含まれる有 効量の生理活性剤を含む1回の用量を形成させる工程、および b)該用量を1回の非経口注射で患者に投与する工程 を含む、患者において生理活性剤の有効血清レベルを維持する方法。 30.少なくとも一部の固相材料がイン・ビボで塊を形成し、前記塊が1回の用 量の少なくとも一部の生理活性剤を含む請求項29記載の方法。 31.固相材料が生体適合性ポリマーを含有する請求項30記載の方法。 32.1回の用量中の固相材料がマイクロキャリアに含まれる請求項30記載の 方法。 33.1回の用量中の少なくとも一部の固相材料が、マイクロキャリアとは別の 粒子に含まれる請求項30記載の方法。 34.a)少なくとも1つの生理活性剤を含むマイクロキャリア、 b)生体適合性固相材料の粒子、および c)生理学的に許容され得る賦形剤 を含む徐放性組成物の有効量を患者に投与する工程を含む、生理活性剤のイン・ ビボの徐放性放出方法。 35.下記工程: a)生理活性剤、固相材料の粒子および生理学的に許容され得る賦形剤を含有す るマイクロキャリアの混合物を生成する工程、ならびに b)該混合物を1回の用量で患者に投与する工程 を含む患者における生理活性剤の徐放性放出方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US300695P | 1995-08-31 | 1995-08-31 | |
US60/003,006 | 1995-08-31 | ||
PCT/US1996/013787 WO1997007788A2 (en) | 1995-08-31 | 1996-08-29 | Composition for sustained release of an agent |
Publications (1)
Publication Number | Publication Date |
---|---|
JP2000507912A true JP2000507912A (ja) | 2000-06-27 |
Family
ID=21703628
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP9510527A Withdrawn JP2000507912A (ja) | 1995-08-31 | 1996-08-29 | 作用剤の徐放性組成物 |
Country Status (6)
Country | Link |
---|---|
US (1) | US5916597A (ja) |
EP (1) | EP0850051A2 (ja) |
JP (1) | JP2000507912A (ja) |
AU (1) | AU710347B2 (ja) |
CA (1) | CA2230494A1 (ja) |
WO (1) | WO1997007788A2 (ja) |
Cited By (1)
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AU710347B2 (en) | 1999-09-16 |
CA2230494A1 (en) | 1997-03-06 |
US5916597A (en) | 1999-06-29 |
AU7010496A (en) | 1997-03-19 |
WO1997007788A2 (en) | 1997-03-06 |
EP0850051A2 (en) | 1998-07-01 |
WO1997007788A3 (en) | 1997-04-17 |
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