JP2013505212A - 活性物質を含有するコーティングにより被覆されたペレット - Google Patents
活性物質を含有するコーティングにより被覆されたペレット Download PDFInfo
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- JP2013505212A JP2013505212A JP2012529229A JP2012529229A JP2013505212A JP 2013505212 A JP2013505212 A JP 2013505212A JP 2012529229 A JP2012529229 A JP 2012529229A JP 2012529229 A JP2012529229 A JP 2012529229A JP 2013505212 A JP2013505212 A JP 2013505212A
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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
- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
- A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
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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
- A61K9/1629—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
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08F—MACROMOLECULAR COMPOUNDS OBTAINED BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS
- C08F226/00—Copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a single or double bond to nitrogen or by a heterocyclic ring containing nitrogen
- C08F226/06—Copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a single or double bond to nitrogen or by a heterocyclic ring containing nitrogen by a heterocyclic ring containing nitrogen
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08F—MACROMOLECULAR COMPOUNDS OBTAINED BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS
- C08F283/00—Macromolecular compounds obtained by polymerising monomers on to polymers provided for in subclass C08G
- C08F283/06—Macromolecular compounds obtained by polymerising monomers on to polymers provided for in subclass C08G on to polyethers, polyoxymethylenes or polyacetals
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L1/00—Compositions of cellulose, modified cellulose or cellulose derivatives
- C08L1/02—Cellulose; Modified cellulose
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L5/00—Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
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- C—CHEMISTRY; METALLURGY
- C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
- C09D—COATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR
- C09D151/00—Coating compositions based on graft polymers in which the grafted component is obtained by reactions only involving carbon-to-carbon unsaturated bonds; Coating compositions based on derivatives of such polymers
- C09D151/08—Coating compositions based on graft polymers in which the grafted component is obtained by reactions only involving carbon-to-carbon unsaturated bonds; Coating compositions based on derivatives of such polymers grafted on to macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
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- C—CHEMISTRY; METALLURGY
- C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
- C09D—COATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR
- C09D171/00—Coating compositions based on polyethers obtained by reactions forming an ether link in the main chain; Coating compositions based on derivatives of such polymers
- C09D171/02—Polyalkylene oxides
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08F—MACROMOLECULAR COMPOUNDS OBTAINED BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS
- C08F218/00—Copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by an acyloxy radical of a saturated carboxylic acid, of carbonic acid or of a haloformic acid
- C08F218/02—Esters of monocarboxylic acids
- C08F218/04—Vinyl esters
- C08F218/08—Vinyl acetate
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L51/00—Compositions of graft polymers in which the grafted component is obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers
- C08L51/08—Compositions of graft polymers in which the grafted component is obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers grafted on to macromolecular compounds obtained otherwise than by reactions only involving unsaturated carbon-to-carbon bonds
Abstract
【選択図】なし
Description
i) 30〜80重量%のN-ビニルラクタム、
ii) 10〜50重量%の酢酸ビニル、および
iii) 10〜50重量%のポリエーテル
(ただし、i)、ii)およびiii)の合計は100重量%である)
の混合物の、フリーラジカル開始重合により得られる。
i) 30〜70重量%のN-ビニルラクタム、
ii) 15〜35重量%の酢酸ビニル、および
iii) 10〜35重量%のポリエーテル
より得られる好ましいコポリマーを使用する。
i) 40〜60重量%のN-ビニルラクタム、
ii) 15〜35重量%の酢酸ビニル、および
iii) 10〜30重量%のポリエーテル
より得ることができる。
i) 50〜60重量%のN-ビニルラクタム、
ii) 25〜35重量%の酢酸ビニル、および
iii) 10〜20重量%のポリエーテル
より得ることができる。
攪拌した装置の中で、フィード2の一部を除く初期チャージをN2雰囲気下で77℃に加熱した。77℃の内部温度に到達した時に、フィード2の一部を加えて、15分間に渡って部分的に重合させた。次に、フィード1を5時間以内に計量添加し、フィード2を2時間以内に計量添加した。すべてのフィードを計量添加した後、反応混合物をさらに3時間重合させた。さらなる重合の後、溶液を50重量%の固体含有量に調節した。
104.0 g PEG 6000
1.0 gのフィード2
フィード1:240 gの酢酸ビニル
456 gのビニルカプロラクタム
240 gの酢酸エチル
フィード2:10.44 gのtert-ブチルペルピバレート(脂肪族混合物中75重量%)
67.90 gの酢酸エチル
次に、噴霧法により溶媒を除去して粉末状の製品を得た。K値は、1重量%のエタノール溶液において測定して、36であった。ガラス転移温度は70℃であった。
装置:9管の試料交換装置を有するD 8 Advance回折計(Bruker/AXS製)
測定方法:反射におけるθ-θジオメトリー
角度範囲2シータ:2〜80°
ステップ幅:0.02°
角度ステップあたりの測定時間:4.8秒
発散スリット:0.4 mmの挿入されたアパーチャを有するGoebel鏡
散乱防止スリット:Sollerスリット
検出器:Sol-X検出器
温度:室温
発電機の設定:40kV/50mA
DSC Q 2000(TA Instruments製)
パラメーター:
開始時の重さ:約8.5 mg
加熱速度:20K/分
使用した開始剤粒子は、コポリマーおよびカルバマゼピン(carbamazepine)の固溶体(組成60:40)を粉砕したもの(<500μm押出物)であった。
使用した開始剤粒子は、コポリマーおよびダナゾール(danazole)の固溶体(組成70:30)を粉砕したもの(<500μm押出物)であった。
Claims (16)
- 水に難溶性の活性成分の製剤であって、活性成分を含有するコーティングを施された担体粒子を含み、難溶性活性成分が両親媒性コポリマーを含むコーティング中に埋め込まれている、前記製剤。
- 両親媒性コポリマーが、
i) 30〜80重量%のN-ビニルラクタム、
ii) 10〜50重量%の酢酸ビニル、および
iii) 10〜50重量%のポリエーテル
(ただし、i)、ii)およびiii)の合計は100重量%である)
の混合物のフリーラジカル開始重合により得られる、請求項1に記載の製剤。 - コポリマーが、
i) 30〜70重量%のN-ビニルラクタム、
ii) 15〜35重量%の酢酸ビニル、および
ii) 10〜35重量%のポリエーテル
より得られる、請求項1または2に記載の製剤。 - コポリマーが、
i) 40〜60重量%のN-ビニルラクタム、
ii) 15〜35重量%の酢酸ビニル、および
iii) 10〜30重量%のポリエーテル
より得られる、請求項1〜3のいずれか1項に記載の製剤。 - コポリマーが、
i) 50〜60重量%のN-ビニルラクタム、
ii) 25〜35重量%の酢酸ビニル、および
iii) 10〜20重量%のポリエーテル
より得られる、請求項1〜4のいずれか1項に記載の製剤。 - 使用される担体粒子が、医薬品賦形剤を含むペレットである、請求項1〜5のいずれか1項に記載の製剤。
- 担体粒子が、スクロース、カラギーナン、デンプンまたは微結晶セルロースを含む、請求項1〜6のいずれか1項に記載の製剤。
- 担体粒子が、100〜2000μmの粒径を有する、請求項1〜7のいずれか1項に記載の製剤。
- 使用される担体粒子が、活性成分および両親媒性ポリマーを含む粒子である、請求項1〜5のいずれか1項に記載の製剤。
- コーティングがさらに医薬品賦形剤を含む、請求項1〜9のいずれか1項に記載の製剤。
- コーティングが、20〜99重量%の両親媒性ポリマーを含む、請求項1〜10のいずれか1項に記載の製剤。
- 1種以上の活性成分および両親媒性コポリマーを有機溶媒中に含む溶液を担体粒子を含む流動層上に噴霧することにより製剤を製造することを含む、請求項1〜11のいずれか1項に記載の製剤を製造する方法。
- 有機溶媒が、常圧で160℃よりも低い温度で蒸発可能である、請求項12に記載の方法。
- 使用される溶媒が、エタノール、メタノール、イソプロパノール、アセトン、酢酸エチル、ジクロロメタン、クロロホルム、ジメチルホルムアミド、メチルエチルケトンまたはそれらの混合物である、請求項12または13に記載の方法。
- 請求項1〜11のいずれか1項に記載の製剤を含む剤形。
- 錠剤、カプセル剤またはサシェ剤の形態である、請求項15に記載の剤形。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP09170553.3 | 2009-09-17 | ||
EP09170553 | 2009-09-17 | ||
PCT/EP2010/063393 WO2011032916A1 (de) | 2009-09-17 | 2010-09-13 | Mit wirkstoffhaltigen überzügen beschichtete pellets |
Publications (2)
Publication Number | Publication Date |
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JP2013505212A true JP2013505212A (ja) | 2013-02-14 |
JP5758899B2 JP5758899B2 (ja) | 2015-08-05 |
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Application Number | Title | Priority Date | Filing Date |
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JP2012529229A Active JP5758899B2 (ja) | 2009-09-17 | 2010-09-13 | 活性物質を含有するコーティングにより被覆されたペレット |
Country Status (6)
Country | Link |
---|---|
US (1) | US8951569B2 (ja) |
EP (1) | EP2478019B1 (ja) |
JP (1) | JP5758899B2 (ja) |
CN (1) | CN102549029B (ja) |
BR (1) | BR112012006067B1 (ja) |
WO (1) | WO2011032916A1 (ja) |
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US9032390B2 (en) * | 2008-07-29 | 2015-05-12 | Qualcomm Incorporated | Framework versioning |
US8636929B2 (en) | 2010-05-21 | 2014-01-28 | Basf Se | Nanoporous foamed active compound-containing preparations based on pharmaceutically acceptable thermoplastically workable polymers |
GB201119985D0 (en) * | 2011-11-19 | 2012-01-04 | Diurnal Ltd | Treatment of adrenal insufficiency |
Citations (5)
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JPH07126153A (ja) * | 1993-11-04 | 1995-05-16 | Ota Seiyaku Kk | 大腸内放出型医薬製剤用粒状物 |
JP2003522097A (ja) * | 1998-02-16 | 2003-07-22 | フイズ インターナショナル リミテッド | 可溶化デリバリーシステムおよび製造方法 |
JP2007506786A (ja) * | 2003-09-26 | 2007-03-22 | アルザ・コーポレーシヨン | 高い薬剤配合量を提供する薬剤コーティング及びそれを提供する方法 |
WO2008027993A2 (en) * | 2006-08-31 | 2008-03-06 | Eurand, Inc. | Drug delivery systems comprising solid solutions of weakly basic drugs |
JP2009515000A (ja) * | 2005-11-04 | 2009-04-09 | ビーエーエスエフ ソシエタス・ヨーロピア | 弱水溶性化合物のための可溶化剤としてのコポリマーの使用 |
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DE19935063A1 (de) | 1999-07-28 | 2001-02-01 | Basf Ag | Pfropfpolymerisate als Gashydratinhibitoren |
US20040043070A1 (en) * | 2002-05-14 | 2004-03-04 | Ayres James W. | Hot melt coating by direct blending and coated substrates |
WO2006037344A1 (en) * | 2004-10-01 | 2006-04-13 | Lifecycle Pharma A/S | Pharmaceutical compositions comprising fenofibrate and atorvastatin |
JP2007517042A (ja) * | 2003-12-30 | 2007-06-28 | デュレクト コーポレーション | 活性物質、好ましくはgnrhの制御放出のための、好ましくはpegおよびplgの混合物を含有するポリマーインプラント |
CA2581775A1 (en) * | 2004-09-27 | 2006-04-06 | Sigmoid Biotechnologies Limited | Dihydropyrimidine microcapsule - formulations |
EP2173781A1 (de) | 2007-07-26 | 2010-04-14 | Basf Se | Verfahren zur herstellung von durch pfropfpolymerisation in lösung erhaltenen copolymeren auf basis von polyethern in fester form |
US20110178183A1 (en) | 2008-09-25 | 2011-07-21 | Meyer-Boehm Kathrin | Use Of Polyether-Based And Vinyl Monomer-Based Copolymers As Binders For Dosing Forms Comprising Solid Active Ingredients |
CN102176901B (zh) | 2008-10-07 | 2014-10-08 | 巴斯夫欧洲公司 | 生产可控释放口服剂型的方法 |
US20110256193A1 (en) | 2008-12-23 | 2011-10-20 | Basf Se | Use Of Copolymers Based On Polyethers And Vinyl Monomers As Stabilizing Agents For Emulsions |
BRPI1012651A2 (pt) | 2009-03-31 | 2016-04-05 | Basf Se | processo para produzir preparações de substâncias fracamente solúveis em água |
BRPI1010550B1 (pt) | 2009-05-13 | 2019-11-05 | Basf Se | formas de dosagem, e, processo para a produção de preparações para formas de dosagem de substâncias ativas fracamente solúveis em água |
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2010
- 2010-09-13 JP JP2012529229A patent/JP5758899B2/ja active Active
- 2010-09-13 WO PCT/EP2010/063393 patent/WO2011032916A1/de active Application Filing
- 2010-09-13 EP EP10755128.5A patent/EP2478019B1/de active Active
- 2010-09-13 US US13/496,533 patent/US8951569B2/en active Active
- 2010-09-13 CN CN201080041534.9A patent/CN102549029B/zh active Active
- 2010-09-13 BR BR112012006067-8A patent/BR112012006067B1/pt active IP Right Grant
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
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JPH07126153A (ja) * | 1993-11-04 | 1995-05-16 | Ota Seiyaku Kk | 大腸内放出型医薬製剤用粒状物 |
JP2003522097A (ja) * | 1998-02-16 | 2003-07-22 | フイズ インターナショナル リミテッド | 可溶化デリバリーシステムおよび製造方法 |
JP2007506786A (ja) * | 2003-09-26 | 2007-03-22 | アルザ・コーポレーシヨン | 高い薬剤配合量を提供する薬剤コーティング及びそれを提供する方法 |
JP2009515000A (ja) * | 2005-11-04 | 2009-04-09 | ビーエーエスエフ ソシエタス・ヨーロピア | 弱水溶性化合物のための可溶化剤としてのコポリマーの使用 |
WO2008027993A2 (en) * | 2006-08-31 | 2008-03-06 | Eurand, Inc. | Drug delivery systems comprising solid solutions of weakly basic drugs |
Also Published As
Publication number | Publication date |
---|---|
BR112012006067A2 (pt) | 2016-03-29 |
WO2011032916A1 (de) | 2011-03-24 |
US20120183623A1 (en) | 2012-07-19 |
CN102549029B (zh) | 2015-03-04 |
EP2478019B1 (de) | 2015-04-01 |
EP2478019A1 (de) | 2012-07-25 |
JP5758899B2 (ja) | 2015-08-05 |
BR112012006067B1 (pt) | 2019-10-01 |
CN102549029A (zh) | 2012-07-04 |
US8951569B2 (en) | 2015-02-10 |
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