JP2011511059A - 経口懸濁液用免疫抑制性マクロライド粉末 - Google Patents
経口懸濁液用免疫抑制性マクロライド粉末 Download PDFInfo
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/436—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
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- 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
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- 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
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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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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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
- A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
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- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61P37/00—Drugs for immunological or allergic disorders
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P37/08—Antiallergic agents
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Abstract
【選択図】なし
Description
1.No.40メッシュで製剤の成分をふるいにかける。
2.適切な大きさのミキサー内にすべての成分を置き、選択した添加剤で処理を開始し、製剤の外見の逆順で続け、タクロリムス及び着色剤で終えるように、20〜30分間混合する。
3.ポリエチレンバッグで2重に包装した包装容器内に置く。
4.適切な大きさのバイアル瓶、好ましくは、安全性カバーを有する琥珀色のヨーロッパ加水分解タイプIII中に分注する。
プラスチック安全カバーを有する琥珀色ヨーロッパ加水分解タイプIIIバイアル瓶内に含まれている懸濁液(1mg/mL)に対してタクロリムス粉末7gを、20mLの精製水で再懸濁して、25mLの懸濁液を得て、25℃±2℃、60%±5%の相対湿度で維持した。懸濁液を調製してから8日後、15日後、22日後及び30日後に、視覚的外観、pH、タクロリムス量(滴定)及び不純物量を評価し、懸濁液を再懸濁したときに示された特性(初期条件)と比較した。
Claims (12)
- タクロリムス又は薬学的に許容可能なその塩の1つの経口懸濁液用粉末と、高度な安定性を示すその水和物又は溶媒和物と、薬学的に許容可能な添加剤と、を含むことを特徴とする医薬品組成物。
- 請求項1に記載の医薬品組成物において、前記薬学的に許容可能な添加剤が、バッファー、増粘剤、抗被着剤、保存剤、稀釈剤、甘味料、着色剤及び着香料に少なくとも相当することを特徴とする医薬品組成物。
- 請求項1又は2に記載の医薬品組成物において、前記バッファーが、0.5〜10.0重量%の濃度のクエン酸及び薬学的に許容可能なその塩から選択されることを特徴とする医薬品組成物。
- 請求項1〜3のいずれか1項に記載の医薬品組成物において、前記増粘剤が、0.5〜10.0重量%の濃度の、グアーガム、キサンタンガム、トラガント、カルメロース、メチルセルロース、エチルセルロース、プロピルセルロース、ヒドロキシメチルセルロース、ヒドロキシエチルセルロース、ヒドロキシプロピルメチルセルロース、カルボキシメチルセルロース、ケイ酸アルミニウム、ケイ酸マグネシウム、ポリビニルアルコール、カルボマー、ゼラチン、バクガデキストリン及びポリデキストロース又はこれらの混合物から選択されることを特徴とする医薬品組成物。
- 請求項1〜4のいずれか1項に記載の医薬品組成物において、前記保存剤が、0.5〜10.0重量%の濃度の、ソルビン酸ナトリウム、ソルビン酸カリウム、安息香酸ナトリウム、酢酸フェニル水銀、フェニル硝酸水銀、プロピオン酸ナトリウム及びチオマーサル又はこれらの混合物から選択されることを特徴とする医薬品組成物。
- 請求項1〜5のいずれか1項に記載の医薬品組成物において、前記稀釈剤が、10.0〜95.0重量%の濃度の、ソルビトール、リン酸カルシウム、硫酸カルシウム、フルクトース、カオリン、炭酸マグネシウム、マルトース、微結晶性セルロース及びαデンプン又はこれらの混合物から選択されることを特徴とする医薬品組成物。
- 請求項1〜6のいずれか1項に記載の医薬品組成物において、前記抗被着剤が、0.1〜5.0重量%の濃度の、コロイドシリカジオキシド、ステアリン酸カルシウム、酸化マグネシウム及び滑石又はこれらの混合物から選択されることを特徴とする医薬品組成物。
- 請求項1〜7のいずれか1項に記載の医薬品組成物において、前記甘味料が、0.1〜5.0重量%の濃度の、スクラロース、スクロース、アスパルテーム、サッカリンナトリウム、サイクラミン酸ナトリウム、フルクトース、マルトース及びソルビトール又はこれらの混合物から選択されることを特徴とする医薬品組成物。
- 請求項1〜8のいずれか1項に記載の医薬品組成物において、前記着香料が、0.1〜5.0重量%の濃度の、トゥッティフルッティエッセンス、バニラエッセンス及びメントールから選択されることを特徴とする医薬品組成物。
- 請求項1〜9のいずれか1項に記載の医薬品組成物において、前記着色剤が、0.001〜0.5重量%の濃度の、食品医薬品化粧品法イエローNo.6、食品医薬品化粧品法レッドNo.40、β−カロチン及び酸化鉄又はこれらの混合物から選択されることを特徴とする医薬品組成物。
- 請求項1〜10のいずれか1項に記載の医薬品組成物を調製する方法において、製剤の各成分をふるいにかけるステップと、ミキサーへの前記各成分の添加をソルビトールから開始してタクロリムス及び着色剤で終えるようにして20〜30分間混合するステップと、その混合物を包装容器内に置いてバイアル瓶に分注するステップとを具えることを特徴とする方法。
- 請求項1〜11のいずれか1項に記載の医薬品組成物の使用であって、移植器官の拒絶反応及びアトピー性皮膚炎の予防及び治療に主として用いられる薬剤を調製するように用いることを特徴とする使用。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CL2008000374A CL2008000374A1 (es) | 2008-02-05 | 2008-02-05 | Composicion farmaceutica que comprende un polvo para suspension oral de tacrolimus o una de sus sales, hidratos o solvatos y excipientes farmaceuticamente aceptables; procedimiento de preparacion de dicha composicion farmaceutica; y uso para la preve |
PCT/IB2009/050455 WO2009098649A1 (es) | 2008-02-05 | 2009-02-05 | Polvo para suspensión oral de un macrólido inmunosupresor |
Publications (1)
Publication Number | Publication Date |
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JP2011511059A true JP2011511059A (ja) | 2011-04-07 |
Family
ID=40261181
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2010545589A Pending JP2011511059A (ja) | 2008-02-05 | 2009-02-05 | 経口懸濁液用免疫抑制性マクロライド粉末 |
Country Status (15)
Country | Link |
---|---|
US (2) | US20110021553A1 (ja) |
EP (1) | EP2248522B1 (ja) |
JP (1) | JP2011511059A (ja) |
CN (1) | CN101977602A (ja) |
AR (1) | AR070323A1 (ja) |
BR (1) | BRPI0908072A2 (ja) |
CA (1) | CA2714237A1 (ja) |
CL (1) | CL2008000374A1 (ja) |
CO (1) | CO6660422A2 (ja) |
EC (1) | ECSP10010383A (ja) |
ES (1) | ES2355884B1 (ja) |
MX (1) | MX349358B (ja) |
PE (1) | PE20091372A1 (ja) |
PT (1) | PT2248522T (ja) |
WO (1) | WO2009098649A1 (ja) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
BR112014010551A2 (pt) | 2011-10-31 | 2017-05-02 | Glaxosmithkline Ip Dev Ltd | composição adequada para a reconstituição em uma suspensão aquosa, pó para a combinação direta para o uso em composição farmacêutica, formulação farmacêutica de suspensão oral, e, suspensão oral |
CN115804760A (zh) * | 2022-11-23 | 2023-03-17 | 无锡福祈制药有限公司 | 一种他克莫司纳米晶体胶囊剂及其制备方法 |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2004352727A (ja) * | 1998-03-26 | 2004-12-16 | Fujisawa Pharmaceut Co Ltd | 徐放性製剤 |
JP2007519758A (ja) * | 2004-12-01 | 2007-07-19 | テバ ジョジセルジャール ザ−トケルエン ムケド レ−スベニュタ−ルシャシャ−グ | 結晶マクロライドの生成方法 |
Family Cites Families (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB8608080D0 (en) * | 1986-04-02 | 1986-05-08 | Fujisawa Pharmaceutical Co | Solid dispersion composition |
KR0177158B1 (ko) | 1990-03-01 | 1999-03-20 | 후지사와 도모기찌로 | 면역억제 활성을 갖는 트리사이클릭 화합물 함유 용액 제제 |
IE65341B1 (en) * | 1990-11-08 | 1995-10-18 | Fujisawa Pharmaceutical Co | Suspensions containing tricyclic compounds |
SI1663217T1 (sl) | 2003-08-29 | 2010-10-29 | Lifecycle Pharma As | Trdne disperzije, ki vsebujejo takrolimus |
US7994214B2 (en) | 2003-08-29 | 2011-08-09 | Lifecycle Pharma A/S | Solid dispersions comprising tacrolimus |
KR100866728B1 (ko) | 2004-11-12 | 2008-11-03 | 주식회사종근당 | 타크로리무스를 함유하는 주사제 |
KR100678829B1 (ko) | 2004-12-06 | 2007-02-05 | 한미약품 주식회사 | 타크로리무스의 경구용 마이크로에멀젼 조성물 |
US20060159766A1 (en) | 2004-12-15 | 2006-07-20 | Elan Pharma International Limited | Nanoparticulate tacrolimus formulations |
KR100678824B1 (ko) * | 2005-02-04 | 2007-02-05 | 한미약품 주식회사 | 용해성이 증가된 무정형 타크로리무스 고체분산체 및 이를포함하는 약제학적 조성물 |
HUP0600097A3 (en) | 2006-02-08 | 2008-07-28 | Richter Gedeon Nyrt | Pharmaceutical compositions comprising tacrolimus and process for their preparation |
WO2008013416A1 (en) * | 2006-07-27 | 2008-01-31 | Amorepacific Corporation | Process for preparing powder comprising nanoparticles of sparingly soluble drug |
CN100515413C (zh) | 2006-09-15 | 2009-07-22 | 杭州平和安康医药科技有限公司 | 他克莫司口服制剂 |
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2008
- 2008-02-05 CL CL2008000374A patent/CL2008000374A1/es unknown
-
2009
- 2009-01-29 AR ARP090100290 patent/AR070323A1/es unknown
- 2009-02-04 PE PE2009000163A patent/PE20091372A1/es not_active Application Discontinuation
- 2009-02-05 US US12/866,392 patent/US20110021553A1/en not_active Abandoned
- 2009-02-05 JP JP2010545589A patent/JP2011511059A/ja active Pending
- 2009-02-05 BR BRPI0908072-4A patent/BRPI0908072A2/pt not_active Application Discontinuation
- 2009-02-05 CA CA 2714237 patent/CA2714237A1/en not_active Abandoned
- 2009-02-05 ES ES201050015A patent/ES2355884B1/es not_active Expired - Fee Related
- 2009-02-05 EP EP09708715.9A patent/EP2248522B1/en not_active Not-in-force
- 2009-02-05 WO PCT/IB2009/050455 patent/WO2009098649A1/es active Application Filing
- 2009-02-05 MX MX2010008327A patent/MX349358B/es active IP Right Grant
- 2009-02-05 CN CN2009801101026A patent/CN101977602A/zh active Pending
- 2009-02-05 PT PT97087159T patent/PT2248522T/pt unknown
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2010
- 2010-08-05 EC ECSP10010383 patent/ECSP10010383A/es unknown
- 2010-08-09 CO CO10097188A patent/CO6660422A2/es not_active Application Discontinuation
-
2013
- 2013-03-18 US US13/846,804 patent/US20140088135A1/en not_active Abandoned
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2004352727A (ja) * | 1998-03-26 | 2004-12-16 | Fujisawa Pharmaceut Co Ltd | 徐放性製剤 |
JP2007519758A (ja) * | 2004-12-01 | 2007-07-19 | テバ ジョジセルジャール ザ−トケルエン ムケド レ−スベニュタ−ルシャシャ−グ | 結晶マクロライドの生成方法 |
Also Published As
Publication number | Publication date |
---|---|
EP2248522A1 (en) | 2010-11-10 |
EP2248522A4 (en) | 2013-01-09 |
MX349358B (es) | 2015-08-25 |
PE20091372A1 (es) | 2009-10-18 |
MX2010008327A (es) | 2010-11-30 |
US20110021553A1 (en) | 2011-01-27 |
EP2248522B1 (en) | 2017-05-03 |
US20140088135A1 (en) | 2014-03-27 |
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