JP2010540491A - タムスロシン塩酸塩徐放錠およびこの製造方法 - Google Patents
タムスロシン塩酸塩徐放錠およびこの製造方法 Download PDFInfo
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- JP2010540491A JP2010540491A JP2010526282A JP2010526282A JP2010540491A JP 2010540491 A JP2010540491 A JP 2010540491A JP 2010526282 A JP2010526282 A JP 2010526282A JP 2010526282 A JP2010526282 A JP 2010526282A JP 2010540491 A JP2010540491 A JP 2010540491A
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/18—Sulfonamides
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/08—Drugs for disorders of the urinary system of the prostate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/10—Drugs for disorders of the urinary system of the bladder
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- Bioinformatics & Cheminformatics (AREA)
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- Chemical Kinetics & Catalysis (AREA)
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- Molecular Biology (AREA)
- Urology & Nephrology (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
a)錠剤組成
タムスロシン塩酸塩、微結晶性セルロース、および中粘度ヒドロキシプロピルセルロースを1:40.25:8.75の比でビニール袋中混合してこれらの成分の倍散剤を調製した。
バッチ内内容物一様性
a)錠剤組成
タムスロシン塩酸塩、微結晶性セルロース、および中粘度ヒドロキシプロピルセルロースを1:40.25:8.75の比でビニール袋中混合してこれらの成分の倍散剤を調製した。
バッチ内内容物一様性
a)錠剤組成
タムスロシン塩酸塩、微結晶性セルロース、および中粘度ヒドロキシプロピルセルロースを1:40.25:8.75の比でビニール袋中混合してこれらの成分の倍散剤を調製した。
a)被覆した錠剤組成
全ての成分を水に分散させて均一な分酸液となるまでUltra turraxで混合した。
Claims (10)
- ヒドロキシプロピルセルロースおよびポリエチレンオキシドを含むことを特徴とするタムスロシン塩酸塩徐放性医薬組成物。
- 前記ヒドロキシプロピルセルロースが中粘度および高粘度ヒドロキシプロピルセルロースを含むことを特徴とする、請求項1に記載の医薬組成物。
- 前記中粘度ヒドロキシプロピルセルロースが10から2000mPa・sの粘度を有することを特徴とする、請求項2に記載の医薬組成物。
- 前記中粘度ヒドロキシプロピルセルロースの量が錠剤の合計質量の10から90%を占めることを特徴とする、請求項3に記載の医薬組成物。
- 前記高粘度ヒドロキシプロピルセルロースが2000mPa・s超の粘度を有することを特徴とする、請求項2に記載の医薬組成物。
- 前記高粘度ヒドロキシプロピルセルロースの量が錠剤の合計質量の10から90%を占めることを特徴とする、請求項5に記載の医薬組成物。
- 前記ポリエチレンオキシドの量が、1錠中、上限70mgまでであることを特徴とする、請求項1に記載の医薬組成物。
- 前記医薬組成物が被覆されている、請求項1から7のいずれか一項に記載の医薬組成物。
- 以下の工程、
(i)顆粒の製造、
(ii)該顆粒の粉砕、および
(iii)該粉砕した顆粒の錠剤化、
を含むことを特徴とする、請求項1から7のいずれか一項に記載の医薬組成物の製造方法。 - 良性前立腺肥大および他の関連する状態または症状の予防あるいは治療のための医薬を製造するための、請求項1から8のいずれか一項に記載の医薬組成物の使用。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP07117285A EP2042169A1 (en) | 2007-09-26 | 2007-09-26 | Controlled release tamsulosin hydrochloride tablets and a process of making them |
EP07117285.2 | 2007-09-26 | ||
PCT/EP2008/062815 WO2009040388A1 (en) | 2007-09-26 | 2008-09-25 | Controlled release tamsulosin hydrochloride tablets and a process of making them |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2010540491A true JP2010540491A (ja) | 2010-12-24 |
JP5662150B2 JP5662150B2 (ja) | 2015-01-28 |
Family
ID=38738954
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2010526282A Expired - Fee Related JP5662150B2 (ja) | 2007-09-26 | 2008-09-25 | タムスロシン塩酸塩徐放錠およびこの製造方法 |
Country Status (7)
Country | Link |
---|---|
US (1) | US20110033534A1 (ja) |
EP (2) | EP2042169A1 (ja) |
JP (1) | JP5662150B2 (ja) |
CN (1) | CN101808632A (ja) |
BR (1) | BRPI0817301A2 (ja) |
CA (1) | CA2700591A1 (ja) |
WO (1) | WO2009040388A1 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPWO2010001574A1 (ja) * | 2008-07-01 | 2011-12-15 | 沢井製薬株式会社 | タムスロシン塩酸塩を含有する球形微粒子の製造方法 |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EA024365B1 (ru) * | 2009-05-28 | 2016-09-30 | Крка, Товарна Здравил, Д.Д., Ново Место | Фармацевтическая композиция, содержащая тамсулозин, и способ ее получения |
EP2255793A1 (en) * | 2009-05-28 | 2010-12-01 | Krka Tovarna Zdravil, D.D., Novo Mesto | Pharmaceutical composition comprising tamsulosin |
CN111320559A (zh) * | 2018-12-14 | 2020-06-23 | 苏州盛迪亚生物医药有限公司 | 一种盐酸坦索罗辛的制备方法 |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2005162736A (ja) * | 2003-11-10 | 2005-06-23 | Astellas Pharma Inc | 徐放性医薬組成物 |
JP2005232185A (ja) * | 2003-03-06 | 2005-09-02 | Astellas Pharma Inc | 放出制御用医薬組成物およびその製造方法 |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20030050620A1 (en) * | 2001-09-07 | 2003-03-13 | Isa Odidi | Combinatorial type controlled release drug delivery device |
CA2465110A1 (en) * | 2001-11-07 | 2003-05-15 | Synthon B.V. | Tamsulosin tablets |
US8197846B2 (en) * | 2003-11-10 | 2012-06-12 | Astellas Pharma Inc. | Sustained release pharmaceutical composition |
US8128958B2 (en) * | 2003-11-10 | 2012-03-06 | Astellas Pharma Inc. | Sustained release pharmaceutical composition |
-
2007
- 2007-09-26 EP EP07117285A patent/EP2042169A1/en not_active Ceased
-
2008
- 2008-09-25 JP JP2010526282A patent/JP5662150B2/ja not_active Expired - Fee Related
- 2008-09-25 CA CA2700591A patent/CA2700591A1/en not_active Abandoned
- 2008-09-25 EP EP08804714A patent/EP2200602A1/en not_active Withdrawn
- 2008-09-25 BR BRPI0817301-0A patent/BRPI0817301A2/pt not_active Application Discontinuation
- 2008-09-25 CN CN200880108589A patent/CN101808632A/zh active Pending
- 2008-09-25 US US12/680,135 patent/US20110033534A1/en not_active Abandoned
- 2008-09-25 WO PCT/EP2008/062815 patent/WO2009040388A1/en active Application Filing
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2005232185A (ja) * | 2003-03-06 | 2005-09-02 | Astellas Pharma Inc | 放出制御用医薬組成物およびその製造方法 |
JP2005162736A (ja) * | 2003-11-10 | 2005-06-23 | Astellas Pharma Inc | 徐放性医薬組成物 |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPWO2010001574A1 (ja) * | 2008-07-01 | 2011-12-15 | 沢井製薬株式会社 | タムスロシン塩酸塩を含有する球形微粒子の製造方法 |
JP5511663B2 (ja) * | 2008-07-01 | 2014-06-04 | 沢井製薬株式会社 | タムスロシン塩酸塩を含有する球形微粒子の製造方法 |
Also Published As
Publication number | Publication date |
---|---|
JP5662150B2 (ja) | 2015-01-28 |
EP2200602A1 (en) | 2010-06-30 |
CN101808632A (zh) | 2010-08-18 |
CA2700591A1 (en) | 2009-04-02 |
US20110033534A1 (en) | 2011-02-10 |
BRPI0817301A2 (pt) | 2015-06-16 |
EP2042169A1 (en) | 2009-04-01 |
WO2009040388A1 (en) | 2009-04-02 |
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