JP5662150B2 - 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
- Publication number
- JP5662150B2 JP5662150B2 JP2010526282A JP2010526282A JP5662150B2 JP 5662150 B2 JP5662150 B2 JP 5662150B2 JP 2010526282 A JP2010526282 A JP 2010526282A JP 2010526282 A JP2010526282 A JP 2010526282A JP 5662150 B2 JP5662150 B2 JP 5662150B2
- Authority
- JP
- Japan
- Prior art keywords
- viscosity
- pharmaceutical composition
- granules
- tablet
- polyethylene oxide
- 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.)
- Expired - Fee Related
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
- A61K9/20—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
-
- 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
-
- 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
-
- 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
-
- 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)
-
- 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
-
- 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
-
- 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
-
- 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
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 (8)
- 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み、ヒドロキシプロピルセルロース:ポリエチレンオキシドの重量比が94.5−121.75:62.5であり、前記ヒドロキシプロピルセルロースが、2000mPa・s超の25℃における2%水溶液の粘度を有する高粘度ヒドロキシプロピルセルロースと、10から2000mPa・sの25℃における2%水溶液の粘度を有する中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タムスロシン塩酸塩徐放性医薬組成物。
- 中粘度ヒドロキシプロピルセルロース:高粘度ヒドロキシプロピルセルロース:ポリエチレンオキシドの重量比が7:87.5−114.75:62.5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2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5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5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6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 JP2010540491A (ja) | 2010-12-24 |
JP5662150B2 true 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) |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8529953B2 (en) | 2008-07-01 | 2013-09-10 | Sawai Pharmaceutical Co., Ltd. | Process for production of spherical microparticles comprising tamsulosin hydrochloride |
EP2255793A1 (en) * | 2009-05-28 | 2010-12-01 | Krka Tovarna Zdravil, D.D., Novo Mesto | Pharmaceutical composition comprising tamsulosin |
WO2010136193A1 (en) * | 2009-05-28 | 2010-12-02 | 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 |
Family Cites Families (6)
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 |
ZA200403281B (en) * | 2001-11-07 | 2005-12-13 | Synthon Bv | Tamsulosin tablets. |
US7442387B2 (en) * | 2003-03-06 | 2008-10-28 | Astellas Pharma Inc. | Pharmaceutical composition for controlled release of active substances and manufacturing method thereof |
US8128958B2 (en) * | 2003-11-10 | 2012-03-06 | Astellas Pharma Inc. | Sustained release pharmaceutical composition |
US8197846B2 (en) * | 2003-11-10 | 2012-06-12 | Astellas Pharma Inc. | Sustained release pharmaceutical composition |
JP2005162736A (ja) * | 2003-11-10 | 2005-06-23 | Astellas Pharma Inc | 徐放性医薬組成物 |
-
2007
- 2007-09-26 EP EP07117285A patent/EP2042169A1/en not_active Ceased
-
2008
- 2008-09-25 CA CA2700591A patent/CA2700591A1/en not_active Abandoned
- 2008-09-25 BR BRPI0817301-0A patent/BRPI0817301A2/pt not_active Application Discontinuation
- 2008-09-25 JP JP2010526282A patent/JP5662150B2/ja not_active Expired - Fee Related
- 2008-09-25 US US12/680,135 patent/US20110033534A1/en not_active Abandoned
- 2008-09-25 EP EP08804714A patent/EP2200602A1/en not_active Withdrawn
- 2008-09-25 WO PCT/EP2008/062815 patent/WO2009040388A1/en active Application Filing
- 2008-09-25 CN CN200880108589A patent/CN101808632A/zh active Pending
Also Published As
Publication number | Publication date |
---|---|
BRPI0817301A2 (pt) | 2015-06-16 |
CA2700591A1 (en) | 2009-04-02 |
WO2009040388A1 (en) | 2009-04-02 |
US20110033534A1 (en) | 2011-02-10 |
EP2200602A1 (en) | 2010-06-30 |
EP2042169A1 (en) | 2009-04-01 |
CN101808632A (zh) | 2010-08-18 |
JP2010540491A (ja) | 2010-12-24 |
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