JP5433235B2 - 固形製剤の製造方法 - Google Patents
固形製剤の製造方法 Download PDFInfo
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- JP5433235B2 JP5433235B2 JP2008549266A JP2008549266A JP5433235B2 JP 5433235 B2 JP5433235 B2 JP 5433235B2 JP 2008549266 A JP2008549266 A JP 2008549266A JP 2008549266 A JP2008549266 A JP 2008549266A JP 5433235 B2 JP5433235 B2 JP 5433235B2
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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
-
- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
-
- 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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- 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
- A61K31/33—Heterocyclic compounds
- 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
- A61K31/4365—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 having sulfur as a ring hetero atom, e.g. ticlopidine
-
- 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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- 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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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
Description
(1) 下記一般式(I)
(2) 攪拌羽根を有した容器固定型混合機を用いて、攪拌羽根を1.4m/s〜40m/sの先端周速度で回転させることによって、上記一般式(I)を有する化合物又はその薬理上許容される塩を含有する組成物を混合する工程を含む、上記一般式(I)を有する化合物又はその薬理上許容される塩を含有する固形製剤を製造する方法、
(3) 攪拌羽根の先端周速度が、5.0m/s〜20m/sである、(2)に記載の方法、
(4) 一般式(I)を有する化合物又はその薬理上許容される塩が、下記式(Ia)
(5) 固形製剤が錠剤である、(1)乃至(4)のいずれか一項に記載の方法である。
(6) 下記一般式(I)
(7) 攪拌羽根を有した撹拌機を用いて、攪拌羽根を1.4m/s〜40m/sの先端周速度で回転させることによって、上記一般式(I)を有する化合物又はその薬理上許容される塩を含有する組成物を混合する工程を含む方法で製造された、上記一般式(I)を有する化合物又はその薬理上許容される塩を含有する固形製剤、
(8) 攪拌羽根の先端周速度が、5.0m/s〜20m/sである、(7)に記載の固形製剤、
(9) 一般式(I)を有する化合物又はその薬理上許容される塩が、下記式(Ia)
(10) 製剤が錠剤である、(6)乃至(9)のいずれか一項に記載の固形製剤
である。
化合物A(85.8g)、ヒドロキシプロピルセルロース(125.0g)、架橋カルボキシメチルセルロースナトリウム(125.0g)及び乳糖(2139.0g)をヘンシェルミキサー FM−20B(三井三池製作所社製)で攪拌羽根の先端速度が14.1m/sで3分間混合した後、ステアリン酸マグネシウム(25.0g)を添加し、再度ヘンシェルミキサー FM−20B(三井三池製作所社製)で攪拌羽根の先端速度が14.1m/sで15秒間混合することにより、混合末を得た。
化合物A(68.6g)、ヒドロキシプロピルセルロース(100.0g)、架橋カルボキシメチルセルロースナトリウム(100.0g)及び乳糖(1711.0g)を容器回転型混合機であるV型混合機10L(徳寿工作所社製)で30分間混合した後、ステアリン酸マグネシウム(20.0g)を添加し、再度V型混合機10L(徳寿工作所社製)で混合することにより、混合末を得た。
日本薬局方第14改正の項に記載されている溶出試験法(第2法)に従い、毎分50回転、試験液としてMcIlvaine緩衝液(pH4.4)900mLを用い、試験を行った。試験開始から5分、10分、15分及び30分後の試験液を採取し、吸光度測定法により化合物Aの溶出率を測定した。〔富山産業(株)社製:溶出試験器、(株)島津製作所社製:分光光度計〕。試験は6錠について行い、その溶出率の平均値を算出した。
――――――――――――――――――――――――――――――――――
溶出時間(分) 実施例1 比較例1
溶出率(%) 溶出率(%)
――――――――――――――――――――――――――――――――――
5 58 57
10 83 66
15 92 70
30 98 77
――――――――――――――――――――――――――――――――――
表1より、容器固定型混合機を用いて攪拌羽根の先端速度を14.1m/sとし混合することにより得られた実施例1の製剤は、容器回転型混合機で混合することにより得られた比較例1の製剤に比べて、優れた溶出性を有することが明らかである。
Claims (5)
- 攪拌羽根を有した容器固定型混合機を用いて、攪拌羽根を1.4 m/s〜40 m/sの先端周速度で回転させることによって、式(I)
を有する化合物又はその薬理上許容される塩を含有する組成物を混合する工程を含む、式(I)を有する化合物又はその薬理上許容される塩を含有する固形製剤を製造する方法。 - 攪拌羽根の先端周速度が、5.0 m/s〜20 m/sである、請求項1に記載の方法。
- 一般式(I)を有する化合物又はその薬理上許容される塩が、下記式(Ia)
を有する化合物である請求項1又は2に記載の方法。 - 固形製剤が錠剤である、請求項1乃至3のいずれか一項に記載の方法。
- 式(Ia)を有する化合物、
ヒドロキシプロピルセルロース、架橋カルボキシメチルセルロースナトリウム、乳糖及びステアリン酸マグネシウムを、攪拌羽根を有した容器固定型混合機を用いて、攪拌羽根を14.1 m/sの先端周速度で回転させることにより混合する工程を含む、請求項4に記載の方法。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2008549266A JP5433235B2 (ja) | 2006-12-07 | 2007-12-06 | 固形製剤の製造方法 |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2006330373 | 2006-12-07 | ||
JP2006330373 | 2006-12-07 | ||
PCT/JP2007/073549 WO2008072533A1 (ja) | 2006-12-07 | 2007-12-06 | 固形製剤の製造方法 |
JP2008549266A JP5433235B2 (ja) | 2006-12-07 | 2007-12-06 | 固形製剤の製造方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
JPWO2008072533A1 JPWO2008072533A1 (ja) | 2010-03-25 |
JP5433235B2 true JP5433235B2 (ja) | 2014-03-05 |
Family
ID=39511553
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Application Number | Title | Priority Date | Filing Date |
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JP2008549266A Active JP5433235B2 (ja) | 2006-12-07 | 2007-12-06 | 固形製剤の製造方法 |
Country Status (9)
Country | Link |
---|---|
US (3) | US20110201814A1 (ja) |
EP (1) | EP2100608A4 (ja) |
JP (1) | JP5433235B2 (ja) |
KR (1) | KR101503083B1 (ja) |
CN (1) | CN101594864B (ja) |
BR (1) | BRPI0719529B8 (ja) |
CA (1) | CA2672157C (ja) |
TW (1) | TWI405591B (ja) |
WO (1) | WO2008072533A1 (ja) |
Families Citing this family (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
TWI482641B (zh) | 2006-12-07 | 2015-05-01 | Daiichi Sankyo Co Ltd | 含有低取代度羥丙基纖維素之醫藥組成物 |
DE102009036646A1 (de) | 2009-08-07 | 2011-02-10 | Ratiopharm Gmbh | Prasugrel in nicht-kristalliner Form und pharmazeutische Zusammensetzung davon |
EP2360159A1 (de) * | 2010-02-11 | 2011-08-24 | Ratiopharm GmbH | Prasugrel in mikronisierter, kristalliner Form und pharmazeutische Zusammensetzung davon |
CN102268012B (zh) * | 2011-08-24 | 2014-04-09 | 天津药物研究院 | 噻唑衍生物、其制备方法和用途 |
CZ2011872A3 (cs) | 2011-12-22 | 2013-07-03 | Zentiva, K.S. | Farmaceutická formulace prasugrelu hydrobromidu |
US8603537B2 (en) | 2012-04-02 | 2013-12-10 | Egis Pharmaceuticals Plc | Prasugrel containing quickly released stable oral pharmaceutical compositions |
WO2018073437A1 (en) | 2016-10-21 | 2018-04-26 | Laboratorios Lesvi, Sl | Pharmaceutical formulations of prasugrel and processes for the preparation thereof |
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JPH10310586A (ja) * | 1996-06-26 | 1998-11-24 | Sankyo Co Ltd | ヒドロピリジン類の新規医薬用途 |
JP2002145883A (ja) * | 2000-07-06 | 2002-05-22 | Sankyo Co Ltd | ヒドロピリジン誘導体酸付加塩 |
JP2002255814A (ja) * | 2000-12-25 | 2002-09-11 | Sankyo Co Ltd | アスピリンを含有する医薬組成物 |
JP2003246735A (ja) * | 2001-12-21 | 2003-09-02 | Sankyo Co Ltd | ヒドロピリジン誘導体酸付加塩を含有する医薬 |
WO2004009713A1 (en) * | 2002-07-24 | 2004-01-29 | Geotech Chemical Company, Llc | Method for applying a coating that acts as an electrolytic barrier and cathodic corrosion prevention system |
JP2004051639A (ja) * | 2002-07-18 | 2004-02-19 | Sankyo Co Ltd | 動脈硬化症治療のための医薬組成物 |
WO2006135605A2 (en) * | 2005-06-10 | 2006-12-21 | Eli Lilly And Company | Formulation of a thienopyridine platelet aggregation inhibitor |
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DE60135780D1 (de) * | 2000-12-25 | 2008-10-23 | Daiichi Sankyo Co Ltd | Aspirin enthaltende medizinische zusammensetzungen |
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-
2007
- 2007-12-06 CA CA2672157A patent/CA2672157C/en active Active
- 2007-12-06 WO PCT/JP2007/073549 patent/WO2008072533A1/ja active Application Filing
- 2007-12-06 EP EP07850165A patent/EP2100608A4/en not_active Ceased
- 2007-12-06 US US12/312,970 patent/US20110201814A1/en not_active Abandoned
- 2007-12-06 CN CN2007800449625A patent/CN101594864B/zh active Active
- 2007-12-06 KR KR1020097011250A patent/KR101503083B1/ko active IP Right Grant
- 2007-12-06 BR BRPI0719529A patent/BRPI0719529B8/pt active IP Right Grant
- 2007-12-06 JP JP2008549266A patent/JP5433235B2/ja active Active
- 2007-12-06 TW TW096146467A patent/TWI405591B/zh active
-
2011
- 2011-12-07 US US13/313,165 patent/US20120077980A1/en not_active Abandoned
-
2013
- 2013-04-24 US US13/869,375 patent/US20130249140A1/en not_active Abandoned
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JPH10310586A (ja) * | 1996-06-26 | 1998-11-24 | Sankyo Co Ltd | ヒドロピリジン類の新規医薬用途 |
JP2002145883A (ja) * | 2000-07-06 | 2002-05-22 | Sankyo Co Ltd | ヒドロピリジン誘導体酸付加塩 |
JP2002255814A (ja) * | 2000-12-25 | 2002-09-11 | Sankyo Co Ltd | アスピリンを含有する医薬組成物 |
JP2003246735A (ja) * | 2001-12-21 | 2003-09-02 | Sankyo Co Ltd | ヒドロピリジン誘導体酸付加塩を含有する医薬 |
JP2004051639A (ja) * | 2002-07-18 | 2004-02-19 | Sankyo Co Ltd | 動脈硬化症治療のための医薬組成物 |
WO2004009713A1 (en) * | 2002-07-24 | 2004-01-29 | Geotech Chemical Company, Llc | Method for applying a coating that acts as an electrolytic barrier and cathodic corrosion prevention system |
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Title |
---|
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Also Published As
Publication number | Publication date |
---|---|
CA2672157C (en) | 2016-07-26 |
US20110201814A1 (en) | 2011-08-18 |
TWI405591B (zh) | 2013-08-21 |
JPWO2008072533A1 (ja) | 2010-03-25 |
CN101594864B (zh) | 2012-04-18 |
BRPI0719529A2 (pt) | 2014-01-21 |
KR20090090322A (ko) | 2009-08-25 |
BRPI0719529B8 (pt) | 2021-05-25 |
BRPI0719529B1 (pt) | 2020-10-06 |
US20120077980A1 (en) | 2012-03-29 |
WO2008072533A1 (ja) | 2008-06-19 |
EP2100608A4 (en) | 2009-12-09 |
TW200833371A (en) | 2008-08-16 |
CN101594864A (zh) | 2009-12-02 |
US20130249140A1 (en) | 2013-09-26 |
EP2100608A1 (en) | 2009-09-16 |
CA2672157A1 (en) | 2008-06-19 |
KR101503083B1 (ko) | 2015-03-16 |
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