JP2007530415A - 脂質制御薬物製剤の製造のための方法 - Google Patents
脂質制御薬物製剤の製造のための方法 Download PDFInfo
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- JP2007530415A JP2007530415A JP2006518798A JP2006518798A JP2007530415A JP 2007530415 A JP2007530415 A JP 2007530415A JP 2006518798 A JP2006518798 A JP 2006518798A JP 2006518798 A JP2006518798 A JP 2006518798A JP 2007530415 A JP2007530415 A JP 2007530415A
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- 239000000203 mixture Substances 0.000 title claims abstract description 46
- 238000000034 method Methods 0.000 title claims abstract description 34
- 150000002632 lipids Chemical class 0.000 title claims abstract description 14
- 239000000599 controlled substance Substances 0.000 title claims abstract description 10
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 10
- 238000009472 formulation Methods 0.000 title abstract description 13
- 229940079593 drug Drugs 0.000 claims abstract description 20
- 239000003814 drug Substances 0.000 claims abstract description 20
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 15
- 239000002904 solvent Substances 0.000 claims abstract description 7
- 239000002552 dosage form Substances 0.000 claims abstract description 5
- 229960002297 fenofibrate Drugs 0.000 claims description 21
- YMTINGFKWWXKFG-UHFFFAOYSA-N fenofibrate Chemical compound C1=CC(OC(C)(C)C(=O)OC(C)C)=CC=C1C(=O)C1=CC=C(Cl)C=C1 YMTINGFKWWXKFG-UHFFFAOYSA-N 0.000 claims description 20
- 239000002775 capsule Substances 0.000 claims description 13
- 238000001035 drying Methods 0.000 claims description 11
- 229940125753 fibrate Drugs 0.000 claims description 4
- 229920002472 Starch Polymers 0.000 claims description 3
- 238000007908 dry granulation Methods 0.000 claims description 3
- 238000001704 evaporation Methods 0.000 claims description 3
- 239000008107 starch Substances 0.000 claims description 3
- 235000019698 starch Nutrition 0.000 claims description 3
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 2
- 239000008101 lactose Substances 0.000 claims description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 2
- 239000013583 drug formulation Substances 0.000 claims 5
- 208000031226 Hyperlipidaemia Diseases 0.000 claims 3
- 238000005469 granulation Methods 0.000 claims 3
- 230000003179 granulation Effects 0.000 claims 3
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 2
- 235000019359 magnesium stearate Nutrition 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 239000008187 granular material Substances 0.000 abstract description 3
- 239000000243 solution Substances 0.000 description 12
- 239000004094 surface-active agent Substances 0.000 description 10
- 239000002245 particle Substances 0.000 description 7
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 6
- 238000000338 in vitro Methods 0.000 description 6
- 239000007787 solid Substances 0.000 description 6
- 238000004090 dissolution Methods 0.000 description 5
- 238000010828 elution Methods 0.000 description 5
- 150000001875 compounds Chemical class 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 3
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 3
- 239000011230 binding agent Substances 0.000 description 3
- 239000011859 microparticle Substances 0.000 description 3
- 229940079832 sodium starch glycolate Drugs 0.000 description 3
- 239000008109 sodium starch glycolate Substances 0.000 description 3
- 229920003109 sodium starch glycolate Polymers 0.000 description 3
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 239000004480 active ingredient Substances 0.000 description 2
- 229960004977 anhydrous lactose Drugs 0.000 description 2
- 238000007796 conventional method Methods 0.000 description 2
- 238000007922 dissolution test Methods 0.000 description 2
- 239000010419 fine particle Substances 0.000 description 2
- 239000007903 gelatin capsule Substances 0.000 description 2
- 238000001727 in vivo Methods 0.000 description 2
- 230000007935 neutral effect Effects 0.000 description 2
- 239000006186 oral dosage form Substances 0.000 description 2
- 229940032147 starch Drugs 0.000 description 2
- 239000012085 test solution Substances 0.000 description 2
- 238000000870 ultraviolet spectroscopy Methods 0.000 description 2
- 206010064147 Gastrointestinal inflammation Diseases 0.000 description 1
- 108010010803 Gelatin Proteins 0.000 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 1
- HGWPFSBHDACWNL-GFBLOWMDSA-N [(1r,5s)-8-methyl-8-oxido-8-azoniabicyclo[3.2.1]octan-3-yl] 3-hydroxy-2-phenylpropanoate Chemical compound C([C@H]1CC[C@@H](C2)[N+]1([O-])C)C2OC(=O)C(CO)C1=CC=CC=C1 HGWPFSBHDACWNL-GFBLOWMDSA-N 0.000 description 1
- 239000003741 agents affecting lipid metabolism Substances 0.000 description 1
- 239000003524 antilipemic agent Substances 0.000 description 1
- 239000000969 carrier Substances 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000013270 controlled release Methods 0.000 description 1
- 230000002596 correlated effect Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 238000007907 direct compression Methods 0.000 description 1
- 239000007884 disintegrant Substances 0.000 description 1
- 238000007580 dry-mixing Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- -1 fenofibrate compound Chemical class 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 229920000159 gelatin Polymers 0.000 description 1
- 239000008273 gelatin Substances 0.000 description 1
- 235000019322 gelatine Nutrition 0.000 description 1
- 235000011852 gelatine desserts Nutrition 0.000 description 1
- 230000002209 hydrophobic effect Effects 0.000 description 1
- 229960001375 lactose Drugs 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 239000011148 porous material Substances 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000000935 solvent evaporation Methods 0.000 description 1
- 238000001694 spray drying Methods 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
Images
Classifications
-
- 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
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
-
- 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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
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- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Emergency Medicine (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
Claims (18)
- 脂質制御薬物をサーファクタント不含の溶媒に溶解して薬物溶液を形成するステップ、
賦形剤を予混合して混合物を生成するステップ、
前記混合物と前記薬物溶液とを湿式造粒して、造粒薬物混合物を形成するステップ、および
前記造粒混合物を乾燥させるステップを含む、薬物製剤を製造するための方法。 - 前記脂質制御薬物がフィブラートである請求項1に記載の方法。
- 前記フィブラートがフェノフィブラートである請求項2に記載の方法。
- 前記乾燥させるステップが溶媒を蒸発させることを含む請求項1に記載の方法。
- 前記蒸発させることが減圧下に実施される請求項4に記載の方法。
- 前記乾燥させるステップが流動層、トレイ乾燥器または回転噴霧器を使用して遂行される請求項1に記載の方法。
- 他の賦形剤を添加する追加のステップを含む請求項1に記載の方法。
- 最終剤形を形成する追加のステップを含む請求項1に記載の方法。
- 脂質制御薬物をサーファクタント不含の溶媒に溶解して薬物溶液を形成するステップ、
賦形剤を予混合して混合物を生成するステップ、
前記混合物と前記薬物溶液とを湿式造粒して、造粒薬物混合物を形成するステップ、
前記造粒混合物を乾燥させるステップ、および
前記乾燥造粒混合物を錠剤にするステップを含む、薬物製剤を製造するための方法。 - 脂質制御薬物をサーファクタント不含の溶媒に溶解して薬物溶液を形成するステップ、
賦形剤を予混合して混合物を生成するステップ、
前記混合物と前記薬物溶液とを湿式造粒して、造粒薬物混合物を形成するステップ、
前記造粒混合物を乾燥させるステップ、および
前記乾燥造粒混合物をカプセルに充填するステップを含む、薬物製剤を製造するための方法。 - 前記賦形剤が乳糖、デンプン、ポリビニルピロリドン、ステアリン酸マグネシウム、および他の薬学的に許容される賦形剤からなる群から選択された1つまたは複数のメンバーである請求項1に記載の方法。
- 前記混合物を流動層中で造粒する請求項1に記載の方法。
- 前記混合物を低速せん断または高速せん断の混合機中で造粒する請求項1に記載の方法。
- 請求項1に記載の方法によって製造される組成物。
- 請求項3に記載の方法によって製造される組成物。
- 請求項9に記載の方法によって製造された最終薬物製剤を投与するステップを含む高脂血症を治療するための方法。
- 請求項10に記載の方法によって製造された最終薬物製剤を投与するステップを含む高脂血症を治療するための方法。
- 請求項3に記載の方法によって製造された製剤を投与することを含む高脂血症を治療するための方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US61362203A | 2003-07-02 | 2003-07-02 | |
US10/613,622 | 2003-07-02 | ||
PCT/US2004/021361 WO2005002541A2 (en) | 2003-07-02 | 2004-07-02 | Process for preparing formulations of lipid-regulating drugs |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2012063143A Division JP2012149078A (ja) | 2003-07-02 | 2012-03-21 | 脂質制御薬物製剤の製造のための方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2007530415A true JP2007530415A (ja) | 2007-11-01 |
JP5134818B2 JP5134818B2 (ja) | 2013-01-30 |
Family
ID=33564305
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2006518798A Expired - Fee Related JP5134818B2 (ja) | 2003-07-02 | 2004-07-02 | 脂質制御薬物製剤の製造のための方法 |
JP2012063143A Pending JP2012149078A (ja) | 2003-07-02 | 2012-03-21 | 脂質制御薬物製剤の製造のための方法 |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
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JP2012063143A Pending JP2012149078A (ja) | 2003-07-02 | 2012-03-21 | 脂質制御薬物製剤の製造のための方法 |
Country Status (5)
Country | Link |
---|---|
EP (1) | EP1643975A2 (ja) |
JP (2) | JP5134818B2 (ja) |
CA (1) | CA2531097C (ja) |
MX (1) | MXPA06000111A (ja) |
WO (1) | WO2005002541A2 (ja) |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH04103525A (ja) * | 1990-08-22 | 1992-04-06 | Sanwa Kagaku Kenkyusho Co Ltd | 難水溶性薬物の持続性製剤化方法 |
JP2002507569A (ja) * | 1998-03-24 | 2002-03-12 | スミスクライン・ビーチャム・パブリック・リミテッド・カンパニー | パロキセチン組成物 |
JP2003504331A (ja) * | 1999-07-09 | 2003-02-04 | ラボラトワール デ プロデュイ エチク エチファルム | フェノフィブレート含有医薬組成物およびこれを調製するための方法 |
Family Cites Families (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2494112B1 (ja) * | 1980-11-19 | 1986-01-10 | Laruelle Claude | |
DE4317127A1 (de) * | 1993-05-19 | 1994-11-24 | Merz & Co Gmbh & Co | Verwendung von Etofibrat und pharmazeutische Zusammensetzungen, enthaltend Etofibrat, zur Behandlung der diabetischen Angio- und Retinopathie |
US6383517B1 (en) * | 1999-01-29 | 2002-05-07 | Abbott Laboratories | Process for preparing solid formulations of lipid-regulating agents with enhanced dissolution and absorption |
-
2004
- 2004-07-02 EP EP04777483A patent/EP1643975A2/en not_active Withdrawn
- 2004-07-02 JP JP2006518798A patent/JP5134818B2/ja not_active Expired - Fee Related
- 2004-07-02 MX MXPA06000111A patent/MXPA06000111A/es active IP Right Grant
- 2004-07-02 CA CA2531097A patent/CA2531097C/en not_active Expired - Fee Related
- 2004-07-02 WO PCT/US2004/021361 patent/WO2005002541A2/en active Application Filing
-
2012
- 2012-03-21 JP JP2012063143A patent/JP2012149078A/ja active Pending
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH04103525A (ja) * | 1990-08-22 | 1992-04-06 | Sanwa Kagaku Kenkyusho Co Ltd | 難水溶性薬物の持続性製剤化方法 |
JP2002507569A (ja) * | 1998-03-24 | 2002-03-12 | スミスクライン・ビーチャム・パブリック・リミテッド・カンパニー | パロキセチン組成物 |
JP2003504331A (ja) * | 1999-07-09 | 2003-02-04 | ラボラトワール デ プロデュイ エチク エチファルム | フェノフィブレート含有医薬組成物およびこれを調製するための方法 |
Also Published As
Publication number | Publication date |
---|---|
CA2531097C (en) | 2012-10-09 |
JP5134818B2 (ja) | 2013-01-30 |
JP2012149078A (ja) | 2012-08-09 |
MXPA06000111A (es) | 2006-04-27 |
WO2005002541A2 (en) | 2005-01-13 |
EP1643975A2 (en) | 2006-04-12 |
WO2005002541A3 (en) | 2005-09-15 |
CA2531097A1 (en) | 2005-01-13 |
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