JP2014024874A - 圧縮製剤 - Google Patents
圧縮製剤 Download PDFInfo
- Publication number
- JP2014024874A JP2014024874A JP2013231673A JP2013231673A JP2014024874A JP 2014024874 A JP2014024874 A JP 2014024874A JP 2013231673 A JP2013231673 A JP 2013231673A JP 2013231673 A JP2013231673 A JP 2013231673A JP 2014024874 A JP2014024874 A JP 2014024874A
- Authority
- JP
- Japan
- Prior art keywords
- tableting
- composition
- dissolution
- olmesartan medoxomil
- compressing
- 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.)
- Pending
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4178—1,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
-
- 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
-
- 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
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/06—Antiarrhythmics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
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- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Epidemiology (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Urology & Nephrology (AREA)
- Vascular Medicine (AREA)
- Hospice & Palliative Care (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Plural Heterocyclic Compounds (AREA)
Abstract
【解決手段】組成物を圧縮する工程を含むことを特徴とするオルメサルタンメドキソミル含有製剤の製造方法。
【選択図】なし
Description
(1)組成物を圧縮する工程を含むことを特徴とするオルメサルタンメドキソミル含有製剤の製造方法。
(2)組成物を圧縮する工程が、20 N/mm2以上の圧力を使用する工程である(1)に記載の製造方法。
(3)組成物を圧縮する工程が、40-600 N/mm2の圧力を使用する工程である(1)に記載の製造方法。
(4)組成物を圧縮する工程が、60-400 N/mm2の圧力を使用する工程である(1)に記載の製造方法。
(5)組成物を圧縮する工程が、打錠工程である(1)乃至(4)に記載の製造方法。
(6)製剤が、散剤、細粒剤または顆粒剤である(1)乃至(4)に記載の製造方法。
(7)製剤が、錠剤である(1)乃至(5)に記載の製造方法。
(8)組成物が、溶出改善剤を含む(1)乃至(7)に記載の製造方法。
(9)(1)乃至(8)に記載の方法で製造されたオルメサルタンメドキソミル含有製剤。
処方A中のステアリン酸マグネシウムを除く成分を乳鉢混合した後、ステアリン酸マグネシウムを加えて袋混合し、打錠用混合末を得た。得られた打錠用混合末を打錠圧力28 N/mm2で打錠した。
オルメサルタンメドキソミル 20 mg
乳糖 106 mg
L−HPC 20 mg
HPC−L 3 mg
アビセル 10 mg
ステアリン酸マグネシウム 1 mg
----------------------------------------------------------
160 mg
実施例A−1で得られた打錠用混合末を打錠圧力85 N/mm2で打錠した。
実施例A−1で得られた打錠用混合末を打錠圧力141 N/mm2で打錠した。
実施例A-3で得られた錠剤を乳鉢粉砕した。
処方B中のステアリン酸マグネシウムを除く成分を乳鉢混合した後、ステアリン酸マグネシウムを加えて袋混合し、打錠用混合末を得た。得られた打錠用混合末を打錠圧力28 N/mm2で打錠した。
オルメサルタンメドキソミル 20 mg
エリスリトール 139.5 mg
D−マンニトール 25 mg
アスパルテーム 7.5 mg
HPC−SSL 6 mg
ステアリン酸マグネシウム 2 mg
----------------------------------------------------------
200 mg
実施例B−1で得られた打錠用混合末を打錠圧力85 N/mm2で打錠した。
実施例B−1で得られた打錠用混合末を打錠圧力141 N/mm2で打錠した。
実施例B-3で得られた錠剤を乳鉢粉砕した。
実施例A−1で得られた打錠用混合末を使用した。
実施例B−1で得られた打錠用混合末を使用した。
オルメサルタンメドキソミル原体を使用した。
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(パドル法)に従い、毎分50回転、試験液として日局第2液(JP-2)900mLを用い、試験を行った。試験開始から30分および60分後の試験液を採取し、吸光度測定法によりオルメサルタンメドキソミルの溶出率を測定した。〔富山産業(株):溶出試験器NTR-6000、(株)島津製作所:分光光度計UV-1600〕。試験は2錠について行い、その平均値を示した。
-----------------------------------------------------
溶出率(%)
検体 30分後 60分後
-----------------------------------------------------
実施例A−1 65.7 77.5
実施例A−2 77.9 87.4
実施例A−3 83.1 90.3
実施例A−4 79.1 82.9
実施例B−1 61.8 74.3
実施例B−2 71.4 82.5
実施例B−3 81.2 91.4
実施例B−4 83.2 91.2
-----------------------------------------------------
比較例C−1 60.6 71.0
比較例C−2 58.5 71.0
比較例C−3 60.0 68.4
-----------------------------------------------------
Claims (2)
- 組成物を圧縮する打錠工程を含むことを特徴とするオルメサルタンメドキソミル含有錠剤(但し、結晶セルロース又はトウモロコシデンプンを含有する錠剤を除く)の溶出性改善方法であって、前記打錠工程が、60-400 N/mm2の圧力を使用する工程であり、ステアリン酸マグネシウムを除く成分を混合した後、ステアリン酸マグネシウムを加えて混合した組成物を打錠する工程である方法。
- 組成物が、溶出改善剤を含む請求項1に記載の溶出性改善方法。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2013231673A JP2014024874A (ja) | 2006-06-27 | 2013-11-08 | 圧縮製剤 |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2006176146 | 2006-06-27 | ||
JP2006176146 | 2006-06-27 | ||
JP2013231673A JP2014024874A (ja) | 2006-06-27 | 2013-11-08 | 圧縮製剤 |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2008522575A Division JP5769362B2 (ja) | 2006-06-27 | 2007-06-26 | 圧縮製剤 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2014024874A true JP2014024874A (ja) | 2014-02-06 |
JP2014024874A5 JP2014024874A5 (ja) | 2014-08-07 |
Family
ID=38845498
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2008522575A Active JP5769362B2 (ja) | 2006-06-27 | 2007-06-26 | 圧縮製剤 |
JP2013231673A Pending JP2014024874A (ja) | 2006-06-27 | 2013-11-08 | 圧縮製剤 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2008522575A Active JP5769362B2 (ja) | 2006-06-27 | 2007-06-26 | 圧縮製剤 |
Country Status (9)
Country | Link |
---|---|
US (1) | US20100237530A1 (ja) |
EP (1) | EP2033643A4 (ja) |
JP (2) | JP5769362B2 (ja) |
KR (1) | KR101628028B1 (ja) |
CN (1) | CN101478966B (ja) |
BR (1) | BRPI0713371A2 (ja) |
CA (1) | CA2656181C (ja) |
TW (1) | TWI492747B (ja) |
WO (1) | WO2008001734A1 (ja) |
Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2009113420A1 (ja) * | 2008-03-13 | 2009-09-17 | 第一三共株式会社 | オルメサルタンメドキソミルを含む製剤の溶出性の改善 |
JP2011136908A (ja) * | 2009-12-25 | 2011-07-14 | Kyowa Yakuhin Kogyo Kk | アンギオテンシンii受容体拮抗剤を含む固形製剤および固形製剤におけるアンギオテンシンii受容体拮抗剤の保存安定性向上方法 |
CN102119930B (zh) * | 2010-07-13 | 2013-01-30 | 福建天泉药业股份有限公司 | 一种奥美沙坦酯片及制备方法 |
EP2425859A1 (en) | 2010-08-08 | 2012-03-07 | Abdi Ibrahim Ilac Sanayi ve Ticaret Anonim Sirketi | Olmesartan formulations |
CN102028663B (zh) * | 2010-12-14 | 2011-11-30 | 北京万生药业有限责任公司 | 一种稳定的奥美沙坦酯固体制剂 |
MX362400B (es) * | 2012-03-30 | 2019-01-16 | Dae Woong Pharma | Composicion farmaceutica que comprende olmesartan medoxomilo y rosuvastatina o su sal. |
CN105663070A (zh) * | 2014-11-21 | 2016-06-15 | 深圳信立泰药业股份有限公司 | 一种含有奥美沙坦酯的药物组合物及其制备方法 |
CN105640913B (zh) * | 2016-01-22 | 2018-11-02 | 山东省医学科学院药物研究所 | 一种奥美沙坦酯片及其制备方法 |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2000336027A (ja) * | 1999-05-26 | 2000-12-05 | Lion Corp | 多層錠の剥離抑制方法 |
JP2002167327A (ja) * | 2000-09-22 | 2002-06-11 | Takeda Chem Ind Ltd | 固形製剤 |
WO2004067003A1 (ja) * | 2003-01-31 | 2004-08-12 | Sankyo Company, Limited | 動脈硬化及び高血圧症の予防及び治療のための医薬 |
WO2005037254A1 (ja) * | 2003-10-15 | 2005-04-28 | Fuji Chemical Industry Co., Ltd. | 口腔内速崩壊性錠剤 |
Family Cites Families (17)
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US3096248A (en) * | 1959-04-06 | 1963-07-02 | Rexall Drug & Chemical Company | Method of making an encapsulated tablet |
JPH0282519A (ja) | 1988-09-19 | 1990-03-23 | Sanyo Electric Co Ltd | 固相エピタキシャル成長方法 |
US5616599A (en) | 1991-02-21 | 1997-04-01 | Sankyo Company, Limited | Angiotensin II antagosist 1-biphenylmethylimidazole compounds and their therapeutic use |
JPH0624959A (ja) * | 1991-10-04 | 1994-02-01 | Bayer Yakuhin Kk | 胃内浮遊型薬物徐放性固形製剤 |
US5298261A (en) * | 1992-04-20 | 1994-03-29 | Oregon Freeze Dry, Inc. | Rapidly distintegrating tablet |
US6465009B1 (en) * | 1998-03-18 | 2002-10-15 | Yamanouchi Pharmaceutical Co., Ltd. | Water soluble polymer-based rapidly dissolving tablets and production processes thereof |
AU743109B2 (en) * | 1998-07-15 | 2002-01-17 | Asahi Kasei Kabushiki Kaisha | Excipient |
AU6786001A (en) * | 2000-07-05 | 2002-01-14 | Asahi Chemical Ind | Cellulose powder |
US20040132731A1 (en) * | 2002-06-26 | 2004-07-08 | Fox David Nathan Abraham | Novel combination |
CA2532450C (en) | 2003-07-16 | 2012-09-11 | Boehringer Ingelheim International Gmbh | Chlorthalidone combinations |
GB0325291D0 (en) * | 2003-10-29 | 2003-12-03 | Pfizer Ltd | Novel combination |
US7700128B2 (en) | 2003-10-31 | 2010-04-20 | Takeda Pharmaceutical Company Limited | Solid preparation comprising an insulin sensitizer, an insulin secretagogue and a polyoxyethylene sorbitan fatty acid ester |
CA2575177A1 (en) * | 2004-09-02 | 2006-03-16 | Teva Pharmaceutical Industries Ltd. | Purification of olmesartan medoxomil |
JP5063370B2 (ja) * | 2005-06-27 | 2012-10-31 | 第一三共株式会社 | 湿式造粒製薬の調製方法 |
TWI388345B (zh) * | 2005-06-27 | 2013-03-11 | Sankyo Co | 用於高血壓之預防或治療之包含血管緊張素ⅱ受體拮抗劑及鈣通道阻斷劑之固體劑型 |
ES2404939T3 (es) * | 2005-06-27 | 2013-05-29 | Daiichi Sankyo Company, Limited | Preparación farmacéutica que contiene un antagonista del receptor de la angiotensina II y un bloqueador de los canales de calcio |
SI1891952T1 (sl) | 2006-05-04 | 2012-02-29 | Lek Pharmaceuticals, D.D. | Farmacevtski sestavek, ki vsebuje olmesartan medoksomil |
-
2007
- 2007-06-26 EP EP20070767540 patent/EP2033643A4/en not_active Withdrawn
- 2007-06-26 TW TW096122976A patent/TWI492747B/zh active
- 2007-06-26 CA CA2656181A patent/CA2656181C/en not_active Expired - Fee Related
- 2007-06-26 KR KR1020087031327A patent/KR101628028B1/ko active IP Right Grant
- 2007-06-26 US US12/305,705 patent/US20100237530A1/en not_active Abandoned
- 2007-06-26 WO PCT/JP2007/062734 patent/WO2008001734A1/ja active Application Filing
- 2007-06-26 JP JP2008522575A patent/JP5769362B2/ja active Active
- 2007-06-26 CN CN2007800236173A patent/CN101478966B/zh active Active
- 2007-06-26 BR BRPI0713371-5A patent/BRPI0713371A2/pt not_active Application Discontinuation
-
2013
- 2013-11-08 JP JP2013231673A patent/JP2014024874A/ja active Pending
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2000336027A (ja) * | 1999-05-26 | 2000-12-05 | Lion Corp | 多層錠の剥離抑制方法 |
JP2002167327A (ja) * | 2000-09-22 | 2002-06-11 | Takeda Chem Ind Ltd | 固形製剤 |
WO2004067003A1 (ja) * | 2003-01-31 | 2004-08-12 | Sankyo Company, Limited | 動脈硬化及び高血圧症の予防及び治療のための医薬 |
WO2005037254A1 (ja) * | 2003-10-15 | 2005-04-28 | Fuji Chemical Industry Co., Ltd. | 口腔内速崩壊性錠剤 |
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Title |
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JPN6013039713; 薬剤学マニュアル , 1989, p.89, 株式会社 南山堂 * |
JPN6013039716; オルメテック錠 インタビューフォーム , 2004, p.6-9 * |
JPN6014045927; 新・薬剤学総論(改訂第3版) , 1987, p.414-416, 株式会社南江堂 * |
Also Published As
Publication number | Publication date |
---|---|
CN101478966A (zh) | 2009-07-08 |
BRPI0713371A2 (pt) | 2012-03-13 |
TW200815000A (en) | 2008-04-01 |
WO2008001734A1 (en) | 2008-01-03 |
JP5769362B2 (ja) | 2015-08-26 |
CA2656181A1 (en) | 2008-01-03 |
KR101628028B1 (ko) | 2016-06-08 |
US20100237530A1 (en) | 2010-09-23 |
JPWO2008001734A1 (ja) | 2009-11-26 |
EP2033643A1 (en) | 2009-03-11 |
CA2656181C (en) | 2011-09-06 |
KR20090021184A (ko) | 2009-02-27 |
CN101478966B (zh) | 2013-08-21 |
TWI492747B (zh) | 2015-07-21 |
EP2033643A4 (en) | 2013-01-02 |
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