BRPI0509062A - composição para preparação farmacêutica sólida de solifenacina ou seu sal - Google Patents
composição para preparação farmacêutica sólida de solifenacina ou seu salInfo
- Publication number
- BRPI0509062A BRPI0509062A BRPI0509062-8A BRPI0509062A BRPI0509062A BR PI0509062 A BRPI0509062 A BR PI0509062A BR PI0509062 A BRPI0509062 A BR PI0509062A BR PI0509062 A BRPI0509062 A BR PI0509062A
- Authority
- BR
- Brazil
- Prior art keywords
- solifenacin
- salt
- solid pharmaceutical
- pharmaceutical preparation
- composition
- Prior art date
Links
- FBOUYBDGKBSUES-VXKWHMMOSA-N solifenacin Chemical group C1([C@H]2C3=CC=CC=C3CCN2C(O[C@@H]2C3CCN(CC3)C2)=O)=CC=CC=C1 FBOUYBDGKBSUES-VXKWHMMOSA-N 0.000 title abstract 7
- 229960003855 solifenacin Drugs 0.000 title abstract 7
- 239000000825 pharmaceutical preparation Substances 0.000 title abstract 6
- 150000003839 salts Chemical class 0.000 title abstract 6
- 239000000203 mixture Substances 0.000 title abstract 5
- 239000007787 solid Substances 0.000 title abstract 5
- 150000001875 compounds Chemical class 0.000 abstract 2
- 238000000354 decomposition reaction Methods 0.000 abstract 2
- 238000005280 amorphization Methods 0.000 abstract 1
- 229940079593 drug Drugs 0.000 abstract 1
- 239000003814 drug Substances 0.000 abstract 1
- 239000003112 inhibitor Substances 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 238000002360 preparation method Methods 0.000 abstract 1
Classifications
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D453/00—Heterocyclic compounds containing quinuclidine or iso-quinuclidine ring systems, e.g. quinine alkaloids
- C07D453/02—Heterocyclic compounds containing quinuclidine or iso-quinuclidine ring systems, e.g. quinine alkaloids containing not further condensed quinuclidine ring systems
-
- 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
- A61K31/439—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 the ring forming part of a bridged ring system, e.g. quinuclidine
-
- 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
- A61K9/20—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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/12—Antidiarrhoeals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/02—Nasal agents, e.g. decongestants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/08—Bronchodilators
-
- 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
-
- 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
- A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
-
- 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
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A61P27/08—Mydriatics or cycloplegics
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Pulmonology (AREA)
- Urology & Nephrology (AREA)
- Ophthalmology & Optometry (AREA)
- Otolaryngology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
Abstract
COMPOSIçãO PARA PREPARAçãO FARMACêUTICA SóLIDA DE SOLIFENACINA OU SEU SAL Preparação farmacêutica sólida de solifenacina ou um seu sal, a preparação sendo estável e inibida de se decompor com o tempo quando fornecida para áreas clínicas. Em uma preparação farmacêutica contendo solifenacina ou um seu sal, o composto em uma forma amorfa se revelou ser causador da decomposição do fármaco principal ao longo do tempo. A composição para uma preparação farmacêutica sólida de solifenacina ou de um seu sal contém solifenacina ou seu sal cada um em forma cristalina, e o teor do composto em uma forma amorfa na composição está situado dentro da faixa que não apresenta influência sobre a estabilidade do produto. Também, são providos: um processo para produzir a co posição; e uma composição medicinal para preparações farmacêuticas sólidas as quais contêm solifenacina e um inibidor de amorfização.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US55602504P | 2004-03-25 | 2004-03-25 | |
| US63838804P | 2004-12-27 | 2004-12-27 | |
| PCT/JP2005/005377 WO2005092889A1 (ja) | 2004-03-25 | 2005-03-24 | ソリフェナシンまたはその塩の固形製剤用組成物 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BRPI0509062A true BRPI0509062A (pt) | 2007-08-21 |
Family
ID=35056127
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BRPI0509062-8A BRPI0509062A (pt) | 2004-03-25 | 2005-03-24 | composição para preparação farmacêutica sólida de solifenacina ou seu sal |
Country Status (19)
| Country | Link |
|---|---|
| US (2) | US8039482B2 (pt) |
| EP (2) | EP1728791A4 (pt) |
| JP (3) | JP5168711B2 (pt) |
| KR (5) | KR101836467B1 (pt) |
| AU (1) | AU2005226357B2 (pt) |
| BG (2) | BG1638U1 (pt) |
| BR (1) | BRPI0509062A (pt) |
| CA (1) | CA2561167C (pt) |
| CZ (2) | CZ23088U1 (pt) |
| DK (1) | DK2156824T3 (pt) |
| ES (1) | ES2397307T3 (pt) |
| IL (1) | IL178249A (pt) |
| MX (1) | MXPA06010908A (pt) |
| NO (1) | NO340020B1 (pt) |
| PL (1) | PL2156824T3 (pt) |
| PT (1) | PT2156824E (pt) |
| RU (1) | RU2359670C2 (pt) |
| SK (2) | SK6199Y1 (pt) |
| WO (1) | WO2005092889A1 (pt) |
Families Citing this family (39)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20050175689A1 (en) * | 2003-10-27 | 2005-08-11 | Yamanouchi Pharmaceutical Co., Ltd. | Coated fine particles containing drug for intrabuccally fast disintegrating tablet |
| KR101836467B1 (ko) | 2004-03-25 | 2018-03-08 | 아스텔라스세이야쿠 가부시키가이샤 | 솔리페나신 또는 그의 염의 고형 제제용 조성물 |
| US20080103171A1 (en) * | 2004-12-27 | 2008-05-01 | Astellas Pharma Inc. | Stable Particular Pharmaceutical Composition of Solifenacin or Salt Thereof |
| CA2599158C (en) * | 2005-02-25 | 2011-01-25 | Astellas Pharma Inc. | Pharmaceutical agent comprising solifenacin |
| US7815939B2 (en) * | 2005-07-20 | 2010-10-19 | Astellas Pharma Inc. | Coated fine particles containing drug for intrabuccally fast disintegrating dosage forms |
| EP1945636A2 (en) * | 2006-08-03 | 2008-07-23 | Teva Pharmaceutical Industries Ltd. | Polymorphs of solifenacin intermediate |
| EP2018850A1 (en) * | 2007-07-24 | 2009-01-28 | Ratiopharm GmbH | Pharmaceutical composition comprising solifenacin or a pharmaceutically acceptable salt thereof |
| SI2225230T1 (sl) | 2007-12-07 | 2017-03-31 | Vertex Pharmaceuticals Incorporated | Trdne oblike 3-(6-(1-2,2-difluorobenzo(d)(1,3)dioxol-5-il)ciklopropan- karboksamido)-3-metilpiridin-2-il) benzojske kisline |
| EP2210595A1 (en) * | 2009-01-14 | 2010-07-28 | LEK Pharmaceuticals d.d. | Active coating of pharmaceutical dosage forms |
| ES2609061T3 (es) | 2009-02-27 | 2017-04-18 | Krka, D.D., Novo Mesto | Procedimiento para formar unas formas farmacéuticas orales sólidas de solifenacina y sus sales farmacéuticamente aceptables |
| US20100273825A1 (en) * | 2009-03-30 | 2010-10-28 | Astellas Pharma Inc. | Solid pharmaceutical composition containing solifenacin amorphous form |
| WO2011137877A2 (en) | 2010-05-07 | 2011-11-10 | Zentiva K.S. | A pharmaceutical composition containing solifenacin and a method of its manufacture |
| HRP20160901T1 (hr) | 2010-05-19 | 2016-10-07 | Astellas Pharma Inc. | Farmaceutski pripravak koji sadrži solifenacin |
| CA2804107A1 (en) | 2010-07-05 | 2012-01-12 | Crystal Pharma S.A.U. | Solifenacin salts |
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| US8957066B2 (en) | 2011-02-28 | 2015-02-17 | Biomarin Pharmaceutical Inc. | Histone deacetylase inhibitors |
| US10059723B2 (en) | 2011-02-28 | 2018-08-28 | Biomarin Pharmaceutical Inc. | Histone deacetylase inhibitors |
| EP2500013B1 (en) | 2011-03-15 | 2019-10-02 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Pharmaceutical composition comprising solifenacin |
| US8940763B2 (en) * | 2011-05-10 | 2015-01-27 | Theravida, Inc. | Combinations of solifenacin and salivary stimulants for the treatment of overactive bladder |
| WO2013112804A1 (en) | 2012-01-25 | 2013-08-01 | Vertex Pharmaceuticals Incorporated | Formulations of 3-(6-(1-(2.2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid |
| TWI500223B (zh) * | 2012-09-17 | 2015-09-11 | Delta Electronics Inc | Rj連接器的端子結構、應用其之rj連接器模組及rj連接器系統 |
| EP2778167A1 (en) | 2013-03-11 | 2014-09-17 | Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi | Stable pharmaceutical composition comprising amorphous solifenacin or its pharmaceutically acceptable salt |
| JP6963896B2 (ja) * | 2013-11-12 | 2021-11-10 | バーテックス ファーマシューティカルズ インコーポレイテッドVertex Pharmaceuticals Incorporated | Cftr媒介性疾患の処置のための医薬組成物を調製する方法 |
| KR20150092385A (ko) * | 2014-02-03 | 2015-08-13 | 씨제이헬스케어 주식회사 | 솔리페나신을 포함하는 안정한 제제 및 이의 제조방법 |
| KR20150102852A (ko) * | 2014-02-28 | 2015-09-08 | 대원제약주식회사 | 무정형 솔리페나신 또는 그의 염을 포함하는 안정성이 증가된 고체분산체 조성물 및 그 제조방법 |
| JP2015189677A (ja) * | 2014-03-27 | 2015-11-02 | テバ製薬株式会社 | ソリフェナシン非晶質体を含有する医薬組成物 |
| WO2015170237A1 (en) * | 2014-05-05 | 2015-11-12 | Torrent Pharmaceuticals Limited | Stable solifenacin composition |
| BR112017012558A2 (pt) * | 2014-12-19 | 2018-01-02 | Merck Sharp & Dohme | Composições de (s)-n-(3-(6-isopropoxipiridin-3-il)-1h- indazol-5-il)-1-(2-(4-(4-(1-metil-1h-1,2,4-triazol-3-il) fenil)-3,6-diidropiridin-1(2h)-il)-2-oxoetil)-3-(metiltio) pirrolidina-3-carboxamida para preparações farmacêuticas |
| JP6639024B2 (ja) * | 2016-04-08 | 2020-02-05 | 大原薬品工業株式会社 | 化学的な安定性を改善した、非晶質体ソリフェナシン含有製剤 |
| KR20180003340A (ko) * | 2016-06-30 | 2018-01-09 | 한미약품 주식회사 | 무정형 솔리페나신 함유 경구용 고형제제 및 그 제조방법 |
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| KR102148414B1 (ko) | 2017-05-15 | 2020-08-26 | 주식회사 서울제약 | 솔리페나신을 유효성분으로 하는 구강붕해필름 |
| EP3697392B1 (en) | 2017-10-17 | 2023-11-15 | Synthon B.V. | Tablets comprising tamsulosin and solifenacin |
| UY38137A (es) | 2018-03-08 | 2019-07-31 | Intas Third Party Sales 2005 S L | Una forma de dosificación oral sólida farmacéutica de solifenacina |
| KR20200077268A (ko) | 2018-12-20 | 2020-06-30 | 충북대학교 산학협력단 | 솔리페나신 타르타르산염의 구강 투여용 약학 제제로서의 용도 |
| KR20210114271A (ko) | 2020-03-10 | 2021-09-23 | 주식회사 종근당 | 솔리페나신 또는 이의 약제학적으로 허용가능한 염을 함유하는 약제학적 조성물 |
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| JP4523265B2 (ja) | 2002-11-13 | 2010-08-11 | 旭化成ファーマ株式会社 | 排尿障害治療用口腔内崩壊製剤 |
| AU2004224322A1 (en) * | 2003-03-21 | 2004-10-07 | Dynogen Pharmaceuticals, Inc. | Methods of treating lower urinary tract disorders using smooth muscle modulators and alpha-2-delta subunit calcium channel modulators |
| US20060147531A1 (en) * | 2003-07-01 | 2006-07-06 | Mojca Segula | Tamsulosin core with a coating of polyvinylpyrrolidone and polyfinylacetate |
| US20050175689A1 (en) * | 2003-10-27 | 2005-08-11 | Yamanouchi Pharmaceutical Co., Ltd. | Coated fine particles containing drug for intrabuccally fast disintegrating tablet |
| CA2543454A1 (en) | 2003-10-27 | 2005-05-06 | Astellas Pharma Inc. | Drug-containing coated microparticles for quick-disintegrating oral tablets |
| US20080287680A1 (en) | 2004-02-09 | 2008-11-20 | Astellas Pharma Inc. | Solifenacin Succinate-Containing Composition |
| WO2005077364A1 (ja) * | 2004-02-18 | 2005-08-25 | Yamanouchi Pharmaceutical Co., Ltd. | ソリフェナシンの経皮投与製剤およびその経皮透過改善方法 |
| WO2005087231A1 (ja) | 2004-03-16 | 2005-09-22 | Astellas Pharma Inc. | ソリフェナシン含有組成物 |
| KR101836467B1 (ko) | 2004-03-25 | 2018-03-08 | 아스텔라스세이야쿠 가부시키가이샤 | 솔리페나신 또는 그의 염의 고형 제제용 조성물 |
| US20080103171A1 (en) * | 2004-12-27 | 2008-05-01 | Astellas Pharma Inc. | Stable Particular Pharmaceutical Composition of Solifenacin or Salt Thereof |
| US7815939B2 (en) * | 2005-07-20 | 2010-10-19 | Astellas Pharma Inc. | Coated fine particles containing drug for intrabuccally fast disintegrating dosage forms |
-
2005
- 2005-03-24 KR KR1020147008466A patent/KR101836467B1/ko not_active Ceased
- 2005-03-24 PL PL09014500T patent/PL2156824T3/pl unknown
- 2005-03-24 CZ CZ201124172U patent/CZ23088U1/cs not_active IP Right Cessation
- 2005-03-24 AU AU2005226357A patent/AU2005226357B2/en not_active Ceased
- 2005-03-24 KR KR1020137006732A patent/KR20130041346A/ko not_active Ceased
- 2005-03-24 DK DK09014500.4T patent/DK2156824T3/da active
- 2005-03-24 JP JP2006511497A patent/JP5168711B2/ja not_active Expired - Fee Related
- 2005-03-24 RU RU2006137565/15A patent/RU2359670C2/ru active
- 2005-03-24 EP EP05721391A patent/EP1728791A4/en not_active Withdrawn
- 2005-03-24 SK SK5020-2011U patent/SK6199Y1/sk unknown
- 2005-03-24 MX MXPA06010908A patent/MXPA06010908A/es active IP Right Grant
- 2005-03-24 CA CA2561167A patent/CA2561167C/en not_active Expired - Fee Related
- 2005-03-24 EP EP09014500A patent/EP2156824B1/en not_active Expired - Lifetime
- 2005-03-24 SK SK5022-2011U patent/SK50222011U1/sk unknown
- 2005-03-24 PT PT90145004T patent/PT2156824E/pt unknown
- 2005-03-24 ES ES09014500T patent/ES2397307T3/es not_active Expired - Lifetime
- 2005-03-24 US US10/594,127 patent/US8039482B2/en not_active Expired - Fee Related
- 2005-03-24 KR KR1020117007484A patent/KR101156406B1/ko not_active Expired - Fee Related
- 2005-03-24 KR KR1020127004903A patent/KR101270908B1/ko not_active Ceased
- 2005-03-24 BR BRPI0509062-8A patent/BRPI0509062A/pt not_active Application Discontinuation
- 2005-03-24 WO PCT/JP2005/005377 patent/WO2005092889A1/ja not_active Ceased
- 2005-03-24 KR KR1020067019783A patent/KR20070010132A/ko not_active Ceased
- 2005-03-24 CZ CZ201124174U patent/CZ23090U1/cs not_active IP Right Cessation
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2006
- 2006-09-21 IL IL178249A patent/IL178249A/en active IP Right Review Request
- 2006-10-24 NO NO20064830A patent/NO340020B1/no not_active IP Right Cessation
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2010
- 2010-03-05 JP JP2010049166A patent/JP5177156B2/ja not_active Expired - Fee Related
- 2010-11-19 US US12/950,492 patent/US20110065746A1/en not_active Abandoned
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2011
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- 2012-10-17 JP JP2012229790A patent/JP2013040193A/ja not_active Withdrawn
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