EA201590449A1 - Перорально вводимая лекарственная композиция - Google Patents
Перорально вводимая лекарственная композицияInfo
- Publication number
- EA201590449A1 EA201590449A1 EA201590449A EA201590449A EA201590449A1 EA 201590449 A1 EA201590449 A1 EA 201590449A1 EA 201590449 A EA201590449 A EA 201590449A EA 201590449 A EA201590449 A EA 201590449A EA 201590449 A1 EA201590449 A1 EA 201590449A1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- composition
- pharmaceutically acceptable
- acceptable salt
- release portion
- portion containing
- Prior art date
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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- 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
- A61K31/425—Thiazoles
- A61K31/426—1,3-Thiazoles
-
- 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/472—Non-condensed isoquinolines, e.g. papaverine
- A61K31/4725—Non-condensed isoquinolines, e.g. papaverine containing further heterocyclic rings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- 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
-
- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
-
- 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
- A61P13/10—Drugs for disorders of the urinary system of the bladder
-
- 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
- A61K9/146—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 with organic macromolecular compounds
-
- 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
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (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)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Urology & Nephrology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Для предоставления в области медицины одного состава, содержащего часть с модифицированным высвобождением, содержащую мирабегрон или его фармацевтически приемлемую соль, и часть с немедленным высвобождением, содержащую солифенацин или его фармацевтически приемлемую соль, представлен (1) один состав, обладающий скоростями растворения обоих лекарственных средств, сходными со скоростями растворения в современных составах лекарственных средств, и (2) один состав, обладающий максимальными процентами растворения обоих лекарственных средств 90% или более и обладающий биодоступностью, эквивалентной биодоступности в современных составах отдельных лекарственных средств. Кроме того, для предоставления одного состава представлен (3) один состав, обладающий хорошей эффективностью производства, в соответствии с чем уменьшены трудности в изготовлении таблеток, и обладающий хорошей стабильностью при хранении, в соответствии с чем уменьшено окрашивание части с немедленным высвобождением. Фармацевтическая композиция для перорального введения по настоящему изобретению содержит (1) часть с модифицированным высвобождением, содержащую мирабегрон или его фармацевтически приемлемую соль, и (2) часть с немедленным высвобождением, содержащую солифенацин или его фармацевтически приемлемую соль и стеарат кальция.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2012191833 | 2012-08-31 | ||
PCT/JP2013/073351 WO2014034860A1 (ja) | 2012-08-31 | 2013-08-30 | 経口投与用医薬組成物 |
Publications (1)
Publication Number | Publication Date |
---|---|
EA201590449A1 true EA201590449A1 (ru) | 2015-06-30 |
Family
ID=50183665
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EA201590449A EA201590449A1 (ru) | 2012-08-31 | 2013-08-30 | Перорально вводимая лекарственная композиция |
Country Status (17)
Country | Link |
---|---|
US (1) | US20150306090A1 (ru) |
EP (1) | EP2891493A4 (ru) |
JP (1) | JPWO2014034860A1 (ru) |
KR (1) | KR20150045500A (ru) |
CN (1) | CN104602693A (ru) |
AU (1) | AU2013309922A1 (ru) |
BR (1) | BR112015004244A2 (ru) |
CA (1) | CA2883270A1 (ru) |
EA (1) | EA201590449A1 (ru) |
HK (1) | HK1208801A1 (ru) |
IL (1) | IL237423A0 (ru) |
MX (1) | MX2015002633A (ru) |
PH (1) | PH12015500313A1 (ru) |
SG (1) | SG11201501415RA (ru) |
TW (1) | TW201424772A (ru) |
WO (1) | WO2014034860A1 (ru) |
ZA (1) | ZA201501977B (ru) |
Families Citing this family (21)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9907767B2 (en) | 2010-08-03 | 2018-03-06 | Velicept Therapeutics, Inc. | Pharmaceutical compositions and the treatment of overactive bladder |
JP2017078023A (ja) * | 2014-02-28 | 2017-04-27 | アステラス製薬株式会社 | 経口投与用医薬組成物 |
AU2015358378A1 (en) | 2014-12-03 | 2017-06-29 | Velicept Therapeutics, Inc. | Compositions and methods of using modified release solabegron for lower urinary tract symptoms |
PT3365321T (pt) | 2015-10-23 | 2024-01-12 | B3Ar Therapeutics Inc | Zwiterião de solabegron e suas utilizações |
WO2017186598A1 (en) * | 2016-04-25 | 2017-11-02 | Synthon B.V. | Modified release tablet composition comprising mirabegron |
EP3448367A1 (en) | 2016-04-25 | 2019-03-06 | Synthon BV | Tablets comprising mirabegron and solifenacin |
CN107397733B (zh) * | 2016-05-20 | 2020-02-07 | 山东威智百科药业有限公司 | 一种米拉贝隆缓释片及其制备方法 |
WO2017210696A1 (en) * | 2016-06-03 | 2017-12-07 | Velicept Therapeutics, Inc. | Dosing regimens for beta-3 adrenoceptor agonists and anti-muscarinic agents for the treatment and prevention of lower urinary tract symptoms and overactive bladder |
CN106361715A (zh) * | 2016-09-02 | 2017-02-01 | 迪沙药业集团有限公司 | 米拉贝隆组合物 |
KR102051132B1 (ko) * | 2017-03-17 | 2019-12-02 | 주식회사 종근당 | 미라베그론 또는 이의 염을 포함하는 방출조절용 약제학적 조성물 |
KR101877834B1 (ko) * | 2017-04-27 | 2018-07-12 | 주식회사 다산제약 | 미라베그론의 신규한 염 및 이의 제조방법 |
KR20170088783A (ko) * | 2017-07-07 | 2017-08-02 | 지엘팜텍주식회사 | 미라베그론의 습식과립 조성물 |
WO2019013583A2 (ko) * | 2017-07-14 | 2019-01-17 | 주식회사 대웅제약 | 약제학적 제제 및 그 제조방법 |
KR101937713B1 (ko) | 2017-07-14 | 2019-01-14 | 주식회사 대웅제약 | 약제학적 제제 및 그 제조방법 |
US10478399B2 (en) * | 2017-10-12 | 2019-11-19 | Synthon B.V. | Modified release tablet composition comprising mirabegron |
KR102018495B1 (ko) * | 2018-03-13 | 2019-09-05 | 충북대학교 산학협력단 | 과민성 방광의 치료를 위한 서방형의 이중층 정제 및 이의 제조방법 |
KR102371567B1 (ko) * | 2018-04-06 | 2022-03-07 | 한미약품 주식회사 | 미라베그론이 함유된 방출 제어 약학적 조성물 |
WO2020097328A1 (en) * | 2018-11-07 | 2020-05-14 | Velicept Therapeutics, Inc | Fixed dose pharmaceutical compositions for treating overactive bladder and related conditions |
KR102062791B1 (ko) * | 2019-02-26 | 2020-01-06 | 신일제약 주식회사 | 미라베그론 또는 그의 약제학적으로 허용되는 염을 함유한 방출조절 제제 |
US20210353546A1 (en) * | 2020-05-12 | 2021-11-18 | Jubilant Pharma Holdings Inc. | Dual release pharmaceutical compositions comprising the combination of a beta-3 adrenoreceptor agonist and a muscarinic receptor antagonist |
EP4159199A1 (en) | 2021-09-29 | 2023-04-05 | Lotus Pharmaceutical Co., Ltd. | Combined formulation of mirabegron and solifenacin |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
NO2005012I1 (no) | 1994-12-28 | 2005-06-06 | Debio Rech Pharma Sa | Triptorelin og farmasoytisk akseptable salter derav |
PT1019039E (pt) * | 1997-10-03 | 2002-04-29 | Warner Lambert Co | Comprimido de nitroglicerina comprimida e metodo para o seu fabrico |
BR9804500B1 (pt) | 1997-10-17 | 2010-06-15 | derivado de amida, referida composição farmacêutica e agente terapêutico. | |
US7342117B2 (en) | 2001-10-30 | 2008-03-11 | Astellas Pharma Inc. | α-form or β-form crystal of acetanilide derivative |
CA2503570C (en) | 2002-11-07 | 2011-04-19 | Yamanouchi Pharmaceutical Co., Ltd. | Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient |
US20100240697A1 (en) * | 2007-11-02 | 2010-09-23 | Astellas Pharma Inc. | Pharmaceutical composition for treating overactive bladder |
TWI478712B (zh) * | 2008-09-30 | 2015-04-01 | Astellas Pharma Inc | 釋控性醫藥組成物 |
MY160652A (en) * | 2009-02-04 | 2017-03-15 | Astellas Pharma Inc | Pharmaceutical composition for oral administration |
MX353105B (es) * | 2010-08-03 | 2017-12-19 | Velicept Therapeutics Inc | Combinaciones de agonistas del receptor beta-3-adrenergico y antagonistas del receptor muscarinico para tratar vejiga hiperactiva. |
TWI612975B (zh) * | 2012-03-02 | 2018-02-01 | 安斯泰來製藥股份有限公司 | 速崩散性錠劑 |
-
2013
- 2013-08-30 CN CN201380045454.4A patent/CN104602693A/zh active Pending
- 2013-08-30 SG SG11201501415RA patent/SG11201501415RA/en unknown
- 2013-08-30 MX MX2015002633A patent/MX2015002633A/es unknown
- 2013-08-30 JP JP2014533112A patent/JPWO2014034860A1/ja active Pending
- 2013-08-30 BR BR112015004244A patent/BR112015004244A2/pt not_active IP Right Cessation
- 2013-08-30 US US14/423,679 patent/US20150306090A1/en not_active Abandoned
- 2013-08-30 CA CA2883270A patent/CA2883270A1/en not_active Abandoned
- 2013-08-30 AU AU2013309922A patent/AU2013309922A1/en not_active Abandoned
- 2013-08-30 KR KR1020157007248A patent/KR20150045500A/ko not_active Application Discontinuation
- 2013-08-30 TW TW102131296A patent/TW201424772A/zh unknown
- 2013-08-30 EP EP13832156.7A patent/EP2891493A4/en not_active Withdrawn
- 2013-08-30 WO PCT/JP2013/073351 patent/WO2014034860A1/ja active Application Filing
- 2013-08-30 EA EA201590449A patent/EA201590449A1/ru unknown
-
2015
- 2015-02-12 PH PH12015500313A patent/PH12015500313A1/en unknown
- 2015-02-25 IL IL237423A patent/IL237423A0/en unknown
- 2015-03-23 ZA ZA2015/01977A patent/ZA201501977B/en unknown
- 2015-09-25 HK HK15109476.7A patent/HK1208801A1/xx unknown
Also Published As
Publication number | Publication date |
---|---|
CN104602693A (zh) | 2015-05-06 |
WO2014034860A1 (ja) | 2014-03-06 |
PH12015500313A1 (en) | 2015-04-20 |
IL237423A0 (en) | 2015-04-30 |
KR20150045500A (ko) | 2015-04-28 |
AU2013309922A1 (en) | 2015-04-09 |
EP2891493A4 (en) | 2016-05-18 |
JPWO2014034860A1 (ja) | 2016-08-08 |
MX2015002633A (es) | 2015-06-24 |
SG11201501415RA (en) | 2015-05-28 |
BR112015004244A2 (pt) | 2017-07-04 |
TW201424772A (zh) | 2014-07-01 |
HK1208801A1 (en) | 2016-03-18 |
EP2891493A1 (en) | 2015-07-08 |
CA2883270A1 (en) | 2014-03-06 |
ZA201501977B (en) | 2016-07-27 |
US20150306090A1 (en) | 2015-10-29 |
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