BRPI0919466B1 - Composição farmacêutica oral para liberação modificada e processo para fabricação de uma composição farmacêutica oral para liberação modificada - Google Patents

Composição farmacêutica oral para liberação modificada e processo para fabricação de uma composição farmacêutica oral para liberação modificada Download PDF

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Publication number
BRPI0919466B1
BRPI0919466B1 BRPI0919466-5A BRPI0919466A BRPI0919466B1 BR PI0919466 B1 BRPI0919466 B1 BR PI0919466B1 BR PI0919466 A BRPI0919466 A BR PI0919466A BR PI0919466 B1 BRPI0919466 B1 BR PI0919466B1
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BR
Brazil
Prior art keywords
pharmaceutical composition
weight
modified release
fact
mpa
Prior art date
Application number
BRPI0919466-5A
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English (en)
Portuguese (pt)
Inventor
Yuuki Takaishi
Yutaka Takahashi
Takashi Nishizato
Daisuke Murayama
Emiko Murayama
Soichiro Nakamura
Kazuhiro Sako
Original Assignee
Astellas Pharma Inc
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42073454&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI0919466(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Astellas Pharma Inc filed Critical Astellas Pharma Inc
Publication of BRPI0919466A2 publication Critical patent/BRPI0919466A2/pt
Publication of BRPI0919466B1 publication Critical patent/BRPI0919466B1/pt

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    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives 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
    • A61K9/06—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
    • A61K9/2009—Inorganic 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • 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
    • 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
    • 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
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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
    • 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
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • 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
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • 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
    • 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
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • 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
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth 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)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Urology & Nephrology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
BRPI0919466-5A 2008-09-30 2009-09-28 Composição farmacêutica oral para liberação modificada e processo para fabricação de uma composição farmacêutica oral para liberação modificada BRPI0919466B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10133808P 2008-09-30 2008-09-30
US61/101,338 2008-09-30
PCT/JP2009/066742 WO2010038690A1 (ja) 2008-09-30 2009-09-28 放出制御医薬組成物

Publications (2)

Publication Number Publication Date
BRPI0919466A2 BRPI0919466A2 (pt) 2015-12-01
BRPI0919466B1 true BRPI0919466B1 (pt) 2021-05-25

Family

ID=42073454

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0919466-5A BRPI0919466B1 (pt) 2008-09-30 2009-09-28 Composição farmacêutica oral para liberação modificada e processo para fabricação de uma composição farmacêutica oral para liberação modificada

Country Status (24)

Country Link
US (4) US20160184275A2 (enExample)
EP (2) EP3827826A1 (enExample)
JP (2) JP4688089B2 (enExample)
KR (1) KR101524164B1 (enExample)
CN (2) CN105232448A (enExample)
AU (1) AU2009300752C1 (enExample)
BR (1) BRPI0919466B1 (enExample)
CA (1) CA2740342C (enExample)
CY (1) CY1123724T1 (enExample)
DK (1) DK2345410T3 (enExample)
ES (1) ES2847876T3 (enExample)
HK (1) HK1216232A1 (enExample)
HR (1) HRP20210179T1 (enExample)
HU (1) HUE052874T2 (enExample)
IL (1) IL212033A (enExample)
LT (1) LT2345410T (enExample)
MX (1) MX351855B (enExample)
PL (1) PL2345410T3 (enExample)
PT (1) PT2345410T (enExample)
RU (1) RU2495666C2 (enExample)
SI (1) SI2345410T1 (enExample)
TW (1) TWI478712B (enExample)
WO (1) WO2010038690A1 (enExample)
ZA (1) ZA201102406B (enExample)

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TWI478712B (zh) 2008-09-30 2015-04-01 Astellas Pharma Inc 釋控性醫藥組成物
JP5849946B2 (ja) * 2010-03-29 2016-02-03 アステラス製薬株式会社 放出制御医薬組成物
ES2665467T3 (es) * 2010-03-29 2018-04-25 Astellas Pharma Inc. Composición farmacéutica de liberación modificada
KR20180118801A (ko) * 2010-09-01 2018-10-31 에자이 알앤드디 매니지먼트 가부시키가이샤 체중 관리에 유용한 5-ｈｔ2ｃ 작동제의 변형-방출 투여 형태
AP2014007645A0 (en) 2011-10-21 2014-05-31 Takeda Pharmaceutical Sustained-release preparation
JP6123795B2 (ja) * 2012-03-30 2017-05-10 アステラス製薬株式会社 放出制御医薬組成物
EP2832730A4 (en) 2012-03-30 2015-09-09 Astellas Pharma Inc MIRABEGRAPHIC PHARMACEUTICAL COMPOSITION
TW201424772A (zh) 2012-08-31 2014-07-01 Astellas Pharma Inc 經口投與用醫藥組成物
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
CN104523635B (zh) * 2014-12-23 2017-05-03 深圳万乐药业有限公司 米拉贝隆缓释药物组合物
JP2018090490A (ja) 2015-03-31 2018-06-14 アステラス製薬株式会社 ミラベグロン含有医薬組成物
JP6618736B2 (ja) * 2015-09-01 2019-12-11 沢井製薬株式会社 ミラベグロン含有錠剤、ミラベグロン含有製剤の製造方法及びミラベグロン含有造粒物の製造方法
EP3448366A1 (en) * 2016-04-25 2019-03-06 Synthon B.V. Modified release tablet composition comprising mirabegron
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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
CA3078568A1 (en) * 2017-10-12 2019-04-18 Synthon B.V. Modified release tablet composition comprising mirabegron
EP3292864A1 (en) * 2017-10-12 2018-03-14 Synthon B.V. Modified release tablet composition comprising mirabegron
KR20190089758A (ko) 2018-01-22 2019-07-31 (주)동구바이오제약 미라베그론 또는 이의 약제학적으로 허용가능한 염을 함유하는 지속 방출 제제
KR102371567B1 (ko) 2018-04-06 2022-03-07 한미약품 주식회사 미라베그론이 함유된 방출 제어 약학적 조성물
KR102659760B1 (ko) 2018-10-18 2024-04-23 한미약품 주식회사 미라베그론이 함유된 방출 제어 약제학적 조성물
KR102062791B1 (ko) 2019-02-26 2020-01-06 신일제약 주식회사 미라베그론 또는 그의 약제학적으로 허용되는 염을 함유한 방출조절 제제
KR102897443B1 (ko) 2019-06-28 2025-12-08 한미약품 주식회사 제어 방출형 미라베그론 제제 및 이의 제조방법
JP7377782B2 (ja) * 2019-09-04 2023-11-10 信越化学工業株式会社 フィルム成形用組成物及びフィルム
AR121207A1 (es) * 2020-01-31 2022-04-27 Nippon Shinyaku Co Ltd Composición de liberación controlada
KR102546923B1 (ko) * 2020-03-03 2023-06-26 동광제약 주식회사 미라베그론을 포함하는 제어 방출 제제
CN113662922A (zh) * 2020-10-29 2021-11-19 北京莱瑞森医药科技有限公司 一种米拉贝隆缓释组合物及其制备方法和应用
JP7904682B2 (ja) * 2021-10-28 2026-08-13 東和薬品株式会社 放出制御医薬組成物
CN114306262B (zh) * 2021-12-30 2023-09-05 乐泰药业有限公司 米拉贝隆缓释片及其制备方法和质量检测方法
EP4338729A1 (en) * 2022-09-19 2024-03-20 Sanovel Ilac Sanayi Ve Ticaret A.S. A tablet comprising mirabegron
JP7820861B2 (ja) * 2024-01-26 2026-02-26 富士化学工業株式会社 徐放性製剤
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WO2025263523A1 (ja) * 2024-06-21 2025-12-26 沢井製薬株式会社 ミラベグロン含有製剤
WO2026064392A1 (en) 2024-09-17 2026-03-26 Flavostar Llc Fixed dose combination of flavoxate and beta-3 adrenergic receptor agonists, and formulations and manufacturing processes thereof

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