HRP20192213T1 - Farmaceutski pripravak koji sadrži mirabegron - Google Patents

Farmaceutski pripravak koji sadrži mirabegron Download PDF

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Publication number
HRP20192213T1
HRP20192213T1 HRP20192213TT HRP20192213T HRP20192213T1 HR P20192213 T1 HRP20192213 T1 HR P20192213T1 HR P20192213T T HRP20192213T T HR P20192213TT HR P20192213 T HRP20192213 T HR P20192213T HR P20192213 T1 HRP20192213 T1 HR P20192213T1
Authority
HR
Croatia
Prior art keywords
pharmaceutical preparation
thickener
weight
preparation according
hydrophobic substance
Prior art date
Application number
HRP20192213TT
Other languages
English (en)
Inventor
Seiji Takae
Toshiro Sakai
Yuki Kasashima
Yurina ANSEI
Tsuyoshi Kiyota
Original Assignee
Astellas Pharma Inc.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Astellas Pharma Inc. filed Critical Astellas Pharma Inc.
Publication of HRP20192213T1 publication Critical patent/HRP20192213T1/hr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic 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
    • A61K31/425Thiazoles
    • A61K31/4261,3-Thiazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/10Drugs for disorders of the urinary system of the bladder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pain & Pain Management (AREA)
  • Dispersion Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Pyrrole Compounds (AREA)

Claims (9)

1. Farmaceutski pripravak koji sadrži kompleks mirabegrona ili njegove farmaceutski prihvatljive soli s natrijevim polistiren sulfonatom, zgušnjivačem i hidrofobnom supstancom, naznačen time što je hidrofobna tvar magnezijev stearat i / ili kalcijev stearat.
2. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što je sadržaj hidrofobne tvari 0,5% težine do 35% težine u odnosu na težinu zgušnjivača.
3. Farmaceutski pripravak prema zahtjevu 1 ili 2, naznačen time, što je zgušnjivač jedan član ili dva ili više članova odabranih iz skupine koja se sastoji od ksantanske gume, guar gume, gume rogača, gelanske gume, karboksimetil celuloze natrija, želatine, hidroksietil celuloze, hidroksipropil celuloze, karagenana, metilceluloze, natrijevog alginata, hipromeloze i polivinil alkohola.
4. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 3, naznačen time, što je zgušnjivač ksantanska guma.
5. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 4, naznačen time, što je sadržaj zgušnjivača 1% težine do 70% težine u odnosu na težinu farmaceutskog pripravka.
6. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 5, naznačen time, što farmaceutski pripravak je farmaceutski pripravak spreman za suspenziju.
7. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 6, naznačen time, što farmaceutski pripravak je farmaceutski pripravak za oralnu primjenu.
8. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 7, naznačen time, što farmaceutski pripravak je farmaceutski pripravak za liječenje jednog člana ili dva ili više članova, izabranih iz skupine koja se sastoji urinarne hitnosti, urinarne učestalosti, urinarne inkontinencije i prekomjerne aktivnosti neuropatskog detruzora, koji su povezani s prekomjerno aktivnim mjehurom.
9. Uporaba hidrofobne tvari odabrane iz skupine koja se sastoji od magnezijevog stearata, kalcijevog stearata i njihove kombinacije, za sprečavanje stvaranja nerastopljenih kvržica u pripremi farmaceutskog pripravka koji sadrži kompleks mirabegrona ili njegove farmaceutski prihvatljive soli s natrijevim polistiren sulfonatom i zgušnjivačem.
HRP20192213TT 2015-03-31 2019-12-10 Farmaceutski pripravak koji sadrži mirabegron HRP20192213T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2015073911A JP2018090490A (ja) 2015-03-31 2015-03-31 ミラベグロン含有医薬組成物
EP16773147.0A EP3278801B1 (en) 2015-03-31 2016-03-31 Pharmaceutical composition containing mirabegron
PCT/JP2016/060745 WO2016159267A1 (ja) 2015-03-31 2016-03-31 ミラベグロン含有医薬組成物

Publications (1)

Publication Number Publication Date
HRP20192213T1 true HRP20192213T1 (hr) 2020-03-20

Family

ID=57005157

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20192213TT HRP20192213T1 (hr) 2015-03-31 2019-12-10 Farmaceutski pripravak koji sadrži mirabegron

Country Status (14)

Country Link
US (1) US10058536B2 (hr)
EP (1) EP3278801B1 (hr)
JP (1) JP2018090490A (hr)
CY (1) CY1122352T1 (hr)
DK (1) DK3278801T3 (hr)
ES (1) ES2760673T3 (hr)
HR (1) HRP20192213T1 (hr)
HU (1) HUE046729T2 (hr)
LT (1) LT3278801T (hr)
PL (1) PL3278801T3 (hr)
PT (1) PT3278801T (hr)
RS (1) RS59626B1 (hr)
SI (1) SI3278801T1 (hr)
WO (1) WO2016159267A1 (hr)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6713734B2 (ja) * 2015-07-02 2020-06-24 三栄源エフ・エフ・アイ株式会社 粉体組成物のダマの形成を抑制する方法
JPWO2019167978A1 (ja) * 2018-02-28 2021-02-04 大日本住友製薬株式会社 溶出が制御された水性懸濁型医薬製剤
JPWO2019167977A1 (ja) * 2018-02-28 2021-02-04 大日本住友製薬株式会社 水性懸濁型医薬製剤
KR102067261B1 (ko) * 2018-03-13 2020-01-16 충북대학교 산학협력단 미라베그론을 유효 성분으로 포함하는 서방형의 약학 조성물 및 이의 제조방법
WO2022006336A1 (en) * 2020-07-01 2022-01-06 Jubilant Pharma Holdings Inc. Long-acting injection dosage form of beta 3 adrenoreceptor agonists
US11311518B1 (en) * 2021-06-29 2022-04-26 Jubilant Pharma Holdings Inc. Parenteral dosage form of β3 adrenoreceptor agonists
CN114617881A (zh) * 2022-02-19 2022-06-14 苏州海景医药科技有限公司 一种米拉贝隆组合物

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2985714B2 (ja) 1995-03-20 1999-12-06 栗田工業株式会社 抗菌性組成物
EP1028111B1 (en) 1997-10-17 2004-05-12 Yamanouchi Pharmaceutical Co. Ltd. Amide derivatives or salts thereof
US6514492B1 (en) * 1999-07-14 2003-02-04 Schering-Plough Veterinary Corporation Taste masking of oral quinolone liquid preparations using ion exchange resins
CA2379987A1 (en) 1999-07-29 2001-02-08 Roxane Laboratories, Inc. Opioid sustained-released formulation
JP3795365B2 (ja) 2001-09-28 2006-07-12 和光堂株式会社 服薬補助食品
US7342117B2 (en) 2001-10-30 2008-03-11 Astellas Pharma Inc. α-form or β-form crystal of acetanilide derivative
US7750029B2 (en) 2002-11-07 2010-07-06 Astellas Pharma Inc. Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient
JP4211668B2 (ja) 2004-04-21 2009-01-21 キユーピー株式会社 ゾル状又はゲル状食品調製用粉末組成物
CN1879610A (zh) 2006-04-03 2006-12-20 哈尔滨工业大学 口服多肽药物缓释微胶囊的制备方法
JP3930897B1 (ja) 2006-08-16 2007-06-13 太陽化学株式会社 粘度発現性を改良した増粘用組成物
TWI478712B (zh) 2008-09-30 2015-04-01 Astellas Pharma Inc 釋控性醫藥組成物
WO2013147134A1 (ja) 2012-03-30 2013-10-03 アステラス製薬株式会社 ミラベグロン含有医薬組成物

Also Published As

Publication number Publication date
RS59626B1 (sr) 2020-01-31
ES2760673T3 (es) 2020-05-14
EP3278801B1 (en) 2019-11-13
WO2016159267A1 (ja) 2016-10-06
CY1122352T1 (el) 2021-01-27
PT3278801T (pt) 2019-12-18
US10058536B2 (en) 2018-08-28
EP3278801A1 (en) 2018-02-07
JP2018090490A (ja) 2018-06-14
EP3278801A4 (en) 2018-11-14
PL3278801T3 (pl) 2020-03-31
DK3278801T3 (da) 2019-12-16
SI3278801T1 (sl) 2020-01-31
LT3278801T (lt) 2020-01-10
HUE046729T2 (hu) 2020-03-30
US20180036288A1 (en) 2018-02-08

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