WO2016175546A3 - 리바스티그민 함유 서방출 의약조성물 - Google Patents

리바스티그민 함유 서방출 의약조성물 Download PDF

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WO2016175546A3
WO2016175546A3 PCT/KR2016/004380 KR2016004380W WO2016175546A3 WO 2016175546 A3 WO2016175546 A3 WO 2016175546A3 KR 2016004380 W KR2016004380 W KR 2016004380W WO 2016175546 A3 WO2016175546 A3 WO 2016175546A3
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Prior art keywords
pharmaceutical composition
release
sustained
rivastigmine
blood concentration
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PCT/KR2016/004380
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English (en)
French (fr)
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WO2016175546A2 (ko
Inventor
박상근
신혜경
배정우
최현주
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주식회사 네비팜
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Publication date
Priority to AU2016255302A priority Critical patent/AU2016255302B2/en
Priority to RU2017136567A priority patent/RU2727721C2/ru
Priority to DK16786732.4T priority patent/DK3290023T3/da
Priority to CN201680024737.4A priority patent/CN107530290B/zh
Priority to US15/569,693 priority patent/US10835497B2/en
Priority to LTEP16786732.4T priority patent/LT3290023T/lt
Priority to ES16786732T priority patent/ES2860694T3/es
Application filed by 주식회사 네비팜 filed Critical 주식회사 네비팜
Priority to SI201631161T priority patent/SI3290023T1/sl
Priority to CA2984235A priority patent/CA2984235C/en
Priority to JP2017555575A priority patent/JP6787928B2/ja
Priority to EP16786732.4A priority patent/EP3290023B1/en
Priority to PL16786732T priority patent/PL3290023T3/pl
Priority to RS20210290A priority patent/RS61548B1/sr
Priority to BR112017022478-0A priority patent/BR112017022478B1/pt
Priority to MX2017013481A priority patent/MX2017013481A/es
Publication of WO2016175546A2 publication Critical patent/WO2016175546A2/ko
Publication of WO2016175546A3 publication Critical patent/WO2016175546A3/ko
Priority to HRP20210434TT priority patent/HRP20210434T1/hr
Priority to CY20211100324T priority patent/CY1124339T1/el

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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
    • 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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/27—Esters, e.g. nitroglycerine, selenocyanates of carbamic or thiocarbamic acids, meprobamate, carbachol, neostigmine
    • 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
    • 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
    • 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
    • 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
    • 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
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Emergency Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Psychology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

본 발명은 리바스티그민 함유 서방출 의약조성물에 관한 것으로서, 보다 구체적으로 설명하면, 본 발명은 pH-의존성 지연방출상을 포함하는 서방출성 제제에 관한 것으로써, 복용 후 초기 위장에서의 방출을 최소화하도록 제어함으로써 유효혈중농도에 도달하면서도 최고혈중농도(Cmax)는 기존 제품에 비해 낮출 수 있어 부작용을 줄이며, 이후 주성분의 지속적인 방출을 통하여 유효혈중농도를 유지할 수 있도록 한 리바스티그민 서방출 의약조성물에 관한 것이다. 그 결과, 본 발명에 따른 의약조성물은 1일 1회 복용만으로도 기존의 1일 2회 용법과 동일한 효과를 나타내도록 하였으며, 환자의 복용편리성 개선을 통해 환자의 치료 효율도 높일 수 있는 효과가 있다.
PCT/KR2016/004380 2015-04-27 2016-04-27 리바스티그민 함유 서방출 의약조성물 WO2016175546A2 (ko)

Priority Applications (17)

Application Number Priority Date Filing Date Title
RS20210290A RS61548B1 (sr) 2015-04-27 2016-04-27 Farmaceutski sastav sa produženim oslobađanjem koji sadrži rivastigmin
DK16786732.4T DK3290023T3 (da) 2015-04-27 2016-04-27 Farmaceutisk sammensætning med langvarig frigivelse, som indeholder rivastigmin
CN201680024737.4A CN107530290B (zh) 2015-04-27 2016-04-27 含利凡斯的明的缓释性医药组合物
US15/569,693 US10835497B2 (en) 2015-04-27 2016-04-27 Rivastigmine-containing sustained-release pharmaceutical composition
LTEP16786732.4T LT3290023T (lt) 2015-04-27 2016-04-27 Sulėtinto atpalaidavimo farmacinė kompozicija, kurios sudėtyje yra rivastigminas
ES16786732T ES2860694T3 (es) 2015-04-27 2016-04-27 Composición farmacéutica de liberación sostenida que contiene rivastigmina
JP2017555575A JP6787928B2 (ja) 2015-04-27 2016-04-27 リバスチグミン含有徐放出医薬組成物
SI201631161T SI3290023T1 (sl) 2015-04-27 2016-04-27 Farmacevtski sestavek z zadržanim sproščanjem, ki vsebuje rivastigmin
CA2984235A CA2984235C (en) 2015-04-27 2016-04-27 Rivastigmine-containing sustained-release pharmaceutical composition
AU2016255302A AU2016255302B2 (en) 2015-04-27 2016-04-27 Rivastigmine-containing sustained-release pharmaceutical composition
EP16786732.4A EP3290023B1 (en) 2015-04-27 2016-04-27 Rivastigmine-containing sustained-release pharmaceutical composition
PL16786732T PL3290023T3 (pl) 2015-04-27 2016-04-27 Kompozycja farmaceutyczna o przedłużonym uwalnianiu zawierająca rywastygminę
RU2017136567A RU2727721C2 (ru) 2015-04-27 2016-04-27 Фармацевтическая композиция с замедленным высвобождением, содержащая ривастигмин
BR112017022478-0A BR112017022478B1 (pt) 2015-04-27 2016-04-27 Composição farmacêutica de liberação sustentada que contém rivastigmina
MX2017013481A MX2017013481A (es) 2015-04-27 2016-04-27 Composicion farmaceutica de liberacion sostenida que contiene rivastigmina.
HRP20210434TT HRP20210434T1 (hr) 2015-04-27 2021-03-16 Farmaceutski pripravak s produljenim oslobađanjem koji sadrži rivastigmin
CY20211100324T CY1124339T1 (el) 2015-04-27 2021-04-14 Φαρμακευτικη συνθεση παρατεταμενης αποδεσμευσης η οποια εμπεριεχει ριβαστιγμινη

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020150058759A KR101990951B1 (ko) 2015-04-27 2015-04-27 리바스티그민 함유 서방출 의약조성물
KR10-2015-0058759 2015-04-27

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WO2016175546A2 WO2016175546A2 (ko) 2016-11-03
WO2016175546A3 true WO2016175546A3 (ko) 2016-12-22

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Country Status (21)

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US (1) US10835497B2 (ko)
EP (1) EP3290023B1 (ko)
JP (1) JP6787928B2 (ko)
KR (1) KR101990951B1 (ko)
CN (1) CN107530290B (ko)
AU (1) AU2016255302B2 (ko)
BR (1) BR112017022478B1 (ko)
CA (1) CA2984235C (ko)
CY (1) CY1124339T1 (ko)
DK (1) DK3290023T3 (ko)
ES (1) ES2860694T3 (ko)
HR (1) HRP20210434T1 (ko)
HU (1) HUE053816T2 (ko)
LT (1) LT3290023T (ko)
MX (1) MX2017013481A (ko)
PL (1) PL3290023T3 (ko)
PT (1) PT3290023T (ko)
RS (1) RS61548B1 (ko)
RU (1) RU2727721C2 (ko)
SI (1) SI3290023T1 (ko)
WO (1) WO2016175546A2 (ko)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102209420B1 (ko) * 2019-03-08 2021-01-29 에이치엘비제약 주식회사 리바스티그민의 일정한(0-차) 방출형 경구용 서방성 정제 조성물
CN112546037A (zh) * 2020-12-08 2021-03-26 苏州大学 卡巴拉汀在制备抗辐射药中的应用

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KR20070086667A (ko) * 2004-12-27 2007-08-27 에자이 알앤드디 매니지먼트 가부시키가이샤 항치매 약물의 안정화 방법
WO2007133203A1 (en) * 2006-05-12 2007-11-22 Shire Llc Controlled dose drug delivery system
US20090317473A1 (en) * 2008-06-20 2009-12-24 Naringrekar Gandha V Controlled-release formulations, method of manufacture, and use thereof
KR20140113542A (ko) * 2013-03-15 2014-09-24 한국유나이티드제약 주식회사 1일 1회 투여로 약리학적 임상 효과를 제공하는 모사프리드 서방성 제제

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US10835497B2 (en) 2020-11-17
PT3290023T (pt) 2021-03-24
HRP20210434T1 (hr) 2021-04-30
LT3290023T (lt) 2021-03-25
MX2017013481A (es) 2018-05-17
AU2016255302B2 (en) 2021-03-04
US20180125785A1 (en) 2018-05-10
EP3290023B1 (en) 2021-02-17
BR112017022478A2 (pt) 2018-07-10
AU2016255302A1 (en) 2017-12-07
KR20160127405A (ko) 2016-11-04
ES2860694T3 (es) 2021-10-05
BR112017022478B1 (pt) 2023-11-21
EP3290023A4 (en) 2018-12-19
SI3290023T1 (sl) 2021-08-31
DK3290023T3 (da) 2021-04-12
CN107530290A (zh) 2018-01-02
PL3290023T3 (pl) 2021-08-30
RU2017136567A (ru) 2019-05-27
HUE053816T2 (hu) 2021-07-28
RS61548B1 (sr) 2021-04-29
RU2017136567A3 (ko) 2019-09-19
JP2018514530A (ja) 2018-06-07
CA2984235C (en) 2023-02-21
CY1124339T1 (el) 2022-07-22
CN107530290B (zh) 2021-04-27
RU2727721C2 (ru) 2020-07-23
JP6787928B2 (ja) 2020-11-18
KR101990951B1 (ko) 2019-06-20
WO2016175546A2 (ko) 2016-11-03
CA2984235A1 (en) 2016-11-03
EP3290023A2 (en) 2018-03-07

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