WO2019031898A3 - 약학 조성물 및 이의 제조방법 - Google Patents

약학 조성물 및 이의 제조방법 Download PDF

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Publication number
WO2019031898A3
WO2019031898A3 PCT/KR2018/009142 KR2018009142W WO2019031898A3 WO 2019031898 A3 WO2019031898 A3 WO 2019031898A3 KR 2018009142 W KR2018009142 W KR 2018009142W WO 2019031898 A3 WO2019031898 A3 WO 2019031898A3
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WO
WIPO (PCT)
Prior art keywords
pharmaceutical composition
adenine
present
preparing same
stability
Prior art date
Application number
PCT/KR2018/009142
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English (en)
French (fr)
Other versions
WO2019031898A2 (ko
Inventor
이병훈
한은지
권시안
박단비
윤소라
서은주
남동연
오동준
문병관
박영준
Original Assignee
주식회사 셀트리온화학연구소
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 주식회사 셀트리온화학연구소 filed Critical 주식회사 셀트리온화학연구소
Priority to CN201880061300.7A priority Critical patent/CN111132665B/zh
Publication of WO2019031898A2 publication Critical patent/WO2019031898A2/ko
Publication of WO2019031898A3 publication Critical patent/WO2019031898A3/ko
Priority to PH12020500278A priority patent/PH12020500278A1/en

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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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/205—Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7135—Compounds containing heavy metals
    • A61K31/714—Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

본 발명에 따른 약학 조성물은 아데닌, 카르니틴 및 시아노코발라민을 포함하며, 차단제 또는 차단구조를 사용하여 아데닌의 안정성을 확보할 수 있는 약학 조성물 및 이의 제조방법을 제공한다. 본 발명에 따른 약학 조성물은 아데닌의 안정성을 확보하여 가속조건(40±2℃/75±5%RH)의 안정성시험에서 6개월 후 아데닌의 함량이 95% 이상으로 유지된다.
PCT/KR2018/009142 2017-08-10 2018-08-09 약학 조성물 및 이의 제조방법 WO2019031898A2 (ko)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN201880061300.7A CN111132665B (zh) 2017-08-10 2018-08-09 药物组合物及其制备方法
PH12020500278A PH12020500278A1 (en) 2017-08-10 2020-02-07 Pharmaceutical composition and method for preparing same

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20170101949 2017-08-10
KR10-2017-0101949 2017-08-10

Publications (2)

Publication Number Publication Date
WO2019031898A2 WO2019031898A2 (ko) 2019-02-14
WO2019031898A3 true WO2019031898A3 (ko) 2019-04-25

Family

ID=65272324

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2018/009142 WO2019031898A2 (ko) 2017-08-10 2018-08-09 약학 조성물 및 이의 제조방법

Country Status (4)

Country Link
KR (1) KR102193989B1 (ko)
CN (1) CN111132665B (ko)
PH (1) PH12020500278A1 (ko)
WO (1) WO2019031898A2 (ko)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102258624B1 (ko) * 2019-04-09 2021-05-31 주식회사 네비팜 경구용 약학 조성물
WO2021040440A1 (ko) * 2019-08-30 2021-03-04 (주)셀트리온 비알콜성 지방간염(nash, nonalcoholic steatohepatitis) 치료 또는 예방을 위한 약학 조성물
CN116261457A (zh) * 2020-07-22 2023-06-13 赛特瑞恩制药股份有限公司 用于预防和治疗肝病的薄膜包衣片剂

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100294329B1 (ko) * 1999-11-08 2001-06-15 권철 간질환 치료 및 예방용 의약 조성물
KR100869444B1 (ko) * 2007-07-11 2008-11-18 주식회사 중외제약 유비데카레논을 함유하는 다층정 비타민 복합제제
US20100233254A1 (en) * 2002-04-10 2010-09-16 Innercap Technologies, Inc. Multi-phase, multi-compartment, capsular delivery apparatus and methods for using the same
KR20140058449A (ko) * 2011-06-15 2014-05-14 오리엔트 파마 컴퍼니 리미티드 다층 캡슐 및 이의 제조 방법
WO2017105090A1 (ko) * 2015-12-14 2017-06-22 제이투에이치바이오텍 (주) 오로트산 l-카르니틴의 결정질 다형체, 이의 제조방법 또는 용도

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100294329B1 (ko) * 1999-11-08 2001-06-15 권철 간질환 치료 및 예방용 의약 조성물
US20100233254A1 (en) * 2002-04-10 2010-09-16 Innercap Technologies, Inc. Multi-phase, multi-compartment, capsular delivery apparatus and methods for using the same
KR100869444B1 (ko) * 2007-07-11 2008-11-18 주식회사 중외제약 유비데카레논을 함유하는 다층정 비타민 복합제제
KR20140058449A (ko) * 2011-06-15 2014-05-14 오리엔트 파마 컴퍼니 리미티드 다층 캡슐 및 이의 제조 방법
WO2017105090A1 (ko) * 2015-12-14 2017-06-22 제이투에이치바이오텍 (주) 오로트산 l-카르니틴의 결정질 다형체, 이의 제조방법 또는 용도

Also Published As

Publication number Publication date
WO2019031898A2 (ko) 2019-02-14
CN111132665A (zh) 2020-05-08
KR102193989B1 (ko) 2020-12-22
CN111132665B (zh) 2022-06-14
KR20190017690A (ko) 2019-02-20
PH12020500278A1 (en) 2021-01-11

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