KR102051804B1 - 시롤리무스를 포함하는 우수한 함량균일성을 갖는 약제학적 제제 - Google Patents

시롤리무스를 포함하는 우수한 함량균일성을 갖는 약제학적 제제 Download PDF

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Publication number
KR102051804B1
KR102051804B1 KR1020180058753A KR20180058753A KR102051804B1 KR 102051804 B1 KR102051804 B1 KR 102051804B1 KR 1020180058753 A KR1020180058753 A KR 1020180058753A KR 20180058753 A KR20180058753 A KR 20180058753A KR 102051804 B1 KR102051804 B1 KR 102051804B1
Authority
KR
South Korea
Prior art keywords
sirolimus
sugar
calcium carbonate
pharmaceutical formulation
content uniformity
Prior art date
Application number
KR1020180058753A
Other languages
English (en)
Korean (ko)
Inventor
이대로
김민수
박신정
임종래
Original Assignee
주식회사 종근당
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 종근당 filed Critical 주식회사 종근당
Priority to KR1020180058753A priority Critical patent/KR102051804B1/ko
Priority to PCT/KR2019/006098 priority patent/WO2019225954A1/en
Priority to JP2020564882A priority patent/JP7076579B2/ja
Priority to CN201980034688.6A priority patent/CN112236132A/zh
Priority to TW108117994A priority patent/TWI698239B/zh
Application granted granted Critical
Publication of KR102051804B1 publication Critical patent/KR102051804B1/ko

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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
    • 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
    • A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436—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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
    • 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
    • A61K9/2813—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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Transplantation (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
KR1020180058753A 2018-05-24 2018-05-24 시롤리무스를 포함하는 우수한 함량균일성을 갖는 약제학적 제제 KR102051804B1 (ko)

Priority Applications (5)

Application Number Priority Date Filing Date Title
KR1020180058753A KR102051804B1 (ko) 2018-05-24 2018-05-24 시롤리무스를 포함하는 우수한 함량균일성을 갖는 약제학적 제제
PCT/KR2019/006098 WO2019225954A1 (en) 2018-05-24 2019-05-21 A pharmaceutical formulation with improved content uniformity comprising sirolimus
JP2020564882A JP7076579B2 (ja) 2018-05-24 2019-05-21 シロリムスを含む、改善された含量均一性を有する薬剤学的製剤
CN201980034688.6A CN112236132A (zh) 2018-05-24 2019-05-21 包含西罗莫司的具有优秀的含量均匀度的药物制剂
TW108117994A TWI698239B (zh) 2018-05-24 2019-05-24 包括斥消靈的有改善含量均勻性的藥物配方

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
KR1020180058753A KR102051804B1 (ko) 2018-05-24 2018-05-24 시롤리무스를 포함하는 우수한 함량균일성을 갖는 약제학적 제제

Publications (1)

Publication Number Publication Date
KR102051804B1 true KR102051804B1 (ko) 2019-12-04

Family

ID=68616026

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020180058753A KR102051804B1 (ko) 2018-05-24 2018-05-24 시롤리무스를 포함하는 우수한 함량균일성을 갖는 약제학적 제제

Country Status (5)

Country Link
JP (1) JP7076579B2 (ja)
KR (1) KR102051804B1 (ja)
CN (1) CN112236132A (ja)
TW (1) TWI698239B (ja)
WO (1) WO2019225954A1 (ja)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090068266A1 (en) * 2007-09-11 2009-03-12 Raheja Praveen Sirolimus having specific particle size and pharmaceutical compositions thereof
KR20090041426A (ko) * 2006-08-11 2009-04-28 파나세아 바이오테크 리미티드 활성제를 전달하기 위한 미립자 및 이의 조제방법 및 조성물

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5985325A (en) * 1997-06-13 1999-11-16 American Home Products Corporation Rapamycin formulations for oral administration
KR100612520B1 (ko) * 2003-05-07 2006-08-11 아키나, 인크. 신속용융 정제를 제조하기 위한 고소성 과립
CN1819819B (zh) * 2003-05-07 2011-03-09 株式会社三养社 用于制备速熔片的高度可塑性颗粒
US20090130210A1 (en) * 2007-09-11 2009-05-21 Raheja Praveen Pharmaceutical compositions of sirolimus
US20100098770A1 (en) * 2008-10-16 2010-04-22 Manikandan Ramalingam Sirolimus pharmaceutical formulations

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20090041426A (ko) * 2006-08-11 2009-04-28 파나세아 바이오테크 리미티드 활성제를 전달하기 위한 미립자 및 이의 조제방법 및 조성물
US20090068266A1 (en) * 2007-09-11 2009-03-12 Raheja Praveen Sirolimus having specific particle size and pharmaceutical compositions thereof

Also Published As

Publication number Publication date
TWI698239B (zh) 2020-07-11
JP7076579B2 (ja) 2022-05-27
JP2021523928A (ja) 2021-09-09
TW202011961A (zh) 2020-04-01
CN112236132A (zh) 2021-01-15
WO2019225954A1 (en) 2019-11-28

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