WO2012053785A3 - 타크롤리무스를 유효성분으로 함유하는 서방형 펠렛 - Google Patents

타크롤리무스를 유효성분으로 함유하는 서방형 펠렛 Download PDF

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Publication number
WO2012053785A3
WO2012053785A3 PCT/KR2011/007708 KR2011007708W WO2012053785A3 WO 2012053785 A3 WO2012053785 A3 WO 2012053785A3 KR 2011007708 W KR2011007708 W KR 2011007708W WO 2012053785 A3 WO2012053785 A3 WO 2012053785A3
Authority
WO
WIPO (PCT)
Prior art keywords
sustained
present
pellets
release pellets
active ingredient
Prior art date
Application number
PCT/KR2011/007708
Other languages
English (en)
French (fr)
Other versions
WO2012053785A2 (ko
Inventor
이희엽
Original Assignee
Lee Hee-Yub
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 Lee Hee-Yub filed Critical Lee Hee-Yub
Priority to US13/879,657 priority Critical patent/US9358210B2/en
Priority to ES11834585T priority patent/ES2727594T3/es
Priority to EP11834585.9A priority patent/EP2630956B8/en
Priority to CN201180052301.3A priority patent/CN103189054B/zh
Publication of WO2012053785A2 publication Critical patent/WO2012053785A2/ko
Publication of WO2012053785A3 publication Critical patent/WO2012053785A3/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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • 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
    • A61K9/14—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
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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

Abstract

본 발명은 타크롤리무스를 유효성분으로 함유하는 서방형 펠렛에 관한 것이다. 본 발명의 서방형 펠렛은 히드록시프로필메칠셀룰로오스가 다층으로 형성되고, 히드록시프로필메칠셀룰로오스 및 슈어릴리즈™의 특정 함량에 의하여 약물의 방출을 조절하여 용출율이 균일하고 안정적이며 원하는 형태로 용출율을 조절할 수 있고, 펠렛 제조의 전 과정이 단일 기계인 유동층 조립기 내에서 진행되기 때문에 제조과정이 간편하고 제조시간이 단축되면서도 제조된 펠렛들의 입도분포와 함량이 균일한 서방성 펠렛을 얻을 수 있으며, 24시간 동안 약효가 지속되므로 1일 1회 투여가 가능하여 환자의 순응도를 높일 수 있는 효과를 나타내므로 타크롤리무스를 유효성분으로 함유하는 경구투여용 펠렛 제제로 유용하게 사용될 수 있다.
PCT/KR2011/007708 2010-10-19 2011-10-17 타크롤리무스를 유효성분으로 함유하는 서방형 펠렛 WO2012053785A2 (ko)

Priority Applications (4)

Application Number Priority Date Filing Date Title
US13/879,657 US9358210B2 (en) 2010-10-19 2011-10-17 Sustained-release pellets containing tacrolimus as an active ingredient
ES11834585T ES2727594T3 (es) 2010-10-19 2011-10-17 Gránulos de liberación sostenida que contienen tacrolimus como principio activo
EP11834585.9A EP2630956B8 (en) 2010-10-19 2011-10-17 Sustained-release pellets containing tacrolimus as an active ingredient
CN201180052301.3A CN103189054B (zh) 2010-10-19 2011-10-17 含有他克莫斯有效成分的缓释微丸

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020100101778A KR101243938B1 (ko) 2010-10-19 2010-10-19 타크롤리무스를 유효성분으로 함유하는 서방형 펠렛
KR10-2010-0101778 2010-10-19

Publications (2)

Publication Number Publication Date
WO2012053785A2 WO2012053785A2 (ko) 2012-04-26
WO2012053785A3 true WO2012053785A3 (ko) 2012-06-28

Family

ID=45975704

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2011/007708 WO2012053785A2 (ko) 2010-10-19 2011-10-17 타크롤리무스를 유효성분으로 함유하는 서방형 펠렛

Country Status (7)

Country Link
US (1) US9358210B2 (ko)
EP (1) EP2630956B8 (ko)
KR (1) KR101243938B1 (ko)
CN (1) CN103189054B (ko)
ES (1) ES2727594T3 (ko)
TR (1) TR201907942T4 (ko)
WO (1) WO2012053785A2 (ko)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9607412B2 (en) * 2010-02-04 2017-03-28 Ciena Corporation Method for rapid determination of lowest cost wavelength routes through a photonic network based on pre-validated paths
CN103432099A (zh) * 2013-08-13 2013-12-11 江苏正大清江制药有限公司 一种他克莫司缓释胶囊及其制备方法
US11813361B2 (en) 2014-04-04 2023-11-14 Pharmaquest International Center, Llp Disintegrating monolithic modified release tablets containing quadri-layer extended release granules
US20170072058A1 (en) 2014-11-21 2017-03-16 Solipharma Llc Pharmaceutical composition containing tacrolimus and preparation methods thereof
CN104473907A (zh) * 2014-12-25 2015-04-01 北京华禧联合科技发展有限公司 一种他克莫司的口服缓释制剂
CA3142240A1 (en) * 2019-06-03 2020-12-10 Synthetic Biologics, Inc. Alkaline phosphatase formulations and uses thereof
JP7361004B2 (ja) * 2020-09-08 2023-10-13 信越化学工業株式会社 アルコール組成物の製造方法
CN112641733B (zh) * 2020-12-30 2022-11-22 北京华氏开元医药科技有限公司 一种西罗莫司缓释微丸及其制备方法
CN116650444B (zh) * 2023-07-31 2023-10-31 国药集团川抗制药有限公司 一种他克莫司缓释药物及其制备方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100539706B1 (ko) * 2005-01-25 2005-12-28 지엘팜텍 주식회사 타크로리무스 및 장용성 고분자를 함유하는 고체분산체
US20080181947A1 (en) * 2006-09-26 2008-07-31 Astellas Pharma Inc. Controlled release dosage form of tacrolimus
US20090011018A1 (en) * 2006-12-28 2009-01-08 Astellas Pharma Inc., Sustained release formulation for tacrolimus
US20100086592A1 (en) * 2007-03-29 2010-04-08 Panacea Biotec Limited. Modified dosage forms of tacrolimus
KR20100060766A (ko) * 2008-11-28 2010-06-07 주식회사 삼양사 생체이용률이 향상된 타크로리무스 제제 및 상기 제제의 제조방법

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GB8608080D0 (en) * 1986-04-02 1986-05-08 Fujisawa Pharmaceutical Co Solid dispersion composition
US5395626A (en) * 1994-03-23 1995-03-07 Ortho Pharmaceutical Corporation Multilayered controlled release pharmaceutical dosage form
US8110226B2 (en) * 2007-07-20 2012-02-07 Mylan Pharmaceuticals Inc. Drug formulations having inert sealed cores
CN101664394A (zh) * 2009-09-25 2010-03-10 宋洪涛 他克莫司缓控释制剂及其制备方法

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100539706B1 (ko) * 2005-01-25 2005-12-28 지엘팜텍 주식회사 타크로리무스 및 장용성 고분자를 함유하는 고체분산체
US20080181947A1 (en) * 2006-09-26 2008-07-31 Astellas Pharma Inc. Controlled release dosage form of tacrolimus
US20090011018A1 (en) * 2006-12-28 2009-01-08 Astellas Pharma Inc., Sustained release formulation for tacrolimus
US20100086592A1 (en) * 2007-03-29 2010-04-08 Panacea Biotec Limited. Modified dosage forms of tacrolimus
KR20100060766A (ko) * 2008-11-28 2010-06-07 주식회사 삼양사 생체이용률이 향상된 타크로리무스 제제 및 상기 제제의 제조방법

Also Published As

Publication number Publication date
US20130216624A1 (en) 2013-08-22
ES2727594T3 (es) 2019-10-17
CN103189054A (zh) 2013-07-03
EP2630956A2 (en) 2013-08-28
US9358210B2 (en) 2016-06-07
TR201907942T4 (tr) 2019-06-21
EP2630956A4 (en) 2016-08-03
KR101243938B1 (ko) 2013-03-19
CN103189054B (zh) 2016-06-01
EP2630956B8 (en) 2019-07-17
WO2012053785A2 (ko) 2012-04-26
EP2630956B1 (en) 2019-02-27
KR20120047339A (ko) 2012-05-14

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