JP6464154B2 - Ｓ字型放出プロファイルを有するポリラクチド−ポリグリコリド微小粒子の調製 - Google Patents

Ｓ字型放出プロファイルを有するポリラクチド−ポリグリコリド微小粒子の調製 Download PDF

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JP6464154B2
JP6464154B2 JP2016520312A JP2016520312A JP6464154B2 JP 6464154 B2 JP6464154 B2 JP 6464154B2 JP 2016520312 A JP2016520312 A JP 2016520312A JP 2016520312 A JP2016520312 A JP 2016520312A JP 6464154 B2 JP6464154 B2 JP 6464154B2
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phase
microparticles
release
polymer
risperidone
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JP2017507895A5 (enExample
JP2017507895A (ja
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エバンゲロス カラバス，
エバンゲロス カラバス，
エフシミオス クトリス，
エフシミオス クトリス，
ソティリア ハイチドー，
ソティリア ハイチドー，
テオファニス マントールリアス，
テオファニス マントールリアス，
イェオルヤ パパニコラウ，
イェオルヤ パパニコラウ，
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ファーマシェン エス．エー．
ファーマシェン エス．エー．
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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
    • 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
    • A61K9/1682—Processes
    • 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
    • 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
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
    • 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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J13/00—Colloid chemistry, e.g. the production of colloidal materials or their solutions, not otherwise provided for; Making microcapsules or microballoons
    • B01J13/02—Making microcapsules or microballoons
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J3/00—Processes of treating or compounding macromolecular substances
    • C08J3/12—Powdering or granulating
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J3/00—Processes of treating or compounding macromolecular substances
    • C08J3/12—Powdering or granulating
    • C08J3/14—Powdering or granulating by precipitation from solutions
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J2300/00—Characterised by the use of unspecified polymers
    • C08J2300/16—Biodegradable polymers
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J2367/00—Characterised by the use of polyesters obtained by reactions forming a carboxylic ester link in the main chain; Derivatives of such polymers
    • C08J2367/04—Polyesters derived from hydroxy carboxylic acids, e.g. lactones

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Polymers & Plastics (AREA)
  • Dispersion Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
JP2016520312A 2013-06-20 2014-06-18 Ｓ字型放出プロファイルを有するポリラクチド−ポリグリコリド微小粒子の調製 Active JP6464154B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP2013001821 2013-06-20
EPPCT/EP2013/001821 2013-06-20
PCT/EP2014/001652 WO2014202214A1 (en) 2013-06-20 2014-06-18 Preparation of polylactide-polyglycolide microparticles having a sigmoidal release profile

Publications (3)

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JP2017507895A JP2017507895A (ja) 2017-03-23
JP2017507895A5 JP2017507895A5 (enExample) 2017-07-20
JP6464154B2 true JP6464154B2 (ja) 2019-02-06

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JP2016520312A Active JP6464154B2 (ja) 2013-06-20 2014-06-18 Ｓ字型放出プロファイルを有するポリラクチド−ポリグリコリド微小粒子の調製

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US (1) US9943484B2 (enExample)
JP (1) JP6464154B2 (enExample)
CN (1) CN105308101B (enExample)
AU (1) AU2014283692B2 (enExample)
CA (1) CA2916301C (enExample)
DK (1) DK3010962T4 (enExample)
ES (1) ES2640486T5 (enExample)
FI (1) FI3010962T4 (enExample)
HU (1) HUE036141T2 (enExample)
LT (1) LT3010962T (enExample)
PT (1) PT3010962T (enExample)
RU (1) RU2658004C2 (enExample)
SA (1) SA515370296B1 (enExample)
WO (1) WO2014202214A1 (enExample)
ZA (1) ZA201509354B (enExample)

Families Citing this family (15)

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Publication number Priority date Publication date Assignee Title
KR20170036768A (ko) * 2014-07-30 2017-04-03 메르크 파텐트 게엠베하 미세결정성 셀룰로오스를 포함하는 직접 압축성 조성물
JP2016102093A (ja) * 2014-11-28 2016-06-02 ニプロ株式会社 塩基性の求核化合物を含有するマイクロカプセルの製造方法
US20170079985A1 (en) 2015-09-21 2017-03-23 Teva Pharmaceuticals International Gmbh Sustained release olanzapine formulations
JP2020511483A (ja) 2017-03-20 2020-04-16 テバ・ファーマシューティカルズ・インターナショナル・ゲーエムベーハーＴｅｖａ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ Ｉｎｔｅｒｎａｔｉｏｎａｌ ＧｍｂＨ 徐放性オランザピン製剤
KR102047983B1 (ko) * 2017-11-30 2019-11-22 주식회사 지투지바이오 안전성 및 저장 안정성이 향상된 생분해성 미립구의 제조방법
GR1009870B (el) * 2019-07-09 2020-11-12 Φαρματεν Α.Β.Ε.Ε. Φαρμακευτικο σκευασμα που περιλαμβανει ενα ατυπο αντιψυχωσικο φαρμακο και μεθοδος παρασκευης αυτου
WO2021134623A1 (zh) * 2019-12-31 2021-07-08 广州帝奇医药技术有限公司 一种叔胺药物组合物及其产业化批量制备方法
EP4125823A1 (en) 2020-03-30 2023-02-08 Biological E Limited Risperidone microspheres, process for their prepartion and uses thereof
KR102259589B1 (ko) * 2020-11-30 2021-06-02 (주)인벤티지랩 미소구체 제조 시스템 및 미소구체 제조 방법
EP4277661A1 (en) 2021-01-18 2023-11-22 Anton Frenkel Pharmaceutical dosage form
EP4297753A4 (en) * 2021-02-24 2025-01-01 Oakwood Laboratories, Llc Microsphere formulations comprising lurasidone and methods for making and using the same
WO2023281406A1 (en) 2021-07-06 2023-01-12 Mark Hasleton Treatment of serotonin reuptake inhibitor withdrawal syndrome
GR1010327B (el) * 2021-10-06 2022-10-17 Φαρματεν Α.Β.Ε.Ε., Παρατεταμενης αποδεσμευσης ενεσιμο φαρμακευτικο σκευασμα λεβοθυροξινης και μεθοδος παρασκευης αυτου
WO2025135778A1 (ko) * 2023-12-18 2025-06-26 주식회사 포스테라헬스사이언스 약물의 특성에 따른 활성형 미립자의 제조 방법, 이의 제조 방법으로 제조된 활성형 미립자 및 상기 활성형 미립자를 이용한 약물을 포함하는 장기 지속 제형의 제조 방법
WO2025207396A1 (en) * 2024-03-27 2025-10-02 Avidence Therapeutics, Inc. Microsphere-based injectable rofecoxib formulation

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5478564A (en) * 1990-02-22 1995-12-26 Teva Pharmaceutical Industries, Ltd. Preparation of microparticles for controlled release of water-soluble substances
US5288496A (en) * 1990-05-15 1994-02-22 Stolle Research & Development Corporation Growth promoters for animals
AU722884B2 (en) * 1996-01-24 2000-08-10 United States Government Represented By The Secretary Of The Army Novel "burst-free" sustained release poly-(lactide/glycolide) microspheres
US5792477A (en) * 1996-05-07 1998-08-11 Alkermes Controlled Therapeutics, Inc. Ii Preparation of extended shelf-life biodegradable, biocompatible microparticles containing a biologically active agent
US6194006B1 (en) * 1998-12-30 2001-02-27 Alkermes Controlled Therapeutics Inc. Ii Preparation of microparticles having a selected release profile
US6264987B1 (en) 2000-05-19 2001-07-24 Alkermes Controlled Therapeutics Inc. Ii Method for preparing microparticles having a selected polymer molecular weight
US7690026B2 (en) * 2005-08-22 2010-03-30 Microsoft Corporation Distributed single sign-on service

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Publication number Publication date
DK3010962T4 (da) 2023-04-17
DK3010962T3 (en) 2017-10-23
ES2640486T5 (es) 2023-04-28
AU2014283692A1 (en) 2016-01-21
AU2014283692B2 (en) 2017-04-27
ZA201509354B (en) 2017-07-26
CA2916301C (en) 2020-01-07
CN105308101B (zh) 2018-10-23
WO2014202214A1 (en) 2014-12-24
US20160143851A1 (en) 2016-05-26
LT3010962T (lt) 2017-09-25
RU2016101418A (ru) 2017-07-25
PT3010962T (pt) 2017-09-05
RU2658004C2 (ru) 2018-06-19
US9943484B2 (en) 2018-04-17
SA515370296B1 (ar) 2017-10-12
ES2640486T3 (es) 2017-11-03
JP2017507895A (ja) 2017-03-23
CN105308101A (zh) 2016-02-03
CA2916301A1 (en) 2014-12-24
FI3010962T4 (fi) 2023-05-04
HUE036141T2 (hu) 2018-06-28

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