ES2607497T3 - Composición de risperidona de microesferas de liberación controlada - Google Patents

Composición de risperidona de microesferas de liberación controlada Download PDF

Info

Publication number
ES2607497T3
ES2607497T3 ES12777430.5T ES12777430T ES2607497T3 ES 2607497 T3 ES2607497 T3 ES 2607497T3 ES 12777430 T ES12777430 T ES 12777430T ES 2607497 T3 ES2607497 T3 ES 2607497T3
Authority
ES
Spain
Prior art keywords
chain terminating
terminating agent
lactic
poly
pharmaceutical composition
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
ES12777430.5T
Other languages
English (en)
Spanish (es)
Inventor
Kaoxiang Sun
Rongcai Liang
Qilin Wang
Wenyan Wang
Wanhui Liu
Youxin Li
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shandong Luye Pharmaceutical Co Ltd
Original Assignee
Shandong Luye Pharmaceutical Co Ltd
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=47071591&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2607497(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Shandong Luye Pharmaceutical Co Ltd filed Critical Shandong Luye Pharmaceutical Co Ltd
Application granted granted Critical
Publication of ES2607497T3 publication Critical patent/ES2607497T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647Polyesters, e.g. poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5089Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Psychiatry (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
ES12777430.5T 2011-04-25 2012-04-10 Composición de risperidona de microesferas de liberación controlada Active ES2607497T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN201110102840 2011-04-25
CN201110102840 2011-04-25
PCT/CN2012/000473 WO2012146052A1 (en) 2011-04-25 2012-04-10 Risperidone sustained release microsphere composition

Publications (1)

Publication Number Publication Date
ES2607497T3 true ES2607497T3 (es) 2017-03-31

Family

ID=47071591

Family Applications (4)

Application Number Title Priority Date Filing Date
ES12777430.5T Active ES2607497T3 (es) 2011-04-25 2012-04-10 Composición de risperidona de microesferas de liberación controlada
ES19176691T Active ES2855349T3 (es) 2011-04-25 2012-04-10 Composición de risperidona de microesferas de liberación controlada
ES16179390T Active ES2749864T3 (es) 2011-04-25 2012-04-10 Composición de risperidona de microesferas de liberación controlada
ES20199849T Active ES2968917T3 (es) 2011-04-25 2012-04-10 Composición de risperidona de microesferas de liberación controlada

Family Applications After (3)

Application Number Title Priority Date Filing Date
ES19176691T Active ES2855349T3 (es) 2011-04-25 2012-04-10 Composición de risperidona de microesferas de liberación controlada
ES16179390T Active ES2749864T3 (es) 2011-04-25 2012-04-10 Composición de risperidona de microesferas de liberación controlada
ES20199849T Active ES2968917T3 (es) 2011-04-25 2012-04-10 Composición de risperidona de microesferas de liberación controlada

Country Status (14)

Country Link
US (5) US9446135B2 (enExample)
EP (4) EP3566696B1 (enExample)
JP (2) JP5728128B2 (enExample)
KR (2) KR101932207B1 (enExample)
CN (2) CN103338752B (enExample)
AU (1) AU2012248038B2 (enExample)
BR (1) BR112013027235B1 (enExample)
CA (1) CA2832663C (enExample)
ES (4) ES2607497T3 (enExample)
HU (4) HUE032310T2 (enExample)
PL (4) PL3199146T3 (enExample)
PT (3) PT2701687T (enExample)
RU (1) RU2586306C2 (enExample)
WO (1) WO2012146052A1 (enExample)

Families Citing this family (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL3199146T3 (pl) 2011-04-25 2020-03-31 Shan Dong Luye Pharmaceutical Co., Ltd. Kompozycja mikrosfery rysperydonu o przedłużonym uwalnianiu
CN103990114B (zh) * 2014-05-06 2016-05-18 浙江圣兆药物科技股份有限公司 一种艾塞那肽缓释微球组合物
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
US20190029969A1 (en) * 2015-09-07 2019-01-31 Nipro Corporation Risperidone-containing microcapsule, method for preparing same and release control method
CN105560192A (zh) * 2016-01-07 2016-05-11 万全万特制药江苏有限公司 一种棕榈酸帕利哌酮长效微球注射液的制备方法
WO2018015915A1 (en) 2016-07-22 2018-01-25 Cadila Healthcare Limited A parenteral controlled release composition of an atypical antipsychotic agent
CN106390102A (zh) * 2016-11-30 2017-02-15 郑州仁宏医药科技有限公司 一种治疗精神分裂症的西药组合物
CN106727589A (zh) * 2017-01-24 2017-05-31 广州帝奇医药技术有限公司 帕利哌酮及其衍生物的缓释组合物与该缓释组合物的制备方法
CN106822043A (zh) * 2017-01-24 2017-06-13 广州帝奇医药技术有限公司 利培酮缓释组合物及其制备方法
CN116270486A (zh) * 2017-01-24 2023-06-23 广州帝奇医药技术有限公司 水难溶或微溶性药物缓释组合物及其制备方法
CN106822042A (zh) * 2017-01-24 2017-06-13 广州帝奇医药技术有限公司 一种利培酮缓释组合物及其制备方法
CN106963746A (zh) * 2017-03-17 2017-07-21 广州帝奇医药技术有限公司 一种水难溶/微溶性药物缓释组合物
CN107349175A (zh) * 2017-06-06 2017-11-17 浙江理工大学 一种负载脂肪褐变剂的微针贴片及其制备方法
CN107049985B (zh) * 2017-06-07 2020-06-19 广州帝奇医药技术有限公司 一种抗帕金森病药物的长效缓释制剂及其制备方法
CN107213136B (zh) * 2017-06-07 2021-06-01 广州帝奇医药技术有限公司 一种长效缓释药物制剂及其制备方法
CN107412188A (zh) * 2017-09-06 2017-12-01 广州中医药大学 阿塞那平微球及其制备方法和其注射剂
CN112545995B (zh) * 2018-05-16 2024-02-23 珠海市丽珠微球科技有限公司 一种阿立哌唑缓释微球及其制备方法
CN108635339B (zh) * 2018-08-06 2021-07-06 深圳市泛谷药业股份有限公司 一种利培酮植入剂及其制备方法
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
CA3222421A1 (en) * 2021-06-23 2022-12-29 Peptron, Inc. Sustained release formulation composition comprising semaglutide or pharmaceutically acceptable salt thereof
CN115006354A (zh) * 2022-06-16 2022-09-06 北京阳光诺和药物研究股份有限公司 一种利培酮-共混plga缓释微球及其制备方法
AU2023352588A1 (en) * 2022-09-26 2025-04-03 The Methodist Hospital Microparticle formulations for intravenous therapy and methods for their manufacture and use
CN118831056A (zh) * 2023-04-11 2024-10-25 珠海市华海康医药科技有限责任公司 一种注射用非奈利酮缓释微球及其制备方法
CN119606887A (zh) * 2023-11-09 2025-03-14 武汉人福创新药物研发中心有限公司 一种药物缓释微球组合物及其制备方法和应用

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IE52535B1 (en) 1981-02-16 1987-12-09 Ici Plc Continuous release pharmaceutical compositions
PT669128E (pt) * 1992-11-17 2000-06-30 Yoshitomi Pharmaceutical Micro-esfera de libertacao sustentada contendo antipsicoticos e processo para produzir a mesma
AU694147B2 (en) 1993-11-19 1998-07-16 Alkermes, Inc. Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles
US6558702B2 (en) * 2001-04-13 2003-05-06 Alkermes Controlled Therapeutics, Inc. Method of modifying the release profile of sustained release compositions
BR0315304A (pt) * 2002-11-06 2005-08-16 Alza Corp Formulações com depósito para liberação controlada
EP1615924A1 (en) 2003-04-22 2006-01-18 Synthon B.V. Water soluble salts of risperidone
WO2005110369A2 (en) * 2004-04-30 2005-11-24 American Pharmaceutical Partners, Inc. Sustained-release microspheres and methods of making and using same
EP1661560B1 (en) * 2004-11-22 2008-11-05 Hisamitsu Pharmaceutical Co., Inc. Transdermal patch comprising a melting point lowering agent
EP1968549B1 (en) 2005-12-22 2014-05-14 Novartis AG Sustained release formulation comprising octreotide and two or more polylactide-co-glycolide polymers
CN101292960B (zh) * 2006-04-29 2011-02-09 中国人民解放军军事医学科学院毒物药物研究所 含利培酮的缓释微球及其制备方法
PE20090387A1 (es) 2007-05-24 2009-04-28 Novartis Ag Formulacion de pasireotida
CA2687979C (en) 2007-05-25 2017-07-04 Tolmar Therapeutics, Inc. Sustained delivery formulations of risperidone compounds
JP5222550B2 (ja) * 2007-12-27 2013-06-26 財團法人工業技術研究院 徐放性組成物およびその製造方法
CN101653422B (zh) * 2008-08-20 2013-03-20 山东绿叶制药有限公司 利培酮缓释微球、其制备方法和用途
CN101584652B (zh) 2009-06-19 2012-06-20 上海医药集团股份有限公司 利培酮缓释凝胶注射剂及其制备方法
UA111162C2 (uk) 2010-08-04 2016-04-11 Флекшен Терап'Ютікс, Інк. Ін'єкційна композиція ацетоніду триамцинолону для лікування болю
PL3199146T3 (pl) 2011-04-25 2020-03-31 Shan Dong Luye Pharmaceutical Co., Ltd. Kompozycja mikrosfery rysperydonu o przedłużonym uwalnianiu

Also Published As

Publication number Publication date
US20190343840A1 (en) 2019-11-14
EP3772354C0 (en) 2023-11-01
AU2012248038B2 (en) 2015-11-12
KR101932207B1 (ko) 2018-12-24
EP3566696B1 (en) 2020-10-07
JP5728128B2 (ja) 2015-06-03
US20160331752A1 (en) 2016-11-17
EP3566696A1 (en) 2019-11-13
BR112013027235B1 (pt) 2021-11-16
WO2012146052A1 (en) 2012-11-01
US20140050799A1 (en) 2014-02-20
RU2013147949A (ru) 2015-05-27
PL3566696T3 (pl) 2021-04-19
CN104127385A (zh) 2014-11-05
PL3772354T3 (pl) 2024-04-02
EP3199146A1 (en) 2017-08-02
EP3772354A1 (en) 2021-02-10
KR101539313B1 (ko) 2015-07-24
PT3199146T (pt) 2019-10-25
HUE046004T2 (hu) 2020-01-28
US9532991B2 (en) 2017-01-03
PL3199146T3 (pl) 2020-03-31
EP2701687A1 (en) 2014-03-05
US11110094B2 (en) 2021-09-07
PT3566696T (pt) 2021-01-11
ES2749864T3 (es) 2020-03-24
US10406161B2 (en) 2019-09-10
AU2012248038A1 (en) 2013-10-24
JP2015143259A (ja) 2015-08-06
CN103338752B (zh) 2014-10-29
PL2701687T3 (pl) 2017-03-31
US20170056407A1 (en) 2017-03-02
ES2968917T3 (es) 2024-05-14
CN103338752A (zh) 2013-10-02
HUE032310T2 (hu) 2017-09-28
RU2586306C2 (ru) 2016-06-10
ES2855349T3 (es) 2021-09-23
US10098882B2 (en) 2018-10-16
BR112013027235A2 (pt) 2016-12-27
CA2832663C (en) 2016-02-09
JP2014512396A (ja) 2014-05-22
EP3772354B1 (en) 2023-11-01
CN104127385B (zh) 2017-08-04
CA2832663A1 (en) 2012-11-01
EP2701687B1 (en) 2016-09-21
EP3199146B1 (en) 2019-07-17
JP6072121B2 (ja) 2017-02-01
HUE066287T2 (hu) 2024-07-28
US9446135B2 (en) 2016-09-20
HK1185560A1 (en) 2014-02-21
KR20150050598A (ko) 2015-05-08
US20190022098A1 (en) 2019-01-24
KR20140026481A (ko) 2014-03-05
EP2701687A4 (en) 2014-12-17
PT2701687T (pt) 2016-12-20
HUE052864T2 (hu) 2021-05-28

Similar Documents

Publication Publication Date Title
ES2607497T3 (es) Composición de risperidona de microesferas de liberación controlada
ES2627531T3 (es) Composición farmacéutica con biodisponibilidad mejorada para un compuesto hidrófobo de alto punto de fusión
CN1371366A (zh) 具有组蛋白脱乙酰酶抑制剂活性的苯甲酰胺制剂
JP2012193212A (ja) 優れた初期放出抑制特性を有する徐放性マイクロカプセルの製造方法及びこれにより製造されるマイクロカプセル
CN102151242A (zh) 一种抗结核药物的原位凝胶缓释制剂及其制备方法
CN117530933A (zh) 一种吡仑帕奈长效缓释微球、制备方法及缓释注射剂
CN120712075A (zh) 微球调配物以及其制备方法
CN104352443A (zh) 伊潘立酮缓释微球及其制备方法
HK1185560B (en) Risperidone sustained release microsphere composition
TWI426929B (zh) 持續性釋放之含抗生素醫藥組合物、製備法及其應用