CN103338752B - 利培酮缓释微球组合物 - Google Patents

利培酮缓释微球组合物 Download PDF

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Publication number
CN103338752B
CN103338752B CN201280006994.7A CN201280006994A CN103338752B CN 103338752 B CN103338752 B CN 103338752B CN 201280006994 A CN201280006994 A CN 201280006994A CN 103338752 B CN103338752 B CN 103338752B
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China
Prior art keywords
plga
blocking
pharmaceutical composition
risperidone
lactide
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CN201280006994.7A
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Chinese (zh)
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CN103338752A (zh
Inventor
孙考祥
梁荣才
王麒麟
王文艳
刘万卉
李又欣
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Nanjing Lvye Pharma Co Ltd
Shandong Luye Pharmaceutical Co Ltd
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Shandong Luye Pharmaceutical Co Ltd
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Application filed by Shandong Luye Pharmaceutical Co Ltd filed Critical Shandong Luye Pharmaceutical Co Ltd
Priority to CN201280006994.7A priority Critical patent/CN103338752B/zh
Priority to CN201410314847.7A priority patent/CN104127385B/zh
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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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular 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
    • 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
    • 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
    • A61K9/19—Particulate 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
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic 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
    • A61K9/48—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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, 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
    • A61K9/48—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
    • A61K9/5089—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • 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

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  • 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)
CN201280006994.7A 2011-04-25 2012-04-10 利培酮缓释微球组合物 Active CN103338752B (zh)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN201280006994.7A CN103338752B (zh) 2011-04-25 2012-04-10 利培酮缓释微球组合物
CN201410314847.7A CN104127385B (zh) 2011-04-25 2012-04-10 利培酮缓释微球组合物

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN201110102840.5 2011-04-25
CN201110102840 2011-04-25
CN201280006994.7A CN103338752B (zh) 2011-04-25 2012-04-10 利培酮缓释微球组合物
PCT/CN2012/000473 WO2012146052A1 (en) 2011-04-25 2012-04-10 Risperidone sustained release microsphere composition

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CN201410314847.7A Division CN104127385B (zh) 2011-04-25 2012-04-10 利培酮缓释微球组合物

Publications (2)

Publication Number Publication Date
CN103338752A CN103338752A (zh) 2013-10-02
CN103338752B true CN103338752B (zh) 2014-10-29

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CN201410314847.7A Active CN104127385B (zh) 2011-04-25 2012-04-10 利培酮缓释微球组合物

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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)

Cited By (1)

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US9532991B2 (en) 2011-04-25 2017-01-03 Shandong Luye Pharmaceutical Co., Ltd. Risperidone sustained release microsphere composition

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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

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9532991B2 (en) 2011-04-25 2017-01-03 Shandong Luye Pharmaceutical Co., Ltd. Risperidone sustained release microsphere composition
US10098882B2 (en) 2011-04-25 2018-10-16 Shandong Luye Pharmaceutical Co., Ltd. Risperidone sustained release microsphere composition
US10406161B2 (en) 2011-04-25 2019-09-10 Shandong Luye Pharmaceutical Co., Ltd. Risperidone sustained release microsphere composition
US11110094B2 (en) 2011-04-25 2021-09-07 Shandong Luye Pharmaceutical Co., Ltd. Risperidone sustained release microsphere composition

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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
ES2607497T3 (es) 2017-03-31
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
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

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