BR112013027235A2 - composição de microesferas de desprendimento sustentado de risperidona - Google Patents
composição de microesferas de desprendimento sustentado de risperidonaInfo
- Publication number
- BR112013027235A2 BR112013027235A2 BR112013027235A BR112013027235A BR112013027235A2 BR 112013027235 A2 BR112013027235 A2 BR 112013027235A2 BR 112013027235 A BR112013027235 A BR 112013027235A BR 112013027235 A BR112013027235 A BR 112013027235A BR 112013027235 A2 BR112013027235 A2 BR 112013027235A2
- Authority
- BR
- Brazil
- Prior art keywords
- risperidone
- copolymer
- sustained release
- lactide
- capless
- Prior art date
Links
- 239000004005 microsphere Substances 0.000 title abstract 5
- 239000000203 mixture Substances 0.000 title abstract 5
- RAPZEAPATHNIPO-UHFFFAOYSA-N risperidone Chemical compound FC1=CC=C2C(C3CCN(CC3)CCC=3C(=O)N4CCCCC4=NC=3C)=NOC2=C1 RAPZEAPATHNIPO-UHFFFAOYSA-N 0.000 title abstract 4
- 229960001534 risperidone Drugs 0.000 title abstract 4
- 238000013268 sustained release Methods 0.000 title abstract 3
- 239000012730 sustained-release form Substances 0.000 title abstract 3
- 229920001577 copolymer Polymers 0.000 abstract 6
- 238000009472 formulation Methods 0.000 abstract 3
- JJTUDXZGHPGLLC-UHFFFAOYSA-N lactide Chemical compound CC1OC(=O)C(C)OC1=O JJTUDXZGHPGLLC-UHFFFAOYSA-N 0.000 abstract 3
- RKDVKSZUMVYZHH-UHFFFAOYSA-N 1,4-dioxane-2,5-dione Chemical compound O=C1COC(=O)CO1 RKDVKSZUMVYZHH-UHFFFAOYSA-N 0.000 abstract 1
- PMXMIIMHBWHSKN-UHFFFAOYSA-N 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one Chemical compound FC1=CC=C2C(C3CCN(CC3)CCC=3C(=O)N4CCCC(O)C4=NC=3C)=NOC2=C1 PMXMIIMHBWHSKN-UHFFFAOYSA-N 0.000 abstract 1
- 238000013265 extended release Methods 0.000 abstract 1
- 238000001727 in vivo Methods 0.000 abstract 1
- 238000009776 industrial production Methods 0.000 abstract 1
- 229920002959 polymer blend Polymers 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
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
- A61K9/0012—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
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)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Biomedical Technology (AREA)
- Psychiatry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
resumo patente de invenção: "composição de microesferas de desprendimento sustentado de risperidona". a presente invenção refere-se a uma formulação de microesferas de risperidona de desprendimento sustentado. a formulação de microesferas compreende risperidona ou 9-hidróxi risperidona ou sais dos mesmos, e uma mistura de polímeros contendo um primeiro copolímero de lactídeo-glicolídeo sem capa e um segundo copolímero de lactídeo-glicolídeo sem capa, sendo que o primeiro copolímero de lactídeo-glicolídeo sem capa é um copolímero com uma elevada viscosidade intrínseca e o segundo copolímero de lactídeo-glicolídeo sem capa é um copolímero com uma baixa viscosidade intrínseca. a formulação de microesferas de desprendimento prolongado de acordo com uma modalidade da presente descrição é apropriada para produção industrial em larga escala com estabilidade melhorada, cujo comportamento de desprendimento in vivo não se alterará após um longo período de armazenamento.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110102840.5 | 2011-04-25 | ||
| CN201110102840 | 2011-04-25 | ||
| PCT/CN2012/000473 WO2012146052A1 (en) | 2011-04-25 | 2012-04-10 | Risperidone sustained release microsphere composition |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| BR112013027235A2 true BR112013027235A2 (pt) | 2016-12-27 |
| BR112013027235B1 BR112013027235B1 (pt) | 2021-11-16 |
Family
ID=47071591
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112013027235-0A BR112013027235B1 (pt) | 2011-04-25 | 2012-04-10 | Composição farmacêutica, seu uso, e formulação de microsferas para injeção de liberação sustentada |
Country Status (15)
| Country | Link |
|---|---|
| US (5) | US9446135B2 (pt) |
| EP (4) | EP3566696B1 (pt) |
| JP (2) | JP5728128B2 (pt) |
| KR (2) | KR101932207B1 (pt) |
| CN (2) | CN103338752B (pt) |
| AU (1) | AU2012248038B2 (pt) |
| BR (1) | BR112013027235B1 (pt) |
| CA (1) | CA2832663C (pt) |
| ES (4) | ES2749864T3 (pt) |
| HK (1) | HK1185560A1 (pt) |
| HU (4) | HUE052864T2 (pt) |
| PL (4) | PL3199146T3 (pt) |
| PT (3) | PT2701687T (pt) |
| RU (1) | RU2586306C2 (pt) |
| WO (1) | WO2012146052A1 (pt) |
Families Citing this family (21)
| 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 |
| EP3348268A4 (en) * | 2015-09-07 | 2019-04-10 | Nipro Corporation | RISPERIDO-CONTAINING MICRO-CAPSULES, METHOD FOR THE MANUFACTURE THEREOF, AND RELEASE CONTROL PROCEDURES |
| 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 |
| 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 |
| 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 |
| CN106822039A (zh) * | 2017-01-24 | 2017-06-13 | 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 |
| CN108498456B (zh) * | 2018-05-16 | 2021-01-01 | 丽珠医药集团股份有限公司 | 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 |
| CN112367997B (zh) * | 2019-12-31 | 2023-12-19 | 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 |
| 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 |
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| IE52535B1 (en) | 1981-02-16 | 1987-12-09 | Ici Plc | Continuous release pharmaceutical compositions |
| DK0669128T3 (da) * | 1992-11-17 | 2000-06-19 | Yoshitomi Pharmaceutical | Sustained-release mikrosfære indeholdende antipsykotikum og fremgangsmåde til at fremstille samme |
| ES2236700T3 (es) | 1993-11-19 | 2005-07-16 | Janssen Pharmaceutica N.V. | 1,2-benzazoles microencapsulados. |
| US6558702B2 (en) * | 2001-04-13 | 2003-05-06 | Alkermes Controlled Therapeutics, Inc. | Method of modifying the release profile of sustained release compositions |
| JP2006508127A (ja) * | 2002-11-06 | 2006-03-09 | アルザ・コーポレーション | 制御された放出性デポー剤配合物 |
| WO2004094415A1 (en) * | 2003-04-22 | 2004-11-04 | Synthon B.V. | Risperidone monohydrochloride |
| WO2005110369A2 (en) * | 2004-04-30 | 2005-11-24 | American Pharmaceutical Partners, Inc. | Sustained-release microspheres and methods of making and using same |
| ATE413166T1 (de) * | 2004-11-22 | 2008-11-15 | Hisamitsu Pharmaceutical Co | Transdermales pflaster enthaltend einen schmelzpunktsenkenden hilfsstoff |
| KR20130024987A (ko) * | 2005-12-22 | 2013-03-08 | 노파르티스 아게 | 옥트레오티드 및 ２종 이상의 폴리락티드-코-글리콜리드 중합체를 포함하는 서방형 제제 |
| 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 |
| BRPI0811319A2 (pt) | 2007-05-25 | 2015-02-10 | Tolmar Therapeutics Inc | Composição fluida, método de formação de uma composição fluida, implante biodegrádavel formado in situ, método de formação de um implante biodegradável in situ, kit, implante e método de trataento |
| 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 |
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2012
- 2012-04-10 PL PL16179390T patent/PL3199146T3/pl unknown
- 2012-04-10 PT PT127774305T patent/PT2701687T/pt unknown
- 2012-04-10 PL PL20199849.9T patent/PL3772354T3/pl unknown
- 2012-04-10 KR KR1020157010621A patent/KR101932207B1/ko active IP Right Grant
- 2012-04-10 HU HUE19176691A patent/HUE052864T2/hu unknown
- 2012-04-10 HU HUE12777430A patent/HUE032310T2/hu unknown
- 2012-04-10 KR KR1020137029953A patent/KR101539313B1/ko active IP Right Grant
- 2012-04-10 RU RU2013147949/15A patent/RU2586306C2/ru active
- 2012-04-10 WO PCT/CN2012/000473 patent/WO2012146052A1/en active Application Filing
- 2012-04-10 EP EP19176691.4A patent/EP3566696B1/en active Active
- 2012-04-10 AU AU2012248038A patent/AU2012248038B2/en active Active
- 2012-04-10 JP JP2014506723A patent/JP5728128B2/ja active Active
- 2012-04-10 CN CN201280006994.7A patent/CN103338752B/zh active Active
- 2012-04-10 CN CN201410314847.7A patent/CN104127385B/zh active Active
- 2012-04-10 ES ES16179390T patent/ES2749864T3/es active Active
- 2012-04-10 PT PT161793906T patent/PT3199146T/pt unknown
- 2012-04-10 PT PT191766914T patent/PT3566696T/pt unknown
- 2012-04-10 ES ES20199849T patent/ES2968917T3/es active Active
- 2012-04-10 EP EP20199849.9A patent/EP3772354B1/en active Active
- 2012-04-10 CA CA2832663A patent/CA2832663C/en active Active
- 2012-04-10 PL PL19176691T patent/PL3566696T3/pl unknown
- 2012-04-10 BR BR112013027235-0A patent/BR112013027235B1/pt active IP Right Grant
- 2012-04-10 EP EP16179390.6A patent/EP3199146B1/en active Active
- 2012-04-10 ES ES12777430.5T patent/ES2607497T3/es active Active
- 2012-04-10 HU HUE16179390A patent/HUE046004T2/hu unknown
- 2012-04-10 PL PL12777430T patent/PL2701687T3/pl unknown
- 2012-04-10 ES ES19176691T patent/ES2855349T3/es active Active
- 2012-04-10 US US14/113,738 patent/US9446135B2/en active Active
- 2012-04-10 HU HUE20199849A patent/HUE066287T2/hu unknown
- 2012-04-10 EP EP12777430.5A patent/EP2701687B1/en active Active
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2013
- 2013-11-21 HK HK13113031.9A patent/HK1185560A1/xx unknown
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2015
- 2015-04-02 JP JP2015075711A patent/JP6072121B2/ja active Active
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2016
- 2016-07-22 US US15/217,696 patent/US9532991B2/en active Active
- 2016-11-09 US US15/347,365 patent/US10098882B2/en active Active
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2018
- 2018-09-27 US US16/144,614 patent/US10406161B2/en active Active
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2019
- 2019-07-29 US US16/525,502 patent/US11110094B2/en active Active
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