CN105377301B - 高药物载量的丁丙诺啡微球和生产其的方法 - Google Patents
高药物载量的丁丙诺啡微球和生产其的方法 Download PDFInfo
- Publication number
- CN105377301B CN105377301B CN201480021351.9A CN201480021351A CN105377301B CN 105377301 B CN105377301 B CN 105377301B CN 201480021351 A CN201480021351 A CN 201480021351A CN 105377301 B CN105377301 B CN 105377301B
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- China
- Prior art keywords
- buprenorphine
- phase
- solvent
- dispersed phase
- prepared
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- 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.)
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Classifications
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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
- A61K9/48—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
- 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
-
- 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
- A61K9/10—Dispersions; Emulsions
-
- 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
- A61K9/48—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
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Emergency Medicine (AREA)
- Dispersion Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US13/837,181 US9393211B2 (en) | 2013-03-15 | 2013-03-15 | High drug load buprenorphine microspheres and method of producing same |
| US13/837,181 | 2013-03-15 | ||
| PCT/US2014/027982 WO2014143839A1 (en) | 2013-03-15 | 2014-03-14 | High drug load buprenorphine microspheres and method of producing the same |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN105377301A CN105377301A (zh) | 2016-03-02 |
| CN105377301B true CN105377301B (zh) | 2020-06-05 |
Family
ID=51528078
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201480021351.9A Active CN105377301B (zh) | 2013-03-15 | 2014-03-14 | 高药物载量的丁丙诺啡微球和生产其的方法 |
Country Status (9)
| Country | Link |
|---|---|
| US (1) | US9393211B2 (https=) |
| EP (1) | EP2968577B1 (https=) |
| JP (1) | JP6678571B2 (https=) |
| CN (1) | CN105377301B (https=) |
| BR (1) | BR112015022985A2 (https=) |
| CA (1) | CA2904432A1 (https=) |
| ES (1) | ES2717942T3 (https=) |
| MX (1) | MX362709B (https=) |
| WO (1) | WO2014143839A1 (https=) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8852638B2 (en) | 2005-09-30 | 2014-10-07 | Durect Corporation | Sustained release small molecule drug formulation |
| EP2152315B1 (en) | 2007-05-25 | 2016-01-06 | Indivior UK Limited | Sustained delivery formulations of risperidone compounds |
| US9272044B2 (en) | 2010-06-08 | 2016-03-01 | Indivior Uk Limited | Injectable flowable composition buprenorphine |
| GB2481017B (en) | 2010-06-08 | 2015-01-07 | Rb Pharmaceuticals Ltd | Microparticle buprenorphine suspension |
| NZ704012A (en) | 2012-07-26 | 2017-09-29 | Camurus Ab | Opioid formulations |
| EP3791861A1 (en) | 2012-07-26 | 2021-03-17 | Camurus AB | Opioid formulations |
| US9636308B2 (en) * | 2013-03-15 | 2017-05-02 | Oakwood Laboratories LLC | High drug load buprenorphine microspheres and method of producing same |
| GB201404139D0 (en) | 2014-03-10 | 2014-04-23 | Rb Pharmaceuticals Ltd | Sustained release buprenorphine solution formulations |
| EP3141241A1 (en) * | 2015-09-08 | 2017-03-15 | Andreas Voigt | Sustained release low dose formulations and uses thereof |
| CN105596298B (zh) * | 2015-12-18 | 2018-08-14 | 山东大学 | 一种包载丁丙诺啡的peg-plga缓释微球及其制备方法 |
| EP3419596A1 (en) * | 2016-02-23 | 2019-01-02 | BioDelivery Sciences International, Inc. | Sustained release buprenorphine microspheres (srbm) and methods of use thereof |
| TWI743193B (zh) | 2016-09-13 | 2021-10-21 | 昱展新藥生技股份有限公司 | 丁基原啡因緩釋製劑 |
| BR112020016576A2 (pt) | 2018-05-11 | 2020-12-15 | Alar Pharmaceuticals Inc. | Formulações injetáveis de ação prolongada e formas cristalinas de derivados de buprenorfina |
| US12433841B2 (en) | 2020-02-26 | 2025-10-07 | Fordoz Pharma Corp. | Injectable controlled-release formulations of progestogen drugs |
| US11992559B2 (en) | 2021-02-24 | 2024-05-28 | Oakwood Laboratories, Llc | Microsphere formulations comprising lurasidone and methods for making and using the same |
| CN114392384B (zh) * | 2021-12-24 | 2023-04-11 | 河南驼人医疗器械研究院有限公司 | 一种制备高载药量栓塞微球的方法及收集装置 |
| CN115317453A (zh) * | 2022-09-01 | 2022-11-11 | 广东嘉博制药有限公司 | 一种缓释微球制剂及其制备方法与用途 |
| CN120152701A (zh) * | 2022-10-31 | 2025-06-13 | 奥克伍德实验室有限责任公司 | 包含奥曲肽的混合释放曲线聚合物微球制剂及其制备和使用方法 |
Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0368406B1 (en) * | 1988-11-10 | 1993-07-28 | Norwich Eaton Pharmaceuticals, Inc. | Compositions for the transdermal delivery of pharmaceutical actives |
| WO2001015699A1 (en) * | 1999-08-27 | 2001-03-08 | Southern Research Institute | Injectable buprenorphine microparticle compositions and their use |
| EP1555023A2 (en) * | 1999-08-27 | 2005-07-20 | Southern Research Institute | Injectable buprenorphine microparticle compositions and their use |
| US7041320B1 (en) * | 2002-05-31 | 2006-05-09 | Biotek, Inc. | High drug loaded injectable microparticle compositions and methods of treating opioid drug dependence |
| TW200836770A (en) * | 2007-03-08 | 2008-09-16 | Univ Kaohsiung Medical | Controlled release system and manufacture method thereof |
| WO2011087496A1 (en) * | 2010-01-13 | 2011-07-21 | Oakwood Laboratories LLC | Microspheres for the sustained release of octreotide without an initial time lag |
| CN102137657A (zh) * | 2008-08-29 | 2011-07-27 | 东国制药株式会社 | 通过溶剂交流蒸发法制备缓释微球的方法 |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20050048115A1 (en) | 2003-08-27 | 2005-03-03 | Murty Mangena | Buprenorphine microspheres |
| US9161943B2 (en) | 2007-12-31 | 2015-10-20 | Industrial Technology Research Institute | Sustained release composition and manufacturing method thereof |
| US20100086597A1 (en) | 2008-10-06 | 2010-04-08 | Oakwood Laboratories LLC | Microspheres for the sustained release of octreotide with a low initial burst |
| GB2481018B (en) | 2010-06-08 | 2015-03-18 | Rb Pharmaceuticals Ltd | Injectable flowable composition comprising buprenorphine |
-
2013
- 2013-03-15 US US13/837,181 patent/US9393211B2/en active Active
-
2014
- 2014-03-14 BR BR112015022985A patent/BR112015022985A2/pt not_active IP Right Cessation
- 2014-03-14 JP JP2016502675A patent/JP6678571B2/ja active Active
- 2014-03-14 WO PCT/US2014/027982 patent/WO2014143839A1/en not_active Ceased
- 2014-03-14 EP EP14764439.7A patent/EP2968577B1/en active Active
- 2014-03-14 MX MX2015012232A patent/MX362709B/es active IP Right Grant
- 2014-03-14 CA CA2904432A patent/CA2904432A1/en not_active Abandoned
- 2014-03-14 ES ES14764439T patent/ES2717942T3/es active Active
- 2014-03-14 CN CN201480021351.9A patent/CN105377301B/zh active Active
Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0368406B1 (en) * | 1988-11-10 | 1993-07-28 | Norwich Eaton Pharmaceuticals, Inc. | Compositions for the transdermal delivery of pharmaceutical actives |
| WO2001015699A1 (en) * | 1999-08-27 | 2001-03-08 | Southern Research Institute | Injectable buprenorphine microparticle compositions and their use |
| CN1382051A (zh) * | 1999-08-27 | 2002-11-27 | 南方研究所 | 可注射的丁丙诺啡微粒组合物及其用途 |
| EP1555023A2 (en) * | 1999-08-27 | 2005-07-20 | Southern Research Institute | Injectable buprenorphine microparticle compositions and their use |
| US7041320B1 (en) * | 2002-05-31 | 2006-05-09 | Biotek, Inc. | High drug loaded injectable microparticle compositions and methods of treating opioid drug dependence |
| TW200836770A (en) * | 2007-03-08 | 2008-09-16 | Univ Kaohsiung Medical | Controlled release system and manufacture method thereof |
| CN102137657A (zh) * | 2008-08-29 | 2011-07-27 | 东国制药株式会社 | 通过溶剂交流蒸发法制备缓释微球的方法 |
| WO2011087496A1 (en) * | 2010-01-13 | 2011-07-21 | Oakwood Laboratories LLC | Microspheres for the sustained release of octreotide without an initial time lag |
Non-Patent Citations (1)
| Title |
|---|
| "Preparation of microspheres by the solvent evaporation technique";Patrick BO"Donnell;《 Advanced Drug Delivery Reviews》;19991013;第28卷(第1期);第28页左栏倒数第1段 * |
Also Published As
| Publication number | Publication date |
|---|---|
| MX2015012232A (es) | 2015-12-01 |
| CN105377301A (zh) | 2016-03-02 |
| US9393211B2 (en) | 2016-07-19 |
| ES2717942T3 (es) | 2019-06-26 |
| US20140271869A1 (en) | 2014-09-18 |
| MX362709B (es) | 2019-02-05 |
| EP2968577A1 (en) | 2016-01-20 |
| EP2968577A4 (en) | 2016-11-23 |
| BR112015022985A2 (pt) | 2017-08-22 |
| CA2904432A1 (en) | 2014-09-18 |
| JP6678571B2 (ja) | 2020-04-08 |
| WO2014143839A1 (en) | 2014-09-18 |
| JP2016513721A (ja) | 2016-05-16 |
| EP2968577B1 (en) | 2019-01-02 |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |