BR112015022985A2 - Microesferas de buprenorfina de carga de fármaco alta e método para produção das mesmas - Google Patents
Microesferas de buprenorfina de carga de fármaco alta e método para produção das mesmasInfo
- Publication number
- BR112015022985A2 BR112015022985A2 BR112015022985A BR112015022985A BR112015022985A2 BR 112015022985 A2 BR112015022985 A2 BR 112015022985A2 BR 112015022985 A BR112015022985 A BR 112015022985A BR 112015022985 A BR112015022985 A BR 112015022985A BR 112015022985 A2 BR112015022985 A2 BR 112015022985A2
- Authority
- BR
- Brazil
- Prior art keywords
- high drug
- dispersed phase
- drug load
- phase
- production
- Prior art date
Links
- 229940079593 drug Drugs 0.000 title abstract 3
- 239000003814 drug Substances 0.000 title abstract 3
- 239000004005 microsphere Substances 0.000 title abstract 3
- RMRJXGBAOAMLHD-IHFGGWKQSA-N buprenorphine Chemical compound C([C@]12[C@H]3OC=4C(O)=CC=C(C2=4)C[C@@H]2[C@]11CC[C@]3([C@H](C1)[C@](C)(O)C(C)(C)C)OC)CN2CC1CC1 RMRJXGBAOAMLHD-IHFGGWKQSA-N 0.000 title abstract 2
- 229960001736 buprenorphine Drugs 0.000 title abstract 2
- 238000004519 manufacturing process Methods 0.000 title abstract 2
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 abstract 3
- 239000013543 active substance Substances 0.000 abstract 2
- 239000004372 Polyvinyl alcohol Substances 0.000 abstract 1
- 239000007864 aqueous solution Substances 0.000 abstract 1
- 239000006184 cosolvent Substances 0.000 abstract 1
- 238000004945 emulsification Methods 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 239000007764 o/w emulsion Substances 0.000 abstract 1
- WVDDGKGOMKODPV-ZQBYOMGUSA-N phenyl(114C)methanol Chemical compound O[14CH2]C1=CC=CC=C1 WVDDGKGOMKODPV-ZQBYOMGUSA-N 0.000 abstract 1
- 229920000642 polymer Polymers 0.000 abstract 1
- 229920002451 polyvinyl alcohol Polymers 0.000 abstract 1
- 239000002904 solvent Substances 0.000 abstract 1
- 238000013268 sustained release Methods 0.000 abstract 1
- 239000012730 sustained-release form Substances 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 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
- A61K9/48—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
Landscapes
- 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)
Abstract
MICROESFERAS DE BUPRENORFINA DE CARGA DE FÁRMACO ALTA E MÉTODO PARA PRODUÇÃO DAS MESMAS. A presente invenção refere-se a uma formulação de microesfera com liberação sustentada com uma carga de fármaco alta que pode ser formada por um processo de emulsão de óleo-em-água contínuo mediante a combinação de uma fase dispersa orgânica com uma fase contínua aquosa. A fase dispersa pode incluir um polímero de encapsulamento, um solvente primário, tal como diclorometano, uma quantidade farmaceuticamente eficaz de um agente ativo que tem uma solubilidade em relação à fase dispersa, e um cossolvente, tal como álcool benzílico, o qual tem capacidade para aumentar a solubilidade do agente ativo em relação à fase dispersa. A fase contínua pode incluir uma solução aquosa de álcool polivinílico e água.
Applications Claiming Priority (2)
| 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 |
| PCT/US2014/027982 WO2014143839A1 (en) | 2013-03-15 | 2014-03-14 | High drug load buprenorphine microspheres and method of producing the same |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BR112015022985A2 true BR112015022985A2 (pt) | 2017-08-22 |
Family
ID=51528078
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112015022985A BR112015022985A2 (pt) | 2013-03-15 | 2014-03-14 | Microesferas de buprenorfina de carga de fármaco alta e método para produção das mesmas |
Country Status (9)
| Country | Link |
|---|---|
| US (1) | US9393211B2 (pt) |
| EP (1) | EP2968577B1 (pt) |
| JP (1) | JP6678571B2 (pt) |
| CN (1) | CN105377301B (pt) |
| BR (1) | BR112015022985A2 (pt) |
| CA (1) | CA2904432A1 (pt) |
| ES (1) | ES2717942T3 (pt) |
| MX (1) | MX362709B (pt) |
| WO (1) | WO2014143839A1 (pt) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8852638B2 (en) | 2005-09-30 | 2014-10-07 | Durect Corporation | Sustained release small molecule drug formulation |
| CN101801415B (zh) | 2007-05-25 | 2015-09-23 | Rb医药品有限公司 | 利培酮化合物的持续递送制剂 |
| GB2513060B (en) | 2010-06-08 | 2015-01-07 | Rb Pharmaceuticals Ltd | Microparticle buprenorphine suspension |
| US9272044B2 (en) | 2010-06-08 | 2016-03-01 | Indivior Uk Limited | Injectable flowable composition buprenorphine |
| AU2013294915C1 (en) | 2012-07-26 | 2019-11-21 | 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 |
| US20170065579A1 (en) * | 2015-09-08 | 2017-03-09 | 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 |
| MX2018010194A (es) * | 2016-02-23 | 2019-06-12 | Biodelivery Sciences Int Inc | Microsferas de buprenorfina de liberacion sostenida (srbm) y metodos de uso de las mismas. |
| LT3512518T (lt) | 2016-09-13 | 2023-02-10 | Alar Pharmaceuticals Inc. | Sulėtinto atpalaidavimo buprenorfino vaisto formos |
| CN111954672B (zh) * | 2018-05-11 | 2023-09-01 | 昱展新药生技股份有限公司 | 丁丙诺啡衍生物的长效注射制剂及结晶形式 |
| CN115605187B (zh) * | 2020-02-26 | 2024-09-17 | 福多兹制药公司 | 载有孕激素药物的可注射控释制剂 |
| AU2022226584A1 (en) | 2021-02-24 | 2023-08-17 | 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 |
| WO2024097696A1 (en) * | 2022-10-31 | 2024-05-10 | Oakwood Laboratories, Llc | Mixed release profile polymer microsphere formulations comprising octreotide and methods for making and using the same |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5026556A (en) | 1988-11-10 | 1991-06-25 | Norwich Eaton Pharmaceuticals, Inc. | Compositions for the transdermal delivery of pharmaceutical actives |
| CA2382577C (en) | 1999-08-27 | 2008-01-22 | Southern Research Institute | Injectable buprenorphine microparticle compositions and their use |
| EP1555023A3 (en) * | 1999-08-27 | 2005-09-28 | 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 |
| US20050048115A1 (en) | 2003-08-27 | 2005-03-03 | Murty Mangena | Buprenorphine microspheres |
| TWI362947B (en) * | 2007-03-08 | 2012-05-01 | Univ Kaohsiung Medical | Controlled release pharmaceutical composition and manufacture method thereof |
| US9161943B2 (en) | 2007-12-31 | 2015-10-20 | Industrial Technology Research Institute | Sustained release composition and manufacturing method thereof |
| KR101113044B1 (ko) * | 2008-08-29 | 2012-02-27 | 동국제약 주식회사 | 용매교류증발법에 의한 서방출성 미립구의 제조방법 |
| US20100086597A1 (en) | 2008-10-06 | 2010-04-08 | Oakwood Laboratories LLC | Microspheres for the sustained release of octreotide with a low initial burst |
| WO2011087496A1 (en) | 2010-01-13 | 2011-07-21 | Oakwood Laboratories LLC | Microspheres for the sustained release of octreotide without an initial time lag |
| 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 CA CA2904432A patent/CA2904432A1/en not_active Abandoned
- 2014-03-14 EP EP14764439.7A patent/EP2968577B1/en active Active
- 2014-03-14 WO PCT/US2014/027982 patent/WO2014143839A1/en active Application Filing
- 2014-03-14 MX MX2015012232A patent/MX362709B/es active IP Right Grant
- 2014-03-14 ES ES14764439T patent/ES2717942T3/es active Active
- 2014-03-14 CN CN201480021351.9A patent/CN105377301B/zh active Active
- 2014-03-14 JP JP2016502675A patent/JP6678571B2/ja active Active
Also Published As
| Publication number | Publication date |
|---|---|
| US9393211B2 (en) | 2016-07-19 |
| CN105377301A (zh) | 2016-03-02 |
| MX2015012232A (es) | 2015-12-01 |
| EP2968577B1 (en) | 2019-01-02 |
| EP2968577A1 (en) | 2016-01-20 |
| EP2968577A4 (en) | 2016-11-23 |
| WO2014143839A1 (en) | 2014-09-18 |
| CA2904432A1 (en) | 2014-09-18 |
| US20140271869A1 (en) | 2014-09-18 |
| ES2717942T3 (es) | 2019-06-26 |
| MX362709B (es) | 2019-02-05 |
| CN105377301B (zh) | 2020-06-05 |
| JP6678571B2 (ja) | 2020-04-08 |
| JP2016513721A (ja) | 2016-05-16 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette] | ||
| B06F | Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette] | ||
| B07E | Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette] |
Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI |
|
| B08F | Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette] |
Free format text: REFERENTE A 8A ANUIDADE. |
|
| B08K | Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette] |
Free format text: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2662 DE 11-01-2022 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013. |