JP2013177406A5 - - Google Patents
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- Publication number
- JP2013177406A5 JP2013177406A5 JP2013092845A JP2013092845A JP2013177406A5 JP 2013177406 A5 JP2013177406 A5 JP 2013177406A5 JP 2013092845 A JP2013092845 A JP 2013092845A JP 2013092845 A JP2013092845 A JP 2013092845A JP 2013177406 A5 JP2013177406 A5 JP 2013177406A5
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical composition
- composition according
- microparticles
- plga
- aggregating agent
- 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.)
- Granted
Links
- 239000008194 pharmaceutical composition Substances 0.000 claims description 14
- 239000011859 microparticle Substances 0.000 claims description 13
- 229920001606 poly(lactic acid-co-glycolic acid) Polymers 0.000 claims description 13
- 239000000203 mixture Substances 0.000 claims description 7
- 229920000642 polymer Polymers 0.000 claims description 6
- DEQANNDTNATYII-OULOTJBUSA-N (4r,7s,10s,13r,16s,19r)-10-(4-aminobutyl)-19-[[(2r)-2-amino-3-phenylpropanoyl]amino]-16-benzyl-n-[(2r,3r)-1,3-dihydroxybutan-2-yl]-7-[(1r)-1-hydroxyethyl]-13-(1h-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicosane-4-carboxa Chemical compound C([C@@H](N)C(=O)N[C@H]1CSSC[C@H](NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CCCCN)NC(=O)[C@@H](CC=2C3=CC=CC=C3NC=2)NC(=O)[C@H](CC=2C=CC=CC=2)NC1=O)C(=O)N[C@H](CO)[C@H](O)C)C1=CC=CC=C1 DEQANNDTNATYII-OULOTJBUSA-N 0.000 claims description 4
- 108010016076 Octreotide Proteins 0.000 claims description 4
- 229960002700 octreotide Drugs 0.000 claims description 4
- 229920002959 polymer blend Polymers 0.000 claims description 4
- 239000010419 fine particle Substances 0.000 claims description 2
- 230000002744 anti-aggregatory effect Effects 0.000 claims 6
- 239000003795 chemical substances by application Substances 0.000 claims 6
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 claims 4
- RKDVKSZUMVYZHH-UHFFFAOYSA-N 1,4-dioxane-2,5-dione Chemical compound O=C1COC(=O)CO1 RKDVKSZUMVYZHH-UHFFFAOYSA-N 0.000 claims 3
- JJTUDXZGHPGLLC-UHFFFAOYSA-N lactide Chemical compound CC1OC(=O)C(C)OC1=O JJTUDXZGHPGLLC-UHFFFAOYSA-N 0.000 claims 3
- 239000000178 monomer Substances 0.000 claims 3
- 150000003839 salts Chemical class 0.000 claims 3
- 239000004480 active ingredient Substances 0.000 claims 2
- 239000008346 aqueous phase Substances 0.000 claims 2
- 239000012074 organic phase Substances 0.000 claims 2
- 239000003791 organic solvent mixture Substances 0.000 claims 2
- 238000013268 sustained release Methods 0.000 claims 2
- 239000012730 sustained-release form Substances 0.000 claims 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- 239000003708 ampul Substances 0.000 claims 1
- 239000008135 aqueous vehicle Substances 0.000 claims 1
- 238000001035 drying Methods 0.000 claims 1
- 230000001804 emulsifying effect Effects 0.000 claims 1
- 239000000839 emulsion Substances 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 238000002156 mixing Methods 0.000 claims 1
- 229920000747 poly(lactic acid) Polymers 0.000 claims 1
- 230000005855 radiation Effects 0.000 claims 1
- 238000007873 sieving Methods 0.000 claims 1
- 238000000935 solvent evaporation Methods 0.000 claims 1
- 238000000638 solvent extraction Methods 0.000 claims 1
- 239000003381 stabilizer Substances 0.000 claims 1
- 239000003981 vehicle Substances 0.000 claims 1
- 238000005406 washing Methods 0.000 claims 1
- 239000007943 implant Substances 0.000 description 2
- 238000009472 formulation Methods 0.000 description 1
- 239000006104 solid solution Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB0526247A GB0526247D0 (en) | 2005-12-22 | 2005-12-22 | Organic compounds |
| GB0526247.2 | 2005-12-22 | ||
| EP06119086 | 2006-08-17 | ||
| EP06119086.4 | 2006-08-17 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2008546248A Division JP2009520727A (ja) | 2005-12-22 | 2006-12-20 | オクトレオチドおよび２種またはそれ以上のポリラクチドコグリコリドポリマーを含む徐放性製剤 |
Related Child Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2014207464A Division JP6178772B2 (ja) | 2005-12-22 | 2014-10-08 | オクトレオチドおよび２種またはそれ以上のポリラクチドコグリコリドポリマーを含む徐放性製剤 |
| JP2016115579A Division JP2016216467A (ja) | 2005-12-22 | 2016-06-09 | オクトレオチドおよび２種またはそれ以上のポリラクチドコグリコリドポリマーを含む徐放性製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2013177406A JP2013177406A (ja) | 2013-09-09 |
| JP2013177406A5 true JP2013177406A5 (https=) | 2016-08-04 |
| JP6239851B2 JP6239851B2 (ja) | 2017-11-29 |
Family
ID=37772904
Family Applications (4)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2008546248A Pending JP2009520727A (ja) | 2005-12-22 | 2006-12-20 | オクトレオチドおよび２種またはそれ以上のポリラクチドコグリコリドポリマーを含む徐放性製剤 |
| JP2013092845A Active JP6239851B2 (ja) | 2005-12-22 | 2013-04-25 | オクトレオチドおよび２種またはそれ以上のポリラクチドコグリコリドポリマーを含む徐放性製剤 |
| JP2014207464A Active JP6178772B2 (ja) | 2005-12-22 | 2014-10-08 | オクトレオチドおよび２種またはそれ以上のポリラクチドコグリコリドポリマーを含む徐放性製剤 |
| JP2016115579A Withdrawn JP2016216467A (ja) | 2005-12-22 | 2016-06-09 | オクトレオチドおよび２種またはそれ以上のポリラクチドコグリコリドポリマーを含む徐放性製剤 |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2008546248A Pending JP2009520727A (ja) | 2005-12-22 | 2006-12-20 | オクトレオチドおよび２種またはそれ以上のポリラクチドコグリコリドポリマーを含む徐放性製剤 |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2014207464A Active JP6178772B2 (ja) | 2005-12-22 | 2014-10-08 | オクトレオチドおよび２種またはそれ以上のポリラクチドコグリコリドポリマーを含む徐放性製剤 |
| JP2016115579A Withdrawn JP2016216467A (ja) | 2005-12-22 | 2016-06-09 | オクトレオチドおよび２種またはそれ以上のポリラクチドコグリコリドポリマーを含む徐放性製剤 |
Country Status (22)
| Country | Link |
|---|---|
| US (7) | US20090004283A1 (https=) |
| EP (3) | EP2359809B1 (https=) |
| JP (4) | JP2009520727A (https=) |
| KR (5) | KR101458728B1 (https=) |
| CN (1) | CN103251929A (https=) |
| AR (1) | AR058591A1 (https=) |
| AU (1) | AU2006328950B2 (https=) |
| BR (2) | BR122019027412B8 (https=) |
| CA (1) | CA2631811C (https=) |
| CL (1) | CL2018003398A1 (https=) |
| EC (1) | ECSP088560A (https=) |
| ES (2) | ES2755032T3 (https=) |
| IL (1) | IL191842A0 (https=) |
| IN (1) | IN2015DN03936A (https=) |
| MA (1) | MA30064B1 (https=) |
| NO (1) | NO20082988L (https=) |
| PE (1) | PE20071139A1 (https=) |
| PL (2) | PL2359809T3 (https=) |
| PT (2) | PT2359809T (https=) |
| RU (1) | RU2464972C2 (https=) |
| TW (2) | TWI469788B (https=) |
| WO (1) | WO2007071395A1 (https=) |
Families Citing this family (26)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP5419169B2 (ja) | 2007-06-06 | 2014-02-19 | デビオファーム リサーチ アンド マニュファクチャリング ソシエテ アノニム | 微小粒子で構成される徐放性医薬組成物 |
| US8470360B2 (en) * | 2008-04-18 | 2013-06-25 | Warsaw Orthopedic, Inc. | Drug depots having different release profiles for reducing, preventing or treating pain and inflammation |
| ES2324009B1 (es) * | 2007-11-23 | 2010-05-21 | Gp Pharm S.A. | Composicion farmaceutica de liberacion sostenida de somatostatina o un analogo suyo. |
| KR101921800B1 (ko) * | 2008-01-30 | 2018-11-23 | 노파르티스 아게 | 옥트레오티드 및 3종의 선형 폴리락티드-코-글리콜리드 중합체를 포함하는 서방형 제제 |
| AU2013201877B2 (en) * | 2008-01-30 | 2015-01-29 | Novartis Ag | Sustained release formulation comprising octreotide and three linear polylactide-co-glycolide polymers |
| AU2015201581B2 (en) * | 2008-09-17 | 2017-03-09 | Amryt Endo, Inc. | Pharmaceutical Compositions and Related Methods of Delivery |
| KR101814186B1 (ko) * | 2008-09-17 | 2018-03-14 | 키아스마 인코포레이티드 | 약제학적 조성물 및 연관된 투여방법 |
| US20100151033A1 (en) * | 2008-12-15 | 2010-06-17 | Novartis Ag | Octreotide depot formulation with constantly high exposure levels |
| CA2750003A1 (en) * | 2009-01-23 | 2010-07-29 | Surmodics Pharmaceuticals, Inc. | Controlled release systems from polymer blends |
| WO2012012546A2 (en) * | 2010-07-21 | 2012-01-26 | Allergan, Inc. | METHOD OF CONTROLLING INITIAL DRUG RELEASE OF siRNA FROM SUSTAINED-RELEASE IMPLANTS |
| GB201016436D0 (en) | 2010-09-30 | 2010-11-17 | Q Chip Ltd | Method of making solid beads |
| GB201016433D0 (en) | 2010-09-30 | 2010-11-17 | Q Chip Ltd | Apparatus and method for making solid beads |
| WO2012083026A1 (en) * | 2010-12-15 | 2012-06-21 | Evonik Degussa Corporation | Branched polyol polyesters, blends and pharmaceutical formulations comprising same |
| HUE046004T2 (hu) | 2011-04-25 | 2020-01-28 | Shan Dong Luye Pharm Co Ltd | Risperidon nyújtott hatóanyagleadású mikroszféra készítmény |
| CN102488619B (zh) * | 2011-12-05 | 2014-08-06 | 上海交通大学 | 连续生产艾塞那肽微球的装置及控制微球释放速度的方法 |
| WO2016084849A1 (ja) * | 2014-11-25 | 2016-06-02 | Cbc株式会社 | ヤヌス微粒子及びその製造方法 |
| WO2016126830A1 (en) | 2015-02-03 | 2016-08-11 | Chiasma Inc. | Method of treating diseases |
| JP6165356B2 (ja) * | 2015-06-26 | 2017-07-19 | オリンパス株式会社 | 内視鏡システム |
| US12396951B2 (en) * | 2016-12-27 | 2025-08-26 | Upexmed Co. Ltd. | Prevention of local tumor recurrence following surgery using sustainedand/or delayed release of medicaments contained in micro-particles |
| KR102142026B1 (ko) * | 2017-05-31 | 2020-08-06 | 주식회사 대웅제약 | 방출제어가 용이한 서방성 약물 미립자의 제조방법 |
| MX2022002980A (es) | 2019-09-16 | 2022-04-06 | Amgen Inc | Metodo para la esterilizacion externa de un dispositivo de suministro de farmacos. |
| CN111214643A (zh) * | 2020-03-11 | 2020-06-02 | 苏州善湾生物医药科技有限公司 | 一种基于皮下凝胶缓释的奥曲肽组合物、制备方法及应用 |
| JP6852943B1 (ja) * | 2020-05-08 | 2021-03-31 | エム・テクニック株式会社 | 主剤が均一に分散されたマイクロスフェアー及びそれを含有する徐放性製剤 |
| KR102947969B1 (ko) * | 2020-05-08 | 2026-04-06 | 엠. 테크닉 가부시키가이샤 | 생리 활성 물질이 균일하게 분산된 마이크로스피어 및 그것을 함유하는 서방성 제제 |
| KR102947972B1 (ko) * | 2020-05-08 | 2026-04-06 | 엠. 테크닉 가부시키가이샤 | 생리 활성 물질이 균일하게 분산된 마이크로스피어 및 그것을 함유하는 서방성 제제 |
| US11141457B1 (en) | 2020-12-28 | 2021-10-12 | Amryt Endo, Inc. | Oral octreotide therapy and contraceptive methods |
Family Cites Families (27)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3773919A (en) * | 1969-10-23 | 1973-11-20 | Du Pont | Polylactide-drug mixtures |
| DE3062075D1 (en) | 1979-11-27 | 1983-03-24 | Sandoz Ag | Polypeptides, processes for their production, pharmaceutical compositions comprising said polypeptides and their use |
| US4675189A (en) * | 1980-11-18 | 1987-06-23 | Syntex (U.S.A.) Inc. | Microencapsulation of water soluble active polypeptides |
| US4897268A (en) * | 1987-08-03 | 1990-01-30 | Southern Research Institute | Drug delivery system and method of making the same |
| US5538739A (en) | 1989-07-07 | 1996-07-23 | Sandoz Ltd. | Sustained release formulations of water soluble peptides |
| PH30995A (en) * | 1989-07-07 | 1997-12-23 | Novartis Inc | Sustained release formulations of water soluble peptides. |
| HU221294B1 (en) * | 1989-07-07 | 2002-09-28 | Novartis Ag | Process for producing retarde compositions containing the active ingredient in a polymeric carrier |
| MY107937A (en) * | 1990-02-13 | 1996-06-29 | Takeda Chemical Industries Ltd | Prolonged release microcapsules. |
| CH683149A5 (fr) * | 1991-07-22 | 1994-01-31 | Debio Rech Pharma Sa | Procédé pour la préparation de microsphères en matériau polymère biodégradable. |
| US5470582A (en) * | 1992-02-07 | 1995-11-28 | Syntex (U.S.A.) Inc. | Controlled delivery of pharmaceuticals from preformed porous polymeric microparticles |
| KR100260632B1 (ko) * | 1992-12-28 | 2000-07-01 | 성재갑 | 이식형 소마토트로핀 조성물 |
| US5603960A (en) * | 1993-05-25 | 1997-02-18 | O'hagan; Derek T. | Preparation of microparticles and method of immunization |
| US5417982A (en) * | 1994-02-17 | 1995-05-23 | Modi; Pankaj | Controlled release of drugs or hormones in biodegradable polymer microspheres |
| US6447796B1 (en) * | 1994-05-16 | 2002-09-10 | The United States Of America As Represented By The Secretary Of The Army | Sustained release hydrophobic bioactive PLGA microspheres |
| WO1998027980A2 (en) * | 1996-12-20 | 1998-07-02 | Takeda Chemical Industries, Ltd. | Method of producing a sustained-release preparation |
| MY118835A (en) * | 1997-04-18 | 2005-01-31 | Ipsen Pharma Biotech | Sustained release compositions and the process for their preparation |
| IL133105A (en) * | 1997-06-04 | 2004-09-27 | Debio Rech Pharma Sa | Implants for controlled release of pharmaceutically active principles and method for making same |
| ES2169980B1 (es) * | 1999-12-17 | 2003-11-01 | Lipotec Sa | Microcapsulas para la liberacion prolongada de farmacos. |
| KR100392501B1 (ko) * | 2000-06-28 | 2003-07-22 | 동국제약 주식회사 | 다중 에멀젼법에 의한 서방출성 미립구의 제조방법 |
| ES2292655T3 (es) * | 2002-03-15 | 2008-03-16 | Alrise Biosystems Gmbh | Microparticulas y procedimiento para su preparacion. |
| RU2355385C2 (ru) * | 2002-11-06 | 2009-05-20 | Алза Корпорейшн | Композиции пролонгированного действия с контролируемым высвобождением |
| US20040097419A1 (en) * | 2002-11-19 | 2004-05-20 | Holger Petersen | Organic compounds |
| KR100466637B1 (ko) * | 2003-06-26 | 2005-01-13 | 주식회사 펩트론 | 서방성 미립구의 혼합 제형을 연속한 단일 공정으로제조하는 방법 |
| ES2600554T3 (es) * | 2003-07-18 | 2017-02-09 | Oakwood Laboratories L.L.C. | Prevención de la reducción del peso molecular del polímero, de la formación de impurezas y de la gelificación en composiciones poliméricas |
| JP5165240B2 (ja) * | 2003-07-23 | 2013-03-21 | ピーアール ファーマシューティカルズ， インコーポレイテッド | 徐放組成物 |
| MY158342A (en) * | 2003-11-14 | 2016-09-30 | Novartis Ag | Pharmaceutical composition |
| DE602005013244D1 (de) * | 2004-08-12 | 2009-04-23 | Quest Pharmaceutical Services | Pharmazeutische zusammensetzungen für die kontroll |
-
2006
- 2006-12-20 ES ES10175382T patent/ES2755032T3/es active Active
- 2006-12-20 PE PE2006001665A patent/PE20071139A1/es not_active Application Discontinuation
- 2006-12-20 US US12/158,345 patent/US20090004283A1/en not_active Abandoned
- 2006-12-20 KR KR1020137004517A patent/KR101458728B1/ko active Active
- 2006-12-20 WO PCT/EP2006/012313 patent/WO2007071395A1/en not_active Ceased
- 2006-12-20 AU AU2006328950A patent/AU2006328950B2/en active Active
- 2006-12-20 KR KR1020147031146A patent/KR20140133968A/ko not_active Ceased
- 2006-12-20 PT PT101753820T patent/PT2359809T/pt unknown
- 2006-12-20 KR KR1020137004518A patent/KR20130024987A/ko not_active Ceased
- 2006-12-20 EP EP10175382.0A patent/EP2359809B1/en active Active
- 2006-12-20 KR KR1020137004520A patent/KR20130024988A/ko not_active Ceased
- 2006-12-20 PL PL10175382T patent/PL2359809T3/pl unknown
- 2006-12-20 ES ES06841059.6T patent/ES2492641T3/es active Active
- 2006-12-20 BR BR122019027412A patent/BR122019027412B8/pt active IP Right Grant
- 2006-12-20 CN CN2013101523825A patent/CN103251929A/zh active Pending
- 2006-12-20 AR ARP060105668A patent/AR058591A1/es unknown
- 2006-12-20 RU RU2008129626/15A patent/RU2464972C2/ru active
- 2006-12-20 KR KR1020087014985A patent/KR101245919B1/ko active Active
- 2006-12-20 BR BRPI0620063A patent/BRPI0620063B8/pt active IP Right Grant
- 2006-12-20 EP EP06841059.6A patent/EP1968549B1/en active Active
- 2006-12-20 CA CA2631811A patent/CA2631811C/en active Active
- 2006-12-20 JP JP2008546248A patent/JP2009520727A/ja active Pending
- 2006-12-20 PT PT68410596T patent/PT1968549E/pt unknown
- 2006-12-20 IN IN3936DEN2015 patent/IN2015DN03936A/en unknown
- 2006-12-20 PL PL06841059T patent/PL1968549T3/pl unknown
- 2006-12-20 EP EP19188892.4A patent/EP3603623A1/en not_active Withdrawn
- 2006-12-21 TW TW95148218A patent/TWI469788B/zh active
- 2006-12-21 TW TW103107772A patent/TWI468172B/zh active
-
2008
- 2008-05-29 IL IL191842A patent/IL191842A0/en unknown
- 2008-06-18 MA MA31048A patent/MA30064B1/fr unknown
- 2008-06-19 EC EC2008008560A patent/ECSP088560A/es unknown
- 2008-07-02 NO NO20082988A patent/NO20082988L/no not_active Application Discontinuation
-
2013
- 2013-04-25 JP JP2013092845A patent/JP6239851B2/ja active Active
-
2014
- 2014-10-08 JP JP2014207464A patent/JP6178772B2/ja active Active
- 2014-10-16 US US14/516,016 patent/US20150037420A1/en not_active Abandoned
-
2015
- 2015-12-22 US US14/977,801 patent/US20160120935A1/en not_active Abandoned
-
2016
- 2016-06-09 JP JP2016115579A patent/JP2016216467A/ja not_active Withdrawn
-
2018
- 2018-01-17 US US15/873,473 patent/US20180140662A1/en not_active Abandoned
- 2018-11-29 CL CL2018003398A patent/CL2018003398A1/es unknown
-
2020
- 2020-03-10 US US16/813,864 patent/US20200206306A1/en not_active Abandoned
-
2022
- 2022-06-07 US US17/834,014 patent/US20220296675A1/en not_active Abandoned
-
2024
- 2024-11-22 US US18/956,119 patent/US20250082718A1/en active Pending
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