JP2007504103A5 - - Google Patents
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- Publication number
- JP2007504103A5 JP2007504103A5 JP2006524227A JP2006524227A JP2007504103A5 JP 2007504103 A5 JP2007504103 A5 JP 2007504103A5 JP 2006524227 A JP2006524227 A JP 2006524227A JP 2006524227 A JP2006524227 A JP 2006524227A JP 2007504103 A5 JP2007504103 A5 JP 2007504103A5
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical composition
- tacrolimus
- solid
- composition according
- poloxamer
- 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
- 239000007962 solid dispersion Substances 0.000 claims description 25
- 239000006104 solid solution Substances 0.000 claims description 22
- QJJXYPPXXYFBGM-LFZNUXCKSA-N Tacrolimus Chemical compound C1C[C@@H](O)[C@H](OC)C[C@@H]1\C=C(/C)[C@@H]1[C@H](C)[C@@H](O)CC(=O)[C@H](CC=C)/C=C(C)/C[C@H](C)C[C@H](OC)[C@H]([C@H](C[C@H]2C)OC)O[C@@]2(O)C(=O)C(=O)N2CCCC[C@H]2C(=O)O1 QJJXYPPXXYFBGM-LFZNUXCKSA-N 0.000 claims description 19
- 229960001967 tacrolimus Drugs 0.000 claims description 19
- QJJXYPPXXYFBGM-SHYZHZOCSA-N tacrolimus Natural products CO[C@H]1C[C@H](CC[C@@H]1O)C=C(C)[C@H]2OC(=O)[C@H]3CCCCN3C(=O)C(=O)[C@@]4(O)O[C@@H]([C@H](C[C@H]4C)OC)[C@@H](C[C@H](C)CC(=C[C@@H](CC=C)C(=O)C[C@H](O)[C@H]2C)C)OC QJJXYPPXXYFBGM-SHYZHZOCSA-N 0.000 claims description 19
- 239000008194 pharmaceutical composition Substances 0.000 claims description 16
- 239000000203 mixture Substances 0.000 claims description 5
- 239000012738 dissolution medium Substances 0.000 claims description 4
- 238000007922 dissolution test Methods 0.000 claims description 4
- 238000004519 manufacturing process Methods 0.000 claims description 2
- 239000006208 topical dosage form Substances 0.000 claims description 2
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims 6
- 239000002202 Polyethylene glycol Substances 0.000 claims 5
- 229920001983 poloxamer Polymers 0.000 claims 5
- 229960000502 poloxamer Drugs 0.000 claims 5
- 229920001223 polyethylene glycol Polymers 0.000 claims 5
- 239000008118 PEG 6000 Substances 0.000 claims 1
- 229920002584 Polyethylene Glycol 6000 Polymers 0.000 claims 1
- 230000002708 enhancing effect Effects 0.000 claims 1
- 239000004518 granules dosage form Substances 0.000 claims 1
- 229920001993 poloxamer 188 Polymers 0.000 claims 1
- 229940044519 poloxamer 188 Drugs 0.000 claims 1
- 239000004480 active ingredient Substances 0.000 description 11
- 239000002552 dosage form Substances 0.000 description 10
- 239000003981 vehicle Substances 0.000 description 8
- 239000000546 pharmaceutical excipient Substances 0.000 description 6
- 239000007787 solid Substances 0.000 description 5
- 239000006185 dispersion Substances 0.000 description 4
- 238000000034 method Methods 0.000 description 4
- 238000002360 preparation method Methods 0.000 description 4
- 238000013268 sustained release Methods 0.000 description 3
- 239000012730 sustained-release form Substances 0.000 description 3
- 239000008136 water-miscible vehicle Substances 0.000 description 3
- 239000013543 active substance Substances 0.000 description 2
- 239000011230 binding agent Substances 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 239000007884 disintegrant Substances 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 238000002149 energy-dispersive X-ray emission spectroscopy Methods 0.000 description 2
- 239000000945 filler Substances 0.000 description 2
- 239000000314 lubricant Substances 0.000 description 2
- 230000008018 melting Effects 0.000 description 2
- 238000002844 melting Methods 0.000 description 2
- 230000004060 metabolic process Effects 0.000 description 2
- 239000006186 oral dosage form Substances 0.000 description 2
- 239000007909 solid dosage form Substances 0.000 description 2
- 102000004328 Cytochrome P-450 CYP3A Human genes 0.000 description 1
- 108010081668 Cytochrome P-450 CYP3A Proteins 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 238000005054 agglomeration Methods 0.000 description 1
- 230000002776 aggregation Effects 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- -1 carrier Substances 0.000 description 1
- 238000005266 casting Methods 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 239000003086 colorant Substances 0.000 description 1
- 238000000113 differential scanning calorimetry Methods 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 210000001198 duodenum Anatomy 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000003623 enhancer Substances 0.000 description 1
- 239000002702 enteric coating Substances 0.000 description 1
- 238000009505 enteric coating Methods 0.000 description 1
- 239000003205 fragrance Substances 0.000 description 1
- 238000004108 freeze drying Methods 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 230000001404 mediated effect Effects 0.000 description 1
- 238000000386 microscopy Methods 0.000 description 1
- 239000004005 microsphere Substances 0.000 description 1
- 239000003607 modifier Substances 0.000 description 1
- 239000002105 nanoparticle Substances 0.000 description 1
- 239000003002 pH adjusting agent Substances 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 239000008188 pellet Substances 0.000 description 1
- 238000000634 powder X-ray diffraction Methods 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 238000004626 scanning electron microscopy Methods 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 238000001694 spray drying Methods 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 239000000375 suspending agent Substances 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 1
- 239000006068 taste-masking agent Substances 0.000 description 1
Applications Claiming Priority (13)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DKPA200301232 | 2003-08-29 | ||
| DKPA200301232 | 2003-08-29 | ||
| DKPA200301837 | 2003-12-11 | ||
| DKPA200301837 | 2003-12-11 | ||
| US52979303P | 2003-12-15 | 2003-12-15 | |
| US60/529,793 | 2003-12-15 | ||
| DKPA200400079 | 2004-01-21 | ||
| DKPA200400079 | 2004-01-21 | ||
| DKPA200400467 | 2004-03-23 | ||
| DKPA200400463 | 2004-03-23 | ||
| DKPA200400467 | 2004-03-23 | ||
| DKPA200400463 | 2004-03-23 | ||
| PCT/DK2004/000574 WO2005020994A1 (en) | 2003-08-29 | 2004-08-30 | Solid dispersions comprising tacrolimus |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2011150025A Division JP2011251972A (ja) | 2003-08-29 | 2011-07-06 | タクロリムスを含む医薬組成物 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2007504103A JP2007504103A (ja) | 2007-03-01 |
| JP2007504103A5 true JP2007504103A5 (enExample) | 2011-12-22 |
| JP4903568B2 JP4903568B2 (ja) | 2012-03-28 |
Family
ID=42994769
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2006524227A Expired - Lifetime JP4903568B2 (ja) | 2003-08-29 | 2004-08-30 | タクロリムスを含む固体分散体 |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US8591946B2 (enExample) |
| JP (1) | JP4903568B2 (enExample) |
| CN (2) | CN101869561A (enExample) |
| AT (1) | ATE531368T1 (enExample) |
| DK (2) | DK1663217T3 (enExample) |
| ES (1) | ES2376238T3 (enExample) |
| PT (2) | PT1663217E (enExample) |
| SI (2) | SI1663216T1 (enExample) |
Families Citing this family (40)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7994214B2 (en) | 2003-08-29 | 2011-08-09 | Lifecycle Pharma A/S | Solid dispersions comprising tacrolimus |
| KR100678824B1 (ko) * | 2005-02-04 | 2007-02-05 | 한미약품 주식회사 | 용해성이 증가된 무정형 타크로리무스 고체분산체 및 이를포함하는 약제학적 조성물 |
| US20060210638A1 (en) * | 2005-03-17 | 2006-09-21 | Elan Pharma International Limited | Injectable compositions of nanoparticulate immunosuppressive compounds |
| US20080181947A1 (en) * | 2006-09-26 | 2008-07-31 | Astellas Pharma Inc. | Controlled release dosage form of tacrolimus |
| WO2008084698A1 (ja) * | 2006-12-28 | 2008-07-17 | Astellas Pharma Inc. | タクロリムス徐放性医薬組成物 |
| JP2010515753A (ja) | 2007-01-10 | 2010-05-13 | ボード・オブ・リージエンツ，ザ・ユニバーシテイ・オブ・テキサス・システム | 肺内送達用免疫抑制剤組成物の送達の増強 |
| AU2008288105A1 (en) | 2007-03-29 | 2009-02-19 | Panacea Biotec Limited. | Modified dosage forms of tacrolimus |
| PL2167033T4 (pl) | 2007-05-30 | 2018-08-31 | Veloxis Pharmaceuticals A/S | Podawana raz dziennie doustna postać dawkowania zawierająca takrolimus |
| US12083103B2 (en) * | 2007-05-30 | 2024-09-10 | Veloxis Pharmaceuticals, Inc. | Tacrolimus for improved treatment of transplant patients |
| US8349033B2 (en) * | 2007-05-31 | 2013-01-08 | The Penray Companies, Inc. | Diesel fuel, diesel fuel additive, and associated method for using the same |
| HRP20191104T1 (hr) | 2007-09-25 | 2019-09-20 | Solubest Ltd. | Pripravci koji sadrže lipofilne aktivne spojeve i postupak za njihovu pripremu |
| CL2008000374A1 (es) | 2008-02-05 | 2008-04-04 | Igloo Zone Chile S A | Composicion farmaceutica que comprende un polvo para suspension oral de tacrolimus o una de sus sales, hidratos o solvatos y excipientes farmaceuticamente aceptables; procedimiento de preparacion de dicha composicion farmaceutica; y uso para la preve |
| US8222272B2 (en) | 2008-04-11 | 2012-07-17 | Roxane Laboratories, Inc. | Pharmaceutical formulation and process comprising a solid dispersion of macrolide (tacrolimus) |
| US12403095B2 (en) | 2008-05-30 | 2025-09-02 | Veloxis Pharmaceuticals, Inc. | Stabilized tacrolimus composition |
| US7794750B2 (en) * | 2008-06-20 | 2010-09-14 | Mutual Pharmaceutical Company, Inc. | Controlled-release formulations, method of manufacture, and use thereof |
| US8632805B2 (en) * | 2008-06-20 | 2014-01-21 | Mutual Pharmaceutical Company, Inc. | Controlled-release formulations, method of manufacture, and use thereof |
| CA2729948C (en) * | 2008-07-08 | 2021-11-23 | Lifecycle Pharma A/S | Tacrolimus for improved treatment of transplant patients |
| KR101174183B1 (ko) | 2008-11-28 | 2012-08-16 | 주식회사 삼양바이오팜 | 생체이용률이 향상된 타크로리무스 제제 및 상기 제제의 제조방법 |
| PT2467136E (pt) * | 2009-12-07 | 2014-08-26 | Raptor Therapeutics Inc | Formulações de 4-metilpirazol |
| WO2011080716A2 (en) * | 2010-01-04 | 2011-07-07 | Wockhardt Limited | Pharmaceutical composition for modified delivery of actives |
| ES2591352T3 (es) * | 2010-02-17 | 2016-11-28 | Veloxis Pharmaceuticals A/S | Composición de tacrolimus estabilizada |
| EP2560621A1 (en) * | 2010-04-22 | 2013-02-27 | Ratiopharm GmbH | Fingolimod in the form of a solid solution |
| US20130102683A1 (en) * | 2010-04-22 | 2013-04-25 | Ratiopharm Gmbh | Melt-granulated fingolimod |
| US8951996B2 (en) * | 2011-07-28 | 2015-02-10 | Lipocine Inc. | 17-hydroxyprogesterone ester-containing oral compositions and related methods |
| WO2013057570A2 (en) * | 2011-10-18 | 2013-04-25 | Purdue Pharma L.P. | Acrylic polymer formulations |
| US9168246B2 (en) | 2013-06-27 | 2015-10-27 | Veloxis Pharmaceutical A/S | Regimen for suppressing organ rejection |
| US9545407B2 (en) * | 2014-08-07 | 2017-01-17 | Pharmacyclics Llc | Formulations of a bruton's tyrosine kinase inhibitor |
| CN105828827A (zh) | 2014-11-21 | 2016-08-03 | 杭州领业医药科技有限公司 | 一种含他克莫司的药物组合物及其制备方法 |
| ES2889905T3 (es) * | 2015-10-23 | 2022-01-14 | Basf Se | Formulaciones de liberación controlada de sustancias aromáticas para aplicación dérmica |
| CN107126419B (zh) * | 2016-02-26 | 2020-06-19 | 石药集团中诺药业（石家庄）有限公司 | 一种奥贝胆酸片剂及其制备方法 |
| CN106309395B (zh) * | 2016-09-22 | 2019-09-20 | 沈阳药科大学 | 一种他克莫司缓释片及其制备方法 |
| CN107595799A (zh) * | 2017-10-30 | 2018-01-19 | 无锡福祈制药有限公司 | 一种复方肠溶口崩片及其制备方法 |
| CN113825495A (zh) * | 2018-10-11 | 2021-12-21 | 阿利维奥治疗学股份有限公司 | 用于智能释放的不可注射水凝胶调配物 |
| US10752642B1 (en) | 2019-04-30 | 2020-08-25 | George Mason University | Macrocyclic lactones |
| EP4101469A4 (en) * | 2020-02-03 | 2024-05-29 | Senju Pharmaceutical Co., Ltd. | USE OF A POLYETHER COMPOUND |
| US11666560B2 (en) | 2020-09-24 | 2023-06-06 | George Mason University | Anti-fibrotic agent |
| CA3212370A1 (en) | 2021-03-03 | 2022-09-09 | Sana Biotechnology, Inc. | Immunosuppressive therapies for use with cardiomyocyte cell therapies, and associated methods and compositions |
| CN114469847B (zh) * | 2021-12-29 | 2024-08-13 | 北京鑫开元医药科技有限公司 | 他克莫司栓剂及其制备方法和用途 |
| CN117049933B (zh) * | 2023-08-11 | 2025-02-18 | 西北大学 | 一种可热塑成型的复合钨系延期药及其制备方法 |
| CN121197078A (zh) * | 2025-09-28 | 2025-12-26 | 湖州润宠生物科技有限公司 | 一种雷帕霉素多相释放或渗透泵型周效口服控释组合物及其制备方法 |
Family Cites Families (28)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4894366A (en) | 1984-12-03 | 1990-01-16 | Fujisawa Pharmaceutical Company, Ltd. | Tricyclo compounds, a process for their production and a pharmaceutical composition containing the same |
| GB8608080D0 (en) * | 1986-04-02 | 1986-05-08 | Fujisawa Pharmaceutical Co | Solid dispersion composition |
| KR0177158B1 (ko) | 1990-03-01 | 1999-03-20 | 후지사와 도모기찌로 | 면역억제 활성을 갖는 트리사이클릭 화합물 함유 용액 제제 |
| US5281420A (en) | 1992-05-19 | 1994-01-25 | The Procter & Gamble Company | Solid dispersion compositions of tebufelone |
| ES2134860T3 (es) * | 1992-11-18 | 1999-10-16 | Fujisawa Pharmaceutical Co | Preparacion farmaceutica de accion prolongada. |
| US6204243B1 (en) * | 1993-09-01 | 2001-03-20 | Novatis Ag | Pharmaceutical preparations for the targeted treatment of crohn's disease and ulcerative colitis |
| ZA9710927B (en) * | 1996-12-06 | 1998-06-15 | Fujisawa Pharmaceutical Co | Pharmaceutical composition. |
| TW450810B (en) | 1997-02-20 | 2001-08-21 | Fujisawa Pharmaceutical Co | Macrolides antibiotic pharmaceutical composition for preventing and treating skin diseases |
| AU749623B2 (en) * | 1998-03-26 | 2002-06-27 | Astellas Pharma Inc. | Sustained release preparations |
| US6248363B1 (en) * | 1999-11-23 | 2001-06-19 | Lipocine, Inc. | Solid carriers for improved delivery of active ingredients in pharmaceutical compositions |
| US6168806B1 (en) * | 1999-03-05 | 2001-01-02 | Fang-Yu Lee | Orally administrable nifedipine pellet and process for the preparation thereof |
| US20030180352A1 (en) * | 1999-11-23 | 2003-09-25 | Patel Mahesh V. | Solid carriers for improved delivery of active ingredients in pharmaceutical compositions |
| GB0007842D0 (en) | 2000-03-31 | 2000-05-17 | Spruce Barbara | Sigma receptor ligands and their medical uses |
| US20010036959A1 (en) * | 2000-04-03 | 2001-11-01 | Gabel Rolf Dieter | Carvedilol-hydrophilic solutions |
| US20020028240A1 (en) * | 2000-04-17 | 2002-03-07 | Toyohiro Sawada | Timed-release compression-coated solid composition for oral administration |
| US6761895B2 (en) * | 2000-04-17 | 2004-07-13 | Yamanouchi Pharmaceutical Co., Ltd. | Drug delivery system for averting pharmacokinetic drug interaction and method thereof |
| JPWO2001078681A1 (ja) | 2000-04-17 | 2004-01-08 | 山之内製薬株式会社 | 薬物動態学的な薬物相互作用を回避する薬物送達システム及びその方法 |
| WO2001095939A1 (en) | 2000-06-12 | 2001-12-20 | Smithkline Beecham Corporation | Novel solid dispersion compositions |
| US6367913B1 (en) * | 2000-10-31 | 2002-04-09 | Hewlett-Packard Company | System and method for improving the lightfastness of color printouts |
| US6884436B2 (en) * | 2000-12-22 | 2005-04-26 | Baxter International Inc. | Method for preparing submicron particle suspensions |
| ES2739852T3 (es) * | 2001-07-06 | 2020-02-04 | Veloxis Pharmaceuticals As | Aglomeración controlada |
| US20030129250A1 (en) * | 2001-11-20 | 2003-07-10 | Advanced Inhalation Research Inc. | Particulate compositions for improving solubility of poorly soluble agents |
| BRPI0412329A (pt) * | 2003-07-09 | 2006-09-05 | Chong Kun Dang Pharm Corp | dispersão sólida de tacrolimus e método de processar a mesma |
| US20070122482A1 (en) * | 2003-10-03 | 2007-05-31 | Per Holm | Method for preparing modified release pharmaceutical compositions |
| US20050249799A1 (en) * | 2004-03-03 | 2005-11-10 | Spherics, Inc. | Polymeric drug delivery system for hydrophobic drugs |
| US20060045865A1 (en) * | 2004-08-27 | 2006-03-02 | Spherics, Inc. | Controlled regional oral delivery |
| JP2008524239A (ja) * | 2004-12-15 | 2008-07-10 | エラン ファーマ インターナショナル リミティド | ナノ粒子のタクロリムス製剤 |
| US20060210638A1 (en) * | 2005-03-17 | 2006-09-21 | Elan Pharma International Limited | Injectable compositions of nanoparticulate immunosuppressive compounds |
-
2004
- 2004-08-30 ES ES04762794T patent/ES2376238T3/es not_active Expired - Lifetime
- 2004-08-30 DK DK04762795.5T patent/DK1663217T3/da active
- 2004-08-30 PT PT04762795T patent/PT1663217E/pt unknown
- 2004-08-30 SI SI200431812T patent/SI1663216T1/sl unknown
- 2004-08-30 CN CN201010194179A patent/CN101869561A/zh active Pending
- 2004-08-30 CN CN2004800283344A patent/CN1859909B/zh not_active Expired - Lifetime
- 2004-08-30 AT AT04762794T patent/ATE531368T1/de active
- 2004-08-30 JP JP2006524227A patent/JP4903568B2/ja not_active Expired - Lifetime
- 2004-08-30 SI SI200431491T patent/SI1663217T1/sl unknown
- 2004-08-30 DK DK04762794.8T patent/DK1663216T3/da active
- 2004-08-30 US US10/569,862 patent/US8591946B2/en active Active
- 2004-08-30 PT PT04762794T patent/PT1663216E/pt unknown
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