JP2009513530A5 - - Google Patents
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- Publication number
- JP2009513530A5 JP2009513530A5 JP2006518170A JP2006518170A JP2009513530A5 JP 2009513530 A5 JP2009513530 A5 JP 2009513530A5 JP 2006518170 A JP2006518170 A JP 2006518170A JP 2006518170 A JP2006518170 A JP 2006518170A JP 2009513530 A5 JP2009513530 A5 JP 2009513530A5
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical formulation
- formulation according
- starch
- microcrystalline cellulose
- pharmaceutical
- 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 21
- 229920002472 Starch Polymers 0.000 claims description 20
- 239000008107 starch Substances 0.000 claims description 20
- 235000019698 starch Nutrition 0.000 claims description 15
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 13
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 13
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 13
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 13
- 229960003918 levothyroxine sodium Drugs 0.000 claims description 12
- 239000000203 mixture Substances 0.000 claims description 10
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 8
- 238000009472 formulation Methods 0.000 claims description 8
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 8
- 239000000843 powder Substances 0.000 claims description 6
- 238000004519 manufacturing process Methods 0.000 claims description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 5
- 235000019359 magnesium stearate Nutrition 0.000 claims description 4
- 238000002156 mixing Methods 0.000 claims description 4
- 239000002245 particle Substances 0.000 claims description 4
- 239000000454 talc Substances 0.000 claims description 4
- 229910052623 talc Inorganic materials 0.000 claims description 4
- 239000000377 silicon dioxide Substances 0.000 claims description 3
- JMHCCAYJTTWMCX-QWPJCUCISA-M sodium;(2s)-2-amino-3-[4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl]propanoate;pentahydrate Chemical compound O.O.O.O.O.[Na+].IC1=CC(C[C@H](N)C([O-])=O)=CC(I)=C1OC1=CC(I)=C(O)C(I)=C1 JMHCCAYJTTWMCX-QWPJCUCISA-M 0.000 claims 4
- 241000124008 Mammalia Species 0.000 claims 2
- AUYYCJSJGJYCDS-LBPRGKRZSA-N Thyrolar Chemical class IC1=CC(C[C@H](N)C(O)=O)=CC(I)=C1OC1=CC=C(O)C(I)=C1 AUYYCJSJGJYCDS-LBPRGKRZSA-N 0.000 claims 2
- 239000002552 dosage form Substances 0.000 claims 2
- 239000000314 lubricant Substances 0.000 claims 2
- 229940036555 thyroid hormone Drugs 0.000 claims 2
- 239000005495 thyroid hormone Substances 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 1
- 239000004615 ingredient Substances 0.000 claims 1
- 150000004686 pentahydrates Chemical group 0.000 claims 1
- 238000003825 pressing Methods 0.000 claims 1
- YDTFRJLNMPSCFM-YDALLXLXSA-M levothyroxine sodium anhydrous Chemical compound [Na+].IC1=CC(C[C@H](N)C([O-])=O)=CC(I)=C1OC1=CC(I)=C(O)C(I)=C1 YDTFRJLNMPSCFM-YDALLXLXSA-M 0.000 description 10
- 229940075614 colloidal silicon dioxide Drugs 0.000 description 2
- 229920000945 Amylopectin Polymers 0.000 description 1
- 229920000856 Amylose Polymers 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 238000007907 direct compression Methods 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 239000007909 solid dosage form Substances 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB0316206.2A GB0316206D0 (en) | 2003-07-10 | 2003-07-10 | Pharmaceutical formulation |
| GB0316206.2 | 2003-07-10 | ||
| PCT/EP2004/007667 WO2005004849A2 (en) | 2003-07-10 | 2004-07-08 | Pharmaceutical formulation comprising levothyroxine sodium |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2011160067A Division JP2011213736A (ja) | 2003-07-10 | 2011-07-21 | レボチロキシンナトリウムを含む医薬処方 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2009513530A JP2009513530A (ja) | 2009-04-02 |
| JP2009513530A5 true JP2009513530A5 (enExample) | 2011-01-27 |
| JP4880457B2 JP4880457B2 (ja) | 2012-02-22 |
Family
ID=27741962
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2006518170A Expired - Lifetime JP4880457B2 (ja) | 2003-07-10 | 2004-07-08 | レボチロキシンナトリウムを含む医薬処方 |
| JP2011160067A Pending JP2011213736A (ja) | 2003-07-10 | 2011-07-21 | レボチロキシンナトリウムを含む医薬処方 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2011160067A Pending JP2011213736A (ja) | 2003-07-10 | 2011-07-21 | レボチロキシンナトリウムを含む医薬処方 |
Country Status (28)
| Country | Link |
|---|---|
| US (1) | US7955621B2 (enExample) |
| EP (1) | EP1643976B1 (enExample) |
| JP (2) | JP4880457B2 (enExample) |
| KR (1) | KR101136655B1 (enExample) |
| CN (1) | CN100430051C (enExample) |
| AR (1) | AR045719A1 (enExample) |
| AT (1) | ATE415949T1 (enExample) |
| AU (1) | AU2004255466B2 (enExample) |
| BR (1) | BRPI0412391B8 (enExample) |
| CA (1) | CA2531853C (enExample) |
| CO (1) | CO5700710A2 (enExample) |
| DE (1) | DE602004018142D1 (enExample) |
| DK (1) | DK1643976T3 (enExample) |
| ES (1) | ES2319193T3 (enExample) |
| GB (1) | GB0316206D0 (enExample) |
| IL (1) | IL172619A (enExample) |
| IS (1) | IS2616B (enExample) |
| MA (1) | MA27898A1 (enExample) |
| MX (1) | MXPA06000353A (enExample) |
| MY (1) | MY140127A (enExample) |
| NO (1) | NO338465B1 (enExample) |
| NZ (1) | NZ544174A (enExample) |
| PL (1) | PL1643976T3 (enExample) |
| PT (1) | PT1643976E (enExample) |
| RU (1) | RU2349345C2 (enExample) |
| TW (1) | TWI329026B (enExample) |
| WO (1) | WO2005004849A2 (enExample) |
| ZA (1) | ZA200510224B (enExample) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ITMI20022394A1 (it) | 2002-11-13 | 2004-05-14 | Bracco Spa | Uso di triiodotironina 3-solfato come farmaco ad attivita' tireomimetica e relative formulazioni farmaceutiche. |
| ITMI20110713A1 (it) | 2011-04-29 | 2012-10-30 | Bracco Imaging Spa | Processo per la preparazione di un derivato solfatato di3,5-diiodo-o-[3-iodofenil]-l-tirosina |
| US8318712B2 (en) | 2006-01-06 | 2012-11-27 | Intervet International B.V. | Concentrated liquid thyroid hormone composition |
| IT1395454B1 (it) * | 2009-03-24 | 2012-09-21 | Altergon Sa | Composizioni e forme farmaceutiche per somministrazione orale di ormoni tiroidei in grado di contrastare l'azione di agenti sequestranti nel tratto gastrointestinale |
| ITMI20112066A1 (it) * | 2011-11-14 | 2013-05-15 | Altergon Sa | Preparazione farmaceutica orale monodose di ormoni tiroidei t3 e t4 |
| EP2941272A1 (en) * | 2012-12-21 | 2015-11-11 | Mylan Inc. | Levothyroxine formulation with acacia |
| WO2014098886A1 (en) * | 2012-12-21 | 2014-06-26 | Mylan Inc. | Levothyroxine formulation with carrageenan |
| US9271951B2 (en) | 2012-12-21 | 2016-03-01 | Mylan Inc. | Levothyroxine formulation with acacia |
| EP2932963A1 (en) | 2014-04-16 | 2015-10-21 | Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. | Stable pharmaceutical dosage forms comprising Levothyroxine sodium |
| KR102488488B1 (ko) | 2015-10-07 | 2023-01-12 | 쿄와 기린 가부시키가이샤 | 아릴알킬아민 화합물 함유 의약 조성물 |
| JP6168673B2 (ja) | 2015-10-07 | 2017-07-26 | 協和発酵キリン株式会社 | アリールアルキルアミン化合物含有医薬組成物 |
| WO2018069805A2 (en) | 2016-10-10 | 2018-04-19 | Ftf Pharma Private Limited | Method for preparation of liquid oral composition of l-thyroxin |
| LT3576795T (lt) * | 2017-02-03 | 2021-07-26 | Berlin-Chemie Ag | Geriamasis skydliaukės terapinis agentas |
| IT201800003615A1 (it) * | 2018-03-15 | 2019-09-15 | Altergon Sa | Formulazioni altamente stabili di ormone tiroideo in capsule molli |
| CN118894787A (zh) * | 2019-05-05 | 2024-11-05 | 上海葆隆生物科技有限公司 | 一种左甲状腺素钠杂质及其制备 |
| KR20220085086A (ko) | 2020-12-14 | 2022-06-22 | 메디케어제약 주식회사 | 갑상선 기능 저하증을 동반한 대사 증후군을 치료하는 약제학적 복합제제 |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5225204A (en) * | 1991-11-05 | 1993-07-06 | Chen Jivn Ren | Stable dosage of levothyroxine sodium and process of production |
| AU4856093A (en) * | 1992-09-22 | 1994-04-12 | Fmc Corporation | Product and process of making microcrystalline cellulose |
| GB9401879D0 (en) | 1994-02-01 | 1994-03-30 | Boots Co Plc | Therapeutic agents |
| DE19541128C2 (de) * | 1995-10-27 | 1997-11-27 | Henning Berlin Gmbh & Co | Stabilisierte schilddrüsenhormonhaltige Arzneimittel |
| DE69633018T2 (de) * | 1995-11-14 | 2004-12-09 | Abbott Gmbh & Co. Kg | Schilddrüsenhormone enthaltende stabilisierte arzneimittel und verfahren |
| JPH11286456A (ja) * | 1998-03-31 | 1999-10-19 | Lion Corp | 複合粉体組成物及び錠剤 |
| DE19821625C1 (de) * | 1998-05-15 | 2000-01-05 | Merck Patent Gmbh | Pharmazeutische Zubereitung |
| WO1999063969A1 (en) * | 1998-06-08 | 1999-12-16 | Groenewoud Pieter J | Stabilized thyroxine medications |
| JP2001064177A (ja) | 1999-08-16 | 2001-03-13 | Schering Ag | ベンズアミド誘導体を有効成分とする製剤 |
| JP3435664B2 (ja) | 1999-12-08 | 2003-08-11 | ヤンセンファーマ株式会社 | 口腔内速崩壊型錠剤及びその製造方法 |
| US6399101B1 (en) * | 2000-03-30 | 2002-06-04 | Mova Pharmaceutical Corp. | Stable thyroid hormone preparations and method of making same |
| US20030032675A1 (en) * | 2001-02-15 | 2003-02-13 | Franz G. Andrew | Manufacture of thyroid hormone tablets having consistent active moiety amounts |
| US6555581B1 (en) * | 2001-02-15 | 2003-04-29 | Jones Pharma, Inc. | Levothyroxine compositions and methods |
-
2003
- 2003-07-10 GB GBGB0316206.2A patent/GB0316206D0/en not_active Ceased
-
2004
- 2004-07-08 TW TW093120412A patent/TWI329026B/zh not_active IP Right Cessation
- 2004-07-08 JP JP2006518170A patent/JP4880457B2/ja not_active Expired - Lifetime
- 2004-07-08 DE DE602004018142T patent/DE602004018142D1/de not_active Expired - Lifetime
- 2004-07-08 PT PT04740922T patent/PT1643976E/pt unknown
- 2004-07-08 KR KR1020067000484A patent/KR101136655B1/ko not_active Expired - Lifetime
- 2004-07-08 EP EP04740922A patent/EP1643976B1/en not_active Expired - Lifetime
- 2004-07-08 PL PL04740922T patent/PL1643976T3/pl unknown
- 2004-07-08 CN CNB2004800197743A patent/CN100430051C/zh not_active Expired - Lifetime
- 2004-07-08 AT AT04740922T patent/ATE415949T1/de active
- 2004-07-08 BR BRPI0412391A patent/BRPI0412391B8/pt not_active IP Right Cessation
- 2004-07-08 WO PCT/EP2004/007667 patent/WO2005004849A2/en not_active Ceased
- 2004-07-08 CA CA2531853A patent/CA2531853C/en not_active Expired - Lifetime
- 2004-07-08 AU AU2004255466A patent/AU2004255466B2/en not_active Expired
- 2004-07-08 AR ARP040102405A patent/AR045719A1/es not_active Application Discontinuation
- 2004-07-08 NZ NZ544174A patent/NZ544174A/en not_active IP Right Cessation
- 2004-07-08 RU RU2006104009/15A patent/RU2349345C2/ru active
- 2004-07-08 MX MXPA06000353A patent/MXPA06000353A/es active IP Right Grant
- 2004-07-08 DK DK04740922T patent/DK1643976T3/da active
- 2004-07-08 US US10/564,148 patent/US7955621B2/en not_active Expired - Lifetime
- 2004-07-08 ES ES04740922T patent/ES2319193T3/es not_active Expired - Lifetime
- 2004-07-08 MY MYPI20042725A patent/MY140127A/en unknown
-
2005
- 2005-12-15 ZA ZA200510224A patent/ZA200510224B/en unknown
- 2005-12-15 IL IL172619A patent/IL172619A/en active IP Right Grant
- 2005-12-30 CO CO05131486A patent/CO5700710A2/es not_active Application Discontinuation
-
2006
- 2006-01-06 MA MA28702A patent/MA27898A1/fr unknown
- 2006-01-13 NO NO20060208A patent/NO338465B1/no unknown
- 2006-02-07 IS IS8287A patent/IS2616B/is unknown
-
2011
- 2011-07-21 JP JP2011160067A patent/JP2011213736A/ja active Pending
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