NO20060208L - Farmasoytisk preparat - Google Patents
Farmasoytisk preparatInfo
- Publication number
- NO20060208L NO20060208L NO20060208A NO20060208A NO20060208L NO 20060208 L NO20060208 L NO 20060208L NO 20060208 A NO20060208 A NO 20060208A NO 20060208 A NO20060208 A NO 20060208A NO 20060208 L NO20060208 L NO 20060208L
- Authority
- NO
- Norway
- Prior art keywords
- weight
- amount
- preparation
- pharmaceutical preparation
- total
- Prior art date
Links
- 239000000825 pharmaceutical preparation Substances 0.000 title 1
- XUIIKFGFIJCVMT-LBPRGKRZSA-N L-thyroxine Chemical compound IC1=CC(C[C@H]([NH3+])C([O-])=O)=CC(I)=C1OC1=CC(I)=C(O)C(I)=C1 XUIIKFGFIJCVMT-LBPRGKRZSA-N 0.000 abstract 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 abstract 1
- 229920000881 Modified starch Polymers 0.000 abstract 1
- 229960003918 levothyroxine sodium Drugs 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 abstract 1
- 239000008108 microcrystalline cellulose Substances 0.000 abstract 1
- 229940016286 microcrystalline cellulose Drugs 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 239000002245 particle Substances 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 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
- A61K9/20—Pills, tablets, discs, rods
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/14—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
Landscapes
- Health & Medical Sciences (AREA)
- Public Health (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Endocrinology (AREA)
- Diabetes (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Det er beskrevet et stabilt farmasøytisk preparat omfattende (a) en effektiv mengde av levotyroksinnatrium, (b) mikrokiystallinsk cellulose som har en midlere partikkelstørrelse på mindre enn 125 jxm og er til stede i en mengde på 60 til 85 vekt/vekt basert på den samlede vekten av formuleringen, og (c) pregelatinisert stivelse til stede i en mengde på 5 til 30 % vekt/vekt basert på samlet vekt av preparatet. Det er videre tilveiebragt en fremgangsmåte for fremstilling av et slikt preparat.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB0316206.2A GB0316206D0 (en) | 2003-07-10 | 2003-07-10 | Pharmaceutical formulation |
| PCT/EP2004/007667 WO2005004849A2 (en) | 2003-07-10 | 2004-07-08 | Pharmaceutical formulation comprising levothyroxine sodium |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| NO20060208L true NO20060208L (no) | 2006-01-13 |
| NO338465B1 NO338465B1 (no) | 2016-08-22 |
Family
ID=27741962
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| NO20060208A NO338465B1 (no) | 2003-07-10 | 2006-01-13 | Farmasøytisk preparat omfattende levotyroksinnatrium, fremgangsmåte for fremstilling samt anvendelse derav |
Country Status (28)
| Country | Link |
|---|---|
| US (1) | US7955621B2 (no) |
| EP (1) | EP1643976B1 (no) |
| JP (2) | JP4880457B2 (no) |
| KR (1) | KR101136655B1 (no) |
| CN (1) | CN100430051C (no) |
| AR (1) | AR045719A1 (no) |
| AT (1) | ATE415949T1 (no) |
| AU (1) | AU2004255466B2 (no) |
| BR (1) | BRPI0412391B8 (no) |
| CA (1) | CA2531853C (no) |
| CO (1) | CO5700710A2 (no) |
| DE (1) | DE602004018142D1 (no) |
| DK (1) | DK1643976T3 (no) |
| ES (1) | ES2319193T3 (no) |
| GB (1) | GB0316206D0 (no) |
| IL (1) | IL172619A (no) |
| IS (1) | IS2616B (no) |
| MA (1) | MA27898A1 (no) |
| MX (1) | MXPA06000353A (no) |
| MY (1) | MY140127A (no) |
| NO (1) | NO338465B1 (no) |
| NZ (1) | NZ544174A (no) |
| PL (1) | PL1643976T3 (no) |
| PT (1) | PT1643976E (no) |
| RU (1) | RU2349345C2 (no) |
| TW (1) | TWI329026B (no) |
| WO (1) | WO2005004849A2 (no) |
| ZA (1) | ZA200510224B (no) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| ITMI20022394A1 (it) | 2002-11-13 | 2004-05-14 | Bracco Spa | Uso di triiodotironina 3-solfato come farmaco ad attivita' tireomimetica e relative formulazioni farmaceutiche. |
| JP5173832B2 (ja) * | 2006-01-06 | 2013-04-03 | インターベツト・インターナシヨナル・ベー・ベー | 濃縮液体甲状腺ホルモン組成物 |
| 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 |
| WO2014098887A1 (en) * | 2012-12-21 | 2014-06-26 | Mylan Inc. | Levothyroxine formulation with acacia |
| US9271951B2 (en) | 2012-12-21 | 2016-03-01 | Mylan Inc. | Levothyroxine formulation with acacia |
| WO2014098886A1 (en) * | 2012-12-21 | 2014-06-26 | Mylan Inc. | Levothyroxine formulation with carrageenan |
| 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 |
| ES2872249T3 (es) * | 2017-02-03 | 2021-11-02 | Berlin Chemie Ag | Agente terapéutico tiroideo oral |
| IT201800003615A1 (it) * | 2018-03-15 | 2019-09-15 | Altergon Sa | Formulazioni altamente stabili di ormone tiroideo in capsule molli |
| CN109988076A (zh) * | 2019-05-05 | 2019-07-09 | 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 |
| WO2025181833A1 (en) * | 2024-03-01 | 2025-09-04 | Srushti Pharmaceuticals Pvt Ltd | Levothyroxine sodium pellets composition and method of preparation |
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 |
| CA2145171C (en) * | 1992-09-22 | 1999-09-21 | Thomas A. Ruszkay | 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 |
| US6190696B1 (en) * | 1998-06-08 | 2001-02-20 | Pieter J. Groenewoud | 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 |
| US6555581B1 (en) * | 2001-02-15 | 2003-04-29 | Jones Pharma, Inc. | Levothyroxine compositions and methods |
| US20030032675A1 (en) * | 2001-02-15 | 2003-02-13 | Franz G. Andrew | Manufacture of thyroid hormone tablets having consistent active moiety amounts |
-
2003
- 2003-07-10 GB GBGB0316206.2A patent/GB0316206D0/en not_active Ceased
-
2004
- 2004-07-08 EP EP04740922A patent/EP1643976B1/en not_active Expired - Lifetime
- 2004-07-08 DK DK04740922T patent/DK1643976T3/da active
- 2004-07-08 WO PCT/EP2004/007667 patent/WO2005004849A2/en not_active Ceased
- 2004-07-08 ES ES04740922T patent/ES2319193T3/es not_active Expired - Lifetime
- 2004-07-08 PT PT04740922T patent/PT1643976E/pt unknown
- 2004-07-08 AT AT04740922T patent/ATE415949T1/de active
- 2004-07-08 RU RU2006104009/15A patent/RU2349345C2/ru active
- 2004-07-08 AR ARP040102405A patent/AR045719A1/es not_active Application Discontinuation
- 2004-07-08 CA CA2531853A patent/CA2531853C/en not_active Expired - Lifetime
- 2004-07-08 DE DE602004018142T patent/DE602004018142D1/de not_active Expired - Lifetime
- 2004-07-08 NZ NZ544174A patent/NZ544174A/en not_active IP Right Cessation
- 2004-07-08 JP JP2006518170A patent/JP4880457B2/ja not_active Expired - Lifetime
- 2004-07-08 TW TW093120412A patent/TWI329026B/zh not_active IP Right Cessation
- 2004-07-08 MX MXPA06000353A patent/MXPA06000353A/es active IP Right Grant
- 2004-07-08 CN CNB2004800197743A patent/CN100430051C/zh not_active Expired - Lifetime
- 2004-07-08 BR BRPI0412391A patent/BRPI0412391B8/pt not_active IP Right Cessation
- 2004-07-08 MY MYPI20042725A patent/MY140127A/en unknown
- 2004-07-08 PL PL04740922T patent/PL1643976T3/pl unknown
- 2004-07-08 US US10/564,148 patent/US7955621B2/en not_active Expired - Lifetime
- 2004-07-08 KR KR1020067000484A patent/KR101136655B1/ko not_active Expired - Lifetime
- 2004-07-08 AU AU2004255466A patent/AU2004255466B2/en not_active Expired
-
2005
- 2005-12-15 IL IL172619A patent/IL172619A/en active IP Right Grant
- 2005-12-15 ZA ZA200510224A patent/ZA200510224B/en unknown
- 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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