JP4880457B2 - レボチロキシンナトリウムを含む医薬処方 - Google Patents

レボチロキシンナトリウムを含む医薬処方 Download PDF

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Publication number
JP4880457B2
JP4880457B2 JP2006518170A JP2006518170A JP4880457B2 JP 4880457 B2 JP4880457 B2 JP 4880457B2 JP 2006518170 A JP2006518170 A JP 2006518170A JP 2006518170 A JP2006518170 A JP 2006518170A JP 4880457 B2 JP4880457 B2 JP 4880457B2
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JP
Japan
Prior art keywords
pharmaceutical formulation
levothyroxine sodium
formulation according
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.)
Expired - Lifetime
Application number
JP2006518170A
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English (en)
Japanese (ja)
Other versions
JP2009513530A (ja
JP2009513530A5 (enExample
Inventor
マルゴジャタ・コニェツナ
ハイナー・クローン
ヴァンダ・ロマン
ヘンドリック・シュレーアーン
マルゴジャタ・アンナ・ストロジク
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Glaxo Group Ltd
Original Assignee
Glaxo Group Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Glaxo Group Ltd filed Critical Glaxo Group Ltd
Publication of JP2009513530A publication Critical patent/JP2009513530A/ja
Publication of JP2009513530A5 publication Critical patent/JP2009513530A5/ja
Application granted granted Critical
Publication of JP4880457B2 publication Critical patent/JP4880457B2/ja
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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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
    • 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
    • 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
    • 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

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  • 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)
JP2006518170A 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 Expired - Lifetime JP4880457B2 (ja)

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 JP2009513530A5 (enExample) 2011-01-27
JP4880457B2 true 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)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10350194B2 (en) 2015-10-07 2019-07-16 Kyowa Hakko Kirin Co., Ltd. Pharmaceutical composition containing an arylalkylamine compound
KR20190085171A (ko) 2015-10-07 2019-07-17 교와 핫꼬 기린 가부시키가이샤 아릴알킬아민 화합물 함유 의약 조성물

Families Citing this family (14)

* Cited by examiner, † Cited by third party
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
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)

* Cited by examiner, † Cited by third party
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

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10350194B2 (en) 2015-10-07 2019-07-16 Kyowa Hakko Kirin Co., Ltd. Pharmaceutical composition containing an arylalkylamine compound
KR20190085171A (ko) 2015-10-07 2019-07-17 교와 핫꼬 기린 가부시키가이샤 아릴알킬아민 화합물 함유 의약 조성물

Also Published As

Publication number Publication date
CA2531853C (en) 2010-09-14
CN1819820A (zh) 2006-08-16
ZA200510224B (en) 2007-09-26
ES2319193T3 (es) 2009-05-05
JP2009513530A (ja) 2009-04-02
PL1643976T3 (pl) 2009-05-29
DE602004018142D1 (de) 2009-01-15
RU2006104009A (ru) 2006-06-27
NO338465B1 (no) 2016-08-22
AU2004255466A1 (en) 2005-01-20
IL172619A (en) 2010-12-30
US7955621B2 (en) 2011-06-07
HK1089094A1 (en) 2006-11-24
KR20060065628A (ko) 2006-06-14
KR101136655B1 (ko) 2012-04-18
MY140127A (en) 2009-11-30
IS8287A (is) 2006-02-07
CA2531853A1 (en) 2005-01-20
IL172619A0 (en) 2006-04-10
ATE415949T1 (de) 2008-12-15
BRPI0412391B1 (pt) 2017-10-31
IS2616B (is) 2010-04-15
NO20060208L (no) 2006-01-13
TW200518785A (en) 2005-06-16
PT1643976E (pt) 2009-03-03
EP1643976A2 (en) 2006-04-12
AR045719A1 (es) 2005-11-09
NZ544174A (en) 2008-07-31
BRPI0412391B8 (pt) 2021-05-25
US20070110803A1 (en) 2007-05-17
DK1643976T3 (da) 2009-04-06
JP2011213736A (ja) 2011-10-27
MA27898A1 (fr) 2006-05-02
CN100430051C (zh) 2008-11-05
BRPI0412391A (pt) 2006-09-19
TWI329026B (en) 2010-08-21
RU2349345C2 (ru) 2009-03-20
GB0316206D0 (en) 2003-08-13
EP1643976B1 (en) 2008-12-03
WO2005004849A2 (en) 2005-01-20
MXPA06000353A (es) 2006-03-28
WO2005004849A3 (en) 2005-05-06
CO5700710A2 (es) 2006-11-30
AU2004255466B2 (en) 2007-07-26

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