AU2004255466B2 - Pharmaceutical formulation comprising levothyroxine sodium - Google Patents

Pharmaceutical formulation comprising levothyroxine sodium Download PDF

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Publication number
AU2004255466B2
AU2004255466B2 AU2004255466A AU2004255466A AU2004255466B2 AU 2004255466 B2 AU2004255466 B2 AU 2004255466B2 AU 2004255466 A AU2004255466 A AU 2004255466A AU 2004255466 A AU2004255466 A AU 2004255466A AU 2004255466 B2 AU2004255466 B2 AU 2004255466B2
Authority
AU
Australia
Prior art keywords
pharmaceutical formulation
levothyroxine sodium
formulation
total weight
tablets
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
Application number
AU2004255466A
Other languages
English (en)
Other versions
AU2004255466A1 (en
Inventor
Malgorzata Konieczna
Heiner Krohn
Wanda Roman
Hendrik Schlehahn
Malgorzata Anna Strozyk
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.)
Aspen Global Inc
Original Assignee
Aspen Global Inc
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 Aspen Global Inc filed Critical Aspen Global Inc
Publication of AU2004255466A1 publication Critical patent/AU2004255466A1/en
Application granted granted Critical
Publication of AU2004255466B2 publication Critical patent/AU2004255466B2/en
Assigned to ASPEN GLOBAL INCORPORATED reassignment ASPEN GLOBAL INCORPORATED Request for Assignment Assignors: GLAXO GROUP LIMITED
Anticipated expiration legal-status Critical
Expired legal-status Critical Current

Links

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
    • 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
    • A61K9/2059—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)
AU2004255466A 2003-07-10 2004-07-08 Pharmaceutical formulation comprising levothyroxine sodium Expired AU2004255466B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB0316206.2 2003-07-10
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
AU2004255466A1 AU2004255466A1 (en) 2005-01-20
AU2004255466B2 true AU2004255466B2 (en) 2007-07-26

Family

ID=27741962

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2004255466A Expired AU2004255466B2 (en) 2003-07-10 2004-07-08 Pharmaceutical formulation comprising levothyroxine sodium

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 (17)

* 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
ATE519480T1 (de) * 2006-01-06 2011-08-15 Intervet Int Bv Konzentrierte flüssige schilddrüsenhormonzusammensetzung
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
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
WO2014098887A1 (en) * 2012-12-21 2014-06-26 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
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
WO2017061621A1 (ja) 2015-10-07 2017-04-13 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
RS61998B1 (sr) * 2017-02-03 2021-07-30 Berlin Chemie Ag Sredstvo za oralnu terapiju štitaste žlezde
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)

* 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
BR9611306A (pt) * 1995-11-14 1999-12-28 Knoll Pharmaceuticals Co Preparação farmacêutica e, composto farmacêutica estável.
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
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

Also Published As

Publication number Publication date
NO20060208L (no) 2006-01-13
US20070110803A1 (en) 2007-05-17
MA27898A1 (fr) 2006-05-02
KR101136655B1 (ko) 2012-04-18
HK1089094A1 (en) 2006-11-24
JP2011213736A (ja) 2011-10-27
WO2005004849A3 (en) 2005-05-06
CO5700710A2 (es) 2006-11-30
IS8287A (is) 2006-02-07
CA2531853A1 (en) 2005-01-20
IL172619A0 (en) 2006-04-10
ES2319193T3 (es) 2009-05-05
DE602004018142D1 (de) 2009-01-15
GB0316206D0 (en) 2003-08-13
ZA200510224B (en) 2007-09-26
CN1819820A (zh) 2006-08-16
CN100430051C (zh) 2008-11-05
BRPI0412391B1 (pt) 2017-10-31
MY140127A (en) 2009-11-30
NO338465B1 (no) 2016-08-22
JP4880457B2 (ja) 2012-02-22
RU2349345C2 (ru) 2009-03-20
TWI329026B (en) 2010-08-21
NZ544174A (en) 2008-07-31
BRPI0412391B8 (pt) 2021-05-25
BRPI0412391A (pt) 2006-09-19
TW200518785A (en) 2005-06-16
IS2616B (is) 2010-04-15
DK1643976T3 (da) 2009-04-06
CA2531853C (en) 2010-09-14
RU2006104009A (ru) 2006-06-27
ATE415949T1 (de) 2008-12-15
IL172619A (en) 2010-12-30
AU2004255466A1 (en) 2005-01-20
US7955621B2 (en) 2011-06-07
PL1643976T3 (pl) 2009-05-29
AR045719A1 (es) 2005-11-09
MXPA06000353A (es) 2006-03-28
PT1643976E (pt) 2009-03-03
EP1643976B1 (en) 2008-12-03
WO2005004849A2 (en) 2005-01-20
JP2009513530A (ja) 2009-04-02
KR20060065628A (ko) 2006-06-14
EP1643976A2 (en) 2006-04-12

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Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)
PC Assignment registered

Owner name: ASPEN GLOBAL INCORPORATED

Free format text: FORMER OWNER WAS: GLAXO GROUP LIMITED

MK14 Patent ceased section 143(a) (annual fees not paid) or expired