BRPI0412391B8 - formulação farmacêutica compreendendo levotiroxina sódica, seu uso e processo para sua preparação e - Google Patents

formulação farmacêutica compreendendo levotiroxina sódica, seu uso e processo para sua preparação e

Info

Publication number
BRPI0412391B8
BRPI0412391B8 BRPI0412391A BRPI0412391A BRPI0412391B8 BR PI0412391 B8 BRPI0412391 B8 BR PI0412391B8 BR PI0412391 A BRPI0412391 A BR PI0412391A BR PI0412391 A BRPI0412391 A BR PI0412391A BR PI0412391 B8 BRPI0412391 B8 BR PI0412391B8
Authority
BR
Brazil
Prior art keywords
pharmaceutical formulation
levothyroxine sodium
formulation
preparation
amount
Prior art date
Application number
BRPI0412391A
Other languages
English (en)
Portuguese (pt)
Inventor
Krohn Heiner
Schlelhahn Hendrik
Anna Strozyk Malgorzata
Konieczna Malgorzata
Roman Wanda
Original Assignee
Aspen Global Incorporated
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 Aspen Global Incorporated, Glaxo Group Ltd filed Critical Aspen Global Incorporated
Publication of BRPI0412391A publication Critical patent/BRPI0412391A/pt
Publication of BRPI0412391B1 publication Critical patent/BRPI0412391B1/pt
Publication of BRPI0412391B8 publication Critical patent/BRPI0412391B8/pt

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
    • 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
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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)
BRPI0412391A 2003-07-10 2004-07-08 formulação farmacêutica compreendendo levotiroxina sódica, seu uso e processo para sua preparação e BRPI0412391B8 (pt)

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

Publications (3)

Publication Number Publication Date
BRPI0412391A BRPI0412391A (pt) 2006-09-19
BRPI0412391B1 BRPI0412391B1 (pt) 2017-10-31
BRPI0412391B8 true BRPI0412391B8 (pt) 2021-05-25

Family

ID=27741962

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0412391A BRPI0412391B8 (pt) 2003-07-10 2004-07-08 formulação farmacêutica compreendendo levotiroxina sódica, seu uso e processo para sua preparação e

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)

* 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
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)

* 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

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
JP4880457B2 (ja) 2012-02-22
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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Legal Events

Date Code Title Description
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B25A Requested transfer of rights approved

Owner name: ASPEN GLOBAL INCORPORATED (MU)

Free format text: TRANSFERIDO DE: GLAXO GROUP LIMITED

B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]
B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 08/07/2004 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: REFERENTE A RPI 2629 DE 25/05/2021, QUANTO AO ITEM (73) ENDERECO DO TITULAR.

B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

Free format text: REFERENTE A 21A ANUIDADE.

B24J Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12)

Free format text: EM VIRTUDE DA EXTINCAO PUBLICADA NA RPI 2840 DE 10-06-2025 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDA A EXTINCAO DA PATENTE E SEUS CERTIFICADOS, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.