WO2004014318A3 - Levothyroxine compositions and methods - Google Patents

Levothyroxine compositions and methods Download PDF

Info

Publication number
WO2004014318A3
WO2004014318A3 PCT/US2003/025170 US0325170W WO2004014318A3 WO 2004014318 A3 WO2004014318 A3 WO 2004014318A3 US 0325170 W US0325170 W US 0325170W WO 2004014318 A3 WO2004014318 A3 WO 2004014318A3
Authority
WO
WIPO (PCT)
Prior art keywords
methods
compositions
sodium
making
levothyroxine
Prior art date
Application number
PCT/US2003/025170
Other languages
French (fr)
Other versions
WO2004014318A2 (en
Inventor
Elaine A Strauss
G Andrew Franz
Philip A Dimenna
Rocco L Gemma
Original Assignee
King Pharmaceuticals Inc
Elaine A Strauss
G Andrew Franz
Philip A Dimenna
Rocco L Gemma
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 King Pharmaceuticals Inc, Elaine A Strauss, G Andrew Franz, Philip A Dimenna, Rocco L Gemma filed Critical King Pharmaceuticals Inc
Priority to AU2003268078A priority Critical patent/AU2003268078A1/en
Publication of WO2004014318A2 publication Critical patent/WO2004014318A2/en
Publication of WO2004014318A3 publication Critical patent/WO2004014318A3/en

Links

Classifications

    • 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, pantothenic acid
    • A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms

Abstract

The present invention generally relates to stable pharmaceutical compositions, and methods of making and administering such compositions. In one aspect, the invention features stabilized pharmaceutical compositions that include pharmaceutically active ingredients such as levothyroxine (T4) sodium and liothyronine (T3) sodium (thyroid hormone drugs), preferably in an immediate release solid dosage form. Also provided are methods for making and using such immediate release and stabilized compositions.
PCT/US2003/025170 2002-08-10 2003-08-08 Levothyroxine compositions and methods WO2004014318A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2003268078A AU2003268078A1 (en) 2002-08-10 2003-08-08 Levothyroxine compositions and methods

Applications Claiming Priority (12)

Application Number Priority Date Filing Date Title
US40238102P 2002-08-10 2002-08-10
US40232802P 2002-08-10 2002-08-10
US60/402,381 2002-08-10
US60/402,328 2002-08-10
US40330002P 2002-08-14 2002-08-14
US40357202P 2002-08-14 2002-08-14
US40354102P 2002-08-14 2002-08-14
US40356902P 2002-08-14 2002-08-14
US60/403,569 2002-08-14
US60/403,541 2002-08-14
US60/403,300 2002-08-14
US60/403,572 2002-08-14

Publications (2)

Publication Number Publication Date
WO2004014318A2 WO2004014318A2 (en) 2004-02-19
WO2004014318A3 true WO2004014318A3 (en) 2004-10-28

Family

ID=31721935

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2003/025170 WO2004014318A2 (en) 2002-08-10 2003-08-08 Levothyroxine compositions and methods

Country Status (2)

Country Link
AU (1) AU2003268078A1 (en)
WO (1) WO2004014318A2 (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2428516A1 (en) 2003-11-19 2012-03-14 Metabasis Therapeutics, Inc. Novel phosphorus-containing thyromimetics
MX2007014502A (en) 2005-05-26 2008-02-07 Metabasis Therapeutics Inc Thyromimetics for the treatment of fatty liver diseases.
US11202789B2 (en) 2016-11-21 2021-12-21 Viking Therapeutics, Inc. Method of treating glycogen storage disease
BR112019025659A2 (en) 2017-06-05 2020-08-25 Viking Therapeutics, Inc. compositions for the treatment of fibrosis
KR20200138283A (en) 2018-03-22 2020-12-09 바이킹 테라퓨틱스 인코포레이티드 Crystalline forms, and methods of preparing compounds in crystalline form

Citations (5)

* 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
US5753254A (en) * 1994-02-01 1998-05-19 Knoll Aktiengesellschaft Therapeutic agents containing thyroid hormones
US5955105A (en) * 1995-11-14 1999-09-21 Knoll Pharmaceutical Company Stabilized thyroid hormone preparations and methods of making same
US6190696B1 (en) * 1998-06-08 2001-02-20 Pieter J. Groenewoud Stabilized thyroxine medications
US6290990B1 (en) * 1994-04-18 2001-09-18 Basf Aktiengesellschaft Slow-release matrix pellets and the production thereof

Patent Citations (5)

* 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
US5753254A (en) * 1994-02-01 1998-05-19 Knoll Aktiengesellschaft Therapeutic agents containing thyroid hormones
US6290990B1 (en) * 1994-04-18 2001-09-18 Basf Aktiengesellschaft Slow-release matrix pellets and the production thereof
US5955105A (en) * 1995-11-14 1999-09-21 Knoll Pharmaceutical Company Stabilized thyroid hormone preparations and methods of making same
US6190696B1 (en) * 1998-06-08 2001-02-20 Pieter J. Groenewoud Stabilized thyroxine medications

Also Published As

Publication number Publication date
AU2003268078A1 (en) 2004-02-25
WO2004014318A2 (en) 2004-02-19
AU2003268078A8 (en) 2004-02-25

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