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WO2003028624A3 - Levothyroxine compositions and methods - Google Patents

Levothyroxine compositions and methods Download PDF

Info

Publication number
WO2003028624A3
WO2003028624A3 PCT/US2002/025752 US0225752W WO03028624A3 WO 2003028624 A3 WO2003028624 A3 WO 2003028624A3 US 0225752 W US0225752 W US 0225752W WO 03028624 A3 WO03028624 A3 WO 03028624A3
Authority
WO
WIPO (PCT)
Prior art keywords
methods
compositions
sodium
making
levothyroxine
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.)
Ceased
Application number
PCT/US2002/025752
Other languages
French (fr)
Other versions
WO2003028624A2 (en
Inventor
G Andrew Franz
Elaine A Strauss
Phillip A Dimenna
Rocco L Gemma
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.)
King Pharmaceuticals Inc
Original Assignee
King Pharmaceuticals 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 King Pharmaceuticals Inc filed Critical King Pharmaceuticals Inc
Priority to AU2002362468A priority Critical patent/AU2002362468A1/en
Publication of WO2003028624A2 publication Critical patent/WO2003028624A2/en
Publication of WO2003028624A3 publication Critical patent/WO2003028624A3/en
Anticipated expiration legal-status Critical
Ceased 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
    • 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
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

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/US2002/025752 2001-08-14 2002-08-14 Levothyroxine compositions and methods Ceased WO2003028624A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2002362468A AU2002362468A1 (en) 2001-08-14 2002-08-14 Levothyroxine compositions and methods

Applications Claiming Priority (11)

Application Number Priority Date Filing Date Title
US31248301P 2001-08-14 2001-08-14
US31227301P 2001-08-14 2001-08-14
US31218401P 2001-08-14 2001-08-14
US31211401P 2001-08-14 2001-08-14
US31228701P 2001-08-14 2001-08-14
US31211301P 2001-08-14 2001-08-14
US60/312,114 2001-08-14
US60/312,184 2001-08-14
US60/312,113 2001-08-14
US60/312,287 2001-08-14
US60/312,273 2001-08-14

Publications (2)

Publication Number Publication Date
WO2003028624A2 WO2003028624A2 (en) 2003-04-10
WO2003028624A3 true WO2003028624A3 (en) 2003-11-06

Family

ID=27617967

Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/US2002/025854 Ceased WO2003061557A2 (en) 2001-08-14 2002-08-14 Levothyroxine pharmaceutical compositions, methods of making and methods of administration
PCT/US2002/025752 Ceased WO2003028624A2 (en) 2001-08-14 2002-08-14 Levothyroxine compositions and methods

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PCT/US2002/025854 Ceased WO2003061557A2 (en) 2001-08-14 2002-08-14 Levothyroxine pharmaceutical compositions, methods of making and methods of administration

Country Status (2)

Country Link
AU (1) AU2002341555A1 (en)
WO (2) WO2003061557A2 (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7067148B2 (en) 2001-02-15 2006-06-27 King Pharmaceutical Research & Development, Inc. Stabilized pharmaceutical and thyroid hormone compositions and method of preparation
US7101569B2 (en) 2001-08-14 2006-09-05 Franz G Andrew Methods of administering levothyroxine pharmaceutical compositions

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030099699A1 (en) 2001-11-13 2003-05-29 Hanshew Dwight D. Storage stable thyroxine active drug formulations and methods for their production
US6645526B2 (en) 2001-11-13 2003-11-11 Mylan Pharmaceuticals, Inc. Storage stable thyroxine active drug formulations and methods for their production
KR20060109926A (en) 2003-11-19 2006-10-23 메타베이시스 테라퓨틱스, 인크. New phosphorus-containing thyroid hormone mimetics
US20090232879A1 (en) 2005-05-26 2009-09-17 Metabasis Therapeutics, Inc. Thyromimetics for the Treatment of Fatty Liver Diseases
EP3541395A4 (en) 2016-11-21 2020-07-01 Viking Therapeutics, Inc. Method of treating glycogen storage disease
JP7168660B2 (en) 2017-06-05 2022-11-09 バイキング・セラピューティクス・インコーポレイテッド Compositions for the treatment of fibrosis
MX2020009843A (en) 2018-03-22 2020-12-11 Viking Therapeutics Inc Crystalline forms and methods of producing crystalline forms of a compound.
WO2020117962A1 (en) 2018-12-05 2020-06-11 Viking Therapeutics, Inc. Compositions for the treatment of fibrosis and inflammation
EP4360705A3 (en) * 2020-01-13 2024-07-10 Amneal Complex Products Research LLC Sustained release compositions comprising liothyronine
US11964048B2 (en) 2020-12-18 2024-04-23 Amneal Complex Products Research Llc Sustained release compositions comprising liothyronine

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5753254A (en) * 1994-02-01 1998-05-19 Knoll Aktiengesellschaft Therapeutic agents containing thyroid hormones
US6190696B1 (en) * 1998-06-08 2001-02-20 Pieter J. Groenewoud Stabilized thyroxine medications

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MXPA98003802A (en) * 1995-11-14 2005-04-29 Abbott Gmbh & Co Kg Stabilized thyroid hormone preparations and methods of making same.

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5753254A (en) * 1994-02-01 1998-05-19 Knoll Aktiengesellschaft Therapeutic agents containing thyroid hormones
US6190696B1 (en) * 1998-06-08 2001-02-20 Pieter J. Groenewoud Stabilized thyroxine medications

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7067148B2 (en) 2001-02-15 2006-06-27 King Pharmaceutical Research & Development, Inc. Stabilized pharmaceutical and thyroid hormone compositions and method of preparation
US7101569B2 (en) 2001-08-14 2006-09-05 Franz G Andrew Methods of administering levothyroxine pharmaceutical compositions

Also Published As

Publication number Publication date
WO2003061557A2 (en) 2003-07-31
WO2003028624A2 (en) 2003-04-10
WO2003061557A3 (en) 2003-11-06
AU2002341555A1 (en) 2003-09-02

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