WO2003061557A3 - Levothyroxine pharmaceutical compositions, methods of making and methods of administration - Google Patents

Levothyroxine pharmaceutical compositions, methods of making and methods of administration Download PDF

Info

Publication number
WO2003061557A3
WO2003061557A3 PCT/US2002/025854 US0225854W WO03061557A3 WO 2003061557 A3 WO2003061557 A3 WO 2003061557A3 US 0225854 W US0225854 W US 0225854W WO 03061557 A3 WO03061557 A3 WO 03061557A3
Authority
WO
WIPO (PCT)
Prior art keywords
methods
making
pharmaceutical compositions
administration
compositions
Prior art date
Application number
PCT/US2002/025854
Other languages
French (fr)
Other versions
WO2003061557A2 (en
Inventor
Andrew G Franz
Elaine A Strauss
Phillip A Dimenna
Rocco L Gemma
Original Assignee
King Pharmaceuticals Inc
Andrew G Franz
Elaine A Strauss
Phillip 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, Andrew G Franz, Elaine A Strauss, Phillip A Dimenna, Rocco L Gemma filed Critical King Pharmaceuticals Inc
Priority to AU2002341555A priority Critical patent/AU2002341555A1/en
Publication of WO2003061557A2 publication Critical patent/WO2003061557A2/en
Publication of WO2003061557A3 publication Critical patent/WO2003061557A3/en

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

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/US2002/025854 2001-08-14 2002-08-14 Levothyroxine pharmaceutical compositions, methods of making and methods of administration WO2003061557A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2002341555A AU2002341555A1 (en) 2001-08-14 2002-08-14 Levothyroxine pharmaceutical compositions, methods of making and methods of administration

Applications Claiming Priority (12)

Application Number Priority Date Filing Date Title
US31211401P 2001-08-14 2001-08-14
US31218401P 2001-08-14 2001-08-14
US31228701P 2001-08-14 2001-08-14
US31211301P 2001-08-14 2001-08-14
US31227301P 2001-08-14 2001-08-14
US31248301P 2001-08-14 2001-08-14
US60/312,113 2001-08-14
US60/312,273 2001-08-14
US60/312,287 2001-08-14
US60/312,114 2001-08-14
US60/312,184 2001-08-14
US60/312,483 2001-08-15

Publications (2)

Publication Number Publication Date
WO2003061557A2 WO2003061557A2 (en) 2003-07-31
WO2003061557A3 true WO2003061557A3 (en) 2003-11-06

Family

ID=27617967

Family Applications (2)

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

Family Applications After (1)

Application Number Title Priority Date Filing Date
PCT/US2002/025752 WO2003028624A2 (en) 2001-08-14 2002-08-14 Levothyroxine compositions and methods

Country Status (2)

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

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11964048B2 (en) 2020-12-18 2024-04-23 Amneal Complex Products Research Llc Sustained release compositions comprising liothyronine

Families Citing this family (8)

* 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
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.
JP2020500199A (en) 2016-11-21 2020-01-09 バイキング・セラピューティクス・インコーポレイテッド Methods of treating glycogen storage disease
WO2018226604A1 (en) 2017-06-05 2018-12-13 Viking Therapeutics, Inc. Compositions for the treatment of fibrosis
US11787828B2 (en) 2018-03-22 2023-10-17 Viking Therapeutics, Inc. Crystalline forms and methods of producing crystalline forms of a compound
US20230023032A1 (en) * 2020-01-13 2023-01-26 Amneal Complex Products Research Llc Sustained release compositions comprising liothyronine

Citations (3)

* 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
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

Patent Citations (3)

* 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
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

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11964048B2 (en) 2020-12-18 2024-04-23 Amneal Complex Products Research Llc Sustained release compositions comprising liothyronine

Also Published As

Publication number Publication date
AU2002341555A1 (en) 2003-09-02
WO2003028624A3 (en) 2003-11-06
WO2003028624A2 (en) 2003-04-10
WO2003061557A2 (en) 2003-07-31

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