WO2003013441A3 - Levothyroxine compositions and methods - Google Patents

Levothyroxine compositions and methods Download PDF

Info

Publication number
WO2003013441A3
WO2003013441A3 PCT/US2002/025475 US0225475W WO03013441A3 WO 2003013441 A3 WO2003013441 A3 WO 2003013441A3 US 0225475 W US0225475 W US 0225475W WO 03013441 A3 WO03013441 A3 WO 03013441A3
Authority
WO
WIPO (PCT)
Prior art keywords
methods
compositions
sodium
making
levothyroxine
Prior art date
Application number
PCT/US2002/025475
Other languages
French (fr)
Other versions
WO2003013441A2 (en
Inventor
G Andrew Franz
Elaine A Strauss
Phillip A Dimenna
Rocco L Gemma
Original Assignee
King Pharmaceuticals Inc
G Andrew 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, G Andrew Franz, Elaine A Strauss, Phillip A Dimenna, Rocco L Gemma filed Critical King Pharmaceuticals Inc
Priority to AU2002332507A priority Critical patent/AU2002332507A1/en
Publication of WO2003013441A2 publication Critical patent/WO2003013441A2/en
Publication of WO2003013441A3 publication Critical patent/WO2003013441A3/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
    • 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
    • A61K9/2004—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
    • A61K9/2072—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/US2002/025475 2001-08-10 2002-08-10 Levothyroxine compositions and methods WO2003013441A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2002332507A AU2002332507A1 (en) 2001-08-10 2002-08-10 Levothyroxine compositions and methods

Applications Claiming Priority (10)

Application Number Priority Date Filing Date Title
US31152401P 2001-08-10 2001-08-10
US31155201P 2001-08-10 2001-08-10
US31152201P 2001-08-10 2001-08-10
US31152301P 2001-08-10 2001-08-10
US31154901P 2001-08-10 2001-08-10
US60/311,524 2001-08-10
US60/311,549 2001-08-10
US60/311,523 2001-08-10
US60/311,522 2001-08-10
US60/311,552 2001-08-10

Publications (2)

Publication Number Publication Date
WO2003013441A2 WO2003013441A2 (en) 2003-02-20
WO2003013441A3 true WO2003013441A3 (en) 2003-10-30

Family

ID=27540960

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2002/025475 WO2003013441A2 (en) 2001-08-10 2002-08-10 Levothyroxine compositions and methods

Country Status (2)

Country Link
AU (1) AU2002332507A1 (en)
WO (1) WO2003013441A2 (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6645526B2 (en) 2001-11-13 2003-11-11 Mylan Pharmaceuticals, Inc. Storage stable thyroxine active drug formulations and methods for their production
US20030099699A1 (en) 2001-11-13 2003-05-29 Hanshew Dwight D. Storage stable thyroxine active drug formulations and methods for their production
US20060141054A1 (en) * 2004-10-25 2006-06-29 Thomas Piccariello Metal coordinated compositions
US8779175B2 (en) 2004-10-25 2014-07-15 Synthonics, Inc. Coordination complexes, pharmaceutical solutions comprising coordination complexes, and methods of treating patients
CN115078576B (en) * 2022-06-14 2024-02-13 陕西九州制药有限责任公司 Analytical method for related substances of paracetamol and dihydrocodeine tablet

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

Also Published As

Publication number Publication date
AU2002332507A1 (en) 2003-02-24
WO2003013441A2 (en) 2003-02-20

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