WO2002064093A3 - Stabilized pharmaceutical and thyroid hormone compositions and method of preparation - Google Patents

Stabilized pharmaceutical and thyroid hormone compositions and method of preparation Download PDF

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Publication number
WO2002064093A3
WO2002064093A3 PCT/US2002/004664 US0204664W WO02064093A3 WO 2002064093 A3 WO2002064093 A3 WO 2002064093A3 US 0204664 W US0204664 W US 0204664W WO 02064093 A3 WO02064093 A3 WO 02064093A3
Authority
WO
WIPO (PCT)
Prior art keywords
thyroid hormone
preparation
stabilized pharmaceutical
hormone compositions
sheet
Prior art date
Application number
PCT/US2002/004664
Other languages
French (fr)
Other versions
WO2002064093A2 (en
WO2002064093A8 (en
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 EP02709558A priority Critical patent/EP1365745A2/en
Priority to MXPA03007337A priority patent/MXPA03007337A/en
Priority to JP2002563890A priority patent/JP2004525109A/en
Priority to BR0207297-1A priority patent/BR0207297A/en
Priority to CA002438641A priority patent/CA2438641A1/en
Priority to KR10-2003-7010807A priority patent/KR20040100835A/en
Publication of WO2002064093A2 publication Critical patent/WO2002064093A2/en
Publication of WO2002064093A3 publication Critical patent/WO2002064093A3/en
Priority to NO20033637A priority patent/NO20033637L/en
Publication of WO2002064093A8 publication Critical patent/WO2002064093A8/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F25/00Flow mixers; Mixers for falling materials, e.g. solid particles
    • B01F25/40Static mixers
    • B01F25/42Static mixers in which the mixing is affected by moving the components jointly in changing directions, e.g. in tubes provided with baffles or obstructions
    • B01F25/43Mixing tubes, e.g. wherein the material is moved in a radial or partly reversed direction
    • B01F25/433Mixing tubes wherein the shape of the tube influences the mixing, e.g. mixing tubes with varying cross-section or provided with inwardly extending profiles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic 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
    • A61K31/198Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/14Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F25/00Flow mixers; Mixers for falling materials, e.g. solid particles
    • B01F25/40Static mixers
    • B01F25/42Static mixers in which the mixing is affected by moving the components jointly in changing directions, e.g. in tubes provided with baffles or obstructions
    • B01F25/43Mixing tubes, e.g. wherein the material is moved in a radial or partly reversed direction
    • B01F25/433Mixing tubes wherein the shape of the tube influences the mixing, e.g. mixing tubes with varying cross-section or provided with inwardly extending profiles
    • B01F25/4334Mixers with a converging cross-section
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F25/00Flow mixers; Mixers for falling materials, e.g. solid particles
    • B01F25/80Falling particle mixers, e.g. with repeated agitation along a vertical axis
    • B01F25/82Falling particle mixers, e.g. with repeated agitation along a vertical axis uniting flows of material taken from different parts of a receptacle or from a set of different receptacles

Abstract

A pharmaceutical composition with B-sheet microcrygtalline cellulose with improved potency life and methods of preparation therefor. Improved thyroid hormone pharmaceutical compositions comprising 50 weight % or more of B-sheet microcrystalline cellulose.
PCT/US2002/004664 2001-02-15 2002-02-15 Stabilized pharmaceutical and thyroid hormone compositions and method of preparation WO2002064093A2 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
EP02709558A EP1365745A2 (en) 2001-02-15 2002-02-15 Stabilized pharmaceutical and thyroid hormone compositions and method of preparation
MXPA03007337A MXPA03007337A (en) 2001-02-15 2002-02-15 Stabilized pharmaceutical and thyroid hormone compositions and method of preparation.
JP2002563890A JP2004525109A (en) 2001-02-15 2002-02-15 Stabilized thyroid hormone pharmaceutical composition and method for producing the same
BR0207297-1A BR0207297A (en) 2001-02-15 2002-02-15 Pharmaceutical composition in solid form and method of preparing a solid dosage form of a pharmaceutically active ingredient.
CA002438641A CA2438641A1 (en) 2001-02-15 2002-02-15 Stabilized pharmaceutical and thyroid hormone compositions and method of preparation
KR10-2003-7010807A KR20040100835A (en) 2001-02-15 2002-02-15 Stabilized pharmaceutical and thyroid hormone compositions and method of preparation
NO20033637A NO20033637L (en) 2001-02-15 2003-08-15 Stabilized pharmaceutical and thyroid hormone compositions and methods of manufacture

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US26900901P 2001-02-15 2001-02-15
US60/269,009 2001-02-15

Publications (3)

Publication Number Publication Date
WO2002064093A2 WO2002064093A2 (en) 2002-08-22
WO2002064093A3 true WO2002064093A3 (en) 2002-12-12
WO2002064093A8 WO2002064093A8 (en) 2004-09-16

Family

ID=23025455

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2002/004664 WO2002064093A2 (en) 2001-02-15 2002-02-15 Stabilized pharmaceutical and thyroid hormone compositions and method of preparation

Country Status (9)

Country Link
US (1) US7067148B2 (en)
EP (1) EP1365745A2 (en)
JP (1) JP2004525109A (en)
KR (1) KR20040100835A (en)
BR (1) BR0207297A (en)
CA (1) CA2438641A1 (en)
MX (1) MXPA03007337A (en)
NO (1) NO20033637L (en)
WO (1) WO2002064093A2 (en)

Families Citing this family (10)

* 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
ITMI20110713A1 (en) 2011-04-29 2012-10-30 Bracco Imaging Spa PROCESS FOR THE PREPARATION OF A SULFATE DERIVATIVE DI3,5-DIIODO-O- [3-IODOFENIL] -L-TIROSINA
ITMI20022394A1 (en) 2002-11-13 2004-05-14 Bracco Spa USE OF 3-SULPHATE TRIODOTHYRONIN AS A THYROIMIMETIC ACTIVITY AND RELATED PHARMACEUTICAL FORMULATIONS.
AU2004234176B2 (en) * 2003-05-02 2010-05-13 Globopharm Pharmazeutische Produktions- Und Handelsgesellschaft M.B.H. Solid pharmaceutical preparation containing levothyroxine and/or liothyronine salts
EP2019306A1 (en) * 2007-07-24 2009-01-28 Uhlmann VisioTec GmbH System for manufacturing and testing tablets
EP2932963A1 (en) 2014-04-16 2015-10-21 Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. Stable pharmaceutical dosage forms comprising Levothyroxine sodium
US9682045B2 (en) 2014-11-21 2017-06-20 Cadila Healthcare Limited Stable pharmaceutical compositions of thyroid hormone drug
KR102338803B1 (en) * 2016-05-03 2021-12-14 스펙트릭스 테라퓨틱스, 엘엘씨 Compositions and methods of providing thyroid hormone or analogs thereof
US10231931B1 (en) 2018-03-23 2019-03-19 Genus Lifesciences Inc. Thyroid hormone oral dosage forms and methods of using the same

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US5955105A (en) * 1995-11-14 1999-09-21 Knoll Pharmaceutical Company Stabilized thyroid hormone preparations and methods of making same

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US5225204A (en) * 1991-11-05 1993-07-06 Chen Jivn Ren Stable dosage of levothyroxine sodium and process of production
US5955105A (en) * 1995-11-14 1999-09-21 Knoll Pharmaceutical Company Stabilized thyroid hormone preparations and methods of making same

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US7067148B2 (en) 2006-06-27
BR0207297A (en) 2005-04-19
JP2004525109A (en) 2004-08-19
MXPA03007337A (en) 2005-03-07
CA2438641A1 (en) 2002-08-22
WO2002064093A2 (en) 2002-08-22
US20030119911A1 (en) 2003-06-26
WO2002064093A8 (en) 2004-09-16
NO20033637L (en) 2003-10-15
NO20033637D0 (en) 2003-08-15
KR20040100835A (en) 2004-12-02
EP1365745A2 (en) 2003-12-03

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