AU2003247409B2 - Combination immediate release controlled release levodopa/carbidopa dosage forms - Google Patents

Combination immediate release controlled release levodopa/carbidopa dosage forms Download PDF

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Publication number
AU2003247409B2
AU2003247409B2 AU2003247409A AU2003247409A AU2003247409B2 AU 2003247409 B2 AU2003247409 B2 AU 2003247409B2 AU 2003247409 A AU2003247409 A AU 2003247409A AU 2003247409 A AU2003247409 A AU 2003247409A AU 2003247409 B2 AU2003247409 B2 AU 2003247409B2
Authority
AU
Australia
Prior art keywords
levodopa
dosage form
carbidopa
release component
pharmaceutical dosage
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
AU2003247409A
Other languages
English (en)
Other versions
AU2003247409A1 (en
Inventor
Chien-Hsuan Han
Anne F. Hsu
Larry Hsu
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.)
Impax Laboratories LLC
Original Assignee
Impax Laboratories LLC
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
Priority claimed from US10/241,837 external-priority patent/US7094427B2/en
Application filed by Impax Laboratories LLC filed Critical Impax Laboratories LLC
Publication of AU2003247409A1 publication Critical patent/AU2003247409A1/en
Application granted granted Critical
Publication of AU2003247409B2 publication Critical patent/AU2003247409B2/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
    • A61K9/2072—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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • 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 or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Psychology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
AU2003247409A 2002-05-29 2003-05-23 Combination immediate release controlled release levodopa/carbidopa dosage forms Ceased AU2003247409B2 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US10/158,412 2002-05-29
US10/158,412 US20030224045A1 (en) 2002-05-29 2002-05-29 Combination immediate release sustained release levodopa/carbidopa dosage forms
US10/241,837 US7094427B2 (en) 2002-05-29 2002-09-12 Combination immediate release controlled release levodopa/carbidopa dosage forms
US10/241,837 2002-09-12
PCT/US2003/016391 WO2003101432A1 (en) 2002-05-29 2003-05-23 Combination immediate release controlled release levodopa/carbidopa dosage forms

Publications (2)

Publication Number Publication Date
AU2003247409A1 AU2003247409A1 (en) 2003-12-19
AU2003247409B2 true AU2003247409B2 (en) 2008-04-17

Family

ID=29582673

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2003247409A Ceased AU2003247409B2 (en) 2002-05-29 2003-05-23 Combination immediate release controlled release levodopa/carbidopa dosage forms

Country Status (7)

Country Link
US (1) US20030224045A1 (enExample)
EP (1) EP1507518B1 (enExample)
JP (1) JP2005528430A (enExample)
AU (1) AU2003247409B2 (enExample)
CA (1) CA2486859C (enExample)
IL (1) IL164856A (enExample)
WO (1) WO2003101432A1 (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10098845B2 (en) 2013-10-07 2018-10-16 Impax Laboratories, Llc Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040052843A1 (en) * 2001-12-24 2004-03-18 Lerner E. Itzhak Controlled release dosage forms
US20040166159A1 (en) * 2002-05-29 2004-08-26 Chien-Hsuan Han Pharmaceutical dosage forms having immediate and controlled release properties that contain an aromatic amino acid decarboxylase inhibitor and levodopa
US7094427B2 (en) * 2002-05-29 2006-08-22 Impax Laboratories, Inc. Combination immediate release controlled release levodopa/carbidopa dosage forms
US20060013875A1 (en) * 2002-05-29 2006-01-19 Impax Laboratories, Inc. Combination immediate release controlled release levodopa/carbidopa dosage forms
ITMI20030827A1 (it) * 2003-04-18 2004-10-19 Unihart Corp Composizione farmaceutica contenente l'associazione levodopa/carbidopa.
US8007827B2 (en) 2004-04-02 2011-08-30 Impax Laboratories, Inc. Pharmaceutical dosage forms having immediate release and/or controlled release properties
WO2006035414A2 (en) * 2004-09-30 2006-04-06 Ranbaxy Laboratories Limited Carbidopa and levodopa dispersible tablets
US20070003621A1 (en) * 2005-06-23 2007-01-04 Spherics, Inc. Dosage forms for movement disorder treatment
AR055106A1 (es) * 2005-08-05 2007-08-08 Osmotica Pharmaceutical Argent Composicion farmaceutica solida de liberacion extendida que contiene carbidopa y levodopa
WO2007073702A2 (es) 2005-12-29 2007-07-05 Osmotica Corp. Comprimido multicapa con combinación de triple liberación
US20080131492A1 (en) * 2006-06-23 2008-06-05 Spherics, Inc. Dosage forms for movement disorder treatment
PE20080669A1 (es) * 2006-09-08 2008-07-18 Drugtech Corp Composicion de liberacion sostenida que comprende levodopa
US20100316712A1 (en) * 2006-12-22 2010-12-16 Combinatorx, Incorporated Pharmaceutical compositions for treatment of parkinson's disease and related disorders
KR101752080B1 (ko) * 2007-12-28 2017-06-28 임팩스 라보라토리즈, 인코포레이티드 레보도파 방출 제어형 제제 및 이의 용도
WO2010019915A1 (en) 2008-08-15 2010-02-18 Depomed Inc. Gastric retentive pharmaceutical compositions for treatment and prevention of cns disorders
EP2508174A1 (en) 2011-04-06 2012-10-10 Ljiljana Sovic Brkicic Pharmaceutical composition
US10987313B2 (en) 2013-10-07 2021-04-27 Impax Laboratories, Llc Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof
WO2018011181A1 (en) * 2016-07-11 2018-01-18 Contera Pharma Aps Pulsatile drug delivery system for treating morning akinesia
US11986449B2 (en) 2020-12-22 2024-05-21 Amneal Pharmaceuticals Llc Levodopa dosing regimen
JP2024501235A (ja) 2020-12-22 2024-01-11 アムニール ファーマスーティカルズ エルエルシー レボドパ投薬レジメン
WO2024024865A1 (ja) * 2022-07-28 2024-02-01 大原薬品工業株式会社 レボドパ持続性製剤

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DE2513940A1 (de) * 1975-03-29 1976-10-14 Merck Patent Gmbh Pharmazeutische zubereitung
US4077407A (en) * 1975-11-24 1978-03-07 Alza Corporation Osmotic devices having composite walls
US4424235A (en) * 1981-09-14 1984-01-03 Hoffmann-La Roche Inc. Hydrodynamically balanced controlled release compositions containing L-dopa and a decarboxylase inhibitor
US5188840A (en) * 1985-09-26 1993-02-23 Chugai Seiyaku Kabushiki Kaisha Slow-release pharmaceutical agent
IT1188212B (it) * 1985-12-20 1988-01-07 Paolo Colombo Sistema per il rilascio a velocita' controllata di sostanze attive
ZA889189B (en) * 1986-06-16 1989-08-30 Merck & Co Inc Controlled release combination of carbidopa/levodopa
IT1255522B (it) * 1992-09-24 1995-11-09 Ubaldo Conte Compressa per impiego terapeutico atta a cedere una o piu' sostanze attive con differenti velocita'
GB9309749D0 (en) * 1993-05-12 1993-06-23 Boots Co Plc Therapeutic agents
IT1282576B1 (it) * 1996-02-06 1998-03-31 Jagotec Ag Compressa farmaceutica atta a cedere la sostanza attiva in tempi successivi e predeterminabili
US6756056B2 (en) * 1997-04-08 2004-06-29 Alan A. Rubin Treatment of Parkinson's disease and related disorders by novel formulations of the combination carbidopa-levodopa
IT1295271B1 (it) * 1997-10-03 1999-05-04 Chiesi Farma Spa Monolita contenente uno o piu'farmaci costituito da tre strati a meccanismo di rilascio differenziato
WO2000015197A1 (en) * 1998-09-14 2000-03-23 Rubin Alan A Improvement in treatment of parkinson's disease and related disorders by novel formulations of the combination carbidopa-levodopa
FI109453B (fi) * 1999-06-30 2002-08-15 Orion Yhtymae Oyj Farmaseuttinen koostumus
JP2004501190A (ja) * 2000-06-23 2004-01-15 テバ　ファーマシューティカル　インダストリーズ　リミティド 治療薬の胃部保留および制御された放出のための急速膨張する組成物とその組成物を含む剤形
IL159813A0 (en) * 2001-07-12 2004-06-20 Teva Pharma Dual release formulation comprising levodopa ethyl ester and a decarboxylase inhibitor in immediate release layer with levodopa ethyl ester and a decarboxylase inhibitor in a controlled release core

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10098845B2 (en) 2013-10-07 2018-10-16 Impax Laboratories, Llc Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof
US10292935B2 (en) 2013-10-07 2019-05-21 Impax Laboratories, Inc. Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof

Also Published As

Publication number Publication date
US20030224045A1 (en) 2003-12-04
AU2003247409A1 (en) 2003-12-19
WO2003101432A1 (en) 2003-12-11
IL164856A (en) 2010-05-17
JP2005528430A (ja) 2005-09-22
EP1507518B1 (en) 2016-09-21
EP1507518A4 (en) 2010-01-13
IL164856A0 (en) 2005-12-18
CA2486859C (en) 2009-12-22
CA2486859A1 (en) 2003-12-11
EP1507518A1 (en) 2005-02-23

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Legal Events

Date Code Title Description
DA3 Amendments made section 104

Free format text: THE NATURE OF THE AMENDMENT IS: AMEND THE NAME OF THE INVENTOR TO REMOVE CO-INVENTOR HSIAO, CHARLES AND ADD CO-INVENTOR HSU, ANNE F.

DA3 Amendments made section 104

Free format text: THE NATURE OF THE AMENDMENT IS: AMEND THE NAME OF THE INVENTORS TO READ HAN, CHIEN-HSUAN; HSU, LARRY AND HSU, ANNE F.

FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired