CA2486859C - 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
CA2486859C
CA2486859C CA002486859A CA2486859A CA2486859C CA 2486859 C CA2486859 C CA 2486859C CA 002486859 A CA002486859 A CA 002486859A CA 2486859 A CA2486859 A CA 2486859A CA 2486859 C CA2486859 C CA 2486859C
Authority
CA
Canada
Prior art keywords
levodopa
dosage form
carbidopa
pharmaceutical dosage
controlled release
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.)
Expired - Fee Related
Application number
CA002486859A
Other languages
English (en)
French (fr)
Other versions
CA2486859A1 (en
Inventor
Chien-Hsuan Han
Larry Hsu
Ann F. 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 CA2486859A1 publication Critical patent/CA2486859A1/en
Application granted granted Critical
Publication of CA2486859C publication Critical patent/CA2486859C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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
    • 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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
    • 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 or pantothenic acid
    • A61K31/198Alpha-amino acids, e.g. alanine or edetic acid [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
    • A61K9/2004Excipients; 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16Anti-Parkinson drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Psychology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
CA002486859A 2002-05-29 2003-05-23 Combination immediate release controlled release levodopa/carbidopa dosage forms Expired - Fee Related CA2486859C (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 2002-09-12
US10/241,837 US7094427B2 (en) 2002-05-29 2002-09-12 Combination immediate release controlled release levodopa/carbidopa dosage forms
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
CA2486859A1 CA2486859A1 (en) 2003-12-11
CA2486859C true CA2486859C (en) 2009-12-22

Family

ID=29582673

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002486859A Expired - Fee Related CA2486859C (en) 2002-05-29 2003-05-23 Combination immediate release controlled release levodopa/carbidopa dosage forms

Country Status (7)

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

Families Citing this family (22)

* 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
US20060013875A1 (en) * 2002-05-29 2006-01-19 Impax Laboratories, Inc. Combination immediate release controlled release levodopa/carbidopa 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
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
CA2613631A1 (en) * 2005-06-23 2007-01-04 Spherics, Inc. Improved 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
CA2635313C (en) 2005-12-29 2013-12-31 Osmotica Corp. Triple combination release multi-layered tablet
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
AU2007338631A1 (en) * 2006-12-22 2008-07-03 Combinatorx, Incorporated Pharmaceutical compositions for treatment of parkinson's disease and related disorders
CN101910113A (zh) * 2007-12-28 2010-12-08 怡百克制药公司 左旋多巴控释制剂及其用途
CN102202656A (zh) * 2008-08-15 2011-09-28 蒂宝制药公司 治疗和预防cns障碍的胃滞留药用组合物
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
CN105658211A (zh) 2013-10-07 2016-06-08 怡百克制药公司 左旋多巴和/或左旋多巴的酯的粘膜粘附性、控制释放调配物和其用途
AU2017297718B2 (en) * 2016-07-11 2023-06-08 Contera Pharma A/S Pulsatile drug delivery system for treating morning akinesia
KR20230124622A (ko) 2020-12-22 2023-08-25 암닐 파마슈티컬스 엘엘씨 레보도파 투여 요법
US11986449B2 (en) 2020-12-22 2024-05-21 Amneal Pharmaceuticals Llc Levodopa dosing regimen
JPWO2024024865A1 (https=) * 2022-07-28 2024-02-01

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Also Published As

Publication number Publication date
EP1507518B1 (en) 2016-09-21
EP1507518A1 (en) 2005-02-23
CA2486859A1 (en) 2003-12-11
WO2003101432A1 (en) 2003-12-11
EP1507518A4 (en) 2010-01-13
US20030224045A1 (en) 2003-12-04
AU2003247409A1 (en) 2003-12-19
AU2003247409B2 (en) 2008-04-17
JP2005528430A (ja) 2005-09-22
IL164856A0 (en) 2005-12-18
IL164856A (en) 2010-05-17

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Effective date: 20200831