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1. WO2003005968 - DUAL RELEASE LEVODOPA ETHYL ESTER AND DECARBOXYLASE INHIBITOR WITH IMMEDIATE RELEASE LEVODOPA

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Publication Number WO/2003/005968
Publication Date 23.01.2003
International Application No. PCT/US2002/022207
International Filing Date 12.07.2002
Chapter 2 Demand Filed 12.02.2003
IPC
A61K 9/20 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, lozenges or tablets
A61K 9/24 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, lozenges or tablets
22Sustained or differential release type
24Layered or laminated unitary dosage forms
A61K 31/198 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
19Carboxylic acids, e.g. valproic acid
195having an amino group
197the 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
198Alpha-amino acids, e.g. alanine, edetic acid (EDTA)
A61K 45/06 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
45Medicinal preparations containing active ingredients not provided for in groups A61K31/-A61K41/132
06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
CPC
A61K 31/198
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic, hydroximic acids
19Carboxylic acids, e.g. valproic acid
195having an amino group
197the 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
198Alpha-aminoacids, e.g. alanine, edetic acids [EDTA],
A61K 45/06
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
45Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
A61K 9/2054
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, tablets, ; discs, rods
2004Excipients; Inactive ingredients
2022Organic macromolecular compounds
205Polysaccharides, e.g. alginate, gums; Cyclodextrin
2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
A61K 9/2059
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, tablets, ; discs, rods
2004Excipients; Inactive ingredients
2022Organic macromolecular compounds
205Polysaccharides, e.g. alginate, gums; Cyclodextrin
2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
A61K 9/2077
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, tablets, ; discs, rods
2072characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
A61K 9/209
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, tablets, ; discs, rods
2072characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
209containing drug in at least two layers or in the core and in at least one outer layer
Applicants
  • TEVA PHARMACEUTICAL INDUSTRIES, LTD. [IL]/[IL] (AE, AG, AL, AM, AT, AU, AZ, BA, BE, BF, BG, BJ, BR, BY, BZ, CA, CF, CG, CH, CI, CM, CN, CO, CR, CU, CY, CZ, DE, DK, DM, DZ, EC, EE, ES, FI, FR, GA, GB, GD, GE, GH, GM, GN, GQ, GR, GW, HR, HU, ID, IE, IL, IN, IS, IT, JP, KE, KG, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MA, MC, MD, MG, MK, ML, MN, MR, MW, MX, MZ, NE, NL, NO, NZ, OM, PH, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL, SN, SZ, TD, TG, TJ, TM, TN, TR, TT, TZ, UA, UG, UZ, VN, YU, ZA, ZM, ZW)
  • TEVA PHARMACEUTICALS USA, INC. [US]/[US] (BB)
  • LICHT, Daniela [IL]/[IL] (UsOnly)
  • PATASHNIK, Shulamit [IL]/[IL] (UsOnly)
  • NAFTALI, Ezmira [IL]/[IL] (UsOnly)
  • SAYAG, Naim [IL]/[IL] (UsOnly)
  • GILBERT, Adrian [IL]/[IL] (UsOnly)
  • COHEN, Sasson [IL]/[IL] (UsOnly)
  • ZOLLMANN, Corinne [IL]/[IL] (UsOnly)
Inventors
  • LICHT, Daniela
  • PATASHNIK, Shulamit
  • NAFTALI, Ezmira
  • SAYAG, Naim
  • GILBERT, Adrian
  • COHEN, Sasson
  • ZOLLMANN, Corinne
Agents
  • WHITE, John
Priority Data
60/305,17912.07.2001US
60/346,71907.01.2002US
Publication Language English (en)
Filing Language English (EN)
Designated States
Title
(EN) DUAL RELEASE LEVODOPA ETHYL ESTER AND DECARBOXYLASE INHIBITOR WITH IMMEDIATE RELEASE LEVODOPA
(FR) FORMULATION A DOUBLE LIBERATION COMPORTANT UN ESTER ETHYLIQUE DE LEVODOPA ET UN INHIBITEUR DE DECARBOXYLASE DANS UNE COUCHE A LIBERATION INSTANTANEE AVEC UN ESTER ETHYLIQUE DE LEVODOPA DANS UN NOYAU A LIBERATION CONTROLEE
Abstract
(EN) A tablet which comprises an inner core formulated for controlled release consisting essentially of a mixture of levodopa ethyl ester or a derivative or a pharmaceutically acceptable salt thereof, a carrier and an inner core excipient; and an outer layer encapsulating the inner core and formulated for immediate release comprising a mixture of a decarboxylase inhibitor and levodopa ethyl ester or a derivative or a pharmaceutically acceptable salt thereof. The subject invention also encompasses a method of treating patients suffering from Parkinson's disease or related disorders by the administration of the pharmaceutical compositions of the subject invention. The subject invention also provides methods of manufacturing the tablets of the subject invention.
(FR) La présente invention concerne un comprimé comportant un noyau intérieur formulé pour la libération contrôlée constitué essentiellement d'un mélange d'un ester éthylique de lévodopa ou un dérivé ou un sel pharmaceutiquement acceptable de celui-ci, un support et un excipient de noyau intérieur, et une couche extérieure d'enrobage du noyau intérieur et formulée pour la libération instantanée comprenant un mélange d'un inhibiteur de décarboxylase et un ester éthylique de lévodopa ou un dérivé ou un sel pharmaceutiquement acceptable de celui-ci. L'invention concerne également un procédé de traitement de patients atteints de la maladie de Parkinson et de troubles associés par l'administration des compositions pharmaceutiques de l'invention. L'invention concerne en outre des procédés de fabrication de comprimés de l'invention.
Related patent documents
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US20030152628
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Latest bibliographic data on file with the International Bureau
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