AR062509A1 - Proceso para preparar comprimidos de dihidrocloruro de pramipexol - Google Patents

Proceso para preparar comprimidos de dihidrocloruro de pramipexol

Info

Publication number
AR062509A1
AR062509A1 ARP070103757A ARP070103757A AR062509A1 AR 062509 A1 AR062509 A1 AR 062509A1 AR P070103757 A ARP070103757 A AR P070103757A AR P070103757 A ARP070103757 A AR P070103757A AR 062509 A1 AR062509 A1 AR 062509A1
Authority
AR
Argentina
Prior art keywords
tablets
pramipexole dihydrochloride
solution
fluid bed
tablet forming
Prior art date
Application number
ARP070103757A
Other languages
English (en)
Inventor
Hans-Werner Wernersbach
Original Assignee
Boehringer Ingelheim Int
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=38963081&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR062509(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from US11/734,041 external-priority patent/US20080254118A1/en
Application filed by Boehringer Ingelheim Int filed Critical Boehringer Ingelheim Int
Publication of AR062509A1 publication Critical patent/AR062509A1/es

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
    • 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
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425Thiazoles
    • A61K31/428Thiazoles condensed with carbocyclic rings
    • 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
    • A61K9/2009Inorganic compounds
    • 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
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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

Abstract

En particular, se refiere a un proceso para preparar comprimidos de dihidrocloruro de pramipexol, en el que los comprimidos muestran elevadas propiedades de estabilidad de conservacion. Reivindicacion 1: Un proceso para preparar comprimidos de dihidrocloruro de pramipexol que comprenden ingredientes de formacion de comprimidos intragranulares, dihidrocloruro de pramipexol o su solvato farmacéuticamente aceptable, un ligante y agentes de formacion de comprimidos extragranulares, en el que el proceso se realiza en un sistema cerrado, y comprende las etapas de: (a) cargar partículas de los ingredientes de formacion de comprimidos intragranulares en un granulador de lecho fluido, (b) disolver el dihidrocloruro de pramipexol, o su solvato farmacéuticamente aceptable, y povidona en agua para formar una disolucion acuosa de dihidrocloruro de pramipexol, y pulverizar la disolucion de dihidrocloruro de pramipexol sobre las partículas de los ingredientes de formacion de comprimidos intragranulares en el granulador de lecho fluido, (c) preparar una disolucion, suspension o pasta de ligante, y anadir la disolucion, suspension o pasta de ligante al granulador de lecho fluido para formar un granulado, (d) secar dicha premezcla granulada hasta un contenido en humedad final de aproximadamente 1,0% a aproximadamente 2,5%, (g) mezclar dicha mezcla granulada con los agentes de formacion de comprimidos extragranulares y mezclar para formar una mezcla final, (f) comprimir la mezcla final en comprimidos utilizando una prensa de comprimidos.
ARP070103757A 2006-08-24 2007-08-24 Proceso para preparar comprimidos de dihidrocloruro de pramipexol AR062509A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US46705006A 2006-08-24 2006-08-24
US11/734,041 US20080254118A1 (en) 2007-04-11 2007-04-11 Process for preparing pramipexole dihydrochloride tablets

Publications (1)

Publication Number Publication Date
AR062509A1 true AR062509A1 (es) 2008-11-12

Family

ID=38963081

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP070103757A AR062509A1 (es) 2006-08-24 2007-08-24 Proceso para preparar comprimidos de dihidrocloruro de pramipexol

Country Status (13)

Country Link
EP (1) EP2056795A2 (es)
JP (1) JP2010501525A (es)
KR (1) KR20090045943A (es)
AR (1) AR062509A1 (es)
AU (1) AU2007287560A1 (es)
BR (1) BRPI0715835A2 (es)
CA (1) CA2661616A1 (es)
CL (1) CL2007002477A1 (es)
IL (1) IL197130A0 (es)
MX (1) MX2009001884A (es)
RU (1) RU2009110253A (es)
TW (1) TW200816998A (es)
WO (1) WO2008023027A2 (es)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8518926B2 (en) 2006-04-10 2013-08-27 Knopp Neurosciences, Inc. Compositions and methods of using (R)-pramipexole
PL2026803T3 (pl) 2006-05-16 2012-05-31 Knopp Neurosciences Inc Kompozycje R(+) i S(-) pramipeksolu i sposoby ich zastosowania
US8524695B2 (en) 2006-12-14 2013-09-03 Knopp Neurosciences, Inc. Modified release formulations of (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazole-diamine and methods of using the same
CA2681110A1 (en) 2007-03-14 2008-09-18 Knopp Neurosciences, Inc. Synthesis of chirally purified substituted benzothiazole diamines
US20080254117A1 (en) * 2007-04-10 2008-10-16 Noel Cotton Process for preparing pramipexole dihydrochloride tablets
CA2734491A1 (en) 2008-08-19 2010-02-25 Knopp Neurosciences, Inc. Compositions and methods of using (r)-pramipexole
TR200906997A1 (tr) * 2009-09-11 2011-03-21 Sanovel �La� San. Ve T�C. A. �. Pramipeksol farmasötik bileşimleri.
EP2462925A1 (en) 2010-11-12 2012-06-13 Neuraxpharm Arzneimittel GmbH Pramipexole Dihydrochloride Granulate
KR101712049B1 (ko) * 2010-11-17 2017-03-03 엘지이노텍 주식회사 발광 소자
WO2013096816A1 (en) 2011-12-22 2013-06-27 Biogen Idec Ma Inc. Improved synthesis of amine substituted 4,5,6,7-tetrahydrobenzothiazole compounds
US9662313B2 (en) 2013-02-28 2017-05-30 Knopp Biosciences Llc Compositions and methods for treating amyotrophic lateral sclerosis in responders
US9468630B2 (en) 2013-07-12 2016-10-18 Knopp Biosciences Llc Compositions and methods for treating conditions related to increased eosinophils
WO2015006708A1 (en) 2013-07-12 2015-01-15 Knopp Biosciences Llc Treating elevated levels of eosinophils and/or basophils
AU2014306597B2 (en) 2013-08-13 2018-05-17 Knopp Biosciences Llc Compositions and methods for treating chronic urticaria
US9642840B2 (en) 2013-08-13 2017-05-09 Knopp Biosciences, Llc Compositions and methods for treating plasma cell disorders and B-cell prolymphocytic disorders

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0998933A1 (de) * 1998-10-09 2000-05-10 Boehringer Mannheim Gmbh Verfahren zur Herstellung von bisphosphonathaltigen pharmazeutischen Zusammensetzungen zur oralen Applikation
ES2197600T3 (es) * 1999-01-29 2004-01-01 Disphar International B.V. Composiciones farmaceuticas.
US20030133982A1 (en) * 2001-12-20 2003-07-17 Heimlich John M. Zero-order sustained release dosage forms and method of making same
EP1620075B1 (en) * 2003-05-07 2020-06-24 Samyang Biopharmaceuticals Corporation Highly plastic granules for making fast melting tablets
EP2431026A1 (en) * 2004-08-13 2012-03-21 Boehringer Ingelheim International GmbH Extended release pellet formulation containing Pramipexole or a pharmaceutically acceptable salt thereof, method for manufacturing the same and use thereof
ES2355735T5 (es) * 2004-08-13 2014-06-27 Boehringer Ingelheim International Gmbh Formulación en comprimidos de liberación extendida que contiene pramipexol o una de sus sales farmac�uticamente aceptables, método para su fabricación y su uso
JP4446177B2 (ja) * 2005-01-21 2010-04-07 東和薬品株式会社 耐湿性口腔内崩壊錠の製造方法
JP2009519970A (ja) * 2005-12-15 2009-05-21 アキュスフィア, インコーポレイテッド 粒子ベースの経口投与用製薬剤形の製造方法

Also Published As

Publication number Publication date
MX2009001884A (es) 2009-03-06
AU2007287560A1 (en) 2008-02-28
TW200816998A (en) 2008-04-16
IL197130A0 (en) 2009-11-18
JP2010501525A (ja) 2010-01-21
BRPI0715835A2 (pt) 2013-07-23
CL2007002477A1 (es) 2008-04-18
RU2009110253A (ru) 2010-09-27
EP2056795A2 (en) 2009-05-13
KR20090045943A (ko) 2009-05-08
WO2008023027A2 (en) 2008-02-28
CA2661616A1 (en) 2008-02-28
WO2008023027A3 (en) 2008-04-17

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