AR062509A1 - PROCESS TO PREPARE PRAMIPEXOL DIHYDROCLORIDE TABLETS - Google Patents

PROCESS TO PREPARE PRAMIPEXOL DIHYDROCLORIDE TABLETS

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
Spanish (es)
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/en

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
    • 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
    • A61K9/2095—Tabletting 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
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic 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
    • A61K31/425—Thiazoles
    • A61K31/428—Thiazoles condensed with carbocyclic rings
    • 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
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Psychology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

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.In particular, it refers to a process for preparing pramipexole dihydrochloride tablets, in which the tablets show high preservation stability properties. Claim 1: A process for preparing pramipexole dihydrochloride tablets comprising intragranular tablet forming ingredients, pramipexole dihydrochloride or its pharmaceutically acceptable solvate, a binder and extragranular tablet forming agents, wherein the process is performed in a system closed, and comprises the steps of: (a) loading particles of the intragranular tablet formation ingredients in a fluid bed granulator, (b) dissolving pramipexole dihydrochloride, or its pharmaceutically acceptable solvate, and povidone in water to form a aqueous solution of pramipexole dihydrochloride, and spray the solution of pramipexole dihydrochloride on the particles of the intragranular tablet forming ingredients in the fluid bed granulator, (c) prepare a solution, suspension or binder paste, and add the solution , suspension or binder paste to the fluid bed granulator p To form a granulate, (d) dry said granulated premix to a final moisture content of about 1.0% to about 2.5%, (g) mix said granulated mixture with the extragranular tablet forming agents and mix to form a final mixture, (f) compressing the final mixture into tablets using a tablet press.

ARP070103757A 2006-08-24 2007-08-24 PROCESS TO PREPARE PRAMIPEXOL DIHYDROCLORIDE TABLETS AR062509A1 (en)

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 (en) 2008-11-12

Family

ID=38963081

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP070103757A AR062509A1 (en) 2006-08-24 2007-08-24 PROCESS TO PREPARE PRAMIPEXOL DIHYDROCLORIDE TABLETS

Country Status (13)

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

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
ATE537826T1 (en) 2006-05-16 2012-01-15 Knopp Neurosciences Inc COMPOSITIONS OF R(+)- AND S(-)-PRAMIPEXOLE AND METHOD FOR THEIR USE
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
US8519148B2 (en) 2007-03-14 2013-08-27 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
US20110190356A1 (en) 2008-08-19 2011-08-04 Knopp Neurosciences Inc. Compositions and Methods of Using (R)- Pramipexole
TR200906997A1 (en) 2009-09-11 2011-03-21 Sanovel �La� San. Ve T�C. A. �. Pramipexole pharmaceutical compositions.
EP2462925A1 (en) 2010-11-12 2012-06-13 Neuraxpharm Arzneimittel GmbH Pramipexole Dihydrochloride Granulate
KR101712049B1 (en) * 2010-11-17 2017-03-03 엘지이노텍 주식회사 Light emitting device
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
PT3019167T (en) 2013-07-12 2021-03-04 Knopp Biosciences Llc Treating elevated levels of eosinophils and/or basophils
US9468630B2 (en) 2013-07-12 2016-10-18 Knopp Biosciences Llc Compositions and methods for treating conditions related to increased eosinophils
US9642840B2 (en) 2013-08-13 2017-05-09 Knopp Biosciences, Llc Compositions and methods for treating plasma cell disorders and B-cell prolymphocytic disorders
AU2014306597B2 (en) 2013-08-13 2018-05-17 Knopp Biosciences Llc Compositions and methods for treating chronic urticaria

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0998933A1 (en) * 1998-10-09 2000-05-10 Boehringer Mannheim Gmbh Process for producing pharmaceutical compositions containing diphosphonates for oral administration
AU764469B2 (en) * 1999-01-29 2003-08-21 Disphar International B.V. Pharmaceutical compositions
CA2470636A1 (en) * 2001-12-20 2003-07-03 Pharmacia Corporation Zero-order sustained released dosage forms and method of making the same
AU2004238321B2 (en) * 2003-05-07 2009-08-27 Samyang Biopharmaceuticals Corporation Highly plastic granules for making fast melting tablets
CA2576386A1 (en) * 2004-08-13 2006-02-16 Boehringer Ingelheim International Gmbh Extended release pellet formulation containing pramipexole or a pharmaceutically acceptable salt thereof, method for manufacturing the same and use thereof
BRPI0513846A (en) * 2004-08-13 2008-05-20 Boehringer Ingelheim Int prolonged-release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof, method of manufacture thereof and use thereof
JP4446177B2 (en) * 2005-01-21 2010-04-07 東和薬品株式会社 Method for producing moisture-resistant orally disintegrating tablets
EP1978933A2 (en) * 2005-12-15 2008-10-15 Acusphere, Inc. Processes for making particle-based pharmaceutical formulations for oral administration

Also Published As

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

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