WO2012002644A3 - Sustained-release pharmaceutical composition containing pramipexole or pharmaceutically acceptable salt thereof with improved stability - Google Patents

Sustained-release pharmaceutical composition containing pramipexole or pharmaceutically acceptable salt thereof with improved stability Download PDF

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Publication number
WO2012002644A3
WO2012002644A3 PCT/KR2011/003515 KR2011003515W WO2012002644A3 WO 2012002644 A3 WO2012002644 A3 WO 2012002644A3 KR 2011003515 W KR2011003515 W KR 2011003515W WO 2012002644 A3 WO2012002644 A3 WO 2012002644A3
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical composition
sustained
pharmaceutically acceptable
acceptable salt
pramipexole
Prior art date
Application number
PCT/KR2011/003515
Other languages
French (fr)
Other versions
WO2012002644A2 (en
Inventor
Sang-Joon Lee
Kwan-Young Chang
Jae-Soon Ahn
Jae-Min Cho
Sung-Hoon Kam
Original Assignee
Hyundai Pharm Co., Ltd.
Bio Pharmartis Co., Ltd.
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
Application filed by Hyundai Pharm Co., Ltd., Bio Pharmartis Co., Ltd. filed Critical Hyundai Pharm Co., Ltd.
Priority to EP11801051.1A priority Critical patent/EP2588106A4/en
Priority to JP2013518223A priority patent/JP2013530212A/en
Publication of WO2012002644A2 publication Critical patent/WO2012002644A2/en
Publication of WO2012002644A3 publication Critical patent/WO2012002644A3/en

Links

Classifications

    • 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
    • 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
    • A61K9/2054—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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (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)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Psychiatry (AREA)
  • Psychology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Disclosed is a sustained-release pharmaceutical composition containing pramipexole or a pharmaceutically acceptable salt thereof and, more particularly, a pharmaceutical composition that uses a stabilizer for inhibiting production of related substances caused by additives and greatly enhances stability. The pharmaceutical composition shows an effectively controlled dissolution profile, realizing its usefulness in the manufacture of pramipexole-containing sustained-release preparations in various dosage forms easy for drug release control; includes a stabilizer to minimize impurity production of the drug-containing products during drug storage, remarkably improving chemical stability; and thereby eliminates a need for separate studies on the physical chemical structure analysis and/or on the toxicological effects of the corresponding impurities.
PCT/KR2011/003515 2010-07-02 2011-05-12 Sustained-release pharmaceutical composition containing pramipexole or pharmaceutically acceptable salt thereof with improved stability WO2012002644A2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP11801051.1A EP2588106A4 (en) 2010-07-02 2011-05-12 Sustained-release pharmaceutical composition containing pramipexole or pharmaceutically acceptable salt thereof with improved stability
JP2013518223A JP2013530212A (en) 2010-07-02 2011-05-12 Sustained release pharmaceutical composition with improved stability comprising pramipexole or a pharmaceutically acceptable salt thereof

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020100064044A KR101307334B1 (en) 2010-07-02 2010-07-02 Sustained-release pharmaceutical composition comprising pramipexole or pharmaceutically acceptable salt thereof having improved stability
KR10-2010-0064044 2010-07-02

Publications (2)

Publication Number Publication Date
WO2012002644A2 WO2012002644A2 (en) 2012-01-05
WO2012002644A3 true WO2012002644A3 (en) 2012-04-12

Family

ID=45402507

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2011/003515 WO2012002644A2 (en) 2010-07-02 2011-05-12 Sustained-release pharmaceutical composition containing pramipexole or pharmaceutically acceptable salt thereof with improved stability

Country Status (4)

Country Link
EP (1) EP2588106A4 (en)
JP (1) JP2013530212A (en)
KR (1) KR101307334B1 (en)
WO (1) WO2012002644A2 (en)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8802139B2 (en) 2003-06-26 2014-08-12 Intellipharmaceutics Corp. Proton pump-inhibitor-containing capsules which comprise subunits differently structured for a delayed release of the active ingredient
US10624858B2 (en) 2004-08-23 2020-04-21 Intellipharmaceutics Corp Controlled release composition using transition coating, and method of preparing same
US10064828B1 (en) 2005-12-23 2018-09-04 Intellipharmaceutics Corp. Pulsed extended-pulsed and extended-pulsed pulsed drug delivery systems
CN101453993A (en) 2006-04-03 2009-06-10 伊萨·奥迪迪 Controlled release delivery device comprising an organosol coat
US10960077B2 (en) 2006-05-12 2021-03-30 Intellipharmaceutics Corp. Abuse and alcohol resistant drug composition
EP2906202A4 (en) * 2012-10-15 2016-04-27 Isa Odidi Oral drug delivery formulations
CN105456216B (en) * 2014-08-18 2019-11-05 江苏神龙药业股份有限公司 Pramipexole hydrochloride slow release tablet composition and preparation method thereof
CN106474084B (en) * 2015-08-28 2020-12-11 江苏先声药业有限公司 Pramipexole dihydrochloride sustained-release preparation and preparation method thereof
CN107951853B (en) * 2016-10-17 2022-04-08 海思科制药(眉山)有限公司 Pramipexole dihydrochloride sustained-release pharmaceutical composition and preparation method thereof
CN108785263B (en) * 2017-04-26 2021-06-29 江苏恒瑞医药股份有限公司 Solid pharmaceutical composition of pramipexole or pharmaceutical salt thereof and preparation method thereof
CN109966256B (en) * 2017-12-28 2022-08-02 北京北大维信生物科技有限公司 Pramipexole sustained-release pharmaceutical composition, preparation method and application thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050226926A1 (en) * 2002-07-25 2005-10-13 Pfizer Inc Sustained-release tablet composition of pramipexole
US20060110454A1 (en) * 2004-10-27 2006-05-25 Rajesh Kshirsagar Extended release formulation of pramipexole dihydrochloride
WO2008068778A2 (en) * 2006-12-05 2008-06-12 Alembic Limited Extended release pharmaceutical composition of pramipexole
US20100086589A1 (en) * 2004-08-13 2010-04-08 Thomas Friedl Extended release pellet formulation containing pramipexole or a pharmaceutically acceptable salt thereof

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3937271A1 (en) * 1989-11-09 1991-05-16 Boehringer Ingelheim Kg TRANSDERMAL APPLICATION OF 2-AMINO-6-N-PROPYLAMINO-4,5,6,7-TETRAHYDROBENZOTHIAZOLE
JP2005538105A (en) * 2002-07-25 2005-12-15 ファルマシア・コーポレーション Method for producing a solid dosage form coated with two layers comprising a water-insoluble polymer and a water-soluble pore-forming substance
WO2007002518A1 (en) * 2005-06-23 2007-01-04 Spherics, Inc. Delayed release or extended-delayed release dosage forms of pramipexole
WO2007054976A2 (en) * 2005-11-08 2007-05-18 Panacea Biotec Ltd. Lipid based controlled release pharmaceutical composition
WO2007090882A2 (en) * 2006-02-10 2007-08-16 Boehringer Ingelheim International Gmbh Pharmaceutical extended release compositions comprising pramipexole
WO2009152041A2 (en) * 2008-06-09 2009-12-17 Supernus Pharmaceuticals, Inc. Controlled release formulations of pramipexole
WO2011037976A2 (en) * 2009-09-22 2011-03-31 Dr. Reddy's Laboratories Limited Pramipexole pharmaceutical formulations

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050226926A1 (en) * 2002-07-25 2005-10-13 Pfizer Inc Sustained-release tablet composition of pramipexole
US20100086589A1 (en) * 2004-08-13 2010-04-08 Thomas Friedl Extended release pellet formulation containing pramipexole or a pharmaceutically acceptable salt thereof
US20060110454A1 (en) * 2004-10-27 2006-05-25 Rajesh Kshirsagar Extended release formulation of pramipexole dihydrochloride
WO2008068778A2 (en) * 2006-12-05 2008-06-12 Alembic Limited Extended release pharmaceutical composition of pramipexole

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP2588106A4 *

Also Published As

Publication number Publication date
KR101307334B1 (en) 2013-09-12
WO2012002644A2 (en) 2012-01-05
EP2588106A2 (en) 2013-05-08
EP2588106A4 (en) 2014-01-01
KR20120003278A (en) 2012-01-10
JP2013530212A (en) 2013-07-25

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