WO2009078034A3 - Orally disintegrating tablets of ropinirole hydrochloride - Google Patents

Orally disintegrating tablets of ropinirole hydrochloride Download PDF

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Publication number
WO2009078034A3
WO2009078034A3 PCT/IN2008/000787 IN2008000787W WO2009078034A3 WO 2009078034 A3 WO2009078034 A3 WO 2009078034A3 IN 2008000787 W IN2008000787 W IN 2008000787W WO 2009078034 A3 WO2009078034 A3 WO 2009078034A3
Authority
WO
WIPO (PCT)
Prior art keywords
ropinirole
orally disintegrating
disintegrating tablets
ropinirole hydrochloride
present
Prior art date
Application number
PCT/IN2008/000787
Other languages
French (fr)
Other versions
WO2009078034A2 (en
Inventor
Pratibha S. Pilgaonkar
Maharukh T. Rustomjee
Anilkumar S. Gandhi
Atul Kelkar
Original Assignee
Rubicon Research Private Limited
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 Rubicon Research Private Limited filed Critical Rubicon Research Private Limited
Publication of WO2009078034A2 publication Critical patent/WO2009078034A2/en
Publication of WO2009078034A3 publication Critical patent/WO2009078034A3/en

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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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/148—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with compounds of unknown constitution, e.g. material from plants or animals
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1664—Compounds of unknown constitution, e.g. material from plants or animals
    • 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
    • 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
    • A61K9/2072—Pills, 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Botany (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The present invention relates to a solid pharmaceutical composition comprising ropinirole, which dissolves or disintegrates in the oral cavity within about sixty (60) seconds. The present invention further discloses orally disintegrating tablets of ropinirole of optimal mechanical strength comprising taste-masked ropinirole and at least one pharmaceutically acceptable excipient.
PCT/IN2008/000787 2007-11-26 2008-11-26 Oral disintegrating tablets of ropinirole hydrochloride WO2009078034A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2320MU2007 2007-11-26
IN2320/MUM/2007 2007-11-26

Publications (2)

Publication Number Publication Date
WO2009078034A2 WO2009078034A2 (en) 2009-06-25
WO2009078034A3 true WO2009078034A3 (en) 2010-01-28

Family

ID=40673431

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2008/000787 WO2009078034A2 (en) 2007-11-26 2008-11-26 Oral disintegrating tablets of ropinirole hydrochloride

Country Status (1)

Country Link
WO (1) WO2009078034A2 (en)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120093738A1 (en) * 2009-06-11 2012-04-19 Rubicon Research Private Limited Taste-masked oral formulations of influenza antivirals
WO2011110939A2 (en) * 2010-03-11 2011-09-15 Rubicon Research Private Limited Pharmaceutical compositions of substituted benzhydrylpiperazines
US9861577B2 (en) 2010-08-31 2018-01-09 Kyowa Hakko Kirin Co., Ltd. Orally disintegrating tablet
JP4803686B2 (en) * 2010-08-31 2011-10-26 協和発酵キリン株式会社 Granules and orally disintegrating tablets containing a bitter-tasting drug
CA2853117C (en) * 2011-10-25 2018-08-07 Expermed S.A. Sublingual pharmaceutical composition containing an antihistamine agent and method for the preparation thereof
CN105307645A (en) * 2013-06-03 2016-02-03 麦克内尔股份公司 Solid pharmaceutical dosage form for release of at least one active pharmaceutical ingredient in the oral cavity
WO2015130760A1 (en) 2014-02-25 2015-09-03 Orbis Biosciences, Inc. Taste masking drug formulations
CN107334744B (en) * 2017-07-24 2020-09-04 湖南洞庭药业股份有限公司 Memantine hydrochloride medicine composition and preparation method thereof
CN118141772B (en) * 2024-03-08 2024-09-10 四川鲁徽制药有限责任公司 Ropinirole Luo Jia hydrochloride sulfonic acid rasagiline compound orally disintegrating controlled release tablet and preparation method thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004022037A1 (en) * 2002-09-04 2004-03-18 Ranbaxy Laboratories Limited Taste masked dosage forms and processes for their preparation
WO2005018605A2 (en) * 2003-08-22 2005-03-03 Smithkline Beecham (Cork) Limited Novel formulation of ropinirole
WO2007036952A2 (en) * 2005-07-01 2007-04-05 Rubicon Research Pvt Ltd. Novel sustained release dosage form
WO2007113856A2 (en) * 2006-03-31 2007-10-11 Rubicon Research Private Limited Directly compressible composite for orally disintegrating tablets

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004022037A1 (en) * 2002-09-04 2004-03-18 Ranbaxy Laboratories Limited Taste masked dosage forms and processes for their preparation
WO2005018605A2 (en) * 2003-08-22 2005-03-03 Smithkline Beecham (Cork) Limited Novel formulation of ropinirole
WO2007036952A2 (en) * 2005-07-01 2007-04-05 Rubicon Research Pvt Ltd. Novel sustained release dosage form
WO2007113856A2 (en) * 2006-03-31 2007-10-11 Rubicon Research Private Limited Directly compressible composite for orally disintegrating tablets

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
RAILKAR A: "Taste masking strategies: A brief review", AMERICAN PHARMACEUTICAL REVIEW 200701 US,, vol. 10, no. 1, 1 January 2007 (2007-01-01), pages 80 - 82, XP002529545 *

Also Published As

Publication number Publication date
WO2009078034A2 (en) 2009-06-25

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