WO2010100658A3 - Stable olanzapine tablets and the process for its preparation - Google Patents

Stable olanzapine tablets and the process for its preparation Download PDF

Info

Publication number
WO2010100658A3
WO2010100658A3 PCT/IN2010/000127 IN2010000127W WO2010100658A3 WO 2010100658 A3 WO2010100658 A3 WO 2010100658A3 IN 2010000127 W IN2010000127 W IN 2010000127W WO 2010100658 A3 WO2010100658 A3 WO 2010100658A3
Authority
WO
WIPO (PCT)
Prior art keywords
stable
tablets
preparation
olanzapine
olanzapine tablets
Prior art date
Application number
PCT/IN2010/000127
Other languages
French (fr)
Other versions
WO2010100658A2 (en
Inventor
Deepak Murpani
Alexaki Pandora
Original Assignee
Genepharm India 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 Genepharm India Private Limited filed Critical Genepharm India Private Limited
Priority to EP10748416.4A priority Critical patent/EP2403500A4/en
Publication of WO2010100658A2 publication Critical patent/WO2010100658A2/en
Publication of WO2010100658A3 publication Critical patent/WO2010100658A3/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
    • 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
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • 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
    • 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
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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

Abstract

Stable olanzapine tablets comprising compacted blend of olanzapine and at least one pharmaceutical excipient; mixed with extragranular blend of diluent(s), disintegrant(s), lubricant(s) and optional sweetener(s); wherein the said tablets are stable to color, chemical degradation and polymorphic changes for at least 3 months at 40°C / 75% relative humidity in open vials.
PCT/IN2010/000127 2009-03-05 2010-03-05 Stable olanzapine tablets and the process for its preparation WO2010100658A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP10748416.4A EP2403500A4 (en) 2009-03-05 2010-03-05 Stable olanzapine tablets and the process for its preparation

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN481MU2009 2009-03-05
IN481/MUM/2009 2009-03-05

Publications (2)

Publication Number Publication Date
WO2010100658A2 WO2010100658A2 (en) 2010-09-10
WO2010100658A3 true WO2010100658A3 (en) 2010-12-23

Family

ID=42710069

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2010/000127 WO2010100658A2 (en) 2009-03-05 2010-03-05 Stable olanzapine tablets and the process for its preparation

Country Status (2)

Country Link
EP (1) EP2403500A4 (en)
WO (1) WO2010100658A2 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014218472A (en) * 2013-05-10 2014-11-20 エルメッド エーザイ株式会社 Tablet containing olanzapine or salt thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003086343A2 (en) * 2002-04-05 2003-10-23 Cadila Healthcare Limited Fast disintegrating oral dosage forms
US20040121003A1 (en) * 2002-12-19 2004-06-24 Acusphere, Inc. Methods for making pharmaceutical formulations comprising deagglomerated microparticles
US20050013857A1 (en) * 2003-05-07 2005-01-20 Yourong Fu Highly plastic granules for making fast melting tablets
WO2005070938A1 (en) * 2004-01-27 2005-08-04 Synthon B.V. Stable salts of olanzapine

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005009407A2 (en) * 2003-07-29 2005-02-03 Ranbaxy Laboratories Limited Oral pharmaceutical formulations of olanzapine
US20070293479A1 (en) * 2006-05-18 2007-12-20 Osinga Niels J Olanzapine pharmaceutical composition

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003086343A2 (en) * 2002-04-05 2003-10-23 Cadila Healthcare Limited Fast disintegrating oral dosage forms
US20040121003A1 (en) * 2002-12-19 2004-06-24 Acusphere, Inc. Methods for making pharmaceutical formulations comprising deagglomerated microparticles
US20050013857A1 (en) * 2003-05-07 2005-01-20 Yourong Fu Highly plastic granules for making fast melting tablets
WO2005070938A1 (en) * 2004-01-27 2005-08-04 Synthon B.V. Stable salts of olanzapine

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP2403500A4 *

Also Published As

Publication number Publication date
EP2403500A2 (en) 2012-01-11
WO2010100658A2 (en) 2010-09-10
EP2403500A4 (en) 2013-12-25

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