EP2403500A4 - Stable olanzapine tablets and the process for its preparation - Google Patents

Stable olanzapine tablets and the process for its preparation

Info

Publication number
EP2403500A4
EP2403500A4 EP10748416.4A EP10748416A EP2403500A4 EP 2403500 A4 EP2403500 A4 EP 2403500A4 EP 10748416 A EP10748416 A EP 10748416A EP 2403500 A4 EP2403500 A4 EP 2403500A4
Authority
EP
European Patent Office
Prior art keywords
stable
tablets
preparation
olanzapine
olanzapine tablets
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP10748416.4A
Other languages
German (de)
French (fr)
Other versions
EP2403500A2 (en
Inventor
Deepak Murpani
Alexaki Pandora
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
GENEPHARM INDIA PRIVATE Ltd
Original Assignee
GENEPHARM INDIA PRIVATE 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 GENEPHARM INDIA PRIVATE Ltd filed Critical GENEPHARM INDIA PRIVATE Ltd
Publication of EP2403500A2 publication Critical patent/EP2403500A2/en
Publication of EP2403500A4 publication Critical patent/EP2403500A4/en
Withdrawn legal-status Critical Current

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.
EP10748416.4A 2009-03-05 2010-03-05 Stable olanzapine tablets and the process for its preparation Withdrawn EP2403500A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN481MU2009 2009-03-05
PCT/IN2010/000127 WO2010100658A2 (en) 2009-03-05 2010-03-05 Stable olanzapine tablets and the process for its preparation

Publications (2)

Publication Number Publication Date
EP2403500A2 EP2403500A2 (en) 2012-01-11
EP2403500A4 true EP2403500A4 (en) 2013-12-25

Family

ID=42710069

Family Applications (1)

Application Number Title Priority Date Filing Date
EP10748416.4A Withdrawn EP2403500A4 (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 (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
WO2007134845A2 (en) * 2006-05-18 2007-11-29 Synthon B.V. Olanzapine pharmaceutical composition

Family Cites Families (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
EP1620075B1 (en) * 2003-05-07 2020-06-24 Samyang Biopharmaceuticals Corporation Highly plastic granules for making fast melting tablets
WO2005070938A1 (en) * 2004-01-27 2005-08-04 Synthon B.V. Stable salts of olanzapine

Patent Citations (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
WO2007134845A2 (en) * 2006-05-18 2007-11-29 Synthon B.V. Olanzapine pharmaceutical composition

Also Published As

Publication number Publication date
EP2403500A2 (en) 2012-01-11
WO2010100658A3 (en) 2010-12-23
WO2010100658A2 (en) 2010-09-10

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Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20110926

AK Designated contracting states

Kind code of ref document: A2

Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO SE SI SK SM TR

DAX Request for extension of the european patent (deleted)
A4 Supplementary search report drawn up and despatched

Effective date: 20131125

RIC1 Information provided on ipc code assigned before grant

Ipc: A61K 31/551 20060101ALI20131119BHEP

Ipc: A61K 9/20 20060101AFI20131119BHEP

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN

18D Application deemed to be withdrawn

Effective date: 20140624