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WO2004082587A3 - Stable lamotrigine pharmaceutical compositions and processes for their preparation - Google Patents

Stable lamotrigine pharmaceutical compositions and processes for their preparation Download PDF

Info

Publication number
WO2004082587A3
WO2004082587A3 PCT/IB2004/000820 IB2004000820W WO2004082587A3 WO 2004082587 A3 WO2004082587 A3 WO 2004082587A3 IB 2004000820 W IB2004000820 W IB 2004000820W WO 2004082587 A3 WO2004082587 A3 WO 2004082587A3
Authority
WO
WIPO (PCT)
Prior art keywords
preparation
stable
processes
weight
lamotrigine
Prior art date
Application number
PCT/IB2004/000820
Other languages
French (fr)
Other versions
WO2004082587A2 (en
Inventor
Kamal Mehta
Rajeev Shanker Mathur
Sanjeev Sethi
Rajiv Malik
Suhani Sinha
Original Assignee
Ranbaxy Lab Ltd
Kamal Mehta
Rajeev Shanker Mathur
Sanjeev Sethi
Rajiv Malik
Suhani Sinha
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 Ranbaxy Lab Ltd, Kamal Mehta, Rajeev Shanker Mathur, Sanjeev Sethi, Rajiv Malik, Suhani Sinha filed Critical Ranbaxy Lab Ltd
Priority to EP04721960A priority Critical patent/EP1608342A2/en
Publication of WO2004082587A2 publication Critical patent/WO2004082587A2/en
Publication of WO2004082587A3 publication Critical patent/WO2004082587A3/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
    • A61K31/53—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine
    • 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
    • A61K9/2004—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
    • 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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

The present invention relates to a stable pharmaceutical composition of lamotrigine and pharmaceutically acceptable acid addition salts thereof. The invention also relates to a process for the preparation of such a composition. The pharmaceutical composition includes: (a) from about 0.1% to about 50 % by weight of lamotrigine or acid addition salt thereof; (b) from about 15.5% to about 70% by weight of microcrystalline cellulose; (c) from about 0.1% to about 14.5% by weight of sodium starch glycolate; and (d) from about 0.1% to about 4.5% by weight of polyvinylpyrrolidone
PCT/IB2004/000820 2003-03-21 2004-03-19 Stable lamotrigine pharmaceutical compositions and processes for their preparation WO2004082587A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP04721960A EP1608342A2 (en) 2003-03-21 2004-03-19 Stable lamotrigine pharmaceutical compositions and processes for their preparation

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN355DE2003 2003-03-21
IN355/DEL/2003 2003-03-21

Publications (2)

Publication Number Publication Date
WO2004082587A2 WO2004082587A2 (en) 2004-09-30
WO2004082587A3 true WO2004082587A3 (en) 2004-12-02

Family

ID=33017827

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2004/000820 WO2004082587A2 (en) 2003-03-21 2004-03-19 Stable lamotrigine pharmaceutical compositions and processes for their preparation

Country Status (2)

Country Link
EP (1) EP1608342A2 (en)
WO (1) WO2004082587A2 (en)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992013527A1 (en) * 1991-01-30 1992-08-20 The Wellcome Foundation Limited Water-dispersible tablets
US5861179A (en) * 1994-12-07 1999-01-19 The Wellcome Foundation Limited Pharmaceutical composition of lamotrigine

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992013527A1 (en) * 1991-01-30 1992-08-20 The Wellcome Foundation Limited Water-dispersible tablets
US5861179A (en) * 1994-12-07 1999-01-19 The Wellcome Foundation Limited Pharmaceutical composition of lamotrigine

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
GLAXO WELLCOME INC.: "Lamictal tablets - FDA approved labeling text", INTERNET CITATION, 2001, XP002296818, Retrieved from the Internet <URL:http://www.fda.gov/cder/foi/label/2001/20764s5lbl.pdf> [retrieved on 20040915] *

Also Published As

Publication number Publication date
WO2004082587A2 (en) 2004-09-30
EP1608342A2 (en) 2005-12-28

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