WO2007089926A3 - Oxcarbazepine pharmaceutical formulation and its method of preparation, wherein oxcarbazepine has a broad and multi-modal particle size distribution - Google Patents

Oxcarbazepine pharmaceutical formulation and its method of preparation, wherein oxcarbazepine has a broad and multi-modal particle size distribution Download PDF

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Publication number
WO2007089926A3
WO2007089926A3 PCT/US2007/002882 US2007002882W WO2007089926A3 WO 2007089926 A3 WO2007089926 A3 WO 2007089926A3 US 2007002882 W US2007002882 W US 2007002882W WO 2007089926 A3 WO2007089926 A3 WO 2007089926A3
Authority
WO
WIPO (PCT)
Prior art keywords
oxcarbazepine
particle size
size distribution
broad
preparation
Prior art date
Application number
PCT/US2007/002882
Other languages
French (fr)
Other versions
WO2007089926A2 (en
Inventor
Sigal Blau
Ilan Zalit
Gershon Kolatkar
Carolina Abrutzky Azaria
Original Assignee
Teva Pharma
Sigal Blau
Ilan Zalit
Gershon Kolatkar
Carolina Abrutzky Azaria
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
Priority claimed from US11/350,606 external-priority patent/US20070178164A1/en
Application filed by Teva Pharma, Sigal Blau, Ilan Zalit, Gershon Kolatkar, Carolina Abrutzky Azaria filed Critical Teva Pharma
Priority to JP2008509257A priority Critical patent/JP2008540346A/en
Priority to EP07762826A priority patent/EP2029118A2/en
Priority to AU2007211210A priority patent/AU2007211210A1/en
Priority to CA002634879A priority patent/CA2634879A1/en
Publication of WO2007089926A2 publication Critical patent/WO2007089926A2/en
Priority to IL191922A priority patent/IL191922A0/en
Publication of WO2007089926A3 publication Critical patent/WO2007089926A3/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
    • A61K9/48—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
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/08—Antiepileptics; Anticonvulsants
    • 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
    • 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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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

Abstract

The present invention provides a pharmaceutical composition comprising oxcarbazepine and at least one pharmaceutical excipient, wherein the oxcarbazepine in the composition has a broad particle size distribution. The broad particle size distribution of oxcarbazepine in the pharmaceutical composition is preferably a multi-modal oxcarbazepine particle size distribution, preferably with an enhanced oxcarbazepine dissolution rate.
PCT/US2007/002882 2006-01-31 2007-01-31 Oxcarbazepine pharmaceutical formulation and its method of preparation, wherein oxcarbazepine has a broad and multi-modal particle size distribution WO2007089926A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
JP2008509257A JP2008540346A (en) 2006-01-31 2007-01-31 Pharmaceutical formulation of oxcarbazepine and preparation method thereof
EP07762826A EP2029118A2 (en) 2006-01-31 2007-01-31 Oxcarbazepine pharmaceutical formulation and its method of preparation, wherein oxcarbazepine has a broad and multi-modal particle size distribution
AU2007211210A AU2007211210A1 (en) 2006-01-31 2007-01-31 Oxcarbazepine pharmaceutical formulation and its method of preparation, wherein oxcarbazepine has a broad and multi-modal particle size distribution
CA002634879A CA2634879A1 (en) 2006-01-31 2007-01-31 Pharmaceutical formulations of oxcarbazepine and methods for its preparation
IL191922A IL191922A0 (en) 2006-01-31 2008-06-03 Pharmaceutical formulations of oxcarbazepine and methods for its preparation

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US76413406P 2006-01-31 2006-01-31
US60/764,134 2006-01-31
US11/350,606 US20070178164A1 (en) 2006-01-31 2006-02-08 Pharmaceutical formulations of oxcarbazepine and methods for its preparation
US11/350,606 2006-02-08
US86033306P 2006-11-20 2006-11-20
US60/860,333 2006-11-20
US89736107P 2007-01-24 2007-01-24
US60/897,361 2007-01-24

Publications (2)

Publication Number Publication Date
WO2007089926A2 WO2007089926A2 (en) 2007-08-09
WO2007089926A3 true WO2007089926A3 (en) 2008-12-24

Family

ID=38328068

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2007/002882 WO2007089926A2 (en) 2006-01-31 2007-01-31 Oxcarbazepine pharmaceutical formulation and its method of preparation, wherein oxcarbazepine has a broad and multi-modal particle size distribution

Country Status (6)

Country Link
EP (1) EP2029118A2 (en)
JP (1) JP2008540346A (en)
AU (1) AU2007211210A1 (en)
CA (1) CA2634879A1 (en)
IL (1) IL191922A0 (en)
WO (1) WO2007089926A2 (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070178164A1 (en) * 2006-01-31 2007-08-02 Sigal Blau Pharmaceutical formulations of oxcarbazepine and methods for its preparation
US8372431B2 (en) 2007-10-26 2013-02-12 Bial-Portela & C.A., S.A. Pharmaceutical composition comprising licarbazepine acetate
EP2968354B1 (en) * 2013-03-15 2019-11-13 Aprecia Pharmaceuticals LLC Rapidly dispersible dosage form of oxcarbazepine
JP6843498B2 (en) * 2015-10-14 2021-03-17 Ｅａファーマ株式会社 Tablets, solid dispersion granules and methods for producing them

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5354563A (en) * 1985-07-15 1994-10-11 Research Development Corp. Of Japan Water dispersion containing ultrafine particles of organic compounds
US5472714A (en) * 1993-09-08 1995-12-05 Ciba-Geigy Corporation Double-layered oxcarbazepine tablets
WO1998035681A1 (en) * 1997-02-14 1998-08-20 Novartis Ag Oxacarbazepine film-coated tablets
WO2002094774A2 (en) * 2001-05-18 2002-11-28 Ranbaxy Laboratories Limited Oxcarbazepine dosage forms
US20040142033A1 (en) * 2002-05-31 2004-07-22 Desitin Arzneimittel Gmbh Pharmaceutical composition, containing oxcarbazepine with sustained release of an active-ingredient
WO2006046105A1 (en) * 2004-10-25 2006-05-04 Ranbaxy Laboratories Limited Oxcarbazepine dosage forms
WO2007007182A2 (en) * 2005-07-08 2007-01-18 Aurobindo Pharma Limited Solid and liquid dosage forms of an antiepileptic agent
EP1815849A1 (en) * 2006-01-31 2007-08-08 Teva Pharmaceutical Industries Ltd Oxcarbazepine pharmaceutical formulation and its method of preparation, wherein oxcarbazepine has a broad and multi-modal particle size distribution
WO2007121523A1 (en) * 2006-04-21 2007-11-01 Alphapharm Pty Ltd Pharmaceutical compositions of oxcarbazepine with a median particle size of 15 to 30 microns

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3170069B2 (en) * 1992-10-06 2001-05-28 日水製薬株式会社 Sustained release granules
GB9925962D0 (en) * 1999-11-02 1999-12-29 Novartis Ag Organic compounds
GB0221956D0 (en) * 2002-09-20 2002-10-30 Novartis Ag Organic compounds

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5354563A (en) * 1985-07-15 1994-10-11 Research Development Corp. Of Japan Water dispersion containing ultrafine particles of organic compounds
US5472714A (en) * 1993-09-08 1995-12-05 Ciba-Geigy Corporation Double-layered oxcarbazepine tablets
WO1998035681A1 (en) * 1997-02-14 1998-08-20 Novartis Ag Oxacarbazepine film-coated tablets
WO2002094774A2 (en) * 2001-05-18 2002-11-28 Ranbaxy Laboratories Limited Oxcarbazepine dosage forms
US20040142033A1 (en) * 2002-05-31 2004-07-22 Desitin Arzneimittel Gmbh Pharmaceutical composition, containing oxcarbazepine with sustained release of an active-ingredient
WO2006046105A1 (en) * 2004-10-25 2006-05-04 Ranbaxy Laboratories Limited Oxcarbazepine dosage forms
WO2007007182A2 (en) * 2005-07-08 2007-01-18 Aurobindo Pharma Limited Solid and liquid dosage forms of an antiepileptic agent
EP1815849A1 (en) * 2006-01-31 2007-08-08 Teva Pharmaceutical Industries Ltd Oxcarbazepine pharmaceutical formulation and its method of preparation, wherein oxcarbazepine has a broad and multi-modal particle size distribution
WO2007121523A1 (en) * 2006-04-21 2007-11-01 Alphapharm Pty Ltd Pharmaceutical compositions of oxcarbazepine with a median particle size of 15 to 30 microns

Also Published As

Publication number Publication date
CA2634879A1 (en) 2007-08-09
WO2007089926A2 (en) 2007-08-09
IL191922A0 (en) 2009-08-03
JP2008540346A (en) 2008-11-20
AU2007211210A1 (en) 2007-08-09
EP2029118A2 (en) 2009-03-04

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