WO2003057150A3 - A stable pharmaceutical formulation of paroxetine hydrochloride and a process for preparation thereof - Google Patents

A stable pharmaceutical formulation of paroxetine hydrochloride and a process for preparation thereof Download PDF

Info

Publication number
WO2003057150A3
WO2003057150A3 PCT/US2002/041429 US0241429W WO03057150A3 WO 2003057150 A3 WO2003057150 A3 WO 2003057150A3 US 0241429 W US0241429 W US 0241429W WO 03057150 A3 WO03057150 A3 WO 03057150A3
Authority
WO
WIPO (PCT)
Prior art keywords
paroxetine hydrochloride
preparation
pharmaceutical formulation
stable pharmaceutical
paroxetine
Prior art date
Application number
PCT/US2002/041429
Other languages
French (fr)
Other versions
WO2003057150A2 (en
Inventor
Michael Fox
Rakefet Cohen
Anne Braunstein
Minutza Leibovici
Original Assignee
Teva Pharma
Michael Fox
Rakefet Cohen
Anne Braunstein
Minutza Leibovici
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 Teva Pharma, Michael Fox, Rakefet Cohen, Anne Braunstein, Minutza Leibovici filed Critical Teva Pharma
Priority to AU2002360775A priority Critical patent/AU2002360775B9/en
Priority to EP02796057A priority patent/EP1575478A2/en
Priority to IL16266602A priority patent/IL162666A0/en
Priority to CA002470496A priority patent/CA2470496A1/en
Publication of WO2003057150A2 publication Critical patent/WO2003057150A2/en
Publication of WO2003057150A3 publication Critical patent/WO2003057150A3/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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4525—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with oxygen as a ring hetero atom
    • 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
    • A61K9/2022—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
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing

Abstract

Provided are formulations of a stable paroxetine hydrochloride tablet comprising paroxetine hydrochloride, povidone or copovidone as a binder, and an HCl free/non-hygroscopic filler, prepared by the wet granulation method. Preferably, the paroxetine hydrochloride is paroxetine hydrochloride hemihydrate.
PCT/US2002/041429 2001-12-28 2002-12-27 A stable pharmaceutical formulation of paroxetine hydrochloride and a process for preparation thereof WO2003057150A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
AU2002360775A AU2002360775B9 (en) 2001-12-28 2002-12-27 A stable pharmaceutical formulation of paroxetine hydrochloride and a process for preparation thereof
EP02796057A EP1575478A2 (en) 2001-12-28 2002-12-27 A stable pharmaceutical formulation of paroxetine hydrochloride and a process for preparation thereof
IL16266602A IL162666A0 (en) 2001-12-28 2002-12-27 A stable pharmaceutical formulation of paroxetine hydrochloride and a process for preparation thereof
CA002470496A CA2470496A1 (en) 2001-12-28 2002-12-27 A stable pharmaceutical formulation of paroxetine hydrochloride and a process for preparation thereof

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US34412001P 2001-12-28 2001-12-28
US60/344,120 2001-12-28
US36635102P 2002-03-21 2002-03-21
US60/366,351 2002-03-21

Publications (2)

Publication Number Publication Date
WO2003057150A2 WO2003057150A2 (en) 2003-07-17
WO2003057150A3 true WO2003057150A3 (en) 2006-06-08

Family

ID=26993762

Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/US2002/041430 WO2003057151A2 (en) 2001-12-28 2002-12-27 A stable pharmaceutical formulation of paroxetine hydrochloride anhydrous and a process for preparation thereof
PCT/US2002/041429 WO2003057150A2 (en) 2001-12-28 2002-12-27 A stable pharmaceutical formulation of paroxetine hydrochloride and a process for preparation thereof

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PCT/US2002/041430 WO2003057151A2 (en) 2001-12-28 2002-12-27 A stable pharmaceutical formulation of paroxetine hydrochloride anhydrous and a process for preparation thereof

Country Status (6)

Country Link
US (5) US7138137B2 (en)
EP (2) EP1575478A2 (en)
AU (2) AU2002360775B9 (en)
CA (2) CA2471715A1 (en)
IL (2) IL162666A0 (en)
WO (2) WO2003057151A2 (en)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040208932A1 (en) * 2003-04-17 2004-10-21 Ramachandran Thembalath Stabilized paroxetine hydrochloride formulation
EP1675574A2 (en) * 2003-10-08 2006-07-05 Ranbaxy Laboratories, Ltd. Pharmaceutical compositions of paroxetine containing microcrystalline cellulose, prepared by wet granulation
AR047948A1 (en) * 2003-11-21 2006-03-15 Schering Corp FORMULATIONS OF PHOSPHODIESTERASE V INHIBITORS
CN100558252C (en) * 2004-03-08 2009-11-11 维他麦食品（福建）有限公司 The manufacture method of compression oatmeal and compression oatmeal thereof
WO2005107716A1 (en) * 2004-03-25 2005-11-17 Cadila Healthcare Limited Controlled release paroxetine-containing tablets based on a core and a coating
US20050244492A1 (en) * 2004-04-30 2005-11-03 Mehra Dev K Rapidly disintegrating tablets comprising titanium dioxide
EP1726591B1 (en) * 2005-05-26 2008-09-10 Apotecnia , S.A. Process for manufacturing paroxetine hydrochloride hemihydrate
WO2007012968A2 (en) * 2005-07-29 2007-02-01 Aurobindo Pharma Ltd Stable dosage form of an antidepressant
WO2007035816A2 (en) * 2005-09-20 2007-03-29 Dr. Reddy's Laboratories Ltd. Paroxetine compositions
US8703191B2 (en) * 2006-07-25 2014-04-22 Intelgenx Corp. Controlled-release pharmaceutical tablets
US9138430B2 (en) * 2007-12-27 2015-09-22 Mylan Specialty L.P. Formulation and method for the release of paroxetine in the large intestine
EP2285377A1 (en) * 2008-05-07 2011-02-23 H. Lundbeck A/S Method for treating cognitive deficits
US20090285889A1 (en) * 2008-05-14 2009-11-19 Capricom Pharma Inc. Modified release formulations of dihydropyridine compounds and methods of making same
BRPI0919165A2 (en) * 2008-10-03 2015-12-08 Lundbeck & Co As H pharmaceutical composition and use of a compound
NZ592719A (en) 2008-10-07 2012-09-28 Astrazeneca Uk Ltd PHARMACEUTICAL FORMULATION 514 comprising 4-[3-( 4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one
WO2010088385A1 (en) * 2009-01-30 2010-08-05 Sepracor Inc. Coated tablets of 6-(5-chloro-2-pyridyl) -5-[ (4-methyl-1-piperazinyl) carbonyloxy]-7-oxo-6, 7-dihydro-5h-pyrrol o [3,4-b] pyrazine and methods for measuring effectiveness of coating
US10610528B2 (en) 2009-12-08 2020-04-07 Intelgenx Corp. Solid oral film dosage forms and methods for making same
US20110136815A1 (en) * 2009-12-08 2011-06-09 Horst Zerbe Solid oral film dosage forms and methods for making same
MA52088A (en) * 2018-03-22 2021-01-27 Komipharm Int Australia Pty Ltd PHARMACEUTICAL COMPOSITION CONSISTING OF META-ARSENITE AND METHOD OF MANUFACTURING
CN110037995B (en) * 2019-04-17 2021-07-06 石家庄龙泽制药股份有限公司 Stable paroxetine hydrochloride tablet and preparation method thereof

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6168805B1 (en) * 1998-05-07 2001-01-02 Endo Pharmaceuticals, Inc. Aqueous process for manufacturing paroxetine solid dispersions

Family Cites Families (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US35145A (en) * 1862-05-06 Improvement in spindles for spinning
US15066A (en) * 1856-06-10 Machine for rubbing and polishing painted cloth
US65301A (en) * 1867-05-28 Improved compound foe coating oil-cloths
US48600A (en) * 1865-07-04 Improvement in horse-powers
US8896A (en) * 1852-04-20 Hame-ttjg
GB1422263A (en) * 1973-01-30 1976-01-21 Ferrosan As 4-phenyl-piperidine compounds
ES2058061T3 (en) 1985-10-25 1994-11-01 Beecham Group Plc DERIVED FROM PIPERIDINE, ITS PREPARATION AND ITS USE AS A MEDICINAL PRODUCT.
US4721196A (en) * 1986-01-29 1988-01-26 Sundstrand Corporation Overtravel stop
GB8626936D0 (en) * 1986-11-11 1986-12-10 Ferrosan As Treatment
US5371092A (en) * 1990-11-24 1994-12-06 Beecham Group, P.L.C. Use of paroxetine for the treatment of senile dementia, bulimia, migraine or anorexia
GB9325644D0 (en) * 1993-12-15 1994-02-16 Smithkline Beecham Plc Novel formulation
US5856493A (en) * 1995-02-06 1999-01-05 Smithkline Beecham Corporation Process for making novel form of paroxeting hydrochloride anhydrate
US6638948B1 (en) 1996-09-09 2003-10-28 Pentech Pharmaceuticals, Inc. Amorphous paroxetine composition
US5776969A (en) * 1997-02-27 1998-07-07 Eli Lilly And Company Treatment of sleep disorders
WO1999000313A1 (en) 1997-06-26 1999-01-07 Trexel, Inc. Microcellular food container and method for storing food in such a container
US5955475A (en) * 1997-06-30 1999-09-21 Endo Pharmaceuticals Inc. Process for manufacturing paroxetine solid dispersions
JP3230468B2 (en) * 1997-09-11 2001-11-19 村田機械株式会社 Braiding mandrel pulling jig and method for forming elongated braided molded product
EP0919234A3 (en) 1997-10-17 1999-08-25 Eli Lilly And Company Potentiation of pharmaceuticals by moxonidine
US6228864B1 (en) 1997-10-28 2001-05-08 Vivus, Inc. Administration of 5-HT receptor agonists and antagonists, to treat premature ejaculation
ES2164040T3 (en) 1998-04-14 2008-02-01 The General Hospital Corporation USE OF D-SERINE OR D-ALANINE FOR THE TREATMENT OF CHICHOPHRENIA.
GB9812941D0 (en) 1998-06-16 1998-08-12 Smithkline Beecham Plc Method of treatment
US6150376A (en) * 1998-08-05 2000-11-21 Georgetown University Bi- and tri-cyclic aza compounds and their uses
RU2246295C2 (en) 1998-11-02 2005-02-20 Элзэ Копэрейшн Medicinal formulation with constant rate for releasing medicinal substance, core of medicinal formulation and method for providing relieved release of medicinal substance from medicinal formulation
GB9826180D0 (en) 1998-11-30 1999-01-20 Smithkline Beecham Plc Novel process
WO2000071098A1 (en) 1999-05-24 2000-11-30 Purepac Pharmaceutical Co. A pharmaceutical composition containing an active agent that is maintained in solid amorphous form and method of making the same
JP2001304057A (en) * 2000-04-27 2001-10-31 Tigers Polymer Corp Intake device for internal combustion engine
US6660298B1 (en) 2000-07-27 2003-12-09 Pentech Pharmaceuticals, Inc. Paroxetine tablets and capsules
EP1313474A2 (en) * 2000-08-28 2003-05-28 Synthon B.V. Paroxetine compositions and processes for making the same
US6720003B2 (en) * 2001-02-16 2004-04-13 Andrx Corporation Serotonin reuptake inhibitor formulations
DK200100341A (en) * 2001-03-02 2002-09-03 Gea Farmaceutisk Fabrik As Process for the preparation of pharmaceutical tablets containing paroxetine hydrochloride anhydrate

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6168805B1 (en) * 1998-05-07 2001-01-02 Endo Pharmaceuticals, Inc. Aqueous process for manufacturing paroxetine solid dispersions

Also Published As

Publication number Publication date
AU2002359857A1 (en) 2003-07-24
US20030144324A1 (en) 2003-07-31
CA2471715A1 (en) 2003-07-17
AU2002360775B2 (en) 2008-06-19
EP1575478A2 (en) 2005-09-21
IL162666A0 (en) 2005-11-20
IL162458A0 (en) 2005-11-20
AU2002359857B8 (en) 2009-01-08
EP1465601A2 (en) 2004-10-13
US20050191350A1 (en) 2005-09-01
AU2002360775A1 (en) 2003-07-24
WO2003057151A2 (en) 2003-07-17
CA2470496A1 (en) 2003-07-17
WO2003057150A2 (en) 2003-07-17
US7396542B2 (en) 2008-07-08
AU2002360775B9 (en) 2008-07-24
EP1465601A4 (en) 2006-02-15
US20080187584A1 (en) 2008-08-07
US20050059701A1 (en) 2005-03-17
US7138137B2 (en) 2006-11-21
US7357945B2 (en) 2008-04-15
AU2002359857B2 (en) 2008-12-11
WO2003057151A3 (en) 2004-01-08
US20030158230A1 (en) 2003-08-21

Similar Documents

Publication Publication Date Title
WO2003057150A3 (en) A stable pharmaceutical formulation of paroxetine hydrochloride and a process for preparation thereof
AU2003244632A1 (en) Bicyclo-pyrazoles active as kinase inhibitors, process for their preparation and pharmaceutical compositions comprising them
AU2002350719A1 (en) Pharmaceutical compositions comprising a basic respectively acidic drug compound, a surfactant and a physiologically tolerable water-soluble acid respectively base
WO2006025070A3 (en) Nebivolol and its pharmaceutically acceptable salts, process for preparation and pharmaceutical compositions of nebivolol
ZA992951B (en) N-substituted aminotetralins as ligands for the neuropeptide Y Y5 receptor useful in the treatment of obesity and other disorders.
AU2003227741A1 (en) Aminoindazole derivatives active as kinase inhibitors, process for their preparation and pharmaceutical compositions comprising them
AU2003244649A1 (en) Bicyclo-pyrazoles active as kinase inhibitors, process for their preparation and pharmaceutical compositions comprising them
HUP0303891A3 (en) Pharmaceutically active piridine derivatives, process for their preparation and pharmaceutical compositions containing them
IL153997A0 (en) Bicyclo-pyrazoles active as kinase inhibitors, process for their preparation and pharmaceutical compositions comprising them
WO2006039499A3 (en) Method for improving the biovailability of orally delivered therapeutics
HK1067626A1 (en) Novel 2h-pyridazine-3-one derivatives, pharmaceutical compositions containing the same and a process for the preparation of the active ingredient
WO2003002136A3 (en) Stable formulation of modified glp-1
HK1070585A1 (en) Pharmaceutical formulation of iressa comprising a water-soluble cellulose derivative
WO2007009806A3 (en) Solid dosage formulations of narcotic drugs having improved buccal adsorption
EP1619180A4 (en) CaSR ANTAGONIST
AU2002358676A1 (en) Hydroxyphenyl-pyrazole derivatives active as kinase inhibitors, process for their preparation and pharmaceutical compositions comprising them
WO2007064719A3 (en) Formulations of quinolinones
AU2003251290A1 (en) Process for preparation of polymorphic form ii of sertraline hydrochloride, pharmaceutical formulations and methods of administration thereof
WO2003005967A3 (en) Dual release levodopa ethyl ester and decarboxylase in controlled release core
WO2005051350A3 (en) Water dispersible tablet
WO2003086362A3 (en) Method of stabilizing bupropion hydrochloride tablets
HUP0401369A3 (en) Pharmaceutical formulation comprising (r)-bicalutamide, process for its preparation and use thereof
AU2002306687A1 (en) Heterocyclic compounds, process for their preparation and pharmaceutical compositions containing them
WO2002009710A3 (en) Paroxetine tablets and capsules
WO2005034954A3 (en) Pharmaceutical compositions of paroxetine containing microcrystalline cellulose, prepared by wet granulation

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A2

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NO NZ OM PH PL PT RO RU SC SD SE SG SK SL TJ TM TN TR TT TZ UA UG US UZ VC VN YU ZA ZM ZW

AL Designated countries for regional patents

Kind code of ref document: A2

Designated state(s): GH GM KE LS MW MZ SD SL SZ TZ UG ZM ZW AM AZ BY KG KZ MD RU TJ TM AT BE BG CH CY CZ DE DK EE ES FI FR GB GR IE IT LU MC NL PT SE SI SK TR BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
WWE Wipo information: entry into national phase

Ref document number: 162666

Country of ref document: IL

WWE Wipo information: entry into national phase

Ref document number: 2470496

Country of ref document: CA

WWE Wipo information: entry into national phase

Ref document number: 2004/05080

Country of ref document: ZA

Ref document number: 200405080

Country of ref document: ZA

WWE Wipo information: entry into national phase

Ref document number: 2002360775

Country of ref document: AU

WWE Wipo information: entry into national phase

Ref document number: 2002796057

Country of ref document: EP

DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
WWP Wipo information: published in national office

Ref document number: 2002796057

Country of ref document: EP

NENP Non-entry into the national phase

Ref country code: JP

WWW Wipo information: withdrawn in national office

Country of ref document: JP