WO2001019337A3 - Dosage forms and methods for providing effective reboxetine therapy with once-a-day dosing - Google Patents

Dosage forms and methods for providing effective reboxetine therapy with once-a-day dosing Download PDF

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Publication number
WO2001019337A3
WO2001019337A3 PCT/US2000/025333 US0025333W WO0119337A3 WO 2001019337 A3 WO2001019337 A3 WO 2001019337A3 US 0025333 W US0025333 W US 0025333W WO 0119337 A3 WO0119337 A3 WO 0119337A3
Authority
WO
WIPO (PCT)
Prior art keywords
reboxetine
dosage forms
methods
once
day dosing
Prior art date
Application number
PCT/US2000/025333
Other languages
French (fr)
Other versions
WO2001019337A2 (en
Inventor
Sylvia Seroff
Noymi Yam
Atul D Ayer
Padmanabh Bhatt
Michael A Desjardin
Andrew C Lam
David E Edgren
Phillip R Nixon
Original Assignee
Alza Corp
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 Alza Corp filed Critical Alza Corp
Priority to JP2001522972A priority Critical patent/JP2003509354A/en
Priority to EP00963500A priority patent/EP1216031B1/en
Priority to DE60033947T priority patent/DE60033947T2/en
Priority to AU74907/00A priority patent/AU7490700A/en
Priority to CA002384624A priority patent/CA2384624C/en
Publication of WO2001019337A2 publication Critical patent/WO2001019337A2/en
Publication of WO2001019337A3 publication Critical patent/WO2001019337A3/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/53751,4-Oxazines, e.g. morpholine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Psychiatry (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Nitrogen And Oxygen As The Only Ring Hetero Atoms (AREA)

Abstract

Dosage forms and methods for providing sustained release of reboxetine are provided. The sustained release dosage forms provide therapeutically effective average steady-state plasma reboxetine concentrations when administered once per day. This once-a-day dosing regimen results in only one peak plasma reboxetine concentration occurrence in each 24 hour period. In addition, the peak plasma reboxetine concentration occurs at a later time following dose administration and exhibits a lesser magnitude than the peak plasma reboxetine concentration that occurs following administration of reboxetine in an immediate-release dosage form.
PCT/US2000/025333 1999-09-15 2000-09-15 Dosage forms and methods for providing effective reboxetine therapy with once-a-day dosing WO2001019337A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
JP2001522972A JP2003509354A (en) 1999-09-15 2000-09-15 Formulation and method for providing effective reboxetine treatment once a day
EP00963500A EP1216031B1 (en) 1999-09-15 2000-09-15 Dosage forms and methods for providing effective reboxetine therapy with once-a-day dosing
DE60033947T DE60033947T2 (en) 1999-09-15 2000-09-15 DOSAGE FORM AND COMPOSITION FOR THE CONTINUOUS DELIVERANCE OF REBOXETIN ONCE DAILY ADMINISTRATION FOR EFFECTIVE THERAPY
AU74907/00A AU7490700A (en) 1999-09-15 2000-09-15 Dosage forms and methods for providing effective reboxetine therapy with once-a-day dosing
CA002384624A CA2384624C (en) 1999-09-15 2000-09-15 Dosage forms and methods for providing effective reboxetine therapy with once-a-day dosing

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US15399799P 1999-09-15 1999-09-15
US60/153,997 1999-09-15

Publications (2)

Publication Number Publication Date
WO2001019337A2 WO2001019337A2 (en) 2001-03-22
WO2001019337A3 true WO2001019337A3 (en) 2001-08-09

Family

ID=22549601

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2000/025333 WO2001019337A2 (en) 1999-09-15 2000-09-15 Dosage forms and methods for providing effective reboxetine therapy with once-a-day dosing

Country Status (13)

Country Link
US (2) US6387403B1 (en)
EP (1) EP1216031B1 (en)
JP (1) JP2003509354A (en)
KR (2) KR100723850B1 (en)
AR (1) AR031978A1 (en)
AT (1) ATE356619T1 (en)
AU (1) AU7490700A (en)
CA (1) CA2384624C (en)
CO (1) CO5210862A1 (en)
DE (1) DE60033947T2 (en)
PE (1) PE20010625A1 (en)
TW (1) TWI233809B (en)
WO (1) WO2001019337A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9393192B2 (en) 2002-07-29 2016-07-19 Alza Corporation Methods and dosage forms for controlled delivery of paliperidone and risperidone

Families Citing this family (36)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0203296D0 (en) * 2002-02-12 2002-03-27 Glaxo Group Ltd Novel composition
ATE410146T1 (en) * 2002-04-29 2008-10-15 Alza Corp REDUCED FORMAT POLY(ALKYLENE OXIDES) WITH REBOXETINE TO REDUCE IMPURITIES FORMATION
US20050226926A1 (en) 2002-07-25 2005-10-13 Pfizer Inc Sustained-release tablet composition of pramipexole
AR040680A1 (en) * 2002-07-25 2005-04-13 Pharmacia Corp COMPOSITION OF SUSTAINED RELEASE TABLETS
US8637512B2 (en) * 2002-07-29 2014-01-28 Glaxo Group Limited Formulations and method of treatment
US20070077301A1 (en) * 2002-12-23 2007-04-05 Meyer Glenn A Venlafaxine osmotic device formulation
US8293799B2 (en) * 2003-12-29 2012-10-23 Osmotica Keresleedelmo és Szolgáltató KFT Osmotic device containing a venlafaxine salt and a salt having an ion in common
DE602004015246D1 (en) * 2003-02-11 2008-09-04 Alza Corp METHOD AND DOSAGE FORMS WITH MODIFIED LAYERING GEOMETRY
AU2004222339A1 (en) * 2003-03-14 2004-09-30 Nirmal Mulye A process for preparing sustained release tablets
RU2350327C2 (en) 2003-04-29 2009-03-27 Ориксиджен Серапьютикс, Инкорпорэйтд Compounds causing weight loss
MEP3608A (en) * 2003-08-08 2011-05-10 Biovail Lab Int Srl Modified-release tablet of bupropion hydrochloride
US20050131028A1 (en) * 2003-09-11 2005-06-16 Pharmacia Corporation Methods and compositions for the extended duration treatment of pain, inflammation and inflammation-related disorders
NZ546183A (en) * 2003-09-26 2011-04-29 Alza Corp Controlled release formulations exhibiting an ascending rate of release
NZ546148A (en) 2003-09-26 2009-05-31 Alza Corp Drug coating providing high drug loading and methods for providing the same
US20050182122A1 (en) * 2003-11-20 2005-08-18 Bello Carlo L. Method of treating abnormal cell growth using indolinone compounds
US20050265955A1 (en) * 2004-05-28 2005-12-01 Mallinckrodt Inc. Sustained release preparations
JP4785847B2 (en) 2004-08-13 2011-10-05 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング Tablet formulation with extended release comprising pramipexole or a pharmaceutically acceptable salt thereof, process for its production and use thereof
AR053986A1 (en) 2004-12-03 2007-05-30 Osmotica Pharmaceutical Argent OSMOTIC DEVICE CONTAINING AMANTADINE AND AN OSMOTIC SALT
DK1888080T3 (en) * 2005-06-09 2010-07-19 Euro Celtique Sa Pharmaceutical compositions of a neuroactive steroid and uses thereof
WO2007044234A1 (en) * 2005-10-07 2007-04-19 Alza Corporation Osmotic dosage form with controlled release and fast release aspects
EP3132792B1 (en) 2005-11-22 2019-09-11 Nalpropion Pharmaceuticals, Inc. Composition and methods for increasing insulin sensitivity
WO2007089318A2 (en) * 2005-11-23 2007-08-09 Orexigen Therapeutics, Inc. Compositions and methods for reducing food cravings
US20070128282A1 (en) * 2005-12-02 2007-06-07 Patel Hasmukh B Oral osmotic drug delivery system
US8916195B2 (en) 2006-06-05 2014-12-23 Orexigen Therapeutics, Inc. Sustained release formulation of naltrexone
KR101479324B1 (en) 2006-11-09 2015-01-05 오렉시젠 세러퓨틱스 인크. Layered pharmaceutical formulations comprising an intermediate rapidly dissolving layer
KR20140088619A (en) 2006-11-09 2014-07-10 오렉시젠 세러퓨틱스 인크. Unit dosage packages
US7714201B2 (en) * 2006-12-22 2010-05-11 Monsanto Technology Llc Cotton variety 781000G
US7419684B2 (en) * 2006-12-22 2008-09-02 Reliant Pharmaceuticals, Inc. System and method for manufacturing oral osmotic drug delivery devices, and methods of administering same
MX2010012909A (en) 2008-05-30 2011-02-25 Orexigen Therapeutics Inc Methods for treating visceral fat conditions.
US20100069389A1 (en) * 2008-09-06 2010-03-18 Bionevia Pharmaceuticals, Inc. Novel forms of reboxetine
US10485770B2 (en) * 2009-12-21 2019-11-26 Aptapharma, Inc. Functionally-coated multilayer tablets
JP6196041B2 (en) 2010-01-11 2017-09-13 オレキシジェン・セラピューティクス・インコーポレーテッド Methods for providing weight loss therapy in patients with major depression
JP6068454B2 (en) 2011-06-06 2017-01-25 オーク・クレスト・インスティテュート・オブ・サイエンスOak Crest Institute Of Science Drug delivery device using wicking release window
MA37714A1 (en) 2012-06-06 2017-12-29 Orexigen Therapeutics Inc Methods of treating overweight and obesity
US10716761B2 (en) 2017-07-24 2020-07-21 Alcresta Therapeutics, Inc. Ingestible medical delivery devices
CN111077238A (en) * 2019-11-12 2020-04-28 北京和合医学诊断技术股份有限公司 Liquid chromatography analysis method for detecting reboxetine drug content in blood

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2167407A (en) * 1984-11-22 1986-05-29 Erba Farmitalia Enantiomers of phenoxy derivatives of benzyl morpholine and salts thereof
WO1999015176A1 (en) * 1997-09-23 1999-04-01 Eli Lilly And Company Treatment of oppositional defiant disorder

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3995631A (en) 1971-01-13 1976-12-07 Alza Corporation Osmotic dispenser with means for dispensing active agent responsive to osmotic gradient
US3845770A (en) 1972-06-05 1974-11-05 Alza Corp Osmatic dispensing device for releasing beneficial agent
US3916899A (en) 1973-04-25 1975-11-04 Alza Corp Osmotic dispensing device with maximum and minimum sizes for the passageway
US4077407A (en) 1975-11-24 1978-03-07 Alza Corporation Osmotic devices having composite walls
US4008719A (en) 1976-02-02 1977-02-22 Alza Corporation Osmotic system having laminar arrangement for programming delivery of active agent
US4111201A (en) 1976-11-22 1978-09-05 Alza Corporation Osmotic system for delivering selected beneficial agents having varying degrees of solubility
IL56369A (en) 1978-01-20 1984-05-31 Erba Farmitalia Alpha-phenoxybenzyl propanolamine derivatives,their preparation and pharmaceutical compositions comprising them
US4384005A (en) * 1980-09-26 1983-05-17 General Foods Corporation Non-friable, readily-soluble, compressed tablets and process for preparing same
US4327725A (en) 1980-11-25 1982-05-04 Alza Corporation Osmotic device with hydrogel driving member
US4519801A (en) 1982-07-12 1985-05-28 Alza Corporation Osmotic device with wall comprising cellulose ether and permeability enhancer
US4578075A (en) 1982-12-20 1986-03-25 Alza Corporation Delivery system housing a plurality of delivery devices
US4681583A (en) 1982-12-20 1987-07-21 Alza Corporation System for dispersing drug in biological environment
US5019397A (en) 1988-04-21 1991-05-28 Alza Corporation Aqueous emulsion for pharmaceutical dosage form
US5156850A (en) 1990-08-31 1992-10-20 Alza Corporation Dosage form for time-varying patterns of drug delivery
ES2149781T3 (en) * 1991-11-22 2000-11-16 Procter & Gamble Pharma RISEDRONATE COMPOSITIONS OF DELAYED RELEASE.
US5688518A (en) * 1992-02-27 1997-11-18 Alza Corporation Antidepressive therapy
WO1995034582A1 (en) 1994-06-16 1995-12-21 Pharmacia S.P.A. Bioadhesive starches and process for their preparation
UA57107C2 (en) * 1997-09-23 2003-06-16 Елі Ліллі Енд Компані Treatment of conduct disorders
WO1999015177A1 (en) * 1997-09-23 1999-04-01 Eli Lilly And Company Treatment of attention-deficit/hyperactivity disorder
WO1999020279A1 (en) * 1997-10-17 1999-04-29 Eli Lilly And Company Potentiation of pharmaceuticals

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2167407A (en) * 1984-11-22 1986-05-29 Erba Farmitalia Enantiomers of phenoxy derivatives of benzyl morpholine and salts thereof
WO1999015176A1 (en) * 1997-09-23 1999-04-01 Eli Lilly And Company Treatment of oppositional defiant disorder

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
H BERZEWSKI ET AL: "Efficacy and tolerability of reboxetine compared with imipramine in a double-blind study oin patients suffering from major depressive episodes", EUROPEAN NEUROPSYCHOPHARMACOLOGY,NL,ELSEVIER SCIENCE PUBLISHERS BV, AMSTERDAM, vol. 7, no. SUPPL. 01, 1997, pages S37 - S47, XP002113307, ISSN: 0924-977X *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9393192B2 (en) 2002-07-29 2016-07-19 Alza Corporation Methods and dosage forms for controlled delivery of paliperidone and risperidone

Also Published As

Publication number Publication date
WO2001019337A2 (en) 2001-03-22
US6630165B2 (en) 2003-10-07
US20020146453A1 (en) 2002-10-10
CO5210862A1 (en) 2002-10-30
DE60033947T2 (en) 2007-11-29
AU7490700A (en) 2001-04-17
ATE356619T1 (en) 2007-04-15
CA2384624C (en) 2009-12-29
KR20020031424A (en) 2002-05-01
KR20070007215A (en) 2007-01-12
AR031978A1 (en) 2003-10-22
CA2384624A1 (en) 2001-03-22
EP1216031A2 (en) 2002-06-26
DE60033947D1 (en) 2007-04-26
KR100723850B1 (en) 2007-05-31
PE20010625A1 (en) 2001-06-04
JP2003509354A (en) 2003-03-11
EP1216031B1 (en) 2007-03-14
KR100831181B1 (en) 2008-05-21
TWI233809B (en) 2005-06-11
US6387403B1 (en) 2002-05-14

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