WO2007048220A3 - Trazodone composition for once a day adminisitiation - Google Patents

Trazodone composition for once a day adminisitiation Download PDF

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Publication number
WO2007048220A3
WO2007048220A3 PCT/CA2006/001484 CA2006001484W WO2007048220A3 WO 2007048220 A3 WO2007048220 A3 WO 2007048220A3 CA 2006001484 W CA2006001484 W CA 2006001484W WO 2007048220 A3 WO2007048220 A3 WO 2007048220A3
Authority
WO
WIPO (PCT)
Prior art keywords
trazodone
once
hours
day
derivative
Prior art date
Application number
PCT/CA2006/001484
Other languages
French (fr)
Other versions
WO2007048220A2 (en
Inventor
Sonia Gervais
Damon Smith
Milloud Rahmouni
Pauline Contamin
Rachid Ouzerourou
My Linh Ma
Angela Ferrada
Fouzia Soulhi
Original Assignee
Labopharm Inc
Labopharm Europe Ltd
Labopharm Barbados 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
Priority to EP06790661A priority Critical patent/EP1931346B1/en
Priority to AU2006308449A priority patent/AU2006308449B8/en
Priority to EA200800783A priority patent/EA014739B1/en
Priority to NZ565591A priority patent/NZ565591A/en
Priority to CN2006800316099A priority patent/CN101252932B/en
Priority to JP2008529431A priority patent/JP5269595B2/en
Priority to DK06790661.0T priority patent/DK1931346T3/en
Application filed by Labopharm Inc, Labopharm Europe Ltd, Labopharm Barbados Ltd filed Critical Labopharm Inc
Priority to BRPI0615577-4A priority patent/BRPI0615577B1/en
Priority to ES06790661T priority patent/ES2389666T3/en
Priority to CA002616416A priority patent/CA2616416A1/en
Priority to SI200631406T priority patent/SI1931346T1/en
Priority to PL06790661T priority patent/PL1931346T3/en
Priority to TW096107347A priority patent/TW200812585A/en
Publication of WO2007048220A2 publication Critical patent/WO2007048220A2/en
Publication of WO2007048220A3 publication Critical patent/WO2007048220A3/en
Priority to IL189139A priority patent/IL189139A/en
Priority to EC2008008240A priority patent/ECSP088240A/en
Priority to NO20081731A priority patent/NO342381B1/en
Priority to HK09101139.1A priority patent/HK1124237A1/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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene
    • 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
    • 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
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • 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
    • A61K31/4402—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • 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
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • 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
    • A61P25/20—Hypnotics; Sedatives
    • 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
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/08—Vasodilators for multiple indications

Abstract

The invention relates to a once a day formulation of trazodone or a trazodone derivative. The formulation contains trazodone or a trazodone derivative and a controlled release excipient so that, once administered orally, the trazodone or the trazodone derivative is maintained at a therapeutic plasma concentration from at least 1 hour to at least 24 hours after initial administration. After administration, the initial therapeutic action takes effect within the first hour and lasts at least about 24 hours. This therapeutic effect remains relatively and substantially stable for the remaining period of 24 hours. The formulations can be used for treating depression and/or sleeping disorders.
PCT/CA2006/001484 2005-09-09 2006-09-11 Trazodone composition for once a day adminisitiation WO2007048220A2 (en)

Priority Applications (17)

Application Number Priority Date Filing Date Title
AU2006308449A AU2006308449B8 (en) 2005-09-09 2006-09-11 Trazodone composition for once a day administration
EA200800783A EA014739B1 (en) 2005-09-09 2006-09-11 Trazodone composition for once day administration
NZ565591A NZ565591A (en) 2005-09-09 2006-09-11 Trazodone and cross linked high amylose starch composition for once a day administration
CN2006800316099A CN101252932B (en) 2005-09-09 2006-09-11 Trazodone composition for once a day administration
JP2008529431A JP5269595B2 (en) 2005-09-09 2006-09-11 Trazodone composition for once daily administration
DK06790661.0T DK1931346T3 (en) 2005-09-09 2006-09-11 Trazodone composition for once daily administration
CA002616416A CA2616416A1 (en) 2005-09-09 2006-09-11 Trazodone composition for once a day adminisitiation
BRPI0615577-4A BRPI0615577B1 (en) 2005-09-09 2006-09-11 PROLONGED-RELEASE PHARMACEUTICAL COMPOSITION AND USE THEREOF
ES06790661T ES2389666T3 (en) 2005-09-09 2006-09-11 Trazodone composition for once-daily administration
EP06790661A EP1931346B1 (en) 2005-09-09 2006-09-11 Trazodone composition for once a day administration
SI200631406T SI1931346T1 (en) 2005-09-09 2006-09-11 Trazodone composition for once a day administration
PL06790661T PL1931346T3 (en) 2005-09-09 2006-09-11 Trazodone composition for once a day administration
TW096107347A TW200812585A (en) 2006-09-11 2007-03-03 Trazodone composition for once a day administration
IL189139A IL189139A (en) 2005-09-09 2008-01-31 Trazodone composition for once a day administration
EC2008008240A ECSP088240A (en) 2005-09-09 2008-03-04 COMPOSITION OF TRAZODONE FOR ADMINISTRATION ONCE A DAY
NO20081731A NO342381B1 (en) 2005-09-09 2008-04-07 Trazodone composition for once a day administration as well as its use
HK09101139.1A HK1124237A1 (en) 2005-09-09 2009-02-09 Trazodone composition for once a day adminstration

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US71516205P 2005-09-09 2005-09-09
US60/715,162 2005-09-09

Publications (2)

Publication Number Publication Date
WO2007048220A2 WO2007048220A2 (en) 2007-05-03
WO2007048220A3 true WO2007048220A3 (en) 2007-08-02

Family

ID=37968167

Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/CA2006/001484 WO2007048220A2 (en) 2005-09-09 2006-09-11 Trazodone composition for once a day adminisitiation
PCT/CA2006/001483 WO2007048219A2 (en) 2005-09-09 2006-09-11 Sustained drug release composition

Family Applications After (1)

Application Number Title Priority Date Filing Date
PCT/CA2006/001483 WO2007048219A2 (en) 2005-09-09 2006-09-11 Sustained drug release composition

Country Status (23)

Country Link
US (8) US7829120B2 (en)
EP (2) EP1931346B1 (en)
JP (3) JP5269595B2 (en)
KR (2) KR101655455B1 (en)
CN (2) CN101242856A (en)
AR (1) AR109571A2 (en)
AU (2) AU2006308449B8 (en)
BR (1) BRPI0615860B8 (en)
CA (2) CA2616416A1 (en)
DK (2) DK1931346T3 (en)
EA (1) EA014739B1 (en)
EC (2) ECSP088240A (en)
ES (2) ES2620293T3 (en)
HK (1) HK1124237A1 (en)
IL (2) IL188964A0 (en)
NO (2) NO20081593L (en)
NZ (1) NZ565591A (en)
PL (1) PL1931346T3 (en)
PT (1) PT1931346E (en)
RU (1) RU2008113439A (en)
UA (1) UA94916C2 (en)
WO (2) WO2007048220A2 (en)
ZA (2) ZA200801162B (en)

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