CA2290966A1 - Sertraline salts and sustained-release dosage forms of sertraline - Google Patents

Sertraline salts and sustained-release dosage forms of sertraline Download PDF

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Publication number
CA2290966A1
CA2290966A1 CA002290966A CA2290966A CA2290966A1 CA 2290966 A1 CA2290966 A1 CA 2290966A1 CA 002290966 A CA002290966 A CA 002290966A CA 2290966 A CA2290966 A CA 2290966A CA 2290966 A1 CA2290966 A1 CA 2290966A1
Authority
CA
Canada
Prior art keywords
sertraline
dosage forms
salt
mga
sustained
Prior art date
Legal status (The legal status 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 status listed.)
Granted
Application number
CA002290966A
Other languages
French (fr)
Other versions
CA2290966C (en
Inventor
Mary Tanya Am Ende
William John Curatolo
Hylar Lewis Friedman
Ravi Mysore Shanker
Scott Max Herbig
Dwayne Thomas Friesen
James Blair West
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Pfizer Inc
Original Assignee
Pfizer Inc.
Mary Tanya Am Ende
William John Curatolo
Hylar Lewis Friedman
Ravi Mysore Shanker
Scott Max Herbig
Dwayne Thomas Friesen
James Blair West
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 Pfizer Inc., Mary Tanya Am Ende, William John Curatolo, Hylar Lewis Friedman, Ravi Mysore Shanker, Scott Max Herbig, Dwayne Thomas Friesen, James Blair West filed Critical Pfizer Inc.
Publication of CA2290966A1 publication Critical patent/CA2290966A1/en
Application granted granted Critical
Publication of CA2290966C publication Critical patent/CA2290966C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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
    • A61K9/2004—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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • 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
    • A61P25/24—Antidepressants
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • 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
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose

Abstract

Sustained release dosage forms of sertraline which release sertraline at a rate between 1 mgA/hr and 40 mgA/hr. The dosage forms may exhibit an initial delay period during which sertraline is released at a rate less than 1 mgA/hr. The present invention is further directed to an acetate salt, an L-lactate salt and an L-aspartate salt of sertraline, pharmaceutical compositions thereof and methods of using that salt for treating various conditions and disorders. The present invention is also directed to processes for preparing sertraline acetate, sertraline L-lactate and sertraline L-aspartate.
CA002290966A 1997-07-01 1998-06-15 Sertraline salts and sustained-release dosage forms of sertraline Expired - Fee Related CA2290966C (en)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US5142097P 1997-07-01 1997-07-01
US5140297P 1997-07-01 1997-07-01
US5141497P 1997-07-01 1997-07-01
US5149897P 1997-07-01 1997-07-01
US60/051,402 1997-07-01
US60/051,498 1997-07-01
US60/051,414 1997-07-01
US60/051,420 1997-07-01
PCT/IB1998/000934 WO1999001121A1 (en) 1997-07-01 1998-06-15 Sertraline salts and sustained-release dosage forms of sertraline

Publications (2)

Publication Number Publication Date
CA2290966A1 true CA2290966A1 (en) 1999-01-14
CA2290966C CA2290966C (en) 2005-12-20

Family

ID=27489408

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002290966A Expired - Fee Related CA2290966C (en) 1997-07-01 1998-06-15 Sertraline salts and sustained-release dosage forms of sertraline

Country Status (33)

Country Link
US (1) US6517866B1 (en)
EP (1) EP0999830A1 (en)
JP (1) JP2000514101A (en)
KR (2) KR100446366B1 (en)
CN (1) CN1256085C (en)
AP (1) AP1526A (en)
AR (2) AR015919A1 (en)
AU (1) AU739261B2 (en)
BG (1) BG103915A (en)
BR (1) BR9810403A (en)
CA (1) CA2290966C (en)
CO (1) CO4940402A1 (en)
DZ (1) DZ2546A1 (en)
EA (1) EA002482B1 (en)
HK (1) HK1026630A1 (en)
HR (1) HRP980379B1 (en)
HU (1) HUP0002296A3 (en)
ID (1) ID23503A (en)
IL (2) IL133080A0 (en)
IS (1) IS5265A (en)
MY (1) MY129175A (en)
NO (1) NO996518L (en)
NZ (2) NZ501251A (en)
OA (1) OA11245A (en)
PA (1) PA8454401A1 (en)
PE (1) PE88699A1 (en)
PL (1) PL337806A1 (en)
SK (1) SK180499A3 (en)
TN (1) TNSN98125A1 (en)
TR (1) TR199903280T2 (en)
TW (1) TWI241188B (en)
UY (1) UY25067A1 (en)
WO (1) WO1999001121A1 (en)

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